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Autio, Karen A.; Klebanoff, Christopher A.; Schaer, David; Kauh, John Sae Wook; Slovin, Susan F.; Adamow, Matthew; Blinder, Victoria S.; Brahmachary, Manisha; Carlsen, Michelle; Comen, Elizabeth; Danila, Daniel C.; Doman, Thompson N.; Durack, Jeremy C.; Fox, Josef J.; Gluskin, Jill S.; Hoffman, David M.; Kang, Suhyun; Kang, Praneet; Landa, Jonathan; McAndrew, Philomena F.; Modi, Shanu; Morris, Michael J.; Novosiadly, Ruslan; Rathkopf, Dana E.; [...]

Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study

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  • Medientyp: E-Artikel
  • Titel: Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study
  • Beteiligte: Autio, Karen A.; Klebanoff, Christopher A.; Schaer, David; Kauh, John Sae Wook; Slovin, Susan F.; Adamow, Matthew; Blinder, Victoria S.; Brahmachary, Manisha; Carlsen, Michelle; Comen, Elizabeth; Danila, Daniel C.; Doman, Thompson N.; Durack, Jeremy C.; Fox, Josef J.; Gluskin, Jill S.; Hoffman, David M.; Kang, Suhyun; Kang, Praneet; Landa, Jonathan; McAndrew, Philomena F.; Modi, Shanu; Morris, Michael J.; Novosiadly, Ruslan; Rathkopf, Dana E.; [...]
  • Erschienen: American Association for Cancer Research (AACR), 2020
  • Erschienen in: Clinical Cancer Research, 26 (2020) 21, Seite 5609-5620
  • Sprache: Englisch
  • DOI: 10.1158/1078-0432.ccr-20-0855
  • ISSN: 1078-0432; 1557-3265
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: Abstract Purpose: Tumor-associated macrophages correlate with increased invasiveness, growth, and immunosuppression. Activation of the colony-stimulating factor-1 receptor (CSF-1R) results in proliferation, differentiation, and migration of monocytes/macrophages. This phase I study evaluated the immunologic and clinical activity, and safety profile of CSF-1R inhibition with the mAb LY3022855. Patients and Methods: Patients with advanced refractory metastatic breast cancer (MBC) or metastatic castration-resistant prostate cancer (mCRPC) were treated with LY3022855 intravenously in 6-week cycles in cohorts: (A) 1.25 mg/kg every 2 weeks (Q2W); (B) 1.0 mg/kg on weeks 1, 2, 4, and 5; (C) 100 mg once weekly; (D)100 mg Q2W. mCRPC patients were enrolled in cohorts A and B; patients with MBC were enrolled in all cohorts. Efficacy was assessed by RECIST and Prostate Cancer Clinical Trials Working Group 2 criteria. Results: Thirty-four patients (22 MBC; 12 mCRPC) received ≥1 dose of LY3022855. At day 8, circulating CSF-1 levels increased and proinflammatory monocytes CD14DIMCD16BRIGHT decreased. Best RECIST response was stable disease in five patients with MBC (23%; duration, 82–302 days) and three patients with mCRPC (25%; duration, 50–124 days). Two patients with MBC (cohort A) had durable stable disease >9 months and a third patient with MBC had palpable reduction in a nontarget neck mass. Immune-related gene activation in tumor biopsies posttreatment was observed. Common any grade treatment-related adverse events were fatigue, decreased appetite, nausea, asymptomatic increased lipase, and creatine phosphokinase. Conclusions: LY3022855 was well tolerated and showed evidence of immune modulation. Clinically meaningful stable disease >9 months was observed in two patients with MBC.
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