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Journal of Skin Cancer
Volume 2017, Article ID 6121760, 7 pages
https://doi.org/10.1155/2017/6121760
Research Article

A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma

Dawn Odom,1 Deirdre Mladsi,1 Molly Purser,1 James A. Kaye,1 Eirini Palaka,2 Alina Charter,2 Jo Annah Jensen,2 and Dalila Sellami3

1RTI Health Solutions, 200 Park Offices Dr., Research Triangle Park, NC, USA
2Novartis Pharma AG, Forum 1, Novartis Campus, 4056 Basel, Switzerland
3Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA

Correspondence should be addressed to Dawn Odom; gro.itr@modod

Received 30 December 2016; Accepted 13 April 2017; Published 21 May 2017

Academic Editor: Silvia Moretti

Copyright © 2017 Dawn Odom et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. American Cancer Society, “Skin cancer: basal and squamous cell, detailed guide,” 2013, http://www.cancer.org/acs/groups/cid/documents/webcontent/003139-pdf.pdf.
  2. H. W. Walling, S. W. Fosko, P. A. Geraminejad, D. C. Whitaker, and C. J. Arpey, “Aggressive basal cell carcinoma: presentation, pathogenesis, and management,” Cancer and Metastasis Reviews, vol. 23, no. 3-4, pp. 389–402, 2004. View at Publisher · View at Google Scholar · View at Scopus
  3. J. T. Lear, C. Corner, P. Dziewulski et al., “Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective,” British Journal of Cancer, vol. 111, no. 8, pp. 1476–1481, 2014. View at Publisher · View at Google Scholar · View at Scopus
  4. S. L. Shingler, J. Garside, K. Samanta, J. T. Lear, S. Keohane, and A. J. Lloyd, “Utilities for advanced basal cell carcinoma,” Journal of Medical Economics, vol. 16, no. 6, pp. 777–783, 2013. View at Publisher · View at Google Scholar · View at Scopus
  5. M. R. Migden, A. Guminski, R. Gutzmer et al., “Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial,” The Lancet Oncology, vol. 16, no. 6, pp. 716–728, 2015. View at Publisher · View at Google Scholar · View at Scopus
  6. Food and Drug Administration (FDA), “FDA approves new treatment for most common form of advanced skin cancer,” 2015, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455862.htm.
  7. European Medicines Agency (EMA), “Assessment report: odomzo. EMEA/H/C/002839/0000,” 2015, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002839/WC500192972.pdf.
  8. A. Sekulic, M. R. Migden, A. E. Oro et al., “Efficacy and safety of vismodegib in advanced basal-cell carcinoma,” The New England Journal of Medicine, vol. 366, no. 23, pp. 2171–2179, 2012. View at Publisher · View at Google Scholar · View at Scopus
  9. European Medicines Agency (EMA), “Assessment report: erivedge. EMEA/H/C/002602,” 2013, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002602/WC500146820.pdf.
  10. A. Castellino, “New drug treatments for basal cell carcinoma,” 2015, http://www.medscape.com/viewarticle/845314.
  11. J. E. Signorovitch, V. Sikirica, M. H. Erder et al., “Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research,” Value in Health, vol. 15, no. 6, pp. 940–947, 2012. View at Publisher · View at Google Scholar · View at Scopus
  12. J. E. Signorovitch, E. Q. Wu, A. P. Yu et al., “Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept,” PharmacoEconomics, vol. 28, no. 10, pp. 935–945, 2010. View at Publisher · View at Google Scholar · View at Scopus
  13. H. Thom, S. M. Jugl, E. Palaka, and S. Jawla, “Matching adjusted indirect comparison to assess comparative effectiveness of therapies: usage in scientific literature and health technology appraisals,” in Proceedings of the 21st Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Washington, DC, USA, May 2016.
  14. M. Migden, A. Guminski, R. Gutzmer, L. Dirix, K. Lewis, P. Combemale et al., “Randomized, double-blind study of sonidegib (LDE225) in patients with locally advanced or metastatic basal cell carcinoma,” in Proceeding the Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, USA, June 2014.
  15. A. Sekulic, M. R. Migden, A. E. Oro, K. D. Lewis, J. D. Hainsworth, S. Yoo et al., “Efficacy and safety of the hedgehog pathway inhibitor vismodegib in patients with advanced basal cell carcinoma (BCC): ERIVANCE BCC study update,” Journal of Clinical Oncology, vol. 30, supplement 8579, 2012. View at Google Scholar
  16. A. Sekulic, M. R. Migden, K. Lewis et al., “Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC,” Journal of the American Academy of Dermatology, vol. 72, no. 6, pp. 1021–1026.e8, 2015. View at Publisher · View at Google Scholar · View at Scopus
  17. A. Sekulic, M. R. Migden, N. Basset-Seguin et al., “Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma (aBCC): 18-month update of the pivotal ERIVANCE BCC study,” Journal of Clinical Oncology, vol. 31, supplement 9037, 2013. View at Google Scholar
  18. A. Sekulic, D. Schadendorf, J. Solomon, J. Hainsworth, K. Lewis, L. Dirix et al., “Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma (aBCC): 24-month update of the pivotal ERIVANCE,” Journal of the American Academy of Dermatology, vol. 70, no. 5, article AB137, 2013. View at Google Scholar
  19. A. Sekulic, M. R. Migden, N. Basset-Seguin, C. Garbe, A. Gesierich, C. D. Lao et al., “Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update (30-month) of the pivotal ERIVANCE BCC study,” Journal of Clinical Oncology, vol. 32, no. 5s, 2014. View at Google Scholar
  20. E. A. Eisenhauer, P. Therasse, J. Bogaerts et al., “New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1),” European Journal of Cancer, vol. 45, no. 2, pp. 228–247, 2009. View at Publisher · View at Google Scholar · View at Scopus
  21. World Health Organization, WHO Handbook for Reporting Results of Cancer Treatment, World Health Organization, Geneva, Switzerland, 1979.
  22. P. Therasse, S. G. Arbuck, E. A. Eisenhauer et al., “New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the United States, national cancer institute of Canada,” Journal of the National Cancer Institute, vol. 92, no. 3, pp. 205–216, 2000. View at Publisher · View at Google Scholar · View at Scopus
  23. R. Dummer, V. K. Sondak, J. M. Grichnik et al., “Composite assessment of treatment response in patients (pts) with locally advanced basal cell carcinoma (laBCC): sonidegib efficacy using two sets of response criteria,” Journal of Clinical Oncology, vol. 33, 2015. View at Google Scholar
  24. R. Dummer, A. Guminski, R. Gutzmer et al., “The 12-month analysis from basal cell carcinoma outcomes with LDE225 treatment (BOLT): a phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma,” Journal of the American Academy of Dermatology, vol. 75, no. 1, pp. 113–125, 2016. View at Publisher · View at Google Scholar · View at Scopus
  25. A. L. S. Chang, J. A. Solomon, J. D. Hainsworth et al., “Expanded access study of patients with advanced basal cell carcinoma treated with the hedgehog pathway inhibitor, vismodegib,” Journal of the American Academy of Dermatology, vol. 70, no. 1, pp. 60–69, 2014. View at Publisher · View at Google Scholar · View at Scopus
  26. J. Dreier, P. F. Cheng, I. Bogdan Alleman et al., “Basal cell carcinomas in a tertiary referral centre: a systematic analysis,” British Journal of Dermatology, vol. 171, no. 5, pp. 1066–1072, 2014. View at Publisher · View at Google Scholar · View at Scopus