Comparative effectiveness and safety of nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin in first-line treatment of advanced squamous cell non-small cell lung cancer in a US community oncology setting

Raja Mudad,1 Manish B Patel,2 Sandra Margunato-Debay,2 David Garofalo,3 Lincy S Lal4 1University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, Hollywood, FL, USA; 2Celgene Corporation, Summit, NJ, USA; 3Cardinal Health, Dallas, TX, USA; 4University of Texas School of Public Health, Houston, TX, USA Introduction: Real-world comparative effectiveness, safety, and supportive care use of nab-paclitaxel plus carboplatin vs gemcitabine plus platinum were analyzed in patients with advanced or metastatic squamous cell non-small cell lung cancer (NSCLC).Materials and methods: Patients who received ≥ 1 cycle of first-line nab-paclitaxel plus carboplatin or gemcitabine plus platinum were identified from the Navigating Cancer database. Clinical effectiveness endpoints included overall survival (OS) and time to treatment discontinuation (TTD). Other endpoints included safety and utilization of supportive care. Cox proportional hazards models were used to control for potential confounding effects of baseline characteristics.Results: In total, 193 patients were included (nab-paclitaxel plus carboplatin, n = 61; gemcitabine plus platinum, n = 132). Baseline characteristics were generally similar between the cohorts. Patients receiving nab-paclitaxel plus carboplatin had a significantly longer OS than those receiving gemcitabine plus carboplatin (median, 12.8 vs 9.0 months; P = 0.03). However, the adjusted difference was not statistically significant (adjusted HR 1.55; 95% CI, 0.99–2.42; P = 0.06). nab-Paclitaxel plus carboplatin-treated patients had significantly longer TTD than gemcitabine plus carboplatin-treated patients (median, 4.3 vs 3.5 months; P = 0.03; adjusted HR 1.39; 95% CI, 1.01–1.90; P = 0.04). Grade 3 or 4 anemia and neutropenia were significantly lower in patients treated with nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin. Nausea and neuropathy (grade not specified) were significantly higher in the nab-paclitaxel plus carboplatin than the gemcitabine plus carboplatin group. No differences in supportive care use were observed between the cohorts.Conclusion: These real-world data support the effectiveness and safety of nab-paclitaxel plus carboplatin for first-line treatment of advanced squamous cell NSCLC. Keywords: chemotherapy, doublet treatment options, electronic medical records, NSCLC, real-world evidence, retrospective analysi

Performance status dynamics during treatment with nab-paclitaxel plus gemcitabine versus gemcitabine alone for metastatic pancreatic cancer

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, gemcitabin

Performance status dynamics during treatment with nab-paclitaxel plus gemcitabine versus gemcitabine alone for metastatic pancreatic cancer

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-tolymphocyte 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