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A Randomized Phase 2 Study of Neoadjuvant Chemoradiaton Therapy With 5-Fluorouracil/Leucovorin or Irinotecan/S-1 in Patients With Locally Advanced Rectal Cancer

Authors
 Minkyu Jung  ;  Sang Joon Shin  ;  Woong Sub Koom  ;  Inkyung Jung  ;  Ki Chang Keum  ;  Hyuk Hur  ;  Byung Soh Min  ;  Seung Hyuk Baik  ;  Nam Kyu Kim  ;  Hoguen Kim  ;  Joon Seok Lim  ;  Sung Pil Hong  ;  Tae Il Kim  ;  Jae Kyung Roh  ;  Young Suk Park  ;  Joong Bae Ahn 
Citation
 International Journal of Radiation Oncology Biology Physics, Vol.93(5) : 1015-1022, 2015 
Journal Title
 International Journal of Radiation Oncology Biology Physics 
ISSN
 0360-3016 
Issue Date
2015
MeSH
Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Adenocarcinoma/therapy* ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage* ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Camptothecin/administration & dosage ; Camptothecin/adverse effects ; Camptothecin/analogs & derivatives ; Chemoradiotherapy, Adjuvant/methods* ; Chemoradiotherapy, Adjuvant/mortality ; Chi-Square Distribution ; Confidence Intervals ; Disease-Free Survival ; Drug Administration Schedule ; Drug Combinations ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/adverse effects ; Humans ; Induction Chemotherapy/methods ; Leucovorin/administration & dosage ; Leucovorin/adverse effects ; Male ; Middle Aged ; Neoadjuvant Therapy/adverse effects ; Neoadjuvant Therapy/methods* ; Oxonic Acid/administration & dosage ; Rectal Neoplasms/mortality ; Rectal Neoplasms/pathology ; Rectal Neoplasms/therapy* ; Tegafur/administration & dosage
Abstract
PURPOSE: The purpose of this study was to evaluate the rate of pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiation therapy (CRT) with leucovorin (FL) versus irinotecan/S-1 (IS). METHODS AND MATERIALS: Patients with resectable LARC (clinical stage T3/4, lymph node positive, or both) were randomly assigned to receive preoperative radiation (45-50.4 Gy in 25 to 28 daily fractions) and concomitant chemotherapy either with a bolus injection of FL (400 mg/m(2)/day 5-fluorouracil and 20 mg/m(2)/day leucovorin) for 3 consecutive days every 4 weeks for 2 cycles (FL group) or with 40 mg/m(2) irinotecan on days 1, 8, 15, 22, and 29, and 35 mg/m(2) S-1 twice on the day of irradiation (IS group). Curative surgery was performed approximately 4 to 8 weeks after the completion of CRT. The postoperative chemotherapy regimen was FL with a primary endpoint of a pCR rate evaluation. RESULTS: One hundred forty-two eligible patients were randomly assigned, and the median follow-up duration was 43.8 months (95% confidence interval, 40.8-46.8 months). One hundred thirty-three patients (93.7%) of 142 underwent total mesorectal excision; pCR was achieved in 11 (16.7%) of 66 patients in the FL group and 17 (25.8%) of 67 patients in the IS group (P=.246). When good responders were defined as patients with Mandard grades 1 and 2, the rate of good responders was significantly higher in the IS group than in the FL group (54.6% vs 36.4%, respectively, P=.036). The preoperative rates of grade 3 and 4 toxicities were higher in the IS group (7.0%) than in the FL group (1.4%, P=.095). The 3-year disease-free survival was not significantly different between the 2 groups (79.7% vs 76.6%, respectively, P=.896). CONCLUSIONS: IS-based preoperative CRT did not increase pCR rate, but it did increase acute toxicities compared with standard 5-FU treatment. Therefore, further investigation is needed.
Full Text
http://www.sciencedirect.com/science/article/pii/S0360301615031946
DOI
10.1016/j.ijrobp.2015.08.037
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실)
Yonsei Authors
금기창(Keum, Ki Chang) ORCID logo https://orcid.org/0000-0003-4123-7998
금웅섭(Koom, Woong Sub) ORCID logo https://orcid.org/0000-0002-9435-7750
김남규(Kim, Nam Kyu) ORCID logo https://orcid.org/0000-0003-0639-5632
김태일(Kim, Tae Il) ORCID logo https://orcid.org/0000-0003-4807-890X
김호근(Kim, Ho Keun)
노재경(Roh, Jae Kyung)
민병소(Min, Byung Soh)
백승혁(Baik, Seung Hyuk)
신상준(Shin, Sang Joon) ORCID logo https://orcid.org/0000-0001-5350-7241
안중배(Ahn, Joong Bae) ORCID logo https://orcid.org/0000-0001-6787-1503
임준석(Lim, Joon Seok) ORCID logo https://orcid.org/0000-0002-0334-5042
정민규(Jung, Min Kyu) ORCID logo https://orcid.org/0000-0001-8281-3387
정인경(Jung, Inkyung) ORCID logo https://orcid.org/0000-0003-3780-3213
허혁(Hur, Hyuk) ORCID logo https://orcid.org/0000-0002-9864-7229
홍성필(Hong, Sung Pil)
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/157228
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