High-dose versus standard-dose intensity-modulated radiotherapy with concurrent paclitaxel plus carboplatin for patients with thoracic esophageal squamous cell carcinoma: a randomized, multicenter, open-label, phase 3 superiority trial
Mené en Chine sur 167 patients atteints d'un carcinome épidermoïde de l'oesophage thoracique inopérable (durée médiane de suivi : 36 mois), cet essai randomisé multicentrique de phase III évalue l'efficacité, du point de vue de la survie médiane globale, et la toxicité d'une forte dose de radiothérapie avec modulation d'intensité (59,4 Gy)
Purpose: The standard dose of definitive concurrent chemoradiotherapy (dCRT) remains 50.4 Gy in patients with esophageal cancer; a higher dose, when applied conventional radiotherapy techniques, increases toxicities without improving survival. We investigated whether a high dose of 59.4 Gy using intensity-modulated radiotherapy (IMRT) improve survival without increasing toxicities. Methods and Materials: Patients with inoperable thoracic esophageal squamous cell carcinoma (SCC) referred for dCRT were randomly assigned (1:1) to high-dose (HD) IMRT (59.4 Gy) or standard-dose (SD) IMRT (50.4 Gy). Chemotherapy consisted of six cycles of concurrent weekly paclitaxel and carboplatin, and a maximum of 2 cycles of consolidation chemotherapy. Nutritional intervention was implemented for patients with malnutrition on the basis of nutritional screening. The primary endpoint was median overall survival (mOS). Analyses were by modified intention to treat. Results: Between April 30, 2016 and April 30, 2019, 167 patients were enrolled at nine participating centers in China, 71 patients in the HD and 73 patients in the SD groups were included in the analysis. 86.8% of the patients completed radiotherapy and 70.1% received five or six cycles of concurrent chemotherapy. The median follow-up was 36.0 months. The mOS was 28.1 months and 26.0 months in the HD and SD arms, respectively (P = .54). A total of seven treatment related deaths were observed. Grade 3 or worse treatment related toxicities were observed in 62% and 68.5% of the patients in the HD and SD arms, respectively (P = .675). Conclusions: For patients with inoperable thoracic esophageal SCC, a dose of 59.4 Gy did not improve survival compared with the standard dose of dCRT using IMRT.
International Journal of Radiation Oncology, Biology, Physics 2022