Abstract P6-11-17: Nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy in patients receiving neoadjuvant or adjuvant chemotherapy for breast cancer
Authors: Yoshidome K , Morimoto T , Matsunami N , Tsunashima R , Tsukamoto F , Ryo T , Nishida Y , Shimo T , Anno K , Shimada M , Udo M , Kagawa M , Morishima H , Oda N 
Published: February 2018

Abstract
A brief background discussion.
Nanoparticle albumin-bound paclitaxel (nab-PTX) has been developed under the concept of improved drug delivery. nab-PTX has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel (PTX) in metastatic breast cancer. However, the long-term outcomes of nab-PTX induced peripheral neuropathy (nPIPN) have not yet been fully elucidated.
Trial design: observational cohort study (UMIN20852)
Primary objective: The long-term outcome of nPIPN
Secondary objectives
(1)The validity of the Neuropathic Pain Screening Questionnaire (Japan–Q, Ishikawa et al. Pain Research 2016 )
(2) To evaluate the effect of frozen gloves and elastic stockings for nPIPN
nPIPN was assessed by the Japan-Q (J-Q) and Common Toxicity Criteria for Adverse Events ver 4.0 (CTC). The J-Q is an assessment tool for patient-reported pain severity, which consists of seven items, each rated on a five-point scale 0-4; grade 0 (no symptoms) to grade 4 (verysevere symptoms). Pricking pain, electric shock pain, burn like pain, tingling pain with numbness, allodynia, reduced or hyper sensitivity and hand-foot syndrome. Assessment was performed every day during chemotherapy, six months and one year after completion of nab-PTX therapy. Total of 28 points for each day and 588 points for each cycle, higher point correlates with severity. Frozen gloves during administration of nab-PTX and/or elastic stockings were optionally used.
Statistical methods
Kruskal Wallis test was used and p&lt;0.05 was considered as significant.
RESULTS:
Between May 2013, and April 2016, 105 patients were enrolled from 7 hospitals. In 73 patients (69.5%) nab-PTX was administered as primary and in 32 patients (30.5%) as adjuvant therapy. Forty three (41.0%) patients received nab-PTX as first line and 62 (59.0%) received after anthracycline contained regimen. Trastuzumab was administered as combination therapy with nab-PTX for Her2 positive patients. Both frozen gloves and stockings were used in 21 patients (20.0%) and frozen gloves only were used in 21 patients (20.0%) according to patient preference.
One hundred patients (95.2%) completed four courses, and overall relative dose intensity was 91.4%.
During chemotherapy, J-Q scores go elevated from day 1 to day 5 and gradually declined throughout the rest of the cycle. Without using frozen gloves, there was a significant increase according to courses (1st: 45.0 ± 5.7, 2nd: 76.7 ± 8.6, 3rd: 94.3 ± 11.8, 4th: 95.4 ± 11.8). Using frozen gloves, there was a significant increase from 1st course to 2nd, but no further increase was observed(1st: 37.4 ± 8.1, 2nd: 61.9 ± 12.4, 3rd: 62.9 ± 10.4, 4th: 55.3 ± 10.6). After six month and one year, the scores were significantly lower compared with the last day of the fourth cycle (4.28 ± 0.50, 2.53 ± 0.25, 2.85 ± 0.39, respectively). CTC, grade 2 or more sensory disturbance was observed in 57.9% after four cycles, but improved to 9.5% and 5.4% after six month and one year respectively.
CONCLUSIONS:
Patient-reported nPIPN was significantly getting worse without frozen gloves during chemotherapy, however be largely reversible within 1 year of PST or adjuvant treatment. The J-Q findings support that nab-PTX treatment is tolerable.
Citation Format: Yoshidome K, Morimoto T, Matsunami N, Tsunashima R, Tsukamoto F, Ryo T, Nishida Y, Shimo T, Anno K, Shimada M, Udo M, Kagawa M, Morishima H, Oda N. Nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy in patients receiving neoadjuvant or adjuvant chemotherapy for breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-17.