Phase II study of preoperative chemoradiotherapy (CRT) with irinotecan plus S-1 in locally advanced rectal cancer.
OBJECTIVE
The aim of this study is to evaluate the efficacy and safety of preoperative radiation therapy combined with S-1 and irinotecan (SI) in LARC.


METHODS
Patients were considered LARC if they had a T3/T4 lesion or node positive. Weekly doses of 40 mg/m(2) irinotecan were intravenously administered once per week during weeks 1-5 of radiotherapy. S-1 (70 mg/m(2)) was given from Monday to Friday in all weeks of radiotherapy. 3-D conformal radiotherapy was given at daily fractions of 1.8Gy for 5days for a total dose of 50.4 (45+5.4)Gy. Surgery was performed 4-6 weeks following the completion of chemoradiation.


RESULTS
Between June 2006 and November 2007, 43 pts were enrolled. The stage was: cT3 24 patients, cT4 6 patients; 28 patients were cN+. Forty-one patients completed the chemoradiation and 42 patients underwent operation: a low anterior resection was performed in 36 patients, a total colectomy in 1 patient, and an abdominal perineal resection in 5 patients. T downstaging was observed in 50%; 23 N+ patients became N- (55%). The complete pathological response was observed in 9 patients (21%). The 3-year locoregional failure rate, distant failure rate, disease-free survival, and overall survival were 9.5%, 18.6%, 72.1%, and 94.3%, respectively. Only three patients experienced G3 diarrhea; one had G3 sepsis and two had septic shock. Hematological toxicity (G3-G4) was observed in five patients.


CONCLUSIONS
This study demonstrated the efficacy of preoperative CRT with S-1 and irinotecan with 21% of complete response. However, prompt recognition and management of infection is needed to use it in patients with locally advanced rectal cancer.
Shin
Sang Joon
SJ
Department of Internal Medicine, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, Republic of Korea.
Kim
Nam Kyu
NK
Keum
Ki Chang
KC
Kim
Ho Geun
HG
Im
Jun Seok
JS
Choi
Hye Jin
HJ
Baik
Seung Hyuk
SH
Choen
Jae Hee
JH
Jeung
Hei-Cheul
HC
Rha
Sun Young
SY
Roh
Jae Kyung
JK
Chung
Hyun Cheol
HC
Ahn
Joong Bae
JB
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin