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Surg Today. 2019 Mar 5. doi: 10.1007/s00595-019-01788-8. [Epub ahead of print]

Preoperative FOLFOX in resectable locally advanced rectal cancer can be a safe and promising strategy: the R-NAC-01 study.

Author information

1
Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, N-15, W-7, Kita-ku, Sapporo, 060-8638, Japan.
2
Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, N-15, W-7, Kita-ku, Sapporo, 060-8638, Japan. homma.s@nifty.com.
3
Department of Surgery, Asahikawa-Kosei General Hospital, Asahikawa, 078-8211, Japan.
4
Department of Surgery, Sapporo Hokuyu Hospital, Sapporo, 003-0006, Japan.
5
Department of Surgery, Iwamizawa Municipal Hospital, Iwamizawa, 068-8555, Japan.
6
Department of Surgery, Keiwakai Ebetsu Hospital, Ebetsu, 069-0817, Japan.
7
Department of Surgery, Sunagawa City Medical Center, Sunagawa, 073-0196, Japan.
8
Department of Surgery, KKR Sapporo Medical Center, Toyohira-ku, Sapporo, 062-0931, Japan.
9
Department of Surgery, Sapporo-Kosei, General Hospital, Sapporo, 060-0033, Japan.
10
Department of Surgery, Tomakomai City Hospital, Tomakomai, 053-8567, Japan.
11
Department of Surgery, Abashiri-Kosei General Hospital, Abashiri, 093-0076, Japan.
12
Department of Surgery, Otaru General Hospital, Otaru, 047-8550, Japan.
13
Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, 060-8638, Japan.

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/m2. 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.

KEYWORDS:

Downstaging; FOLFOX; Neoadjuvant therapy; Rectal cancer; Resection

PMID:
30838443
DOI:
10.1007/s00595-019-01788-8

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