A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial

Autor: Carolien H. Smorenburg, Juleon L.L.M. Coenen, Alfons J.M. van den Eertwegh, Aart Beeker, H. Pieter van den Berg, Winald R. Gerritsen, Walter L. Vervenne, Henk M.W. Verheul, Linda de Munck, Esther W. Bouman-Wammes
Přispěvatelé: Internal medicine, CCA - Cancer Treatment and quality of life, Medical oncology, CCA - Cancer Treatment and Quality of Life
Rok vydání: 2018
Předmět:
Oncology
Male
Cancer Research
medicine.medical_specialty
Combination therapy
medicine.medical_treatment
Docetaxel
Kaplan-Meier Estimate
Adenocarcinoma
urologic and male genital diseases
Disease-Free Survival
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
Prostate cancer
0302 clinical medicine
All institutes and research themes of the Radboud University Medical Center
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
030212 general & internal medicine
neoplasms
Aged
Aged
80 and over
Chemotherapy
business.industry
organic chemicals
Incidence (epidemiology)
Middle Aged
medicine.disease
Interim analysis
Prostatic Neoplasms
Castration-Resistant
chemistry
030220 oncology & carcinogenesis
Urological cancers Radboud Institute for Health Sciences [Radboudumc 15]
Early Termination of Clinical Trials
Taxoids
Neoplasm Recurrence
Local
business
therapeutics
medicine.drug
Zdroj: European Journal of Cancer, 90, pp. 1-9
Bouman-Wammes, E W, van den Berg, H P, de Munck, L, Beeker, A, Smorenburg, C H, Vervenne, W L, Coenen, J L L M, Verheul, H M W, Gerritsen, W R & van den Eertwegh, A J M 2018, ' A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial ', European Journal of Cancer, vol. 90, pp. 1-9 . https://doi.org/10.1016/j.ejca.2017.11.021
European Journal of Cancer, 90, 1-9
European Journal of Cancer, 90, 1-9. Pergamon
European journal of cancer (Oxford, England, 90, 1-9. Elsevier Limited
ISSN: 0959-8049
DOI: 10.1016/j.ejca.2017.11.021
Popis: Background Docetaxel is standard first-line chemotherapy for patients with metastatic castration–resistant prostate carcinoma (mCRPC). Docetaxel re-challenge has never been tested in a prospective randomised controlled study. As some studies support the addition of carboplatin to docetaxel, we performed a phase II trial investigating the combination of docetaxel plus carboplatin versus docetaxel re-treatment in docetaxel pre-treated mCRPC patients. Methods Patients with mCRPC with a progression-free interval of ≥3 months after initial docetaxel treatment were randomised between docetaxel 75 mg/m2 or docetaxel 60 mg/m2 plus carboplatin AUC4. The primary end-point was progression-free survival (PFS; PSA/RECIST). Results Owing to insufficient recruitment, the study was discontinued early after inclusion of 75 patients (targeted 150) PFS and overall survival (OS) were comparable between both groups (median PFS 12.7 months (95% CI 9.9–17.5 months) with docetaxel monotherapy and 11.7 months (95% CI 8.5–21.0 months) with combination therapy (p = 0.98); OS 18.5 months (95% CI 11.8–24.5 months) versus 18.9 months (95% CI 16.0–23.7 months) (p = 0.79). An interim analysis (SEQTEST) showed that the null hypothesis could already be excepted, and no significant difference between both study arms was expected if inclusion would be completed. The incidence of grade 3–4 infections and gastrointestinal side-effects was numerical higher in the carboplatin arm (p = 0.056). Conclusion This early terminated study suggests no benefit from the addition of carboplatin to docetaxel re-treatment in patients with mCRPC, whereas the combination resulted in more toxicity. Re-treatment with docetaxel monotherapy appears to be feasible, save and effective for patients with mCRPC and an initial good response to docetaxel. Trial registration NTR3070.
Databáze: OpenAIRE
Externí odkaz: