Open Access

ARTICLE

Neoadjuvant intermediate-course versus long-course chemoradiotherapy in T3-4/N0+ rectal cancer: Istanbul R-02 phase II randomized study

SUKRAN SENYUREK¹, SEZER SAGLAM^2,*, ESRA KAYTAN SAGLAM³, HAKAN YANAR⁴, KAAN GOK⁴, DIDEM TASTEKIN⁵, CANAN KOKSAL AKBAS⁶, NERGIZ DAGOGLU SAKIN³, GULBIZ DAGOGLU KARTAL⁷, EMRE BALIK⁸, METIN KESKIN⁴, YASEMIN SANLI⁹, MINE GULLUOGLU¹⁰, ZULEYHA AKGUN¹¹

1 Department of Radiation Oncology, Koc University School of Medicine, Istanbul, 34450, Türkiye
2 Department of Medical Oncology, Demiroglu Bilim University Faculty of Medicine, Istanbul, 34394, Türkiye
3 Department of Radiation Oncology, Istanbul University Oncology Institute, Istanbul, 34093, Türkiye
4 Department of General Surgery, Istanbul University Istanbul Faculty of Medicine, Istanbul, 34093, Türkiye
5 Department of Medical Oncology, Istanbul University Oncology Institute, Istanbul, 34093, Türkiye
6 Department of Medical Physics, Istanbul University Oncology Institute, Istanbul, 34093, Türkiye
7 Department of Radiology, Istanbul University Istanbul Faculty of Medicine, Istanbul, 34093, Türkiye
8 Department of General Surgery, Koc University School of Medicine, Istanbul, 34450, Türkiye
9 Department of Nuclear Medicine, Istanbul University Istanbul Faculty of Medicine, Istanbul, 34093, Türkiye
10 Department of Pathology, Istanbul University Istanbul Faculty of Medicine, Istanbul, 34093, Türkiye
11 Department of Radiation Oncology, Memorial Sisli Hospital, Istanbul, 34384, Türkiye

* Corresponding Author: SEZER SAGLAM. Email:

Oncology Research 2023, 31(5), 689-696. https://doi.org/10.32604/or.2023.030351

Received 04 April 2023; Accepted 09 June 2023; Issue published 21 July 2023

Abstract

Radiation therapy (RT) is typically applied using one of two standard approaches for preoperative treatment of resectable locally advanced rectal cancer (LARC): short-course RT (SC-RT) alone or long-course RT (LC-RT) with concurrent fluorouracil (5-FU) chemotherapy. The Phase II single-arm KROG 11-02 study using intermediate-course (IC) (33 Gy (Gray)/10 fr (fraction) with concurrent capecitabine) preoperative chemoradiotherapy (CRT) demonstrated a pathologically complete response rate and a sphincter-sparing rate that were close to those of LC-CRT. The current trial aim to compare the pathological/oncological outcomes, toxicity, and quality of life results of LC-CRT and IC-CRT in cases of LARC. The prescribed dose was 33 Gy/10 fr for the IC-CRT group and 50.4 Gy/28 fr for the LC-CRT group. Concurrent chronomodulated capecitabine (Brunch regimen) 1650 mg/m²/daily chemotherapy treatment was applied in both groups. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module (EORTC QLQ-CR29) was administered at baseline and at three and six months after CRT. A total of 60 patients with LARC randomized to receive IC-CRT (n = 30) or LC-CRT (n = 30) were included in this phase II randomized trial. No significant difference was noted between groups in terms of pathological outcomes, including pathological response rates (ypT0N0-complete response: 23.3% vs. 16.7%, respectively, and ypT0-2N0-downstaging: 50% for each; p = 0.809) and Dworak score-based pathological tumor regression grade (Grade 4-complete response: 23.3 vs. 16.7%, p = 0.839). The 5-year overall survival (73.3 vs. 86.7%, p = 0.173) rate was also similar. The acute radiation dermatitis (p < 0.001) and any hematological toxicity (p = 0.004) rates were significantly higher in the LC-CRT group, while no significant difference was noted between treatment groups in terms of baseline, third month, and sixth month EORTC QLQ-CR29 scores.

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