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Weekly Paclitaxel and Carboplatin Benefits Elderly Patients with Lung Cancer: Presented at CFS

By Charlene Laino

NEW YORK, NY -- November 21, 2003 -- Regardless of age, patients with advanced non-small-cell lung cancer (NSCLC) will benefit from a weekly administration of paclitaxel plus carboplatin, a Phase III randomised trial shows.

Chandra P. Belani, MD, Professor of Medicine, University of Pittsburgh School of Medicine and Co-Director, The Lung Cancer Program, University of Pittsburgh Cancer Institute, Pennsylvania, United States, presented these findings here on November 14^th at Chemotherapy Foundation Symposium XXI.

The purpose of the trial was to determine the efficacy and toxicity of 3 different schedules of weekly paclitaxel in combination with carboplatin in patients with advanced NSCLC, and to see if the benefits extend to elderly as well as younger patients, said Dr Belani.

The trial enrolled 403 patients, 28% of whom were 70 years or older. The patients were randomly assigned to one of three regimens. Arm 1 received paclitaxel 100 mg/m² weekly for 3 of 4 weeks with carboplatin area under the curve (AUC) 6 on Day 1; Arm 2 received paclitaxel 100 mg/m² and carboplatin AUC 2 weekly for 3 of 4 weeks; Arm 3 received paclitaxel 150 mg/m² in Cycle 1 and 100 mg/m² in Cycle 2 plus carboplatin AUC 2 weekly for 6 of 8 weeks.

The 130 patients who responded by week 16 were then randomly assigned to either weekly paclitaxel therapy 70 mg/m² for 3 of 4 weeks or to observation.

For the 390 evaluable patients, the objective response rates observed with initial therapy were 32% for Arm 1, 24% for Arm 2, and 18% for Arm 3. The median time to progression was 30 weeks for Arm 1, 21 weeks for Arm 2, and 27 weeks for Arm 3, the study showed.

The median survival times were 49 weeks for Arm 1, 31 weeks for Arm 2, and 40 weeks for Arm 3, while the 1-year survival rates were 47% for Arm 1, 31% for Arm 2, and 41% for Arm 3, Dr. Belani reported.

Since the dosage for Arm 1 patients demonstrated the most favorable therapeutic index, the researchers then performed an age-specific analysis of patients in Arm 1 to determine whether the efficacy benefit was independent of age.

The analysis showed that, among patients in Arm 1, the median survival for those aged 70 years and over was 49 weeks, compared with 48 weeks for younger patients. The median time to progression was 31 weeks and 30 weeks in the older and younger patients, respectively.

Of the elderly patients in Arm 1, 14% developed Grade 4 neutropaenia, compared with 5% of younger patients.

"Although elderly patients did demonstrate a modest increase in toxicity," Dr. Belani reported, "the efficacy of the regimen appears to be independent of age."

This study was supported by a grant from Bristol-Myers Squibb Company.


[Study Title: Optimizing the Schedule of Weekly Paclitaxel Alone and In Combination with carboplatin for Elderly Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC). Abstract 55]

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