Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial

Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therap...

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Vydáno v:Journal of clinical oncology Ročník 35; číslo 14; s. 1530
Hlavní autoři: Mason, Malcolm D, Clarke, Noel W, James, Nicholas D, Dearnaley, David P, Spears, Melissa R, Ritchie, Alastair W S, Attard, Gerhardt, Cross, William, Jones, Rob J, Parker, Christopher C, Russell, J Martin, Thalmann, George N, Schiavone, Francesca, Cassoly, Estelle, Matheson, David, Millman, Robin, Rentsch, Cyrill A, Barber, Jim, Gilson, Clare, Ibrahim, Azman, Logue, John, Lydon, Anna, Nikapota, Ashok D, O'Sullivan, Joe M, Porfiri, Emilio, Protheroe, Andrew, Srihari, Narayanan Nair, Tsang, David, Wagstaff, John, Wallace, Jan, Walmsley, Catherine, Parmar, Mahesh K B, Sydes, Matthew R
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 10.05.2017
Témata:
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cause of Death
Celecoxib - administration & dosage
Diphosphonates - administration & dosage
Disease-Free Survival
Early Termination of Clinical Trials
Follow-Up Studies
Gonadotropin-Releasing Hormone - agonists
Gonadotropin-Releasing Hormone - antagonists & inhibitors
Humans
Imidazoles - administration & dosage
Lymphatic Metastasis
Male
Middle Aged
Orchiectomy
Proportional Hazards Models
Prostate-Specific Antigen - blood
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - pathology
Prostatic Neoplasms - surgery
Survival Rate
Time Factors
Zoledronic Acid
ISSN:1527-7755, 1527-7755
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Shrnutí:Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. Results A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. Conclusion These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies.
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2016.69.0677