Three-dimensional radiotherapy to the primary tumor with concurrent chemotherapy in patients with stage IV non-small cell lung cancer:results of a multicentre phase II study
Mené en Chine sur 198 patients atteints d'un cancer du poumon non à petites cellules de stade IV traité entre 2008 et 2012 (âge : 18 à 80 ans), cet essai multicentrique de phase II évalue l'efficacité, du point de vue de la survie globale, et la toxicité aiguë d'une radiothérapie thoracique tridimensionnelle en combinaison avec une chimiothérapie concomitante à base de sels de platine
Purpose : The aim of this prospective multi-institutional phase II study was to investigate disease control, survival outcomes, and toxicity after thoracic three-dimensional radiation therapy (3D-RT) with concurrent chemotherapy for newly diagnosed stage IV non-small cell lung cancer (NSCLC). Patients and Methods : Eligible patients were aged 18-80 years, had a Karnofskyperformance status (KPS) score ≥70%, and newly diagnosed stage IV NSCLC with limited metastatic disease (defined as involving ≤3 organs). Patients received platinum-doublet chemotherapy with concurrent irradiation to the primary tumor. Primary endpoints were overall survival (OS) and acute toxicity. Results : From May 2008 to May 2012, 198 eligible patients were enrolled from seven cancer centers. Most patients died with distant metastasis; only 10% died with isolated primary recurrence. Median OS time was 13.0 months (95% confidence interval [CI] 11.7–14.3); OS rates were 53.5% at 1 year, 15.8% at 2 years, and 9.2% at 3years. Median progression-free survival (PFS) time was 9.0 months (95%CI 7.7–10.3);corresponding PFS rates were 30.8%, 8.2%, and 6.1%. Corresponding local (primary tumor) control rates were 78.8%, 57.7%, and 55.4%. Multivariate analysis showed that the delivery of ≥63 Gy to the primary tumor (P=0.014), primary tumor volume<134 cm3 (P=0.008), and having a stable or higher KPS score after treatment (P=0.01) were independent predictors of better OS. The most common severe (grade 3-4) acute toxicities were hematologic: leukopenia, 37.9%; thrombocytopenia, 10.1%; and anemia, 6.9%. No patients experienced grade 4 or 5 radiation-related toxicity;2.5% had acute grade 3 pneumonitis and 6.6% had acute grade 3 radiation esophagitis. Conclusions : Thoracic 3D-RT to the primary tumor with concurrent chemotherapy led to satisfactory survival outcomes with acceptable toxicity. Radiation dose, primary tumor volume, and PS after treatment all predicted survival in these patients with limited-metastasis NSCLC.