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, Manish B Patel, Sandra Margunato-Debay, David Garofalo, Lincy S Lal, Raja Mudad, Manish B Patel, Sandra Margunato-Debay, David Garofalo, Lincy S Lal

Abstract

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: NSCLC; chemotherapy; doublet treatment options; electronic medical records; real-world evidence; retrospective analysis.

Conflict of interest statement

Disclosure RM is a consultant for Celgene Corporation; MBP and SMD are employees of Celgene; DG and LSL were employees of Cardinal Health, which received research funding from Celgene Corporation. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study flow diagram: patients with squamous cell non-small cell lung cancer who received first-line nab-paclitaxel- or gemcitabine-based treatment. Abbreviation: NSCLC, non-small cell lung cancer.
Figure 2
Figure 2
(A) Overall survival (initiation of first-line therapy until death) and (B) time to treatment discontinuation (initiation of first-line therapy until treatment discontinuation) among patients who received nab-paclitaxel plus carboplatin or gemcitabine plus carboplatin. Abbreviations:nab-P/C, nab-paclitaxel plus carboplatin; Gem/C, gemcitabine plus carboplatin.

References

    1. [homepage on the Internet] GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. World Health Organization; 2012. [Accessed August 29, 2017]. [updated 2017; cited July 13, 2016]. Available from: .
    1. [homepage on the Internet] Cancer Facts & Figures 2017. American Cancer Society; 2017. [Accessed August 29, 2017]. [updated 2017; cited February 8, 2017]. Available from: .
    1. [homepage on the Internet] Non-small cell lung cancer. American Cancer Society; 2017. [Accessed August 29, 2017]. [updated 2017; cited February 10, 2017]. Available from: .
    1. Brahmer J, Horn L, Jackman D, et al. Five-year follow-up from the CA209-003 study of nivolumab in previously treated advanced non-small cell lung cancer (NSCLC): clinical characteristics of long-term survivors [abstract] Cancer Res. 2017;77(13 Suppl):CT077.
    1. Cetin K, Ettinger DS, Hei YJ, O’Malley CD. Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139–148.
    1. National Comprehensive Cancer Network . NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. V8.2017. National Comprehensive Cancer Network; 2017. [Accessed August 29, 2017]. Available from: .
    1. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018–2028.
    1. Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540–1550.
    1. Keytruda® (pembrolizumab) [package insert] Whitehouse Station, NJ: Merck & Co Inc; 2017.
    1. Novello S, Barlesi F, Califano R, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(Suppl 5):v1–v27.
    1. Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012;30(17):2055–2062.
    1. Socinski MA, Okamoto I, Hon JK, et al. Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. Ann Oncol. 2013;24(9):2390–2396.
    1. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(21):3543–3551.
    1. [homepage on the Internet] SEER Cancer Stat Facts: lung and bronchus cancer Surveillance, Epidemiology, and End Results Program. National Cancer Institute; 2014. [Accessed August 29, 2017]. [updated June 28, 2017; cited Jul 25, 2017]. Available from: .
    1. Gajra A. Defining the issues in the treatment of elderly patients with advanced non-small-cell lung cancer. Lung Cancer Management. 2015;4(1):17–30.
    1. Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) [package insert] Summit, NJ: Celgene Corporation; 2015.
    1. Gemzar (gemcitabine) [package insert] Indianapolis, IN: Eli Lilly and Company; 2017.
    1. Wang XS, Lu C, Shi Q, et al. Symptom burden and survival outcome: 3 cycles versus 6 cycles of chemotherapy in advanced NSCLC [abstract] J Clin Oncol. 2007;25(18 Suppl):17054.
    1. Soon YY, Stockler MR, Askie LM, Boyer MJ. Duration of chemotherapy for advanced non-small-cell lung cancer: a systematic review and meta-analysis of randomized trials. J Clin Oncol. 2009;27(20):3277–3283.
    1. Sculier JP, Moro-Sibilot D. First- and second-line therapy for advanced nonsmall cell lung cancer. Eur Respir J. 2009;33(4):915–930.
    1. De Marinis F, De Santis S, De Petris L. Second-line chemotherapy for non-small cell lung cancer. Ann Oncol. 2006;(17Suppl 5):v68–v71.
    1. Keytruda® (pembrolizumab) [package insert] Whitehouse Station, NJ: Merck & Co Inc; 2015.
    1. Opdivo® (nivolumab) [package insert] Princeton, NJ: Bristol-Myers Squibb Company; 2015.
    1. Tecentriq® (atezolizumab) [package insert] South San Francisco, CA: Genentech, Inc; 2016.
    1. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639.
    1. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373(2):123–135.
    1. Barlesi F, Park K, Ciardiello F, et al. Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC [abstract] Ann Oncol. 2016;27(Suppl 6):LBA44_PR.
    1. Fehrenbacher L, Spira A, Ballinger M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387(10030):1837–1846.
    1. US Food and Drug Administration . FDA expands approved use of Opdivo to treat lung cancer [press release] Silver Spring, MD: US Food and Drug Administration; 2015. [Accessed August 29, 2017]. [March 5]. Available from: .
    1. US Food and Drug Administration . FDA approves Keytruda for advanced non-small cell lung cancer [press release] Silver Spring, MD: US Food and Drug Administration; 2015. Oct 5, [Accessed August 29, 2017]. Available from: .
    1. [homepage on the Internet] Atezolizumab (TECENTRIQ) US Food and Drug Administration; 2016. 2016. [Accessed August 29, 2017]. [updated October 19, 2016; cited November 30, 2016]. Available from: .

Source: PubMed

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