Renaud de Crevoisier1, Mohamed Amine Bayar2, Pascal Pommier3, Xavier Muracciole4, Françoise Pêne5, Philippe Dudouet6, Igor Latorzeff7, Véronique Beckendorf8, Jean-Marc Bachaud9, Agnès Laplanche10, Stéphane Supiot11, Bruno Chauvet12, Tan-Dat Nguyen13, Alberto Bossi14, Gilles Créhange15, Jean Léon Lagrange16. 1. Department of Radiotherapy, Centre Eugène Marquis, LTSI INSERM 1099, Rennes, France. Electronic address: r.de-crevoisier@rennes.unicancer.fr. 2. Department of Biostatistics, Gustave-Roussy Institute, Villejuif, France; CESP, Faculté de médecine, Université Paris-Sud, Faculté de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, France. 3. Department of Radiotherapy, Léon Bérard Cancer Center, Lyon, France. 4. Department of Radiotherapy, de la Timone Hospital, Marseille, France. 5. Department of Radiotherapy, Tenon Hospital, Paris, France; Clinique Hartmann, Levallois-Perret, France. 6. Department of Radiotherapy, Clinique du Pont de Chaume Clinic, Montauban, France. 7. Department of Radiotherapy, Clinique Pasteur, Toulouse, France. 8. Department of Radiotherapy, Alexis Vautrin Center, Vandoeuvre les Nancy, France. 9. Department of Radiotherapy, Institut Claudius Regaud, Toulouse, France. 10. Department of Biostatistics, Gustave-Roussy Institute, Villejuif, France. 11. Department of Radiotherapy, Institut de Cancérologie de l'Ouest, Saint Herblain, France. 12. Department of Radiotherapy, Sainte Catherine Institute, Avignon, France. 13. Department of Radiotherapy, Jean-Godinot Institute, Reims, France. 14. Department of Radiotherapy, Gustave-Roussy Institute, Villejuif, France. 15. Department of Radiotherapy, Georges-François Leclerc Center, Dijon, France. 16. Department of Radiotherapy, APHP Henri Mondor Hospital, UPEC Créteil, France.
Abstract
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.
RCT Entities:
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.
Authors: Paul J Keall; Caterina Brighi; Carri Glide-Hurst; Gary Liney; Paul Z Y Liu; Suzanne Lydiard; Chiara Paganelli; Trang Pham; Shanshan Shan; Alison C Tree; Uulke A van der Heide; David E J Waddington; Brendan Whelan Journal: Nat Rev Clin Oncol Date: 2022-04-19 Impact factor: 65.011
Authors: G M Walls; C Lyons; L J Jellett; R Evans; A Bedair; D Brady; L M McLaughlin; E Reilly; A Reilly; J J McAleer; D P Stewart Journal: Ulster Med J Date: 2019-04-27