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U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.

Author: Amiri-KordestaniLaleh, BalcazarPamela, Barnett-RinggoldKimberly, BeaverJulia A, BlumenthalGideon M, CaoXianhua, ChengJoyce, DanielsSelena R, IbrahimAmna, KluetzPaul G, LiuQi, PalmbyTodd R, PazdurRichard, PierceWilliam F, SinghHarpreet, SridharaRajeshwari, TangShenghui, WalkerAmanda J, YuJingyu, ZhengNan

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

This article summarizes the FDA approval of neratinib for the extended adjuvant treatment of early-stage HER2-overexpressed/amplified breast cancer. Neratinib was shown to improve invasive disease-free survival compared to placebo in a randomized, double-blind, placebo-controlled trial. However, neratinib is associated with a high incidence of diarrhea, which is the most common adverse event leading to treatment discontinuation.
Paper Details　
Original Abstract of the Article :
On July 17, 2017, the FDA approved neratinib (NERLYNX; Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on data from ExteNET, a randomized, dou...See full text at original site
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引用元：
https://doi.org/10.1158/1078-0432.CCR-17-3628

データ提供：米国国立医学図書館（NLM）

Neratinib for Extended Adjuvant Treatment: A Beacon in the Desert of Breast Cancer

This study explores the potential of neratinib (NERLYNX) as an extended adjuvant treatment for early-stage HER2-positive breast cancer, a complex and challenging condition akin to navigating a vast desert. The study examines the effectiveness and safety of neratinib in a randomized, double-blind, placebo-controlled trial, like a scientific expedition meticulously charting uncharted territory.

A Promising Treatment Option

The study found that neratinib demonstrated a statistically significant treatment effect favoring improved invasive disease-free survival (iDFS), like a beacon guiding patients towards a safer path. The trial also showed a favorable iDFS rate at 2 years, providing a glimmer of hope in the desert of breast cancer. The study highlights the potential of neratinib as a valuable tool in the fight against this disease, like a strategic oasis offering respite and nourishment.

Navigating the Side Effects of Neratinib

The study acknowledges that neratinib is associated with certain side effects, like the challenges of navigating a desert environment. The most common side effect was diarrhea, a condition that can be managed with appropriate care. Overall, neratinib was found to have a low incidence of severe side effects, a reassuring finding for patients facing a challenging journey.

Dr. Camel's Conclusion

This study offers a promising advance in the fight against HER2-positive breast cancer, like a newly discovered oasis in the desert. It underscores the potential of neratinib as an extended adjuvant treatment, providing patients with a valuable tool for improving survival and quality of life. The study's findings provide hope and direction for researchers and clinicians navigating the complex and challenging landscape of breast cancer care.

Date :
  1. Date Completed 2019-12-16
  2. Date Revised 2019-12-17
Further Info :

Pubmed ID

29523624

DOI: Digital Object Identifier

10.1158/1078-0432.CCR-17-3628

Related Literature

Article Analysis
・Side Effects of neratinib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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