We previously reported the efficacy of concurrent cisplatin (Platinol)/etoposide (PE) and radiotherapy in stage IIIB non–small-cell lung cancer in which biopsy confirmation of T4 (noneffusion) or N3 status was required (S9019). In view of the activity of docetaxel (Taxotere) as second-line therapy and potential molecular mechanisms of action favoring taxane sequencing, we designed the present study to maintain a core of concurrent PE/radiotherapy, but to substitute docetaxel consolidation for the two additional cycles of PE.
A total of 71 assessable patients were treated with cisplatin 50 mg/m² days 1, 8, 29, 36; etoposide 50 mg/m² days 1–5, 29–33; and concurrent radiotherapy starting day 1 (61 Gy [1.8–2.0 Gy/d]); followed by consolidation docetaxel 75–100 mg/m² every 21 days for three cycles. The median age was 60 years (range: 34–80 years); the male/female ratio was 54/17; performance status 0–1/2 was 67/4. TNM status was T4, N0-1: 30; T4, N2: 19; N3, 22. Median follow-up is 17 months. Concurrent PE/radiotherapy was generally well tolerated. Toxicity during consolidation docetaxel consisted primarily of neutropenia (58% grade 4), with one infection-related death. Three patients died of pulmonary complications (pneumonitis/aspiration pneumonia). Progression-free survival is 13 months. Survival data are shown in the table:
CONCLUSION: Consolidation docetaxel following concurrent PE/radiotherapy is feasible and tolerable. Neutropenia is dose-limiting. The survival endpoints achieved in pathologically documented stage IIIB non–small-cell lung cancer are highly encouraging and unprecedented in available literature. Further study of the S9504 regimen is warranted.