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Randomized Controlled Trial
. 2022 Feb;26(2):398-407.
doi: 10.1007/s11605-021-05143-6. Epub 2021 Sep 20.

Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection

Sundeep Singh Saluja  1 , Phani Kumar Nekarakanti  2 , Pramod Kumar Mishra  2 , Anurita Srivastava  3 , Kishore Singh  3
Affiliations
Randomized Controlled Trial

Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection

Sundeep Singh Saluja et al. J Gastrointest Surg. 2022 Feb.

Abstract

Background: Gallbladder carcinoma (GBC) has a dismal prognosis even after curative resection. The objective of the study was to evaluate the effect of adjuvant chemotherapy in patients with GBC undergoing curative resection in a randomized control trial (RCT).

Methods: A single-center open-labeled prospective RCT was done from January 2012 to June 2018. R0 curative resected GBC patients were randomized in 1:1 to either surveillance alone (control group) or adjuvant chemotherapy (gemcitabine and cisplatin (GemCis group)) for 6 cycles. The primary outcome was disease-free survival (DFS), and the secondary outcomes were overall survival (OS) and toxicity profile.

Results: On the evaluation of 362 patients with GBC, 50 patients were enrolled in each control or GemCis group. Per protocol (PP), it comprised 96 patients. The demographic and clinical profile was similar between the two groups except in the lower nodal stage where patients were higher in the control group (p = 0.01). Recurrences were similar between groups (control 44% vs GemCis 56%; p = 0.23). On the intention to treat (ITT), analyses of median DFS (not reached vs. 24 months, p = 0.14) and OS (not reached vs. 31 months, p = 0.10) were similar between groups. On PP, analyses of median DFS (not reached vs. 24 months, p = 0.16) and OS (not reached vs. 31 months, p = 0.09) were similar between groups. The common toxicity profile was hematological followed by gastrointestinal symptoms.

Conclusions: Adjuvant GemCis therapy for 6 cycles does not improve DFS or OS than R0 surgery alone patients with GBC.

Trial registration: NCT02778308 ( https://www.clinicaltrials.gov ).

Keywords: Adjuvant chemotherapy; Cisplatin; Gall bladder carcinoma; Gemcitabine; RCT.

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References

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