Number of patients screened | Total of 59 across both groups before randomization |
Number of patients enrolled | 25 |
Number of patients evaluable for toxicity | 24 |
Number of patients evaluated for efficacy | 19 |
Evaluation method | The number and proportion of patients without CIPN (any grade) of the hands at the completion of 84 days of chemotherapy treatment |
Response duration | 15/19 (78.8%) patients completed 84 days of treatment without neuropathy |
Duration of treatment | 84 days or until CIPN developed |
Outcome notes | In the traditional group, 15/19 patients (78.8%) completed 84 days of treatment without neuropathy. Overall mean compliance with home prescribed occupational therapy based on patient completed diary was 92.2% in 16/19 patients that returned their patient diaries. Four of 19 patients (21.1%) in traditional group developed CIPN, P = .721. Cumulative doses of albumin-bound paclitaxel and cisplatin per patient of those who developed CIPN are listed in Tables 1 and 2. Patient characteristics, disease states, treatment dates, number of days on study, and time to onset of CIPN are detailed in Supplementary Table S1. Results of a Kaplan-Meier analysis showed those in Traditional Group with a mean time-to-event of 75.8 days (90% CI: 68.5, 83.2). Fifteen of 19 (78.9%) in the traditional group were censored in the analysis as they did not develop CIPN while on study (Figure 2). |