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Navelbine-Herceptin Combo Appears Safe and Effective as First-Line Treatment For HER2-Positive Breast Cancer: Presented at SABCS

By Bruce Sylvester

SAN ANTONIO, TX -- December 5, 2003 -- Results from a multinational study confirm that Navelbine (vinorelbine) and Herceptin (trastuzumab) in combination is efficacious and safe for first-line treatment for patients with HER2-positive metastatic breast cancer, researchers reported here on December 3^rd at the 26^th Annual San Antonio Breast Cancer Symposium

"This research shows that this combination is not only extremely well tolerated with a lack of significant grade 3 or 4 toxicities, but it is also extremely efficacious," said lead investigator Arlene Chan, MD, medical oncologist, Mount Hospital, Perth, Australia. "We will be looking next at an oral formulation of Navelbine as a way of improving patient compliance."

Subject eligibility included HER2-positive metastatic breast cancer with Karnofsky Performance Scale score greater than 70%, normal baseline left ventricular ejection fraction, no prior Herceptin treatment and no prior chemotherapy for metastatic breast cancer.

Subjects received weekly intravenous Navelbine (30 mg/m²) and Herceptin (4 mg/kg on Day 1 and then 2 mg/kg) within a 4-week-cycle. The researchers restaged the subjects every 8 weeks.

Between October 2000 and June 2002, the investigators enrolled 68 subjects out of 147 patients screened. The median age was 53 years (30-74). The median Karnofsky score was 90% (70%-100%). Rate of prior adjuvant/neoadjuvant chemotherapy use was 66.2% -- anthracyclines 51.1%; anthracyclines + taxanes 28.9%; Cytoxan, methotrexate, 5-fluorouracil 20%. Prior hormonal therapy use was 48.5%. Incidence of visceral metastasis was 75%. The median disease free interval was 19.8 months.

Researchers administered a total of 484 cycles with a median of 6 cycles per patient (1 to more than 20). They administered doses of 20 mg/m² week of Navelbine and 2 mg/kg week of Herceptin.

Sixty-five subjects could be evaluated for response to treatment. Forty subjects achieved an objective clinical response (overall response rate [ORR] 61.5%; partial response [PR] 47.7%; complete response [CR] 13.8%). Stable disease was achieved in 23.1% of evaluated patients.

The site of metastasis did not affect the results (visceral/non visceral OR 58.8%) or disease free interval (ORR: 56.6%<2yrs; 52.6% >2yrs) nor by previous adjuvant chemotherapy (anthracyclines ORR: 60.9%; anthracyclines + taxanes ORR: 53.8%).

"Treatment has been well tolerated," the researchers reported.

Incidence of World Health Organization grade 3/4 neutropenia occurred in 46.8% of cycles, with one episode of febrile neutropenia, which was manageable without growth factor support. Reactions to Herceptin infusion were moderate, with grade 3 reactions occurring in 0.2% of cycles; grade 3 asthenia in 2.1% of cycles; grade 3 peripheral neuropathy in 0.8% of cycles; grade 3 constipation in 0.4% of cycles. One patient dropped out of the study for grade 3 cardiotoxicity with symptomatic cardiac dysfunction and decline of left ventricular ejection fraction that resolved with treatment. There were no cases of severe nausea, vomiting or alopecia.


[Study title: Navelbine and Herceptin combination as first line therapy for HER 2-overexpressing metastatic breast cancer is a highly active and safe regimen. Final results of multinational trial. Abstract 219]

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