Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial
Valentina Orlando
,
Damien Drubay
(1, 2)
,
Pernelle Lavaud
(2, 3)
,
Laura Faivre
(2, 3)
,
François Lesaunier
(4)
,
Rémy G. Delva
(5)
,
Gwénaëlle Gravis
(6)
,
Frédéric Rolland
(5)
,
Frank Priou
(7)
,
Jean Marc Ferrero
(8)
,
Nadine Houede
(9)
,
Loïc Mourey
(10)
,
Christine A. Theodore
(11)
,
Ivan Krakowski
(12)
,
Jean François Berdah
,
Marjorie Baciuchka
(13)
,
Brigitte Laguerre
(14)
,
Aude Fléchon
(15)
,
Marine Grosse-Goupil
(16)
,
Isabelle Cojean-Zelek
(17)
,
Stephane Marie Oudard
(18)
,
Jean Luc Labourey
,
Paule Chinet-Charrot
(19)
,
Éric Legouffe
,
Jean Léon E. Lagrange
(20)
,
Claude Linassier
(21)
,
Gaël Deplanque
(22)
,
Philippe Beuzeboc
(11)
,
Jean Louis Davin
,
Anne Laure Martin
(23)
,
Meryem Brihoum
(23)
,
Stéphane Culine
(24)
,
Gwénaël Le Teuff
(1)
,
Karim S. Fizazi
(25)
1
CESP -
Centre de recherche en épidémiologie et santé des populations
2 IGR - Institut Gustave Roussy
3 Département de médecine oncologique [Gustave Roussy]
4 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
5 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
6 IPC - Institut Paoli-Calmettes
7 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
8 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
9 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
10 Institut Claudius Regaud
11 Hôpital Foch [Suresnes]
12 CAV - Centre Alexis Vautrin
13 APHM - Assistance Publique - Hôpitaux de Marseille
14 CRLCC - CRLCC Eugène Marquis
15 Centre Léon Bérard [Lyon]
16 Hôpital Saint-André
17 Groupe Hospitalier Diaconesses Croix Saint-Simon
18 HEGP - Hôpital Européen Georges Pompidou [APHP]
19 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
20 Hôpital Henri Mondor
21 Hôpital Bretonneau
22 CHUV - Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne]
23 UNICANCER
24 AP-HP - Hopital Saint-Louis [AP-HP]
25 Université Paris-Saclay
2 IGR - Institut Gustave Roussy
3 Département de médecine oncologique [Gustave Roussy]
4 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
5 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
6 IPC - Institut Paoli-Calmettes
7 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
8 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
9 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
10 Institut Claudius Regaud
11 Hôpital Foch [Suresnes]
12 CAV - Centre Alexis Vautrin
13 APHM - Assistance Publique - Hôpitaux de Marseille
14 CRLCC - CRLCC Eugène Marquis
15 Centre Léon Bérard [Lyon]
16 Hôpital Saint-André
17 Groupe Hospitalier Diaconesses Croix Saint-Simon
18 HEGP - Hôpital Européen Georges Pompidou [APHP]
19 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
20 Hôpital Henri Mondor
21 Hôpital Bretonneau
22 CHUV - Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne]
23 UNICANCER
24 AP-HP - Hopital Saint-Louis [AP-HP]
25 Université Paris-Saclay
Valentina Orlando
- Fonction : Auteur
Damien Drubay
- Fonction : Auteur
- PersonId : 1098917
Gwénaëlle Gravis
- Fonction : Auteur
- PersonId : 754826
- IdHAL : gwenaelle-gravis
- ORCID : 0000-0002-3127-1554
Jean François Berdah
- Fonction : Auteur
Jean Luc Labourey
- Fonction : Auteur
Éric Legouffe
- Fonction : Auteur
Jean Louis Davin
- Fonction : Auteur
Résumé
Introduction: Serum prostate specific antigen (PSA) is a well-known prognostic parameter in men with prostate cancer. The treatment of men with very high PSA values and apparently no detectable metastases is not fully established. Patients and Methods: Ancillary analysis from the GETUG 12 phase 3 trial. Patients with non-metastatic high-risk prostate cancer by bone and computerized tomography (CT) scan were randomly assigned to receive androgen deprivation therapy (ADT) and docetaxel plus estramustine or ADT alone. Relapse-free survival (RFS), clinical RFS, metastases-free survival (MFS), overall survival (OS), and prostate cancer-specific survival (PCSS) were estimated using the Kaplan–Meier method for different levels of PSA (50 ng/mL, 75 ng/mL, and 100 ng/mL). The relationship between PSA and outcomes was studied using residual-based approaches and spline functions. Results: The median follow-up was 12 years (range: 0-15.3). Baseline PSA (<50 ng/mL, n = 328; ≥50ng/mL, n = 85) was associated with improved RFS (P = .0005), cRFS (P = .0024), and MFS (P = .0068). The 12-year RFS rate was 46.33% (CI 40.59-51.86), 33.59% (CI 22.55-44.97), and 11.76% (1.96-31.20) in men with PSA values <50 ng/mL (n = 328), 50-100 ng/mL (n = 68), and ≥100 ng/mL (n = 17), respectively. Exploratory analyses revealed no deviation from the linear relationship assumption between PSA and the log hazard of events. Conclusions: Men with apparently localized prostate cancer and a high baseline PSA value have a reasonable chance of being long-term disease-free when treated with curative intent combining systemic and local therapy.