title: A phase II study of gemcitabine and oxaliplatin (Oxigem) in unresectable gall bladder cancer.
abstract: OBJECTIVE
  There is a need for effective chemotherapy protocols for gall bladder cancer (GBC). Gemcitabine has antitumor activity in pancreatic cancer. Oxaliplatin is effective in GI cancers. Based on evidence of synergy between these two, we designed this study to evaluate efficacy of this combination in unresectable GBC.
  
  
  METHODS
  Unresectable GBC was enrolled for single center phase II study. Drugs gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IV infusion (Oxigem) on days 1 and 8 every 3 weeks for a maximum of six cycles or unacceptable toxicity which ever was earlier.
  
  
  METHODS
  Fifty patients were enrolled and analysis was restricted to 48 who were treated. Median age was 50 years and 31 patients were females.
  
  
  RESULTS
  CR 3 (6.2%), PR 7 (15%), SD 17 (35.4%), and PD 18. One had complete pathological response. Median OS and PFS were 7.5 and 3 months, respectively. OS in responders was 10.5 versus 4 months in non-responders (p<0.0000). Eleven patients (23%) survived for a year or more. There was no toxic death and grade III/IV toxicity seen in 10 (22%) patients: diarrhea 3, vomiting 2, neutropenia and thrombocytopenia 5 patients.
  
  
  CONCLUSIONS
  This combination of Oxigem effective in unresectable GBC. It may even induce complete pathological response. One-year survival was 20%. There is a need for controlled trial to assess efficacy of this combination.
authors: Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India. atul1@hotmail.com
authors: Atul
authors: A
authors: Sharma
authors: Bidhu
authors: B
authors: Mohanti
authors: Vinod
authors: V
authors: Raina
authors: Nootan
authors: N
authors: Shukla
authors: Sujoy
authors: S
authors: Pal
authors: Amit
authors: A
authors: Dwary
authors: Surya
authors: S
authors: Deo
authors: Peush
authors: P
authors: Sahni
authors: Pramod
authors: P
authors: Garg
authors: Sanjay
authors: S
authors: Thulkar
authors: Siddhartha
authors: S
authors: DattaGupta
authors: Goura
authors: G
authors: Rath
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D016019:Survival Analysis; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine