Phase II study of preoperative chemoradiation with S-1 plus oxaliplatin in patients with locally advanced rectal cancer.
A phase II study of preoperative chemoradiation (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer was conducted. The total radiotherapy dose was 50.4 Gy. Chemotherapy consisted of oxaliplatin 50 mg/m(2) on days 1, 8, 22 and 29 and S-1 80 mg/m(2) per day on days 1-14 and 22-35. The tumor apparent diffusion coefficient (ADC) was measured using diffusion-weighted magnetic resonance imaging (DW-MRI) before and after CRT. Total mesorectal excision was performed within 6 ± 2 weeks. The primary end-point was the pathological complete response (pCR) rate. A total of 38 patients were enrolled. The pCR rate was 22.9% (8/35; 95% CI, 10.9-42.1), and 10 (28.6%) patients showed near-total tumor regression. There was no grade 4 adverse event, and grade 3 adverse events included leukopenia (5.4%), diarrhea (5.4%), anorexia (2.7%) and nausea (2.7%). The tumor ADC was calculated in 38 patients (including those who participated in the phase I study). The post-CRT ADC (P = 0.037) and the percentage change in ADC (P = 0.026) were significantly correlated with pathological response. In conclusion, preoperative CRT with S-1 plus oxaliplatin showed promising results in pathological responses and favorable toxicity profiles.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Eun Mi
EM
Lee
Yong Sang
YS
Hong
Kyu-Pyo
KP
Kim
Jae-Lyun
JL
Lee
Sun Young
SY
Kim
Young Suk
YS
Park
Doo Ho
DH
Choi
Jong Hoon
JH
Kim
Seok-Byung
SB
Lim
Chang Sik
CS
Yu
Jin Cheon
JC
Kim
Ju Hee
JH
Lee
Ah Young
AY
Kim
Tae Won
TW
Kim
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects* / Q000627:therapeutic use*; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000009:adverse effects* / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000601:surgery / Q000628:therapy*; D005641:Tegafur / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid