29 Sep Perjeta Extended Lives In Metastatic Breast Cancer
MedicalResearch.com Interview with:
Giuseppe Curigliano M.D. Ph.D.
Medico Direttore, Director
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
Early Drug Development for Innovative Therapies Division
Via Ripamonti, Milano
Medical Research: What are the main findings of the study?
Dr. Curigliano: In the CLEOPATRA study, 808 patients from 25 countries with HER2-positive metastatic breast cancer were randomised to receive first-line placebo/trastuzumab/docetaxel or pertuzumab/trastuzumab/docetaxel. Randomisation was stratified by geographic region and neo/adjuvant chemotherapy.
At ESMO 2014 the CLEOPATRA researchers reported results of a final prespecified OS analysis (February 2014). This overall survival (OS) analysis was planned when ≥385 deaths were reported. The log-rank test, stratified by prior treatment status and geographic region, was used to compare OS between arms, applying the threshold of p ≤ 0.0456. Subgroup analyses of OS were performed for stratification factors and other key baseline characteristics.At median follow-up of 50 months (range 0 to 70 months), the statistically significant improvement in OS in favour of pertuzumab/trastuzumab/docetaxel arm was maintained (HR = 0.68, p = 0.0002). Median OS was 40.8 months in the placebo arm and 56.5 months in the pertuzumab arm, with difference of 15.7 months. The PFS in pertuzumab arm was 18.7 vs 12.4 months in placebo arm, HR 0.68 (p < 0.0001).
Medical Research: What was most surprising about the results?
Dr. Curigliano: First-line treatment with pertuzumab/trastuzumab/docetaxel significantly improved overall survival (OS) for patients with HER2-positive metastatic breast cancer compared with placebo/trastuzumab/docetaxel, providing a 15.7 month increase in the median values. The median OS of 56.5 months is unprecedented in first-line and this substantial improvement confirms the pertuzumab containing regimen as standard of care in this setting.
Medical Research: What should clinicians and patients take away from your report?
Dr. Curigliano: CLEOPATRA is an unquestionable therapeutic success with an unquestionable clinical implication: docetaxel/trastuzumab/pertuzumab is the new standard, not an option for first-line treatment of HER2-positive metastatic breast cancer.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Curigliano: Identify patients who are most likely to respond to dual targeting with trastuzumab and pertuzumab. Improvements can be expected by addressing key features of HER2-positive breast cancer linked to different sensitivity in term of hormone receptor status (positive vs negative), PIK3CA status (wild type vs mutant), and immune environment benefit.
ESMO European Society Medical Oncology: 2014 abstract:
Final overall survival (OS) analysis from the CLEOPATRA study of first-line (1L) pertuzumab (Ptz), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC)