Influence of major hepatectomy on gemcitabine-based chemotherapy for recurrent biliary tract cancer after surgery: a subgroup analysis of JCOG1113.

Biliary tract cancers Chemotherapy Major hepatectomy

Journal

International journal of clinical oncology
ISSN: 1437-7772
Titre abrégé: Int J Clin Oncol
Pays: Japan
ID NLM: 9616295

Informations de publication

Date de publication:
23 Oct 2024
Historique:
received: 21 04 2024
accepted: 05 10 2024
medline: 23 10 2024
pubmed: 23 10 2024
entrez: 23 10 2024
Statut: aheadofprint

Résumé

Major hepatectomy (MH) can increase the risk of adverse events (AEs) owing to impaired drug metabolism due to decreased liver volume and surgical injury. Thus, we performed this subgroup analysis using data from JCOG1113, a phase III trial comparing gemcitabine plus S-1 (GS) and gemcitabine plus cisplatin (GC) in patients with advanced and recurrent biliary tract cancer (BTC), to evaluate the effect of MH on the safety and efficacy of GC and GS regimens in patients with recurrent BTC. Of the 354 patients with advanced BTC enrolled in JCOG1113, 76 patients with postoperative recurrence (30 in the MH group and 46 in the non-MH group) were analyzed. Grade ≥ 3 platelet count decreased in both arms was more frequent in the MH group than in non-MH group (GC, 0.0 vs. 17.6%; GS, 3.9 vs. 15.4%). However, in the MH group, the white blood cell decreased (GC, 55.0 vs. 38.5%; GS, 23.1 vs. 7.7%) and anemia (GC, 15.0 vs. 11.8%; GS, 23.1 vs. 7.7%) were less common than in the non-MH group. The MH and non-MH groups showed no significant difference in overall survival (OS) in both GC [median OS, 23.0 in MH vs. 16.9 months in non-MH (hazard ratio, 0.857; 95% CI 0.387-1.899)], and GS [median OS, 21.5 vs. 14.9 months (hazard ratio, 0.670; 95% CI 0.310-1.447)] arms. The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.

Sections du résumé

BACKGROUND BACKGROUND
Major hepatectomy (MH) can increase the risk of adverse events (AEs) owing to impaired drug metabolism due to decreased liver volume and surgical injury. Thus, we performed this subgroup analysis using data from JCOG1113, a phase III trial comparing gemcitabine plus S-1 (GS) and gemcitabine plus cisplatin (GC) in patients with advanced and recurrent biliary tract cancer (BTC), to evaluate the effect of MH on the safety and efficacy of GC and GS regimens in patients with recurrent BTC.
METHODS METHODS
Of the 354 patients with advanced BTC enrolled in JCOG1113, 76 patients with postoperative recurrence (30 in the MH group and 46 in the non-MH group) were analyzed.
RESULTS RESULTS
Grade ≥ 3 platelet count decreased in both arms was more frequent in the MH group than in non-MH group (GC, 0.0 vs. 17.6%; GS, 3.9 vs. 15.4%). However, in the MH group, the white blood cell decreased (GC, 55.0 vs. 38.5%; GS, 23.1 vs. 7.7%) and anemia (GC, 15.0 vs. 11.8%; GS, 23.1 vs. 7.7%) were less common than in the non-MH group. The MH and non-MH groups showed no significant difference in overall survival (OS) in both GC [median OS, 23.0 in MH vs. 16.9 months in non-MH (hazard ratio, 0.857; 95% CI 0.387-1.899)], and GS [median OS, 21.5 vs. 14.9 months (hazard ratio, 0.670; 95% CI 0.310-1.447)] arms.
CONCLUSIONS CONCLUSIONS
The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.

Identifiants

DOI: 10.1007/s10147-024-02642-9 PMID: 39441453
pubmed: 39441453
doi: 10.1007/s10147-024-02642-9
pii: 10.1007/s10147-024-02642-9
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.

Références

Khan SA, Tavolari S, Brandi G (2019) Cholangiocarcinoma: epidemiology and risk factors. Liver Int 39(Suppl 1):19–31
doi: 10.1111/liv.14095 pubmed: 30851228
Bridgewater J, Galle PR, Khan SA et al (2014) Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol 60(6):1268–1289
doi: 10.1016/j.jhep.2014.01.021 pubmed: 24681130
Mavros MN, Economopoulos KP, Alexiou VG et al (2014) Treatment and prognosis for patients with intrahepatic cholangiocarcinoma: systematic review and meta-analysis. JAMA Surg 149(6):565–574
doi: 10.1001/jamasurg.2013.5137 pubmed: 24718873
Primrose JN, Fox RP, Palmer DH et al (2019) Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol 20(5):663–673
doi: 10.1016/S1470-2045(18)30915-X pubmed: 30922733
Nakachi K, Ikeda M, Konishi M et al (2023) Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet (London, England) 401(10372):195–203
doi: 10.1016/S0140-6736(22)02038-4 pubmed: 36681415
El-Diwany R, Pawlik TM, Ejaz A (2019) Intrahepatic cholangiocarcinoma. Surg Oncol Clin N Am 28(4):587–599
doi: 10.1016/j.soc.2019.06.002 pubmed: 31472907
Valle J, Wasan H, Palmer DH et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362(14):1273–1281
doi: 10.1056/NEJMoa0908721 pubmed: 20375404
Morizane C, Okusaka T, Mizusawa J et al (2013) Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci 104(9):1211–1216
doi: 10.1111/cas.12218 pubmed: 23763511 pmcid: 7657216
Morizane C, Okusaka T, Mizusawa J et al (2019) Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol 30(12):1950–1958
doi: 10.1093/annonc/mdz402 pubmed: 31566666
Ioka T, Kanai M, Kobayashi S et al (2023) Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). J Hepatobiliary Pancreat Sci 30(1):102–110
doi: 10.1002/jhbp.1219 pubmed: 35900311
Oh D-Y, Ruth He A, Qin S et al (2022) Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. https://doi.org/10.1056/EVIDoa2200015
doi: 10.1056/EVIDoa2200015 pubmed: 38319896
Kelley RK, Ueno M, Yoo C et al (2023) Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 401(10391):1853–1865
doi: 10.1016/S0140-6736(23)00727-4 pubmed: 37075781
Nam NH, Taura K, Kimura Y et al (2020) Extent of liver resection is associated with incomplete liver restoration and splenomegaly a long period after liver resection. Surgery 168(1):40–48
doi: 10.1016/j.surg.2020.02.022 pubmed: 32349870
Murakami Y, Uemura K, Sudo T et al (2009) Gemcitabine-based adjuvant chemotherapy improves survival after aggressive surgery for hilar cholangiocarcinoma. J Gastrointest Surg 13(8):1470–1479
doi: 10.1007/s11605-009-0900-0 pubmed: 19421824
Murakami Y, Uemura K, Sudo T et al (2009) Adjuvant gemcitabine plus S-1 chemotherapy improves survival after aggressive surgical resection for advanced biliary carcinoma. Ann Surg 250(6):950–956
doi: 10.1097/SLA.0b013e3181b0fc8b pubmed: 19953713
Takahara T, Nitta H, Hasegawa Y et al (2012) A phase I study for adjuvant chemotherapy of gemcitabine plus S-1 in curatively resected patients with biliary tract cancer: adjusting the dose of adjuvant chemotherapy according to the surgical procedures. Cancer Chemother Pharmacol 69(5):1127–1133
doi: 10.1007/s00280-011-1805-7 pubmed: 22207029
Kobayashi S, Nagano H, Sakai D et al (2014) Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol 74(4):699–709
doi: 10.1007/s00280-014-2543-4 pubmed: 25074036
Fujiwara Y, Kobayashi S, Nagano H et al (2015) Pharmacokinetic study of adjuvant gemcitabine therapy for biliary tract cancer following major hepatectomy (KHBO1101). PLoS ONE 10(12):e0143072
doi: 10.1371/journal.pone.0143072 pubmed: 26633034 pmcid: 4669083
Kobayashi S, Nagano H, Tomokuni A et al (2019) 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 270(2):230–237
doi: 10.1097/SLA.0000000000002865 pubmed: 30339627
Mole DJ, Fallowfield JA, Sherif AE et al (2020) Quantitative magnetic resonance imaging predicts individual future liver performance after liver resection for cancer. PloS One 15(12):e0238568
doi: 10.1371/journal.pone.0238568 pubmed: 33264327 pmcid: 7710097
Kohno H, Inokuchi K (1984) Effects of postoperative adjuvant chemotherapy on liver regeneration in partially hepatectomized rats. Jpn J Surg 14(6):515–523
doi: 10.1007/BF02469796 pubmed: 6530847

Auteurs

Tatsuya Okuno (T)

Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama City, 377-2, Ohno-Higashi, Osaka, 589-8511, Japan. t-okuno@pg7.so-net.ne.jp.
ORCID: 0000-0002-5450-8841

Chigusa Morizane (C)

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Junki Mizusawa (J)

JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.

Hiroaki Yanagimoto (H)

Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.

Satoshi Kobayashi (S)

Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.

Hiroshi Imaoka (H)

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Takeshi Terashima (T)

Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Ishikawa, Japan.

Hisato Kawakami (H)

Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama City, 377-2, Ohno-Higashi, Osaka, 589-8511, Japan.

Yusuke Sano (Y)

JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.

Takuji Okusaka (T)

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Masafumi Ikeda (M)

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Masato Ozaka (M)

Hepato-Biliary-Pancreatic Medicine Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Haruo Miwa (H)

Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.

Akiko Todaka (A)

Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Satoshi Shimizu (S)

Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.

Nobumasa Mizuno (N)

Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.

Mitsugu Sekimoto (M)

Department of Surgery, Kansai Medical University Hospital, Osaka, Japan.

Keiji Sano (K)

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.

Kazutoshi Tobimatsu (K)

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.

Akio Katanuma (A)

Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.

Kunihito Gotoh (K)

Department of Surgery, NHO Osaka National Hospital, Osaka, Japan.

Hironori Yamaguchi (H)

Department of Clinical Oncology, Jichi Medical University, Tochigi, Japan.

Hiroshi Ishii (H)

Clinical Research Center, Chiba Cancer Center, Chiba, Japan.

Junji Furuse (J)

Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.

Makoto Ueno (M)

Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.

Classifications MeSH