The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.


Journal

Surgery today
ISSN: 1436-2813
Titre abrégé: Surg Today
Pays: Japan
ID NLM: 9204360

Informations de publication

Date de publication:
Aug 2021
Historique:
received: 22 08 2020
accepted: 10 12 2020
pubmed: 16 2 2021
medline: 30 11 2021
entrez: 15 2 2021
Statut: ppublish

Résumé

We previously reported the first evidence of oncological benefits from a Japanese phase II trial of oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (the FACOS study). We herein report the long-term survival and persistent oxaliplatin-related peripheral sensory neuropathy (PSN) for patients enrolled in this trial. Patients were scheduled to receive the mFOLFOX6 or CAPOX regimen in the adjuvant setting. The five-year overall survival (OS) rate and persistent PSN were evaluated. A total of 130 patients (mFOLFOX6, n = 73; CAPOX, n = 57) were eligible. The 5-year OS rate was 91.4%. No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25). The incidence of PSN during adjuvant treatment was 55.4% in grade 1 (G1), 30.0% in G2, and 4.6% in G3. No patients showed G3 PSN at 12 months, but G1 or G2 residual PSN after 5 years was observed in 21.8% (G1, 20%; G2, 1.8%). Updated results from the FACOS study support the benefits of oxaliplatin-based adjuvant chemotherapy in terms of the long-term survival among Japanese patients with stage III colon cancer. However, long-term persistent PSN occurs in about 20% of survivors, counterbalancing the favorable OS.

Identifiants

pubmed: 33586034
doi: 10.1007/s00595-021-02230-8
pii: 10.1007/s00595-021-02230-8
doi:

Substances chimiques

Antineoplastic Agents 0
Organoplatinum Compounds 0
Oxaliplatin 04ZR38536J
Leucovorin Q573I9DVLP
Fluorouracil U3P01618RT

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1309-1319

Informations de copyright

© 2021. Springer Nature Singapore Pte Ltd.

Références

André T, de GramontVernerey AD, Chibaudel B, Bonnetain F, Tijeras-Raballand A, et al. Adjuvant fluorouracil, leucovorin, and oxaliplatin in stage II to III colon cancer: updated 10-year survival and outcomes according to BRAF mutation and mismatch repair status of the MOSAIC study. J Clin Oncol. 2015;33:4176–87.
doi: 10.1200/JCO.2015.63.4238
Kuebler JP, Wieand HS, O’Connell MJ, Smith RE, Colangelo LH, Yothers G, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198–204.
doi: 10.1200/JCO.2006.08.2974
Schmoll HJ, Tabernero J, Maroun J, de BraudPrice FT, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil/folinic acid as adjuvant therapy for stage III colon cancer: final results of the NO16968 randomized controlled phase III trial. J Clin Oncol. 2015;33:3733–40.
doi: 10.1200/JCO.2015.60.9107
Ishibashi K, Kumamoto K, Koda K, Kato H, Nishimura G, Yoshimatsu K, et al. A phase II clinical study of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: the FACOS study. Ann Cancer Res Ther. 2016;24:17–22.
doi: 10.4993/acrt.24.17
Yoshimatsu K, Ishibashi K, Koda K, Yokomizo H, Oda N, Oshiro M, et al. A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy. Surg Today. 2019;49:498–506.
doi: 10.1007/s00595-019-1771-y
Kosugi C, Koda K, Ishibashi K, Yoshimatsu K, Tanaka S, Kato R, et al. Safety of FOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (the FACOS study). Int J Colorectal Dis. 2018;33:809–17.
doi: 10.1007/s00384-018-2979-9
Brungs D, Aghmesheh M, de Souza P, et al. Safety and efficacy of oxaliplatin doublet adjuvant chemotherapy in elderly patients with stage III colon cancer. Clin Colorectal Cancer. 2018;17(3):e549–55.
doi: 10.1016/j.clcc.2018.05.004
Pietrangeli A, Leandri M, Terzoli E, Jandolo B, Garufi C. Persistence of high-dose oxaliplatin-induced neuropathy at long-term follow-up. Eur Neurol. 2006;56:13–6.
doi: 10.1159/000094376
Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, et al. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol. 2007;25:2205–11.
doi: 10.1200/JCO.2006.08.6652
Yoshino T, Yamanaka T, Oki E, Kotaka M, Manaka D, Eto T, et al. Efficacy and long-term peripheral sensory neuropathy of 3 vs 6 months of oxaliplatin-based adjuvant chemotherapy for colon cancer the ACHIEVE phase 3 randomized clinical trial. JAMA Oncol. 2019;5:1574–81.
doi: 10.1001/jamaoncol.2019.2572
Yoshino T, Kotaka M, Shinozaki K, Touyama T, Manaka D, Matsui T, et al. JOIN trial: treatment outcome and recovery status of peripheral sensory neuropathy during a 3-year follow-up in patients receiving modified FOLFOX6 as adjuvant treatment for stage II/III colon cancer. Cancer Chemother Pharmacol. 2019;84:1269–77.
doi: 10.1007/s00280-019-03957-5
Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009;27:3109–16.
doi: 10.1200/JCO.2008.20.6771
Haller DG, Tabernero J, Maroun J, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29(11):1465–71.
doi: 10.1200/JCO.2010.33.6297
Watanabe T, Muro K, Ajioka Y, Hashiguchi Y, Ito Y, Saito Y, Japanese Society for Cancer of the Colon and Rectum, et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer. Int J Clin Oncol. 2018;23:1–34.
doi: 10.1007/s10147-017-1101-6
Japanese Society for Cancer of the Colon and Rectum. Japanese classification of colorectal carcinoma. 2nd ed. Tokyo: Kanehara; 2009.
National Cancer Institute. National Cancer Institute common toxicity criteria, version 4.0. http://cancer.gov/ . Accessed 5 Apr 2020.
Brierley JD, Gospodarowicz MK, Wittekind C. The TNM classification of malignant tumours. 8th ed. Hoboken: Wiley; 2016.
Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, et al. Duration of adjuvant chemotherapy for stage III colon cancer. N Engl J Med. 2018;378:1177–88.
doi: 10.1056/NEJMoa1713709
Kotaka M, Yoshino T, Oba K, Shinozaki K, Touyama T, Manaka D, et al. Initial safety report on the tolerability of modified FOLFOX6 as adjuvant therapy in patients with curatively resected stage II or III colon cancer (JFMC41-1001-C2: JOIN trial). Cancer Chemother Pharmacol. 2015;76:75–84.
doi: 10.1007/s00280-015-2757-0
Pectasides D, Karavasilis V, Papaxoinis G, Gourgioti G, Makatsoris T, Raptou G, et al. Randomized phase III clinical trial comparing the combination of capecitabine and oxaliplatin (CAPOX) with the combination of 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) as adjuvant therapy in patients with operated high-risk stage II or stage III colorectal cancer. BMC Cancer. 2015;15:384.
doi: 10.1186/s12885-015-1406-7
Beijers AJ, Mols F, Tjan-Heijnen VC, Faber CG, van de Poll-Franse LV, Vreugdenhil G. Peripheral neuropathy in colorectal cancer survivors: the influence of oxaliplatin administration. Results from the population-based PROFILES registry. Acta Oncol. 2015;54(4):463–9.
doi: 10.3109/0284186X.2014.980912
Gill S, Sargent D. End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival? Oncologist. 2006;11(6):624–9.
doi: 10.1634/theoncologist.11-6-624
Loree JM, Sha A, Soleimani M, Kennecke HF, Ho MY, Cheung WY, et al. Survival impact of CAPOX versus FOLFOX in the adjuvant treatment of stage III colon cancer. Clin Colorectal Cancer. 2018;17(2):156–63.
doi: 10.1016/j.clcc.2018.01.010
Chau I, Norman AR, Cunningham D, Tait D, Ross PJ, Iveson T, et al. A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer. Ann Oncol. 2005;16:549–57.
doi: 10.1093/annonc/mdi116
Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005;352:2696–704.
doi: 10.1056/NEJMoa043116
Ishibashi K, Okada N, Miyazaki T, Sano M, Ishida H. Effect of calcium and magnesium on neurotoxicity and blood platinum concentrations in patients receiving mFOLFOX6 therapy: a prospective randomized study. Int J Clin Oncol. 2010;15(1):82–7.
doi: 10.1007/s10147-009-0015-3
Gamelin L, Boisdron-Celle M, Delva R, et al. Prevention of oxaliplatin-related neurotoxicity by calcium and magnesium infusions: a retrospective study of 161 patients receiving oxaliplatin combined with 5-fluorouracil and leucovorin for advanced colorectal cancer. Clin Cancer Res. 2004;10:4055–61.
doi: 10.1158/1078-0432.CCR-03-0666
Lersch C, Schmelz R, Eckel F, Erdmann J, Mayr M, Schulte-Frohlinde E, et al. Prevention of oxaliplatin-induced peripheral sensory neuropathy by carbamazepine in patients with advanced colorectal cancer. Clin Colorectal Cancer. 2002;2(1):54–8.
doi: 10.3816/CCC.2002.n.011
Penz M, Kornek GV, Raderer M, Ulrich-Pur H, Fiebiger W, Scheithauer W. Subcutaneous administration of amifostine: a promising therapeutic option in patients with oxaliplatin-related peripheral sensitive neuropathy. Ann Oncol. 2001;12(3):421–2.
doi: 10.1023/A:1011184609963
Guo Y, Jones D, Palmer JL, Forman A, Dakhil SR, Velasco MR, et al. Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial. Support Care Cancer. 2014;22(5):1223–31.
doi: 10.1007/s00520-013-2075-1
Gedlicka C, Scheithauer W, Schüll B, Kornek GV. Effective treatment of oxaliplatin-induced cumulative polyneuropathy with alpha-lipoic acid. J Clin Oncol. 2002;20(15):3359–61.
doi: 10.1200/JCO.2002.99.502
Takimoto N, Sugawara S, Iida A, Sakakibara T, Mori K, Sugiura M, et al. Prevention of oxaliplatin-related neurotoxicity by glutathione infusions. Gan To Kagaku Ryoho. 2008;35(13):2373–6 (in Japanese).
pubmed: 19098405
Cascinu S, Catalano V, Cordella L, Labiance R, Giordani P, Baldelli AM, et al. Neuroprotective effect of reduced glutathione on oxaliplatin-based chemotherapy in advanced colorectal cancer: a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2002;20(16):3478–83.
doi: 10.1200/JCO.2002.07.061
Kawashiri T, Shimizu S, Shigematsu N, Kobayashi D, Shimazoe T. Donepezil ameliorates oxaliplatin-induced peripheral neuropathy via a neuroprotective effect. J Pharmacol Sci. 2019;140(3):291–4.
doi: 10.1016/j.jphs.2019.05.009
Nakagawa T, Kaneko S. Roles of transient receptor potential ankyrin 1 in oxaliplatin-induced peripheral neuropathy. Biol Pharm Bull. 2017;40(7):947–53.
doi: 10.1248/bpb.b17-00243
Nishida K, Takeuchi K, Hosoda A, Sugano S, Morisaki E, Ohishi A, et al. Ergothioneine ameliorates oxaliplatin-induced peripheral neuropathy in rats. Life Sci. 2018;207:516–24.
doi: 10.1016/j.lfs.2018.07.006
Guillaumot MA, Cerles O, Bertrand HC, Benoit E, Nicco C, Chouzenoux S, et al. Oxaliplatin-induced neuropathy: the preventive effect of a new super-oxide dismutase modulator. Oncotarget. 2019;10(60):6418–31.
doi: 10.18632/oncotarget.27248
Park SB, Kiernan MC. Oxaliplatin and neuropathy: a role for sodium channels. Clin Neurophysiol. 2018;129(3):670–1.
doi: 10.1016/j.clinph.2017.12.028
Starobova H, Vetter I. Pathophysiology of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2017;10:174.
doi: 10.3389/fnmol.2017.00174

Auteurs

Emiko Takeshita (E)

Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.

Keiichiro Ishibashi (K)

Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.

Keiji Koda (K)

Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.

Noritaka Oda (N)

Colo-Proctological Institute, Matsuda Hospital, Hamamatsu, Japan.

Kazuhiko Yoshimatsu (K)

Department of Surgery, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.

Yu Sato (Y)

Department of Surgery, Toho University Sakura Medical Center, Sakura, Japan.

Masatoshi Oya (M)

Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.

Satoru Yamaguchi (S)

First Department of Surgery, Dokkyo Medical University, Mibu, Japan.

Hideo Nakajima (H)

Department of Oncology, Ageo Central General Hospital, Ageo, Japan.

Tomoyuki Momma (T)

Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.

Hiroshi Maekawa (H)

Department of Surgery, Juntendo University Shizuoka Hospital, Izunokuni, Japan.

Masahiro Tsubaki (M)

Department of Surgery, Yuai Memorial Hospital, Koga, Japan.

Takeshi Yamada (T)

Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.

Michiya Kobayashi (M)

Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Japan.

Kohji Tanakaya (K)

Department of Surgery, Iwakuni Clinical Center, Iwakuni, Japan.

Hideyuki Ishida (H)

Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 05hishi@saitama-med.ac.jp.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH