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.
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.
- 2022
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
0167-6806
10.1007/s10549-022-06743-9 [doi] 10.1007/s10549-022-06743-9 [pii] PMC9633499 [pmc]
*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
Trastuzumab
MedStar Franklin Square Medical Center
Associate Dean for Research Development
Hematology/Oncology
MedStar Health
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
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
0167-6806
10.1007/s10549-022-06743-9 [doi] 10.1007/s10549-022-06743-9 [pii] PMC9633499 [pmc]
*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
Trastuzumab
MedStar Franklin Square Medical Center
Associate Dean for Research Development
Hematology/Oncology
MedStar Health
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial