title: Safety and efficacy of single-day GemOx regimen in patients with pancreatobiliary cancer: a single institution experience.
abstract: BACKGROUND
  GemOx (gemcitabine 1000 mg/m(2) > 100 min on day 1 and oxaliplatin 100 mg/m(2) on day 2 every 2 weeks) achieved a response rate of 26.8%, improved progression-free survival (PFS) but failed to demonstrate a benefit in overall survival (OS) compared with gemcitabine in pancreatic cancer. This regimen has regained attention after recent pooled- and meta-analysis suggested a survival benefit of gemcitabine-platinum doublets over gemcitabine. However, GemOx is associated with inconvenience to patients, early cumulative dose developing neuropathy and thrombocytopenia. In addition, fixed dose rate of gemcitabine showed no benefit > 30 min infusion schedule in the ECOG6201 study. Pharmacokinetic profiles of both drugs did not show statistically significant difference regardless of the order of administration.
  
  
  METHODS
  In order to create a more convenient and equally effective regimen, we conducted a retrospective study to evaluate the efficacy and safety of single-day modified GemOx (S-GemOx, gemcitabine 1000 mg/m(2) > 30 min and oxaliplatin 85 mg/m(2) > 2 h on day 1 every 2 weeks) in patients with pancreatic and biliary cancers.
  
  
  RESULTS
  In all, 34 patients (median age 60 years, male/female: 17/17) received S-GemOx including locally advanced or metastatic pancreatic cancer (26) and biliary duct carcinoma (8). Median treatment was six cycles with duration of 12 weeks (range (r): 2 - 56). Median cumulative dose of oxaliplatin was 517.5 mg/m(2) (r: 85 - 2380). A total of 27 of 34 patients were evaluated for efficacy after initial staging: 1 (3.7%) complete response (CR), 4 (14.8%) partial response (PR), 18 (66.7%) stable disease and 4 (14.8%) progression of disease. Overall response rate (CR + PR) was 18.5%. Median PFS and OS were 7 and 11.6 months, respectively. All patients were assessed for toxicities. Grade 3/4 hematological toxicities include anemia (8%), neutropenia (11%), thrombocytopenia (5%), nausea/vomiting (3%), diarrhea (3%), hypersensitivity reaction (14%) and neuropathy (3%). No deaths occurred due to therapy.
  
  
  CONCLUSIONS
  S-GemOx regimen provides convenient schedule, toxicities appear to be comparable with GemOx. The incidence of neuropathy (3 vs 19.1%) and thrombocytopenia (5 vs 14%) are substantially lower compared with GemOx. Prospective studies of S-GemOx in a large patient population are warranted.
authors.affiliation: Division of Medical Oncology, Yale School of Medicine, Yale Cancer Center, New Haven, CT 06520, USA. wasif.saif@yale.edu
authors.forename: Jia
authors.initials: J
authors.lastname: Li
authors.forename: Manyee
authors.initials: M
authors.lastname: Merl
authors.forename: Mike X
authors.initials: MX
authors.lastname: Lee
authors.forename: Kristin
authors.initials: K
authors.lastname: Kaley
authors.forename: Muhammad W
authors.initials: MW
authors.lastname: Saif
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000401:mortality; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D003841:Deoxycytidine