A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy
| Autor: | Lisa Sengeløv, Nathalie Germann, M. Moe, Frederique Baton, Cora N. Sternberg, L. Stachurski, Joaquim Bellmunt, Gedske Daugaard, Albertas Ulys, Sylvain Ladoire, Aude Flechon, Miguel Angel Climent, Herlinde Dumez, A. Guida, Michaela Matouskova, Simon Chowdhury, Karim Fizazi, Sigita Liutkauskiene, Nicolas Penel, Antoine Thiery-Vuillemin |
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| Přispěvatelé: | Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), National Cancer Institute (Vilnius), Herlev and Gentofte Hospital, Aalborg University Hospital, Département d'oncologie médicale [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc (CRLCC - CGFL), Développement et amélioration des plantes (UMR DAP), Centre National de la Recherche Scientifique (CNRS)-Université Montpellier 2 - Sciences et Techniques (UM2)-Institut National de la Recherche Agronomique (INRA)-Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad), Centre Léon Bérard [Lyon], University of Ferrara and Azienda Ospedaliero-Universitaria Sant'Anna Hospital of Ferrara, Dana-Farber Cancer Institute [Boston], Instituto Valenciano de Oncologia, Guy's & St Thomas' NHS Foundation Trust, University Hospitals Leuven [Leuven], Urocentrum (Prague), CRLCC Oscar Lambret, Hospital of Lithuanian University of Health Sciences Kauno Klinikos [Kaunas, Lithuania], Regional Hospital San Camillo-Forlanini, IPSEN Innovation, Rigshospitalet [Copenhagen], Aarhus University Hospital, Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Institut National de la Recherche Agronomique (INRA)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Università degli Studi di Ferrara = University of Ferrara (UniFE), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Copenhagen University Hospital, Université Lille Nord de France (COMUE)-UNICANCER |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
0301 basic medicine Oncology medicine.medical_specialty maintenance therapy Phases of clinical research [SDV.CAN]Life Sciences [q-bio]/Cancer Quinolones Placebo tasquinimod law.invention Tasquinimod 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Maintenance therapy law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans docetaxel Progression-free survival Aged Aged 80 and over business.industry Disease Management International Agencies Original Articles Hematology Middle Aged Prognosis prostate cancer Chemotherapy regimen castrate-resistant 3. Good health Survival Rate Prostatic Neoplasms Castration-Resistant Treatment Outcome 030104 developmental biology Docetaxel 030220 oncology & carcinogenesis Quality of Life Taxoids business Follow-Up Studies medicine.drug |
| Zdroj: | Annals of Oncology Annals of Oncology, Oxford University Press (OUP), 2017, 28 (11), pp.2741-2746. ⟨10.1093/annonc/mdx487⟩ Annals of Oncology, 2017, 28 (11), pp.2741-2746. ⟨10.1093/annonc/mdx487⟩ Annals of Oncology, Elsevier, 2017, 28 (11), pp.2741-2746. ⟨10.1093/annonc/mdx487⟩ |
| ISSN: | 0923-7534 1569-8041 |
| Popis: | IF 11.855; International audience; BackgroundThis phase II study was conducted to assess clinical efficacy of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy.Patients and methodsPatients were randomly assigned (1 : 1) to receive tasquinimod (0.25–1.0 mg/day orally) or placebo. The primary end point was radiologic progression-free survival (rPFS); secondary efficacy end points included: overall survival (OS); PFS on next-line therapy (PFS 2) and symptomatic PFS, assessed using the Brief Pain Inventory (BPI) questionnaire and analgesic use. Quality of life was measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol-5 Dimension Quality of Life Instrument (EQ-5D). Adverse events were recorded.ResultsA total of 219 patients were screened and 144 patients randomized. The median duration of treatment was 18.7 weeks (range 0.6–102.7 weeks) for the tasquinimod arm and 19.2 weeks (range 0.4–80.0 weeks) for the placebo arm. Median (90% CI) rPFS was 31.7 (24.3–53.7) and 22.7 (16.1–25.9) weeks in the tasquinimod and placebo arms, respectively [HR (90% CI) 0.6 (0.4–0.9), P = 0.0162]. The median OS was not reached because only 14 deaths occurred by the cut-off date. No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3–5) incidence was higher in the tasquinimod group (50.7% versus 27.1%).ConclusionsRandomized trials testing new drugs as maintenance can be successfully conducted after chemotherapy in castrate-resistant prostate cancer. Maintenance tasquinimod therapy significantly reduced the risk of rPFS by 40%.ClinicalTrialsgov identifier NCT01732549. |
| Databáze: | OpenAIRE |
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