Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC seems excessively poisonous: Outcomes from a prematurely terminated randomized section 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 remedy for NSCLC stage III illness. To analyze whether or not radiation dose escalation based mostly on particular person regular tissue constraints can enhance consequence, the Swedish lung most cancers examine group launched this randomized section II trial.
MATERIALS AND METHODS: NSCLC sufferers with stage III illness, good efficiency standing (Zero-1) and satisfactory lung perform (FEV1?>?1.Zero?L and CO diffusion capability > 40%) acquired 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 every day, 5 days per week, to 68?Gy (A) or escalated remedy (B) based mostly 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 have 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 total survival (OS) have 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 have been 56% and 33% (B) and 72% and 56% (A), respectively. There have been seven toxicity-related deaths as a result of esophageal perforations and pneumonitis: 5 within the escalated group and two with customary remedy.
CONCLUSION: Dose-escalated concurrent chemoradiotherapy to 84?Gy to major tumor and nodal illness is hazardous, with a excessive danger of extreme toxicity, whereas fashionable customary dose chemoradiotherapy with correct staging given within the management arm exhibits a promising consequence with a median survival of 45 months and a Three-year survival of 56% (NCT01664663).
PMID: 30032828 [PubMed – in process]