Daily versus weekly prostate cancer image-guided radiotherapy Phase 3 multicenter randomized trial
| Autor: | P. Dudouet, Xavier Muracciole, Gilles Créhange, Véronique Beckendorf, Jean Léon Lagrange, Jean-Marc Bachaud, Alberto Bossi, Mohamed Amine Bayar, Bruno Chauvet, Stéphane Supiot, Agnès Laplanche, Igor Latorzeff, Françoise Pene, Tan-Dat Nguyen, Renaud de Crevoisier, Pascal Pommier |
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| Přispěvatelé: | Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), CRLCC Eugène Marquis (CRLCC), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Centre Léon Bérard [Lyon], Institut Claudius Regaud, Institut Gustave Roussy (IGR), CRLCC René Gauducheau, Département de radiothérapie [Gustave Roussy], Institut National Du Cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Time Factors medicine.medical_treatment Urology 030218 nuclear medicine & medical imaging law.invention 03 medical and health sciences Prostate cancer 0302 clinical medicine Randomized controlled trial law Prostate medicine Humans Radiology Nuclear Medicine and imaging Survival analysis Aged Radiation business.industry Hazard ratio Prostatic Neoplasms medicine.disease Survival Analysis Confidence interval 3. Good health Clinical trial Radiation therapy medicine.anatomical_structure Treatment Outcome Oncology 030220 oncology & carcinogenesis [SDV.IB]Life Sciences [q-bio]/Bioengineering Safety business Radiotherapy Image-Guided |
| Zdroj: | International Journal of Radiation Oncology, Biology, Physics International Journal of Radiation Oncology, Biology, Physics, 2018, 102 (5), pp.1420-1429. ⟨10.1016/j.ijrobp.2018.07.2006⟩ International Journal of Radiation Oncology-Biology-Physics International Journal of Radiation Oncology-Biology-Physics, Elsevier, 2018, 102 (5), pp.1420-1429. ⟨10.1016/j.ijrobp.2018.07.2006⟩ |
| ISSN: | 0360-3016 1879-355X |
| DOI: | 10.1016/j.ijrobp.2018.07.2006⟩ |
| Popis: | International audience; 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. |
| Databáze: | OpenAIRE |
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