Second Line Treatment with Oxaloplatin, Folinic Acid and 5-Fluorouracil (OFF) in Gemcitabine Refractory Advanced Pancreatic Carcinoma
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- Category: Vol. 80, June 2012
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Second Line Treatment with Oxaloplatin, Folinic Acid and 5-Fluorouracil (OFF) in Gemcitabine Refractory Advanced Pancreatic Carcinoma,FATMA M.F. AKL, GHADA E. ELADAWEI and WAFAA EL-BESHBESHI
Abstract
Background and Objective: Although single agent gem-citabine is widely accepted as first-line therapy for pancreatic carcinoma, there is no current standard of care for gemcitabine-refractory patients. Common second line chemotherapy in-cluded oxaloplatin and 5-FU/leucoverin (OFF), gemcitabine and oxaloplatin (GEMOX), oxaloplatin and capecitabine (XELOX) and irinotecan-oxaliplatin. Oxaloplatin-based cy-totoxic therapy has emerged as a potential option both in the first and second line setting for gemcitabine-refractory patients. This study was designed to evaluate activity and tolerability of oxaloplatin, folinic acid and 5-FU (OFF) regimen, moreover, the progression free and overall survival.
Patients and Methods: This prospective study was con-ducted on 23 patients with advanced pancreatic carcinoma, who had progressed during or following gemcitabine therapy. The OFF regimen consisted of 6 weeks cycle of folinic acid (FA) (200mg/m2 half an hour I.V infusion), followed by 5- FU (200mg/m2 24 hours I.V) received on days 1, 8, 15 and 22. Oxaloplatin (85mg/m2, 2 hours I.V) was administrated before FA/5FU on days 8, 22. After 3 weeks rest, the next cycle was started (D43 is D 1 of the next cycle). The primary end point of the study was efficacy of OFF regimen measured by response rate and toxicity. Secondary end points were progression free survival (PFS) and second line survival, which was calculated from the start of OFF administration until death of the patients or last follow-up.
Results: Overall, treatment was well tolerated, acute haematologic toxicities were limited, with grade II anaemia (26.8%) the commonest. No grade III or IV haematologic toxicities were reported. The most common non-haematologic toxicity was peripheral neuropathy (56.5%). GIII non-haematologic toxicities occurred only in two patients. There were no reports of grade IV non-haematologic toxicities. The activity of the (OFF) regimen was good, achieving partial response in 5 patients (21.7%), 7 patients showed stable disease (30.4%) and 11 patients showed progressive disease (47.8%). The median second line survival and the progression free survival were 4.5 months (95% CI: 2.74-6.26) and 2.6 months (95% CI: 1.5-3.7), respectively.
Conclusion: Our study showed that the OFF regimen is active and well tolerated second-line treatment for patients with advanced pancreatic carcinoma after progression on first-line gemcitabine.
Miniabstract: OFF regimen is active and well tolerated second-line treatment for patients with advanced pancreatic carcinoma after progression on first-line gemcitabine.