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Rowbotham Reports: Should Gleevec Be Front-Line Therapy For New Patients?


ASH 2001 Orlando, Florida, Part 1

Editor's Note: Peter Rowbotham attended the 2001 meeting of the American Society of Hematology, held from Dec. 7-11 in Orlando, Florida, U.S.A. Rowbotham, whose wife has CML, has long dedicated himself to researching new treatment advances and passing that information along to others. Here, his series is presented verbatim.

By Peter Rowbotham
Dec. 7, 2001
Reprinted with permission

[Note from Peter: This report, and any following reports, are based on written notes which may be inaccurate or incomplete. Patients should check with medical professionals as necessary.]

I left the convention at 8 pm today, prior to the end of a symposium on "Advancing the Treatment of Hematologic Malignancies," with more interesting material than I can report on this evening. Here are a few of the highlights.

The most important educational symposium was "Controversies in the Management of CML." The initial question debated was "Is Imatinib Mesylate [Gleevec] or SCT the Therapy of Choice for De Novo CML patients." There were a large number of professionals in attendance to hear Kantarjian of MDACC "wrestle" with Storb who is the Program Head of Transplantation Biology at the 'Hutch' in Seattle. Kantarjian, like Talpaz, has very strong and clearly expressed opinions, and he is always a delight to listen to. He doesn't mince words, and the sparks flew. MDACC and the Hutch seem to approach the treatment of CML very differently. I generalize, of course, but MDACC takes a largely non-SCT stance, and the Hutch a more pro-SCT position.

Kantarjian said that Imatinib (the name now usually given to Gleevec by ASH hematologists) is the frontline therapy for all (presumably De Novo[i.e. newly diagnosed]) CML patients at MDACC. Patients are no longer put on IFN. He spoke very positively about the Gleevec figures, and compared the results to IFN. Gleevec, he said, has a three times higher major-cytogenetic response rate than IFN, it is non-toxic (that`s relative, of course), and can be given orally. Apparently 75% of MDACC's newly-diagnosed patients had a major (less than 35% Ph+) cytogenetic response, and Kantarjian implied that the data for all this class of patients in the trials would be very positive, and it should be available in the next few months. He predicted significant prolongation of survival for many of these patients, beyond even the 10 years reached by some IFN patients with good responses.

There were two issues that he felt strongly about. One of these was the importance of molecular response, which he clearly thought was over-emphasized. The only argument for an SCT, he said, was this notion of cure, and the implication seemed to be that patients on Gleevec therapy were not cured in the same sense that some SCT patients were. That is to say, they weren`t getting the same degree of molecular response. But in Kantarjian's view, getting this degree of molecular response wasn`t crucial, and he clearly felt quite strongly that there needed to be some new thinking about this. In essence, he felt that it is a "false notion that molecular cure is a targeted aim" and it "should not be an endpoint." The second issue that he wanted to stress, was that SCT has risks. SCTs could have a mortality of 10-50% in the first year, depending on the patient's risk factors. Not only that, but there was the problem of morbidities such as sterility, cataracts, secondary cancer, quality of life, and GVHD. In short, a better proponent of Gleevec would be hard to find. Kantarjian is optimistic about its future, thinks that results will continue to improve, that resistance is low, and that "event-free, survival should be the measure" (i.e., not some conventional notion of "cure").

I like Kantarjian's euphoria, and his confidence in Gleevec gives hope to so many. But there is another side to this story, and we should not overlook the strong arguments in favor of SCTs in certain limited situations. There may be 20% of patients who realistically have this option, and there are still many hematologists who like this therapeutic approach. It is quite clear from the views expressed by the speakers that there is no unanimity about the best choice amongst the treatments available. It is also clear that the audience itself has very different views, as the electronic voting that we could do on treatment issues demonstrated.

Tomorrow (?), I will comment on some of the points made in favour of SCTs in certain situations, as well as other ASH information.

Good night from Orlando
Peter

Source: Peter Rowbotham, reprinted with permission




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