卡巴齐塔塞尔
多西紫杉醇
医学
紫杉烷
前列腺癌
恩扎鲁胺
临床终点
肿瘤科
内科学
不利影响
随机对照试验
化疗
癌症
雄激素剥夺疗法
乳腺癌
雄激素受体
作者
Giulia Baciarello,R. Delva,Gwénaëlle Gravis,Youssef Tazi,Philippe Beuzeboc,Marine Gross‐Goupil,Emmanuelle Bompas,Florence Joly,Charlotte Greilsamer,Thierry Nguyen Tan Hon,Philippe Barthélémy,Stéphane Culine,Jean François Berdah,Mathilde Deblock,Raffaele Ratta,Aude Fléchon,Caroline Cheneau,Aline Maillard,Géraldine Martineau,Isabelle Borget,Karim Fizazi,Groupe d’Etude des Tumeurs Uro-Genitales .
标识
DOI:10.1016/j.eururo.2021.10.016
摘要
The taxanes docetaxel and cabazitaxel prolong overall survival for men with metastatic castration-resistant prostate cancer (mCRPC), with cabazitaxel approved in the postdocetaxel setting only. Recent data suggest they have similar efficacy but a different safety profile in the first-line mCRPC setting.To assess patient preference between docetaxel and cabazitaxel among men who received one or more doses of each taxane and did not experience progression after the first taxane.Chemotherapy-naïve patients with mCRPC were randomized 1:1 to receive docetaxel (75 mg/m2 every 3 wk × 4 cycles) followed by cabazitaxel (25 mg/m2 every 3 wk × 4 cycles) or the reverse sequence. Randomization was stratified by prior abiraterone or enzalutamide use.The primary endpoint was patient preference, assessed via a dedicated questionnaire after the second taxane. Secondary endpoints included reasons for patient preference, prostate-specific antigen response, radiological progression-free survival, and overall survival. This clinical trial is registered at ClinicalTrials.gov as NCT02044354.Of 195 men randomized, 152 met the prespecified modified intent-to-treat criteria for analysis. Overall, 66 patients (43%) preferred cabazitaxel, 40 (27%) preferred docetaxel, and 46 (30%) had no preference (p = 0.004, adjusted for treatment period effect). More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%). Patient preference for cabazitaxel was mainly related to less fatigue (72%), better quality of life (64%), and other adverse events (hair loss, pain, nail disorders, edema). Adverse events were consistent with the known safety profile of each drug.A significantly higher proportion of chemotherapy-naïve men with mCRPC who received both taxanes preferred cabazitaxel over docetaxel. Less fatigue and better quality of life were the two main reasons driving patient choice.Men with metastatic castration-resistant prostate cancer preferred cabazitaxel over docetaxel for chemotherapy, mainly because of less fatigue and better quality of life.
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