title: Sequential FOLFOX-6 and gemcitabine for locally advanced and/or metastatic pancreatic cancer.
abstract: This prospective phase II trial aims to evaluate the sequential FOLFOX-6 and gemcitabine followed by adapted maintenance for advanced pancreatic cancer. Treatment included FOLFOX-6 for 4 cycles, followed sequentially by gemcitabine for 3 cycles. Patients, who show clinical benefit after both sequences, will receive maintenance treatment based on the investigator's discretion. From January 2005 to June 2008, 32 patients with median age of 63 were included; 75% of patients had metastatic disease, 81% had pure adenocarcinoma, while 19% had adenocarcinoma with a neuroendocrine component. There were 22% PR and 22% SD resulting in 44% tumor growth control. Under FOLFOX, grade 3/4 toxicities were neutropenia in 8 patients, thrombocytopenia and anemia in 3 patients each, and diarrhea in 2 patients. Under Gem, grade 3/4 neutropenia was observed in 4 patients, thrombocytopenia and anemia were observed in 2 patients, and hand-foot syndrome was observed in 3 patients. The median TTP and OS were 4 and 10 months, respectively. In APC, FOLFOX-6 regimen followed by gemcitabine achieved an interesting RR within a tolerable level of toxicity. This regimen seems to warrant further investigation to confirm its efficacy.
authors.affiliation: Department of Oncology-Hematology, Hotel-Dieu de France University Hospital, Achrafieh, Blvd Alfred Naccache, P.O.Box: 166830, Beirut, Lebanon. mghosn.hdf@usj.edu.lb
authors.forename: M
authors.initials: M
authors.lastname: Ghosn
authors.forename: A
authors.initials: A
authors.lastname: Saroufim
authors.forename: J
authors.initials: J
authors.lastname: Kattan
authors.forename: G
authors.initials: G
authors.lastname: Chahine
authors.forename: F
authors.initials: F
authors.lastname: Nasr
authors.forename: F
authors.initials: F
authors.lastname: Farhat
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011446:Prospective Studies; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine