Stereotactic ablative radiotherapy after concomitant chemoradiotherapy in non-small cell lung cancer: A TITE-CRM phase 1 trial. Issue 2 (May 2018)

• Record Type: Journal Article
• Authors: Doyen, Jérôme; Poudenx, Michel; Gal, Jocelyn; Otto, Josiane; Guerder, Caroline; Naghavi, Arash O.; Gérard, Anais; Leysalle, Axel; Cohen, Charlotte; Padovani, Bernard; Ianessi, Antoine; Schiappa, Renaud; Chamorey, Emmanuel; Bondiau, Pierre-Yves
• Is Part Of: Radiotherapy and oncology. Volume 127:Issue 2(2018)
• Page Start: 239
• Page End: 245
• Publication Date: 2018-05
• Subjects: Phase 1 -- Non-small cell lung cancer -- Chemoradiotherapy -- Stereotactic ablative radiotherapy -- Boost; Oncology -- Periodicals; Radiotherapy -- Periodicals; Tumors -- Periodicals; Medical Oncology -- Periodicals; Neoplasms -- radiotherapy -- Periodicals; Radiotherapy -- Periodicals; Radiothérapie -- Périodiques; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9940642
• DOI: 10.1016/j.radonc.2018.03.024
• Languages: English
• ISSNs: 0167-8140

Abstract

Abstract: Background and purpose: Platinum based chemoradiotherapy is the standard of care for inoperable non-small cell lung cancer (NSCLC). With evidence that NSCLC can have a dose dependent response with stereotactic ablative radiotherapy (SABR), we hypothesize that a SABR boost on residual tumor treated with chemoradiotherapy could increase treatment efficacy. The purpose of this study was to determine feasibility of such an approach. Material and methods: A prospective phase I trial was performed including 26 patients. Time-to-event continual reassessment method (TITE-CRM) was used for dose escalation which ranged from 3 × 7 to 3 × 12 Gy for the stereotactic boost, after 46 Gy (2 Gy per day) of chemoradiotherapy. Results: Median follow-up was of 37.1 months (1.7–60.7), and 3, 4, 3, 3, 9 and 4 patients were included at the dose levels 1, 2, 3, 4, 5 and 6, respectively. During chemoradiotherapy, 9 patients experienced grade 3 toxicity. After stereotactic radiotherapy, 1 patient experienced an esophageal fistula (with local relapse) at the 3 × 11 Gy level, and 1 patient died from hemoptysis at the 3 × 12 Gy level. The 2-year rate of local control, locoregional free survival, metastasis-free survival, and overall survival was 70.3%, 55.5%, 44.5% and 50.8%, respectively. Conclusion: In the treatment of NSCLC with chemoradiotherapy followed by a stereotactic boost, the safe recommended dose in our protocol was a boost dose of 3 × 11 Gy.