International journal of radiation oncology, biology, physics · 2026
Dose-Escalated Versus Standard Neoadjuvant Chemoradiation Therapy for Locally Advanced Rectal Cancer: Nine-Year Results of a Randomized Phase 2 Trial.
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Li Haoyue, Wang Ningyu, Xu Tongzhen, Zhang Wenjue, Lu Ningning, Fang Hui, Song Yongwen, Liu Yueping, Chen Bo, Qi Shunan, Jing Hao, Wang Shulian, Li Yexiong, Zhou Haitao, Li Ning, Zhang Wenwen, Ren Hua, Tang Yuan, Jin Jing
Аннотация
PURPOSE: To compare the safety and efficacy of preoperative simultaneous integrated boost chemoradiation therapy (SIB-CRT) versus standard chemoradiation therapy (CRT) for locally advanced rectal cancer.
METHODS AND MATERIALS: This prospective, randomized phase II trial (NCT02195141) enrolled patients with stage II/III rectal adenocarcinoma. Patients were randomly assigned (1:1) to CRT (50 Gy/25 fx to the pelvis) or SIB-CRT (50 Gy/25 fx to the pelvis with a simultaneous integrated boost of 56 Gy to PGTV and 60 Gy to lateral metastatic nodes if present). Radical surgery was planned 6-8 weeks after CRT. The primary endpoint was pathologic complete response (pCR) rate; secondary endpoints were disease-free survival (DFS), overall survival, metastasis-free survival, local control, cancer-specific survival, and toxicity.
RESULTS: From August 2013 to February 2015, 106 patients were enrolled: 55 in the SIB-CRT group and 51 in the CRT group. Acute grade 3 toxicity occurred in 14.5% (SIB-CRT) and 19.6% (CRT) of patients, primarily manifested as radiation dermatitis. Curative treatment (radical surgery or watch-and-wait) was achieved in 89.1% (49/55) of SIB-CRT patients and 78.4% (40/51) of CRT patients (P = .135). After a median follow-up of 116.6 months, the SIB-CRT group showed superior 9-year outcomes in the intention-to-treat population: DFS (70.8% vs 47.4%; hazard ratio [HR], 0.46; P = .013), overall survival (74.3% vs 48.9%; HR, 0.43; P = .008), metastasis-free survival (70.8% vs 47.2%; HR, 0.48; P = .017), local control (87.1% vs 70.1%; HR, 0.40; P = .038) and cancer-specific survival (77.4% vs 57.2%, P = .027). Similar benefits were observed in the curative treatment cohort. The pCR rates were comparable (15.2% vs 18.4%, P = .695). Exploratory subgroup analysis showed that the survival benefit of SIB-CRT was statistically significant in patients who did not receive perioperative chemotherapy (9-year DFS, 70.8%; HR, 0.343; P = .014), whereas no additional benefit was observed in those receiving chemotherapy.
CONCLUSIONS: Dose escalation through simultaneous integrated boost during neoadjuvant CRT translates into superior long-term survival outcomes. Despite comparable pCR rates, the intensified control of both local disease and micrometastases by SIB-CRT, coupled with its significant superiority within the chemotherapy-naive subgroup, likely contributed to these robust results. These findings establish dose escalation as a potent strategy for optimizing long-term cure in the modern management of locally advanced rectal cancer, particularly in chemotherapy-ineligible patients.
METHODS AND MATERIALS: This prospective, randomized phase II trial (NCT02195141) enrolled patients with stage II/III rectal adenocarcinoma. Patients were randomly assigned (1:1) to CRT (50 Gy/25 fx to the pelvis) or SIB-CRT (50 Gy/25 fx to the pelvis with a simultaneous integrated boost of 56 Gy to PGTV and 60 Gy to lateral metastatic nodes if present). Radical surgery was planned 6-8 weeks after CRT. The primary endpoint was pathologic complete response (pCR) rate; secondary endpoints were disease-free survival (DFS), overall survival, metastasis-free survival, local control, cancer-specific survival, and toxicity.
RESULTS: From August 2013 to February 2015, 106 patients were enrolled: 55 in the SIB-CRT group and 51 in the CRT group. Acute grade 3 toxicity occurred in 14.5% (SIB-CRT) and 19.6% (CRT) of patients, primarily manifested as radiation dermatitis. Curative treatment (radical surgery or watch-and-wait) was achieved in 89.1% (49/55) of SIB-CRT patients and 78.4% (40/51) of CRT patients (P = .135). After a median follow-up of 116.6 months, the SIB-CRT group showed superior 9-year outcomes in the intention-to-treat population: DFS (70.8% vs 47.4%; hazard ratio [HR], 0.46; P = .013), overall survival (74.3% vs 48.9%; HR, 0.43; P = .008), metastasis-free survival (70.8% vs 47.2%; HR, 0.48; P = .017), local control (87.1% vs 70.1%; HR, 0.40; P = .038) and cancer-specific survival (77.4% vs 57.2%, P = .027). Similar benefits were observed in the curative treatment cohort. The pCR rates were comparable (15.2% vs 18.4%, P = .695). Exploratory subgroup analysis showed that the survival benefit of SIB-CRT was statistically significant in patients who did not receive perioperative chemotherapy (9-year DFS, 70.8%; HR, 0.343; P = .014), whereas no additional benefit was observed in those receiving chemotherapy.
CONCLUSIONS: Dose escalation through simultaneous integrated boost during neoadjuvant CRT translates into superior long-term survival outcomes. Despite comparable pCR rates, the intensified control of both local disease and micrometastases by SIB-CRT, coupled with its significant superiority within the chemotherapy-naive subgroup, likely contributed to these robust results. These findings establish dose escalation as a potent strategy for optimizing long-term cure in the modern management of locally advanced rectal cancer, particularly in chemotherapy-ineligible patients.