title: 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.
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/m(2 )on day 1), oxaliplatin (85 mg/m(2 )on day 2); levofolinic acid (100 mg/m 2) and 5-FU (400 mg/m(2 )as bolus, and 800 mg/m(2 )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 oxaliplatin-related 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.
authors.affiliation: Medical Oncology Division, Department of Human Pathology and Oncology, Siena University School of Medicine, Italy. correale@unisi.it
authors.forename: P
authors.initials: P
authors.lastname: Correale
authors.forename: F
authors.initials: F
authors.lastname: Montagnani
authors.forename: S
authors.initials: S
authors.lastname: Miano
authors.forename: A
authors.initials: A
authors.lastname: Sciandivasci
authors.forename: A
authors.initials: A
authors.lastname: Pascucci
authors.forename: R
authors.initials: R
authors.lastname: Petrioli
authors.forename: W
authors.initials: W
authors.lastname: Testi
authors.forename: G
authors.initials: G
authors.lastname: Tanzini
authors.forename: G
authors.initials: G
authors.lastname: Francini
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine