دورية أكاديمية
أعرض في EDS

Intermittent versus continuous androgen deprivation in prostate cancer.

التفاصيل البيبلوغرافية
العنوان: Intermittent versus continuous androgen deprivation in prostate cancer.
المؤلفون: Hussain M; University of Michigan, Division of Hematology/Oncology, 1500 E Medical Center Dr., 7314 CC, Ann Arbor, MI 48109-0946, USA. mahahuss@umich.edu, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr
المصدر: The New England journal of medicine [N Engl J Med] 2013 Apr 04; Vol. 368 (14), pp. 1314-25.
نوع المنشور: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Boston, Massachusetts Medical Society.
مواضيع طبية MeSH: Quality of Life*, Androgen Antagonists/*administration & dosage , Anilides/*administration & dosage , Gonadotropin-Releasing Hormone/*analogs & derivatives , Goserelin/*administration & dosage , Nitriles/*administration & dosage , Prostatic Neoplasms/*drug therapy , Tosyl Compounds/*administration & dosage, Aged ; Anilides/adverse effects ; Antineoplastic Agents, Hormonal/administration & dosage ; Antineoplastic Agents, Hormonal/adverse effects ; Confidence Intervals ; Drug Administration Schedule ; Follow-Up Studies ; Gonadotropin-Releasing Hormone/therapeutic use ; Goserelin/adverse effects ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis/drug therapy ; Nitriles/adverse effects ; Penile Erection/drug effects ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms/mortality ; Prostatic Neoplasms/pathology ; Survival Analysis ; Tosyl Compounds/adverse effects
مستخلص: Background: Castration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.
Methods: Men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.
Results: A total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.
Conclusions: Our findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.).
التعليقات: Comment in: Nat Rev Clin Oncol. 2013 Jun;10(6):307-8. doi: 10.1038/nrclinonc.2013.78. (PMID: 23648827)
Comment in: Asian J Androl. 2013 Jul;15(4):445-6. doi: 10.1038/aja.2013.57. (PMID: 23685907)
Comment in: Eur Urol. 2013 Dec;64(6):1014-5. doi: 10.1016/j.eururo.2013.09.031. (PMID: 24209449)
Comment in: J Urol. 2013 Dec;190(6):2093-4. doi: 10.1016/j.juro.2013.08.102. (PMID: 24209518)
Comment in: Urol Oncol. 2013 Nov;31(8):1847. doi: 10.1016/j.urolonc.2013.07.020. (PMID: 24210086)
Comment in: Aktuelle Urol. 2014 May;45(3):180-1. doi: 10.1055/s-0034-1383482. (PMID: 24932555)
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معلومات مُعتمدة: N01 CA004919 United States CA NCI NIH HHS; CA22433 United States CA NCI NIH HHS; U10 CA014028 United States CA NCI NIH HHS; CCSRI 015469 United States PHS HHS; U10 CA032102 United States CA NCI NIH HHS; U10 CA046368 United States CA NCI NIH HHS; U10 CA035176 United States CA NCI NIH HHS; U10 CA063844 United States CA NCI NIH HHS; CA63848 United States CA NCI NIH HHS; CA86780 United States CA NCI NIH HHS; CA37981 United States CA NCI NIH HHS; U10 CA022433 United States CA NCI NIH HHS; CA58416 United States CA NCI NIH HHS; U10 CA027057 United States CA NCI NIH HHS; N01 CA035176 United States CA NCI NIH HHS; U10 CA012644 United States CA NCI NIH HHS; CA46136 United States CA NCI NIH HHS; CA35261 United States CA NCI NIH HHS; U10 CA037981 United States CA NCI NIH HHS; U10 CA004919 United States CA NCI NIH HHS; N01 CA035431 United States CA NCI NIH HHS; CA55582 United States CA NCI NIH HHS; U10 CA046113 United States CA NCI NIH HHS; U10 CA045560 United States CA NCI NIH HHS; CA12644 United States CA NCI NIH HHS; CA20319 United States CA NCI NIH HHS; U10 CA076447 United States CA NCI NIH HHS; U10 CA128567 United States CA NCI NIH HHS; N01 CA032102 United States CA NCI NIH HHS; U10 CA035192 United States CA NCI NIH HHS; U10 CA077202 United States CA NCI NIH HHS; U10 CA021115 United States CA NCI NIH HHS; U10 CA180835 United States CA NCI NIH HHS; U10 CA058416 United States CA NCI NIH HHS; CA68183 United States CA NCI NIH HHS; CA35281 United States CA NCI NIH HHS; P30 CA014520 United States CA NCI NIH HHS; N01 CA045807 United States CA NCI NIH HHS; CA128567 United States CA NCI NIH HHS; N01 CA046441 United States CA NCI NIH HHS; U10 CA063848 United States CA NCI NIH HHS; CA14028 United States CA NCI NIH HHS; U10 CA035281 United States CA NCI NIH HHS; CA11083 United States CA NCI NIH HHS; CA58861 United States CA NCI NIH HHS; CA46282 United States CA NCI NIH HHS; CA76132 United States CA NCI NIH HHS; N01 CA063844 United States CA NCI NIH HHS; U10 CA035261 United States CA NCI NIH HHS; U10 CA035178 United States CA NCI NIH HHS; CA31949 United States CA NCI NIH HHS; U10 CA037403 United States CA NCI NIH HHS; CA76447 United States CA NCI NIH HHS; U10 CA046282 United States CA NCI NIH HHS; N01 CA035178 United States CA NCI NIH HHS; CA46368 United States CA NCI NIH HHS; CA67663 United States CA NCI NIH HHS; N01 CA038926 United States CA NCI NIH HHS; U10 CA067575 United States CA NCI NIH HHS; N01 CA027057 United States CA NCI NIH HHS; CA77202 United States CA NCI NIH HHS; U10 CA058686 United States CA NCI NIH HHS; U10 CA046441 United States CA NCI NIH HHS; CA35192 United States CA NCI NIH HHS; U10 CA020319 United States CA NCI NIH HHS; CA46113 United States CA NCI NIH HHS; U10 CA038926 United States CA NCI NIH HHS; CA58686 United States CA NCI NIH HHS; U10 CA086780 United States CA NCI NIH HHS; U10 CA042777 United States CA NCI NIH HHS; U10 CA035431 United States CA NCI NIH HHS; U10 CA095860 United States CA NCI NIH HHS; CA42777 United States CA NCI NIH HHS; U10 CA011083 United States CA NCI NIH HHS; CA21115 United States CA NCI NIH HHS; N01 CA067575 United States CA NCI NIH HHS; U10 CA067663 United States CA NCI NIH HHS; CA95860 United States CA NCI NIH HHS; U10 CA058861 United States CA NCI NIH HHS; U10 CA045807 United States CA NCI NIH HHS; U10 CA068183 United States CA NCI NIH HHS; N01 CA045560 United States CA NCI NIH HHS
سلسلة جزيئية: ClinicalTrials.gov NCT00002651
المشرفين على المادة: 0 (Androgen Antagonists)
0 (Anilides)
0 (Antineoplastic Agents, Hormonal)
0 (Nitriles)
0 (Tosyl Compounds)
0F65R8P09N (Goserelin)
33515-09-2 (Gonadotropin-Releasing Hormone)
A0Z3NAU9DP (bicalutamide)
EC 3.4.21.77 (Prostate-Specific Antigen)
تواريخ الأحداث: Date Created: 20130405 Date Completed: 20130411 Latest Revision: 20240610
رمز التحديث: 20240610
مُعرف محوري في PubMed: PMC3682658
DOI: 10.1056/NEJMoa1212299
PMID: 23550669
قاعدة البيانات: MEDLINE
الوصف
تدمد:1533-4406
DOI:10.1056/NEJMoa1212299