Engels Benedikt, De Paoli Antonino, Delmastro Elena, Munoz Fernando, Vagge Stefano, Norkus Darius, Everaert Hendrik, Tabaro Gianna, Gariboldi Elisabetta, Ricardi Umberto, Borsatti Eugenio, Gabriele Pietro, Innocente Roberto, Palazzari Elisa, Dubaere Emilie, Mahé Marc-André, Van Laere Sven, Gevaert Thierry, De Ridder Mark
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel, 1090 Brussels, Belgium.
Department of Radiation Oncology, Centro di Riferimento Oncologico (CRO)-IRCCS, 33081 Aviano, Italy.
Cancers (Basel). 2023 Jul 29;15(15):3869. doi: 10.3390/cancers15153869.
Preoperative chemoradiotherapy (CRT) is the standard treatment for T3-4 rectal cancer. Here, we compared image-guided and intensity-modulated RT (IG-IMRT) with a simultaneous integrated boost (SIB) (instead of concomitant chemotherapy) versus CRT in a multi-centric randomized trial.
cT3-4 rectal cancer patients were randomly assigned to receive preoperative IG-IMRT 46 Gy/23 fractions plus capecitabine 825 mg/m² twice daily (CRT arm) or IG-IMRT 46 Gy/23 fractions with an SIB to the rectal tumor up to a total dose of 55.2 Gy (RTSIB arm).
A total of 174 patients were randomly assigned between April 2010 and May 2014. Grade 3 acute toxicities were 6% and 4% in the CRT and RTSIB arms, respectively. The mean fractional change in SUVmax at 5 weeks after completion of preoperative RT were -55.8% (±24.0%) and -52.9% (±21.6%) for patients in the CRT arm and RTSIB arm, respectively ( = 0.43). The pathologic complete response rate was 24% with CRT compared to 14% with RTSIB. There were no differences in 5-year overall survival (OS), progression-free survival (PFS) or local control (LC).
The preoperative RTSIB approach was not inferior to CRT in terms of metabolic response, toxicity, OS, PFS and LC, and could be considered an available option for patients unfit for fluorouracil-based CRT.
术前放化疗（CRT）是T3 - 4期直肠癌的标准治疗方法。在此，我们在一项多中心随机试验中比较了图像引导调强放疗（IG - IMRT）联合同步整合加量（SIB）（而非同步化疗）与CRT的疗效。
cT3 - 4期直肠癌患者被随机分配接受术前IG - IMRT 46 Gy/23次分割，联合卡培他滨825 mg/m²，每日两次（CRT组），或IG - IMRT 46 Gy/23次分割，对直肠肿瘤进行SIB，总剂量达55.2 Gy（RTSIB组）。
2010年4月至2014年5月期间，共有174例患者被随机分组。CRT组和RTSIB组3级急性毒性反应发生率分别为6%和4%。术前放疗完成后5周时，CRT组和RTSIB组患者SUVmax的平均分数变化分别为 - 55.8%（±24.0%）和 - 52.9%（±21.6%）（P = 0.43）。CRT组的病理完全缓解率为24%，RTSIB组为14%。5年总生存率（OS）、无进展生存率（PFS）或局部控制率（LC）无差异。
术前RTSIB方法在代谢反应、毒性、OS、PFS和LC方面不劣于CRT，对于不适合基于氟尿嘧啶的CRT的患者可被视为一种可行的选择。
