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Genitourinary tumours, prostate

4679 - Docetaxel (D) with androgen suppression (AS) for high-risk localized prostate cancer (HrPC) patients (pts) who relapsed PSA after radical prostatectomy (RP) and/or radiotherapy (RT): a randomized phase III trial.

Date

08 Sep 2017

Session

Genitourinary tumours, prostate

Topics

Cytotoxic Therapy;  Surgical Oncology;  Radiation Oncology;  Prostate Cancer

Presenters

Stephane Oudard

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

S. Oudard1, I. Latorzeff2, A. Caty3, L. Miglianico4, E. Sevin5, A. Hardy Bessard6, R. Delva7, F. Rolland8, C. Chevreau9, F. Priou10, P. Beuzeboc11, G. Gravis12, C. Linassier13, P. Gomez14, E. Voog15, P. Chinet14, X. Muracciole16, C. Abraham Jaillon17, R. Elaidi18, S. Culine19

Author affiliations

  • 1 Oncology Department, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Oncologie, Clinique du Parc, 31500 - Toulouse/FR
  • 3 Medical Oncology, Hôpital Saint-Lambret, 59020 - Lille Cedex/FR
  • 4 Oncology, CHP Saint-Grégoire, 35760 - St. Grégoire/FR
  • 5 Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 6 Medical Oncology, Centre CARIO - HPCA, 22190 - Plérin sur mer/FR
  • 7 Oncology, Centre Paul Papin, 49100 - Angers/FR
  • 8 Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 9 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 10 Oncology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 11 Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 12 Medical Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 13 Medical Oncology, CHRU Bretonneau, 37044 - Tours/FR
  • 14 Oncology, Centre Frédéric Joliot, 76000 - Rouen/FR
  • 15 Oncology, Clinique Victor Hugo Le Mans, 72000 - Le Mans/FR
  • 16 Oncology, Hôpital de la Timone, 13385 - Marseille/FR
  • 17 Oncology, Centre Hospitalier de Versailles - Hopital Andre Mignot, 78157 - Le Chesnay/FR
  • 18 Medical Oncology, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, 75015 - Paris/FR
  • 19 Medical Oncology, Hôpital St. Louis, 75010 - Paris/FR
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Abstract 4679

Background

HrPC pts with PSA relapse after local therapy may have a poor prognosis and AS may be a therapeutic option. D+AS is standard of care in hormone-naive metastatic PC. We evaluated the benefit of D+AS in HrPC pts with PSA relapse after RP and/or RT.

Methods

Multicenter, randomized phase 3 study (NCT00764166) comparing AS (triptorelin, every 3 months for 1 year) versus AS+D (70 mg/m2 Q3W, 6 cycles). To be enrolled, pts needed ≥ 3 rising PSA values >0.2ng/mL (after RP) or > 1ng/mL above nadir (after RT) modified by nadir + 2ng/ml (RTOG-ASTRO Phoenix, 2006) and ≥ 1 of the following criteria: Gleason ≥8, PSA doubling time (PSADT) ≤6 mths, PSA velocity >0.75 ng/mL/year, positive surgical margins (SM), pN1, time from curative therapy to PSA relapse ≤12 months. Pts were stratified on type of local treatment (RP or RT) and PSADT (≤ or > 6 mths). Primary endpoint was PSA-PFS defined by a PSA above 0.2ng/ml and rise ≥ 50% from baseline confirmed by 2 subsequent values. Secondary endpoints were PSA response (decrease ≥50%), radiological progression (rPFS), overall survival (OS) and safety.

Results

between 2003-2007, 250 pts (median age 65 years), were randomized to AS+D (arm A, n = 125) or AS (arm B, n = 125). Local treatment: RP (95 pts, 38%), RT (69 pts, 28%) or RP+RT (86 pts, 34%). Risk factors were as follows: Gleason ≥8: 29%, PSADT≤ 6 mths 54%, PSA velocity >0.75 ng/mL/yr 84%, positive SM 37%, pN1 4%, PSA relapse ≤12 mths 45%. 58% of pts had ≥3 risk factors. Six pts had a PSA >20 ng/ml at baseline. There was no significant difference in PSA response (94% vs 98%), PSA-PFS and rPFS between 2 arms (table). Median OS was not mature. Most common grade ≥3 toxicities in arm A were neutropenia (58%), febrile neutropenia (8%) and hair loss (4%). AS toxicities were mainly grade 2 hot flushes (47%) and depression (11%).Table:

784O

AS + D (n = 125)AS alone (n = 125)HR (95%)p-value
PSA-PFS (months)20.7 [19.2-21.5]18.6 [17.6-20.2]0.85 (0.62-1.16)0.31
rPFS (years)8.8 [7.7-10.2]9.7 [6.9-10.9]1.01 (0.72-1.40)0.95
25eme percentile (OS, years)8.38.11.16 (0.76-1.77)0.49

Conclusions

AS+D failed to improve PSA-PFS, rPFS in HrPC pts relapsing PSA after local therapy.

Clinical trial identification

NCT00764166

Legal entity responsible for the study

Stéphane OUDARD, MD, PhD

Funding

Sanofi Aventis

Disclosure

S. Oudard: Honoraria from Sanofi, Novartis, Roche, Ipsen, BMS outside submited work L. Miglianico, E. Sevin, A-C. Hardy Bessard: Fees from Sanofi. C. Chevreau, C. Linassier, S. Culine: Fees from Sanofi, Astellas, Janssen. F. Priou: Fees from Sanofi. P. Beuzeboc: Fees from Sanofis, Astellas, Janssen. G. Gravis: Travel paid by Sanofi, Astellas, Janssen All other authors have declared no conflicts of interest.

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