Abstract PS9-52: A randomized phase II trial of interventions with frozen groves and compression stockings to prevent nab-paclitaxel induced chemotherapy-induced peripheral neuropathy (SPOT trial)

Abstract

Abstract Background: Nab-paclitaxel(nab-PTX) is improved taxane in terms of solubility, alcohol-free and reduced incidence of anaphylaxis. On the other hand, chemotherapy-induced peripheral neuropathy (PN) is known as a major adverse event which was failed to suppress by many medications. Recently, some reports describe about cooling and compression of extremities of patients treated by taxane can reduce the incidence and severity of PN. The efficacies of interventions with frozen groves and compression stockings to prevent nab-PTX-induced PN was examined.Methods: The patients with HER2 negative primary breast cancers treated by four cycles of nab-PTX pre-/post- operative chemotherapies were randomized to two groups (interventions with frozen groves (FG) and compression stockings (CS), and with standard care (SD)). Primary endpoint was frequency and time to onset of >Grade 2 PN by CTCAE ver.4.0, and secondary endpoints are frequency of >Grade2 PN at the end of four cycles of nab-PTX, HRQOL, recovery of PN for 5 years from the end of nab-PTX and safety. Also, we requested to keep diary with several questions for patient reported outcomes (PRO).Results: Of the 124pts enrolled, 123(62 FG/CS, 61 SD) were included in the intent-to-treat analysis. There were no significant differences in clinicopathological findings between two groups. As a primary endpoint, frequency and time to onset of >Grade 2 motor-PN /sensory-NP of hands comparing FG and SD showed p=0.162/0.599, and of foots comparing CS and SD showed p=0.525/0.933 (Log-rank test with one sided significant level of 10%). Conversely, the worst Grade of sensory-PN is statistically significant difference at Cycle 2 (p=0.021; Mann-Whitney’s U-test with two-sided significant level of 5%), >Grade3 of motor-PN was statistically significant low in all cycles (p=0.022; Log-rank test with one sided significant level of 10%), >Grade1 of sensory-PN was statistically significant low (p=0.022; Log-rank test with one sided significant level of 10%), and >Grade3 of sensory-PN was statistically significant low in all cycles (p=0.072; Log-rank test with one sided significant level of 10%) with FG in detail. In addition, Grade3 of motor-PN was statistically significant low in all cycles (p=0.022; Log-rank test with one sided significant level of 10%), >Grade1 of sensory-PN was statistically significant low (p=0.015; Log-rank test with one sided significant level of 10%), and >Grade3 of sensory-PN was statistically significant low in all cycles (p=0.089; Log-rank test with one sided significant level of 10%)in all cycles (p=0.022; Log-rank test with one sided significant level of 10%) with CS in detail. Moreover, PRO indicated by patients’ diary showed interesting patterns of increase and decrease in sense of pain and paralyzed which might be corresponding to efficacy of interventions with FG and CS.Conclusion: Although primary endpoints were not met by the interventions with FG and CS, this trial revealed the detail of PN caused by nab-PTX, and these interventions might delay beginning of sensory and motor PN and reduce the worst grade of PN. The adverse events grading according to CTCAE and PRO indicated by patients’ diary seems to be not completely matched, the usefulness of FG and CS are investigating with more questionnaire. (UMIN: UMIN000016902) Citation Format: Masahiro Kashiwaba, Takahiro Nakayama, Takafumi Sangai, Takashi Morimoto, Hiroyuki Yasojima, Yutaka Yamamoto, Shinji Ohno, Norikazu Masuda. A randomized phase II trial of interventions with frozen groves and compression stockings to prevent nab-paclitaxel induced chemotherapy-induced peripheral neuropathy (SPOT trial) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-52.