Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Citation: 26244877 Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.

Active as of 2023-12-17

Generated Narrative: Citation

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title: 26244877 Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.

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date: 2023-12-17 16:55:23+0000

publisher: HL7 International / Clinical Decision Support

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***BACKGROUND:** Androgen-deprivation therapy (ADT) has been the backbone of treatment for metastatic prostate cancer since the 1940s. We assessed whether concomitant treatment with ADT plus docetaxel would result in longer overall survival than that with ADT alone. **METHODS:** We assigned men with metastatic, hormone-sensitive prostate cancer to receive either ADT plus docetaxel (at a dose of 75 mg per square meter of body-surface area every 3 weeks for six cycles) or ADT alone. The primary objective was to test the hypothesis that the median overall survival would be 33.3% longer among patients receiving docetaxel added to ADT early during therapy than among patients receiving ADT alone. **RESULTS:** A total of 790 patients (median age, 63 years) underwent randomization. After a median follow-up of 28.9 months, the median overall survival was 13.6 months longer with ADT plus docetaxel (combination therapy) than with ADT alone (57.6 months vs. 44.0 months; hazard ratio for death in the combination group, 0.61; 95% confidence interval [CI], 0.47 to 0.80; P<0.001). The median time to biochemical, symptomatic, or radiographic progression was 20.2 months in the combination group, as compared with 11.7 months in the ADT-alone group (hazard ratio, 0.61; 95% CI, 0.51 to 0.72; P<0.001). The rate of a prostate-specific antigen level of less than 0.2 ng per milliliter at 12 months was 27.7% in the combination group versus 16.8% in the ADT-alone group (P<0.001). In the combination group, the rate of grade 3 or 4 febrile neutropenia was 6.2%, the rate of grade 3 or 4 infection with neutropenia was 2.3%, and the rate of grade 3 sensory neuropathy and of grade 3 motor neuropathy was 0.5%. **CONCLUSIONS:** Six cycles of docetaxel at the beginning of ADT for metastatic prostate cancer resulted in significantly longer overall survival than that with ADT alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00309985.).

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citation: Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res. 1941;1:293–7.

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citation: Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14:149–58.

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Generated Narrative: Practitioner #author3

name: Glenn Liu

Generated Narrative: Practitioner #author4

name: David F Jarrard

Generated Narrative: Practitioner #author5

name: Mario Eisenberger

Generated Narrative: Practitioner #author6

name: Yu-Ning Wong

Generated Narrative: Practitioner #author7

name: Noah Hahn

Generated Narrative: Practitioner #author8

name: Manish Kohli

Generated Narrative: Practitioner #author9

name: Matthew M Cooney

Generated Narrative: Practitioner #author10

name: Robert Dreicer

Generated Narrative: Practitioner #author11

name: Nicholas J Vogelzang

Generated Narrative: Practitioner #author12

name: Joel Picus

Generated Narrative: Practitioner #author13

name: Daniel Shevrin

Generated Narrative: Practitioner #author14

name: Maha Hussain

Generated Narrative: Practitioner #author15

name: Jorge A Garcia

Generated Narrative: Practitioner #author16

name: Robert S DiPaola

Generated Narrative: ArtifactAssessment #meshHeading0

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Components

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Components

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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")

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Components

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Components

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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")

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Components

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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")

classifier: Humans (#D006801)

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Components

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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")

classifier: Kaplan-Meier Estimate (#D053208)

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Components

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classifier: Male (#D008297)

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Components

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Components

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informationType: classifier

type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")

classifier: Neutropenia (#D009503)

freeToShare: true

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type: qualifier ()

classifier: chemically induced (#Q000139)

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classifier: Prostate-Specific Antigen (#D017430)

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