Generated Narrative: PublicationRecord 179613 version: 20; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/179613 identifier: FEvIR Object Identifier/179613, https://pubmed.ncbi.nlm.nih.gov/27308831 title: 27308831 Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis. status: Active author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2017-07-26 lastReviewDate: 2024-03-27 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of epublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2016-04-01 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2016-06-02 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2016-06-17 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2016-06-17 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2017-07-27 06:00:00+0000 statusDate activity: PubMed Pubstatus of PMC release period: ?? --> 2016-06-16 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/27308831, https://www.ncbi.nlm.nih.gov/pmc//PMC4911003, https://doi.org/10.1371/journal.pone.0157660, pii/PONE-D-16-10077 Titles - Type Language Text * Primary title English Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis. Abstracts - Type Text * Primary human use OBJECTIVE: Prostate cancer is the most common nonskin cancer and second most common cause of cancer mortality in older men in the United States (USA) and Western Europe. Androgen-deprivation therapy alone (ADT) remains the first line of treatment in most cases, for metastatic disease. We performed a systematic review and meta-analysis of all randomized controlled trials (RCT) that compared the efficacy and adverse events profile of a chemohormonal therapy (ADT ± docetaxel) for metastatic hormone-naive prostate cancer (mHNPC). METHODS: Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoint was overall survival. Data extracted from the studies were combined by using the hazard ratio (HR) or risk ratio (RR) with their corresponding 95% confidence intervals (95% CI). RESULTS: The final analysis included 3 trials comprising 2,264 patients (mHNPC). Patients who received the chemohormonal therapy had a longer clinical progression-free survival interval (HR = 0.64; 95% CI: 0.55 to 0.75; p<0.00001), and no heterogeneity (Chi2 = 0.64; df = 1 [p = 0.42]; I2 = 0%). The biochemical progression-free survival (bPFS) also was higher in patients treated with ADT plus docetaxel (HR = 0.63; 95% CI: 0.57 to 0.69; p<0.00001), also with no heterogeneity noted (Chi2 = 0.48; df = 2 [p = 0.79]; I2 = 0%). Finally, the combination of ADT with docetaxel showed a superior overall survival (OS) compared with ADT alone (HR = 0.73; 95% CI: 0.64 to 0.84; p<0.0001), with moderate heterogeneity (Chi2 = 3.84; df = 2 [p = 0.15]; I2 = 48%). A random-effects model analysis was performed, and the results remained favorable to the use of ADT plus docetaxel (HR = 0.73; 95% CI: 0.60 to 0.89; p = 0.002). In the final combined analysis of the high-volume disease patients, the use of the combination therapy also favored an increased overall survival (HR = 0.67; 95% CI: 0.54 to 0.83; p = 0.0003). Regarding adverse events and severe toxicity (grade ≥3), the group receiving the combined therapy had higher rates of neutropenia, febrile neutropenia and fatigue. CONCLUSION: The combination of ADT with docetaxel improved the clinical progression-free survival, bPFS and OS of patients with mHNPC. A superior OS was seen especially for patients with metastatic and high-volume disease. This contemporary combination therapy may now be offered as a first-line treatment for selected patients. relatesTo type: Cites citation: http://clinicaltrials.gov/ct2/show/NCT00514540. relatesTo type: Cites classifier: Journal Article citation: Beltran H, Beer TM, Carducci MA, de Bono J, Gleave M, Hussain M, et al. New therapies for castration-resistant prostate cancer: efficacy and safety. 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The American Journal of Hematology/oncology 2015; 11(9):17–20 publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1932-6203, ISOAbbreviation/PLoS One, ISSN Linking/1932-6203, Medline Title Abbreviation/PLoS One, NLM Unique ID/101285081 title: PloS one publisherLocation: United States citedMedium: Internet volume: 11 issue: 6 articleDate: 2016 pageString: e0157660 publicationForm citedMedium: Internet without issue articleDate: 2016-06-16 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/27308831/ webLocation classifier: DOI Based url: https://doi.org/10.1371/journal.pone.0157660 classification type: Publishing Model classifier: Electronic-eCollection classification type: Chemical classifier: Androgen Antagonists, Antineoplastic Agents, Taxoids, Tubulin Modulators, Docetaxel classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Journal Article, Meta-Analysis, Review, Systematic Review classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC classification type: Citation subset classifier: IM contributorship complete: true entry contributor: Botrel TE forenameInitials: TE affiliation: Evidencias - A Kantar Health Company, Campinas, São Paulo, Brazil. Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Clark O forenameInitials: O affiliation: Evidencias - A Kantar Health Company, Campinas, São Paulo, Brazil. Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Lima Pompeo AC forenameInitials: AC affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Horta Bretas FF forenameInitials: FF affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Sadi MV forenameInitials: MV affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Ferreira U forenameInitials: U affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. entry contributor: Borges Dos Reis R forenameInitials: R affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia - CoBEU, São Paulo, São Paulo, Brazil. Generated Narrative: Practitioner #contributor0 name: Tobias Engel Ayer Botrel Generated Narrative: Practitioner #contributor1 name: Otávio Clark Generated Narrative: Practitioner #contributor2 name: Antônio Carlos Lima Pompeo Generated Narrative: Practitioner #contributor3 name: Francisco Flávio Horta Bretas Generated Narrative: Practitioner #contributor4 name: Marcus Vinicius Sadi Generated Narrative: Practitioner #contributor5 name: Ubirajara Ferreira Generated Narrative: Practitioner #contributor6 name: Rodolfo Borges Dos Reis Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord 27308831 Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Androgen Antagonists freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Antineoplastic Agents freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Antineoplastic Combined Chemotherapy Protocols freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Docetaxel freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Humans freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Lymphatic Metastasis freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Male freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Middle Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Patient Safety freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Prostatic Neoplasms freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic Yes component type: qualifier classifier: mortality Components - Type Classifier * is Major topic No component type: qualifier classifier: pathology Components - Type Classifier * is Major topic No content type: components (if present) include qualifier codings classifier: Randomized Controlled Trials as Topic freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Survival Analysis freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Taxoids freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Treatment Outcome freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Tubulin Modulators freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes
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27308831 Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis.
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National Library of Medicine, Index Section
Efficacy and Safety of Combined Androgen Deprivation Therapy (ADT) and Docetaxel Compared with ADT Alone for Metastatic Hormone-Naive Prostate Cancer: A Systematic Review and Meta-Analysis.
**OBJECTIVE:** Prostate cancer is the most common nonskin cancer and second most common cause of cancer mortality in older men in the United States (USA) and Western Europe. Androgen-deprivation therapy alone (ADT) remains the first line of treatment in most cases, for metastatic disease. We performed a systematic review and meta-analysis of all randomized controlled trials (RCT) that compared the efficacy and adverse events profile of a chemohormonal therapy (ADT ± docetaxel) for metastatic hormone-naive prostate cancer (mHNPC). **METHODS:** Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoint was overall survival. Data extracted from the studies were combined by using the hazard ratio (HR) or risk ratio (RR) with their corresponding 95% confidence intervals (95% CI). **RESULTS:** The final analysis included 3 trials comprising 2,264 patients (mHNPC). Patients who received the chemohormonal therapy had a longer clinical progression-free survival interval (HR = 0.64; 95% CI: 0.55 to 0.75; p<0.00001), and no heterogeneity (Chi2 = 0.64; df = 1 [p = 0.42]; I2 = 0%). The biochemical progression-free survival (bPFS) also was higher in patients treated with ADT plus docetaxel (HR = 0.63; 95% CI: 0.57 to 0.69; p<0.00001), also with no heterogeneity noted (Chi2 = 0.48; df = 2 [p = 0.79]; I2 = 0%). Finally, the combination of ADT with docetaxel showed a superior overall survival (OS) compared with ADT alone (HR = 0.73; 95% CI: 0.64 to 0.84; p<0.0001), with moderate heterogeneity (Chi2 = 3.84; df = 2 [p = 0.15]; I2 = 48%). A random-effects model analysis was performed, and the results remained favorable to the use of ADT plus docetaxel (HR = 0.73; 95% CI: 0.60 to 0.89; p = 0.002). In the final combined analysis of the high-volume disease patients, the use of the combination therapy also favored an increased overall survival (HR = 0.67; 95% CI: 0.54 to 0.83; p = 0.0003). Regarding adverse events and severe toxicity (grade ≥3), the group receiving the combined therapy had higher rates of neutropenia, febrile neutropenia and fatigue. **CONCLUSION:** The combination of ADT with docetaxel improved the clinical progression-free survival, bPFS and OS of patients with mHNPC. A superior OS was seen especially for patients with metastatic and high-volume disease. This contemporary combination therapy may now be offered as a first-line treatment for selected patients.
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