In April I shared a web site, Mesothelioma and Me, by UK resident Debbie Brewer, who was recently diagnosed with mesothelioma. The site is Debbie’s personal journal about her experiences as she battles mesothelioma, as well as shares stories about her family and daily life.

Some of you who are following Debbie on her journal have already heard the good news – on June 20, she learned that her tumor (which she wittily nicknamed Theo) has shrunk by 10 percent after the first of three scheduled chemoembolization treatments. She had her first treatment May 20, and the second June 20, when she learned Theo had gotten smaller.

According to www.radiologyinfo.org, chemoembolization is a combination of chemotherapy and a procedure called embolization to treat cancer, most often of the liver. According to the web site, catheter embolization is the deliberate introduction of foreign (“embolic”) material such as gelatin sponge or metal coils to stop bleeding or cut off blood flowing to a tumor or arteriovenous malformation.

Debbie traveled to Frankfurt, Germany, to have the procedure, which is still a trial, done by Dr. Thomas J. Vogl, Chairman, Department of Radiology, Department of Diagnostic and Interventional Radiology – University Hospital, Johann Wolfgang Goethe, University of Frankfurt am Main.

In this procedure, Dr. Vogl catheterizes the tumor and administers localized chemotherapy directly into the arteries feeding the tumor. Once the chemotherapy has been administered, other agents can be administered to block off the blood supply to the tumor.

Debbie’s description of the procedure is a little more colorful:

“A small incision will be made to expose the artery that feeds the tumour which is in the femour. A catheter is inserted and pushed up into the area affected. Embolization is a glue like substance which is put in to seal off the tumour and the chemo is then added and the whole area sealed off. The chemo is left to do its job. It is something like having a room with 2 doors, sealing off the back door and throwing in an explosive and sealing up the front door.”

One of the strangest things? The clinic where Debbie visits Dr. Vogl for these treatments is located on a street of the same name as her tumor’s nickname! Theodore Stern Kia 7. Visit Debbie’s blog to read all about her experiences with Dr. Vogl and this treatment. She even has photos of herself at the clinic.

Debbie points out that chemoembolization is not a cure for mesothelioma, but is thought to slow the growth of the tumor or reduce it, allowing the patient a longer life.

In conjunction with or following this treatment, Debbie will undergo a dendritic cell vaccine. According to the web site drugresearcher.com, dendritic cells – a part of the body’s immune system that detects foreign proteins in the body – can be used as vaccines by mixing them with genetic material from the patient’s tumour and infusing the treated cells back into the patient. The dendritic cells present the tumour antigens to the body’s white blood cells (T lymphocytes) for destruction.

There has been a lot in the news lately about the development of new drugs to treat mesothelioma. But with this boon comes a perhaps unforeseen complication – the increasing cost of treatment. A recent study conducted by the U.S. National Cancer Institute (NCI) and published in the Journal of the National Cancer Institute indicates that costs for treating Medicare patients with cancer has increased substantially from 1991-2002.

The article, which studied the cost of care for elderly cancer patients in the United States, used Surveillance, Epidemiology, and End Results-Medicare files to identify 718,907 cancer patients and 1,623,651 noncancer control subjects. Researchers estimated net costs of care for elderly cancer patients for the 18 most prevalent cancers and for all other tumor sites combined.

The study reports that costs of care were estimated for each phase by use of Medicare claims data from January 1, 1999 through December 31, 2003. They found that costs to Medicare were highest for lung, colorectal and prostate cancers.

An article in HealthDay News examining this latest report says study co-author Robin Yabroff attributes rising costs to a growing population of seniors in the U.S., as well as the inclusion of more prescription drugs in Medicare coverage. Yabroff is an epidemiologist at the U.S. NCI.

The report states that the number of patients receiving chemotherapy for lung, colorectal and breast cancer rose from 1991 to 2002, and that those increasing costs do not even reflect many of the newest, most expensive drugs now in use.

The HealthDay report quotes Dr. Len Lichtenfeld, deupty chief medical officer at the American Cancer Society, as saying that “the impact to Medicare is going to be substantial.” He goes on to say that the increasing costs for new drugs may actually prevent some patients from getting the treatment they need. Even if the drug is covered by Medicare, he says, the cost of the patient’s co-pay may be too high for them to afford it.

Merck & Co. announced May 27 that it is proceeding to Phase III clinical trials for vorinostat, which is currently marketed under the name Zolinza. The drug is an oral histone deacetylase (HDAC) inhibitor, and is being tested in patients with advanced malignant pleaural mesothelioma previously treated with systemic chemotherapy. Merck is currently enrolling patients in the Phase III trial.

According to the company’s news release, available in its entirety on the Mesothelioma Applied Research Foundation web site, the trial is moving forward after a favorable review of currently available safety and efficacy data from the Phase II portion of the study. This is an international study, expected to enroll 660 patients with testing centers in the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden and the United Kingdom. It will be an ongoing randomized, double-blind, placebo-controlled trial.

Information provided by Merck says the trial will examine the safety, tolerability and anti-tumor activity of oral vorinostat with best supportive care as compared to best supportive care plus placebo in patients with advanced mesothelioma who have failed or are intolerant to prior chemotherapy, icnlucing pemetrexed in combination with either cisplatin or carboplatin.

Primary endpoints of the Phase III trial include overall survival as well as characterization of the overall safety and toxicity of vorinostat in patients with advanced malignant mesothelioma.

Patients interested in more information about the trial and how to enroll should call toll-free 1-866-890-6619 (in the U.S.) and 1-888-577-8839 (outside the U.S.) or visit the Merck Cancer Trials web site.

Zolinza is currently approved in the U.S. for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recrruent disease on or following two systemic therapies.

On April 21 I reported that a Madison, Wisconsin-based biotechnology firm, Quintessence Bioscience, was moving forward on a drug similar to Alfacel’s Onconase, to treat mesothelioma. The report, from Steve Clark for WTN (Wisconsin Technology Network) News, noted that the company’s QBI-139 is very similar to Onconase, but has not been clinically tested yet.

Of course, on Monday this week, it was announced and reported here that Onconase had failed the primary objective of its late-stage trial. This news was particularly disappointing since the drug already has orphan drug status in the U.S., Europe and Australia due to the very high hopes for its success. Despite failing in its primary objective, however, testing did show that the drug is effective in a secondary effect, helping to prolong the life of those treated after standard chemotherapy has failed.

The report of Onconase’s initial failure prompted WTN’s Clark to revisit Quintessence to find out if the Onconase failure would derail the development of their QBI-139. In his new report, Clarks says he found researchers undaunted and pressing forward. He says they hope to move the drug into clinical trials sometime this summer, and they believe the success of Onconase’s secondary role and hopeful FDA approval in that area will help pave the way for general acceptance of RNase cancer therapies.

In his earlier report, Clark pointed out that QBI-139 has several differences from Onconase in the way it is produced, which he believes will make it inherently more effective than Onconase.

He points out that mesothelioma is a particularly difficult cancer to treat, and wonders if the selection of mesothelioma as a research track by Alfacell was made to help fast-track the development of the drug. Perhaps, he wonders, the drug might be more effective on “more common and easier to treat cancers than mesothelioma.”

Lung cancer survivor John Atkinson, who I mentioned yesterday, continues to be in the news. Selected by Golf Digest magazine to play as part of a celebrity foursome on the U.S. Open course on Father’s Day, June 15, he is using this opportunity to speak out about lung cancer awareness and research. Of course, mesothelioma is a type of lung cancer caused by asbestos, and affects the lining of the lungs.

Today there was a great article in the Detroit Free Press about Atkinson. The article states that Atkinson considers his “Achilles heel” in the competition to be the fact that he’s never played the tough Torrey Pines U.S. Open course, not that he has lung cancer. The avid golfer was on the links shortly after his diagnosis (he shot a 78) and walked the course after completing four rounds of chemotherapy. His goal for the celebrity tournament is to break 100.

You can also keep an eye out for Atkinson on NBC Nightly News tomorrow, June 5. He is scheduled to appear, barring any unexpected national events that bump him from the slot.

Atkinson will be teamed with celebrities Justin Timberlake, NBC Today Show anchor Matt Lauer, and Dallas Cowboy star Tony Romo in the tournment, which will be aired on NBC Sports at 2 p.m. ET June 15.

How wonderful that Atkinson has this chance in the spotlight to talk about lung cancer, and to promote efforts to increase funding for research and to raise awareness. He also is an official spokesman for the Lung Cancer Alliance.

Alfacell Corp., a biotechnology company that manufactures Onconase, released a disappointing report Wednesday regaring its Onconase product, which was hoped to be a significant treatment for mesothelioma. The drug already has orphan-drug status for the treatment of malignant mesothelioma in the U.S., Europe and Australia.

Results of the company’s late-stage trial of the drug showed that Onconase did not achieve significantly higher survival rates among patients with unresectable malignant mesothelioma when given in combination with doxorubicin, another cancer chemotherapy drug.

According to a report on Pharmaceutical Online, the preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin. The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

However, there is a silver lining to the study. Pharmaceutical Online reports those patients who failed a previous chemotherapy regimen who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin, which is considered a statistically significant result.

Reuters reports as a result of this secondary finding, Alfacell will now submit a marketing application to the Food and Drug Administration for use of the drug on those patients, with hopes to have it approved by the end of the year.

In the ongoing quest for a cure for mesothelioma and other life-threatening illnesses, the debate over the validity and effectiveness of complementary and alternative medicine (CAM) continues to stir up strong emotions.

Complementary medicine is used along with standard medicine, while alternative medicine is used in place of standard treatments.

Complementary and alternative medicine may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation.

Not long ago, I shared Charlene Kaforey’s good news, when she discovered her mesothelioma mass had diminished by half after completing a first round of cancer vaccines, considered an alternative treatment.

Recent news has included reports of research ranging from the effects of nonsteroidal anti-inflammatory medicines in combination with chemotherapy, to the use of Chinese mushrooms in homeopathic treatment, to a study indicating traditional chemotherapy might enhance the effectiveness of cancer vaccines, which are currently in clinical trials.

The problem, according to complementary medicine (CM) professor Edzard Ernst, in an editorial published recently in BMJ Clinical Evidence, is that “one side of the debate argues that there is no scientific evidence that can support CM, while the other side believes scientific evidence cannot be applied to CM.”

The danger, he says, is that waiting for absolute evidence might prevent someone from trying a therapy that could be beneficial, but siding with the idea that CAM simply cannot be proven may lead a patient into treatment that could cause more harm than good.

The National Cancer Institute’s Office of Complementary and Alternative Medicine (OCCAM), which coordinates the Institute’s research program in CAM, has established a goal of evaluating data from CAM practitioners with the same rigorous scientific methods employed in evaluating treatment responses with conventional medicine.

Major categories of CAM therapies, as determined by OCCAM, include alternative medical systems (built upon complete systems of theory and practice, like traditional Chinese medicine or homeopathy), energy and electromagnetic based therapies, exercise therapies (like yoga), manipulative and body-based methods, mind-body interventions (like hypnotherapy), nutritional therapeutics, pharmacological and biologic treatments (like vaccines), and spiritual therapies (healing, prayer).

OCCAM is developing the NCI Best Case Series (BCS) program based on its evaluations of CAM therapies, in which it provides an independent review of medical records and medical imaging from patients treated with unconventional cancer therapies.

But whether or not alternative and complementary medicine can be proven effective, people will still seek it out, says Professor Ernst. The “almost insatiable hunger of patients” for CM has driven its importance, he says, despite criticisms, praise or skepticism from the medical community, scientists or politicians, and in spite of the fact that more often than not health insurance does not cover the treatments.

Obviously, this topic – and its accompanying debate – needs much more examination. I will be exploring it more in the future. Do you have an experience with complementary or alternative medicine? Share it with us!

This week BBC News / Health reported on a recent study published by The Lancet, which features independent and authoritative commentary on global medicine, including research and analysis from all regions of the world. The study suggests that chemotherapy is not effective in dealing with mesothelioma, which is an asbestos-induced cancer that effects the lungs and, more rarely, the abdomen.

The results are based on a study of 409 patients, mostly from the United Kingdom, which set out to assess the potential benefits of combining active symptom control, which usually involves steroid drugs and radiotherapy, with chemotherapy. Results showed no real benefit from adding the chemotherapy drugs compared with just treating the symptoms of the disease.

The BBC quotes one of the authors of the study, Dr Richard Stephens from the Medical Research Council Clinical Trials Unit, as saying, “While thousands are and will be affected by this deadly disease, our trial, which is one of the few large trials ever conducted in this disease, emphasizes how difficult mesothelioma is to treat. This is mainly because mesothelioma forms in the lining of the lung. This makes it hard to target.”

One chemotherapy drug, vinorelbine, was shown by the study to have some promise, but researchers do not think blanket chemotherapy treatment is a promising direction for treatment of mesothelioma, according to the Lancet report.

Researchers do not necessarily consider these findings to be bad news, as a study that defines what does not help can be beneficial to patient health because it helps reduce the chance that patients will undergo stressful treatments that are ineffective.

Results of a completely different chemotherapy study conducted by researchers at Duke Comprehensive Cancer Center were released May 18, revealing that chemotherapy given in conjunction with cancer vaccines may actually boost the immune system’s response to the vaccines, according to a report by ScienceDaily.

The Duke study focused on a drug used to treat lymphoma, but could have implications for clinical trials with vaccines being used to treat many cancers including lung cancer, brain tumors and colorectal cancer.

According to the FDA, it is the goal of cancer vaccine clinical trials not to prevent cancer, but to treat existing tumors. The idea is to train the person’s immune system to recognize the living cancer cells and attack them.

In July 2007, the American Association for Cancer Research examined the issue of cancer vaccines and, according to a report by Medical News Today, they found that “ongoing therapeutic cancer vaccine trials have yet to show evidence of vaccines spurring a patient’s immune system to shrink tumors – yet patients who receive these vaccines in trials tend to live longer and respond better to subsequent treatment.”

The full study, titled Cancer Vaccines: Moving Beyond Current Paradigms is available to read online at Clinical Cancer Research.

Full results of the Duke study will be presented May 31 at the American Society of Clinical Oncology meeting in Chicago, Ill.

Today I received a wonderful email from Charlene Kaforey. Some of you have followed along with her story about her own fight with mesothelioma, which was published here in March and April. For those that are unfamiliar, Charlene, who just turned 49, was diagnosed with mesothelioma in June 2007.

With a stage III diagnosis, she underwent chemotherapy treatments from October to December of that year, and then, faced with the prospect of a pleurectomy or pneumonectomy, which would remove part or all of the affected lung, decided to try alternative medicine.

Charlene went to the ITL Alternative Cancer Treatment Clinic in Freeport, Grand Bahamas, in January 2008, where she underwent an 8-week treatment called Immuno-Augmentation Therapy (IAT). Upon returning home, she administers her own vaccines several times a day, and has been continuing a twice-daily intravenous vitamin C program with the help of a nurse friend.

She celebrated her birthday Sunday, then on Monday went for her first CT scan since beginning her alternative treatment. Charlene reports, “There was overall improvement in my scan results!! The tumor was half of what it was previously, the pleural thickening was reduced, fluid is reduced and the pleural effusion is gone. I am thrilled, and stunned. Of course, I’m still guardedly optimistic, since I do still have cancer and the results could change at any time. But this, for now, this is the best birthday present I could have gotten!”

Alternative therapies like IAT are not authorized by the American Medical Association, and there is still a lot of skepticism and caution surrounding them. Generally, medical insurance does not cover alternative medical treatments like IAT.

Treatments that are not considered conventional medicine, but that are undertaken along with traditional medical therapies, like chemotherapy, radiation and surgery, are called complementary. Treatments used in place of conventional medicine, like the IAT Charlene is undergoing, are called alternative medicine.

IAT, along with other complementary and alternative medicine (CAM) programs, are being studied by the U.S. Department of Health and Human Services, the Food and Drug Administration (FDA) and the National Center for Complementary and Alternative Medicine (NCCAM), which operates under the Department of Health and Human Services.

Patients considering complementary or alternative treatments are encouraged to thoroughly research possible risks, benefits, and scientific evidence, and to discuss alternatives with their physician.

For more information, visit the NCCAM online, in the “health” section under “be an informed consumer.” They have information on topics including what to do when considering using CAM, how to select a CAM practitioner, and paying for CAM treatment.

I will be exploring CAMs in the coming weeks, and hope to talk to physicians and alternative and complementary treatment doctors and specialists about these programs, as well as patients like Charlene who are using them. If you’ve had an experience with a CAM, leave a comment or email me and share your experience.

I am thrilled for Charlene! Happy Birthday!!

The ITL Experience

While undergoing chemotherapy to treat her mesothelioma, Charlene Kaforey had time to explore her options. As a Stage III patient, she was worried about her chances for quality of life or even long-term survival if she underwent surgery.

During this time, she found information about the ITL Alternative Cancer Treatment Clinic, located in Freeport, Grand Bahama Island. After talking to patients who reported success, she decided to try this unusual route for her own treatment.

She made her first visit to the clinic January 7, 2008. Mesothelioma patients like Charlene initially complete an 8-week course of treatment, which includes daily blood tests, several injections daily of a serum designed to boost the body’s immune system so that it can fight the cancer, and intravenous vitamin C plus two shots of cancer vaccines, twice per week, she says.

The blood work is to monitor the body for responsiveness to the treatment in order to fine tune it to the patient and set up an ongoing course that is administered by the patients themselves after leaving the clinic, Charlene says. Treatment at ITL is a process that lasts for the rest of your life, she explains.

Now back home in New York, she administers her own shots eight to 12 times per day. She also is continuing the intravenous vitamin C at home, although she says that is optional. She also needed to complete 5 of the 12 weeks of the cancer vaccines at home. Patients return to the clinic every four months for two weeks at a time for re-evaluation and adjustments to their serum regimen. Charlene is scheduled to return in June.

“What they tell you at ITL is that it will not necessarily make the cancer you have go away, but will hopefully prevent it from spreading any further,” Charlene said. “So if they can do that, and give me six years, that would be wonderful. That would be six quality years instead of two miserable years.”

Patients considering ITL need to know that because the facility is considered alternative medicine, it is not accredited by the American Medical Association or other governing boards of that type, and some insurance companies will not cover the cost of treatments.

ITL requires payment at time of services, which, according to the clinic’s web site, for Immuno Augmentive Therapy (IAT) of the kind Charlene receives, run around $7,500 for the first four weeks and about $700 per week thereafter. That cost does not include the vitamin C IV’s or the vaccines. Patients also must cover the costs to travel to the facility, and for accommodations during their eight weeks of treatment.

“Everyone has had different experiences [with insurance],” Charlene said. “I submitted my bills to my insurance company and I’ll just see what they do. Some people get partial payment, some insurance pays nothing,” she says. “But what’s your life worth to you?”

In addition to the financial challenge, there also is the issue of travel and time away from family. Charlene was lucky; she had different family members with her throughout her 8-week stay. They became as much a part of daily clinic life as she did.

“Seeking treatment at the clinic definitely involves family decisions. The cost is a major consideration and so is the time away from home. While the cost is much less than the approximately $200,000 price tag involved with the surgery/chemo/radiation regime, insurance will pay for those debilitating treatments. Plus, knowing you may have limited time remaining, do you want to leave family and friends for 2 months,” Charlene said. “It is a really individual decision. You have to look realistically at what your own choices are and what you need to do for yourself and your family. We viewed this as an investment of time and financial resources for the long term. Two months away is worth it if I get 4-6 more years with my family.”

A big part of Charlene’s experience at ITL was meeting other mesothelioma patients, as well as people with other types of cancer, and sharing stories. Her last week at the clinic, she said there were seven mesothelioma patients there, all around the same age – mostly women in their 40s and 50s, with whom she felt a real connection.

“You talk to real-life people who are there, who are surviving and living quality lives after their doctors had told them there was no hope. The stories are so different and so amazing, and yet you share so much because you’re all going through this. It gives you hope to meet patients who have survived 28, 20 ,12 or even 4 years after being given a death sentence,” Charlene said.

That connection with other patients has led Charlene to explore forming an outreach and support group where she lives, in Rochester, New York, where she plans to work for fund raising for a cure and to raise awareness of mesothelioma.

Alternative medicine is controversial. Its results often do not have a long history of documentation. People who choose this route understand that they are stepping out into largely uncharted waters.

Charlene is happy to share her story with others who are facing mesothelioma in their own lives, either as a patient or as a family member of someone with meso.

If you would like to talk with Charlene, please email wendi@mymeso.org and I will be happy to forward your information to her.