Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer
Autor: | Antonio Alcaraz, Begoña Mellado, J R M Lorenzo, Pere Gascón, Luis M. Antón Aparicio, Enrique Gallardo, J. Areal, Albert Font, N. Hannaoui, F J G Veiga, Adriano de Sousa, Pedro L. Fernández |
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Rok vydání: | 2009 |
Předmět: |
Male
Cancer Research medicine.medical_specialty medicine.medical_treatment Urology Antineoplastic Agents high risk Docetaxel urologic and male genital diseases Androgen deprivation therapy Prostate cancer Prostate Clinical Studies medicine Humans Neoadjuvant therapy Aged business.industry Prostatectomy Prostatic Neoplasms Cancer Androgen Antagonists Middle Aged prostate cancer medicine.disease Neoadjuvant Therapy Surgery medicine.anatomical_structure Oncology Concomitant Taxoids business medicine.drug |
Zdroj: | British Journal of Cancer |
ISSN: | 1532-1827 0007-0920 |
Popis: | Background: The low probability of curing high-risk prostate cancer (PC) with local therapy suggests the need to study modality of therapeutic approaches. To this end, a prospective phase II trial of neoadjuvant docetaxel (D) and complete androgen blockade (CAB) was carried out in high-risk PC patients. The primary end point was to detect at least 10% of pCRs after chemohormonal treatment. Methods: Patients with T1c–T2 clinical stage with prostate-specific antigen (PSA) >20 ng ml−1 and/or Gleason score ⩾7 (4+3) and T3 were included. Treatment consisted of three cycles of D 36 mg m−2 on days 1, 8 and 15 every 28 days concomitant with CAB, followed by radical prostatectomy (RP). Results: A total of 57 patients were included. Clinical stage was T1c, 11 patients (19.3%); T2, 30 (52.6%) and T3, 16 (28%) patients. Gleason score was ⩾7 (4+3) in 44 (77%) patients and PSA >20 ng ml−1 in 15 (26%) patients. Treatment was well tolerated with 51 (89.9%) patients completing neoadjuvant therapy together with RP. The rate of pCR was 6% (three patients). Three (6%) additional patients had microscopic residual tumour (near pCR) in prostate specimen. With a median follow-up of 35 months, 18 (31.6%) patients presented PSA relapse. Conclusion: Short-term neoadjuvant D and CAB induced a 6% pCR rate, which is close to what would be expected with ADT alone. The combination was generally well tolerated. |
Databáze: | OpenAIRE |
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