title: Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study.
abstract: OBJECTIVE
  We designed this study to evaluate efficacy of modified gemcitabine and oxaliplatin (mGEMOX) over best supportive care (BSC) or fluorouracil (FU) and folinic acid (FA) in unresectable gall bladder cancer (GBC).
  
  
  METHODS
  Patients with unresectable GBC were enrolled for single center randomized study. Arm A, BSC; arm B, FU 425 mg/m(2) and FA 20 mg/m(2) intravenous (IV) bolus weekly for 30 weeks (FUFA); arm C, gemcitabine 900 mg/m(2) and oxaliplatin 80 mg/m(2) IV infusion on days 1 and 8 every 3 weeks for maximum of six cycles. Eighty-one patients were randomly assigned, arms A (n = 27), B (n = 28), and C (n = 26).
  
  
  RESULTS
  Complete response plus partial response in the three groups was 0 (0%), four (14.3%), and eight (30.8%) respectively (P < .001). Two patients in the mGEMOX arm and one patient in the FUFA arm underwent curative resection after chemotherapy. One patient in the mGEMOX arm had complete pathologic response. Median overall survival (OS) was 4.5, 4.6, and 9.5 months for the BSC, FUFA, and mGEMOX arms (P = .039), respectively. Progression-free survival (PFS) was 2.8, 3.5, and 8.5 months for the three groups (P < .001). There was no difference in grade 3/4 toxicities in the chemotherapy arms except transaminitis, which was more prevalent in mGEMOX arm (P = .04). Two patients in the FUFA arm and 10 patients in the mGEMOX arm had grade 3 or 4 myelosuppression. Two patients in the mGEMOX group had neutropenic fever that resolved with antibiotics.
  
  
  CONCLUSIONS
  This randomized controlled trial confirmed the efficacy of chemotherapy (mGEMOX) compared with BSC and FUFA in improving OS and PFS in unresectable GBC.
authors.affiliation: Dr B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India. Atul1@hotmail.com
authors.forename: Atul
authors.initials: A
authors.lastname: Sharma
authors.forename: Amit Dutt
authors.initials: AD
authors.lastname: Dwary
authors.forename: Bidhu Kalyan
authors.initials: BK
authors.lastname: Mohanti
authors.forename: Surya V
authors.initials: SV
authors.lastname: Deo
authors.forename: Sujoy
authors.initials: S
authors.lastname: Pal
authors.forename: Vishnu
authors.initials: V
authors.lastname: Sreenivas
authors.forename: Vinod
authors.initials: V
authors.lastname: Raina
authors.forename: Nootan Kumar
authors.initials: NK
authors.lastname: Shukla
authors.forename: Sanjay
authors.initials: S
authors.lastname: Thulkar
authors.forename: Pramod
authors.initials: P
authors.lastname: Garg
authors.forename: Surendra Pal
authors.initials: SP
authors.lastname: Chaudhary
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005706:Gallbladder Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007194:India; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010166:Palliative Care; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil