How should we treat castration-resistant prostate cancer patients who have received androgen deprivation therapy (ADT) plus docetaxel upfront for hormone-sensitive diseae? Mature analysis of the GETUG-AFU 15 phase III trial

Date

09 Oct 2016

Session

Poster display

Presenters

Pernelle Lavaud

Citation

Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372

Authors

P. Lavaud¹, G. Gravis², C. Legoupil³, S. Foulon³, F. Joly⁴, S. Oudard⁵, F. Priou⁶, M. Soulié⁷, L. Mourey⁸, I. Latorzeff⁹, R. Delva¹⁰, I. Krakowski¹¹, B. Laguerre¹², C. Theodore¹³, J. Ferrero¹⁴, P. Beuzeboc¹⁵, M. Habibian¹⁶, J.M. Boher¹⁷, G. Tergemina-Clain¹⁸, K. Fizazi¹

Author affiliations

¹ Department Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
² Medical Oncology, Institute Paoli Calmettes, 13009 - Marseille/FR
³ Statistics Department, Institut Gustave Roussy, 94805 - Villejuif/FR
⁴ Medical Oncology, Centre Francois Baclesse, Caen/FR
⁵ Medical Oncology Service, Hopital European George Pompidou, 75015 - Paris/FR
⁶ Department Of Oncohématology, CHD Vendee - Hopital Les Oudairies, La Roche sur Yon/FR
⁷ Urology Surgery Department, CHU de Toulouse, Hopital de Rangueil, Toulouse/FR
⁸ Iuct-o, Institut Claudius Regaud, Toulouse/FR
⁹ Medical Oncology, Clinique Pasteur, Toulouse/FR
¹⁰ Medical Oncology, Centre Paul Papin, Angers/FR
¹¹ Medical Oncology And Supportive Care Dpt, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
¹² Medical Oncology, Centre Eugene - Marquis, Rennes/FR
¹³ Medical Oncology, Hopital Foch Service d'Oncologie, Suresnes/FR
¹⁴ Medical Oncology, Centre Antoine Lacassagne, Nice/FR
¹⁵ Department Of Oncology, Institut Curie, Paris/FR
¹⁶ R & D, UNICANCER, Paris/FR
¹⁷ Statistics Department, Institute Paoli Calmettes, Marseille/FR
¹⁸ Département De Biostatistiques, Gustave Roussy, Université Paris-Saclay, Villejuif/FR

Resources

Abstract 3053

Background

Since 2015, docetaxel chemotherapy, combined with ADT, is considered the standard of care in fit men with metastatic hormone-naive prostate cancer (mHNPC), based on data from three phase III trials (GETUG-AFU 15, CHAARTED, and STAMPEDE). No data are currently available regarding activity of treatments used beyond progression after upfront ADT and docetaxel.

Methods

We retrospectively collected data from patients (pts) participating in the GETUG-AFU 15 phase III trial concerning treatments received beyond progression for castration-resistant disease (CRPC) in both arms (ADT and ADT + docetaxel) including treatment efficacy (measured by a PSA decline, physician assessment of clinical benefit, and time to events), and toxicity (NCI-CTC grading).

Results

245 pts received at least one anticancer treatment at CRPC progression. The treatments most frequently used and their efficacy are detailed in the Table. Toxicity was mild, with only rare grade 3-4 events (17%). Median overall survival measured after the onset of CRPC was respectively 2.29 years (IC95% [1.84-2.59]) and 1.97 years (IC95% [1.64-2.73]) in the ADT and ADT + D arms.

Efficacy of treatments used for CRPC

	Treatment used for CRPC (N = 245 pts)	PSA response (ADT vs ADT + D)	Symptomatic response (ADT vs ADT + D)	Median PFS Months (95%CI) (ADT vs ADT + D)
First treatment for CRPC	Docetaxel based chemotherapy (N = 104)	23/68 (34%) vs 3/18 (17%)	16/55 (29%) vs 5/17 (29%)	7.0 (4.3-9.2) vs 4.1 (1.3-5.0)
	Bicalutamide (N = 61)	12/28 (43%) vs 4/24 (17%)	0/12 (0%) vs 3/21 (14%)	5.1 (3.2-11.7 ) vs 3.2 (2.1-6.9 )
	Abiraterone or Enzalutamide (N = 13)	1/2 vs 6/9	1/2 vs 1/4
Second treatment for CRPC	Docetaxel based chemotherapy (N = 49)	12/17 (71%) vs 0/9 (0%)	5/17 (29%) vs 5/12 (42%)	6.0 (4.2-8.5) vs 2.5 (0.9-6.2)
	Abiraterone or Enzalutamide (N = 34)	5/7 (71%) vs 4/7 (57%)	4/8 vs 2/11	6.0 (1.0-9.1 ) vs 5.6 (1.0- )
	Mitoxantrone (N = 17)	0/8 vs 0/4	1/6 vs 2/7
	Platin based chemotherapy (N = 15)	0/6 vs 1/2	4/10 vs 0/1

Conclusions

In this retrospective analysis, anticancer activity was suggested with androgen receptor axis-targeted agents even in patients with metastatic prostate cancer treated upfront with ADT + docetaxel. We observed that docetaxel rechallenge had rather limited activity in this setting.

Clinical trial identification

NCT00104715; release date: 2013 Februray (Lancet Oncol)

Legal entity responsible for the study

Unicancer

Funding

French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen

Disclosure

F. Joly: Roche, Pfizer, Novartis, Sanofi, Jansen, Astellas.

M. Soulié: Amgen, Astellas, Astra Zeneca, Ferring, Glaxo Smith K, Ipsen, Jansen, Keocyt, Novartis, Pierre Fabre, Sanofi, Takeda, Zambon.

B. Laguerre: Pfizer, Novartis, Jansen.

K. Fizazi: Participation to advisory boards and honorarium : Sanofi, Janssen, Astellas.

All other authors have declared no conflicts of interest.

Resources from the same session

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