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.

MedStar author(s):
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
Name of journal: Breast cancer research and treatmentAbstract: 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).All authors: Dilawari A, Graham D, Isaacs C, Kurian S, Lynce F, Mainor C, McNamara D, Mohebtash M, Ottaviano Y, Pohlmann PR, Rao S, Swain SM, Swanson N, Tan M, Warren R, Wu TFiscal year: FY2023Digital Object Identifier: ORCID: Date added to catalog: 2022-12-13
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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).

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