Biweekly Triple Combination Chemotherapy with Gemcitabine, Oxaliplatin, Levofolinic Acid and 5-Fluorouracil (GOLF) Is a Safe and Active Treatment for Patients with Inoperable Pancreatic Cancer
Authors: Correale, P.; Montagnani, F.; Miano, S.; Sciandivasci, A.; Pascucci, A.; Petrioli, R.; Testi, W.; Tanzini, G.; Francini, G.
Source: Journal of Chemotherapy, Number 1, February 2008 , pp. 119-125(7)
Publisher: Maney Publishing
Abstract:GOLF is a triple translational combination chemotherapy regimen with gemcitabine, oxaliplatin, and 5-fluorouracil (5-FU) (plus levofolinic acid), cytotoxic drugs currently used in the treatment of pancreatic carcinoma. Considering its promising anti-tumor effects in patients with gastroenteric malignancies, we carried out the present study to investigate its toxicity and anti-tumor activity in patients with advanced pancreatic carcinoma. Twenty-seven patients were enrolled in the study, 15 males and 12 females with an average age of 61 years and a performance status (ECOG) ≤3. Eight of them had already received first-line chemotherapy, 16 had liver involvement and 11 had inoperable locally (nodes, soft tissue infiltration, peritoneum etc) advanced disease. All patients received biweekly gemcitabine (1000 mg/m2 on day 1), oxaliplatin (85 mg/m2 on day 2); levofolinic acid (100 mg/m2) and 5-FU (400 mg/m2 as bolus, and 800 mg/m2 in 24-h infusion) on days 1 and 2. We report one fatal event occurring just after the first cycle due to lung embolism; grade II-III-diarrhea and mucosytis (44.4%); alopecia (37%); thrombocytopenia (18.5%); grade I-II asthenia, fatigue, non-neutropenic-fever (37%) and oxaliplatinrelated neurotoxicity (18.5%). We also registered fast pain control in most patients, an objective response and disease control rate of 33.3% and 63% (1 complete and 8 partial responses and 8 disease stabilizations) respectively, with clinical benefit in 60% of patients and median time to progression and overall survival of 5.5 and 8 months, respectively.
In conclusion, the GOLF regimen appears to be a feasible treatment for patients with advanced pancreatic carcinoma that deserves to be evaluated in phase III trials.
Document Type: Research Article
Publication date: 2008-02-01