Effect of three-dimensional interstitial high-dose-rate brachytherapy with regional metastatic lymph node intensity-modulated radiation therapy in locally advanced peripheral non-small cell lung cancer: 5-year follow-up of a phase II clinical trial
Mené sur 75 patients atteints d'un cancer du poumon non à petites cellules de stade localement avancé (âge médian : 64 ans ; 25,3 % de femmes ; durée médiane de suivi : 53,7 mois), cet essai de phase II évalue l'efficacité, du point de vue de la survie globale, et la toxicité d'une curiethérapie interstitielle à haut débit de dose associée à une radiothérapie à modulation d'intensité ciblant les ganglions lymphatiques régionaux
Purpose: We aimed to reveal the 5-year clinical outcomes of three-dimensional (3D) interstitial high-dose-rate (HDR) brachytherapy with regional metastatic lymph node intensity-modulated radiation therapy (IMRT) for locally advanced peripheral non-small cell lung cancer (NSCLC), which has been shown to have low toxicity and improved 2-year survival rates in patients with this disease. Methods: In this phase II, single-arm, open-label clinical trial, 83 patients with locally advanced peripheral NSCLC were enrolled (median follow-up [range], 53.7 [4.3–120.4] months). All eligible patients received 3D interstitial HDR brachytherapy with regional metastatic lymph node IMRT. The primary endpoint was overall survival (OS). Secondary endpoints were local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), progression-free survival (PFS), distant metastasis-free survival (DMFS), toxicities, and quality of life. Results: The final analysis included 75 patients (19 [25.3%] females, 56 [74.7%] males; median [range] age, 64 [44–80] years; stage IIIA, 34 [45.3%]; stage IIIB, 41 [54.7%]). At the latest follow-up, 32 (42.7%) patients had survived. The median OS was 38.0 months (5-year OS, 44.5%; 95% confidence interval [CI], 33.8%–58.6%). The LRFS, RRFS, and DMFS at 5 years were 79.2% (95% CI, 68.5%–91.5%), 73.6% (95% CI, 61.5%–88.1%), and 50.3% (95% CI, 38.3%–66.1%), respectively. The dominant failure pattern was distant disease, corresponding to 40% (30/75) of patients and 65.2% (30/46) of all failures. Two (2.7%) patients developed grade 1 acute pneumonitis. Grade 2 and 3 acute esophagitis occurred in 11 (14.7%) and 4 (5.3%) patients, respectively. No late radiation-related grade ≥2 late adverse events were observed. Conclusions: 3D interstitial HDR brachytherapy with regional metastatic lymph node IMRT for locally advanced peripheral NSCLC shows significant OS and has a low toxicity rate. Additional evaluation in a phase III trial is recommended to substantiate these findings.
International Journal of Radiation Oncology, Biology, Physics 2022