A phase II trial of zoptarelin doxorubicin in castration- and taxane-resistant prostate cancer
| Autor: | Steven S. Yu, David I. Quinn, Andrew V. Schally, Kanthi Athreya, Jürgen Engel, Denice D. Tsao-Wei, Jacek Pinski, Susan Groshen, Stephen V. Liu, Tanya B. Dorff, Shigang Xiong |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Taxane business.industry medicine.disease Androgen deprivation therapy chemistry.chemical_compound Regimen Prostate cancer medicine.anatomical_structure chemistry Prostate Zoptarelin doxorubicin Internal medicine Clinical endpoint Medicine Doxorubicin business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 35:210-210 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2017.35.6_suppl.210 |
| Popis: | 210 Background: Luteinizing hormone-releasing hormone receptors (LHRH-R) are expressed in ~86% of prostate cancers, with sustained expression despite prolonged exposure to LHRH agonists. Limited expression of LHRH-R on normal cells suggests LHRH-R may be a therapeutic target for prostate cancer. Zoptarelin doxorubicin is a cytotoxic hybrid molecule linking doxorubicin to an LHRH analog that selectively targets doxorubicin to cancer cells expressing LHRH-R. Methods: This Phase 2 trial evaluated the clinical benefit of zoptarelin doxorubicin for metastatic castration-resistant prostate cancer (mCRPC) following androgen deprivation therapy and ≥1 taxane-based regimen. The primary endpoint was clinical benefit (CB) defined as progression-free survival (PFS) per RECIST v1.1 at 12 weeks with no dose-limiting toxicities (DLT) or other toxicities resulting in treatment cessation. Secondary endpoints were time to overall progression, response rate, pain response, overall survival (OS), and PSA response. Results: Of 25 patients enrolled, 20 had ≥1 measurable lesion at baseline with PFS ≥12 weeks achieved in 56% and PSA response of PR (4%) and SD (84%). Median PFS and OS were 3.8 and 6.0 months, respectively. Reduced pain was reported by 59%. Treatment was well tolerated, with no cardiotoxicity and neutropenia (all grades) the most common hematologic adverse event. Conclusions: This phase 2 trial demonstrated clinical benefit in 56% of patients with no DLT or other toxicity requiring treatment termination. These results suggest a role for zoptarelin doxorubicin for mCRPC following progression on second- and third-line hormonal therapy. Clinical trial information: NCT01240629. [Table: see text] |
| Databáze: | OpenAIRE |
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