Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer

Autor: Martine Piccart, Volker Mobus, Investigators, Jennifer Eng-Wong, José Baselga, Thomas Suter, Giuseppe Viale, Amal Arahmani, José Bines, Emma Clark, Richard D. Gelber, Marion Procter, Eleonora Restuccia, Veerle Van Dooren, Evandro de Azambuja, Dimitrios Zardavas
Rok vydání: 2020
Předmět:
Adult
Bridged-Ring Compounds
Diarrhea
0301 basic medicine
Cancer Research
medicine.medical_specialty
Receptor
ErbB-2
medicine.medical_treatment
Breast Neoplasms
Antibodies
Monoclonal
Humanized
Placebo
Severity of Illness Index
Disease-Free Survival
03 medical and health sciences
0302 clinical medicine
Breast cancer
Trastuzumab
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Multicenter Studies as Topic
Breast
Prospective Studies
Antidiarrheals
Adverse effect
Mastectomy
Aged
Randomized Controlled Trials as Topic
Chemotherapy
business.industry
Incidence
Common Terminology Criteria for Adverse Events
Middle Aged
medicine.disease
Progression-Free Survival
030104 developmental biology
Oncology
Chemotherapy
Adjuvant
030220 oncology & carcinogenesis
Female
Taxoids
Pertuzumab
medicine.symptom
business
medicine.drug
Zdroj: Clinical Breast Cancer. 20:174-181.e3
ISSN: 1526-8209
Popis: Background The APHINITY (BIG 4-11) study showed that pertuzumab significantly improved the rates of invasive disease-free survival among patients with human epidermal growth factor receptor 2 (HER2)-positive, operable breast cancer when added to adjuvant trastuzumab and chemotherapy. Because diarrhea was a common adverse event that could compromise treatment administration, we evaluated the incidence and management of diarrhea in the APHINITY study. Patients and Methods The APHINITY trial is a prospective, randomized, multicenter, multinational, double-blind, placebo-controlled trial. The eligible patients were randomly assigned to receive standard adjuvant chemotherapy and 1 year of trastuzumab combined with pertuzumab or placebo. The diarrhea incidence, severity (National Cancer Institute common terminology criteria for adverse events, version 4.0), onset, and management were analyzed. Results A total of 4805 patients were randomized. Diarrhea of any grade was the most common adverse event and occurred in 71% of patients in the pertuzumab arm versus 45% in the placebo arm. Diarrhea grade 3 to 4 was observed in 10% and 4% in the pertuzumab and placebo arms, respectively. The greatest incidence of diarrhea was reported during the concomitant administration of HER2-targeted therapy and taxane (61% vs. 34% of patients experienced an event with pertuzumab vs. placebo, respectively). A marked decrease was observed on chemotherapy cessation. Antidiarrheal agents were commonly used, and diarrhea rarely caused treatment dose modifications or discontinuation. Conclusion Diarrhea was a common adverse event in the APHINITY study. Most episodes were low grade and were generally manageable with common antidiarrheal agents. The incidence of diarrhea was greater with the combination of a taxane and HER2-targeted treatment and decreased once chemotherapy was stopped.
Databáze: OpenAIRE
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