Weekly Paclitaxel Plus Carboplatin Is Safe And Effective In Patients With Advanced Lung Cancer

PITTSBURGH, May 21, 2001 — New data show that patients with advanced lung cancer may have a safer chemotherapy treatment option. The use of paclitaxel plus carboplatin, administered in a novel weekly regimen, offers a safe and effective treatment option for patients with advanced lung cancer, according to research presented at the 37th Annual Meeting of the American Society of Clinical Oncology. Safety and tolerability are of critical importance in patients with advanced lung cancer .

“These data show that the use of weekly paclitaxel plus carboplatin provides a tolerable treatment for patients with advanced lung cancer,” according to Chandra Belani, M.D., lead investigator of the study from the University of Pittsburgh School of Medicine and the University of Pittsburgh Cancer Institute.

The study enrolled patients with untreated advanced non-small cell lung cancer (NSCLC). It was designed to evaluate three different regimens of weekly paclitaxel plus carboplatin.

This multicenter, phase II, randomized study concludes that a regimen of four cycles of paclitaxel (100 mg/m2) administered weekly for three weeks, with the fourth week off, plus carboplatin (AUC=6) administered on day one of each cycle (arm 1), is the most tolerable regimen compared to the other weekly paclitaxel plus carboplatin regimens for these NSCLC patients. The median survival time, of 49 weeks on this arm, is longer than the other arms. Also, only five percent of patients receiving weekly paclitaxel plus carboplatin experienced grade 3-4 neuropathy.

Reducing the interval between doses from the standard three-week regimen to a weekly regimen increases the dose intensity of treatment. “Increasing the dose intensity may limit the emergence of malignant cell populations that are resistant to chemotherapy and may inhibit tumor regrowth between cycles,” explained Dr. Belani.

The study presented enrolled 390 patients with previously untreated advanced and metastatic NSCLC to determine which of three weekly regimens of induction paclitaxel plus carboplatin was the most safe and effective. On the other two arms of the trial, patients received four cycles of both paclitaxel (100 mg/m2) and carboplatin (AUC=2) weekly for three weeks with the fourth week off (arm B) or paclitaxel (150 mg/m2) and carboplatin (AUC=2) weekly for six weeks, with two weeks off; then paclitaxel (100 mg/m2) and carboplatin (AUC=2) were administered weekly for six weeks with two weeks off (arm C). After receiving 16 weeks of this induction therapy on all three arms, patients who experienced either a complete or partial response or stable disease were further randomized to maintenance weekly paclitaxel (70 mg/m2) vs. observation.

An estimated 169,500 new cases of lung cancer will be diagnosed in 2001, accounting for 13 percent of cancer diagnoses, according to the American Cancer Society. NSCLC accounts for 80 to 85 percent of all lung cancer cases. Lung cancer will claim the lives of more than 157,000 men and women this year, accounting for 28 percent of all cancer deaths. Since 1987, more women have died each year from lung cancer than breast cancer, which, for over 40 years, was the major cause of cancer death in women. It is estimated that approximately 67,300 women will die from lung cancer and 40,200 women will die from breast cancer in 2001.

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