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.
Citation: Breast Cancer Research & Treatment. 196(3):571-581, 2022 Dec.PMID: 36280642Institution: MedStar Franklin Square Medical CenterDepartment: Associate Dean for Research Development | Hematology/Oncology | MedStar HealthForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase II | Journal Article | Randomized Controlled TrialSubject headings: *Antineoplastic Agents | *Breast Neoplasms | Antineoplastic Agents/tu [Therapeutic Use] | Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | Breast Neoplasms/et [Etiology] | Diarrhea/ci [Chemically Induced] | Diarrhea/pc [Prevention & Control] | Docetaxel/ae [Adverse Effects] | Female | Humans | Paclitaxel | Quality of Life | Receptor, ErbB-2 | Taxoids | TrastuzumabYear: 2022Local holdings: Available online from MWHC library: 1997 - presentISSN:- 0167-6806
- Swain, Sandra M:
- http://orcid.org/0000-0002-1320-3830
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
---|---|---|---|---|---|---|
Journal Article | MedStar Authors Catalog | Article | 36280642 | Available | 36280642 |
Available online from MWHC library: 1997 - present
CONCLUSION: 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.
METHODS: 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).
PURPOSE: 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).
RESULTS: 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.
TRIAL REGISTRATION: Clinicaltrials.gov, NCT02910219, prospectively registered September 21, 2016. Copyright © 2022. The Author(s).
English