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Mini Oral session: GU tumours, prostate

1363MO - Cabazitaxel every 2 weeks versus every 3 weeks in older patients with metastatic castration-resistant prostate cancer (mCRPC): The CABASTY randomized phase III trial

Date

11 Sep 2022

Session

Mini Oral session: GU tumours, prostate

Topics

Tumour Site

Prostate Cancer

Presenters

Stephane Oudard

Citation

Annals of Oncology (2022) 33 (suppl_7): S616-S652. 10.1016/annonc/annonc1070

Authors

S. Oudard1, P. Beuzeboc2, E. Voog3, P. Barthelemy4, A. Thiery-Vuillemin5, M. Bennamoun6, A. Hasbini7, K. Aldabbagh8, C. Saldana9, E. Sevin10, Y.E. Amela11, G. Von Amsberg12, N. Houede13, D. Besson14, S. Feyerabend15, M. Boegemann16, D. Pfister17, M. Schostak18, O. Huillard19, C. Helissey20

Author affiliations

  • 1 Oncology Department, HEGP - Hopital Europeen Georges-Pompidou - APHP - University de Paris, 75015 - Paris/FR
  • 2 Oncology Department, Foch Hospital, 92151 - Suresnes/FR
  • 3 Oncology Department, Jean Bernard Center, 72015 - Le Mans/FR
  • 4 Oncology Department, Institut de Cancérologie Strasbourg Europe, 67200 - Strasbourg/FR
  • 5 Oncology Department, CHU Jean-Minjoz, 25030 - Besançon/FR
  • 6 Oncology Department, Institute Mutualiste Montsouris, 75014 - Paris/FR
  • 7 Oncology Department, Clinique Pasteur Lanroze, 29200 - Brest/FR
  • 8 Oncology Department, Polyclinique Saint Côme, 60204 - Compiegne/FR
  • 9 Oncology Department, Henri Mondor Hospital, Paris Est Creteil university, TRePCa, 94010 - Creteil/FR
  • 10 Oncology Department, Centre Maurice Tubiana, 14000 - Caen/FR
  • 11 Oncology Department, Centre de Cancérologie Les Dentellières, 59300 - Valenciennes/FR
  • 12 Department Of Oncology And Martini-klinik, Prostate Cancer Center, University Hospital Hamburg-Eppendorf, 20246 - Hamburg/DE
  • 13 Oncology Department, Institut de cancérologie du Gard, 30029 - Nîmes/FR
  • 14 Oncology Department, Centre Armoricain de Radiothérapie et d'Oncologie, 22190 - Plérin/FR
  • 15 Studienpraxis Urologie, Studienpraxis Urologie, 72622 - Nürtingen/DE
  • 16 Urology, UKM - University Hospital Münster, 48149 - Münster/DE
  • 17 Klinik Für Urologie, Universitaetsklinikum Köln, 48149 - Koln/DE
  • 18 Department Of Urology, University Hospital Magdeburg, Otto von Guericke University Magdeburg, 39120 - Magdeburg/DE
  • 19 Oncology Department, Hopital Cochin AP-HP, 75679 - Paris/FR
  • 20 Oncology Department, Military Hospital Begin, 94160 - Saint-Mandé/FR
More

Resources

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Abstract 1363MO

Background

Cabazitaxel 25 mg/m2 every 3 weeks (CBZ q3w) + G-CSF prolongs overall survival (OS) vs abiraterone or enzalutamide in mCRPC patients (pts) previously treated with docetaxel (DOC) and the alternative androgen-targeted agent (ART) ( De Wit, NEJM 2019 ). CBZ 16 mg/m2 every 2 weeks (CBZ q2w) induces less severe neutropenia and could be useful for older pts unfit to receive CBZ q3w ( Clément-Zhao, BJU Int 2018 ).

Methods

Pts with progressive mCRPC (≥65 yrs, ECOG 0-2, G8 >14 or ≤14 with reversible geriatric impairment) previously treated with DOC were randomized to CBZ q3w + prednisone (P) + G-CSF vs CBZ q2w + P + G-CSF and stratified by age (<70 vs ≥ 70 yrs) and G8 (>14 vs ≤14). Primary endpoint was the percentage of pts with grade ≥3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection, sepsis). Secondary endpoints were radiographic progression-free survival (rPFS), objective tumor response, skeletal related events (SREs), PSA response, quality of life (not reported here), safety and OS.

Results

Overall, 196 pts (median age, 74.0 yrs; ≥ 70 yrs, 79.6%; G8 <14, 19.9%; vulnerable or frail per SIOG guidelines, 30.1%; prior ART, 86.7%) were randomized (CBZ q3w, n=97; CBZ q2w, n=99). Relative dose intensity for CBZ 3qw vs CBZ 2qw was comparable (92.3% vs 91.6%). Rate of Grade ≥3 neutropenia and/or neutropenic complications was significantly higher with CBZ q3w vs CBZ q2w (62.9% vs 5.1%; Odds Ratio = 0.03 [95% CI 29.5-48.9], p<0.001). Grade ≥3 adverse events were more common with CBZ 3qw (72.9% vs 58.2%). One patient (CBZ q3w arm) died of neutropenic complication. No new safety signal was observed. Main secondary criteria are provided below. Table: 1363MO

CBZ q3w (n=97) CBZ q2w (n=99) P-value
Median OS, months 14.1 14.0 0.39
Median rPFS, months 6.3 6.7 0.82
PSA response ≥ 50% 45.2% 42.9% 0.75
Objective tumor response 18.1% 15.4% 0.63
No SRE at 1 year 87.4% 79.7% 0.81

Conclusions

Compared to standard regimen, CBZ q2w plus G-CSF significantly reduced the occurrence of grade ≥3 neutropenia and/or neutropenic complications with comparable clinical outcomes. CBZ q2w regimen could become a practice changing therapy for elderly mCRPC pts.

Clinical trial identification

NCT02961257, EudraCT 2016-001179-60.

Editorial acknowledgement

Legal entity responsible for the study

ARTIC.

Funding

Sanofi.

Disclosure

S. Oudard: Financial Interests, Personal, Advisory Board, Consultancy, Advisory Role: Sanofi; Financial Interests, Personal, Invited Speaker, Public Speaking and Advisory Role: Janssen; Financial Interests, Personal, Advisory Board, Advisory Role and Public Speaking: AstraZeneca, MSD, Merck, Astellas, Ipsen, Pfizer, Roche, Genentech; Financial Interests, Personal, Advisory Board, Advisory Board and Public Speaking: BMS, Bayer, Novartis. A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Board, & Public Speaking: Pfizer, AstraZeneca, Janssen, Ipsen, Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Sanofi, Novartis, Roche/Genentech, MSD, Astellas Pharma; Financial Interests, Institutional, Funding: Pfizer, Ipsen, Bayer; Financial Interests, Institutional, Invited Speaker: Pfizer, AstraZeneca, Sanofi, JNJ, Novartis, Ipsen, Roche, BMS, MSD, Astellas Pharma, Excelixis, UNICANCER / GETUG, Incyte; Financial Interests, Invited Speaker: AstraZeneca, Novartis, BMS; Non-Financial Interests, Member: ASCO, GETUG; Other, Travel, Accommodations: Roche, MSD, JNJ, BMS, AstraZeneca, Pfizer, Astellas Pharma, Ipsen. C. Saldana: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Ipsen, Pfizer. G. Von Amsberg: Financial Interests, Personal, Advisory Board: Roche, Bristol Myers Squibb, Astellas, Sanofi, Ipsen, Janssen, MSD, AstraZeneca, Merck, EISAI, Pfizer; Financial Interests, Personal, Invited Speaker: Roche, Bristol Myers Squibb, Astellas, Sanofi, Ipsen, EISAI, MSD, Janssen, AstraZeneca, Merck, Bayer, Bayer, Ferring, Janssen, Ipsen, BMS, Pfizer, Amgen; Financial Interests, Institutional, Invited Speaker: Pfizer, Sanofi, Bristol Myers Squibb, Roche, MSD, Exelixis, AstraZeneca, AvenCell, Ipsen. S. Feyerabend: Financial Interests, Personal, Advisory Board: Janssen, Astellas, Bayer, Aventis; Other, Honorarium: Janssen; Financial Interests, Personal, Other, Travel and accommodation expenses: Aventis. D. Pfister: Financial Interests, Personal, Invited Speaker: Sanofi, Janssen, MSD, Bayer, AstraZeneca, Merck; Financial Interests, Personal, Advisory Board: Janssen, MSD, Pfizer; Financial Interests, Personal, Other, Consultant: MSD. M. Schostak: Financial Interests, Personal, Other, Consultant: AstraZeneca, BMS, EDAP-TMS, Janssen, Merck, Merck-sharp&dohme; Financial Interests, Personal, Other, Honoraria and travel costs: Amgen, AstraZeneca, Bayer-Vital, BMS, EDAP-TMS, Pfizer, Janssen, NewConcept, Novartis; Financial Interests, Personal, Other, Travel Costs: Deutsche Krebsgesellschaft, Deutsche Gesellschaft für Radioonkologie, Deutsche Gesellschaft für Radiologie, Deutsche Gesellschaft für Urologie, Ipsen; Financial Interests, Institutional, Funding, Funding of scientific projects: AstraZeneca, Bayer-Vital, BMS, AUO, Clinical Laserthermia Systems AB, EDAP-TMS, Ferring, Ipsen, Janssen, Merck, Merck Sharp&Dohme, Parexel. O. Huillard: Financial Interests, Personal, Invited Speaker: Sanofi, Ipsen, Novartis; Financial Interests, Personal, Advisory Board: Janssen, Bristol Myers Squibb, AstraZeneca, Pfizer, Eisai, Bayer. C. Helissey: Financial Interests, Personal, Invited Speaker: Janssens, Roche, Astellas, AstraZeneca, Sanofi; Non-Financial Interests, Principal Investigator: Janssen, Sanofi, Roche, Astellas. All other authors have declared no conflicts of interest.

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