Journal of Clinical Oncology, Vol 16, 3316-3322, Copyright © 1998 by American Society of Clinical Oncology
Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer
H Choy, W Akerley, H Safran, S Graziano, C Chung, T Williams, B Cole and T Kennedy
Vanderbilt University Medical School, Nashville, TN, USA. hak.choy@mcmail.vanderbilt.edu
PURPOSE: Combined modality therapy for non-small-cell lung cancer (NSCLC)
has produced promising results. A multiinstitutional phase II clinical
trial was conducted to evaluate the activity and toxicity of paclitaxel,
carboplatin, and concurrent radiation therapy on patients with locally
advanced NSCLC. PATIENTS AND METHODS: Forty previously untreated patients
with inoperable locally advanced NSCLC entered onto a phase II study from
March 1995 to December 1996. On an outpatient basis for 7 weeks, patients
received paclitaxel 50 mg/m2 weekly over 1 hour; carboplatin at (area under
the curve) AUC 2 weekly; and radiation therapy of 66 Gy in 33 fractions.
After chemoradiation therapy, patients received an additional two cycles of
paclitaxel 200 mg/m2 over 3 hours and carboplatin at AUC 6 every 3 weeks.
RESULTS: Thirty-nine patients were eligible for the study. The survival
rates at 12 months were 56.3%, and at 24 months, 38.3%, with a median
overall survival of 20.5 months. The progression-free survival rates at 12
months were 43.6%, and at 24 months, 34.7%, with a median progression-free
survival of 9.0 months. Two patients did not receive more than 2 weeks of
concurrent chemoradiotherapy and were not assessable for toxicity and
response. The overall response rate (partial plus complete response) of 37
assessable patients was 75.7%. The major toxicity was esophagitis.
Seventeen patients (46%) developed grade 3 or 4 esophagitis. However, only
two patients developed late esophageal toxicity with stricture at 3 and 6
months posttreatment. CONCLUSION: Combined modality therapy with
paclitaxel, carboplatin, and radiation is a promising treatment for locally
advanced NSCLC that has a high response rate and acceptable toxicity and
survival rates. A randomized trial will be necessary to fully evaluate the
usefulness of these findings.
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