Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study.

Abstract

PURPOSE:

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).

PATIENTS AND 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.

CONCLUSION:

This randomized controlled trial confirmed the efficacy of chemotherapy (mGEMOX) compared with BSC and FUFA in improving OS and PFS in unresectable GBC.

• Authors: Atul Sharma, Amit Dutt Dwary, Bidhu Kalyan Mohanti, Surya V Deo, Sujoy Pal, Vishnu Sreenivas, Vinod Raina, Nootan Kumar Shukla, Sanjay Thulkar, Pramod Garg, Surendra Pal Chaudhary
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 28 Issue 30 Pg. 4581-6 (Oct 20 2010) ISSN: 1527-7755 [Electronic] United States
• PMID: 20855823 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Organoplatinum Compounds
• Deoxycytidine
• Leucovorin
• Fluorouracil

Topics

• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage)
• Gallbladder Neoplasms (drug therapy, mortality, pathology, surgery, therapy)
• Humans
• India
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Palliative Care
• Time Factors
• Treatment Outcome