Source: Gastroenterology  |  Posted 9 years ago

By Peggy Peck

ORLANDO, FL -- May 21, 2002 -- A triple combination of vinorelbine, gemcitabine, and carboplatin is active as primary chemotherapy against brain metastases from non-small cell lung cancer (NSCLC), similar to activity seen in systemic disease and primary tumors.

Gianni Bernardo, MD, of the Service of Oncologic Prevention, Pavia, Italy, and colleagues reported the results at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO).

From December 1998 to November 2001 the study enrolled 42 consecutive chemotherapy-naive patients with documented brain metastases and at least one evaluable extracerebral lesion.

Vinorelbine (25 mg/m?) and gemcitabine (1,000 mg/m?) were given intravenously on day 1, combined with a fixed daily dose of carboplatin at area under the curve (AUC) of 5.0 on days 1 to 3. Cycles were repeated every three weeks, in the outpatient setting. A total of 198 cycles were given (median 4, range 3-9 per patient).

Dr. Bernardo said the dosing schedule was well tolerated and easy to use in the outpatient setting. Specific evaluation of brain metastases by contrast-enhanced CT scan showed an overall response rate of 45 percent in 40 evaluable patients (95 percent confidence interval, 31 percent to 60 percent ), with four (10 percent) complete and 14 (35 percent) partial remissions. Moreover, Dr. Bernardo said that patients who responded in the brain also had a response at the extracerebral sites.

There were also eight minor regressions, 11 disease stabilizations, and three progressions.

Remission of symptoms and improvement of performance index was observed in 77 percent of all patients.

Median time to response was 10 weeks (range, 6-14 weeks) and median response duration was 31 weeks (range, 12-32). Median survival time was 38 weeks (range, 18-62+) in the whole group and 58 weeks in responders (range, 26-62+ weeks).

Dr. Bernardo concluded the results support the need for reconsideration of the role of chemotherapy in such a clinical setting, and he said it is now time to initiate controlled trials comparing chemotherapy with radiotherapy or concomitant sequential chemoradiotherapy.