Boston, MA—Hypofractionated (HF) radiation achieves comparable outcomes with conventional radiation in patients with stage II/III non–small-cell lung cancer (NSCLC), with reduced toxicity and much shorter treatment duration. These results from an interim analysis of a randomized, phase 3 clinical trial were presented at the 2016 American Society for Radiation Oncology annual meeting by lead investigator Puneeth Iyengar, MD, PhD, Assistant Professor, Radiation Oncology, the University of Texas Southwestern Medical Center, Dallas.
“I hope that the completion of this study will potentially change the paradigm of how we treat these patients who cannot receive the standard-of-care treatment,” stated Dr Iyengar. Stage III NSCLC is treated with chemoradiation, and stage II NSCLC is treated with surgery, he noted.
“If the final analysis of this trial delivers similar results, HF radiation would be a good option for patients who cannot receive standard therapy due to comorbidities or frailty, and for those patients who do not want chemotherapy, and for those for whom travel time is an issue,” stated press conference moderator George Rodrigues, MD, PhD, FRCPC, Radiation Oncologist, London Health Sciences Centre, Ontario, Canada.
Conventional radiation achieves poor outcomes in patients with stage II or III NSCLC who are not candidates for chemoradiation or surgery.
The dose escalation used in the current trial is based on a previous trial by the same investigators showing that HF radiation reaching doses of 60 Gy in 15 fractions did not increase toxicity in patients with NSCLC with poor performance status. In the phase 3 trial, 226 patients with stage II/III NSCLC with poor performance status who could not receive standard therapy were randomized to receive image-guided conventional radiotherapy (60 Gy in 30 fractions over 6 weeks) or accelerated HF radiation (60 Gy in 15 fractions over 3 weeks).
The interim analysis included 60 patients (88% with stage III disease, and 12% with stage II disease). The survival analysis included 48 patients with 24 months of follow-up. The median overall survival was 14 months, and the median progression-free survival was 11.5 months—these rates were similar in both groups of patients.
HF radiation had an advantage in terms of toxicity; grade 3 toxicities were reported in 6 patients receiving accelerated HF radiation, and in 10 patients receiving conventional radiotherapy. Death caused by hypoxia was reported in 1 and 2 patients, respectively. No treatment-related, grade 4 toxicities occurred in either arm.
“A curative approach with accelerated HF radiation alone offers similar survival and progression-free survival compared with conventional radiation in a population of patients who cannot receive the standard of care. There is limited grade 3 to 5 toxicity, and, as important or more importantly, the treatment time was cut in half,” Dr Iyengar stated.
