TY - JOUR
T1 - 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
AU - Correale, P.
AU - Montagnani, F.
AU - Miano, S.
AU - Sciandivasci, A.
AU - Pascucci, A.
AU - Petrioli, R.
AU - Testi, W.
AU - Tanzini, G.
AU - Francini, Guido
PY - 2008/2
Y1 - 2008/2
N2 - 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/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.
AB - 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/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.
KW - 5-fluorouracil
KW - Biweekly schedule
KW - Gemcitabine
KW - Levo-folinic acid
KW - Oxaliplatin
KW - Pancreatic adenocarcinoma
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M3 - Article
C2 - 18343754
AN - SCOPUS:41149159801
VL - 20
SP - 119
EP - 125
JO - Journal of Chemotherapy
JF - Journal of Chemotherapy
SN - 1120-009X
IS - 1
ER -