Long-Term Follow-Up of a Phase I/II Trial of Dose Escalating Three-Dimensional Conformal Thoracic Radiation Therapy with Induction and Concurrent Carboplatin and Paclitaxel in Unresectable Stage IIIA/B Non-small Cell Lung Cancer

We conducted a modified phase I/II trial investigating the incorporation of three-dimensional conformal thoracic radiation therapy (TCRT) into the treatment paradigm of induction and concurrent carboplatin and paclitaxel in patients with unresectable stage IIIA/B non-small cell lung cancer. Patients received 2 cycles of induction carboplatin (area under the curve of 6) and paclitaxel (225 mg/m2) on days 1, and 22. On day 43 concurrent TCRT and weekly ×6 of carboplatin (area under the curve = 2) and paclitaxel (45 mg/m2) was initiated. The TCRT dose was escalated from 60 to 74 Gy in 4 cohorts (60, 66, 70, and 74 Gy), and the 74 Gy cohort was expanded into a phase II trial. Sixty-two patients were enrolled; the median age 57 years (range, 36–82), 39 were male (63%), 61 (98%) had a performance status of 0 or 1, 28 (45%) had stage IIIA disease, 21 (34%) had >5% weight loss, and the median forced expiratory volume 1 = 2.10 liters (range, 1.02–3.75). With a median follow-up for survivors of approximately 9 years (range, 7–11 years) the median progression-free survival, time to tumor progression, and overall survival (OS) (with 95% confidence intervals) were 10 (8.5–17), 15 (9–50), and 25 months (18–37), respectively. The 5-year progression-free survival and OS rates were 21% (12–32%) and 27% (17–39%), respectively. The 10-year OS rate was 14% (7–25%). The long term survival rate compares favorably to other treatment approaches for stage III non-small cell lung cancer.