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Modified DCF plus bevacizumab improved survival, decreased toxicity

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2009 Gastrointestinal Cancers Symposium

The addition of bevacizumab to a schedule of modified docetaxel, cisplatin and fluorouracil appeared to improve tolerance and survival for patients with metastatic gastroesophageal adenocarcinoma, according to the results of a phase-2 study.

Manish A. Shah, MD, an attending physician at Memorial-Sloan Kettering Cancer Center, presented results from the single site study at the 2009 Gastrointestinal Cancers Symposium in San Francisco. He said the schedule of modified DCF plus bevacizumab (Avastin, Genentech) demonstrated “very encouraging efficacy.”

“Six-month PFS is 79%, which surpasses the efficacy threshold for our phase-2 study,” he said. “Median OS is 16 months, which is approaching double the rate of some phase-3 studies.”

Forty-two patients were assigned to 10 mg/kg bevacizumab, 40 mg/m² docetaxel, 400 mg/m² fluorouracil on day one and 400 mg/m² leucovorin, two days of 1,000 mg/m² daily fluorouracil and 40 mg/m² cisplatin on day three. Treatment was repeated every 14 days.

Six-month PFS was 79% (95% CI, 68%-93%). With 12.4-months median follow-up, median survival was 16.4 months.

Twelve patients (31%) had stable disease (95% CI, 17%-48%) and 26 patients (67%) had partial response (95% CI, 50%-81%).

Neutropenia was the most common grade-3/grade-4 hematologic adverse event, observed in 51% of patients. Four percent of patients had febrile neutropenia, 16% developed thrombocytopenia and 11% developed anemia.

The most common grade-3/grade-4 non-hematologic adverse event was venous thromboembolism (31%).

Shah explained that these results require validation, but they are “certainly encouraging.” – by Jason Harris

Their primary endpoint was PFS and they clearly met that goal. The overall survival benefit was up to 16 months, which was pretty remarkable, but remember that this is a phase-2 trial so they only had 45 patients in the trial. It’s a small study, but a promising study using the combination of a cytotoxic chemotherapy plus this targeted therapy. They need to do a phase-3 trial to confirm this finding.

– Richard D. Kim, MD

Clinical Assistant Professor of Medicine
Taussig Cancer Institute, Cleveland

For more information:

• Jhawer M. #10. Presented at: the 2009 Gastrointestinal Cancers Symposium; Jan. 15-17, 2009; San Francisco.