Abstract B69: Intensive daily monitoring to identify onset, severity, and persistence of peripheral neuropathy following initiation of neurotoxic chemotherapy for women newly diagnosed with ovarian cancer
Authors: Campbell Grace B. , Hagan Teresa L. , Bovbjerg Dana H. , Donovan Heidi S. 
Published: August 2018

Abstract
Background: Aggressive combination therapy with taxane and platinum-based therapy places women with ovarian cancer at high risk for chemotherapy-induced peripheral neuropathy (CIPN). Incidence rates for CIPN during front-line therapy are estimated to range from 51% to 80% and are most commonly reported to occur by Cycle 3. However, these findings are limited by retrospective PRO or adverse event reporting on Day 1 of each cycle. The aim of this study was to identify a) time to onset of CIPN and b) changes in average and peak CIPN severity over time.
Methods: Participants (n=30) were enrolled prior to beginning first-line adjuvant or neoadjuvant chemotherapy for ovarian, fallopian, primary peritoneal, or uterine cancer. Peripheral neuropathy was assessed at baseline and 1) daily using a single numbness/tingling (N/T) severity item (0=did not experience to 10 = as bad as I can imagine) and 2) on day 1 of each cycle using the 13-item FACT/GOG-Ntx (0=not at all to 4=very much). For each cycle, average FACT/GOG-ntx13 and ntx-4 (sensory component only) score, and average, peak, and last day of cycle N/T severity scores were calculated.
Results: Of the 30 women enrolled, 25 completed at least 3 complete cycles of daily symptom diaries and are included in this analysis. Participants were 59.6 ± 10.0 years old and had 13.7 ± 4.21 years of formal education. 33% of women reported having a GED/high school diploma as their highest level of education, 92% were white, 60% were married, and 67% were employed at baseline. Based on daily N/T diaries, the average time to first occurrence of CIPN &gt; 0 was 26.83 ± 31.76 days (range 1-123 days) and 33.63 ± 33.82 days (range 1 to 126 days) for first occurrence of CIPN &gt; 2. Of note, 4 women (16%) did not ever experience CIPN &gt; 2 during the 6 cycles of chemotherapy. Based on the daily N/T item, 32% of women reported n/t at baseline compared to 40% based on the FACT/GOG-ntx4 and 72% based on the FACT/GOG-ntx13. Mean ± SD N/T severity ranged from 1.18 ± 1.96 (average), 2.43± 2.94 (peak), and 1.27 ± 2.27 (last day of cycle) during Cycle 1 to 3.05 ± 2.42 (average), 4.26 ± 2.53 (peak), and 2.95 ± 3.01 (last day of cycle) during Cycle 6. CIPN severity was highly variable across participants over time: 13 participants (52%) never experienced sustained (21 days) of continuous N/T severity &gt;2. However, among the 12 participants who did, the average time to continuous N/T was only 35.0 ± 36.7 days (range 0-87).
Discussion: Time to onset, average, peak, and duration of CIPN are highly variable among women receiving neurotoxic chemotherapy. A majority of women report some CIPN during cycle number 2; however, over half of all women do not experience continuous (daily) N/T, returning to no or minimal severity (&lt;3) prior to their next cycle. A focus on the subset of women who develop continuous N/T during treatment could help to identify risk factors for long-term, persistent CIPN. Discrepancies in rates of peripheral neuropathy based on the single item N/T, ntx-4 and ntx-13 require further research to determine whether items in the motor subscale of the ntx-13 (weakness and joint pain/muscle spasm) are early harbingers of CIPN or whether they are capturing nonspecific symptoms of cancer and treatment.
Citation Format: Grace B. Campbell, Teresa L. Hagan, Dana H. Bovbjerg, Heidi S. Donovan. Intensive daily monitoring to identify onset, severity, and persistence of peripheral neuropathy following initiation of neurotoxic chemotherapy for women newly diagnosed with ovarian cancer. [abstract]. In: Proceedings of the AACR Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment; Oct 1-4, 2017; Pittsburgh, PA. Philadelphia (PA): AACR; Clin Cancer Res 2018;24(15_Suppl):Abstract nr B69.