Chemotalk Newsletter

Chemotalk Newsletter, Vol. 16:  August 1, 2009

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Are these the dog days of summer? What does that MEAN, anyway?

Well, there's a lot to cover. The first story relates to a recent piece that ran in The New York Times, positing that cancer research moves so slowly because researchers don't take risks necessary to make major advances. I read the original story, and sadly, it rings true. See for yourself, in this complimentary piece by Seattle writer Robert Fortner ...


Following the Gates Foundation's lead on global health, many critics fault play-it-safe research for the failed war against CANCER. Will upping the dose of risk in research bring about new cures?

The war on cancer, perhaps the largest scientific undertaking in human history, has failed. Why? Timidity, according to a growing number of critics. The New York Times recently examined the 40-year, $100 billion war and headlined its conclusion: “Grant System Leads Cancer Researchers to Play It Safe.”

The Gates Foundation said the same thing about global health research more than a year ago. Keying off an unavailing, 25-year search for an HIV vaccine, the foundation criticized a process that mostly funded projects that “avoid controversy, and have a high probability of success, if 'success’ is defined as the production of a meaningful but limited increase in knowledge.”

The Times reporting highlights a nearly identical view of cancer research as risk-averse and“only likely to produce incremental progress.” The grant system is broken, according Richard Klausner, who served as director of the National Cancer Institute (NCI) from 1995 to 2001. He told the Times: “There is no conversation that I have ever had about the grant system that doesn't have an incredible sense of consensus that it is not working.” Many of these conversations took place at the Gates Foundation, where Klausner served as the first head of global health after leaving NCI. Gates tasked Klausner with devising a completely new system of goals and grant-making known as the Grand Challenges in Global Health.

The program funds projects considered too "far-out" and risky for traditional National Institutes of Health (NIH) funding. Gates predicted that “80 percent of these are likely to be dead ends.” Not yet satisfied with progress, the foundation launched its Explorations program two years later in 2007. The Explorations seek ideas that directly defy scientific consensus. More than 95 percent of them are expected to fail.

Actual data for this experiment on science will arrive soon. Phase I of the Explorations concludes this fall when the 105 grants from the inaugural round are renewed or dropped. Much as in a clinical drug trial, the foundation plans a “rigorous analysis” of the program. But meanwhile The New York Times appears to be administering the experimental medicine to the National Cancer Institute already.

Yet both the design and momentum of the Grand Challenges might have only just begun. Last February, Elias Zerhouni joined the foundation as a senior fellow. Previously director of NIH from 2002 to 2008, Zerhouni is now the architect of the Grand Challenges. Who better to modify the blueprint of life sciences research to achieve more rapid breakthroughs in global health?

But research practices beyond the global health sphere might also change, and not only in cancer but throughout NIH, whose granting practice “actually discourages innovative work,” as the Scientist recently commented.

Risk might be the new black. And perhaps the trend-setting Bill Gates will break up a government monopoly guilty of stifling innovation.

The Gates Foundation talks of funding up to a thousand Explorations projects — but compare that to the NIH portfolio of some 50,000 grants. Also, with a budget of $28 billion, NIH spends in a year an amount equal to about half of the Gates Foundation’s total assets. If big breakthroughs require taking big risks, it might not only be fashionable but compellingly rational for NIH to follow the Gates Foundation’s example. With the biggest chip stack, NIH can better afford to gamble — and win big.

No one faults the grant system when things are going well. In the fall of 1996, during Richard Klausner’s tenure as head of NCI, it looked like the cancer tide had turned. A New York Times article quoted Klausner as saying: “The 1990s will be remembered as the decade when we measurably turned the tide against cancer.”

But the 40-year, $100 billion war on cancer has not been short of clever, unorthodox, risky ideas: It has devoured them. More than one million scientific papers have been published on cancer. The disease has bested two generations of scientists, with the most recent one based on the incredible powers of DNA sequencing technology. Yet in terms of mortality, we’re at a standstill.

The Explorations are premised on there being sizeable inefficiencies in science and major undiscovered ideas, like a massive arbitrage opportunity in financial markets. Yet the first round of Explorations turned up precious few fundamentally new, radical notions for an HIV/AIDS vaccine. Significantly, the aggressiveness of HIV/AIDS research was recently dialed down, all the way “back to basics,” because of a shocking failure of a trial vaccine.

Our scientific grasp of both HIV/AIDS and cancer is remarkably tenuous, even as their risk pendulums seem to be swinging in opposite directions. The outcome of the Grand Challenges Explorations will have consequences beyond, for example, curing tuberculosis. In guiding biomedical research, the results will shed light on the “science of science.”

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A new drug is attracting a lot of notice for treatment of RHEUMATOID ARTHRITIS:

Masitinib, developed by AB Science pharmaceuticals, reduces joint inflammation in severe cases while causing only mild to moderate side effects, according to a report from the first clinical trial of the drug on humans.

Masitinib is supposed to halt the activity of mast cells, a part of the immune system believed to be involved in the start and progression of rheumatoid arthritis. The results of the French trial, involving 43 people with arthritis that other treatments had failed to help.

"We are encouraged from this study that Masitinib not only appears to be effective, but that within the first three months of treatment, the worst of its side effects were over, possibly making it suitable for long-term treatment regimens," one of the researchers, Olivier Hermine, said, adding that the next step will be placebo-controlled trials.

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Biogen Idec's PEGylated interferon beta-1a, has been granted fast-track designation by the FDA. The drug's potential to treat patients with only one or two injections a month might have been a factor in the agency's decision.. Biogen plans on "working closely with the FDA to expedite the compound's development and review process," a company official said.

PEGylated interferon beta-1a, which may fill a gap in the treatment of MULTIPLE SCLEROSIS, was granted the special status by the FDA and now Biogen Idec is enrolling patients for a phase three study, which will evaluate the drug's effectiveness and the safety.

Michael Panzara, vice president and chief medical officer of neurology at Biogen Idec, said: "Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis." Biogen Idec plans to involve more than 1,200 patients in the phase three trial, which will also look into whether the treatment can slow the progression of multiple sclerosis.

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Not all news is good news, but some of it is important, nevertheless. This next piece is one of those...


People who survived cancer as children face a high lifelong risk for developing another cancer, a new study has found.

A study that appears online May 26 in the Journal of the National Cancer Institute went further than earlier studies by following people from birth through age 79. The researchers analyzed data on more than 47,000 people who had been diagnosed with cancer before the age of 20.

The incidence of new cancers found by the analysis was higher than expected, the researchers said. They found that 1,180 second primary cancers were diagnosed in 1,088 of the people who'd survived a childhood cancer. The brain was the most common site for second primary cancers.

The risk of second primary cancers was significantly higher in men than in women, the researchers reported. "This study quantified long-term temporal patterns of increased risk of cancer at specific sites in survivors of childhood cancer," wrote Dr. Jorgen H. Olsen, of the Institute of Cancer Epidemiology, Danish Cancer Center, and colleagues. "The results may be useful in the screening and care of these individuals."

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DRUG TRIALS SHOW GAINS AGAINST LUNG CANCER That's the conclusion of studies presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla.

Lung cancer remains America's leading cancer killer, and "significant" improvements in time-to-disease recurrence and survival are measured in weeks and months, not years, experts stress.

The benefits from any drug also vary from patient to patient. "Some patients are benefiting much more and some much less," noted Dr. Roy Herbst, chief of thoracic medical oncology at the University of Texas M.D. Anderson Cancer Center in Houston and lead author of one of the studies presented at the meeting.

In data presented at an ASCO news conference, researchers found that the drug Alimta (pemetrexed) prolonged survival by almost three months in patients with ADVANCED NON-SMALL CALL LUNG CANCER, the deadliest form of the disease. This benefit was almost exclusively confined to people with the nonsquamous forms of the disease, the researchers said.

"This is the first randomized, placebo-controlled trial that showed a benefit to pemetrexed in the 'maintenance' setting, after initial therapy. It was also very well tolerated," said study lead author Dr. Chandra P. Belani, deputy director of the Penn State Cancer Institute. Maintenance therapy, given after standard chemotherapy, refers to continuing some portion of a patient's treatment to help stave off a recurrence.

While previous research had shown that pemetrexed as maintenance therapy extended disease-free survival, this was the first study to show a benefit to overall survival, the researchers said.

For this study, 663 patients with advanced non-small cell lung cancer who had successfully responded to four rounds of traditional chemotherapy were randomly chosen to receive either pemetrexed or a placebo along with "best supportive care." The pemetrexed group survived for a median of 13.4 months while those on the placebo survived 10.6 months, the research team reported. The difference was more pronounced in those patients with the nonsquamous type of cancer: 15.5 months overall survival in those taking pemetrexed versus 10.3 months for those taking a placebo.

Maintenance therapy is a new concept in cancer care. In fact, its initial promise emerged about a year ago, when progression-free survival data for pemetrexed was first presented.

"That was promising but people were wondering if this just delayed the time until we had to use pemetrexed as a second-line treatment," said Dr. Karen Reckamp, assistant professor of medicine at City of Hope Cancer Center in Duarte, Calif. In general, cancer patients are treated with four to six cycles of "first line" therapy -- about five months -- and are then stopped and monitored. If the cancer returns, they receive "second line" therapy.

Side effects were worse in the pemetrexed group but overall they were not terrible, the researchers stated. "Patients actually tolerated the drug fairly well," Belani said.

Another study, also presented at the ASCO press briefing, looked at patients with advanced non-small cell lung cancer taking the drug Zactima (vandetanib). Researchers found that adding the medication to chemotherapy (including docetaxel) improved progression-free survival. Unlike other lung cancer drugs, Zactima packs a one-two punch, targeting two separate cellular receptors involved with tumors: epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF).

Following initial chemotherapy, almost 1,400 patients were randomly selected to receive docetaxel plus Zactima, or just docetaxel. After more than a year of follow-up, participants taking Zactima had a median progression-free survival of 17.3 weeks versus 14 weeks for those taking the placebo, a 21 percent reduction in risk.

"There was [also] an improvement in overall survival, a positive trend, but it was not statistically significant: 10.6 months in the Zactima arm versus 10 months in the placebo group," said Herbst, who led the trial.

Patients also felt better on Zactima, the researchers said. The bottom line, according to Herbst, is that "patients [on Zactima] are clearly progressing less quickly. But, unfortunately, all are going to succumb to the disease." Still, "they are reporting they were feeling better," he added. "That's a small step. Do we want more? Absolutely."

Yet a third trial found that combining the targeted therapies Tarceva (erlotinib) with Avastin (bevacizumab) as maintenance therapy in patients with advanced non-small cell lung cancer helped patients live longer before their disease returned -- a median of 4.8 months for the combined group versus 3.7 months in the control group.

These findings should encourage the use of maintenance treatments, Reckamp said. She noted that the pemetrexed (Alimta) trial is "the first study that shows overall survival is improved with maintenance, so it challenges the initial paradigm. This data, [along] with the data on Avastin and erlotinib, helps to bring the information home that maintenance therapy in lung cancer is something we need to think about and it will be easy [non-toxic] for people to use.

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In case you're scheduled for a colonoscopy, this is good to know:


More isn't necessarily better when it comes to surgically removing lymph nodes to diagnose late-stage colorectal cancer, new research shows.

In 1990, the World Congress of Gastroenterology recommended that surgeons remove at least 12 lymph nodes during surgery for colorectal cancer, the study authors noted in Archives of Surgery. The standard was widely adopted as a measure of quality in surgical practices.

Then in 2004, researchers from three medical centers in the Chicago-Skokie, Ill., area embarked on an initiative to increase the number of lymph nodes removed during surgery. They later analyzed the medical records of 701 colorectal cancer patients who'd had surgery between 1996 and 2007. The records included surgeries done before and after the initiative began. The researchers found that the average number of lymph nodes removed increased from 12.8 to 17.3 after the initiative began. About 72% of the patients had at least 12 lymph nodes removed, compared with 53% before the initiative.

Even so, the proportion of patients diagnosed with stage 3 colorectal cancer did not change significantly. About 37% of patients who had surgery before the initiative were diagnosed with late-stage colorectal cancer, compared with 32% of earlier cases.

"Our data suggest that mandatory harvest of a minimum of 12 lymph nodes as a quality indicator or performance measure appears unfounded," the researchers wrote.

The status of lymph nodes near the cancer is one of the best means of determining prognosis and chances of survival in colorectal cancer, which is the third most common type of cancer and the third-leading cause of cancer-related death in the United States, according to background information in the study.

"Accurate lymph node staging also is important for determining prognosis and the need for adjuvant chemotherapy," the researchers wrote. "In addition, lymphadenectomy [lymph node removal] may be therapeutic; several studies have shown a positive association between the number of lymph nodes removed and survival for patients with negative and positive lymph nodes."

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A significant development in pancreatic cancer is the maturation of data showing support for adjuvant chemotherapy in resected localized disease. Surgical resection offers the only chance of cure in patients with localized disease. Only 20% of cases are potentially resectable, and even then, prognosis is poor in patients with resected disease, with 5-year survival rates of between 10% and 25%.

The weight of evidence to show the role of postoperative chemotherapy in patients with resected pancreatic cancer came from two randomized Phase 111 trials. The first was the European Study Group for Pancreatic Cancer, which was constructed to answer the relative benefit of chemo and also chemoradiation in patients with resected pancreatic cancer, utilizing a 5-fluorouracil (5FU) backbone. The trial demonstrated a survival advantage of 6 months (19.7 vs 14 months) for the postoperative chemotherapy arm.

Although the study was flawed, there were some important useable messages. Chemoradiation seemed to have no advantages, with possibly a detrimental effect, with a median survival of 15.5 vs 16.1 months. The 5-year survival rates were also much higher in the group receiving chemotherapy, compared with chemoradiotherapy (21% vs 8%)

A smaller trial randomizing patients to postoperative adjuvant combination chemotherapy, 5FU, doxorubicin, mitomycin C once every 3 weeks for six cycles, or into an observation group, also showed a significant increase in median survival (23 vs 11 months); however, 5-year survival rates were similar (8 vs 4%).

The second recently published important trial of adjuvant therapy is Charite Onkologie (CONKO)-001, which aimed to compare postoperative gemcitabine with observation alone in patients with fully resected pancreatic cancer. It involved 368 patients, and randomized patients on the treatment arm to six cycles of gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 4-weekly cycle. The updated data show a 5-year survival rate of 21% in the gemcitabine arm versus 9% in the observation arm. The median survival was 22.8 versus 20.2 months, with a disease-free interval of 13.4 versus 6.9 months in the observation arm, both of which were statistically significant results. Patients were stratified by resection margins and also nodal status, and chemotherapy was also associated with significant improvements in the above measures. The terminal tail of the overall survival (OS) curve suggests that, although the median survival difference is not large, there is a significant group of long-term survivors who benefit from the use of gemcitabine in the postoperative setting.

There have not been adequate trials to answer whether neoadjuvant chemotherapy is superior to adjuvant therapy for the treatment of patients with resectable pancreatic cancer. While neoadjuvant chemotherapy has theoretical advantages, such as increasing resectability and allowing those patients with rapidly progressive chemotherapy-refractory disease to declare themselves prior to operation, there have been no direct comparisons. Almost all the neoadjuvant trials have used chemoradiotherapy and have had small numbers of patients and, therefore, lack adequate statistical power to be recommend as routine care for this condition.

This approach with adjuvant chemotherapy has been followed mostly in Europe, rather than the American approach of adjuvant chemoradiotherapy. As with the debate between neoadjuvant and adjuvant therapy, this debate has been shaped by small, underpowered studies that enable few firm conclusions.. The Gastrointestinal Tumor Study Group (GITSG) trial managed to only recruit 43 patients, and randomized patients to observation only or 5FU-based chemoradiotherapy followed by adjuvant chemotherapy. Despite the low numbers of patients, there was a significant survival benefit for the chemoradiation group, at 20 compared with 11 months.

No trial has compared 5FU-based chemoradiotherapy with gemcitabine-based treatment, but the Radiation Therapy Oncology Group (RTOG) 9704 trial evaluated the benefit of adding gemcitabine pre- and post-5FU chemoradiotherapy after surgical resection relative to the 5FU pre- and postchemoradiotherapy. There was a modest benefit in improvement in median survival (20.5 vs 16.9 months) that favored the gemcitabine arm in those patients with pancreatic head tumors.

The ESPAC-3 trial comparing adjuvant gemcitabine with adjuvant fluorouracil is currently ongoing and its results may guide clinicians in their choice of adjuvant therapy. Whether chemotherapy alone is superior to chemoradiotherapy in the adjuvant setting is still to be answered in an adequately powered and well-executed and -designed randomized trial. Future trials are necessary to ascertain when the chemotherapy should be given, what the best chemotherapy regimen is and what the contribution of radiotherapy is to the adjuvant treatment plan. Identifying those patients at high risk of disease relapse in the future will need to be based on both well-characterized and validated clinical and potential molecular markers.

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Finally, once again I'm including verbatim a piece that appeared in The New York Times "Science Times" section. It's self-explanatory...


By Andrew Pollack

The newest prognosis for cancer may be longer chemotherapy.

Doctors and pharmaceutical companies are moving toward treating cancer patients with drugs continuously, even when they may not urgently need them.. That would be a departure from the common practice of stopping treatment when the cancer is under control and resuming it only if the cancer worsens..

The strategy is called maintenance therapy - akin to periodic tune-ups aimed at preventing a car from breaking down. Doctors say it could prolong the tie tumors are under control, helping to turn cancer into a chronic disease that is kept in check even if it is not cured.

While maintenance therapy is not entirely new, its use is growing, in part because some of the newer cancer drugs are more tolerable than the toxic ones of old and can be taken for longer periods.

At the recent annual meeting of the American Society of Clinical Oncology, for instance, doctors filled a huge auditorium for a debate on whether it is time to adopt maintenance therapy for lung cancer, the nation's leading cause of cancer death. Other cancers for which maintenance therapy is being used or tried include ovarian cancer, multiple myeloma and non-Hodgkin's lymphoma.

But some experts say that in many cases, the long-term use of drugs has not been proved to prolong life.

Instead, it may just subject cancer patients to more side effects and tens of thousands of dollars in extra costs. There is also concern that tumors might become resistant to a drug used for a long time.

"Generally more is better, in both dose and potentially duration," said Dr. Susan L. Kelley, chief medical officer of the Multiple Myeloma Research Foundation, which sponsors research on treatments for that disease. However, she said "there are numerous kinds of cost to the patient, to the health system, to give these drugs over the longer term."

Dr. Lawrenfe H. Einhorn, a professor at Indiana University, said much of the push for maintenance therapy was coming from pharmaceutical companies, which want their drugs "to be used as early as possible and as long as possible."

And executives of these companies acknowledge that the therapy would mean bigger sales. "This is clearly a game-changing opportunity," Brian P. Gill, vice president for corporate communications at Celgene, which is testing its drug Revlimid for maintenance treatment of multiple myeloma, told investors at a conference in March.

Bt the executives, and many doctors, say there is a good rationale for maintenance therapy.

Although treatment varies with the type of cancer, many patients now receive several initial cycles of chemotherapy. Then, if the cancer goes into remission, or even if the tumor simply stops growing, the therapy is stopped. It is resumed, usually with different drugs, only when the cancer starts worsening again.

That strategy evolved in part because the older chemotherapy drugs were so toxic that patients often needed to take a holiday from treatment.

"But if you think about it practically, you don't really want to give the tumor a holiday," said Colin Goddard, the chief executive of OSI Pharmaceuticals, which is trying to position its lung cancer drug Tarceva for use in maintenance therapy.

Some cancer patients welcome, or even demand, maintenance therapy, wanting to keep up the fight against their disease.

"I was one of those people who was frightened to stop chemo," said Barbara Platzer, 71, of St. Louis, who has ovarian cancer.

So when her initial six cycles of chemotherapy ended with her cancer in remission, she enrolled in a clinical trial that provided her with 12 monthly maintenance treatments of an experimental drug called Xyotax. The results of the trial are not yet known, but Ms. Platzer's cancer has remained in remission.

But Caryl Castleberry of Glen Ellen, Calif., who also has ovarian cancer, turned down maintenance therapy.

"I could hardly wait to be free from treatment, so the extra year they suggested was just not acceptable," said Ms. Castleberry, 61, whose cancer has nonetheless remained in remission for six years.

Dr. Robert L. Coleman, an expert on overian cancer at the M. D. Anderson Cancer Center in Houston, said that because relapses tend to be fatal, there has been an urgent effort to prevent or delay them. But over the years, eight maintenance therapies failed in clinical trials.

Finally, a study published in 2003 showed that 12 monthly maintenance treatments of paclitaxel, a generic drug whose brand name is Taxol, delayed tumor progression by about seven months as compared with 3 monthly treatments with the same drug. But the difference in survival was not was not statistically significant, Dr. Coleman said, so there is still some debate about the merits of maintenance therapy for ovarian cancer.

For lung cancer, the move to maintenance therapy is being spurred by the results of a clinical trial of the drug Alimta that were presented at the oncology meeting in Orlando, Fla., in late May. Based on that trial, both the Food and Drug Administration and European regulators approved the use of Alimta for maintenance therapy earlier this month. (See above)

The trial, sponsored by Eli Lilly, which makes Alimta, involved 663 patients with advanced cancer whose tumors had shrunk or remained stable after the customary four cycles of initial chemotherapy. In typical practice, those patients would not be treated again unless their tumors resumed growing.

But in the trial, some patients got Alimta immediately after completing the initial, or first-line, chemotherapy. They lived a median of 13.4 months, significantly longer than the 10.6 months for those who got a placebo. The patients with the type of tumor for which Alimta works best lived a median of 15.5 months with maintenance therapy.

"This will change the treatment paradigm," said Dr. Chandra P. Belani, deputy director of the Penn State Hershey Cancer Institute and the lead investigator in the trial.

But skeptics said the trial did not directly compare giving Alimta immediately with waiting until the tumor worsened. So it is not clear whether it was just the drug that provided the benefit, rather than the maintenance therapy. Two-thirds of the patients in the placebo group did get second-line therapy when their tumors worsened, but usually not with Alimta.

Alimta, also known as pemetrexed, costs about $4000 per infusion given once every three weeks. Based on data from Lilly's trials, patents getting the drug as maintenance therapy would receive an average of three more infusions than those getting the drug as second-line therapy.

Also, about 30 to 50 percent of lung cancer patients never get second-line chemotherapy, often because their condition worsens too much. So if Alimta were used as maintenance therapy, many more patients would get it.

For non-Hodgkin's lymphoma, the drug used for maintenance is usually Rituxan, or rituximab, which is sold by Genentech and Biogen Idec.

A clinical trial showed that maintenance therapy with Rituxan did not help patients with an aggressive form of the disease. But a separate study, published recently in The Journal of Clinical Oncology, showed that it helped those with less aggressive forms of the disease.

After three years, cancer had not worsened for 68 percent of those who received the maintenance therapy. That was true for only 33 percent orf those who did not receive the therapy. The survival difference was smaller, with 92 percent of those who got the maintenance therapy alive after three years compared with 86 percent of those who did not.

"We need more follow-up to see if it will improve overall survival," said Dr. Thomas M. Habermann of the Mayo Clinic, an author of the study. Nevertheless, many doctors are giving patients maintenance treatment, usually four weekly infusions of Rituxan every six months for two years. That would cost about $30,000 a year.

For multiple Myeloma, the drug being tried most often for maintenance therapy - Revlimid, or lenalidomide - is already being used for patients with relapses. It costs more than $6,000 a month and is taken as a once-a-day pill, making it particularly convenient for long-term use.

Right now it is used for an average for 10 months in the United States; with maintenance therapy that could grow to years, since remissions for multiple myeloma can last that long.

Trials are under way, but some doctors are not waiting. "We really need some randomized data to support it, but in the meantime it seems like a good idea," sai Dr. Brian G. M. Durie, chairman of the International Myeloma Foundation, an advocacy and research group that gets some financing from pharmaceutical companies.

Kevin, a graduate student with multiple myeloma, says he hoped a stem cell transplant would mark the end of his treatment. So he was taken aback when his doctor suggested taking Revlimid for two years as a maintenance therapy as part of a clinical trial. He has been taking it a year so far, with some mild side effects like fatigue and upset stomach.

"I'm not enthusiastic about being on a drug like this indefinitely," said Kevin, who spoke on the condition that his last name not be used because he did not want prospective employers to know about his illness. "But on the other hand, it's a lot better than relapse."

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See you in September... (If you remember than song, you're as old as I am!)

And if you have any thoughts of how this newsletter could be improved, please email me directly, at

Elaine Jesmer

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