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

  • Original Article
  • Published:
Journal of Gastrointestinal Surgery

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)

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Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, India

    Sundeep Singh Saluja, Phani Kumar Nekarakanti & Pramod Kumar Mishra

  2. Department of Radiotherapy, Maulana Azad Medical College, New Delhi, India

    Anurita Srivastava & Kishore Singh

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  1. Sundeep Singh Saluja
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  2. Phani Kumar Nekarakanti
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  3. Pramod Kumar Mishra
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  4. Anurita Srivastava
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All the authors have made substantial contributions to the conception or design of the work; the acquisition, analysis, and interpretation of data; and drafting of the work or revising it critically for important intellectual content.

The final approvers of the version to be published are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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Correspondence to Sundeep Singh Saluja.

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Saluja, S.S., Nekarakanti, P.K., Mishra, P.K. et al. Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection. J Gastrointest Surg 26, 398–407 (2022). https://doi.org/10.1007/s11605-021-05143-6

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  • DOI: https://doi.org/10.1007/s11605-021-05143-6

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