Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC seems excessively poisonous: Outcomes from a prematurely terminated randomized part II trial.
Lung Most cancers. 2018 Aug;122:180-186
Authors: Hallqvist A, Bergström S, Björkestrand H, Svärd AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J
OBJECTIVES: Concurrent chemoradiotherapy is the mainstay therapy for NSCLC stage III illness. To research whether or not radiation dose escalation primarily based on particular person regular tissue constraints can enhance final result, the Swedish lung most cancers examine group launched this randomized part II trial.
MATERIALS AND METHODS: NSCLC sufferers with stage III illness, good efficiency standing (Zero-1) and satisfactory lung operate (FEV1?>?1.Zero?L and CO diffusion capability > 40%) obtained three cycles of cisplatin (75?mg/m2 day 1) and vinorelbine (25?mg/m2 day 1 and eight) each third week. Radiotherapy began concurrently with the second cycle, with both 2?Gy each day, 5 days every week, to 68?Gy (A) or escalated remedy (B) primarily based on constraints to the spinal twine, esophagus and lungs as much as 84?Gy by including an additional fraction of two?Gy per week.
RESULTS: A pre-planned security evaluation revealed extreme toxicity and decreased survival within the escalated arm, and the examine was stopped. Thirty-six sufferers had been included throughout 2011-2013 (56% male, 78% with adenocarcinoma, 64% with PS Zero and 53% with stage IIIB). The median progression-free survival (PFS) and general survival (OS) had been 11 and 17 months in arm B in comparison with the encouraging outcomes of 28 and 45 months in the usual arm. The 1- and Three-year survival charges had been 56% and 33% (B) and 72% and 56% (A), respectively. There have been seven toxicity-related deaths on account of esophageal perforations and pneumonitis: 5 within the escalated group and two with commonplace therapy.
CONCLUSION: Dose-escalated concurrent chemoradiotherapy to 84?Gy to main tumor and nodal illness is hazardous, with a excessive danger of extreme toxicity, whereas fashionable commonplace dose chemoradiotherapy with correct staging given within the management arm exhibits a promising final result with a median survival of 45 months and a Three-year survival of 56% (NCT01664663).
PMID: 30032828 [PubMed – in process]