title: Chemotherapy Compared with Best Supportive Care for Metastatic/Unresectable Gallbladder Cancer: a Non-randomized Prospective Cohort Study.
abstract: Gallbladder cancer (GBC) is the most common biliary tract malignancy. Incidence varies widely with geographic regions, with northern India being the endemic area for GBC. Curative surgery offers the only chance of cure, but most of patients present with unresectable or metastatic disease and are candidates for palliative treatment only. This study was designed to evaluate efficacy of chemotherapy over best supportive care in unresectable/metastatic GBC. Patients with unresectable/metastatic GBC with proven tissue diagnosis were enrolled for single institution non-randomized prospective cohort study between May 2012 and April 2014. A total of 65 patients received palliative chemotherapy; either combination chemotherapy (n = 59) or single agent chemotherapy (n = 6). Combination chemotherapy regimen were either three weekly Gemcitabine-Cisplatin (n = 45) or Gemcitabine-Oxaliplatin (n = 14) for a maximum of six cycles. Twenty patients, either unfit for chemotherapy or unwilling for the same were advised best supportive care (BSC). The overall response rate to chemotherapy was 34 %. Median survival for chemotherapy group and BSC group were 35.6 and 13 weeks, respectively (p value < 0.001). Median OS for combination chemotherapy (n = 59) and single agent chemotherapy (n = 6) were 37 and 26.7 weeks, respectively (p value- 0.002). Median PFS for combination chemotherapy and single agent chemotherapy were 26 and 15 weeks, respectively (p value-0.012). The results of this study are quite encouraging and support use of chemotherapy for unresectable GBC patients over best supportive care, and that gemcitabine based combination chemotherapy may be a better choice for response rates, OS, and PFS.
authors.affiliation: Army Hospital (Research & Referral), New Delhi-10, India.
authors.forename: Santosh Kumar
authors.initials: SK
authors.lastname: Singh
authors.affiliation: Army Hospital (Research & Referral), New Delhi-10, India.
authors.forename: Rajnish
authors.initials: R
authors.lastname: Talwar
authors.affiliation: Command Hospital (SC), Pune, 411040 India.
authors.forename: Narayanan
authors.initials: N
authors.lastname: Kannan
authors.affiliation: Army Hospital (Research & Referral), New Delhi-10, India.
authors.forename: Arvind Kumar
authors.initials: AK
authors.lastname: Tyagi
authors.affiliation: Army Hospital (Research & Referral), New Delhi-10, India.
authors.forename: Pradeep
authors.initials: P
authors.lastname: Jaiswal
authors.affiliation: Army Hospital (Research & Referral), New Delhi-10, India.
authors.forename: Adarsh
authors.initials: A
authors.lastname: Kumar
keywords: Best supportive care; Gallbladder cancer; Overall survival; Palliative chemotherapy