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Profesionales de la salud / / / /
Reviewer: Neha Vapiwala, MD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 6 de junio del 2004
This presentation discusses the use of imatinib at a dose that has not been approved by the FDA.Presenter: J.R. Zalcberg
This international intergroup has previously demonstrated an improvement in progression-free survival (PFS) with the use of high-dose (HD) imatinib in patients with gastrointestinal stromal tumors (GIST), as compared to those treated with low-dose (LD) imatinib. In that trial, patients on the LD arm were permitted to crossover to the HD arm in the event of disease progression during LD treatment. This study was designed to specifically evaluate the safety and efficacy of allowing this "dose escalation" crossover in patients with progressive disease, rather than declaring treatment failure and abandoning imatinib in favor of another therapy.
Materials and Methods
This important study presents preliminary data suggesting that some advanced GIST patients with progressive disease on LD imatinib therapy may benefit from dose escalation to HD imatinib. Although the majority of patients continued to have disease progression after crossing over to HD therapy, there was a response rate of 32.8% and a one-year PFS rate of 18.1%, showing some benefit to the 800 mg dose even after the 400mg dose did not succeed. Furthermore, the GMI calculation lends support to this practice, with an index >1.33 in 24.5% indicating greater activity of HD imatinib compared to LD imatinib. The authors admit that the application of the GMI is hypothesis-generating, but does prompt further research in this area. Overall, this trial does support the practice of attempting higher dose imatinib treatment in patients who fail the low-dose therapy, rather than immediately discontinuing imatinib and switching to a different drug.
Two possible mechanisms might explain the benefit of HD therapy shown here:
What might be useful in this study is a measurement of the drug serum levels of imatinib in the crossover patients before and after the crossover from LD to HD. This might help further clarify the mechanism behind the observed effect.
Finally, it is not surprising that certain adverse effects, such as anemia and fatigue, would be worse on the HD therapy compared to LD, but it is not clear why the neutropenia should improve. This finding raises the possibility that some imatinib-related toxicities may in fact decrease with increasing duration of treament.
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