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Phase II evaluation of fluorouracil and recombinant α‐2a‐interferon in previously untreated patients with pancreatic adenocarcinoma
Author(s) -
Pazdur Richard,
Ajani Jaffer J.,
Abbruzzese James L.,
Belt Robert J.,
Dakhil Shaker R.,
Dubovsky Daniel,
Graham Suzanne,
Pilat Susan,
Winn Rodger,
Levin Bernard
Publication year - 1992
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19921015)70:8<2073::aid-cncr2820700810>3.0.co;2-a
Subject(s) - medicine , mucositis , gastroenterology , fluorouracil , alpha interferon , surgery , regimen , chemotherapy , interferon alfa , pancreatic disease , phases of clinical research , pancreas , immunotherapy , interferon , cancer , virology
Background . Based on initial encouraging results of the combination of 5‐fluorouracil (5‐FU) with recombinant α‐2a‐interferon (rα‐2a‐IFN) in the treatment of advanced colorectal carcinomas, a clinical trial was conducted using 5‐FU with rα‐2a‐IFN in 49 patients with advanced pancreatic adenocarcinoma. Methods . Forty‐nine patients who had bidimensionally measurable disease and had not been treated previously with chemotherapy were entered in the trial. Starting on day 1,5‐FU was administered as a continuous infusion at a dose of 750 mg/m 2 /day for 5 consecutive days. Starting on day 12, it was administered as an intravenous bolus of 750 mg/m 2 a week for 7 weeks. The rα‐2a‐IFN was administered subcutaneously at a dose of 9 × 10 6 units three times a week during weeks 1‐8. Results . Of the 46 patients evaluable for response, none had a complete response, and two had partial responses that lasted 14 and 28 weeks. The overall response rate was 4% (95% confidence interval, 1‐15%). Fourteen patients had minor responses (median duration of response, 12 weeks). The median length of survival of all patients enrolled in this trial was 22 weeks. Grade 3‐4 toxicities included oral mucositis in 19 patients, granulocytopenia in 16, fatigue in 8, and diarrhea in 3. One patient had severe ataxia and leg weakness. Another died of neutropenic sepsis. Conclusions . This regimen had significant toxicity and little evidence of therapeutic activity against advanced pancreatic carcinoma.