Surgery with versus without preoperative concurrent chemoradiotherapy for mid/low rectal cancer: an interim analysis of a prospective, randomized trial.
- Author:
Wen-Hua FAN
1
;
Fu-Long WANG
2
;
Zhen-Hai LU
2
;
Zhi-Zhong PAN
2
;
Li-Ren LI
2
;
Yuan-Hong GAO
2
;
Gong CHEN
2
;
Xiao-Jun WU
2
;
Pei-Rong DING
2
;
Zhi-Fan ZENG
2
;
De-Sen WAN
2
;
Author Information
- Publication Type:Journal Article
- MeSH: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy; Combined Modality Therapy; Deoxycytidine; analogs & derivatives; Disease-Free Survival; Fluorouracil; analogs & derivatives; Humans; Neoadjuvant Therapy; Neoplasm Staging; Organoplatinum Compounds; Prognosis; Prospective Studies; Rectal Neoplasms; Survival Rate
- From:Chinese Journal of Cancer 2015;34(9):394-403
- CountryChina
- Language:English
-
Abstract:
INTRODUCTIONMultimodality therapy, including preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), has effectively reduced local recurrence rates of rectal cancer over the past decade. However, the benefits and risks of the addition of neoadjuvant CRT to surgery need to be evaluated. This study was to compare the efficacy of TME with versus without preoperative concurrent chemoradiotherapy (CCRT) involving XELOX regimen (oxaliplatin plus capecitabine) in Chinese patients with stages II and III mid/low rectal adenocarcinoma.
METHODSWe randomly assigned patients to the TME group (TME without preoperative CCRT) or CCRT + TME group (TME with preoperative CCRT). The primary endpoint was disease-free survival (DFS); the secondary endpoints were overall survival (OS), local and distant recurrence, tumor response to CRT, toxicity, sphincter preservation, and surgical complications. An interim analysis of the potential inferiority of DFS in the CCRT + TME group was planned when the first 180 patients had been followed up for at least 6 months.
RESULTSA total of 94 patients in the TME group and 90 patients in the CCRT + TME group were able to be evaluated. The 3-year DFS and OS rates were 86.3 % and 91.5 % in the whole cohort, respectively. The 3-year DFS rates of the TME and CCRT + TME groups were 85.7% and 87.9 % (P = 0.766), respectively, and the 3-year OS rates were 90.7 % and 92.3 % (P = 0.855), respectively. The functional sphincter preservation rates of the TME and CCRT + TME groups were 71.3 % and 70.0 % (P = 0.849), respectively. In the TME group, 16 (17.0 %) patients were proven to have pTNM stage I disease after surgery. In the CCRT + TME group, 32 (35.6 %) patients achieved a pathologic complete response (pCR).
CONCLUSIONSPreliminary results indicated no significant differences in the DFS, OS, or functional sphincter preservation rates between the TME and CCRT + TME groups. However, preoperative CCRT with XELOX yielded a high pCR rate. Newer techniques are needed to improve the staging accuracy, and further investigation is warranted.
CLINICAL TRIAL REGISTRATION NUMBERChi CTR-TRC-08000122.
