Consolidation Therapy
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.
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.
Click here for Dr. Vincent A. Miller’s commentary on this abstract.
Considerations for Administering Hemoglobinopathy Gene Therapies From a Pharmacist’s Perspective
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