Lowering dose not advised

􀀓 Doctor sees no cause to reduce Gleevec if it’s working, well tolerated

Despite preliminary analysis of one North American study showing no difference in the effectiveness of 400 mg. vs. 800 mg. of Gleevec for GIST, patients on the higher dose should remain on 800 mg. as long as it works and side effects are manageable.

“It does not make sense to decrease the dose if it is working and well tolerated,” Dr. Robert Benjamin, chairman of Sarcoma Medical Oncology at the M.D. Anderson Cancer Center in Houston, Texas, told the Life Raft Group recently.

It was Benjamin who reported on the North American Intergroup study of Gleevec in GIST (S0033) at the annual meeting of the American Society of Clinical Oncology held May 31-June 3 in Chicago. At that gathering of 25,000 cancer professionals, Benjamin said early trial results from 746 patients from 57 institutions showed no difference in response time to progression between 400 mg. and 800 mg. doses.

Noting that the counterpart European study with more patients (946) did show longer time to progression on the 800 mg. dose, and that crossover data in the North American study suggested that crossover appeared beneficial in some cases, Benjamin suggested patients already on the higher dose should stay there.

Whether it will prove better is the main question researchers hope to answer, he said. “The data are still not in on whether higher doses will ultimately prove better,”

Benjamin’s comments came about after the Life Raft Group’s Norman Scherzer brought some patient concerns to his attention in an exchange of e-mails in late October. Patients who were on the higher dosage were concerned that the North American study would be used as a basis for lowering their dosage, or that their insurance companies would no longer pay for the higher dosage.

Benjamin, when contacted, responded promptly by asking “what do you need me to do to help.” This article is the result.