A randomized phase II trial of two regimens of moderate dose chemoradiation therapy for patients with non-small cell lung cancer not suitable for curative therapy: Trans Tasman Radiation Oncology Study TROG 03.07.

Background: There are patients with stage I-III non-small cell lung cancer (NSCLC) who are not suitable for curative radical chemoradiation therapy. There are patients with an isolated solitary extracranial metastasis who have improved outcomes compared with those with cranial or multiple metastases. Patients of good performance status receiving moderate dose radiation therapy have improved survival. Two regimens of moderate dose chemoradiation therapy for such patients were compared in a randomized phase II trial.

Methods: Patients were eligible if they had stage I-IIIB NSCLC, unsuitable for curative therapy, or stage IV with a PET-detected extracranial solitary metastasis. Patients were randomized to the following groups-arm A: 40 Gy/20 fractions/4 weeks with concurrent weekly vinorelbine 25 mg/m + cisplatin 20 mg/m or arm B: 30 Gy/15 fractions/3 weeks with concurrent weekly gemcitabine 200 mg. Primary end points were feasibility, response rates, and toxicity. Secondary end points were progression-free survival, overall survival, and quality of life.

Results: Eighty-four patients were randomized. Compliance was above 90% for both arms. The overall response rate was 51% in arm A and 38% in arm B (p = 0.147). Grade 3/4 toxicity in both arms was acceptable. There was no difference in median progression-free survival between the two arms (5.5 versus 5.0 months, p = 0.19). Patients in arm A had longer median survival but this did not reach statistical significance (13.1 versus 8.3 months, p = 0.25). No difference in quality of life was observed.

Conclusions: Arm A was chosen for a future phase II comparison with radiation therapy alone as it demonstrated a response rate greater than 50%, and data suggested that arm A had superior survival to arm B.