Published: Cancer Management and Research, 2018
Objectives
This analysis examined changes in Karnofsky performance status (KPS) as a surrogate for patient’s well-being during treatment with nab-paclitaxel plus gemcitabine vs gemcitabine alone as first-line therapy for metastatic pancreatic cancer (MPC) in the Phase III MPACT trial.
Participants and Methods
Descriptive analyses were performed for KPS at three time points (3 and 6 months after randomization and 1 month before disease progression) and for time to any KPS deterioration. Time to definitive KPS deterioration (?10-point KPS decrease from baseline) was calculated using the Kaplan-Meier method. A larger decrease from baseline (?20 points) was investigated as a sensitivity analysis. A Cox proportional hazards model analyzed the effect of baseline factors (including treatment) potentially associated with time to definitive deterioration.
Results
The two treatment arms had generally comparable time to any KPS deterioration, similar KPS at 3 and 6 months after randomization and at 1 month before disease progression, and no significant difference in time to definitive deterioration. Baseline KPS, neutrophil-to-lymphocyte ratio, age, liver metastases, and region had a significant effect on time to definitive KPS deterioration, but treatment arm did not.
Conclusion
The increased survival observed with nab-paclitaxel plus gemcitabine was not associated with adverse effects on performance status.
