OBJECTIVES : Bone pain is a known side effect of pegfilgrastim. We evaluated this safety endpoint prospectively in a randomized open-label study of plinabulin compared with pegfilgrastim for the prevention of docetaxel-induced neutropenia in patients with advanced or metastatic non-small cell lung cancer (NSCLC) (NCT03102606) (Blayney et al. ASCO 2018).

METHODS : Patients were randomized to receive four 21-day cycles of docetaxel (75mg/m²) with either pegfilgrastim 6mg or plinabulin 5mg/m², 10mg/m², or 20mg/m². Bone pain was assessed using the Brief Pain Inventory Short Form questionnaire on days 1,3,5,7, 9, and 21 post-cycle 1 dose. Percent change from baseline pain score in “pain on average” and “pain at its worst in the last 24 hours” were analyzed

RESULTS : Forty-one patients completed the study. For the measure “pain at its worst in the last 24 hours,” patients in the plinabulin 20mg/m² arm reported minimal to no bone pain versus patients in the pegfilgrastim 6mg arm who reported pain from day 3 which peaked on day 7 (90% change) before declining. For the measure “pain on average”, patients in the plinabulin 20mg/m² arm showed an 8.3% increase in pain on day 5 which resolved to a slight improvement (negative change in pain) after. Patients in the pegfilgrastim 6mg arm exhibited an increase in pain from day 3 which peaked on day 7 (64.1%) and decreased after.

CONCLUSIONS : Plinabulin at 20mg/m² has a similar efficacy profile in reducing docetaxel-induced neutropenia as pegfilgrastim 6mg with the added safety benefit of avoiding patient reported bone pain observed with pegfilgrastim.