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Neratinib shows anti-tumor activity in HER-2–positive breast cancer

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San Antonio Breast Cancer Symposium

SAN ANTONIO – An irreversible pan-tyrosine kinase inhibitor, neratinib, showed high anti-tumor activity in patients with HER-2-positive breast cancer, according to data presented here.

Miguel Martin, MD, of the Hospital Universitario Gregorio Maranon in Madrid, Spain, and colleagues conducted a phase 2, randomized, open label study of neratinib (Pfizer) vs. lapatinib (Tykerb, GlaxoSmithKline) and capecitabine (Xeloda, Roche).

“The study was originally a phase 3 study, assuming superiority of neratinib vs. the combination of lapatinib plus capecitabine,” Martin said. “Due to the lack of enrollment and prior to any planned interim analysis, it was amended to a phase 2 trial involving only 230 patients to assess the noninferiority of neratinib vs. the standard combination.”

The study included 232 patients who were randomly assigned to neratinib 240 mg/day (n=117) or lapatinib 2,150 mg/day plus capecitabine 2,000 mg/m2/day for 14 days in 21-day cycles. All of the women had HER-2-positive locally advanced or metastatic breast cancer. The patients had two or fewer prior trastuzumab (Herceptin, Genentech) regimens, prior taxane treatment, with no prior anthracycline treatment, with cumulative doses of >400 mg/m² doxorubicin or >800 mg/m² epirubicin or > equivalent dose of other anthracyclines. The primary endpoint was PFS; secondary endpoints included safety, OS, objective response rate and clinical benefit rate.

In the intent-to-treat cohort, the median PFS was 4.5 months for neratinib and 6.8 months for lapatinib plus capecitabine, but this was not significant. The median OS was 19.4 months for neratinib and 19 months for lapatinib plus capecitabine (P=.180). The objective response rate was 29% for neratinib and 40% for lapatinib plus capecitabine (P=.067). The clinical benefit rate was 44% for neratinib and 64% for lapatinib plus capecitabine (P=.003).

The most common drug-related adverse effects included diarrhea, nausea, palmar-plantar erythrodysesthesia and rash. Dose reductions occurred in 13 patients on neratinib and 15 patients on the combination treatment. Discontinuations occurred in 3 patients on neratinib and 7 patients on the combination treatment.

“Neratinib did not demonstrate non-inferiority vs. the standard combination in PFS in this trial,” Martin said. “The median PFS was not statistically superior in the combination arm. However, I think that the activity of neratinib in this particular population is remarkable. Neratinib was also associated with fewer dose reductions and dose delays. These findings support the continued development of neratinib therapy in combination with other agents.”

Disclosures: Dr. Martin reports no relevant financial disclosures.

Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.

For more information:

• Martin M. #S5-7. Presented at: 2011 CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 6-11, 2011; San Antonio.

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