Daily Versus Weekly Prostate Cancer Image Guided Radiation Therapy: Phase 3 Multicenter Randomized Trial

被引:84
作者
de Crevoisier, Renaud [1 ]
Bayar, Mohamed Amine [2 ,3 ]
Pommier, Pascal [4 ]
Muracciole, Xavier [5 ]
Pene, Francoise [6 ,7 ]
Dudouet, Philippe [8 ]
Latorzeff, Igor [9 ]
Beckendorf, Veronique [10 ]
Bachaud, Jean-Marc [11 ]
Laplanche, Agnes [2 ]
Supiot, Stephane [12 ]
Chauvet, Bruno [13 ]
Tan-Dat Nguyen [14 ]
Bossi, Alberto [15 ]
Crehange, Gilles [16 ]
Lagrange, Jean Leon [17 ]
机构
[1] LTSI INSERM 1099, Dept Radiotherapy, Ctr Eugene Marquis, Rennes, France
[2] Gustave Roussy Inst, Dept Biostat, Villejuif, France
[3] Univ Paris Saclay, CESP, Fac Med, Univ Paris Sud,UVSQ,INSERM, Villejuif, France
[4] Leon Berard Canc Ctr, Dept Radiotherapy, Lyon, France
[5] Timone Hosp, Dept Radiotherapy, Marseille, France
[6] Tenon Hosp, Dept Radiotherapy, Paris, France
[7] Clin Hartmann, Levallois Perret, France
[8] Clin Pont Chaume Clin, Dept Radiotherapy, Montauban, France
[9] Clin Pasteur, Dept Radiotherapy, Toulouse, France
[10] Alexis Vautrin Ctr, Dept Radiotherapy, Vandoeuvre Les Nancy, France
[11] Inst Claudius Regaud, Dept Radiotherapy, Toulouse, France
[12] Inst Cancerol Ouest, Dept Radiotherapy, St Herblain, France
[13] St Catherine Inst, Dept Radiotherapy, Avignon, France
[14] Jean Godinot Inst, Dept Radiotherapy, Reims, France
[15] Gustave Roussy Inst, Dept Radiotherapy, Villejuif, France
[16] Georges Francois Leclerc Ctr, Dept Radiotherapy, Dijon, France
[17] UPEC Creteil, Dept Radiotherapy, Henri Mondor Hosp, APHP, Creteil, France
来源
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2018年 / 102卷 / 05期
关键词
CONFORMAL RADIOTHERAPY; RADICAL PROSTATECTOMY; INCREASED RISK; TOXICITY; FAILURE; MARGINS; MALIGNANCIES; GUIDANCE; OUTCOMES; RECTUM;
D O I
10.1016/j.ijrobp.2018.07.2006
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: The optimal frequency of prostate cancer image guided radiation therapy (IGRT) has not yet been clearly identified. This study sought to compare the safety and efficacy of daily versus weekly IGRT. Materials and Methods: This phase 3 randomized trial recruited patients with N0 localized prostate cancer. The total IGRT doses in the prostate ranged from 70 Gy to 80 Gy, sparing the lymph nodes. Patients were randomly assigned (1: 1) to 2 prostate IGRT frequency groups: daily and weekly (ie, on days 1, 2, and 3 and then weekly). The primary outcome was 5-year recurrence-free survival. Secondary outcomes included overall survival and toxicity. Post hoc analyses included biochemical progression-free interval, clinical progression-free interval, and other cancer-free interval. Results: Between June 2007 and November 2012, 470 men from 21 centers were randomized into the 2 groups. Median follow-up was 4.1 years. There was no statistically significant difference in recurrence-free survival between the groups (hazard ratio [HR]=0.81; P=.330). Overall survival was worse in the daily group than in the weekly group (HR=2.12 [95% confidence interval (CI), 1.03-4.37]; P=.042). Acute rectal bleeding (grade >= 1) was significantly lower in the daily group (6%) (n=14) than in the weekly group (11%) (n=26) (P=.014). Late rectal toxicity (grade >= 1) was significantly lower in the daily group (HR=0.71 [95% CI, 0.53-0.96]; P=.027). Biochemical progression-free interval (HR=0.45 [95% CI, 0.25 - 0.80]; P=.007) and clinical progression-free interval (HR=0.50 [95% CI, 0.24-1.02]; P=.057) were better in the daily group, whereas other cancer-free interval was worse in the daily group (HR=2.21 [95% CI, 1.10-4.44]; P=.026). Conclusions: Compared with weekly control, daily IGRT control in prostate cancer significantly improves biochemical progression-free and clinical progression-free interval, and rectal toxicity. (C) 2018 Elsevier Inc. All rights reserved.
引用
收藏
页码:1420 / 1429
页数:10
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