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Novel induction chemotherapy regimen, radiation effective for locally advanced pancreatic adenocarcinoma
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2010 Gastrointestinal Cancers Symposium
Patients with locally advanced pancreatic adenocarcinoma participating in a multicenter phase-2 trial had a one-year OS greater than 66% when assigned a novel chemotherapy regimen followed by chemoradiotherapy.
Sixty-nine patients with treatment-naive pancreatic adenocarcinoma were assigned two cycles of cetuximab (Erbitux, ImClone), gemcitabine and oxaliplatin. Those patients who had not progressed at restaging were then given concurrent cetuximab, capecitabine (Xeloda, Roche) and radiation.
“One-year survival was the primary endpoint,” said Christopher H. Crane, MD, professor of radiation oncology at The University of Texas M.D. Anderson Cancer Center. Crane presented the results during the 2010 Gastrointestinal Cancers Symposium in Orlando, Fla. “Statistics were looking for an expected increase in one-year survival from 45% to 60%.”
Actuarial OS was 66.7% at one year (95% CI, 60.2%-73.2%). In unresected patients, one-year OS was 68.7%, and median OS was 18.8 months (95% CI, 14.3-23.7). Crane said an unexpected finding was that a small number of patients were alive with no evidence of progression without surgery at three years (10.2%).
He said the therapy was reasonably well-tolerated. There were 19 grade-3/4 events reported during the chemotherapy phase. Hematological events were the most common, but fatigue and gastrointestinal events were clinically the most significant.
“During the chemoradiation phase, [there was] 2% grade-3 gastrointestinal toxicity and 23% grade-2 gastrointestinal toxicity. Dose adjustments were made to capecitabine at grade-2 toxicity,” Crane said.
Radiographic response was measured six weeks after chemoradiation. The best observed response was partial response in 19% of patients; 17% had minor response, 48% had stable disease and 15% had progressive disease. – by Jason Harris
For more information:
- Crane CH. #132. Presented at: 2010 Gastrointestinal Cancers Symposium; Jan. 22-24, 2010; Orlando, Fla.
