Adjuvant S-1 vs gemcitabine for node-positive perihilar cholangiocarcinoma: A propensity score-adjusted analysis.


Journal

Journal of hepato-biliary-pancreatic sciences
ISSN: 1868-6982
Titre abrégé: J Hepatobiliary Pancreat Sci
Pays: Japan
ID NLM: 101528587

Informations de publication

Date de publication:
Sep 2021
Historique:
revised: 10 05 2021
received: 20 12 2020
accepted: 29 05 2021
pubmed: 5 6 2021
medline: 16 10 2021
entrez: 4 6 2021
Statut: ppublish

Résumé

The efficacy of adjuvant chemotherapy for biliary cancers remains controversial because of conflicting results from previous phase 3 studies that used different key drugs and enrolled patients with heterogeneous tumor sites and disease stages. Fluoropyrimidine seems more beneficial than gemcitabine (GEM) combination regimens in the adjuvant setting; however, data comparing the survival benefit between GEM- and fluoropyrimidine-based regimens are lacking. Patients who underwent resection for node-positive perihilar cholangiocarcinoma were included. The patients who underwent adjuvant chemotherapy were divided into the S-1 and GEM groups according to the regimen. The recurrence-free survival (RFS) and the overall survival (OS) were compared between the groups and adjusted with propensity scores generated from 14 potentially confounding clinicopathological factors. In total, 186 patients (Surgery alone, n = 71; S-1, n = 60; GEM, n = 55) were included. The S-1 and GEM completion rates were 75% and 65%, respectively. Among the patients who underwent adjuvant therapy, the RFS was longer in the S-1 group patients than the GEM group patients (median, 24.4 months vs 14.9 months; P = .044) whereas the OS was not significantly different between the groups (median, 48.5 months vs 35.0 months; P = .324). After propensity score adjustment, the differences in RFS and OS between the groups were more evident (HR: 2.696, 95% CI: 1.739-4.180 P < .001; HR: 1.988, 95% CI: 1.221-3.238, P < .001, respectively). Compared with adjuvant GEM monotherapy, adjuvant S-1 monotherapy may improve survival in node-positive perihilar cholangiocarcinoma patients.

Sections du résumé

BACKGROUND BACKGROUND
The efficacy of adjuvant chemotherapy for biliary cancers remains controversial because of conflicting results from previous phase 3 studies that used different key drugs and enrolled patients with heterogeneous tumor sites and disease stages. Fluoropyrimidine seems more beneficial than gemcitabine (GEM) combination regimens in the adjuvant setting; however, data comparing the survival benefit between GEM- and fluoropyrimidine-based regimens are lacking.
METHODS METHODS
Patients who underwent resection for node-positive perihilar cholangiocarcinoma were included. The patients who underwent adjuvant chemotherapy were divided into the S-1 and GEM groups according to the regimen. The recurrence-free survival (RFS) and the overall survival (OS) were compared between the groups and adjusted with propensity scores generated from 14 potentially confounding clinicopathological factors.
RESULTS RESULTS
In total, 186 patients (Surgery alone, n = 71; S-1, n = 60; GEM, n = 55) were included. The S-1 and GEM completion rates were 75% and 65%, respectively. Among the patients who underwent adjuvant therapy, the RFS was longer in the S-1 group patients than the GEM group patients (median, 24.4 months vs 14.9 months; P = .044) whereas the OS was not significantly different between the groups (median, 48.5 months vs 35.0 months; P = .324). After propensity score adjustment, the differences in RFS and OS between the groups were more evident (HR: 2.696, 95% CI: 1.739-4.180 P < .001; HR: 1.988, 95% CI: 1.221-3.238, P < .001, respectively).
CONCLUSIONS CONCLUSIONS
Compared with adjuvant GEM monotherapy, adjuvant S-1 monotherapy may improve survival in node-positive perihilar cholangiocarcinoma patients.

Identifiants

pubmed: 34087061
doi: 10.1002/jhbp.1005
doi:

Substances chimiques

Deoxycytidine 0W860991D6
Gemcitabine 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

716-726

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Références

Nagino M, Ebata T, Yokoyama Y, Igami T, Sugawara G, Takahashi YU, et al. Evolution of surgical treatment for perihilar cholangiocarcinoma: a single-center 34-year review of 574 consecutive resections. Ann Surg. 2013;258:129-40.
Khan SA, Davidson BR, Goldin RD, Heaton N, Karani J, Pereira SP, et al. Guidelines for the diagnosis and treatment of cholangiocarcinoma: an update. Gut. 2012;61:1657-69.
Ebata T, Kosuge T, Hirano S, Unno M, Yamamoto M, Miyazaki M, et al. Proposal to modify the International Union Against Cancer staging system for perihilar cholangiocarcinomas. Br J Surg. 2014;101:79-88.
DeOliveira ML, Cunningham SC, Cameron JL, Kamangar F, Winter JM, Lillemoe KD, et al. Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution. Ann Surg. 2007;245:755-62.
Aoba T, Ebata T, Yokoyama Y, Igami T, Sugawara G, Takahashi YU, et al. Assessment of nodal status for perihilar cholangiocarcinoma: location, number, or ratio of involved nodes. Ann Surg. 2013;257:718-25.
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.
Stein A, Arnold D, Bridgewater J, Goldstein D, Jensen LH, Klümpen H-J, et al. Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial. BMC Cancer. 2015;15:564.
Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, et al. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018;105:192-202.
Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly J-P, et al. 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. 2019;37:658-67.
Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, et al. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019;20:663-73.
Seita K, Ebata T, Mizuno T, Maeda A, Yamaguchi R, Kurumiya Y, et al. Phase 2 trial of adjuvant chemotherapy with S - 1 for node-positive biliary tract cancer (N-SOG 09). Ann Surg Oncol. 2020;27:2348-56.
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.
Bismuth H, Nakache R, Diamond T. Management strategies in resection for hilar cholangiocarcinoma. Ann Surg. 1992;215:31-8.
Ikeyama T, Nagino M, Oda K, Ebata T, Nishio H, Nimura Y. Surgical approach to bismuth Type I and II hilar cholangiocarcinomas: audit of 54 consecutive cases. Ann Surg. 2007;246:1052-7.
Natsume S, Ebata T, Yokoyama Y, Igami T, Sugawara G, Shimoyama Y, et al. Clinical significance of left trisectionectomy for perihilar cholangiocarcinoma: an appraisal and comparison with left hepatectomy. Ann Surg. 2012;255:754-62.
Ebata T, Yokoyama Y, Igami T, Sugawara G, Mizuno T, Nagino M. Review of hepatopancreatoduodenectomy for biliary cancer: an extended radical approach of Japanese origin. J Hepatobiliary Pancreat Sci. 2014;21:550-5.
Ebata T, Yokoyama Y, Igami T, Sugawara G, Takahashi YU, Nimura Y, et al. Hepatopancreatoduodenectomy for cholangiocarcinoma: a single-center review of 85 consecutive patients. Ann Surg. 2012;256:297-305.
Nagino M, Nimura Y, Nishio H, Ebata T, Igami T, Matsushita M, et al. Hepatectomy with simultaneous resection of the portal vein and hepatic artery for advanced perihilar cholangiocarcinoma: an audit of 50 consecutive cases. Ann Surg. 2010;252:115-23.
Nagino M, Kamiya J, Nishio H, Ebata T, Arai T, Nimura Y. Two hundred forty consecutive portal vein embolizations before extended hepatectomy for biliary cancer: surgical outcome and long-term follow-up. Ann Surg. 2006;243:364-72.
Ebata T, Yokoyama Y, Igami T, Sugawara G, Takahashi Y, Nagino M. Portal vein embolization before extended hepatectomy for biliary cancer: current technique and review of 494 consecutive embolizations. Dig Surg. 2012;29:23-9.
Japanese Society of Biliary Surgery. General rules for surgical and pathological studies on cancer of the biliary tract. 6th ed. Tokyo, Japan: Kanehara; 2013.
Tsukahara T, Ebata T, Shimoyama Y, Yokoyama Y, Igami T, Sugawara G, et al. Residual carcinoma in situ at the ductal stump has a negative survival effect: an analysis of early-stage cholangiocarcinomas. Ann Surg. 2017;266:126-32.
Shingu Y, Ebata T, Nishio H, Igami T, shimoyama Y, Nagino M. Clinical value of additional resection of a margin-positive proximal bile duct in hilar cholangiocarcinoma. Surgery. 2010;147:49-56.
Igami T, Nagino M, Oda K, Nishio H, Ebata T, Yokoyama Y, et al. Clinicopathologic study of cholangiocarcinoma with superficial spread. Ann Surg. 2009;249:296-302.
Brierley Je, Gospodarowicz MKe, Wittekind Ce. TNM classification of malignant tumours. 8th ed. New York: Wiley-Blackwell; 2017.
Institute NC. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 2009. Retrieved 27 November 2019. [cited 2020 Sep 1]. Available from https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
Takahashi YU, Ebata T, Yokoyama Y, Igami T, Sugawara G, Mizuno T, et al. Surgery for recurrent biliary tract cancer: a single-center experience with 74 consecutive resections. Ann Surg. 2015;262:121-9.
Yamada M, Ebata T, Yokoyama Y, Igami T, Sugawara G, Mizuno T, et al. Pulmonary metastasis after resection of cholangiocarcinoma: incidence, resectability, and survival. World J Surg. 2017;41:1550-7.
Kobayashi S, Nagano H, Tomokuni A, Gotoh K, Sakai D, Hatano E, et al. A prospective, randomized phase II study of adjuvant gemcitabine versus S-1 after major hepatectomy for biliary tract cancer (KHBO 1208): Kansai Hepato-biliary oncology group. Ann Surg. 2019;270:230-7.
Wolpin BM, Mayer RJ. A step forward in the treatment of advanced biliary tract cancer. N Engl J Med. 2010;362:1335-7.
Yanagimoto H, Toyokawa H, Sakai D, Wada H, Satoi S, Yamamoto T, et al. A phase I study for adjuvant chemotherapy of gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1202). Cancer Chemother Pharmacol. 2018;81:461-8.

Auteurs

Daigoro Takahashi (D)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Takashi Mizuno (T)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Yukihiro Yokoyama (Y)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Tsuyoshi Igami (T)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Junpei Yamaguchi (J)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Shunsuke Onoe (S)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Nobuyuki Watanabe (N)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Osamu Maeda (O)

Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.

Masahiko Ando (M)

Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.

Tomoki Ebata (T)

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.

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