Performance status dynamics during treatment with nab-paclitaxel plus gemcitabine versus gemcitabine alone for metastatic pancreatic cancer
Received 23 January 2018
Accepted for publication 16 April 2018
Published 31 May 2018 Volume 2018:10 Pages 1389—1396
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor Lu-Zhe Sun
E Gabriela Chiorean,1 Daniel Von Hoff,2 Yin Wan,3 Sandra Margunato-Debay,4 Marc Botteman,3 David Goldstein5
1Medical Oncology, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, 2Oncology, Translational Genomics Research Institute and HonorHealth, Phoenix, AZ, 3Pharmerit International, Bethesda, MD, 4Celgene Corporation, Summit, NJ, USA; 5Department of Medical Oncology, Prince of Wales Hospital, Sydney, NSW, Australia
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.
Keywords: Karnofsky performance status, metastatic pancreatic cancer, chemotherapy, nab-paclitaxel, gemcitabine
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