The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study.
Adjuvant chemotherapy
Colorectal cancer; FOLFOX regimens
Stage III
Journal
International journal of colorectal disease
ISSN: 1432-1262
Titre abrégé: Int J Colorectal Dis
Pays: Germany
ID NLM: 8607899
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
accepted:
09
02
2021
pubmed:
16
2
2021
medline:
24
6
2021
entrez:
15
2
2021
Statut:
ppublish
Résumé
We aim to compare the efficiency and toxicity of three different 5-fluorouracil (5-FU) administration types in 5-FU, leucovorin, and oxaliplatin (FOLFOX) combination treatment for adjuvant therapy in colorectal cancer (CRC). Five hundred and seventy patients with stage III colorectal carcinoma who received different FOLFOX regimens after curative resection were included. Patients were divided into three groups as FOLFOX-4, modified FOLFOX-6 (mFOLFOX-6), and mFOLFOX-4 for comparison of toxicity and disease-free survival (DFS) and overall survival (OS) times. Three-year DFS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 65%, 72%, and 72%, respectively. Five-year OS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 69%, 75%, and 67%, respectively. There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively). Among grade 1-2 adverse events (AE), thrombocytopenia, neuropathy, and stomatitis were more common in the mFOLFOX-6-treated group. The frequency of grade 1-2 nausea and vomiting were similar in mFOLFOX-6 (36.3% and 24%, respectively) and mFOLFOX-4 (32.4% and 24.7%, respectively) groups but were higher than that in the FOLFOX-4 (19.5% and 11.3%, respectively) group. Among the most common grade 3-4 AE, neutropenia (53.4%, 9%, and 13.5%, respectively) and diarrhea (10.5%, 2.2%, and 2.4, respectively) were more common in FOLFOX-4. The rate of anemia and febrile neutropenia was similar in treatment groups (p = 0.063, and p = 0.210, respectively). In the adjuvant treatment of stage III CRC patients, three different 5-FU administration types in FOLFOX combination treatment can be used with similar efficiency and manageable toxicity.
Identifiants
pubmed: 33586012
doi: 10.1007/s00384-021-03888-9
pii: 10.1007/s00384-021-03888-9
doi:
Substances chimiques
Organoplatinum Compounds
0
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1311-1319Références
Siegel RL, Miller KD, Jemal A (2020) Cancer statistics 2020. CA Cancer J for Clin 7:7–30
doi: 10.3322/caac.21590
Fortea-Sanchis C, Forcadell-Comes E, Martinez-Ramos D et al (2019) Modelling the probability of erroneous negative lymph node staging in patients with colon cancer. Cancer Commun 39:31
doi: 10.1186/s40880-019-0377-5
O’Connell JB, Maggard MA, Ko CY (2004) Colon cancer survival rates with the new American Joint Committee on Cancer sixth edition staging. J Natl Cancer Inst 96:1420–1425
doi: 10.1093/jnci/djh275
Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, Veeder MH, Mailliard JA (1990) Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med 322:352–358
doi: 10.1056/NEJM199002083220602
O’Connell MJ, Laurie JA, Kahn M et al (1998) Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 16:295–300
doi: 10.1200/JCO.1998.16.1.295
Andre T, Boni C, Mounedji-Boudiaf L et al (2004) Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350:2343–2351
doi: 10.1056/NEJMoa032709
Andre T, Boni C, Navarro M et al (2009) 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 27:3109–3116
doi: 10.1200/JCO.2008.20.6771
Sadahiro S, Suzuki T, Ishikawa K, Nakamura T, Tanaka Y, Masuda T, Mukoyama S, Yasuda S, Tajima T, Makuuchi H, Murayama C (2003) Recurrence patterns after curative resection of colorectal cancer in patients followed for a minimum of ten years. Hepatogastroenterology 50:1362–1366
pubmed: 14571738
Sargent DJ, Wieand HS, Haller DG, Gray R, Benedetti JK, Buyse M, Labianca R, Seitz JF, O'Callaghan CJ, Francini G, Grothey A, O'Connell M, Catalano PJ, Blanke CD, Kerr D, Green E, Wolmark N, Andre T, Goldberg RM, de Gramont A (2005) Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol 23:8664–8670
doi: 10.1200/JCO.2005.01.6071
Yothers G, O’Connell MJ, Allegra CJ et al (2011) Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol 29:3768–3774
doi: 10.1200/JCO.2011.36.4539
Allegra CJ, Yothers G, O’Connell MJ et al (2011) Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: Results of NSABP protocol C-08. J Clin Oncol 29:11–16
doi: 10.1200/JCO.2010.30.0855
Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, Smyrk TC, Sinicrope FA, Chan E, Gill S, Kahlenberg MS, Shields AF, Quesenberry JT, Webb TA, Farr GH Jr, Pockaj BA, Grothey A, Goldberg RM (2012) Effect of Oxaliplatin, Fluorouracil, and LeucovorinWith or Without Cetuximab on Survival Among Patients With Resected Stage III Colon Cancer. JAMA 307:1383–1393
doi: 10.1001/jama.2012.7265
Allegra CJ, Yothers G, O’Connell MJ et al (2013) Bevacizumab in Stage II-III Colon Cancer: 5-Year Update of the National Surgical Adjuvant Breast and Bowel Project C-08 Trial. J Clin Oncol 31:359–364
doi: 10.1200/JCO.2012.44.4711
Uncu D, Aksoy S, Çetin B, Yetişyiğit T, Özdemir N, Berk V, Dane F, Inal A, Harputluoğlu H, Budakoğlu B, Koca D, Sevinç A, Cihan S, Durnalı AG, Özkan M, Öztürk MA, Işıkdoğan A, Büyükberber S, Benekli M, Köş T, Alkış N, Karaca H, Turhal NS, Zengin N, Anatolian Society of Medical Oncology (2013) Results of Adjuvant FOLFOX Regimens in Stage III Colorectal Cancer Patients: Retrospective Analysis of 667 Patients. Oncology 84:240–245
doi: 10.1159/000336902
Allegra CJ, Yothers G, O’Connell MJ et al (2009) Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. J Clin Oncol 27:3385–3390
doi: 10.1200/JCO.2009.21.9220
Pectasides D, Karavasilis V, Papaxoinis G et al (2015) 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 15:384–395
doi: 10.1186/s12885-015-1406-7
Cihan Ş, Uncu D, Babacan NA, Özdemir N, Odabaş H, Aksoy S, Öksüzoğlu B, Zengin N (2011) Adjuvant modified FOLFOX-4 in patients with stage III rectum adenocarcinoma. Asian Pac J Cancer Prev 12:967–970
pubmed: 21790235
Aspinall SL, Good CB, ZhaoX et al (2015) Adjuvant chemotherapy for stage III colon cancer: relative dose intensity and survival among veterans. BMC Cancer 15:62
doi: 10.1186/s12885-015-1038-y
Cespedes Feliciano EM, Lee VS, Prado CM, Meyerhardt JA, Alexeeff S, Kroenke CH, Xiao J, Castillo AL, Caan BJ (2017) Muscle mass at the time of diagnosis of nonmetastatic colon cancer and early discontinuation of chemotherapy, delays, and dose reductions on adjuvant FOLFOX: The C-SCANS study. Cancer 123:4868–4877
doi: 10.1002/cncr.30950
Park D, Baek SJ, Kwak JM, Kim J, Kim SH (2018) Analysis of reduced-dose administration of oxaliplatin as adjuvant FOLFOX chemotherapy for colorectal cancer. Ann Surg Treat Res 94:196–202
doi: 10.4174/astr.2018.94.4.196