Generated Narrative: Citation 179624

url: Citation 24598155 Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.

identifier: FEvIR Object Identifier/https://fevir.net/FOI/179624, https://pubmed.ncbi.nlm.nih.gov/24598155, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.40

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title: 24598155 Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.

status: Active

date: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

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approvalDate: 2015-01-02

lastReviewDate: 2021-10-21

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citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/24598155, https://www.ncbi.nlm.nih.gov/pmc//PMC3974001, https://doi.org/10.1186/1756-8722-7-20, pii/1756-8722-7-20

Titles

-	Type	Language	Text
*	Primary title	English	Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.

Abstracts

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Text

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BACKGROUND: Patients with locally advanced and high-risk prostate cancer (LAPC) are prone to experience biochemical recurrence despite radical prostatectomy (RP). We evaluated feasibility, safety and activity of a neoadjuvant chemohormonal therapy (NCHT) with 3-weekly full dose docetaxel and complete androgen blockade (CAB) in locally advanced and high-risk prostate cancer patients (LAPC) undergoing RP. METHODS: Patients (n = 30) were selected by Kattans' preoperative score and received trimestral buserelin 9,45 mg, bicalutamide 50 mg/day and 3 cycles docetaxel (75 mg/m²) followed by RP. Primary endpoints were biochemical (PSA) and local downstaging. Secondary endpoints included toxicity and operability assessments, pathological complete response (pCR), time to PSA progression, 5-year biochemical recurrence free survival (bRFS) and overall survival (OS). RESULTS: Median baseline PSA was 25.8 ng/ml (2.1-293), and the predicted probability of 5-year bRFS was 10% (0-55). NCHT induced PSA-reduction was 97.3% (81.3-99.9%; p < 0.001) and post-RP 96.7% of patients were therapy responders, with undetectable PSA-values. Post- vs. pretreatment MRI indicated a median tumor volume reduction of 46.4% (-31.3-82.8; p < 0.001). A pathological downstaging was observed in 48.3%. Severe hematologic toxicities (≥CTC3) were frequent with 53.8% leucopenia, 90% neutropenia and 13.3% febrile neutropenia. RP was performed in all patients. While resectability was hindered in 26.7%, continence was achieved in 96.7%. Pathologic analyses revealed no pCR. Lymph node- and extracapsular involvement was observed in 36.7% and 56.7% with 33.3% positive surgical margins. After a median of 48.6 (19.9-87.8) months, 55.2% of therapy responders experienced PSA-recurrence. The estimated median time to PSA-progression was 38.6 months (95%CI 30.9-46.4) and 85.3 months (95%CI 39.3-131.3) for OS. The 5-year bRFS was improved to 40%, but limiting for interpretation adjuvant treatment was individualized. CONCLUSIONS: NCHT is feasible despite high hematotoxicity, with excellent functional results. Significant downstaging was observed without pCR. NCHT seems to improve the cohort adjusted 5-year bRFS, but clinical value needs further investigation in randomized trials.

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affiliation: Department of Urology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str, 22, Munich 81675, Germany. mark.thalgott@lrz.tum.de.

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-	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