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Start Over Descriptor "Liposomal irinotecan" Journal breast cancer research and treatment
2 results on '"Liposomal irinotecan"'

1. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase

Author

Sachdev, Jasgit C, Munster, Pamela, Northfelt, Donald W, Han, Hyo Sook, Ma, Cynthia, Maxwell, Fiona, Wang, Tiffany, Belanger, Bruce, Zhang, Bin, Moore, Yan, Thiagalingam, Arunthathi, and Anders, Carey

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adult, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Irinotecan, Survival Rate, Treatment Outcome, Triple Negative Breast Neoplasms, Liposomal irinotecan, Metastatic breast cancer, Objective response rate, Phase I clinical trial, Brain metastases, Heavily pretreated patients, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeMetastatic breast cancer (mBC) remains incurable and is associated with low survival rates. This study assessed the efficacy and safety of liposomal irinotecan in heavily pretreated patients with mBC, with or without active brain metastases (BM).MethodsFollowing the dose escalation phase and determination of recommended phase 2 dose, the expansion phase of this phase I, open-label, non-randomized study, assigned adult women to cohorts based on mBC subtype: cohort 1, hormone receptor +/human epidermal growth factor receptor 2-; cohort 2, triple-negative breast cancer; or cohort 3, any mBC subtype with active BM. Patients received liposomal irinotecan 50 or 70 mg/m2 free base every 2 weeks. Here, we report secondary outcomes including best overall response (BOR), objective response rate (ORR), and treatment-emergent adverse events (TEAEs).ResultsFor non-central nervous system (non-CNS) disease across all cohorts (intent-to-treat population, N = 29), the ORR was 34.5% (95% confidence interval: 17.94-54.33), with a BOR of partial response in 10 patients (34.5%), stable disease in five (17.2%), progressive disease in 10 (34.5%); four patients were unevaluable (13.8%). The ORR for the CNS cohort was 30.0% (95% confidence interval: 6.67-65.25) using modified Response Evaluation Criteria in Solid Tumors. Common grade 3 or higher TEAEs were diarrhea (27.6%), nausea (17.2%), fatigue (13.8%), asthenia (10.3%), and hypokalemia (10.3%). Serious treatment-related TEAEs were reported in six patients (20.7%). No treatment-related TEAEs resulted in death.ConclusionsLiposomal irinotecan monotherapy demonstrated antitumor activity in heavily pretreated patients with mBC, with or without BM. The observed safety profile was consistent with that in previous studies.Clinical trial registrationTrial registration ID NCT01770353.

Published
2021

2. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase

Author

Donald W. Northfelt, Pamela N. Munster, Hyo S. Han, Y. Moore, Fiona Maxwell, Tiffany Wang, Carey K. Anders, Bruce Belanger, Cynthia X. Ma, Bin Zhang, Arunthathi Thiagalingam, and Jasgit C. Sachdev

Subjects
Adult, Oncology, Cancer Research, medicine.medical_specialty, Clinical Sciences, Oncology and Carcinogenesis, Population, Heavily pretreated patients, Phases of clinical research, Breast Neoplasms, Triple Negative Breast Neoplasms, Irinotecan, Objective response rate, Breast cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Oncology & Carcinogenesis, Adverse effect, education, Liposomal irinotecan, education.field_of_study, business.industry, Brain metastases, Metastatic breast cancer, medicine.disease, Clinical Trial, Survival Rate, Treatment Outcome, Response Evaluation Criteria in Solid Tumors, Cohort, Phase I clinical trial, Female, business, Progressive disease
Abstract

Purpose Metastatic breast cancer (mBC) remains incurable and is associated with low survival rates. This study assessed the efficacy and safety of liposomal irinotecan in heavily pretreated patients with mBC, with or without active brain metastases (BM). Methods Following the dose escalation phase and determination of recommended phase 2 dose, the expansion phase of this phase I, open-label, non-randomized study, assigned adult women to cohorts based on mBC subtype: cohort 1, hormone receptor +/human epidermal growth factor receptor 2−; cohort 2, triple-negative breast cancer; or cohort 3, any mBC subtype with active BM. Patients received liposomal irinotecan 50 or 70 mg/m2 free base every 2 weeks. Here, we report secondary outcomes including best overall response (BOR), objective response rate (ORR), and treatment-emergent adverse events (TEAEs). Results For non-central nervous system (non-CNS) disease across all cohorts (intent-to-treat population, N = 29), the ORR was 34.5% (95% confidence interval: 17.94–54.33), with a BOR of partial response in 10 patients (34.5%), stable disease in five (17.2%), progressive disease in 10 (34.5%); four patients were unevaluable (13.8%). The ORR for the CNS cohort was 30.0% (95% confidence interval: 6.67–65.25) using modified Response Evaluation Criteria in Solid Tumors. Common grade 3 or higher TEAEs were diarrhea (27.6%), nausea (17.2%), fatigue (13.8%), asthenia (10.3%), and hypokalemia (10.3%). Serious treatment-related TEAEs were reported in six patients (20.7%). No treatment-related TEAEs resulted in death. Conclusions Liposomal irinotecan monotherapy demonstrated antitumor activity in heavily pretreated patients with mBC, with or without BM. The observed safety profile was consistent with that in previous studies. Clinical trial registration: Trial registration ID NCT01770353.

Published
2020
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