A randomized phase 2 study found that 30 Grays (Gy) in 1 fraction is equivalent to 60 Gy in 3 fractions in terms of toxicity, progression free survival (PFS) and overall survival (OS) for patients with non-small cell lung cancer (NSCLC), according to results presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1
The study was conducted to compare incidence of Radiation Therapy Oncology Group (RTOG) grade 3 or higher adverse events associated with 2 different Stereotactic Body Radiation Therapy (SBRT) regimens for patients with medically inoperable NSCLC.
Ninety-eight patients with NSCLC who had documented medical conditions that precluded lobectomy, and biopsy-proven peripheral T1/T2, N0 (clinically node negative by PET), and M0 tumors were included in the study. All patients received SBRT treatment. Patients were randomized to receive either 30 Gy in 1 fraction (Arm 1) or 60 Gy in 3 fractions (Arm 2) over at least 8 days. Secondary endpoints included local control, greater than 1 year toxicity, OS, and PFS.
Thirteen patients (27%) in Arm 1 and 16 patients (33%) in Arm 2 experienced RTOG grade 3 AEs. There were no grade 4 AEs. Thoracic grade 3 AEs were experienced by 8 patients (16%) in arm 1 and 6 patients (12%) in Arm 2. There were no differences in OS or PFS survival. OS at 2 years was 71% for Arm 1 and 61% for Arm 2. PFS at 1 year was 63% for Arm 1 and 51% for Arm 2.
RELATED: Switching From Docetaxel to Paclitaxel and Bevacizumab in NSCLC
The authors concluded that there is no significant difference between treating patients with 30 Gy in 1 fraction and 60 Gy in 3 fractions for toxicity, OS, or PFS.
- Gomez Suescun JA, Videtic GM, Stephans K, et al. Phase II randomized study of 2 SBRT regimens for medically inoperable patients with node negative peripheral NSCLC. Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.