Journal of Clinical Oncology, Vol 10, 292-296, Copyright © 1992 by American Society of Clinical Oncology
Prolonged administration of oral etoposide in non-small-cell lung cancer: a phase II trial
TM Waits, DH Johnson, JD Hainsworth, KR Hande, M Thomas and FA Greco
Division of Medical Oncology, Vanderbilt University Medical School, Nashville, TN.
PURPOSE: The trial was undertaken to investigate the activity and toxicity
of a prolonged schedule of oral etoposide in the treatment of advanced
non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Between March
1989 and August 1990, 25 patients with advanced NSCLC were treated with
oral etoposide 50 mg/m2/d for 21 consecutive days, repeated every 28 to 35
days. The median patient age was 60 years (range, 38 to 84 years);
male:female ratio was 12:13. Eight patients had stage IIIB disease; 17 had
stage IV. Seventy-six percent of patients had Eastern Cooperative Oncology
Group (ECOG) performance status of 0 or 1. No patient had received previous
chemotherapy with standard agents; nine patients had received previous or
concurrent radiation therapy. Plasma etoposide concentrations were measured
to estimate etoposide bioavailability and kinetics. RESULTS: Five of 22
patients (23%; 95% confidence interval [CI], 10% to 43%) had partial
responses. Median response duration was 5 months (range, 2 to 6 months).
Four of five responders were female. Besides alopecia, which occurred in
all patients, myelosuppression was the most common toxicity, but was mild
or moderate in most patients. Median leukocyte nadir during course 1 was
3,200/microL; only four of 69 courses produced a leukocyte nadir less than
1,000/microL. Severe thrombocythemia (less than 75,000/microL) did not
occur. Gastrointestinal toxicity was uncommon. Median peak etoposide
concentration was 3.4 micrograms/mL. A mean serum etoposide concentration
greater than 1 microgram/L was maintained for more than 13 hours; the
plasma concentration-time curve (AUC) was estimated to be 90% of that
predicted after an identical dose of etoposide given intravenously.
CONCLUSIONS: Etoposide given by this dose and schedule has moderate
activity as first-line systemic therapy for advanced NSCLC. In previously
untreated patients, chronic oral etoposide is well tolerated, and
incorporation into combination regimens should be feasible. Etoposide
bioavailability may be increased at lower oral doses.
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