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May 2007

Adjuvant Gleevec Q&A with Jonathan Trent and Jerry Call

Following the announcement that Gleevec reduces recurrence in GIST (May 2007 newsletter), LRG Science Coordinator Jerry Call asked Dr. Jonathan Trent of MD Anderson Cancer Center in Houston, TX follow-up questions as clarification on the trial.

JC: Are there some patients that should/ should not be taking adjuvant Gleevec?

JT: A formal subset analysis from this study may help us answer that question. I approach patients with the general thought that they should take Gleevec after resection of a primary GIST in order to give them the best chance of being cured. With that said, patients are individuals and there are situations where I may not recommend adjuvant Gleevec. Even with this new data the decision should be individualized between a patient and their physician taking into consideration the many risks and benefits.

JC: No mutational data is available for the trial. In light of the data about exon 9 patients having a dramatically higher response rate to higher doses of Gleevec and to Sutent, should these patients receive adjuvant therapy? With what drug and at what dose?

JT: If I recommend Gleevec, then I recommend the 800mg dose for those patients with exon 9 mutation in the KIT gene. We perform mutation analysis on all GIST patients so we have this information routinely available. If sideeffects are a problem then I recommend the highest dose of Gleevec tolerated up to 800 mg. Sutent and Gleevec have not been compared head to head yet. This trial is in development and it is possible that Sutent might be a better choice but we don't know yet.

JC: The trial allowed some patients with tumors that might be considered “low-risk”. Should patients with lowrisk tumors take adjuvant Gleevec?

JT: Yes. Patients with low-risk tumors were included so the current data supports use of adjuvant Gleevec in that population. Moreover, low-risk does not mean “no-risk”. I have personally been recommending adjuvant Gleevec for intermediate to high-risk patients for the past several years. I only enrolled low-risk patients on the ACOSOG Z9001 trial for reasons of equipoise. Basically, I could not ethically risk putting an intermediate or high-risk GIST patient on a study where they might receive a placebo. Our ongoing study of preoperative plus postoperative Gleevec includes 2 years of adjuvant Gleevec with absolutely no placebo arm. And, once again, low-risk features of the GIST are part of the individualized risk-benefit decision between a patient and their physician.

JC: How long should patients take Gleevec on an adjuvant basis?

JT: The data support one year. The next generation of studies will hopefully focus on duration of adjuvant therapy. Our study of preoperative plus postoperative Gleevec for resectable GIST includes 2 years of adjuvant therapy with Gleevec and is open for patients. This may be a more appropriate study for patients with high-risk tumors or exon 9 mutation.

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