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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

 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 
Journal Title
Issue Date
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
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.
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1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
Yonsei Authors
Keum, Ki Chang(금기창) ORCID logo https://orcid.org/0000-0003-4123-7998
Koom, Woong Sub(금웅섭) ORCID logo https://orcid.org/0000-0002-9435-7750
Kim, Nam Kyu(김남규) ORCID logo https://orcid.org/0000-0003-0639-5632
Kim, Tae Il(김태일) ORCID logo https://orcid.org/0000-0003-4807-890X
Kim, Ho Keun(김호근)
Roh, Jae Kyung(노재경)
Min, Byung Soh(민병소) ORCID logo https://orcid.org/0000-0003-0180-8565
Baik, Seung Hyuk(백승혁) ORCID logo https://orcid.org/0000-0003-4183-2332
Shin, Sang Joon(신상준) ORCID logo https://orcid.org/0000-0001-5350-7241
Ahn, Joong Bae(안중배) ORCID logo https://orcid.org/0000-0001-6787-1503
Lim, Joon Seok(임준석) ORCID logo https://orcid.org/0000-0002-0334-5042
Jung, Min Kyu(정민규) ORCID logo https://orcid.org/0000-0001-8281-3387
Jung, Inkyung(정인경) ORCID logo https://orcid.org/0000-0003-3780-3213
Hur, Hyuk(허혁) ORCID logo https://orcid.org/0000-0002-9864-7229
Hong, Sung Pil(홍성필)
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