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      Adherence to recommended clinical guidelines in extensive disease small-cell lung cancer across the US, Europe, and Japan

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          Abstract

          Purpose

          This study compared real-world treatment patterns of patients with extensive disease small-cell lung cancer (ED-SCLC) across regions and by platinum resistance/platinum sensitivity (PR/PS) and established if these patterns were in line with published guidelines.

          Patients and methods

          The data source was the Oncology Monitor, a global database using retrospective medical chart reviews of oncology patients treated with anticancer drugs. All patients diagnosed with ED-SCLC from January 2014 through December 2016 in the US, and in France, Germany, Italy, Spain, and the UK (European Union; EU5), and Japan were included.

          Results

          Of 5,849 treated patients, 73.4%, 19.8% and 6.8% received first, second, or third/later lines (1L, 2L, 3L) of therapy, respectively. The most frequent 1L treatment, platinum + etoposide, was significantly more common in the US (87.0%) than in the EU5 (82.1%) or Japan (73.3%) ( P<0.05). Platinum + irinotecan was a common 1L treatment in Japan (22.7%) but not in the US (2.0%) or EU5 (0.5%, P<0.0001). Topotecan was the most common 2L treatment in the US and EU5, but amrubicin was the most common in Japan. Among PR patients, 27.3%, 10.8%, and 36.4% received a platinum-based 2L therapy in the US, EU5, and Japan, respectively. Among PS patients, approximately half were not re-challenged with a 2L platinum-based therapy across all regions.

          Conclusion

          In contrast to treatment guidelines, a significant proportion of real-world PR patients were re-challenged with a 2L platinum-based therapy, while conversely, many PS patients did not receive platinum-based therapies in 2L. This study highlights a lack of a consistent paradigm for 2L ED-SCLC treatment, limited therapeutic options, and an unmet need among SCLC patients.

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          Most cited references 21

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          Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer.

          Irinotecan hydrochloride, a topoisomerase I inhibitor, is effective against small-cell lung cancer. In a phase 2 study of irinotecan plus cisplatin in patients with extensive small-cell lung cancer, there was a high response rate and a promising median survival time. We conducted a multicenter, randomized, phase 3 study in which we compared irinotecan plus cisplatin with etoposide plus cisplatin in patients with extensive (metastatic) small-cell lung cancer. The planned size of the study population was 230 patients, but enrollment was terminated early because an interim analysis found a statistically significant difference in survival between the patients assigned to receive irinotecan and cisplatin and those assigned to receive etoposide and cisplatin; as a result, only 154 patients were enrolled. The median survival was 12.8 months in the irinotecan-plus-cisplatin group and 9.4 months in the etoposide-plus-cisplatin group (P=0.002 by the unadjusted log-rank test). At two years, the proportion of patients surviving was 19.5 percent in the irinotecan-plus-cisplatin group and 5.2 percent in the etoposide-plus-cisplatin group. Severe or life-threatening myelosuppression was more frequent in the etoposide-plus-cisplatin group than in the irinotecan-plus-cisplatin group, and severe or life-threatening diarrhea was more frequent in the irinotecan-plus-cisplatin group than in the etoposide-plus-cisplatin group. Irinotecan plus cisplatin is an effective treatment for metastatic small-cell lung cancer.
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            Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

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              Small cell lung cancer: where do we go from here?

              Small cell lung cancer (SCLC) is an aggressive disease that accounts for approximately 14% of all lung cancers. In the United States, approximately 31,000 patients are diagnosed annually with SCLC. Despite numerous clinical trials, including at least 40 phase 3 trials since the 1970s, systemic treatment for patients with SCLC has not changed significantly in the past several decades. Consequently, the 5-year survival rate remains low at <7% overall, and most patients survive for only 1 year or less after diagnosis. Unlike nonsmall cell lung cancer (NSCLC), in which major advances have been made using targeted therapies, there are still no approved targeted drugs for SCLC. Significant barriers to progress in SCLC include 1) a lack of early detection modalities, 2) limited tumor tissue for translational research (eg, molecular profiling of DNA, RNA, and/or protein alterations) because of small diagnostic biopsies and the rare use of surgical resection in standard treatment, and 3) rapid disease progression with poor understanding of the mechanisms contributing to therapeutic resistance. In this report, the authors review the current state of SCLC treatment, recent advances in current understanding of the underlying disease biology, and opportunities to advance translational research and therapeutic approaches for patients with SCLC.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2019
                28 February 2019
                : 15
                : 355-366
                Affiliations
                [1 ]Global Evidence Value and Access (GEVA), Ipsos Healthcare, Mahwah, NJ, USA
                [2 ]Global Evidence Value and Access (GEVA), Ipsos Healthcare, San Francisco, CA, USA, bijal@ 123456noesis.care
                [3 ]Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ, USA
                Author notes
                Correspondence: Bijal Shah-Manek, Noesis Healthcare Technologies, 49 Stevenson Street, 15th Floor, San Francisco, CA 94105, USA, Tel +1 707 315 1870, Email bijal@ 123456noesis.care
                Article
                tcrm-15-355
                10.2147/TCRM.S183216
                6400139
                © 2019 DiBonaventura et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Medicine

                small-cell lung cancer, real-world treatment patterns, clinical guidelines

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