NEWS FROM 2007 WORLD CONGRESS ON GASTROINTESTINAL CANCER
Sutent® (sunitinib maleate) combined with FOLFIRI chemotherapy was active and generally well-tolerated in previously untreated patients with colorectal cancer that had spread according to a Phase I study presented at the World Congress on Gastrointestinal Cancer in Barcelona.
Ten patients received Sutent daily for four weeks, followed by two weeks of rest. They were also getting FOLFIRI chemo treatments. FOLFIRI is a combination of intravenous irinotecan, leuvocorin, and 5FU. The 5FU is given as continuous infusion.
Of the 10 patients in the trial, 4 had a partial response and 6 have had stable disease. Serious side effects included one respiratory infection and two cases of low white cell counts (neutropenia) with fever.
Alfredo Carrato, MD, who will lead a multinational randomized Phase III study of FOLFIRI plus Sutent, said,
Despite progress in recent years, colorectal cancer remains a hard-to-treat cancer for which new options are sorely needed. These data support further research of sunitinib malate in metastatic colorectal cancer, in an effort to potentially expand the range of therapies available to physicians and patients.
Sutent is currently indicated for patients with advanced renal cell carcinoma or gastrointestinal stromal tumor (GIST).
WHAT THIS MEANS FOR PATIENTS
These are results of a small Phase I study whose goal was to find a dose of Sutent that is safe and has tolerable side effects. Effectiveness is not an objective of Phase I clinical trials.
The trial was designed for patients who had not been previously treated for metastatic colorectal cancer, so it is not reasonable to conclude that it might have similar activity in patients who had already had other treatments.
It is too soon to assume that Sutent and FOLFIRI might be a better treatment than FOLFIRI alone. A randomized Phase III trial is planned to answer that question.
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