Journal of Clinical Oncology, Vol 14, 1055-1064, Copyright © 1996 by American Society of Clinical Oncology
Concurrent chemoradiation therapy with oral etoposide and cisplatin for locally advanced inoperable non-small-cell lung cancer: radiation therapy oncology group protocol 91-06
JS Lee, C Scott, R Komaki, FV Fossella, GS Dundas, S McDonald, RW Byhardt and WJ Curran Jr
University of Texas M.D. Anderson Cancer Center, Houston, TX.
PURPOSE: Patients with locally advanced inoperable non-small-cell lung
cancer (NSCLC) have a poor clinical outcome. We conducted a prospective
study to evaluate the merit of chemotherapy administered concurrently with
hyperfractionated thoracic radiation therapy. PATIENTS AND METHODS:
Seventy-nine patients with inoperable NSCLC were enrolled onto a
multicenter phase II trial of concurrent chemoradiation therapy. Treatment
consisted of two cycles of oral etoposide 100 mg/d (50 mg/d if body-surface
area [BSA] < 1.70 m2), intravenous cisplatin 50 mg/m2 on days 1 and 8,
and hyperfractionated radiation therapy 5 days per week (1.2 Gy twice daily
> 6 hours apart; total 69.6 Gy). RESULTS: Seventy-six assessable
patients with a Karnofsky performance status > or = 60 and adequate
organ function who had received no prior therapy were evaluated for
clinical outcome and toxic effects. After a minimum follow-up duration of
21 months, the 1- and 2-year survival rates and the median survival
duration were 67%, 35%, and 18.9 months overall; they were 70%, 42%, and
21.1 months for patients with weight loss of < or = 5%. Toxicity was
significant; 57% developed grade 4 hematologic toxicity, 53% grade 3 or 4
esophagitis, and 25% grade 3 or 4 lung toxicity. However, only 6.6% of
patients had grade 4 or lethal nonhematologic toxicity, which included
three treatment-related deaths (two of pneumonitis and one of renal
failure). CONCLUSION: Concurrent chemoradiation therapy with oral etoposide
and cisplatin plus hyperfractionated radiation therapy is feasible. The
survival outcome from this regimen compares favorably with that of other
chemoradiation trials and even of multimodality trials that have included
surgery.
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