I continue to read about cancer; my type of cancer and cancers in general. I have four primary sources: 1) The daily Wall Street Journal, 2) The Sunday New York Times, 3) friends/family who send me articles, and 4) Google alerts. For those not familiar with Google alerts, it is a Google feature which allows one to set up specific searches to run continuously, daily, or weekly for subjects in which one has an interest. This is where I find most of my cancer-related reading materials. For more information on Google Alerts, just google it.
Today's Sunday New York Times Magazine section had a fascinating research-oriented articles on cancer stem cells, "The Cancer Sleeper Cell." It's a long article, but provided added insight into my understanding of how important it would be to fighting relapses if one could identify, isolate, and destroy the cancer stem cell. What the article highlighted for me was that researchers believe that only one bad cell in a million bad cancer leukemia (a blood cancer) cells is a stem cell which can cause a relapse. The hypothesis being that if they can kill that one cell in a million, they can stop the cancer from relapsing. They were able to take this finding and apply it to various solid tumors. It also raised other important questions about what defines a cure and how to measure a treatment's success.
I was able to Google the article and the link is...
http://www.nytimes.com/2010/10/31/magazine/31Cancer-t.html
For those that are interested, enjoy this somewhat intellectually challenging reading. Take care everyone.
Ed
Sunday, October 31, 2010
Monday, October 11, 2010
Cutting Time and Cost in the Clinical Drug Approval Process Cycle
In my readings about and discussions with cancer researchers, it is clear that the cost of bringing a new drug to market (almost one billion dollars) and the elapse time of 5 plus years at minimum is costing countless lives and untold billions of dollars. The following article printed in the WSJ on 10/2/10, "A New Rx for Medicine" caught my attention.
http://online.wsj.com/article/SB10001424052748703882404575520190576846812.html#articleTabs%3Darticle
The claim is that through personal genetic understanding and this novel approach to testing multiple drugs simultaneously, they can learn as much in 6 months as would be possible to learn in 5 years under current standard testing protocols. To me, this approach is a breakthrough. For ease of reference, the text of the article follows. Be forewarned, it is a long article, but well worth reading.
A New Rx for Medicine
Fed up with slow drug trials, cancer patients and doctors are testing a fast track to personalized treatments.
When 37-year-old Kerry Landreth discovered a lump in her breast last April, she was told it would take three weeks to get a doctor's appointment to have it checked.
"I don't do three weeks," she recalls saying. "How about today?"
By the end of the day, she had talked her way into a doctor's appointment, a mammogram and a biopsy to determine whether the suspicious lump was a tumor. A few days later came the diagnosis: stage 2 invasive ductal breast cancer, a particularly aggressive form of the disease. When a surgeon recommended a double mastectomy, she decided to consider other options.
Now, Ms. Landreth, a vice president at the San Francisco office of a Wall Street investment bank and the mother of two young children, is among the first participants in a novel clinical trial that is similarly impatient with the status quo in cancer treatment.
The trial, called I-Spy 2, employs several innovative approaches to improve the notoriously slow and inefficient process of developing new cancer drugs. Using the latest advances in genetics, I-Spy 2 aims to match experimental drugs with the molecular makeup of tumors most likely to respond to them. And it tests multiple drugs at once, with the intent of getting the most effective ones into late-stage trials more quickly.
The goal is to reverse a dismal record, in which 60% to 70% of late-stage cancer studies fail, and to dramatically reduce the time and cost required to get promising new drugs to the market. Currently it can take $1 billion, thousands of patients and more than a decade to gather the evidence necessary to approve a new cancer drug.
Kerry Landreth just finished her final round ofchemotherapy.
"Predictability is the Holy Grail here—being able to identify promising drug candidates early and figuring out who they might work in," says Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.
The new trial draws from a growing body of research showing that the genetic makeup of tumors varies widely even among patients diagnosed with the same cancer. Some of these molecular traits, called biomarkers, make a tumor vulnerable to a specific medicine, while others may thwart a drug's effect.
A big part of the problem with conventional trials is that they essentially take all comers. Researchers know many participants won't benefit from the treatment. Those who don't respond can cause a drug to fail even though a significant minority of patients might benefit.
"Unless we do something different, people are going to give up on doing trials" for cancer, says Laura Esserman, director of the breast-care center at University of California, San Francisco, and co-leader of I-Spy 2.
The study focuses on women with aggressive breast cancers that have not spread to other organs. It aims to collect information about experimental drugs that would then enable drug companies to design leaner, faster late-stage trials that enroll only patients whose tumors had a high probability of responding to the treatment. Those trials, called phase III trials, provide critical data used in determining whether a drug will be approved.
"The vision is a 300-patient phase III trial instead of a 3,000-patient trial, with better results," says Don Berry, head of Quantitative Sciences at M.D. Anderson Cancer Center in Houston and co-leader of the study.
I-Spy 2's effort to bring much higher standards of productivity to cancer-drug development is inspired partly by Dr. Esserman's experience at business school. In addition to her surgical training, she has an MBA from Stanford University, where she learned about the rapid pace of innovation in high-tech industries. She was particularly influenced by the idea of what Intel Corp. chairman Andrew Grove calls "knowledge turns"—breakthroughs that have led to annual advances in microchip technology and an ongoing revolution in the performance of products like personal computers.
In the development of cancer drugs, by contrast, "knowledge turns" may take 10 or 15 years. Typically treatments are first studied in metastatic patients—for whom cancer has spread from the original tumor site to other parts of the body—who didn't benefit from standard therapies. Even when drugs succeed, benefits often are limited to a few extra weeks or months of life. Then it takes several more years to test successful drugs in early-stage patients, for whom effective treatments could mean a cure.
"We have 45,000 women dying each year of breast cancer," Dr. Esserman says. "We should be compelled to move faster."
About 3½ years ago, she joined forces with Dr. Berry at M.D. Anderson, an expert in a new approach to clinical trials called "adaptive design," to plan I-Spy 2. Unlike conventional trials, in which no one sees results until the end, "we look at the data right away," Dr. Berry says. What is learned in the early going helps to determine which drugs are assigned to patients later in the study, speeding the emergence of winners and losers.
The trial incorporates other new approaches. It's currently testing five drugs at once from three different companies. As compounds graduate to phase III studies or are winnowed out for lack of significant benefit, new candidates are cycled in, sparing the cost and time to mount separate trials. Up to 12 candidates will be screened over the course of the study.
In addition, participants get a six-month course of chemotherapy before having an operation to remove their tumors. In many studies, surgery is performed first, followed by chemotherapy and radiation, reflecting a long-standing preference to quickly remove tumors before beginning drug treatment. As a result, it can take three to five years to determine whether a drug is working, as researchers wait to see if the cancer recurs. Whether surgery occurs before or after chemo does not affect long-term outcomes.
In I-Spy 2, researchers use an MRI to evaluate a tumor's response to a drug early in the trial and get a definitive answer at surgery. "All of a sudden I've taken a five-year learning curve and shortened it to six months," Dr. Esserman says.
Ms. Landreth's ordeal began with a heavy sensation in her left breast that led her to discover the lump. It seemed to come out of nowhere and felt as big and hard as a marble. The news that she had cancer came while she was on a business trip to Los Angeles. "It was a shocker," she says.
She didn't reject out of hand the surgeon's recommendation of a double mastectomy, but as she and her husband, Creighton Reed, cast a net among friends for advice, Dr. Esserman's name kept coming up. They were taken with her on their first meeting.
"She sweeps into the room like this Fleetwood Mac figure," Ms. Landreth says, referring to Dr. Esserman's resemblance to the group's singer Stevie Nicks. "There's no B.S. She cuts completely to the facts. She gives you a hug at the end. You leave thinking, 'All right, I can do this.'"
A key feature of the study is a molecular analysis that determines whether the participants' tumors are positive or negative for estrogen, progesterone and the Her2 protein—the basis for putting patients in one of 10 biomarker categories.
Every patient gets 12 weekly treatments with the standard chemotherapy taxol, followed by four biweekly infusions of the standard drugs Adriamycin and Cytoxan. A precursor study called I-Spy 1 showed that 30% of patients who got that regimen saw their tumors disappear completely.
About 80% of patients are also randomly assigned to one of five experimental agents (from Abbott Laboratories, Amgen Inc. and Pfizer Inc.), given with the taxol treatments. Each drug targets a different molecular pathway affecting the growth and proliferation of tumors.
Tumor response is assessed from MRIs and at the time of surgery after chemo is completed. The associations between tumor response and patient biomarkers among the early participants will influence how subsequent patients are assigned to the treatments.
"The goal is to pair drug and biomarker signatures and graduate them into a small phase III trial that has gotten rid of the subset of patients that don't benefit," says Dr. Berry.
There are challenges. Though biomarkers are a promising predictor of a drug's effectiveness, tumor response to a drug can vary widely despite biomarker status. Doctors say that more evidence is needed linking biomarkers to long-term outcomes.
Eric Winer, the director of breast oncology at Dana-Farber Cancer Institute in Boston, is not involved with I-Spy. He calls it "a very good trial," but he wonders if the bar is set too high. "We have to be very careful not to toss away drugs prematurely based on their failure to pass this screen," he says.
The bar is high, Dr. Esserman acknowledges, but the study isn't after incremental improvement. "This trial will say who are the big winners," she says.
Even if I-Spy 2 succeeds in showing that compounds have a high probability of success in small late-stage studies, it isn't clear yet whether or how the FDA's regulatory system would then enable faster drug approval. "That's our next step," Dr. Esserman says.
The study, to cost $25 million over five years, is sponsored by the Biomarkers Consortium, a public-private partnership managed by the Foundation for the National Institutes of Health. It includes representatives from the National Cancer Institute, the FDA and the pharmaceutical industry. Funders include the Safeway Foundation, UCSF, Quantum Leap Health Care Collaborative and several drug companies. So far, about 20 patients are enrolled, with the expectation that about 800 will participate at some 20 medical centers across the U.S.
Ms. Landreth was assigned to one of the experimental drugs and began treatment on May 18. By the second week, a physical check of her tumor suggested it had shrunk notably after just a single treatment. In one of what became weekly email updates to friends, she wrote: "I have always liked to get good grades, so the nerd in me was fully flourishing when the cancer nurse said she was 'over the moon' about how I'm responding to the drugs."
The next Tuesday, as she awaited her third round of chemo, she wrote: "I got in trouble with my chemo nurse for trying to tough it out this weekend. I didn't think that a 70 min walk, 18 holes of golf (I broke 100) and a little too much heat + a total failure to use the nausea drugs would cause a problem.... oops!" The result, she wrote, was almost unremitting vomiting for 36 hours.
But, she added, the tumor had shrunk dramatically again.
Later that week, an MRI confirmed the progress. After just three weeks, her tumor had shrunk more than 50%, a strong predictor, Dr. Esserman told her, that the tumor would be gone by the end of chemotherapy.
Still, the cumulative effect of the chemo exacted a toll on Ms. Landreth. She lost her hair, shaving it all off just days before her 37th birthday. Frequent nausea posed a persistent challenge to her energy and appetite. At one point, Hope Rugo, her oncologist, warned that she'd lost too much weight, information she disclosed in an update titled, "Bring on the guacamole."
By week eight, her tumor was the size of a watermelon seed, compared with a golf ball the day she enrolled. At week 12, it was the size of a sesame seed. Her medical team was ecstatic. "There's nothing like hearing them cheer," she says.
Not everyone sees tumors melt away. Inne Harry-Ogaree, 54, who entered the trial at about the same time as Ms. Landreth, had her tumor grow despite treatment with taxol and an experimental drug. She was switched to a more standard regimen, which has shrunk the tumor by more than 50%. "It hasn't been easy," Ms. Harry-Ogaree says. "But I have a positive attitude toward my treatment and my care."
Ms. Landreth's final chemo session was last Tuesday. Under the study protocol, she'll undergo surgery in November. The actual status of her tumor won't be known until then.
Three weeks into the trial, she got the results of a test for mutations in the BRCA1 and BRCA2 genes. Dr. Esserman suggested the test because of a family history of ovarian and prostate cancers. The test was positive for BRCA2, putting Ms. Landreth's lifetime risk of another bout with breast cancer as high as 85%; for ovarian cancer, it's 30%.
She knew immediately what her surgical plan would be: the double mastectomy that she had initially resisted. She plans to have her ovaries removed as well.
Ms. Landreth's results will go into the trial database and could affect which other patients are assigned to the drug. If it turns out, as Dr. Esserman expects, that her tumor is gone, she is unlikely to need radiation.
In her email update early this week, she expressed "high hopes" that surgery would reveal her to be "cancer-free." Reflecting both the challenge of the surgery ahead and the battle she has already fought, she wrote: "I have to remember that after 16 rounds of magic poison it is going to take awhile to bounce back, no matter how fierce my determination. Churchill apparently said, '[If] you are going through hell, keep going!'"
Write to Ron Winslow at ron.winslow@wsj.com
http://online.wsj.com/article/SB10001424052748703882404575520190576846812.html#articleTabs%3Darticle
The claim is that through personal genetic understanding and this novel approach to testing multiple drugs simultaneously, they can learn as much in 6 months as would be possible to learn in 5 years under current standard testing protocols. To me, this approach is a breakthrough. For ease of reference, the text of the article follows. Be forewarned, it is a long article, but well worth reading.
A New Rx for Medicine
Fed up with slow drug trials, cancer patients and doctors are testing a fast track to personalized treatments.
When 37-year-old Kerry Landreth discovered a lump in her breast last April, she was told it would take three weeks to get a doctor's appointment to have it checked.
"I don't do three weeks," she recalls saying. "How about today?"
By the end of the day, she had talked her way into a doctor's appointment, a mammogram and a biopsy to determine whether the suspicious lump was a tumor. A few days later came the diagnosis: stage 2 invasive ductal breast cancer, a particularly aggressive form of the disease. When a surgeon recommended a double mastectomy, she decided to consider other options.
Now, Ms. Landreth, a vice president at the San Francisco office of a Wall Street investment bank and the mother of two young children, is among the first participants in a novel clinical trial that is similarly impatient with the status quo in cancer treatment.
The trial, called I-Spy 2, employs several innovative approaches to improve the notoriously slow and inefficient process of developing new cancer drugs. Using the latest advances in genetics, I-Spy 2 aims to match experimental drugs with the molecular makeup of tumors most likely to respond to them. And it tests multiple drugs at once, with the intent of getting the most effective ones into late-stage trials more quickly.
The goal is to reverse a dismal record, in which 60% to 70% of late-stage cancer studies fail, and to dramatically reduce the time and cost required to get promising new drugs to the market. Currently it can take $1 billion, thousands of patients and more than a decade to gather the evidence necessary to approve a new cancer drug.
Kerry Landreth just finished her final round ofchemotherapy.
"Predictability is the Holy Grail here—being able to identify promising drug candidates early and figuring out who they might work in," says Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.
The new trial draws from a growing body of research showing that the genetic makeup of tumors varies widely even among patients diagnosed with the same cancer. Some of these molecular traits, called biomarkers, make a tumor vulnerable to a specific medicine, while others may thwart a drug's effect.
A big part of the problem with conventional trials is that they essentially take all comers. Researchers know many participants won't benefit from the treatment. Those who don't respond can cause a drug to fail even though a significant minority of patients might benefit.
"Unless we do something different, people are going to give up on doing trials" for cancer, says Laura Esserman, director of the breast-care center at University of California, San Francisco, and co-leader of I-Spy 2.
The study focuses on women with aggressive breast cancers that have not spread to other organs. It aims to collect information about experimental drugs that would then enable drug companies to design leaner, faster late-stage trials that enroll only patients whose tumors had a high probability of responding to the treatment. Those trials, called phase III trials, provide critical data used in determining whether a drug will be approved.
"The vision is a 300-patient phase III trial instead of a 3,000-patient trial, with better results," says Don Berry, head of Quantitative Sciences at M.D. Anderson Cancer Center in Houston and co-leader of the study.
I-Spy 2's effort to bring much higher standards of productivity to cancer-drug development is inspired partly by Dr. Esserman's experience at business school. In addition to her surgical training, she has an MBA from Stanford University, where she learned about the rapid pace of innovation in high-tech industries. She was particularly influenced by the idea of what Intel Corp. chairman Andrew Grove calls "knowledge turns"—breakthroughs that have led to annual advances in microchip technology and an ongoing revolution in the performance of products like personal computers.
In the development of cancer drugs, by contrast, "knowledge turns" may take 10 or 15 years. Typically treatments are first studied in metastatic patients—for whom cancer has spread from the original tumor site to other parts of the body—who didn't benefit from standard therapies. Even when drugs succeed, benefits often are limited to a few extra weeks or months of life. Then it takes several more years to test successful drugs in early-stage patients, for whom effective treatments could mean a cure.
"We have 45,000 women dying each year of breast cancer," Dr. Esserman says. "We should be compelled to move faster."
About 3½ years ago, she joined forces with Dr. Berry at M.D. Anderson, an expert in a new approach to clinical trials called "adaptive design," to plan I-Spy 2. Unlike conventional trials, in which no one sees results until the end, "we look at the data right away," Dr. Berry says. What is learned in the early going helps to determine which drugs are assigned to patients later in the study, speeding the emergence of winners and losers.
The trial incorporates other new approaches. It's currently testing five drugs at once from three different companies. As compounds graduate to phase III studies or are winnowed out for lack of significant benefit, new candidates are cycled in, sparing the cost and time to mount separate trials. Up to 12 candidates will be screened over the course of the study.
In addition, participants get a six-month course of chemotherapy before having an operation to remove their tumors. In many studies, surgery is performed first, followed by chemotherapy and radiation, reflecting a long-standing preference to quickly remove tumors before beginning drug treatment. As a result, it can take three to five years to determine whether a drug is working, as researchers wait to see if the cancer recurs. Whether surgery occurs before or after chemo does not affect long-term outcomes.
In I-Spy 2, researchers use an MRI to evaluate a tumor's response to a drug early in the trial and get a definitive answer at surgery. "All of a sudden I've taken a five-year learning curve and shortened it to six months," Dr. Esserman says.
Ms. Landreth's ordeal began with a heavy sensation in her left breast that led her to discover the lump. It seemed to come out of nowhere and felt as big and hard as a marble. The news that she had cancer came while she was on a business trip to Los Angeles. "It was a shocker," she says.
She didn't reject out of hand the surgeon's recommendation of a double mastectomy, but as she and her husband, Creighton Reed, cast a net among friends for advice, Dr. Esserman's name kept coming up. They were taken with her on their first meeting.
"She sweeps into the room like this Fleetwood Mac figure," Ms. Landreth says, referring to Dr. Esserman's resemblance to the group's singer Stevie Nicks. "There's no B.S. She cuts completely to the facts. She gives you a hug at the end. You leave thinking, 'All right, I can do this.'"
A key feature of the study is a molecular analysis that determines whether the participants' tumors are positive or negative for estrogen, progesterone and the Her2 protein—the basis for putting patients in one of 10 biomarker categories.
Every patient gets 12 weekly treatments with the standard chemotherapy taxol, followed by four biweekly infusions of the standard drugs Adriamycin and Cytoxan. A precursor study called I-Spy 1 showed that 30% of patients who got that regimen saw their tumors disappear completely.
About 80% of patients are also randomly assigned to one of five experimental agents (from Abbott Laboratories, Amgen Inc. and Pfizer Inc.), given with the taxol treatments. Each drug targets a different molecular pathway affecting the growth and proliferation of tumors.
Tumor response is assessed from MRIs and at the time of surgery after chemo is completed. The associations between tumor response and patient biomarkers among the early participants will influence how subsequent patients are assigned to the treatments.
"The goal is to pair drug and biomarker signatures and graduate them into a small phase III trial that has gotten rid of the subset of patients that don't benefit," says Dr. Berry.
There are challenges. Though biomarkers are a promising predictor of a drug's effectiveness, tumor response to a drug can vary widely despite biomarker status. Doctors say that more evidence is needed linking biomarkers to long-term outcomes.
Eric Winer, the director of breast oncology at Dana-Farber Cancer Institute in Boston, is not involved with I-Spy. He calls it "a very good trial," but he wonders if the bar is set too high. "We have to be very careful not to toss away drugs prematurely based on their failure to pass this screen," he says.
The bar is high, Dr. Esserman acknowledges, but the study isn't after incremental improvement. "This trial will say who are the big winners," she says.
Even if I-Spy 2 succeeds in showing that compounds have a high probability of success in small late-stage studies, it isn't clear yet whether or how the FDA's regulatory system would then enable faster drug approval. "That's our next step," Dr. Esserman says.
The study, to cost $25 million over five years, is sponsored by the Biomarkers Consortium, a public-private partnership managed by the Foundation for the National Institutes of Health. It includes representatives from the National Cancer Institute, the FDA and the pharmaceutical industry. Funders include the Safeway Foundation, UCSF, Quantum Leap Health Care Collaborative and several drug companies. So far, about 20 patients are enrolled, with the expectation that about 800 will participate at some 20 medical centers across the U.S.
Ms. Landreth was assigned to one of the experimental drugs and began treatment on May 18. By the second week, a physical check of her tumor suggested it had shrunk notably after just a single treatment. In one of what became weekly email updates to friends, she wrote: "I have always liked to get good grades, so the nerd in me was fully flourishing when the cancer nurse said she was 'over the moon' about how I'm responding to the drugs."
The next Tuesday, as she awaited her third round of chemo, she wrote: "I got in trouble with my chemo nurse for trying to tough it out this weekend. I didn't think that a 70 min walk, 18 holes of golf (I broke 100) and a little too much heat + a total failure to use the nausea drugs would cause a problem.... oops!" The result, she wrote, was almost unremitting vomiting for 36 hours.
But, she added, the tumor had shrunk dramatically again.
Later that week, an MRI confirmed the progress. After just three weeks, her tumor had shrunk more than 50%, a strong predictor, Dr. Esserman told her, that the tumor would be gone by the end of chemotherapy.
Still, the cumulative effect of the chemo exacted a toll on Ms. Landreth. She lost her hair, shaving it all off just days before her 37th birthday. Frequent nausea posed a persistent challenge to her energy and appetite. At one point, Hope Rugo, her oncologist, warned that she'd lost too much weight, information she disclosed in an update titled, "Bring on the guacamole."
By week eight, her tumor was the size of a watermelon seed, compared with a golf ball the day she enrolled. At week 12, it was the size of a sesame seed. Her medical team was ecstatic. "There's nothing like hearing them cheer," she says.
Not everyone sees tumors melt away. Inne Harry-Ogaree, 54, who entered the trial at about the same time as Ms. Landreth, had her tumor grow despite treatment with taxol and an experimental drug. She was switched to a more standard regimen, which has shrunk the tumor by more than 50%. "It hasn't been easy," Ms. Harry-Ogaree says. "But I have a positive attitude toward my treatment and my care."
Ms. Landreth's final chemo session was last Tuesday. Under the study protocol, she'll undergo surgery in November. The actual status of her tumor won't be known until then.
Three weeks into the trial, she got the results of a test for mutations in the BRCA1 and BRCA2 genes. Dr. Esserman suggested the test because of a family history of ovarian and prostate cancers. The test was positive for BRCA2, putting Ms. Landreth's lifetime risk of another bout with breast cancer as high as 85%; for ovarian cancer, it's 30%.
She knew immediately what her surgical plan would be: the double mastectomy that she had initially resisted. She plans to have her ovaries removed as well.
Ms. Landreth's results will go into the trial database and could affect which other patients are assigned to the drug. If it turns out, as Dr. Esserman expects, that her tumor is gone, she is unlikely to need radiation.
In her email update early this week, she expressed "high hopes" that surgery would reveal her to be "cancer-free." Reflecting both the challenge of the surgery ahead and the battle she has already fought, she wrote: "I have to remember that after 16 rounds of magic poison it is going to take awhile to bounce back, no matter how fierce my determination. Churchill apparently said, '[If] you are going through hell, keep going!'"
Write to Ron Winslow at ron.winslow@wsj.com
Tuesday, August 3, 2010
Another Potential Weapon Against Head and Neck Cancer
Herpes - the gift that keeps on giving. A phase I/II study completed by BioVex was just published in ASCO (American Society of Clinical Oncology). By injecting a genetically altered form of the Herpes virus directly into the lymph nodes of 17 patients with head and neck cancer in combination with Cisplatin and radiation, head and neck tumour shrinkage could be seen on scans for 14 patients (82.3%), while 93 per cent of patients had no trace of residual cancer in their lymph nodes when subsequently surgically removed. After an average follow-up time of 29 months (19 to 40 months), 82.4 per cent of patients remained alive. Only two of 13 patients given the top virus treatment dose relapsed, and no patient had recurrent loco-regional disease.
Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said: “Up to half of patients given the current standard treatment of chemotherapy combined with radiotherapy typically relapse within two years, following which the prognosis is grim, so these results compare very favorably. This, combined with the very high complete pathological response rate indicates that OncoVEX may provide significant additional clinical benefit to chemotherapy and radiotherapy alone, hence our decision to move directly to a pivotal Phase III trial."
Speaking from a personal experience perspective, this is a potential game changer. After 36 IMRT radiation treatments which ended in July of 2005, they found live squamous cell carcinoma cells in 2 of the 17 lymph nodes removed from my left neck. Within 18 months following the radiation treatments, I had 4 local recurrences which lead to five surgeries one of which was a 12 hour salvage surgery which has left me permanently disabled. I spent almost two years in bed due to the debilitating effects of nine different chemotherapy regimens. All of this saved my life, but the side effects, using Dr. Coffin's word, have been grim. I am currently in remission and have had no evidence of disease for 34 months. I continue to take a maintenance chemo drug and will do so as long as the side effects from that drug are minimal. I have no proof of this, but I suspect the maintenance drug is keeping my cancer from returning.
I wonder at times how my life would have been different if the above treatment had been available to me 5 years ago. This treatment along with others I have written about recently gives me hope that others will not have to travel down my path. For those of you wondering, I was neither a smoker or a drinker. My disease was not related to the HPV virus. Where it came from is a mystery.
Here are two links to articles on the above clinical trial.
http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100802005515&newsLang=en
http://www.aolhealth.com/2010/08/02/herpes-a-new-weapon-against-cancer/
Take care everyone.
Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said: “Up to half of patients given the current standard treatment of chemotherapy combined with radiotherapy typically relapse within two years, following which the prognosis is grim, so these results compare very favorably. This, combined with the very high complete pathological response rate indicates that OncoVEX may provide significant additional clinical benefit to chemotherapy and radiotherapy alone, hence our decision to move directly to a pivotal Phase III trial."
Speaking from a personal experience perspective, this is a potential game changer. After 36 IMRT radiation treatments which ended in July of 2005, they found live squamous cell carcinoma cells in 2 of the 17 lymph nodes removed from my left neck. Within 18 months following the radiation treatments, I had 4 local recurrences which lead to five surgeries one of which was a 12 hour salvage surgery which has left me permanently disabled. I spent almost two years in bed due to the debilitating effects of nine different chemotherapy regimens. All of this saved my life, but the side effects, using Dr. Coffin's word, have been grim. I am currently in remission and have had no evidence of disease for 34 months. I continue to take a maintenance chemo drug and will do so as long as the side effects from that drug are minimal. I have no proof of this, but I suspect the maintenance drug is keeping my cancer from returning.
I wonder at times how my life would have been different if the above treatment had been available to me 5 years ago. This treatment along with others I have written about recently gives me hope that others will not have to travel down my path. For those of you wondering, I was neither a smoker or a drinker. My disease was not related to the HPV virus. Where it came from is a mystery.
Here are two links to articles on the above clinical trial.
http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100802005515&newsLang=en
http://www.aolhealth.com/2010/08/02/herpes-a-new-weapon-against-cancer/
Take care everyone.
Thursday, July 1, 2010
June 30 2010
Having had a little literary fun and a trip down memory lane in my last post dated April 29 2010, it is time to look to the present. I had my quarterly exam at the cancer center on June 30th. It began with blood work, a chest x-ray, and a head & neck CT scan. I visited with a speech therapist to discuss tongue exercises which may help with swallowing issues. Next I met with my oncologist and his physician assistant (PA). They had the finalized radiology report back from the CT scan I had two hours earlier. ALL CLEAR!!!! Both my doctor and his PA did a thorough exam. Again, all clear. That makes it 32 months with no evidence of disease and 6 months for clinical remission. I'm continuing on the daily maintenance chemo drug as the side effects are mild and the risk of a recurrence is still high. But, the further out I get, the smaller the odds of a recurrence. So, all good news. No qualifier.
On a random topic since I have your attention, I discovered a new source of entertainment on the world wide web. For those of you that enjoy music, give http://www.pandora.com/ a try. It is completely free and tailored to your specific tastes. Plug in a few artists whose music you enjoy and it does the rest. Non stop streaming music 24 x 7.
Take care. Ed.
On a random topic since I have your attention, I discovered a new source of entertainment on the world wide web. For those of you that enjoy music, give http://www.pandora.com/ a try. It is completely free and tailored to your specific tastes. Plug in a few artists whose music you enjoy and it does the rest. Non stop streaming music 24 x 7.
Take care. Ed.
Thursday, April 29, 2010
My 5 Year Cancerversary
5 years ago today a doctor walked into my exam room and said, “you have cancer.” This blog entry is about that experience. It covers April 28th and 29th of 2005. Before jumping into that event, I looked up the 5 year survival rate. One website (see reference at bottom of post) put the rate for those diagnosed with late stage head & neck cancer at 27%. It feels pretty good to not be in with the 73% of the people who are no longer with us. Although the cost physically, mentally, and financially to me and my family and friends has been high, I take some solace in beating the odds.
A few blog entries ago I had written that I was writing a book on my cancer journey. I have since abandoned that idea as I did not find it a compelling enough story. I did however crank out 100 pages of pretty solid text before coming to this conclusion. My goal was to write a story that gave the reader a true non fairy tale feel for what it is like to walk in the shoes of someone with cancer. The following are 4 pages from my writings that you may find insightful. It begins with my first exposure to the head & neck cancer clinic at M. D. Anderson.
April 28 2005
===========
The patients in the head and neck cancer unit waiting area were generally older than me, but not all of them. One big difference between here and the Sarcoma unit was the evidence of massive facial deformities. An older woman whom I guessed to be in her mid 70s had a piece of gauze straight across the front of her face between her eyes and her lips where her nose should have been. When she turned sideways and the sun from the window backlit her head I could see a straight plain where her nose used to be. This disturbed me. There were people with blue and red markings on their face with indelible marker. There were multiple patients with tracheotomies. I had never seen so much misery in one place. These were images out of a horror movie.
My wife and I stood until two chairs were vacated. After a few hours my name was called. We both got up and went into the clinic. They took my vital signs: weight, blood pressure, and temperature. We were told to go back into the waiting area until an exam room opened up. Every time we asked how long we would be waiting, we were told “you will be seen shortly.” We waited another hour before being brought back to an exam room. Here again we were asked to wait. “How long?,” I asked. We were told the doctor would see us shortly.
A physician’s assistant joins us in the exam room. She examines me and takes down notes on my background. Yes, I smoked during high school. No, I haven’t smoked in over 30 years. Occasionally, I have a glass of wine, nothing else. She finishes with her note taking, says the doctor will be in shortly and leaves. After more waiting my doctor enters the room. He asks similar questions as those asked by his physician assistant. It is late in the day. We had originally come to the Cancer Center for a scheduled early morning Sarcoma exam and now here it was pushing 5:00 P.M. He examines my neck visually and by feel. He maneuvers an endoscope down through my left nostril which gives him a clear view of my pharynx, upper esophagus, upper windpipe, and vocal cords. He asks me to say “eeeeeee” a few times. He removes the endoscope without difficulty. He tells me to open wide and reaches in as far as his gloved right hand can reach and feels the back of my throat and the base of my tongue with his finger. I gag. It is unpleasant. I ask him what he is seeing and feeling. He provides me with no verbal assessment on one hand or assurances on the other. He says he would like to schedule me for a Fine Needle Aspiration (FNA) and to do it as soon as possible, would tomorrow work for me? We learn that he is from Pittsburgh. My wife is from Pittsburgh and I lived and went to undergraduate and graduate school there. This gives us an instant mini-bond. We’re all Steelers fans. Go Steelers. He has me scheduled for a FNA the following afternoon.
We leave there. My wife is under the impression that I have cancer. I am still under the belief that whatever is wrong with me may be cancer, but it could be something less serious. After all, it is just a few swollen lymph nodes. We meet a friend and her spouse for drinks at a restaurant near our home and neither my wife nor I mention how we spent the day.
April 29 2005
===========
I drive down to the Cancer Center the next day, park, and walk the quarter mile to the Fine Needle Aspiration facility. There is a small waiting room and no other patients are there. I check in with the clinic receptionist and my name is called quickly. I’m led to an ordinary looking exam room. There are a few chairs, an exam table with the white paper pullover to help keep it clean between patients, cabinets underneath and above the counter top. There are a few medical exam devices in the room, but nothing out of the ordinary. A female Asian doctor comes in and introduces herself. She feels and gently palpates my neck and lymph nodes. She tells me that she is going to take sample fluid from multiple spots in each swollen lymph node and examine them. She retrieves a huge hypodermic syringe. The needle is about 4 inches long and the syringe can hold 20 milliliters of fluid. I ask if it will hurt. She says a little, but not too bad. I sit in one chair; she sits in the chair next to me. She pokes the needle slowly into my swollen lymph node. She draws some fluid. She repeats this 3 or 4 times. The syringe is almost full. She excuses herself from the exam room. She returns a few minutes later with a new syringe and wants a few more samples. I am of course thrilled because her fluid extraction shrank the size of my lymph nodes by 50%. I asked her to take all the fluid or as much fluid as possible. She repeats her exercise: stab, pull plunger, remove syringe, put syringe in a vertical position with the needle pointing up, push plunger in until all the air is removed, and then repeat. I continued to be thrilled. My swollen lymph nodes were practically gone, my face and neck contour was almost back to normal; it hadn’t been this way for over 2 months. She had succeeded in 10 minutes what a month of antibiotics had been unable to accomplish. She excused herself again.
I liked her. She was nice and the procedure didn’t hurt too badly. She returned two minutes later. She said, “You have cancer.” I was stunned! I had prepared myself for this mentally, but somehow I did not expect it to play out this way. I thought she might come back into the room and say, “we’d like to schedule you for some additional tests” or “my findings were inconclusive.” That’s not what happened. What happened is that in the two minutes she was out of the room, she squirted some of the fluid on a microscope slide, slid the slide under a microscope, looked at it, and quickly and unequivocally came to the conclusion which she unabashedly shared with me in three life-altering words, “you have cancer.” I wasn’t prepared for this. Sure, I liked how my lymph nodes were no longer swollen, but I HAD CANCER. I did not know what to ask, or where to begin. So, I asked if my lymph nodes were now better. How dumb is that? She said they would continue to swell as they fought the cancer. I asked her what type of cancer I had. She was as matter of fact when answering as the women behind the deli counter when you ask about a type of cheese or salami. She said, “You have squamous cell carcinoma.” In asking what I should do next, she said she would send her findings to my doctor and he would be in touch with me. There were a dozen questions I should or could have asked, but I was in a state of shock. I had watched my mom suffocate from lung cancer less than 4 years earlier. She went from appearing perfectly healthy to being dead in 6 months. My siblings, dad, and I spent the last week of her life with her. It was terrible to watch someone you love go from active tennis player to bed-ridden paraplegic in a matter of months.
What was going to happen to me? I was scared. I had cancer.
====================
Reference
http://emedicine.medscape.com/article/1289986-overview
A few blog entries ago I had written that I was writing a book on my cancer journey. I have since abandoned that idea as I did not find it a compelling enough story. I did however crank out 100 pages of pretty solid text before coming to this conclusion. My goal was to write a story that gave the reader a true non fairy tale feel for what it is like to walk in the shoes of someone with cancer. The following are 4 pages from my writings that you may find insightful. It begins with my first exposure to the head & neck cancer clinic at M. D. Anderson.
April 28 2005
===========
The patients in the head and neck cancer unit waiting area were generally older than me, but not all of them. One big difference between here and the Sarcoma unit was the evidence of massive facial deformities. An older woman whom I guessed to be in her mid 70s had a piece of gauze straight across the front of her face between her eyes and her lips where her nose should have been. When she turned sideways and the sun from the window backlit her head I could see a straight plain where her nose used to be. This disturbed me. There were people with blue and red markings on their face with indelible marker. There were multiple patients with tracheotomies. I had never seen so much misery in one place. These were images out of a horror movie.
My wife and I stood until two chairs were vacated. After a few hours my name was called. We both got up and went into the clinic. They took my vital signs: weight, blood pressure, and temperature. We were told to go back into the waiting area until an exam room opened up. Every time we asked how long we would be waiting, we were told “you will be seen shortly.” We waited another hour before being brought back to an exam room. Here again we were asked to wait. “How long?,” I asked. We were told the doctor would see us shortly.
A physician’s assistant joins us in the exam room. She examines me and takes down notes on my background. Yes, I smoked during high school. No, I haven’t smoked in over 30 years. Occasionally, I have a glass of wine, nothing else. She finishes with her note taking, says the doctor will be in shortly and leaves. After more waiting my doctor enters the room. He asks similar questions as those asked by his physician assistant. It is late in the day. We had originally come to the Cancer Center for a scheduled early morning Sarcoma exam and now here it was pushing 5:00 P.M. He examines my neck visually and by feel. He maneuvers an endoscope down through my left nostril which gives him a clear view of my pharynx, upper esophagus, upper windpipe, and vocal cords. He asks me to say “eeeeeee” a few times. He removes the endoscope without difficulty. He tells me to open wide and reaches in as far as his gloved right hand can reach and feels the back of my throat and the base of my tongue with his finger. I gag. It is unpleasant. I ask him what he is seeing and feeling. He provides me with no verbal assessment on one hand or assurances on the other. He says he would like to schedule me for a Fine Needle Aspiration (FNA) and to do it as soon as possible, would tomorrow work for me? We learn that he is from Pittsburgh. My wife is from Pittsburgh and I lived and went to undergraduate and graduate school there. This gives us an instant mini-bond. We’re all Steelers fans. Go Steelers. He has me scheduled for a FNA the following afternoon.
We leave there. My wife is under the impression that I have cancer. I am still under the belief that whatever is wrong with me may be cancer, but it could be something less serious. After all, it is just a few swollen lymph nodes. We meet a friend and her spouse for drinks at a restaurant near our home and neither my wife nor I mention how we spent the day.
April 29 2005
===========
I drive down to the Cancer Center the next day, park, and walk the quarter mile to the Fine Needle Aspiration facility. There is a small waiting room and no other patients are there. I check in with the clinic receptionist and my name is called quickly. I’m led to an ordinary looking exam room. There are a few chairs, an exam table with the white paper pullover to help keep it clean between patients, cabinets underneath and above the counter top. There are a few medical exam devices in the room, but nothing out of the ordinary. A female Asian doctor comes in and introduces herself. She feels and gently palpates my neck and lymph nodes. She tells me that she is going to take sample fluid from multiple spots in each swollen lymph node and examine them. She retrieves a huge hypodermic syringe. The needle is about 4 inches long and the syringe can hold 20 milliliters of fluid. I ask if it will hurt. She says a little, but not too bad. I sit in one chair; she sits in the chair next to me. She pokes the needle slowly into my swollen lymph node. She draws some fluid. She repeats this 3 or 4 times. The syringe is almost full. She excuses herself from the exam room. She returns a few minutes later with a new syringe and wants a few more samples. I am of course thrilled because her fluid extraction shrank the size of my lymph nodes by 50%. I asked her to take all the fluid or as much fluid as possible. She repeats her exercise: stab, pull plunger, remove syringe, put syringe in a vertical position with the needle pointing up, push plunger in until all the air is removed, and then repeat. I continued to be thrilled. My swollen lymph nodes were practically gone, my face and neck contour was almost back to normal; it hadn’t been this way for over 2 months. She had succeeded in 10 minutes what a month of antibiotics had been unable to accomplish. She excused herself again.
I liked her. She was nice and the procedure didn’t hurt too badly. She returned two minutes later. She said, “You have cancer.” I was stunned! I had prepared myself for this mentally, but somehow I did not expect it to play out this way. I thought she might come back into the room and say, “we’d like to schedule you for some additional tests” or “my findings were inconclusive.” That’s not what happened. What happened is that in the two minutes she was out of the room, she squirted some of the fluid on a microscope slide, slid the slide under a microscope, looked at it, and quickly and unequivocally came to the conclusion which she unabashedly shared with me in three life-altering words, “you have cancer.” I wasn’t prepared for this. Sure, I liked how my lymph nodes were no longer swollen, but I HAD CANCER. I did not know what to ask, or where to begin. So, I asked if my lymph nodes were now better. How dumb is that? She said they would continue to swell as they fought the cancer. I asked her what type of cancer I had. She was as matter of fact when answering as the women behind the deli counter when you ask about a type of cheese or salami. She said, “You have squamous cell carcinoma.” In asking what I should do next, she said she would send her findings to my doctor and he would be in touch with me. There were a dozen questions I should or could have asked, but I was in a state of shock. I had watched my mom suffocate from lung cancer less than 4 years earlier. She went from appearing perfectly healthy to being dead in 6 months. My siblings, dad, and I spent the last week of her life with her. It was terrible to watch someone you love go from active tennis player to bed-ridden paraplegic in a matter of months.
What was going to happen to me? I was scared. I had cancer.
====================
Reference
http://emedicine.medscape.com/article/1289986-overview
Friday, April 2, 2010
All Quiet on the Western Front
The literal translation of that title is "Nothing new in the West" with the West being the war. It was a routine dispatch used by German soldiers during World War I.
On March 31st I had blood drawn and clinic visits with my oncologist and surgeon at my cancer center. They did not see anything suspicious, said I looked well, and will schedule me for a follow up in 3 months. That visit will involve a CT scan of my H&N, maybe my chest, and an x-ray. I have been taking a daily chemo pill, Tarceva, for 28 months. My oncologist thought it best for me to continue with this treatment. This all leads back to the above title, there is nothing new with my own personal war on cancer. I'm still in clinical remission having had no evidence of disease for 30 months.
While at the cancer center, I was able to talk to my speech therapist who scheduled me for a modified barium swallow test later that same day. The results this time were different than the test last August. I'm 100% convinced that my anatomy had not changed. The difference was the skill of the therapist performing this test. The test showed some constriction in my esophagus and felt a consult with a gastrointestinal doctor (and a possible esophageal dilation procedure) may yield some progress in my ability to consume additional types of food. I have been living off of Boost nutrition drinks for over 3 years now. It's good, but not that good. I'm encouraged by this latest development.
I was also able to have a great catch up with a friend that works at the cancer center. So, all-in-all a pretty good day.
Stay well and take care.
Ed
On March 31st I had blood drawn and clinic visits with my oncologist and surgeon at my cancer center. They did not see anything suspicious, said I looked well, and will schedule me for a follow up in 3 months. That visit will involve a CT scan of my H&N, maybe my chest, and an x-ray. I have been taking a daily chemo pill, Tarceva, for 28 months. My oncologist thought it best for me to continue with this treatment. This all leads back to the above title, there is nothing new with my own personal war on cancer. I'm still in clinical remission having had no evidence of disease for 30 months.
While at the cancer center, I was able to talk to my speech therapist who scheduled me for a modified barium swallow test later that same day. The results this time were different than the test last August. I'm 100% convinced that my anatomy had not changed. The difference was the skill of the therapist performing this test. The test showed some constriction in my esophagus and felt a consult with a gastrointestinal doctor (and a possible esophageal dilation procedure) may yield some progress in my ability to consume additional types of food. I have been living off of Boost nutrition drinks for over 3 years now. It's good, but not that good. I'm encouraged by this latest development.
I was also able to have a great catch up with a friend that works at the cancer center. So, all-in-all a pretty good day.
Stay well and take care.
Ed
Wednesday, March 24, 2010
Nothing New in ex-Cancerville
One week from today, on March 31 2010, I go in for a quarterly check up with my oncologist and an annual check up with my surgeon. I'll have blood drawn for testing at about 6:00 AM and am scheduled to see both doctors later in the morning. I am not scheduled for any scans and I don't feel any abnormal growths (e.g., lumps or bumps) in my body, so I'm hoping to skate through there without incident (i.e., cancer detection or other concern).
Take care everyone.
Take care everyone.
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