Ann Hepatobiliary Pancreat Surg.  2025 Feb;29(1):38-47. 10.14701/ahbps.24-169.

Propensity score analysis of adjuvant therapy in radically resected gallbladder cancers: A real world experience from a regional cancer center

Affiliations
  • 1Department of Radiotherapy, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, India
  • 2Department of Surgical Gastroenterology, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, India
  • 3Department of Biostatistics and Health Informatics, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, India

Abstract

Backgrounds/Aims
Given the high mortality associated with gallbladder cancer (GBC), the efficacy of adjuvant therapy (AT) remains controversial. We audited our data over an 11-year period to assess the impact of AT.
Methods
This study included all patients who underwent curative resection for GBC from 2007 to 2017. Analyses were conducted of clinicopathological characteristics, surgical details, and postoperative therapeutic records. The benefits of adjuvant chemotherapy (CT) or chemoradiotherapy (CTRT) were evaluated against surgery alone using SPSS version 20 for statistical analysis.
Results
The median age of patients (n = 142) was 50 years. The median overall survival (OS) was 93, 34, and 30 months with CT, CTRT, and surgery alone respectively (p = 0.612). Multivariate analysis indicated that only disease stage and microscopically involved margins significantly impacted OS and disease-free survival (DFS). CT showed increased effectiveness across all prognostic subsets, except for stage 4 and margin-positive resections. Following propensity score matching, median DFS and OS were higher in the CT group than in the CTRT group, although the differences were not statistically significant (p > 0.05).
Conclusions
Radically resected GBC patients appear to benefit more from adjuvant CT, while CTRT should be reserved for cases with high-risk features.

Keyword

Gallbladder neoplasm; Propensity score; Chemotherapy adjuvant; Radiotherapy

Figure

  • Fig. 1 Overall survival (OS) according to type of treatment (A), overall stage (B). Stagewise overall survival following chemoradiotherapy (CTRT) (C), following chemotherapy (CT) (D).

  • Fig. 2 Overall survival according to sex (A) and resection status (B).

  • Fig. 3 (A) Overall survival after propensity score matching, (B) Disease-free survival after propensity score matching. CTRT, chemoradiotherapy; CT, chemotherapy.


Reference

References

1. Glazer ES, Liu P, Abdalla EK, Vauthey JN, Curley SA. 2012; Neither neoadjuvant nor adjuvant therapy increases survival after biliary tract cancer resection with wide negative margins. J Gastrointest Surg. 16:1666–1671. DOI: 10.1007/s11605-012-1935-1. PMID: 22777053. PMCID: PMC3867946.
Article
2. Gourgiotis S, Kocher HM, Solaini L, Yarollahi A, Tsiambas E, Salemis NS. 2008; Gallbladder cancer. Am J Surg. 196:252–264. DOI: 10.1016/j.amjsurg.2007.11.011. PMID: 18466866.
Article
3. Sharma A, Sharma KL, Gupta A, Yadav A, Kumar A. 2017; Gallbladder cancer epidemiology, pathogenesis and molecular genetics: Recent update. World J Gastroenterol. 23:3978–3998. DOI: 10.3748/wjg.v23.i22.3978. PMID: 28652652. PMCID: PMC5473118.
Article
4. Horgan AM, Amir E, Walter T, Knox JJ. 2012; Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 30:1934–1940. DOI: 10.1200/JCO.2011.40.5381. PMID: 22529261.
Article
5. Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, et al. BILCAP study group. 2019; Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 20:663–673. DOI: 10.1016/S1470-2045(18)30915-X. PMID: 30922733.
Article
6. Ma N, Cheng H, Qin B, Zhong R, Wang B. 2015; Adjuvant therapy in the treatment of gallbladder cancer: a meta-analysis. BMC Cancer. 15:615. DOI: 10.1186/s12885-015-1617-y. PMID: 26337466. PMCID: PMC4559875.
Article
7. Manterola C, Duque G, Grande L, de Aretxabala X, Conejeros R, Otzen T, et al. 2019; A systematic review of the effectiveness of adjuvant therapy for patients with gallbladder cancer. HPB (Oxford). 21:1427–1435. DOI: 10.1016/j.hpb.2019.02.019. PMID: 30922845.
Article
8. Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, et al. SWOG S0809: a phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015; 33:2617–2622. DOI: 10.1200/JCO.2014.60.2219. PMID: 25964250. PMCID: PMC4534524.
Article
9. Ostwal V, Patkar S, Engineer R, Parulekar M, Mandavkar S, Bhargava P, et al. 2024; Adjuvant gemcitabine plus cisplatin and chemoradiation in patients with gallbladder cancer: a randomized clinical trial. JAMA Oncol. 10:1116–1120. DOI: 10.1001/jamaoncol.2024.1944. PMID: 38958997.
Article
10. Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, et al. Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). 2023; Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 401:195–203. DOI: 10.1016/S0140-6736(22)02038-4. PMID: 36681415.
Article
11. Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, et al. 2019; Gemcitabine and oxaliplatin chemotherapy or surveillance in resected biliary tract cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): a randomized phase III study. J Clin Oncol. 37:658–667. DOI: 10.1200/JCO.18.00050. PMID: 30707660.
Article
12. Agrawal S, Saxena R. 2020; Extended field postoperative radiotherapy (EFRT) yields better outcomes as compared to localised field RT (LFRT) in radically resected gallbladder cancer (GBC). Asian Pac J Cancer Care. 5:287–293. DOI: 10.31557/apjcc.2020.5.4.287-293.
Article
13. Ozer M, Goksu SY, Sanford NN, Porembka M, Khurshid H, Ahn C, et al. 2022; A propensity score analysis of chemotherapy use in patients with resectable gallbladder cancer. JAMA Netw Open. 5:e2146912. DOI: 10.1001/jamanetworkopen.2021.46912. PMID: 35171262. PMCID: PMC8851300.
Article
14. Hyder O, Dodson RM, Sachs T, Weiss M, Mayo SC, Choti MA, et al. 2014; Impact of adjuvant external beam radiotherapy on survival in surgically resected gallbladder adenocarcinoma: a propensity score-matched Surveillance, Epidemiology, and End Results analysis. Surgery. 155:85–93. DOI: 10.1016/j.surg.2013.06.001. PMID: 23876364. PMCID: PMC3979596.
Article
15. Jiang Y, Jiang L, Li H, Yuan S, Huang S, Fu Y, et al. 2023; Adjuvant chemoradiotherapy in resected gallbladder cancer: a SEER-based study. Heliyon. 9:e14574. DOI: 10.1016/j.heliyon.2023.e14574. PMID: 36950611. PMCID: PMC10025908.
Article
16. Wan W, Zheng B, Sun W, Wang J, Shen S, Huang L, et al. 2021; Adjuvant therapy in resected nonmetastatic stage II-IV gallbladder cancer: a generalized propensity score analysis. Oncol Res Treat. 44:390–399. DOI: 10.1159/000517113. PMID: 34218220.
Article
17. Lamarca A, Edeline J, McNamara MG, Hubner RA, Nagino M, Bridgewater J, et al. 2020; Current standards and future perspectives in adjuvant treatment for biliary tract cancers. Cancer Treat Rev. 84:101936. DOI: 10.1016/j.ctrv.2019.101936. PMID: 31986437.
Article
18. Ren B, Guo Q, Yang Y, Liu L, Wei S, Chen W, et al. 2020; A meta-analysis of the efficacy of postoperative adjuvant radiotherapy versus no radiotherapy for extrahepatic cholangiocarcinoma and gallbladder carcinoma. Radiat Oncol. 15:15. DOI: 10.1186/s13014-020-1459-x. PMID: 31941520. PMCID: PMC6964081.
Article
19. Todoroki T, Kawamoto T, Otsuka M, Koike N, Yoshida S, Takada Y, et al. 1999; Benefits of combining radiotherapy with aggressive resection for stage IV gallbladder cancer. Hepatogastroenterology. 46:1585–1591.
20. Mojica P, Smith D, Ellenhorn J. 2007; Adjuvant radiation therapy is associated with improved survival for gallbladder carcinoma with regional metastatic disease. J Surg Oncol. 96:8–13. DOI: 10.1002/jso.20831. PMID: 17516546.
Article
21. Lee HY, Kim YH, Jung GJ, Roh YH, Park SY, Kang NU, et al. 2012; Prognostic factors for gallbladder cancer in the laparoscopy era. J Korean Surg Soc. 83:227–236. DOI: 10.4174/jkss.2012.83.4.227. PMID: 23091795. PMCID: PMC3467389.
Article
22. Bridgewater J, Fletcher P, Palmer DH, Malik HZ, Prasad R, Mirza D, et al. BILCAP study group. 2022; Long-term outcomes and exploratory analyses of the randomized phase III BILCAP study. J Clin Oncol. 40:2048–2057. DOI: 10.1200/JCO.21.02568. PMID: 35316080.
Article
23. Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, Malka D, et al. ESMO Guidelines Committee. 2023; Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 34:127–140. DOI: 10.1016/j.annonc.2022.10.506. PMID: 36372281.
Article
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