The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study.
[BACKGROUND] Paclitaxel-induced peripheral neuropathy (PIPN) is a condition that persists chronically in more than 60% of affected individuals, and currently there are no proven PIPN prophylaxis.
- 표본수 (n) 45
- p-value p < 0.001
APA
Mahmoud AMAS, Shash E, et al. (2026). The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study.. Pharmacotherapy, 46(4), e70124. https://doi.org/10.1002/phar.70124
MLA
Mahmoud AMAS, et al.. "The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study.." Pharmacotherapy, vol. 46, no. 4, 2026, pp. e70124.
PMID
41800821
Abstract
[BACKGROUND] Paclitaxel-induced peripheral neuropathy (PIPN) is a condition that persists chronically in more than 60% of affected individuals, and currently there are no proven PIPN prophylaxis. Pre-clinical data suggest the angiotensin-II-receptor blocker losartan may attenuate neuro-inflammation and nerve injury. This study was conducted to assess losartan's neuroprotective effect against PIPN in patients with breast cancer.
[METHODS] In this single-center, open-label, randomized, controlled trial, women with early-stage breast cancer scheduled for weekly paclitaxel (80 mg/mg or 12 doses) were enrolled and randomized 1:1 to losartan 100 mg once daily plus standard care or standard care alone. The primary end point was incidence of grade 2 or higher neuropathy, per National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE v5.0). Secondary end points included time-to-neuropathy (in days), patient quality of life (QoL) assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX), pain intensity using visual-analogue scale (VAS), serum nerve growth factor (NGF) levels, and safety.
[RESULTS] Between December 2023 and December 2024, 89 Patients Were Randomized (Losartan, n = 45; Control, n = 44). Losartan Significantly Reduced Grade ≥ 2 Neuropathy Incidence (33.3% vs. 86.4%, p < 0.001) and Delayed Its Onset (73.27 vs. 43.75 Days; Hazards Ratio [HR] = 0.2, 95% Confidence Interval [CI]: 0.11-0.35) Compared With Standard Care Alone, Respectively. At 12 Weeks, Patients Treated With Losartan Reported Superior QoL (FACT/GOG-NTX: 31.87 ± 6.43 vs. 15.45 ± 10.04; p < 0.001) and Reduced Pain Scores (Median VAS 3 vs. 8; p < 0.001) Compared With Standard Care Alone, Respectively. NGF Levels Were Comparable and Adverse Events Were Similar Between Groups.
[CONCLUSIONS] Daily losartan reduced and delayed clinically significant paclitaxel-induced neuropathy while improving patient-reported outcomes, without additional toxicity. These findings support repurposing losartan as a low-cost PIPN prophylactic and justify validation in larger, multicenter trials.
[TRIAL REGISTRATION] ClinicalTrials.gov (NCT06135493).
[METHODS] In this single-center, open-label, randomized, controlled trial, women with early-stage breast cancer scheduled for weekly paclitaxel (80 mg/mg or 12 doses) were enrolled and randomized 1:1 to losartan 100 mg once daily plus standard care or standard care alone. The primary end point was incidence of grade 2 or higher neuropathy, per National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE v5.0). Secondary end points included time-to-neuropathy (in days), patient quality of life (QoL) assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX), pain intensity using visual-analogue scale (VAS), serum nerve growth factor (NGF) levels, and safety.
[RESULTS] Between December 2023 and December 2024, 89 Patients Were Randomized (Losartan, n = 45; Control, n = 44). Losartan Significantly Reduced Grade ≥ 2 Neuropathy Incidence (33.3% vs. 86.4%, p < 0.001) and Delayed Its Onset (73.27 vs. 43.75 Days; Hazards Ratio [HR] = 0.2, 95% Confidence Interval [CI]: 0.11-0.35) Compared With Standard Care Alone, Respectively. At 12 Weeks, Patients Treated With Losartan Reported Superior QoL (FACT/GOG-NTX: 31.87 ± 6.43 vs. 15.45 ± 10.04; p < 0.001) and Reduced Pain Scores (Median VAS 3 vs. 8; p < 0.001) Compared With Standard Care Alone, Respectively. NGF Levels Were Comparable and Adverse Events Were Similar Between Groups.
[CONCLUSIONS] Daily losartan reduced and delayed clinically significant paclitaxel-induced neuropathy while improving patient-reported outcomes, without additional toxicity. These findings support repurposing losartan as a low-cost PIPN prophylactic and justify validation in larger, multicenter trials.
[TRIAL REGISTRATION] ClinicalTrials.gov (NCT06135493).
MeSH Terms
Humans; Losartan; Female; Paclitaxel; Breast Neoplasms; Peripheral Nervous System Diseases; Middle Aged; Aged; Quality of Life; Antineoplastic Agents, Phytogenic; Adult; Angiotensin II Type 1 Receptor Blockers; Nerve Growth Factor