Pertuzumab ups survival in HER2-positive metastatic breast cancer

September 30, 2014

Patients with HER2-positive metastatic breast cancer who received pertuzumab (Perjeta, Roche) as part of their chemotherapy regimen had a significantly longer median survival rate-by almost 16 months-compared with those who only received the trastuzumab/docetaxel regimen, according to a presentation during the 2014 Congress of the European Society for Medical Oncology in Spain.

Patients with HER2-positive metastatic breast cancer who received pertuzumab (Perjeta, Roche) as part of their chemotherapy regimen had a significantly longer median survival rate-by almost 16 months-compared with those who only received the trastuzumab/docetaxel regimen, according to a presentation during the 2014 Congress of the European Society for Medical Oncology in Spain.

The CLEOPATRA study enrolled more than 800 patients from 25 countries who had HER2-positive metastatic breast cancer. Patients were randomly assigned to first-line treatment of pertuzumab/trastuzumab/docetaxel or placebo plus trastuzumab/docetaxel. Eligible patients had HER2-positive, metastatic, locally recurrent, or unresectable breast cancer. They also could have been previously treated with one hormonal regimen for metastatic disease.

Related content: 2012 FDA approval of pertuzumab for metastatic breast cancer

In earlier analyses, pertuzumab was demonstrated in May 2011 to increase progression-free survival significantly, and exhibited a trend toward overall survival (OS) benefit. In May 2012, OS reached statistical and clinical significance with a hazard ratio of 0.66. By July 2012, patients in the control group were offered the opportunity to crossover and receive pertuzumab and 48 did.

In the final analysis at a median follow-up of 50 months (range: 0 to 70 months), patients who received the combination of pertuzumab/trastuzumab/docetaxel had a statistically significant improvement in OS (HR=0.68).  Median OS was 56.5 months in the pertuzumab /trastuzumab/docetaxel group, and only 40.8 months in the control group of trastuzumab/docetaxel.

 

“The median overall survival of 56.5 months is unprecedented in first-line [treatment] and this substantial improvement confirms the pertuzumab containing regimen as standard of care in this setting,” reported Prof. Sandra Swain of the Medstar Washington Hospital Center, Washington Cancer Institute.

Patients receiving pertuzumab reported more diarrhea, rash, mucosal inflammation, dry and itchy skin, and muscle spasm than those receiving only trastuzumab/docetaxel. There were no new safety concerns at the end of the study.

The CLEOPATRA study was sponsored by Roche, the manufacturer of pertuzumab.