Celecoxib pretreatment and nab-paclitaxel-associated acute pain syndrome in patients with breast cancer: a prospective, non-randomized controlled clinical study.

Abstract

Background: Taxane-associated acute pain syndrome (T-APS) is a frequent adverse effect in breast cancer patients undergoing nab-paclitaxel, affecting treatment adherence and quality of life (QoL). We analyzed the effectiveness of preventative celecoxib on T-APS among these patients.

Methods: This non-randomized controlled trial included 270 breast cancer patients receiving nab-paclitaxel who experienced musculoskeletal pain during the first cycle. Subjects were assigned to receive celecoxib (200 mg, administered on Days 1-7) or a placebo. The main outcome measured was the overall incidence of severe T-APS (> 5 on a 0-10 scale) during cycles 2-4. Secondary endpoints included the incidence, severity, and duration of T-APS (assessed by the Brief Pain Inventory scale); QoL; peripheral nerve function; and adverse events.

Results: The overall incidence of severe T-APS was 10.2% in the celecoxib group and 50.0% in the placebo group during cycles 2-4 (p < 0.001). Mean FACT-B subscale scores were significantly higher in the celecoxib group (101.62, 95% CI: 99.70-103.53; 105.59, 95% CI: 103.57-107.61; and 108.02, 95%CI: 106.18-109.85) than the placebo group (99.02, 95% CI: 97.29-100.76; 99.80, 95% CI: 98.03-101.57; and 99.10, 95% CI: 97.39-100.81) (p < 0.05). QoL on EORTC QLQ-C30 was also better in the celecoxib group, except for appetite loss, fatigue, and insomnia (p < 0.05). Following four cycles, the mean scores on the FACT-Ntx subscale in the celecoxib group remained higher (34.10, 95% CI: 33.29-34.91 vs 32.25, 95% CI: 31.63-32.88) (p < 0.01). Additionally, the incidence of peripheral neuropathy at grade 1 or higher in CTCAE 5.0 was reduced in the celecoxib group (36.7% vs 63.8%, p < 0.001).

Conclusion: Preventative celecoxib significantly reduced the incidence of severe T-APS and improved QoL in breast cancer patients.