Lessons in Getting More Attention for GI Cancers

by Bob Spiegel

"America hasn’t done anything well since World War II."

Not the kind of statement you’ld exactly expect from the chief of oncology/hematology at Georgetown University Medical Center in Washington. And what does it have to do with gastrointestinal cancer? A casual passerby might be led to believe he just heard a rabble-rousing and damning statement from a malcontent at a political rally. But, in fact, the statement was an attention-getting analogy by Dr. John Marshall to highlight how the synergistic efforts of industry, the general population, the government and the medical community enabled the U.S. to prevail in WWII, and how the lack thereof hinders
the present-day fight against cancer.

Dr. Marshall was not the opening speaker at the Gastrointestinal Cancer Symposium’s conference on redefining the benefits of EGFR-Targeted Therapies in GI cancers, but he was the most engaging. Marshall’s focus was on how to get all sectors to cooperate: industry, regulatory agencies, Ëœpayers" (that’s us and insurance companies), and the medical community. He used an AV slide to demonstrate why we’re not making more progress and his bullet points were alarming:

• Adjuvant therapy fails most of the time
• Clinical trial accrual in the U.S. is at an all-time low
• Trials are more often than not being outsourced to other countries, and
• Cancer treatments add little to survival (the most disheartening of all).

A word of caution; this particular conference was a generalized GI cancer session, dealing primarily with carcinomas, not soft tissue sarcomas such as GIST. But the comments were nonetheless frightening and they are uncomfortably Ëœclose to home." Marshall went on to say the current strategy is not something of which we should be proud. The suspect strategy he eschews: Treat everyone the same way and hope they are the one or two people out of ten who will benefit and for which the treating physician can then claim Ëœsuccess." In an obvious understatement, he added advice to his presentation by admonishing the some 100 attending doctors, "We need to refocus."

The hematology/oncology chief went on to put down the value of phase III clinical trials, worth what he described as "little." He urged a refocus to Phase II trials and cited Gleevec (always described as imatinib) as his proof that Phase II studies are of greatest value, and faster drug development could be attained by shifting away from Phase III trials and transitioning to Phase II trials with heavier "translation evidence." Why can’t we? Federal regulatory agencies are not ready for this, he claims. Marshall closed his portion of the program with the optimistic observation that segmentation of cancers into smaller groups has begun and was a step in the right direction.

Dr. Edward Chu, Chief, Section of Medical Oncology at Yale Cancer Center opened and chaired the generalized GI cancer conference and detailed the progress of more carcinoma-related pharmaceuticals being tested, names mostly alien to this reporter since there are few "crossover" drugs. Chu was followed by Dr. Lee Ellis, Professor of Surgery and Cancer Biology at M.D. Anderson in Houston, who focused on how using targeted therapy improves the odds of curative resection, and Dr. Howard Hochster, Professor of Medicine at New York University School of Medicine in NYC. Hochster discussed the impact of anti-EGFR therapy on upper GI
cancers.

Ellis stated that with cytotoxic chemotherapy, tumor cells are left behind an eye-opening 87% of the time and led a discussion on how targeted therapies can impact liver regeneration.

One noteworthy observation made by this lay-person-among-medical professionals was the eyebrow-raising variance of responses when the speakers cited medical cases and asked the attendees to answer, with electronic remote units, how they would deal with the hypothetical cases. Rarely was the group overwhelmingly united on a single therapy or protocol. Some questions drew responses I could only describe as "scary"; that is to say the disparate conclusions pointed out more than anything else (for me) the value of that "second opinion.&quoquot; The longer I listened, the more I wanted to add my own question to the AV slide hypothoses: What would be the average survival rate of the treating physician should his mis-read of a patient’s tests lead to improper prescribing and eventual patient demise? But I restrained myself, for I was a "guest" in the "House of the Gods."