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Pertuzumab improved PFS when given with trastuzumab, chemotherapy
San Antonio Breast Cancer Symposium
SAN ANTONIO — Patients with HER-2–positive metastatic or locally recurrent breast cancer had a longer PFS when they received a triple-drug combination that included pertuzumab, trastuzumab and docetaxel vs. patients who only received trastuzumab and docetaxel, according to data presented here.
Pertuzumab (Omnitarg, Genentech), similar to trastuzumab (Herceptin, Genentech), is a monoclonal antibody that binds to the HER-2 receptor protein. According to study researcher José Baselga, MD, PhD, professor in the department of medicine at Harvard Medical School and associate director of the Massachusetts General Hospital Cancer Center, the two drugs work together as a dual blockade of the HER-2 growth factor.
“The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful improvement in PFS in patients with HER-2–positive metastatic breast cancer,” Baselga said. “This new regimen may be practice-changing in HER-2–positive, first-line treatment for metastatic breast cancer.”
The Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study was a phase 3, double blind, randomized trial that included 808 patients. The patients were randomly assigned to receive trastuzumab and docetaxel with either pertuzumab or placebo.
The PFS was 18.5 months for patients who received pertuzumab vs. 12.4 months for patients who received the placebo. This is a 38% reduction in risk for progression.
“An interim analysis also showed a strong trend in improvement in OS,” Baselga said. “However, this is not yet significant, as we need to wait longer for the data to mature.”
He said it is uncommon to have a clinical trial show this level of improvement in PFS, and most metastatic patients with HER-2–positive breast cancer eventually stop responding to trastuzumab.
“The fact that we now have an agent that can be added to current treatment to delay progression is exciting,” Baselga said. “With the advent of trastuzumab and now pertuzumab, we have come a long way in treating a type of breast cancer that once had a poor prognosis.”
Disclosure: Dr. Baselga is a paid consultant for Roche.
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.
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In the setting of HER-2–positive metastatic breast cancer, the last breakthrough came in 1998. It’s been a long time waiting for data that would change the practice of how we manage patients who are eligible to receive first-line treatment for HER-2–positive metastatic breast cancer. CLEOPATRA has given us that. New data, 12 years later, tell us there may be a better way to treat patients compared with the way we’ve been doing it since 1998. By adding two anti–HER-2 therapies to chemotherapy, the patients do better than having one anti–HER-2 therapy with chemotherapy. The important aspect of CLEOPATRA is that we have triple therapy, instead of double therapy, and that could be extremely important to address many of the different aspects of breast cancer that lead to tumor growth. CLEOPATRA was also important because it was a global trial, so the data are applicable to many groups of patients. There is also little toxicity associated with pertuzumab. This is important because sometimes we see benefit for patients, but there are side effects that worry us. That was not the case with this study. I hope that regulatory agencies around the world look at these data, and that the drug becomes available so that we can incorporate it into our day-to-day practice.
Edith A. Perez, MD
HemOnc Today Editorial Board member
Disclosure: Dr. Perez reports no relevant financial disclosures.
For more information:
- Baselga J. #S5-5. Presented at: the 2011 CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 6-11, 2011; San Antonio.
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