Nobuki Ichikawa1, Shigenori Homma2, Tohru Funakoshi3, Masahiro Hattori4, Masanori Sato4, You Kamiizumi5, Kazuyoshi Omori6, Masaru Nomura6, Ryoichi Yokota7, Masahiko Koike8, Hirofumi Kon8, Keisa Takeda8, Hiroyuki Ishizu9, Kunihiro Hirose10, Daisuke Kuraya10, Takahisa Ishikawa11, Ryohei Murata12, Hiroaki Iijima13, Futoshi Kawamata1, Tadashi Yoshida1, Yosuke Ohno1, Nozomi Minagawa1, Norihiko Takahashi1, Akinobu Taketomi1. 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.
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.
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