TY - JOUR
T1 - Randomized phase II study comparing the efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer (KSCC1301)
AU - Miwa, Keisuke
AU - Oki, Eiji
AU - Enomoto, Masanobu
AU - Ihara, Keisuke
AU - Ando, Koji
AU - Fujita, Fumihiko
AU - Tominaga, Masahiro
AU - Mori, Shinichiro
AU - Nakayama, Goro
AU - Shimokawa, Mototsugu
AU - Saeki, Hiroshi
AU - Baba, Hideo
AU - Mori, Masaki
AU - Akagi, Yoshito
N1 - Funding Information:
Outside the submitted work, Keisuke Miwa received grants and personal fees from Taiho Pharm., Ono Pharm., Chugai Pharm. and Takeda Pharm., grants from Merck Biopharm. and Pfizer Inc. and Tsumura & Co.; personal fees from Yakult Honsha Co., Ltd., Bristol-Myers Squibb Co. and Novartis Pharma K.K., personal fees from AstraZeneca K.K., Kyowa Kirin Co., Ltd., Nippon Kayaku Co., Ltd. and Eli Lilly.. Outside the submitted work, Eiji Oki received personal fees from Taiho Pharm, Bayer, Chugai Pharm., Takeda Pharm., Ono Pharm., Merck Biopharma., MSD and Yakult Honsha. Outside the submitted work, Goro Nakayama received personal fees from Chugai Pharm., Janssen Pharmaceutical K.K., Yakult Honsha Co. Ltd.. Taiho Pharm., Eli Lilly Japan K.K., Takeda Pharm., and Miyarinsan Pharm.
Funding Information:
This study was funding from Taiho Pharmaceutical Co. Ltd. under a research contract, and supported by KSCC (Kyushu study group of clinical cancer) as a division of Clinical Study and data center. The funders had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Preoperative chemoradiotherapy (CRT), the current standard of care for locally advanced rectal cancer (LARC), is associated with many radiotherapy (RT)-related side effects. We aimed to evaluate whether S-1 and oxaliplatin (SOX) or folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) can be as effective as neoadjuvant chemotherapy (NAC) regimens for LARC without RT. Methods: Patients with untreated resectable LARC were randomly assigned to receive SOX or mFOLFOX6. The NAC protocol period was 3 months. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints included pathological effects, surgical completion rate, 3-year survival, and safety. Results: From September 2013 to October 2015, 56 and 54 patients were enrolled in the SOX and mFOLFOX6 arms, respectively. The 3-year DFS rates were 69.4% (95% confidence interval [CI] 54.9–83.6) and 73.4% (95% CI 58.7–83.6) in the SOX and mFOLFOX6 arms, respectively; no significant differences were found between the arms (log-rank test; P = 0.5315, hazard ratio: 0.808, 95% CI 0.414–1.578). The 3-year survival rates were 92.3 and 91.8% in the SOX and mFOLFOX6 arms, respectively. The surgical completion rate was 98.1% overall, 100% in the SOX arm, and 96.0% in the mFOLFOX6 arm. The incidences of pathological response rates ≥grade 1b were 41.5 and 43.8% in the SOX and mFOLFOX6 arms, respectively. Both treatments were manageable and tolerable. Conclusion: We demonstrated the effectiveness and safety of SOX and mFOLFOX6, both of which may be new neoadjuvant treatment candidates in previously untreated LARC cases. Trial registration: Date of enrolment of the first participant to the trial: 3rd Oct 2013; This study was registered in the UMIN clinical trials registry on 14th Aug, 2013. (Prospectively registered, UMIN-CTR number UMIN000011486). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J
AB - Background: Preoperative chemoradiotherapy (CRT), the current standard of care for locally advanced rectal cancer (LARC), is associated with many radiotherapy (RT)-related side effects. We aimed to evaluate whether S-1 and oxaliplatin (SOX) or folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) can be as effective as neoadjuvant chemotherapy (NAC) regimens for LARC without RT. Methods: Patients with untreated resectable LARC were randomly assigned to receive SOX or mFOLFOX6. The NAC protocol period was 3 months. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints included pathological effects, surgical completion rate, 3-year survival, and safety. Results: From September 2013 to October 2015, 56 and 54 patients were enrolled in the SOX and mFOLFOX6 arms, respectively. The 3-year DFS rates were 69.4% (95% confidence interval [CI] 54.9–83.6) and 73.4% (95% CI 58.7–83.6) in the SOX and mFOLFOX6 arms, respectively; no significant differences were found between the arms (log-rank test; P = 0.5315, hazard ratio: 0.808, 95% CI 0.414–1.578). The 3-year survival rates were 92.3 and 91.8% in the SOX and mFOLFOX6 arms, respectively. The surgical completion rate was 98.1% overall, 100% in the SOX arm, and 96.0% in the mFOLFOX6 arm. The incidences of pathological response rates ≥grade 1b were 41.5 and 43.8% in the SOX and mFOLFOX6 arms, respectively. Both treatments were manageable and tolerable. Conclusion: We demonstrated the effectiveness and safety of SOX and mFOLFOX6, both of which may be new neoadjuvant treatment candidates in previously untreated LARC cases. Trial registration: Date of enrolment of the first participant to the trial: 3rd Oct 2013; This study was registered in the UMIN clinical trials registry on 14th Aug, 2013. (Prospectively registered, UMIN-CTR number UMIN000011486). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J
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U2 - 10.1186/s12885-020-07766-5
DO - 10.1186/s12885-020-07766-5
M3 - Article
C2 - 33402130
AN - SCOPUS:85098890333
VL - 21
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
IS - 1
M1 - 23
ER -
