HALT-D: a randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane.
Chemotherapy-induced diarrhea
Crofelemer
HER2-positive breast cancer
Pertuzumab
Taxane
Trastuzumab
Journal
Breast cancer research and treatment
ISSN: 1573-7217
Titre abrégé: Breast Cancer Res Treat
Pays: Netherlands
ID NLM: 8111104
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
09
05
2022
accepted:
05
09
2022
pubmed:
25
10
2022
medline:
8
11
2022
entrez:
24
10
2022
Statut:
ppublish
Résumé
To assess whether crofelemer would prevent chemotherapy-induced diarrhea (CID) diarrhea in patients with HER2-positive, any-stage breast cancer receiving trastuzumab (H), pertuzumab (P), and a taxane (T; docetaxel or paclitaxel), with/without carboplatin (C; always combined with docetaxel rather than paclitaxel). Patients scheduled to receive ≥ 3 consecutive TCHP/THP cycles were randomized to crofelemer 125 mg orally twice daily during chemotherapy cycles 1 and 2 or no scheduled prophylactic medication (control). All received standard breakthrough antidiarrheal medication (BTAD) as needed. The primary endpoint was incidence of any-grade CID for ≥ 2 consecutive days. Secondary endpoints were incidence of all-grade and grade 3/4 CID by cycle/stratum; time to onset and duration of CID; stool consistency; use of BTAD; and quality of life (Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea [FACIT-D] score). Fifty-one patients were randomized to crofelemer (n = 26) or control (n = 25). There was no statistically significant difference between arms for the primary endpoint; however, incidence of grade ≥ 2 CID was reduced with crofelemer vs control (19.2% vs 24.0% in cycle 1; 8.0% vs 39.1%, in cycle 2). Patients receiving crofelemer were 1.8 times more likely to see their diarrhea resolved and had less frequent watery diarrhea. Despite the choice of primary endpoint being insensitive, crofelemer reduced the incidence and severity of CID in patients with HER2-positive breast cancer receiving P-based therapy. These data are supportive of further testing of crofelemer in CID. Clinicaltrials.gov, NCT02910219, prospectively registered September 21, 2016.
Identifiants
pubmed: 36280642
doi: 10.1007/s10549-022-06743-9
pii: 10.1007/s10549-022-06743-9
pmc: PMC9633499
doi:
Substances chimiques
Trastuzumab
P188ANX8CK
pertuzumab
K16AIQ8CTM
crofelemer
PY79D6C8RX
Docetaxel
15H5577CQD
Receptor, ErbB-2
EC 2.7.10.1
taxane
1605-68-1
Taxoids
0
Paclitaxel
P88XT4IS4D
Antineoplastic Agents
0
Banques de données
ClinicalTrials.gov
['NCT02910219']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
571-581Informations de copyright
© 2022. The Author(s).
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