Cancer Res Treat.  2016 Oct;48(4):1274-1285. 10.4143/crt.2015.502.

Is There a Role for Adjuvant Therapy in R0 Resected Gallbladder Cancer?: A Propensity Score-Matched Analysis

Affiliations
  • 1Division of Hematology/Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea. newatp@naver.com
  • 2Division of Hematology/Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
  • 3Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.
  • 4Department of Radiology, Gachon University Gil Medical Center, Incheon, Korea.
  • 5Division of Hematology/Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
  • 6Division of Hematology/Oncology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
  • 7Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. oncopark@skku.edu

Abstract

PURPOSE
The purpose of this study is to assess the role of adjuvant therapy in stage I-III gallbladder cancer (GBC) patients who have undergone R0 resection.
MATERIALS AND METHODS
Clinical data were collected on 441 consecutive patients who underwent R0 resection for stage I-III GBC. Eligible patients were classified into adjuvant therapy and surveillance only groups. Propensity score matching (PSM) between the two groups was performed, adjusting clinical factors.
RESULTS
In total, 84 and 279 patients treated with adjuvant therapy and followed up with surveillance only, respectively, were included in the analysis. Before PSM, the 5-year relapse-free survival (RFS) rate was lower in the adjuvant therapy group than in the surveillance only group (50.8% vs. 74.8%, p < 0.001), although there was no statistically significant difference in the 5-year overall survival (OS) rate (66.2% vs. 79.5%, p=0.089). After the PSM, baseline characteristics became comparable and there were no differences in the 5-year RFS (50.8% vs. 64.8%, p=0.319) and OS (66.2% vs. 70.4%, p=0.703) rates between the two groups.
CONCLUSION
The results suggest that fluoropyrimidine-based adjuvant therapy is not indicated in stage I-III GBC patients who have undergone R0 resection.

Keyword

Gallbladder neoplasms; Adjuvant chemotherapy; Adjuvant chemoradiotherapy; Survival; Propensity score

MeSH Terms

Chemoradiotherapy, Adjuvant
Chemotherapy, Adjuvant
Gallbladder Neoplasms*
Gallbladder*
Humans
Propensity Score

Figure

  • Fig. 1. Study schema. GBC, gallbladder cancer; AJCC, American Joint Committee on Cancer; CA 19-9, carbohydrate antigen 19-9.

  • Fig. 2. Kaplan-Meier survival curves according to the type of postoperative treatment. (A) Relapse-free survival before propensity score matching (PSM). (B) Overall survival before PSM. (C) Relapse-free survival after PSM. (D) Overall survival after PSM.

  • Fig. 3. Forest plot of subgroup analysis of overall survival. HR, hazard ratio; CI, confidence interval; W/D, well-differentiated; M/D, moderately differentiated; P/D, poorly differentiated; U/D, undifferentiated; CA 19-9, carbohydrate antigen 19-9.

  • Fig. 4. Kaplan-Meier survival curves according to the type of postoperative treatment (adjuvant therapy group only). (A) Relapse-free survival. (B) Overall survival. CCRT, concurrent chemoradiotherapy.


Reference

References

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015; 65:5–29.
Article
2. Jung KW, Won YJ, Kong HJ, Oh CM, Cho H, Lee DH, et al. Cancer statistics in Korea: incidence, mortality, survival, and prevalence in 2012. Cancer Res Treat. 2015; 47:127–41.
Article
3. Lim H, Seo DW, Park DH, Lee SS, Lee SK, Kim MH, et al. Prognostic factors in patients with gallbladder cancer after surgical resection: analysis of 279 operated patients. J Clin Gastroenterol. 2013; 47:443–8.
4. Gold DG, Miller RC, Haddock MG, Gunderson LL, Quevedo F, Donohue JH, et al. Adjuvant therapy for gallbladder carcinoma: the Mayo Clinic Experience. Int J Radiat Oncol Biol Phys. 2009; 75:150–5.
Article
5. Wang SJ, Fuller CD, Kim JS, Sittig DF, Thomas CR Jr, Ravdin PM. Prediction model for estimating the survival benefit of adjuvant radiotherapy for gallbladder cancer. J Clin Oncol. 2008; 26:2112–7.
Article
6. Cereda S, Belli C, Reni M. Adjuvant treatment in biliary tract cancer: to treat or not to treat? World J Gastroenterol. 2012; 18:2591–6.
Article
7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: hepatobiliary cancers [Internet]. Fort Washington, PA: National Comprehensive Cancer Network;2015. [cited 2015 Aug 16]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf.
8. Cho SY, Kim SH, Park SJ, Han SS, Kim YK, Lee KW, et al. Adjuvant chemoradiation therapy in gallbladder cancer. J Surg Oncol. 2010; 102:87–93.
Article
9. Wang SJ, Lemieux A, Kalpathy-Cramer J, Ord CB, Walker GV, Fuller CD, et al. Nomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer. J Clin Oncol. 2011; 29:4627–32.
Article
10. Nakamura M, Nakashima H, Abe T, Ensako T, Yoshida K, Hino K. Gemcitabine-based adjuvant chemotherapy for patients with advanced gallbladder cancer. Anticancer Res. 2014; 34:3125–9.
11. Takada T, Amano H, Yasuda H, Nimura Y, Matsushiro T, Kato H, et al. Is postoperative adjuvant chemotherapy useful for gallbladder carcinoma? A phase III multicenter prospective randomized controlled trial in patients with resected pancreaticobiliary carcinoma. Cancer. 2002; 95:1685–95.
12. Park HS, Lim JY, Yoon DS, Park JS, Lee DK, Lee SJ, et al. Outcome of adjuvant therapy for gallbladder cancer. Oncology. 2010; 79:168–73.
Article
13. Horgan AM, Amir E, Walter T, Knox JJ. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012; 30:1934–40.
Article
14. Ma N, Cheng H, Qin B, Zhong R, Wang B. Adjuvant therapy in the treatment of gallbladder cancer: a meta-analysis. BMC Cancer. 2015; 15:615.
Article
15. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011; 46:399–424.
Article
16. Kayahara M, Nagakawa T. Recent trends of gallbladder cancer in Japan: an analysis of 4,770 patients. Cancer. 2007; 110:572–80.
17. Fong Y, Wagman L, Gonen M, Crawford J, Reed W, Swanson R, et al. Evidence-based gallbladder cancer staging: changing cancer staging by analysis of data from the National Cancer Database. Ann Surg. 2006; 243:767–71.
18. Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010; 362:1273–81.
Article
19. Yamanaka K, Hatano E, Kanai M, Tanaka S, Yamamoto K, Narita M, et al. A single-center analysis of the survival benefits of adjuvant gemcitabine chemotherapy for biliary tract cancer. Int J Clin Oncol. 2014; 19:485–9.
Article
20. 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; 33:2617–22.
Article
21. Murakami Y, Uemura K, Sudo T, Hashimoto Y, Nakashima A, Kondo N, et al. Prognostic factors of patients with advanced gallbladder carcinoma following aggressive surgical resection. J Gastrointest Surg. 2011; 15:1007–16.
Article
22. Murakami Y, Uemura K, Sudo T, Hashimoto Y, Nakashima A, Kondo N, et al. Prognostic factors after surgical resection for intrahepatic, hilar, and distal cholangiocarcinoma. Ann Surg Oncol. 2011; 18:651–8.
Article
Full Text Links
  • CRT
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr