ALBUQUERQUE, New Mexico—Carboplatin (Paraplatin), vinorelbine (Navelbine), and capecitabine(Drug information on capecitabine) (Xeloda) given in combination to patients with anthracycline- and taxane-pretreated metastatic breast cancer appears active and well tolerated, according to an interim analysis reported at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 1960).
"We’re seeing patients who have had anthracycline and taxane, and we’re getting a 60% response rate with very good tolerability," said Ian Rabinowitz, MD, of the University of New Mexico Cancer Center, Albuquerque. "So we’re very encouraged by this protocol."
Investigators sought to evaluate the efficacy and tolerability of the three drugs, which are active as single agents for metastatic breast cancer. Eligibility requirements included measurable disease; age 18 to 75; performance status of 2 or less; prior treatment with an anthracycline, a taxane, or both; and no previous exposure to carbo-platin, vinorelbine, or capecitabine.
Nine of the 11 patients enrolled were evaluable at the time of the report. The median age is 53 (range, 40 to 62). Patients had received one to four prior regimens of chemotherapy for metastatic breast cancer, with a median of two prior regimens. Eight patients had visceral disease, and seven had two or more metastatic sites.
Patients received the regimen in 3-week cycles. The initial dosing was carboplatin(Drug information on carboplatin) 300 mg/m2 on day 1, vinorelbine 25 mg/m² on days 1 and 8, and capecitabine 500 mg/m² bid on days 1 through 14. The capecitabine dose was increased by 125 mg/m² bid per protocol. The maximum tolerated dose was capecitabine 1,750 mg/m². Subsequently, patients were started at 750 mg/m² bid. A median of six cycles was given (range, 1 to 12) for a total of 73 cycles.
Six patients required treatment delay or reduced dosages due to toxicities. Three patients experienced grade 3-4 hematologic and gastrointestinal toxicities. One patient had grade 3 neuropathy, and two more had grade 1 neuropathy. Three patients experienced grade 1-2 hand-foot syndrome.
The study currently has 13 patients and is still accruing. All but one patient, who withdrew due to toxicities, have had a response or stable disease. Response rate is 60%. Time to progression is about 7 months. "The most important thing is that patients are tolerating this treatment very well," he said. "Every patient except one has had clinical benefit."
