{"id":26786,"date":"2021-02-17T08:28:00","date_gmt":"2021-02-17T08:28:00","guid":{"rendered":"http:\/\/37988faf113d4b994fcc640be8006b8a"},"modified":"2024-11-03T15:15:46","modified_gmt":"2024-11-03T15:15:46","slug":"efficacy-and-safety-of-adjuvant-pertuzumab-trastuzumab-and-chemotherapy-after-6-years-median-follow-up-in-the-aphinity-study","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/efficacy-and-safety-of-adjuvant-pertuzumab-trastuzumab-and-chemotherapy-after-6-years-median-follow-up-in-the-aphinity-study\/","title":{"rendered":"Efficacy and Safety of Adjuvant Pertuzumab, Trastuzumab and Chemotherapy After 6 Years Median Follow-Up in the APHINITY Study"},"content":{"rendered":"

Findings from 6 years median follow-up in the APHINITY study confirm benefit in invasive disease-free survival (IDFS) from adding pertuzumab to standard adjuvant treatment in patients with node-positive, human epidermal growth factor receptor 2 (HER2)–<\/em>positive early breast cancer. Longer follow-up is needed to fully assess overall survival (OS) benefit. No cardiac safety concerns have emerged. The results are published on 4 February 2021 in the Journal of Clinical Oncology<\/em> by Prof. Martine Piccart of the Institut Jules Bordet and L’Universit\u00e9 Libre de Bruxelles in Brussels, Belgium and colleagues.<\/p>\n

The APHINITY, at 45 months median follow-up, showed that pertuzumab added to adjuvant trastuzumab and chemotherapy significantly improved IDFS (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.66 to 1.00, p = 0.045) for patients with early HER2\u2013positive breast cancer, specifically those with node-positive or hormone receptor\u2013negative disease. A first preplanned interim analysis for OS was performed at the time of primary analysis (HR 0.89; 95% CI 0.66 to 1.21, p = 0.47) with a median follow-up of 45 months. The study team now report the preplanned second interim OS and preplanned descriptive updated IDFS analysis with 74 months median follow-up.<\/p>\n

After surgery and central HER2-positive confirmation, 4,805 patients with node-positive or high-risk node-negative breast cancer were randomly assigned to either 1-year pertuzumab or placebo added to standard adjuvant chemotherapy and 1-year trastuzumab.<\/p>\n

This interim OS analysis comparing pertuzumab versus placebo did not reach the p = 0.0012 level required for statistical significance (p = 0.17, HR 0.85). Six-year OS were 95% versus 94% with 125 deaths (5.2%) versus 147 (6.1%), respectively.<\/p>\n

IDFS analysis based on 508 events in intent-to-treat population showed a HR 0.76 (95% CI 0.64 to 0.91) and 6-year IDFS of 91% and 88% for pertuzumab and placebo groups, respectively. The node-positive cohort continues to derive clear IDFS benefit from pertuzumab (HR 0.72 [95% CI 0.59 to 0.87]), 6-year IDFS being 88% and 83%, respectively. Benefit was not seen in the node-negative cohort. In a subset analysis, IDFS benefit from pertuzumab showed a HR 0.73 (95% CI 0.59 to 0.92) for hormone receptor-positive disease and a HR 0.83 (95% CI 0.63 to 1.10) for hormone receptor-negative disease.<\/p>\n

Primary cardiac events remain <1% in both treatment groups. No new safety signals were reported.<\/p>\n

The authors concluded that the second interim analysis of OS in the APHINITY study did not demonstrate a statistically significant OS benefit from adding pertuzumab to standard chemotherapy plus trastuzumab in HER2-positive early-stage breast cancer; the number of OS events still remains relatively low.<\/p>\n

The benefits of dual HER2 blockade using pertuzumab and trastuzumab in the adjuvant setting for patients with node-positive disease observed at the primary analysis are reinforced in the updated analysis of IDFS. There is no evidence to justify the routine use of adjuvant dual anti-HER2 treatment for patients with node-negative early breast cancer. The longer-term benefit of pertuzumab may not depend on the hormone receptor status of the primary tumour.<\/p>\n

The authors underlined that continued follow-up of patients is important to fully assess OS benefit at the time-driven third interim OS analysis planned for 2022 and the event-driven final OS analysis planned when 640 deaths have occurred.<\/p>\n

The study was supported by F. Hoffmann-La Roche Ltd\/Genentech.<\/p>\n

Reference<\/h4>\n

Piccart M, Procter M, Fumagalli D, et al.<\/em> Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years’ Follow-Up<\/a>. Journal of Clinical Oncology<\/em>; Published online 4 February 2021. DOI: 10.1200\/JCO.20.01204.<\/p>\n

Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Findings from 6 years median follow-up in the APHINITY study confirm benefit in invasive disease-free survival (IDFS) from adding pertuzumab to standard adjuvant treatment in patients with node-positive, human epidermal growth factor receptor 2 (HER2)–positive early breast cancer. Longer follow-up is needed to fully assess overall survival (OS) benefit. No cardiac safety concerns have emerged. […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26786","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26786","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26786"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26786\/revisions"}],"predecessor-version":[{"id":45412,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26786\/revisions\/45412"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26786"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26786"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26786"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}