Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy A Randomized Clinical Trial

被引:27
作者
Oudard, Stephane [1 ]
Latorzeff, Igor [2 ]
Caty, Armelle [3 ]
Miglianico, Laurent [4 ]
Sevin, Emmanuel [5 ]
Hardy-Bessard, Anne Claire [6 ]
Delva, Remy [7 ]
Rolland, Frederic [8 ]
Mouret, Loic [9 ]
Priou, Franck [10 ]
Beuzeboc, Philippe [11 ]
Gravis, Gwenaelle [12 ]
Linassier, Claude [13 ]
Gomez, Philippe [14 ]
Voog, Eric [15 ]
Muracciole, Xavier [16 ]
Abraham, Christine [17 ]
Banu, Eugeniu [18 ]
Ferrero, Jean-Marc [19 ]
Ravaud, Alain [20 ]
Krakowski, Ivan [21 ]
Lagrange, Jean-Leon [22 ]
Deplanque, Gael [23 ]
Zylberait, David [24 ]
Bozec, Laurence [25 ]
Houede, Nadine [26 ]
Culine, Stephane [27 ]
Elaidi, Reza [28 ]
机构
[1] Hop Europeen Georges Pompidou, Dept Med Oncol, Paris, France
[2] Clin Pasteur, Dept Oncol Radiotherapy, Toulouse, France
[3] Hop Prive Louviere, Dept Med Oncol, Ctr Galilee, Lille, France
[4] Ctr Hosp Prive St Gregoire, Dept Oncol Radiotherapy, Rennes, France
[5] Ctr Francois Baclesse, Dept Med Oncol, Caen, France
[6] Hop Prive Cotes Armor, Dept Med Oncol, Plerin, France
[7] Inst Cancerol Ouest, Dept Med Oncol, Angers, France
[8] Inst Cancerol Ouest, Dept Med Oncol, St Herblain, France
[9] Inst Univ Canc Toulouse Oncopole, Dept Med Oncol, Toulouse, France
[10] Ctr Hosp Vendee, Dept Med Oncol, La Roche Sur Yon, France
[11] Inst Curie, Dept Med Oncol, Paris, France
[12] Inst Paoli Calmettes, Dept Med Oncol, Marseille, France
[13] Ctr Hosp Bretonneau, Dept Med Oncol, Tours, France
[14] Ctr Joliot Curie, Dept Oncol Radiotherapy, Rouen, France
[15] Inst Interreg Cancerol, Clin Victor Hugo, Dept Med Oncol, Le Mans, France
[16] Hop La Timone, Dept Oncol Radiotherapy, Marseille, France
[17] Ctr Hosp Versailles Andre Mignot, Dept Med Oncol, Le Chesnay, France
[18] Canc Inst Ion Chiricuta, Dept Med Oncol, Cluj Napoca, Romania
[19] Ctr Antoine Lacassagne, Dept Med Oncol, Nice, France
[20] Hop St Andre, Dept Med Oncol, Bordeaux, France
[21] Ctr Alexis Vautrin, Dept Med Oncol, Vandoeuvre Les Nancy, France
[22] Hop Henri Mondor, Dept Med Oncol, Creteil, France
[23] Fdn Hop St Joseph, Dept Med Oncol, Paris, France
[24] Ctr Hosp Compiegne, Dept Med Oncol, Compiegne, France
[25] Hop Foch, Dept Med Oncol, Suresnes, France
[26] Inst Bergonie, Dept Med Oncol, Bordeaux, France
[27] Hop St Louis, Dept Med Oncol, Paris, France
[28] Assoc Rech Therapeut Innovantes Cancerol, Paris, France
关键词
NATURAL-HISTORY; PROGRESSION; RECURRENCE; MEN;
D O I
10.1001/jamaoncol.2018.6607
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
IMPORTANCE Androgen-deprivation therapy (ADT) plus docetaxel is the standard of care in hormone-naive metastatic prostate cancer but is of uncertain benefit in a nonmetastatic, high-risk prostate cancer setting. OBJECTIVE To assess the benefit of ADT plus docetaxel in patients presenting with rising prostate-specific antigen (PSA) levels after primary local therapy and high-risk factors but no evidence of metastatic disease. DESIGN. SETTING. AND PARTICIPANTS This open-label, phase 3, randomized superiority trial comparing ADT plus docetaxel vs ADT alone enrolled patients from 28 centers in France between June 4, 20 03, and September 25, 2007; final follow-up was conducted April 12, 2017, and analysis was performed May 2 to July 31, 2017. Patients had undergone primary local therapy for prostate cancer, were experiencing rising PSA levels, and were considered to be at high risk of metastatic disease. Stratification was by prior local therapy and PSA-level doubling time (<6 vs >6 months), and intention-to-treat analysis was used. INTERVENTIONS Patients were randomly assigned to receive ADT (lyear) plus docetaxel, 70 mg/m2 (every 3 weeks [6 cyclesp, or ADT alone (lyear). MAIN OUTCOMES AND MEASURES The primary outcome was PSA progression-free survival (PSA-PFS). Secondary end points were PSA response, radiologic PFS, overall survival, safety, and quality of life. RESULTS Overall, 254 patients were randomized (1:1) to the trial; median age, 64 years in the ADT plus docetaxel arm, 66 years in the ADT alone arm. At a median follow-up of 30.0 months, the median PSA-PFS was 20.3 (95% CI, 19.0-21.6) months in the ADT plus docetaxel arm vs 19.3 (95% CI, 18.2-20.8) months in the ADT alone arm (hazard ratio [HR], 0.85; 95% Cl, 0.62-1.16; P =.31). At a median follow-up of 10.5 years, there was no significant between-arm difference in radiologic PFS (HR, 1.03; 95% CI, 0.74-1.43; P =.88). Overall survival data were not mature. The most common grade 3 or 4 hematologic toxic effects in the ADT plus docetaxel arm were neutropenia (60 of 125 patients [48.0%]), febrile neutropenia (10 [8.0%]), and thrombocytopenia (4 [3.0%]). There was no significant between-arm difference in overall quality of life. CONCLUSIONS ANC RELEVANCE Compared with ADT alone, combined ADT plus docetaxel therapy with curative intent did not significantly improve PSA-PFS in patients with high-risk prostate cancer and rising PSA levels and no evidence of metastatic disease.
引用
收藏
页码:623 / 632
页数:10
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