SOCCAR: Sequential or concurrent chemotherapy and hypofractionated accelerated radiotherapy in inoperable stage III NSCLC.

Abstract

7039 Background: Concurrent chemoradiation is standard therapy for inoperable stage III NSCLC but there is uncertainty as to the optimal regimen and outcomes with conventional treatment are disappointing. SOCCAR addresses the feasibility, toxicity and efficacy of accelerated radical radiotherapy when combined with either concurrent (con) or sequential (seq) chemotherapy. Methods: 130 patients were randomised to 55Gy (ICRU reference point) in 20 fractions over four weeks with four cycles of either con or seq cisplatinum and vinorelbine. Entry required pathologically confirmed stage III inoperable NSCLC treatable in a radical RT volume with v20 ≤ 30% and ≤ 12cm oesophagus in PTV; PS 0 or 1, FEV1 ≥ 1L and TLCO ≥ 50%. Patients with weight loss or N3 disease were included, with no upper age limit. Results: Data is on 67 con and 60 seq patients at a median follow up of 31 months. Median age was 62; 61% male, 64% squamous, 27% adenoca; 52% PS 0; 44% IIIA, 56% IIIB. Compliance: median chemo cycles three (con) vs four (seq). Dose delays 53% con vs 60% seq. Toxicity: treatment related deaths - two con vs one seq; deaths within 6 months of starting treatment - three con vs two seq. SAEs - 46% con vs 47% seq. CTC grade 3 oesophagitis - six con vs one seq. Grade 4 oesophagitis did not occur. Survival: deaths 52.2% con vs 68.3% seq; median survival (months) - 27.4 con vs 18.6 seq; 2 year survival 54% con vs 42% seq. 3 year survival 38% con vs 27% seq. Conclusions: These findings confirm that accelerated XRT with concurrent cisplatinum and vinorelbine is feasible, safe and effective for patients with stage III NSCLC, with a two year survival rate in excess of 50%.