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Gemcitabine in Combination with «De Gramont» Protocol as First-Line Chemotherapy for Unresectable or Metastatic Pancreatic Carcinoma. A phase II study

Domenii publicaţii > Ştiinţe medicale + Tipuri publicaţii > Articol în revistã ştiinţificã

Autori: Cebotaru C, Ghilezan N, Todor N, Popa L, Iancu D, Cainap C, Banu E, Eniu A, Mihailov A, Homokos H, Ciuleanu TE

Editorial: Radioterapie & Oncologie Medicala, VII(1), p.77-84, 2001.


This phase II study was initiated to detennine the efficacy and tolerability of gemcitabine added to «De Gramonb> regimen as first line chemotherapy (CT) for advanced/metastatic pancreatic carcinoma. From 1/1999 to 4/2000,23 chemonalve patients were enrolled. Up to 6 cycles ofFOLFUGEM regimen were given: Folinic acid 200 mg/m2 in 2 ills, 5-FU 400 mg/m2 in bolus, 5-FU 600 mg/m2 in 22 hrs infusion days 1,2 and Gemcitabine 800 mg/m2 in 1 hr on d2, every 14 days. Median age was 52, M/F 19/4, perfonnance status (WHO) 1 (14 patients), 2 (3 patients) and 3 (6 patients). Initial weight loss was <5% in 15 and> 5% in 8 patients. In 17 evaluable patients, 3 CRs and 2 PRs were observed, for an overall response rate of29% (0.05 CI: 6%-53%). Four patients (19%) had stable disease. Eight patients (32%) progressed under CT. Overall, 14 patients among 22 evaluable (=64%, CI: 42%-85%) had clinical benefit. With a median follow-up up 3.5 months, median survival was 6.6 months and 1 year actuarial survival 34% (0.05 CI: 13%-64%). Sixtynine cycles were administered; median 2 cycles (range 1-8). Toxicity was mild and there were no toxic deaths. Grade 4 thrombopenia in 1 patient and gr. 3 cardiac toxicity in 1 patient was reported. The FOLFUGEM regimen can safely be administered with mild toxicity and proved to be active in the first line palliative treatment of advanced/metaf:tatic pancreatic cancer.

Cuvinte cheie: cancer pancreatic, chimioterapie // pancreatic cancer, chemotherapy