Public Release:  Weekly Taxol (paclitaxel) plus Paraplatin (carboplatin) is safe and effective in patients with advanced lung cancer

University of Pittsburgh Medical Center

Prolonged TAXOL exposure improves anti-cancer therapy

TOKYO, Sept. 13 - New data shows that patients with advanced lung cancer may have a safer chemotherapy treatment option. The use of TAXOL (paclitaxel) plus Paraplatin (carboplatin), administered in a novel weekly regimen, offers a safe and effective treatment option for patients with advanced lung cancer, according to research presented today at the 9th World Conference on Lung Cancer. Safety and tolerability are of critical importance in patients with advanced lung cancer.

"These data show that the use of weekly TAXOL plus Paraplatin provides a very tolerable treatment for patients with advanced lung cancer," reported Chandra Belani, M.D., lead investigator of the study, University of Pittsburgh School of Medicine and University of Pittsburgh Cancer Institute (UPCI). "The tolerability of weekly TAXOL in advanced non-small cell lung cancer (NSCLC) patients suggests that this regimen may be a favorable option. This could also represent an alternative treatment option for the elderly."

The study enrolled patients with untreated advanced NSCLC. It was designed to evaluate three different regimens of weekly TAXOL plus Paraplatin followed by a further randomization of patients to either weekly TAXOL or observation, based on response.

Preliminary results of this phase II study suggest that a regimen of four cycles of TAXOL (100 mg/m2) administered weekly for three weeks, with the fourth week off, plus Paraplatin (AUC=6) administered on day one of each cycle (arm A), is the most tolerable regimen compared to the other weekly TAXOL plus Paraplatin regimens for these NSCLC patients. Patients on this regimen also experienced less neurotoxicity. Preliminary analyses also show that this regimen was associated with fewer deaths. Also, only 3 percent of patients receiving weekly TAXOL plus Paraplatin experienced grade 3-4 neuropathy.

Reducing the interval between doses of weekly TAXOL 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 today enrolled 214 patients with previously untreated advanced and metastatic NSCLC to determine which of three weekly regimens of induction TAXOL plus Paraplatin was the most safe and effective. On the other two arms of the trial, patients received four cycles of both TAXOL (100 mg/m2) and Paraplatin (AUC=2) weekly for three weeks with the fourth week off (arm B) or TAXOL (150 mg/m2) and Paraplatin (AUC=2) weekly for six weeks, with two weeks off; then TAXOL (100 mg/m2) and Paraplatin (AUC=2) were administered weekly for six weeks with two weeks off (arm C). After receiving 16 weeks of this induction therapy on all the three arms, patients who experienced either a complete or partial response or stable disease were further randomized to maintenance weekly TAXOL (70 mg/m2) or observation. Since December 1999, 76 patients have been randomized to the maintenance phase of the trial.

This three-arm trial adds to a growing database establishing the benefits of weekly TAXOL. Based on the results of this study, a phase III trial has begun that is comparing the standard regimen of TAXOL plus carboplatin every three weeks to the aforementioned weekly regimen.

An estimated 164,100 new cases of lung cancer will be diagnosed in 2000, accounting for 14 percent of cancer diagnoses, according the American Cancer Society. NSCLC accounts for 75 to 80 percent of all lung cancer cases. Lung cancer will claim the lives of an estimated 156,900 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 more than 40 years, was the major cause of cancer death in women. It is estimated that approximately 67,600 women will die from lung cancer and 40,800 women will die from breast cancer in 2000.

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Ranked 12th in NCI funding and the only NCI-designated comprehensive cancer center in western Pennsylvania, UPCI is widely recognized as a leader in translating laboratory findings into applications of potential clinical importance and for its commitment to developing new and effective approaches to cancer prevention, diagnosis, treatment and care. For more information about UPCI please access http://www.upci.upmc.edu or call the UPCI Cancer Information and Referral Service toll-free at 1-800-237-4724.

ta/09-12-00

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Spectrum Science
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