ASCO 2019: Final Results from the Randomized CABADOC Trial: Patient Preference between Cabazitaxel and Docetaxel for First-Line Chemotherapy in mCRPC

Chicago, IL (UroToday.com) Docetaxel and cabazitaxel now represent the standard of care in men with metastatic castration-resistant prostate cancer (mCRPC) with similar efficacy reported in the metastatic first-line setting in the FIRSTANA phase 3 trial.1 In FIRSTANA, 1,168 patients with mCRPC and ECOG PS 0 to 2 were randomly assigned 1:1:1 to receive cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2, or docetaxel 75 mg/mIV every 3 weeks plus daily prednisone. The median overall survival (OS) was 24.5 months with cabazitaxel 20 mg/m2, 25.2 months with cabazitaxel 25 mg/m2, and 24.3 months with docetaxel 75 mg/m2. The hazard ratio (HR) for cabazitaxel 20 mg/m2 versus docetaxel 75 mg/mwas 1.01 (95% CI 0.85-1.20), and the HR for cabazitaxel 25 mg/m2 versus docetaxel 75 mg/m2was 0.97 (95% CI 0.82-1.16). The median progression-free survival (PFS) was 4.4 months with cabazitaxel 20 mg/m2, 5.1 months with cabazitaxel 25 mg/m2, and 5.3 months with docetaxel 75 mg/m2, with no significant differences between treatment arms. This trial concluded that cabazitaxel 20 mg/mand cabazitaxel 25 mg/mdid not demonstrate superiority for OS compared to docetaxel 75 mg/min patients with chemotherapy naïve mCRPC. At the ASCO 2019 prostate cancer session, Dr. Giulia Baciarello and colleagues presented results of their work assessing patient preference between the two taxanes. 

For CABADOC, patients with taxane-naïve mCRPC were randomized 1:1 ratio to receive either docetaxel 75mg/mevery three weeks for four cycles followed by cabazitaxel 25mg/mevery three weeks for four cycles (DO-CA), or the reverse sequence (CA-DO). Randomization was stratified based on prior next generation AR axis inhibitors use. The primary endpoint was patient preference between taxanes, as assessed by questionnaires in patients who had received at least one cycle of each taxane and who had not experienced a progression while on the first taxane.  

From June 2014 to October 2016, 195 men were randomized in 17 centers, of which 152 patients were evaluable. After adjusting for the treatment period effect, more patients preferred cabazitaxel (43%) vs docetaxel (27%) (p < 0.004), whereas 30% had no preference between taxanes. 

ASCO2019_CABADOC_Preference.png

Fatigue, patient-defined quality of life, hair loss, and pain were the most common factors influencing patient preference. Febrile neutropenia was experienced by 5 (7.1%) men treated with cabazitaxel during the first period who received G-CSF and by 2 (7.1%) of those who did not. No febrile neutropenia was reported with docetaxel in both arms and with cabazitaxel during the second period, irrespectively of the use of G-CSF. The incidence of diarrhea during the first 3-month period was slightly reduced with G-CSF use in men receiving cabazitaxel (32.1% vs 24.3%) but not in those receiving docetaxel (23.8% vs 25%). The median progression-free survival was 9.8 months in the DO-CA arm and 9.3 months in the CA-DO arm (log-rank p=0.74). The median overall survival was also similar in the two groups: 22.6 months in the DO-CA arm and 20.7 months in the CA-DO arm (log-rank p=0.63). 

Dr. Baciarello’s conclusion for this study was that although cabazitaxel and docetaxel have similar efficacy when used as first-line in mCRPC men, more patients prefer cabazitaxel. 

Clinical trial information: NCT02044354

Presented by: Giulia Baciarello, Gustave Roussy Cancer Campus, Paris-Sud University, France, Villejuif, France

Co-Authors: Remy Delva, Gwenaelle Gravis, Youssef Tazi, Christine Theodore, Marine Gross-Goupil, Emmanuelle Bompas, Florence Joly, Tifenn Lharidon, Thierry Nguyen Tan Hon, Philippe Barthelemy, Stephane Culine, Jean Francois Berdah, Mathilde Deblock, Philippe Beuzeboc, Aude Flechon, Caroline Cheneau, Geraldine Martineau, Isabelle Borget, Karim Fizazi; Department of Cancer Medicine, Gustave Roussy Cancer Campus, Paris-Sud University, France, Villejuif, France; Institut de Cancerologie de l'Ouest, Angers, France; Medical Oncology, Institut Paoli-Calmettes, Marseille, France; Institut Gustave Roussy, Villejuif, France; Hospital Foch, Suresnes, France; Oncology Department, Centre Hospitalier Universitaire Saint-Andre, Bordeaux, France; Centre René Gauducheau, Nantes, France; GINECO and Regional Centre Control Against Cancer Francois Baclesse, Caen, France; GINECO-Centre Hospitalier Départemental Vendée Les Oudairies, La Roche-Sur-Yon, France; Hopital Jean Minjoz, Besancon, France; Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Hospital Saint-Louis, Paris, France; Clinique Sainte Marguerite, Hyères, France; Institut de Cancerologie de Lorraine, VandœUvre-Les-Nancy, France; Foch Hospital, Suresnes, France; Centre Léon Bérard, Lyon, France; C.H.U. Brest, Brest, France; Clinical Research Department, Institut Gustave Roussy, Villejuif, France; Gustave Roussy, Department of Biostatistics and Epidemiology, University Paris-Saclay, Univ. Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France, Villejuif, France

Written by: Zachary Klaassen, MD, MSc, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md at the 2019 ASCO Annual Meeting #ASCO19, May 31- June 4, 2019, Chicago, IL USA

References:
  1. Oudard S, Fizazi K, Sengelov L, et al. Cabazitaxel versus Docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: A randomized phase III Trial-FIRSTANA. J Clin Oncol 2017;35(28):3189-3197.
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