1. Preoperative FOLFOX in resectable locally advanced rectal cancer can be a safe and promising strategy: the R-NAC-01 study.
- Author
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Ichikawa N, Homma S, Funakoshi T, Hattori M, Sato M, Kamiizumi Y, Omori K, Nomura M, Yokota R, Koike M, Kon H, Takeda K, Ishizu H, Hirose K, Kuraya D, Ishikawa T, Murata R, Iijima H, Kawamata F, Yoshida T, Ohno Y, Minagawa N, Takahashi N, and Taketomi A
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Combined Modality Therapy, Digestive System Surgical Procedures, Female, Fluorouracil administration & dosage, Humans, Leucovorin administration & dosage, Male, Middle Aged, Organoplatinum Compounds administration & dosage, Preoperative Care, Prospective Studies, Safety, Treatment Outcome, Young Adult, Adenocarcinoma therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Neoadjuvant Therapy, Rectal Neoplasms therapy
- Abstract
Purpose: The aim of this study was to assess the safety of rectal surgery after 5-fluorouracil-leucovorin-oxaliplatin chemotherapy (FOLFOX6)., Methods: This was a prospective, multicenter study in 11 Japanese hospitals. We included patients with rectal cancer who received 4 courses of modified FOLFOX6 (mFOLFOX6) before rectal surgery and examined the postoperative complication rate, the clinicopathological response, and the rate of chemotherapy-related adverse events (UMIN 000012559)., Results: The study population included 36 men and 5 women. The average age of the patients was 60.8 years and the average body mass index was 23.1 kg/m
2 . After 4 courses of chemotherapy, grade 2 peripheral nerve disorder and other grade 3 adverse events were seen in 3 patients each (7.3%). Twenty-eight (73.7%) and 8 (21.1%) patients underwent low anterior resection and abdominoperineal resection, respectively. The pelvic nerves were preserved in 35 patients. Surgical morbidity (grade ≥ 3) occurred in 4 patients (10.5%). Anastomotic leakage occurred after surgery in 2 patients (7.1%). No patients achieved pathologically complete remission. However, downstaging of the clinical stage and N stage was seen in 17 (41.5%) and 22 (53.7%) patients, respectively., Conclusions: Surgery after four courses of mFOLFOX6 chemotherapy can be a safe and promising strategy for patients with locally advanced rectal cancer.- Published
- 2019
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