Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial

Breast Cancer Research : BCR
Joanne MortimerMohammad Jahanzeb

Abstract

We characterized patterns of occurrence and the impact of neratinib-associated diarrhea in the absence of protocol-directed antidiarrheal prophylaxis or a formal diarrhea management plan using data from Extended Adjuvant Treatment of Breast Cancer with Neratinib (ExteNET). ExteNET is a multicenter, double-blind, placebo-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months. Safety, a secondary outcome, was assessed using the National Cancer Institute Common Terminology Criteria version 3.0. Health-related quality of life by diarrhea grade was assessed using Functional Assessment of Cancer Therapy-Breast (FACT-B). Two thousand eight hundred sixteen women (1408 per group) were safety-evaluable. Grade 3 and 4 diarrhea occurred in 561 (39.8%) and 1 (0.1%) patients with neratinib versus 23 (1.6%) and 0 patients with placebo, respectively. In the neratinib group, 28.6% of patients had grade 3 events during month 1 decreasing to ≤ 6% after month 3. The median cumulative duration of grade 3...Continue Reading

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Citations

Jan 24, 2019·Breast Cancer Research and Treatment·Hope S RugoLinda Bosserman
Jul 29, 2020·Breast Cancer Research and Treatment·Helena HarderLesley J Fallowfield
Nov 30, 2019·Current Oncology Reports·Alexandra S Zimmer, Neelima Denduluri
Sep 30, 2020·Journal of Clinical Pharmacology·Ariel R Topletz-EricksonChristopher J Endres
May 11, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Diana LüftnerNadia Harbeck
Aug 8, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Thidarath RattanabureePotchanapond Graidist
Aug 21, 2021·Bioorganic & Medicinal Chemistry·Thais Cristina Mendonça Nogueira, Marcus Vinicius Nora de Souza

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Clinical Trials Mentioned

NCT00878709

Software Mentioned

ExteNET

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