Combined Lapatinib And Nab-Paclitaxel (Abraxane) Shows Good Activity In HER2+ Breast Cancer

SAN ANTONIO – Investigators are reporting favorable results in a pilot neoadjuvant trial that tested a combination of lapatinib and nab-paclitaxel (Abraxane^R) for the treatment of HER2+ breast cancer.

The findings were announced at the 32^nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) by Virginia Kaklamani, MD, with Northwestern University in Chicago, Illinois.

Lapatinib, a dual kinase inhibitor against EGFR and HER2, has activity in metastatic HER2+ breast cancer, Dr. Kaklamani noted.

Nab-paclitaxel is a unique albumin formulation of a non-crystalline, amorphous form of paclitaxel in an insoluble nanoparticle state.

While nab-paclitaxel has been shown to be one of the most active agents in metastatic breast cancer, it has not been examined as part of combination therapy in the neoadjuvant setting, she added.

According to the study protocol, women with newly diagnosed HER2+ stage I to III breast cancer received four cycles of lapatinib 1000 mg po/d and nab-paclitaxel 260 mg/m2 IV every three weeks. Postoperative therapy was at the discretion of the investigator.

A total of 28 patients have completed therapy, and the accrual goal of 30 patients has been met.

The study’s primary endpoint was the clinical response rate (CRR) as determined by clinical examination and imaging studies.

Response data in 29 patients showed a CRR of 82%, with 4 (13.8%) patients demonstrating a complete response and 20 (69%) showing a partial response. Five (17.2%) patients had stable disease.

Five (18.5%) patients achieved pathologic complete response (pCR).

The most common toxicities were rash, neuropathy, fatigue, and myalgias. Most toxicities were grade ½ although one patient developed grade 3 rash and five patients developed grade 3 diarrhea. There were no cases of cardiac toxicity.

Toxicities such as diarrhea and rash were medically managed, and patients did not receive prophylactic medications for rash or diarrhea.

The nab-paclitaxel dose was reduced in eight of 104 treatment cycles and the lapatinib dose was reduced in eleven cycles.

“The combination of lapatinib and nab-paclitaxel is very active as first-line treatment in HER+ breast cancer,” Dr. Kaklamani said.

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