Journal of Clinical Oncology, Vol 16, 159-164, Copyright © 1998 by American Society of Clinical Oncology
Phase I study of docetaxel with concomitant thoracic radiation therapy
AM Mauer, GA Masters, DJ Haraf, PC Hoffman, SM Watson, HM Golomb and EE Vokes
University of Chicago Department of Medicine, IL 60637, USA.
PURPOSE: The taxanes have demonstrated activity as radiation sensitizers in
preclinical studies. This study was designed to determine the
maximum-tolerated dose (MTD), optimal schedule, and toxicities of docetaxel
in combination with concomitant standard chest radiotherapy. PATIENTS AND
METHODS: Twenty-nine patients with advanced non-small-cell lung or
esophageal cancer enrolled in this phase I study to evaluate escalating
docetaxel doses at three schedules. Docetaxel was administered as two
21-day cycles at doses of 40, 60, and 75 mg/m2 per cycle. Docetaxel
administration schedules were as follows: schedule A, once every 3 weeks;
schedule B, 2 of 3 weeks; or schedule C, weekly. Six weeks of concomitant
standard chest radiotherapy in 1.8- to 2.0-Gy daily fractions was delivered
to 60 Gy total. RESULTS: Dose-limiting esophagitis and neutropenia were
encountered with schedules A and B at docetaxel doses of 60 mg/m2 per
cycle. The docetaxel MTD for schedules A and B was 40 mg/m2 per cycle.
Dose-limiting esophagitis was also observed with schedule C; however, there
was no neutropenia. For schedule C, we identified the MTD as 60 mg/m2 per
cycle (20 mg/m2/wk). Other toxicities encountered included
thrombocytopenia, hypersensitivity reaction, and pulmonary infiltrates
(fatal in two patients). Late toxicity of esophageal stricture occurred in
five patients. CONCLUSION: Esophagitis and neutropenia are the
dose-limiting toxicities of docetaxel administered with concomitant chest
radiotherapy. Weekly administration of docetaxel allows for the highest
total docetaxel dose during chest radiotherapy. We identified the
recommended phase II docetaxel dose as 20 mg/m2 administered weekly with
concomitant chest radiotherapy for 6 weeks.
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