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PERIOPERATIVE CHEMOTHERAPY FOR CLINICAL STAGE IIIB GALLBLADDER CANCER: A REVIEW OF THE NATIONAL CANCER DATABASE
Grey Leonard
*, Heidy Cos, Clancy J. Clark, Edward Levine, Perry Shen
Atrium Health Wake Forest Baptist, Winston-Salem, NC
Introduction:
Gallbladder cancer is a rare disease with high mortality and treatment options are limited. Patients with IIIB disease (T1-3, N1, M0) are typically not offered resection and may be referred for possible palliative chemotherapy. The purpose of this study is to assess survival of IIIB patients who undergo surgery with or without systemic therapy.
Methods:
The National Cancer Database (NCDB) was analyzed with patients from 2010 to 2017. Only patients who had clinical stage IIIB and curative intent surgery were assessed. This cohort was divided into classes by chemotherapy sequence, including neoadjuvant, adjuvant and no chemotherapy. Kaplan-Meier curves were built comparing classes. Cox proportional hazards models were created. Type of lymphadenectomy and margin status were compared.
Results:
423 surgical patients with stage IIIB were assessed. The neoadjuvant class contained 29 patients, the adjuvant class 271 and the no chemotherapy class 123. The median age was 60 in the neoadjuvant, 66 in the adjuvant and 75 in the no chemotherapy classes (p < 0.01). The median overall survival (OS) in months was 35.5 (95% CI 23.8 - NA) in the neoadjuvant group, 22.2 (95% CI 19.4 – 26.7) in the adjuvant group and 9.1 (95% CI 7.1 – 14.0) in the no chemotherapy group (p < 0.01). Hazard ratios (HR) for OS in a multivariate Cox model in comparison against the adjuvant therapy class were 0.68 (95% CI 0.41 – 1.09, p = 0.11) for neoadjuvant and 1.85 (95% CI 1.43 – 2.39, p < 0.01) for no chemotherapy. Age, HR 1.01 (95% CI 1.00 – 1.02, p < 0.01), tumor size, HR 1.01 (95% CI 1.00 – 1.01, p < 0.01), completion of regional lymphadenectomy, HR 0.64 (95% CI 0.46 – 0.884, p < 0.01) and positive margins, HR 1.80 (95% CI 1.33 – 2.45, p < 0.01) were also significant in this model. Regional lymphadenectomies were performed 79%, 86% and 84% for neoadjuvant, adjuvant and no chemotherapy classes. R0 margins were 79%, 64% and 84% respectively.
Conclusion:
Surgery in combination with systemic therapy should be considered in stage IIIB gallbladder cancer. Perioperative chemotherapy was associated with longer survival compared to no chemotherapy, but occurred more in younger patients. Perioperative systemic therapy, particularly neoadjuvant therapy, in the setting of IIIB disease may be useful in appropriately selected patients.
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