دورية أكاديمية
Randomised phase II study of second-line olaratumab with mitoxantrone/prednisone versus mitoxantrone/prednisone alone in metastatic castration-resistant prostate cancer.
| العنوان: | Randomised phase II study of second-line olaratumab with mitoxantrone/prednisone versus mitoxantrone/prednisone alone in metastatic castration-resistant prostate cancer. |
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| المؤلفون: | Hakenberg, Oliver W., Perez-Gracia, Jose Luis, Castellano, Daniel, Demkow, Tomasz, Ali, Tarek, Caffo, Orazio, Heidenreich, Axel, Schultze-Seemann, Wolfgang, Sautois, Brieuc, Pavlik, Ivan, Qin, Amy, Novosiadly, Ruslan D., Shahir, Ashwin, Ilaria, Robert Jr, Nippgen, Johannes |
| المصدر: | European journal of cancer (Oxford, England : 1990), 107, 186-195 (2019) |
| سنة النشر: | 2019 |
| المجموعة: | University of Liège: ORBi (Open Repository and Bibliography) |
| مصطلحات موضوعية: | Antineoplastics, Metastatic, Mitoxantrone, Monoclonal antibodies, Olaratumab, Platelet-derived growth factor alpha, Prostate cancer, Receptor, Human health sciences, Oncology, Sciences de la santé humaine, Oncologie |
| الوصف: | peer reviewed ; INTRODUCTION: Platelet-derived growth factor receptor-alpha (PDGFRalpha) is expressed in primary prostate adenocarcinoma and in associated skeletal metastases. Olaratumab is a fully human monoclonal antibody that binds PDGFRalpha and blocks downstream signalling. This phase II study assessed the efficacy and safety of olaratumab in combination with mitoxantrone and prednisone (M/P) versus M/P alone in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after docetaxel. METHODS: Patients were randomised to receive 21-d cycles of olaratumab (15 mg/kg, Days 1 and 8) plus mitoxantrone (12 mg/m(2), Day 1) and prednisone (5 mg, twice daily) or M/P alone. Progression-free survival (PFS) was the primary end-point. Secondary end-points included overall survival (OS), safety, and circulating tumour cell (CTC) counts. RESULTS: A total of 123 patients were randomised, 63 to olaratumab + M/P and 60 to M/P. Median PFS was 2.3 months for olaratumab + M/P and 2.4 months for M/P (hazard ratio [HR] = 1.29; 95% confidence interval [CI] = 0.87-1.90). Median OS was 14.2 months for olaratumab + M/P and 12.8 months for M/P (HR = 1.08; 95% CI = 0.72-1.61). Both treatment arms had similar toxicity profiles; neutropenia (24% versus 15%), anaemia (13% versus 14%) and fatigue (11% versus 9%) (olaratumab + M/P versus M/P, respectively) were the most common grade >/=3 events. High CTC count was associated with poorer OS in both arms. Patients with very high cell counts (>37 cells/7.5 ml) exhibited improved OS with olaratumab + M/P (interaction P = 0.043). CONCLUSIONS: Olaratumab + M/P had an acceptable safety profile but did not improve the efficacy of M/P chemotherapy. Further study with selected patient populations and earlier in the disease course might be considered. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0959-8049 1879-0852 |
| العلاقة: | urn:issn:0959-8049; urn:issn:1879-0852; https://orbi.uliege.be/handle/2268/245948Test; info:hdl:2268/245948; scopus-id:2-s2.0-85058478245; info:pmid:30573277 |
| DOI: | 10.1016/j.ejca.2018.10.005 |
| الإتاحة: | https://doi.org/10.1016/j.ejca.2018.10.005Test https://orbi.uliege.be/handle/2268/245948Test |
| حقوق: | restricted access ; http://purl.org/coar/access_right/c_16ecTest ; info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: | edsbas.4A7D57C7 |
| قاعدة البيانات: | BASE |
| تدمد: | 09598049 18790852 |
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| DOI: | 10.1016/j.ejca.2018.10.005 |