Hypo-fractionated radiotherapy with concurrent chemotherapy for locoregional recurrence of non-small cell lung cancer after complete resection: A prospective, single-arm, phase II study (GASTO-1017).

Abstract

OBJECTIVES\nTo explore the efficacy and toxicities of split-course hypo-fractionated radiotherapy with concurrent chemotherapy (HFRT-CHT) with intensity modulated radiotherapy (IMRT) technique in non-small cell lung cancer (NSCLC) patients with postoperative locoregional recurrence (LRR).\n\n\nMATERIALS AND METHODS\nNSCLC patients were eligible if confirmed as LRR disease without distant metastasis after complete resection. HFRT-CHT using IMRT technique was administered with 51\u2009Gy in 17 fractions or 40\u2009Gy in 10 fractions as the first course followed by a break. Patients with no disease progression and no persistent Grade ≥2 toxicities had the second course of 15\u2009Gy in 5 fractions or 28\u2009Gy in 7 fractions as a boost. The primary endpoint was progression-free survival (PFS).\n\n\nRESULTS\nFifty-eight patients were enrolled and analyzed. With a median follow-up of 23.9 months for all, the 2-year and 3-year PFS rate was 59.7 % and 46.4 %, the 2-year and 3-year OS rate was 72.5 % and 52.2 %, respectively, and a favorable objective response rate of 95.9 % was obtained after the whole courses protocol. Grade 3 acute pneumonitis and esophagitis occurred in 2 (3.4 %) and 7 (12.1 %) patients, and fatal pneumonitis was reported in one case (1.7 %). Exploratory subgroup analysis showed that performance status (PS) (PS 0 vs. 1: 2-year PFS, 88.1 % vs. 46.9 %,P\u2009=\u20090.001; 2-year OS, 100 % vs. 59.4 %, P\u2009<\u20090.001), recurrence site (single vs. multiple: 2-year PFS, 93.8 % vs. 47.4 %, P\u2009=\u20090.008; 2-year OS, 100 % vs. 63.0 %, P\u2009=\u20090.001), and gross tumor volume (GTV) (<50cm3 vs.\u2009≥\u200950cm3: 2-year PFS, 70.6 % vs. 46.2 %, P\u2009=\u20090.024; 2-year OS, 85.6 % vs. 57.4 %, P\u2009=\u20090.034) were significantly associated with PFS and OS.\n\n\nCONCLUSION\nSplit-course HFRT-CHT with IMRT technique achieved promising disease control and satisfactory survival with moderate toxicities in postoperative LRR of NSCLC. Good PS, a single recurrence site and GTV<50cm3 tended to have prolonged PFS and OS. Early detection of LRR may improve the efficacy of HFRT-CHT.