Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.

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  • Additional Information
    • Affiliation:
      Center for Cancer Research, NCI, NIH, Building 10 CRC, Room 1W-3750, MSC 110410 Center Drive, Bethesda, MD 20892-1104, USA
      Center for Cancer Research, NCI, NIH, Building 10-CRC, Room 1-5750, Bethesda, MD 20892-1100, USA
      Center for Cancer Research, NCI, NIH, 9609 Medical Center Drive, Room 2W334, MSC 9716, Bethesda, MD 20892, USA
      SARC, 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48106, USA
      Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., MLC 7015, Cincinnati, OH 45229, USA
      Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, 4650 Sunset Boulevard Mail Stop # 54, Los Angeles, CA 90027, USA
      Mattel Children's Hospital, David Geffen School of Medicine, University of California, 10833 Le Conte Avenue, Los Angeles, CA 90095-6901, USA
      Stanford University School of Medicine, Palo Alto, CA 94305, USA
      Sarcoma Oncology Research Center, 2811 Wilshire Boulevard, Suite 411, Santa Monica, CA 90403, USA
      University of Florida Health Shands Children's Hospital, 1600 SW Archer HD 204, Gainesville, FL 32610, USA
      Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA
      University of Iowa Hospitals and Clinics, 200 Hawkins Drive C32 GH, Iowa City, IA 52242, USA
      Children's Hospital at Montefiore, Albert Einstein College of Medicine, 3411 Wayne Ave., Room 910, Bronx, New York, NY 10467, USA
      Willamette Valley Cancer Institute and Research Center, 520 Country Club Road, Eugene, OR 97401, USA
      Cincinnati Children's Hospital Medical Center, 3333 Burnett Avenue, Cincinnati, OH 45229, USA
      Abramson Cancer Center, University of Pennsylvania Health System, 230 W. Washington Square, Philadelphia, PA 19106, USA
      Stanford University School of Medicine, 1000 Welch Road Suite 300, MC 5798, Palo Alto, CA 94304, USA
      The Royal Marsden Hospital and Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK
      Comprehensive Cancer Center University of California, Davis, 2279 45th Street, Sacramento, CA 95717, USA
      University of Michigan, 1500 East Medical Center Dr. Ann Arbor, Ann Arbor, MI 48109, USA
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      Purpose. Osteosarcoma is a rare cancer and a third of patients who have completed primary treatment will develop osteosarcoma recurrence. The Src pathway has been implicated in the metastatic behavior of osteosarcoma; about 95% of samples examined express Src or have evidence of downstream activation of this pathway. Saracatinib (AZD0530) is a potent and selective Src kinase inhibitor that was evaluated in adults in Phase 1 studies. The primary goal of this study was to determine if treatment with saracatinib could increase progression-free survival (PFS) for patients who have undergone complete resection of osteosarcoma lung metastases in a double-blinded, placebo-controlled trial. Patients and Methods. Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules were randomized within six weeks after complete surgical resection. Saracatinib, or placebo, was administered at a dose of 175 mg orally, once daily, for up to thirteen 28-day cycles. Results. Thirty-seven subjects were included in the analyses; 18 subjects were randomized to receive saracatinib and 19 to receive placebo. Intent-to-treat analysis demonstrated a median PFS of 19.4 months in the saracatinib treatment group and 8.6 months in the placebo treatment group (p = 0.47). Median OS was not reached in either arm. Conclusions. Although saracatinib was well tolerated in this patient population, there was no apparent impact of the drug in this double-blinded, placebo-controlled trial on OS, and Src inhibition alone may not be sufficient to suppress metastatic progression in osteosarcoma. There is a suggestion of potential clinical benefit as evidenced by longer PFS in patients randomized to saracatinib based on limited numbers of patients treated.
    • Journal Subset:
      Biomedical; Europe; Peer Reviewed; UK & Ireland
    • ISSN:
      1357-714X
    • MEDLINE Info:
      NLM UID: 9709257
    • Publication Date:
      20200505
    • Publication Date:
      20200515
    • DOI:
      http://dx.doi.org/10.1155/2020/7935475
    • Accession Number:
      143001922
  • Citations
    • ABNT:
      BAIRD, K. et al. Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung. Sarcoma, [s. l.], p. 1–6, 2020. DOI 10.1155/2020/7935475. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143001922. Acesso em: 14 ago. 2020.
    • AMA:
      Baird K, Glod J, Steinberg SM, et al. Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung. Sarcoma. May 2020:1-6. doi:10.1155/2020/7935475
    • APA:
      Baird, K., Glod, J., Steinberg, S. M., Reinke, D., Pressey, J. G., Mascarenhas, L., Federman, N., Marina, N., Chawla, S., Lagmay, J. P., Goldberg, J., Milhem, M., Loeb, D. M., Butrynski, J. E., Turpin, B., Staddon, A., Spunt, S. L., Jones, R. L., Rodler, E. T., & Schuetze, S. M. (2020). Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung. Sarcoma, 1–6. https://doi.org/10.1155/2020/7935475
    • Chicago/Turabian: Author-Date:
      Baird, Kristin, John Glod, Seth M. Steinberg, Denise Reinke, Joseph G. Pressey, Leo Mascarenhas, Noah Federman, et al. 2020. “Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.” Sarcoma, May, 1–6. doi:10.1155/2020/7935475.
    • Harvard:
      Baird, K. et al. (2020) ‘Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung’, Sarcoma, pp. 1–6. doi: 10.1155/2020/7935475.
    • Harvard: Australian:
      Baird, K, Glod, J, Steinberg, SM, Reinke, D, Pressey, JG, Mascarenhas, L, Federman, N, Marina, N, Chawla, S, Lagmay, JP, Goldberg, J, Milhem, M, Loeb, DM, Butrynski, JE, Turpin, B, Staddon, A, Spunt, SL, Jones, RL, Rodler, ET & Schuetze, SM 2020, ‘Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung’, Sarcoma, pp. 1–6, viewed 14 August 2020, .
    • MLA:
      Baird, Kristin, et al. “Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.” Sarcoma, May 2020, pp. 1–6. EBSCOhost, doi:10.1155/2020/7935475.
    • Chicago/Turabian: Humanities:
      Baird, Kristin, John Glod, Seth M. Steinberg, Denise Reinke, Joseph G. Pressey, Leo Mascarenhas, Noah Federman, et al. “Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.” Sarcoma, May 2020, 1–6. doi:10.1155/2020/7935475.
    • Vancouver/ICMJE:
      Baird K, Glod J, Steinberg SM, Reinke D, Pressey JG, Mascarenhas L, et al. Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung. Sarcoma [Internet]. 2020 May [cited 2020 Aug 14];1–6. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143001922