Generated Narrative: PublicationRecord 179624 version: 20; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/179624 identifier: FEvIR Object Identifier/179624, https://pubmed.ncbi.nlm.nih.gov/24598155 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 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: 2015-01-02 lastReviewDate: 2021-10-21 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: ?? --> 2013-12-27 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2014-02-25 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2014-03-07 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2014-03-07 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2015-01-03 06:00:00+0000 statusDate activity: PubMed Pubstatus of PMC release period: ?? --> 2014-03-05 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 - Type Text * Primary human use 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. relatesTo type: Cites classifier: Journal Article citation: Kattan MW, Eastham JA, Stapleton AMF, Wheeler TM, Scardino PT. A preoperative nomogram for disease recurrence following radical prostatectomy for prostate cancer. J Natl Cancer Inst. 1998;90:766–771. doi: 10.1093/jnci/90.10.766. target: https://pubmed.ncbi.nlm.nih.gov/9605647/ relatesTo type: Cites classifier: Journal Article citation: D’Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280(11):969–974. doi: 10.1001/jama.280.11.969. target: https://pubmed.ncbi.nlm.nih.gov/9749478/ relatesTo type: Cites classifier: Journal Article citation: Sonpavde G, Sternberg CN. Neoadjuvant systemic therapy for urological malignancies. 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Cancer. 2007;110(6):1248–1254. doi: 10.1002/cncr.22897. target: https://pubmed.ncbi.nlm.nih.gov/17674353/ relatesTo type: Cites classifier: Journal Article citation: Mellado B, Font A, Alcaraz A, Aparicio LA, Veiga FJ, Areal J, Gallardo E, Hannaoui N, Lorenzo JR, Sousa A, Fernandez PL, Gascon P. Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer. Br J Cancer. 2009;101(8):1248–1252. doi: 10.1038/sj.bjc.6605320. target: https://pubmed.ncbi.nlm.nih.gov/19755998/ relatesTo type: Cites classifier: Journal Article citation: Chi KN, Chin JL, Winquist E, Klotz L, Saad F, Gleave ME. Multicenter phase II study of combined neoadjuvant docetaxel and hormone therapy before radical prostatectomy for patients with high risk localized prostate cancer. 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J Clin Oncol. 1999;17(11):3461–3467. target: https://pubmed.ncbi.nlm.nih.gov/10550143/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1756-8722, ISOAbbreviation/J Hematol Oncol, ISSN Linking/1756-8722, Medline Title Abbreviation/J Hematol Oncol, NLM Unique ID/101468937 title: Journal of hematology & oncology publisherLocation: England citedMedium: Internet volume: 7 articleDate: 2014-03-05 pageString: 20 publicationForm citedMedium: Internet without issue articleDate: 2014-03-05 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/24598155/ webLocation classifier: DOI Based url: https://doi.org/10.1186/1756-8722-7-20 classification type: Publishing Model classifier: Electronic classification type: Chemical classifier: Androgen Antagonists, Taxoids, Docetaxel classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase II, Journal Article 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: Thalgott M forenameInitials: M affiliation: Department of Urology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str, 22, Munich 81675, Germany. mark.thalgott@lrz.tum.de. entry contributor: Horn T forenameInitials: T entry contributor: Heck MM forenameInitials: MM entry contributor: Maurer T forenameInitials: T entry contributor: Eiber M forenameInitials: M entry contributor: Retz M forenameInitials: M entry contributor: Autenrieth M forenameInitials: M entry contributor: Herkommer K forenameInitials: K entry contributor: Krause BJ forenameInitials: BJ entry contributor: Gschwend JE forenameInitials: JE entry contributor: Treiber U forenameInitials: U entry contributor: Kübler HR forenameInitials: HR Generated Narrative: Practitioner #contributor0 name: Mark Thalgott Generated Narrative: Practitioner #contributor1 name: Thomas Horn Generated Narrative: Practitioner #contributor2 name: Matthias M Heck Generated Narrative: Practitioner #contributor3 name: Tobias Maurer Generated Narrative: Practitioner #contributor4 name: Matthias Eiber Generated Narrative: Practitioner #contributor5 name: Margitta Retz Generated Narrative: Practitioner #contributor6 name: Michael Autenrieth Generated Narrative: Practitioner #contributor7 name: Kathleen Herkommer Generated Narrative: Practitioner #contributor8 name: Bernd J Krause Generated Narrative: Practitioner #contributor9 name: Jürgen E Gschwend Generated Narrative: Practitioner #contributor10 name: Uwe Treiber Generated Narrative: Practitioner #contributor11 name: Hubert R Kübler Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord 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. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - 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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.
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Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.
**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.
Kattan MW, Eastham JA, Stapleton AMF, Wheeler TM, Scardino PT. A preoperative nomogram for disease recurrence following radical prostatectomy for prostate cancer. J Natl Cancer Inst. 1998;90:766–771. doi: 10.1093/jnci/90.10.766.
D’Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280(11):969–974. doi: 10.1001/jama.280.11.969.
Sonpavde G, Sternberg CN. Neoadjuvant systemic therapy for urological malignancies. BJU Int. 2010;106(1):6–22.
Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002;360(9327):103–106. doi: 10.1016/S0140-6736(02)09408-4.
Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W, NCIC CTG. PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011;378(9809):2104–2111. doi: 10.1016/S0140-6736(11)61095-7.
Shelley MD, Kumar S, Wilt T, Staffurth J, Coles B, Mason MD. A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinoma. Cancer Treat Rev. 2009;35(1):9–17. doi: 10.1016/j.ctrv.2008.08.002.
Prayer-Galetti T, Sacco E, Pagano F, Gardiman M, Cisternino A, Betto G, Sperandio P. Long-term follow-up of a neoadjuvant chemohormonal taxane-based phase II trial before radical prostatectomy in patients with non-metastatic high-risk prostate cancer. BJU Int. 2007;100(2):274–280. doi: 10.1111/j.1464-410X.2007.06760.x.
Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513–1520. doi: 10.1056/NEJMoa041318.
Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26(2):242–245. doi: 10.1200/JCO.2007.12.4008.
Sartor AO. Progression of metastatic castrate-resistant prostate cancer: impact of therapeutic intervention in the post-docetaxel space. J Hematol Oncol. 2011;4:18. doi: 10.1186/1756-8722-4-18.
Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012;5:35. doi: 10.1186/1756-8722-5-35.
Dreicer R, Magi-Galluzzi C, Zhou M, Rothaermel J, Reuther A, Ulchaker J, Zippe C, Fergany A, Klein EA. Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer. Urology. 2004;63(6):1138–1142. doi: 10.1016/j.urology.2004.01.040.
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Department of Urology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str, 22, Munich 81675, Germany. mark.thalgott@lrz.tum.de.