Society: SSAT

Background
Management of patients with margin negative, T1-T3, N0 (stage IB–IIIA), resected gallbladder cancer (GBC) remains poorly defined. Current guidelines consider observation, chemotherapy (CT), and chemoradiation (CRT) as options. The current study investigates the impact of CT/CRT on overall survival (OS) in these patients.

Methods
Patients with R0 resected stage IB–IIIA GBC were identified within the National Cancer Database. Relevant patient, tumor, and treatment data were analyzed. Multiple logistic regressions were performed for factors associated with receipt of hepatectomy and CT/CRT. Kaplan-Meier analysis for OS was performed. Logrank tests compared OS between treatment groups. Stage-by-stage multivariable Cox regressions assessed the impact of CT and CRT on mortality while adjusting for other risk factors.

Results
Of 2,070 patients identified, resection included cholecystectomy in 950 (45.9%) and cholecystectomy+hepatectomy in 1,120 (54.1%). Overall, 1,419 had resection alone (68.6%), 313 had resection+CT (15.1%), and 338 had resection+CRT (16.3%). Hepatectomy was more commonly performed at academic facilities (OR 2.538; CI 1.969-3.281; P<.01) and for stage IIIA disease (OR 2.670; CI 1.913-3.742; P<.01). Hepatectomy was associated with improved OS in stage IB-IIIA disease (logrank P<.01). Receipt of CT or CRT was associated with stage IIA-IIIA disease, hepatectomy, and private insurance (all P<.05). In univariable analysis, both CT (logrank P<.05) and CRT (logrank P<.01) were associated with improved OS only in patients with stage IIA-IIB disease who did not undergo hepatectomy. Within a multivariable Cox regression model adjusting for age, gender, comorbidities, insurance status, facility type, and tumor grade, only CRT was associated with decreased mortality for patients with stage IIA-IIB disease who did not undergo hepatectomy (HR 0.609; CI 0.400-0.888; P<.05).

Conclusions
The current national study demonstrates the importance of adequate surgical therapy for patients with potentially curable GBC. Among these patients, CT and CRT were not associated with improved OS. However, CRT did result in an OS benefit in patients who did not undergo optimal resection. Prospective trials focused on CT/CRT for adequately resected, node negative GBC are needed.

Noam VanderWalde

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