Abstract P4-11-02: Subjective and objective assessment of efficacy of frozen gloves and socks to prevent nab-paclitaxel-induced peripheral neuropathy in patients with breast cancer

Abstract

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side-effect of taxanes which play a central role in the treatment of breast cancer. CIPN can negatively influence long-term quality of life, warranting the development of effective prevention strategies. This study investigates the efficacy of frozen gloves and socks (FGS) in reducing the incidence and severity of nab-paclitaxel-induced peripheral neuropathy. Endpoints were evaluated using both clinician and patient reports. Methods: This is a multicenter phase II single arm trial study of the effects of FGS for advanced or metastatic breast cancer patients receiving nab-paclitaxel (260 mg/m2) every 3 weeks. Patients wore FGS on their diseased side hand and foot for 60 min during infusion. The other side acted as the untreated control. CIPN was assessed using Patient Neurotoxicity Questionnaire (PNQ), PRO-CTCAE and CTCAE at baseline and every cycle of nab-paclitaxel. The primary endpoint was the incidence of CIPN assessed by PNQ (grade C or higher) after receipt of up to 4 cycles of nab-paclitaxel. Results: Between September 2012 and January 2015, 50 patients from 16 sites were enrolled in this study. Of 50 patients, 27 (54%) received at least 4 cycles of nab-paclitaxel. There was a trend for the incidence of CIPN assessed by PNQ and PRO-CTCAE to be lower in the intervention side than in the control side, although this difference was not statistically significant. The incidence of CIPN assessed by CTCAE was significantly lower in the treated hand (Table). Conclusions: Among breast cancer patients who received nab-paclitaxel, FGS produced favorable effects as detected by reduced clinician-reported CTCAE grades for CIPN, although the study did not detect differences in self-reported symptoms of CIPN using PRO-CTCAE or PNQ. Clinical trial information: UMIN000007907. Difference according to the evaluation method of CIPN Hands (%) Feet (%) InterventionControlp*InterventionControlp*Patient-Reporting CIPNPNQ (grade C or higher)12190.3416160.63Patient-Reporting CIPNPRO-CTCAE Severity ≥ Moderate13180.0815160.56 Interference ≥ Somewhat7100.328100.32Clinician-Grading CIPNCTCAE (≥ Grade II)15190.0314131.0 *McNemar's test Citation Format: Yamashita T, Hattori M, Nakada T, Hayashi T, Kamei K, Tatsuya T, Nagao Y, Mase T, Wada M, Mizuno T, Shimozuma K, Iwata H, Yamaguchi T. Subjective and objective assessment of efficacy of frozen gloves and socks to prevent nab-paclitaxel-induced peripheral neuropathy in patients with breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-11-02.