Randomized phase II study of docetaxel (D) + abiraterone acetate (AA) versus D after disease progression to first-line AA in metastatic castration-resistant prostate cancer (mCRPC): ABIDO-SOGUG Trial.

Authors

null

Miguel Angel Climent Duran

Instituto Valenciano de Oncología, Valencia, Spain

Miguel Angel Climent Duran , Albert Font , Ignacio Duran , Javier Puente , Daniel Castellano , M Isabel Sáez , Maria Jose José Mendez Vidal , Carmen Santander , Jose Angel Arranz Arija , Aranzazu Gonzalez del Alba , Alfredo Sanchez-Hernandez , Emilio Esteban , Teresa Alonso Gordoa , Pablo Maroto , Martín Emilio Lázaro Quintela , Javier Cassinello , Begona Perez Valderrama , María José Juan Fita , Begona Mellado

Organizations

Instituto Valenciano de Oncología, Valencia, Spain, Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Barcelona, Spain, Hospital Universitario Marques de Valdecilla, Santander, Spain, Hospital Universitario Clínico San Carlos, Madrid, Spain, Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain, CRIS Cancer Foundation Prostate Cancer Research Group, Institute of Biomedical Research in Malaga/CNIO-IBIMA Genitourinary Cancer Research Unit, H Universitarios Virgen de la Victoria y Regional de Málaga, Málaga, Spain, Hospital Universitario Reina Sofia, Cordoba, Spain, Hospital Universitario Miguel Servet, Zaragoza, Spain, Hospital General Universitario Gregorio Marañón, Madrid, Spain, Medical Oncology Department, Hospital Universitario Puerta de Hierro Majadahonda, Palma De Mallorca, Spain, Hospital Provincial de Castellón, Castellón, Spain, Hospital Universitario Central de Asturias, Asturias, Spain, Hospital Universitario Ramón y Cajal, Madrid, Spain, Department of Medical Oncology, Hospital de Sant Pau, Barcelona, Spain, Hospital Universitario Vigo, Vigo, Spain, Hospital Universitario de Guadalajara, Guadalajara, Spain, Hospital Universitario Virgen del Rocio, Seville, Spain, Instiuto Valenciano de Oncología, Valencia, Spain, Translational Genomics and Targeted Therapeutics in Solid Tumours Lab, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

Research Funding

Pharmaceutical/Biotech Company
Janssen Cilag.

Background: Abiraterone acetate (AA) improves OS and rPFS in first line mCRPC patients (pts). After AA progression D is commonly used as standard second line therapy. However, the value of maintaining AA in combination with D despite progression has not been tested beyond small exploratory studies (Tagawa ST, Eur Urol 2016) ABIDO is a randomized-phase II trial that evaluates efficacy and safety of D + AA vs D after first-line AA progression in mCRPC. Methods: Asymptomatic or minimally symptomatic mCRPC pts with no visceral metastases, ECOG PS 0-1, and adequate organ functions were included. The study has two stages: In stage I pts receive AA (1000 mg/d + prednisone (P) 10 mg qd) until radiological or unequivocal clinical progression. In stage II pts were randomized to D 75 mg/m2 q3wk in combination with AA 1000 mg/d (arm A) or without AA (arm B) The primary endpoint was rPFS and the secondary endpoints radiological response (RR), OS, PSA-response, PSA-PFS and safety. Results: 88 pts were randomized, (46 arm A, 42 Arm B). Median age was 69 y/o, 43% had ECOG 0 and 91%/11%/5% had bone, liver and lung metastases. Median rPFS was 11.4 months (m) in arm A vs 10.5 m in ARM B; 12-m rPFS was 43% vs 45%; Median PSA PFS was 6.2 vs 5.5 m and median OS was 17.3 vs 16.9 m. Twenty four pts (52%) in arm A and 19 (46%) in arm B achieve ≥50% PSA response. RR was achieved in 15% vs 7% of pts and disease control rate in 74% in both arms. No statistically significant differences were found in efficacy parameters. Half of pts received 10 cycles of D (median 7 and 8). D median dose intensity was 86% and 90% for each arm and 91% for AA. Eleven pts discontinued treatment due to non-hematological toxicity, 5 in arm A and 6 in arm B. Most frequent G3-4 toxicities per arm (A/B) were: neutropenia (57%/29%; P=0.027), febrile neutropenia (17%/10%), diarrhea (9%/7%), and asthenia (11%/10%). Conclusions: ABIDO trial was unable to demonstrate the significant clinical benefit of maintenance AA approach + D after AA first-line therapy. No differences were observed in RR, PSA PFS, rPFS and OS. In AA + D cohort, more frequent and severe hematological toxicity (neutropenia and febrile neutropenia) were reported. Clinical trial information: NCT02036060

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02036060

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 95)

Abstract #

95

Poster Bd #

D19

Abstract Disclosures