Neoadjuvant Concurrent Chemo-immuno-radiation Therapy Followed by Surgery and Adjuvant Immunotherapy for Resectable Stage III N2 Non-Small Cell Lung Cancer: Primary Results from SQUAT trial (WJOG 12119L)
Mené au Japon sur 31 patients atteints d'un cancer du poumon non à petites cellules de stade II-III et résécable (durée médiane de suivi : 28 mois), cet essai évalue l'intérêt, du point de vue du taux de réponse pathologique majeure, d'ajouter une radiothérapie à une chimio-immunothérapie néoadjuvante à base de durvalumab
Introduction: Neoadjuvant chemo-immunotherapy is one of the standard treatment options for resectable stage II-III non-small cell lung cancer (NSCLC). However, this treatment yielded insufficient local control in the CheckMate 816 trial. We hypothesized that adding radiotherapy could improve local control, thereby improving survival outcomes.
Methods: Eligible patients had clinical T1–3/T4 (tumor size) N2 stage IIIA–B NSCLC (AJCC ver. 8), pathologically confirmed as N2 without extranodal invasion. Patients received concurrent chemoradiotherapy (carboplatin [AUC 2] and paclitaxel [40 mg/ml] on days 1, 8, 15, 22, and 29, with 50 Gy radiation over 25 days) and durvalumab [1500 mg] on days 1 and 29, followed by surgical resection within 2–6 weeks. After surgery, durvalumab adjuvant therapy was administered for up to 1 year. The primary endpoint was major pathologic response (MPR: ≤10% viable tumor), with secondary endpoints being pathologic complete response (pCR), progression-free survival (PFS), overall survival (OS), and safety.
Results: From January 2020 through February 2022, 31 patients were enrolled from 10 Japanese institutions. The MPR rate was 63% (90% CI: 47–78%), which met the primary endpoint, and the pCR rate was 23%. At a median follow-up of 28 months, the 2-year PFS and OS rates were 43% and 76%, respectively. Grade 3 or 4 adverse events occurred in 48% of cases, including one treatment-related death.
Conclusions: Compared with recently published results of peri-operative chemo-immunotherapy trials, this treatment regimen had a higher MPR rate. However, this benefit did not necessarily translate into improved PFS or OS.
Journal of Thoracic Oncology , résumé 2024