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Phase II study of weekly cabazitaxel for ‘unfit’ metastatic castration resistant prostate cancer patients (mCRPC) progressing after docetaxel (D) treatment. Circulating tumour cell (CTC) analysis (SOGUG-CABASEM Trial)

Date

09 Oct 2016

Session

Poster display

Presenters

Urbano Anido

Citation

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

Authors

U. Anido1, M.J. Juan Fita2, L. Munielo-Romay3, B. Pérez-Valderrama4, B. Mellado5, M. Ochoa de Olza6, O. Fernandez Calvo7, D. Castellano8, E.M. Fernandez Parra9, M. Domenec10, S. Hernando11, J. Arranz Arija12, C. Caballero13, I. Duran14, M. Campayo5, M.A. Climent15

Author affiliations

  • 1 Dept. Of Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, 15706 - Santiago de Compostela/ES
  • 2 Medical Oncology, Fundación Instituto Valenciano de Oncología, 46009 - Valencia/ES
  • 3 Traslational Medical Oncology Group, Liquid Biopsy Analysis Unit, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, 15706 - Santiago de Compostela/ES
  • 4 Medical Oncology, Hospital Universitario Virgen del Rocio, Sevilla/ES
  • 5 Medical Oncology, Hospital Clinic y Provincial de Barcelona, Barcelona/ES
  • 6 Medical Oncology, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 7 Medical Oncology, Complejo Hospitalario De Orense, Ourense/ES
  • 8 Medical Oncology, University Hospital 12 De Octubre, Madrid/ES
  • 9 Medical Oncology, Hospital Virgen Valme, Sevilla/ES
  • 10 Medical Oncology, Althaia, Xarxa Assistencial i Universitària de Manresa, 08243 - Manresa/ES
  • 11 Medical Oncology, HUFA Hospital Universitario Fundacion Alcorcon, Alcorcon/ES
  • 12 Servicio De Oncologia Medica, Hospital General Universitario Gregorio Marañon, 28007 - Madrid/ES
  • 13 Medical Oncology, Hospital General Universitario Valencia, Valencia/ES
  • 14 Departamento De Oncologia, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 15 Servicio De Oncología Médica, Instituto Valenciano de Oncología, 46009 - Valencia/ES
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Resources

Background

Cabazitaxel (C), a novel taxane developed to overcome D resistance, showed an overall survival improvement after D in mCRPC in a three-weekly schedule. Its main toxicity is hematological,. We aimed to evaluate the relation of CTC counts and its early response with efficacy of weekly C/prednisone (P) schedule in "unfit" mCRPC previously treated with D.

Methods

Unfit pts (ECOG 2, dose reduction due to febrile neutropenia during treatment with D or radiation therapy affecting more than 25% of bone marrow reserve) with mCRPC progressing after D with adequate bone marrow, liver and kidney functions were included. C 10 mg/m2 was administered on days 1, 8, 15 and 22 of 5-week cycles with daily prednisone 5 mg b.i.d. Radiological and PSA response was evaluated according to the PCCTWG II criteria. CellSearch system was used for counting the CTC. Early CTC response defined as a drop of ≥30% at 4 weeks from baseline. Toxicity was evaluated according NCI-CTC AE.

Results

70 pts have been enrolled. Median age was 73 y (range 54-85), 71% pts had ECOG 2, 84% had bone, 16% liver and 11% lung metastases. Twenty-four pts (34.3%) achieve ≥50% PSA response and 7 (10.0%) ≥80%. Radiological response (PR) was observed in 4 pt (5.7%) and SD in 32 pts (45.7%). Median PSA PFS was 4.8 months and 12 weeks PSA PFS was 68.6%. Median OS was 12.6 months. Most frequent toxicities of all grades and grade 3-4 as % of pts were: anemia (80-17%), asthenia (54-19%), thrombocytopenia (20-10%), diarrhea (36-1%), nauseas (27-1%), neutropenia (14-1%), peripheral neuropathy (19-0%), and anorexia (30-3%). Neither grade IV diarrhea nor febrile neutropenia were observed. Nineteen of 32 pts (59%) had early CTC response. Results show a favorable association between early CTC response and PSA response (77% vs 53%) (p = 0,267), clinical benefit (RP + EE) (68% vs 31%) (p = 0,070), overall survival (15.8 m vs 7.2 m) (p = 0,175) and PSA PFS (7.8 m vs 3.1 m) (p = 0,004).

Conclusions

Our results suggest that weekly C plus P in unfit pts is an effective regimen with lower toxicity than the 3-weekly standard treatment. Early CTC response seems to be related with efficacy and could be of value as early efficacy endpoint.

Clinical trial identification

NCT01518283 / EudraCT: 2011-004627-12

Legal entity responsible for the study

SOGUG (Spanish Oncology Genitourinary Group)

Funding

Sanofi

Disclosure

I. Duran: Consulting or advisory role: Amgen, Astellas, Roche-Genetech, Novartis, Janssen, Pierre-Fabre. Research funding: Sanofi, Janssen.

All other authors have declared no conflicts of interest.

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