ALBUQUERQUE, New MexicoCarboplatin (Paraplatin), vinorelbine
(Navelbine), and 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
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 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
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