Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab
Annals of Oncology, ISSN: 0923-7534, Vol: 28, Issue: 4, Page: 761-768
2017
- 29Citations
- 72Captures
- 2Mentions
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Metrics Details
- Citations29
- Citation Indexes29
- 29
- CrossRef18
- Captures72
- Readers72
- 72
- Mentions2
- News Mentions2
- 2
Most Recent News
Diarrhea Common But Manageable With Pertuzumab-containing Regimens
Jason Hoffman, PharmD, RPh January 11, 2017 This article originally appeared on ONA. Share this content: Diarrhea is a common side effect of pertuzumab-containing regimens.
Article Description
Pertuzumab disrupts heterodimerization between human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR), HER3, and HER4. Thus, pertuzumab could result in adverse events similar to those observed with EGFR antagonists, such as diarrhea. We report the incidence and severity of diarrhea observed with pertuzumab in the CLEOPATRA, NeoSphere, and TRYPHAENA studies. Patients ( n = 1443) had metastatic [CLEOPATRA ( n = 804)] or early-stage breast cancer [NeoSphere ( n = 416) and TRYPHAENA ( n = 223)]. The incidence and severity of diarrhea were analyzed by treatment received. The incidence of febrile neutropenia concurrent with diarrhea and the effect of pre-existing gastrointestinal comorbidities were also evaluated. Subgroup analyses were carried out using CLEOPATRA data. The incidence of all-grade diarrhea across studies was generally greater for pertuzumab-based treatment, ranging from 28% to 72% (grade 1, 21%–54%; grade 2, 8%–37%; grade 3, 0%–12%; grade 4, 0%). Incidence was highest during the first pertuzumab-containing cycle, decreasing with subsequent cycles. Dose delays or discontinuations due to diarrhea were infrequent, ranging from 0% to 8%. Among pertuzumab-treated patients with diarrhea, 47%–67% received pharmacological intervention, most commonly with loperamide. Overlap between diarrhea and febrile neutropenia was uncommon, ranging from 0% to 11%. No relationship was observed between pre-existing gastrointestinal comorbidities and diarrhea. In CLEOPATRA, patients ≥65 years treated with pertuzumab had a higher incidence of grade 3 diarrhea than patients <65 years (19% versus 8%). All-grade diarrhea occurred at greater frequency among pertuzumab-treated Asian versus white patients with metastatic breast cancer (74% versus 63%); the corresponding rates in the control arm were 53% and 45%, respectively. In both the metastatic and early-stage breast cancer settings, diarrhea was common but manageable for all pertuzumab-containing regimens. Diarrheal episodes were mainly low grade and occurred most often during the first treatment cycle. Diarrheal-related drug delays or discontinuations were uncommon. NCT00567190 (CLEOPATRA), NCT00545688 (NeoSphere), NCT00976989 (TRYPHAENA).
Bibliographic Details
http://www.sciencedirect.com/science/article/pii/S0923753419320654; http://dx.doi.org/10.1093/annonc/mdw695; http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85019132459&origin=inward; https://clinicaltrials.gov/ct2/show/NCT00567190; http://www.ncbi.nlm.nih.gov/pubmed/28057664; https://linkinghub.elsevier.com/retrieve/pii/S0923753419320654; https://dx.doi.org/10.1093/annonc/mdw695
Elsevier BV
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