Abstract P5-18-13: Compression therapy and goshajinkigan for prevention of nab-paclitaxel-induced peripheral neuropathy in patients with operable breast cancer

Abstract

Purpose: Peripheral neuropathy (PN) is one of the most common toxicities of taxane. Grade2-4 PN occurs in 27-35% of patients treated with taxane and 50-80% of them have persistent symptoms after chemotherapy. PN may result in dose reduction or treatment discontinuation and negatively affect quality of life (QOL). However, there are no established methods for preventing chemotherapy-induced PN. Therefore, we conducted the phase II study to evaluate the efficacy of compression therapy with elastic stockings and oral goshajinkigan (GJG), a traditional Japanese herbal medicine, for prevention of chemotherapy-induced PN in breast cancer patients who treated with dose-dense (DD) nab-paclitaxel (nab-PTX) followed by epirubicin and cycrlophosphamide (EC) as neoadjuvant chemotherapy. Patients and methods: Patients with clinical stage I-III human epidermal growth factor 2 (HER2)-negative breast cancer were included in the study. Nab-PTX (260mg/m2) followed by epirubicin (90mg/m2) plus cycrlophosphamide (600mg/m2) administered every 2 weeks with pegfilgrastim support. Patients wore elastic stockings (ALCARE, Tokyo, Japan) for 24 h from the beginning of each treatment. Oral GJG (7.5g/day) was initiated on day 1 of first cycle of nab-PTX and continued to last cycle of EC. The primary endpoint was the rates of pathological complete response (pCR). Secondary endpoints were clinical response rate, breast conservation rate, safety, and health-related QOL using the Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-NTX). An 11-item FACT-NTX component of FACT-Taxane scale assessed chemotherapy-induced PN at baseline, after each cycle of nab-paclitaxel and EC, and 2 months after last cycle of EC. Lower score indicates worse PN and a 10% or greater decrease in FACT-NTX score was defined as a clinically meaningful worsening of PN. Results: From February 2017 to August 2019, 58 patients were enrolled and 55 of these patients were included in the analysis. Overall, pCR was observed in 13 (23.6%) patients. In patients with triple-negative disease, 10 (38.5%) of 26 achieved pCR, whereas it was observed in 3 (10.3%) of 29 patients with luminal disease. Objective response (complete response or partial response) was achieved in 46 (83.6%) patients, overall. Of 36 patients originally deemed to require mastectomy, conversion to breast-conserving surgery after NAC was achieved by 11 (20.0%) patients. The most common adverse events of grade 3 or higher were myalgia (16.4%), fatigue (14.5%) and transaminase elevation (9.1%). Grade 3 peripheral sensory neuropathy and motor neuropathy occurred in 4 (7.3%) and 3 (5.5%) patients, respectively. No patient experienced grade 4 PN. The dose of nab-PTX had to be reduced in 8 (14.5%) patients, two (3.6%) of whom were due to PN. The EC dose was reduced in 10 (18.2%) patients, this occurred more frequently for non-hematological adverse events (14.5%). The average relative dose intensity of nab-PTX and EC part was 97.4% and 96.3%, respectively. Adverse events led to treatment discontinuation in 8 (14.5%) patients, but there was no discontinuation due to PN. After last cycle of nab-PTX, the average decrease in FACT-NTX scores was 19.9% from baseline, however, it improved to 8.6% decrease at 2 months after last cycle of EC. Conclusions: Compression therapy with elastic stockings and GJG were effective to prevent PN associated with DD nab-PTX regimen. Preventive approach for PN may improve dose intensity of taxane and long-term QOL of breast cancer patients. Citation Format: Akiko Matsumoto, Yuka Maeda, Ayana Sato, Miki Yamada, Tatsuhiko Ikeda, Hiromitsu Jinno. Compression therapy and goshajinkigan for prevention of nab-paclitaxel-induced peripheral neuropathy in patients with operable breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-18-13.