Thoracic radiotherapy plus maintenance Durvalumab after first line Carboplatin and Etoposide plus Durvalumab in extensive-stage disease small cell lung cancer (ES-SCLC) – a multicenter single arm open label phase II trial (SAKK 15/19)
Mené sur 46 patients atteints d'un cancer du poumon à petites cellules (durée de suivi : 29 mois), cet essai multicentrique de phase II évalue l'intérêt, du point de vue de la survie sans progression à 12 mois, d'ajouter un traitement comportant une radiothérapie de consolidation en combinaison avec le durvalumab après une chimiothérapie de première ligne standard
Background: Small cell lung cancer (SCLC) is an aggressive tumour type accounting for 10–15% of lung cancers. The role of thoracic radiotherapy (TRT) in extensive stage SCLC (ES_SCLC) in the era of checkpoint inhibitors (CPIs) is undefined.
Methods: SAKK 15-19 is a national, multicenter, single-arm prospective phase II study evaluating consolidative TRT after standard first-line chemotherapy plus durvalumab in ES-SCLC. Patients (pts) with confirmed ES-SCLC and ECOG ≤1 received carboplatin AUC5 (day 1), etoposide 100 mg/m² (days 1–3) and durvalumab 1500 mg (day 1) for 4 cycles, followed by maintenance durvalumab every 4 weeks for up to 2 years in pts without progression. TRT (39 Gy in 13 fractions over 2.5 weeks) was delivered within 5 weeks after chemoimmunotherapy. Prophylactic cranial irradiation was permitted. The primary endpoint was 12-month progression-free rate (PFR); secondary endpoints included progression-free survival (PFS), response rate and overall survival (OS). The study aimed at a 12-month PFR ≥25% (H1) vs. ≤12.5%.
Results: Forty-six pts were enrolled; 37% had ECOG 0, 30% had asymptomatic brain metastases. At 29-month follow-up, the 12-month PFR was 15.6 (95% CI 7–27.5), median PFS 6.4 months (95% CI 4.8–7.2) and median OS 15.0 months (95% CI 10.2–22.0). Grade 3–4 treatment-related adverse events (TRAEs) occurred in 23.9% of pts, mainly neutropenia (23.9%) and thrombocytopenia (8.4%). One pt (2%) had grade 5 sepsis; no severe TRT-related toxicities were observed.
Conclusions: Adding consolidative TRT after chemotherapy plus durvalumab in ES-SCLC didn’t meet the primary endpoint of the expected 12-month PFR. No additional severe toxicities from TRT were observed. Ongoing larger Phase III trials, including RAPTOR (LNRG LU007), will further define TRT’s role in this setting.
European Journal of Cancer , article en libre accès, 2025