Topic
Pertuzumab
About: Pertuzumab is a research topic. Over the lifetime, 1453 publications have been published within this topic receiving 73219 citations. The topic is also known as: 2C4 Antibody & MOAB 2C4.
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TL;DR: The results suggest similar efficacy and safety for pertuzumab plus trastuzumAB and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.
Abstract: In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup. This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed. At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9–37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3–90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1–not evaluable). Treatment was well tolerated, with no new safety signals detected. Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.
7 citations
TL;DR: Pharmacological targeting of Her2, with monoclonal antibodies in particular, has dramatically improved the outlook of HER2-positive breast cancer, both in the adjuvant and in the metastatic setting, with notable increases in life expectation.
Abstract: Amplification of the human epidermal growth factor receptor 2 (HER2) oncogene occurs in about 15% of newly diagnosed, operable breast cancer, and in about 20% of patients with advanced breast cance...
7 citations
TL;DR: A multivariable clinical prediction model, defined by race and pretreatment platelet count, was able to discriminate subgroups with a significantly different risk of grade ≥ 3 thrombocytopenia after T-DM1 initiation and allows for improved interpretation of the personalized risks and risk/benefit ratio of T- DM1.
7 citations
TL;DR: Investigations continue to evaluate trastuzumab's role in neoadjuvant and adjuvant management of HER2+ breast cancer, with an acceptable toxicity profile, but its role in first-line treatment is less clear.
Abstract: Trastuzumab emtansine is an antibody-drug conjugate comprised of the anti-HER2 monoclonal antibody trastuzumab linked to DM1 (emtansine), a potent cytotoxic maytansinoid derivative, by a stable linker. This structure results in improved tumor-directed cytotoxicity in HER2+ breast cancer with reduced systemic toxicities, particularly the cardiac toxicities associated with single agent trastuzumab. Phase III trials have demonstrated improved progression-free and overall survival in heavily pretreated patients with advanced HER2+ breast cancer, with an acceptable toxicity profile. However, its role in first-line treatment is less clear. Ongoing studies continue to evaluate its role in neoadjuvant and adjuvant management of HER2+ breast cancer.
7 citations
TL;DR: An overview of PH FDC SC is provided, the experience in preparing and administering this product to patients with HER2-positive breast cancer during clinical trials is discussed, and this product takes much less time to administer than IV pertuzumab–trastuzumAB and has the potential to alleviate time constraints for patients and busy clinics.
Abstract: Pertuzumab plus trastuzumab, administered intravenously (IV) with chemotherapy, is standard treatment for HER2-positive metastatic or high-risk early breast cancer. Pertuzumab and trastuzumab are a...
7 citations