Abstract 1710P
Background
Plinabulin is a novel non-G-CSF selective immunomodulating microtubule binding agent (SIMBA) developed for the prevention of CIN in conjunction with pegfilgrastim. QoL was analyzed via Functional Assessment of Cancer Therapy - General questionnaire (FACT-G) and the EQ-5D-5L as part of a phase III (Ph3) clinical trial comparing pegfilgrastim to pegfilgrastim + plinabulin for prevention of neutropenia in newly diagnosed breast cancer patients being treated with docetaxel/doxorubicin/cyclophosphamide (TAC).
Methods
Questionnaires were administered using ePRO app downloaded onto patients' phones in Ukraine and China. Patients completed the FACT-G at Day D-1, D1, D8 and D15 and the EQ-5D-5L at D-1, and D1. The FACT-G measured the impact of cancer in four categories: Physical wellbeing, Social wellbeing, Emotional wellbeing and Functional wellbeing, while the EQ-5D-5L measured 5 QoL dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) rated from 1 (no problems) to 5 (extreme problems).
Results
Compared to pegfilgrastim alone, patients on plinabulin + pegfilgrastim performed significantly better for Physical wellbeing on D8 and D15 of Cycle 2 (p<0.0589 and p<0.0039 respectively) and Cycle 3 (p<0.0360 and p<0.0343 respectively). Further analysis of the sub questions showed that both energy levels “I have a lack of energy” and pain “I have pain” were significantly better for the plinabulin + pegfilgrastim combination versus pegfilgrastim alone (p<0.0377 and p<0.0420 respectively). For the EQ 5D 5L, patients on the plinabulin + pegfilgrastim combination remained stable over time while patients on pegfilgrastim alone deteriorated (p<0.0245). Observed compliance for FACT-G and EQ-5D-5L was 91% and 96% respectively.
Conclusions
The Physical wellbeing (in particular, pain and energy levels) of patients receiving plinabulin + pegfilgrastim was significantly less impacted by TAC compared to pegfilgrastim alone: recovering to their pre-chemotherapy physical wellbeing levels more rapidly and experiencing less deterioration in their QoL over the duration of the trial.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
BeyondSpring Pharmaceuticals Inc.
Funding
BeyondSpring Pharmaceuticals Inc.
Disclosure
D. Blayney: Financial Interests, Institutional, Funding: BeyondSpring Pharmaceuticals. Y. Le Lorier: Financial Interests, Personal and Institutional, Full or part-time Employment: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Leadership Role: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Stocks/Shares: BeyondSpring Pharmaceuticals. D. Mitchell: Financial Interests, Personal and Institutional, Advisory Role: BeyondSpring Pharmaceuticals. L. Huang: Financial Interests, Personal and Institutional, Ownership Interest: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Stocks/Shares: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Royalties: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Funding: BeyondSpring Pharmaceuticals. R. Mohanlal: Financial Interests, Personal and Institutional, Full or part-time Employment: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Stocks/Shares: BeyondSpring Pharmaceuticals; Financial Interests, Personal and Institutional, Leadership Role: BeyondSpring Pharmaceuticals.