Hypofractionated Radiotherapy followed by Hypofractionated Boost with weekly concurrent chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Results of A Prospective Phase II Study (GASTO-1049)
Mené entre 2018 et 2020 sur 75 patients atteints d'un cancer du poumon non à petites cellules de stade localement avancé et non résécable (durée médiane de suivi : 28 mois), cet essai de phase II évalue l'efficacité, du point de vue de la suvie sans progression, d'une radiothérapie hypofractionnée suivie d'un boost hypofractionné en combinaison avec une chimiothérapie hebdomadaire
Purpose: We launched the prospective phase II clinical trial to explore the safety and efficacy of hypofractionated radiotherapy (hypo-RT) followed by hypofractionated boost (hypo-boost) combined with concurrent weekly chemotherapy in unresectable locally advanced non-small cell lung cancer (LA-NSCLC) patients. Methods: Newly diagnosed LA-NSCLC patients with unresectable stage III disease were recruited between June 2018 and June 2020. Patients were treated with hypo-RT (40Gy in 10 fractions) followed by hypo-boost (24-28Gy in 6-7 fractions) combined with concurrent weekly chemotherapy (docetaxel 25mg/m2 and nedaplatin 25mg/m2). The primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints included overall survival (OS), locoregional failure-free survival (LRFS), distant metastasis-free survival (DMFS), objective response rate (ORR) and toxicities. Results: From June 2018 to June 2020, 75 patients were enrolled with a median follow-up duration of 28.0 months. The ORR of the whole cohort was 94.7%. Disease progression or death was recorded in 44 (58.7%) patients, with a median PFS of 21.6 months (95% confidence interval (CI), 15.6-27.6 months). The 1- and 2-year PFS rates were 81.3% (95% CI, 72.5%-90.1%) and 43.3% (95% CI, 31.5%-55.1%), respectively. The median OS, DMFS and LRFS had not been reached at the time of the last follow-up. The 1- and 2-year OS rates were 94.7% (95% CI, 89.6%-99.8%) and 72.4% (95% CI, 62.0%-82.8%), respectively. The most frequent acute non-hematologic toxicity was radiation esophagitis. Grade (G) 2 and G3 acute radiation esophagitis were observed in 20 (26.7%) and 4 (5.3%) patients, respectively. Thirteen patients (13/75, 17.3%) patients had G2 pneumonitis and no G3-5 acute pneumonitis occurred during follow-up. Conclusion: Hypo-RT followed by hypo-boost combined with concurrent weekly chemotherapy could yield satisfactory local control and survival outcomes with moderate radiation-induced toxicity in LA-NSCLC patients. The new potent hypo-CCRT regimen significantly shortened treatment time and provided the potential opportunity for the combination of consolidative immunotherapy.
International Journal of Radiation Oncology, Biology, Physics 2022