Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer

Autor: Amit Bahl, Dirk Boehmer, Laurence Collette, Emad Shash, Christopher D Scrase, Laurette Renard, John Armstrong, Alphonsus C.M. van den Bergh, Salvador Villà, Christian Carrie, Bradley R. Pieters, Corneel Coens, Jean-François Bosset, Fernanda G. Herrera, Philippe Maingon, Santhanam Sundar, P. Kitsios, Elzbieta van der Steen-Banasik, Michel Bolla, Annerie Slot, Philip Poortmans, Rahamim Ben-Yosef
Přispěvatelé: Guided Treatment in Optimal Selected Cancer Patients (GUTS)
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Adult
Male
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
DURATION
030232 urology & nephrology
Urology
Androgen suppression
THERAPY
law.invention
03 medical and health sciences
Prostate cancer
0302 clinical medicine
Randomized controlled trial
Prostate
law
QUALITY-OF-LIFE
Clinical endpoint
Medicine
Humans
DEPRIVATION
RTOG
Aged
Gynecology
Aged
80 and over
business.industry
Cancer
Prostatic Neoplasms
Androgen Antagonists
Radiotherapy Dosage
PHASE-III TRIAL
Middle Aged
Prostate-Specific Antigen
RANDOMIZED CONTROLLED-TRIAL
medicine.disease
ONCOLOGY
Combined Modality Therapy
Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Radiation therapy
Prostate-specific antigen
medicine.anatomical_structure
Androgen Antagonists/therapeutic use
Prostate-Specific Antigen/blood
Prostatic Neoplasms/mortality
Prostatic Neoplasms/therapy
030220 oncology & carcinogenesis
business
RADIOTHERAPY
Zdroj: Journal of Clinical Oncology, 34, 15, pp. 1748-56
Journal of Clinical Oncology, 34(15), 1748-1756. AMER SOC CLINICAL ONCOLOGY
Journal of clinical oncology, vol. 34, no. 15, pp. 1748-1756
Journal of Clinical Oncology, 34, 1748-56
ISSN: 0732-183X
DOI: 10.1200/jco.2015.64.8055
Popis: Purpose Up to 30% of patients who undergo radiation for intermediate- or high-risk localized prostate cancer relapse biochemically within 5 years. We assessed if biochemical disease-free survival (DFS) is improved by adding 6 months of androgen suppression (AS; two injections of every-3-months depot of luteinizing hormone–releasing hormone agonist) to primary radiotherapy (RT) for intermediate- or high-risk localized prostate cancer. Patients and Methods A total of 819 patients staged: (1) cT1b-c, with prostate-specific antigen (PSA) ≥ 10 ng/mL or Gleason ≥ 7, or (2) cT2a (International Union Against Cancer TNM 1997), with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread, with PSA ≤ 50 ng/mL, were centrally randomized 1:1 to either RT or RT plus AS started on day 1 of RT. Centers opted for one dose (70, 74, or 78 Gy). Biochemical DFS, the primary end point, was defined from entry until PSA relapse (Phoenix criteria) and clinical relapse by imaging or death of any cause. The trial had 80% power to detect hazard ratio (HR), 0.714 by intent-to-treat analysis stratified by dose of RT at the two-sided α = 5%. Results The median patient age was 70 years. Among patients, 74.8% were intermediate risk and 24.8% were high risk. In the RT arm, 407 of 409 patients received RT; in the RT plus AS arm, 403 patients received RT plus AS and three patients received RT only. At 7.2 years median follow-up, RT plus AS significantly improved biochemical DFS (HR, 0.52; 95% CI, 0.41 to 0.66; P < .001, with 319 events), as well as clinical progression-free survival (205 events, HR, 0.63; 95% CI, 0.48 to 0.84; P = .001). In exploratory analysis, no statistically significant interaction between treatment effect and dose of RT could be evidenced (heterogeneity P = .79 and P = .66, for biochemical DFS and progression-free survival, respectively). Overall survival data are not mature yet. Conclusion Six months of concomitant and adjuvant AS improves biochemical and clinical DFS of intermediate- and high-risk cT1b-c to cT2a (with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread) prostatic carcinoma, treated by radiation.
Databáze: OpenAIRE
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