Magnetic resonance-guided split-course hypo-fractionated radiotherapy with concurrent chemotherapy and consolidative immunotherapy in locally advanced non–small cell lung cancer: A single arm, phase 2 study
Mené sur 104 patients atteints d'un cancer du poumon non à petites cellules de stade localement avancé et non résécable (durée médiane de suivi : 34,4 mois), cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression, et la sécurité d’une radiothérapie hypofractionnée guidée par IRM (6 séances) en combinaison avec une chimiothérapie concomitante et suivie d’une immunothérapie de consolidation
Background: To evaluate the efficacy and safety of magnetic resonance (MR)-guided split-course hypo-fractionated radiotherapy (hypo-RT) with concurrent chemotherapy followed by consolidative immunotherapy (CIT) in locally advanced non–small cell lung cancer (LA-NSCLC).
Methods: In this phase 2 trial, patients with unresectable stage IIIA–C NSCLC (18–75 years old, Eastern Cooperative Oncology Group 0–1) received MR-guided split-course hypo-RT (30 Gy in six fractions, repeated after 4 weeks for a total of 60 Gy) with concurrent weekly docetaxel (25 mg/m2) and cisplatin (25 mg/m2). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), objective response rate (ORR), and toxicities.
Results: Between July 2020 and January 2023, 104 patients were enrolled with a median follow-up of 34.4 months. Split-course hypo-concurrent chemoradiotherapy (CCRT) was completed in 101 (97.1%) patients, and 74 (71.2%) received CIT. The median PFS was 27.5 months (95% confidence interval [CI], 18.9–36.0 months), and the 1- and 2-year PFS rates were 76.9% (95% CI, 69.2%–85.5%) and 54.7% (95% CI, 45.9%–65.1%), respectively. The 1- and 2-year OS were 87.5% (95% CI, 81.4%–94.1%) and 65.3% (95% CI, 56.8%–75.2%), respectively. The most common grade 3–4 adverse event was lymphopenia (35.6%). Grade 2–3 pneumonitis was observed in eight patients (7.7%) during hypo-CCRT and in seven patients (6.7%) during CIT. Grade 3 esophagitis occurred in three patients (2.8%), and one grade 5 hemoptysis was reported (0.9%).
Conclusion: The MR-guided split-course hypo-CCRT delivered at 5 Gy per fraction to a total dose of 60 Gy followed by CIT yielded encouraging survival outcomes with manageable toxicities in patients with LA-NSCLC.
Cancer , article en libre accès, 2025