1808P - Pain response and health-related quality of life (HRQL) analysis in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel every 2 weeks (16 mg/m²) versus every 3 weeks (25 mg/m²) in the CABASTY phase III trial

Background

In CABASTY trial (NCT02961257), CBZ 16 mg/m² q2w + G-CSF significantly reduced grade ≥3 neutropenia and/or neutropenic complications vs CBZ 25 mg/m² q3w + G-CSF with comparable overall survival (OS) benefit in older and heavily pretreated patients (pts) with mCRPC (Oudard et al. ESMO 2022). Here, we report changes in HRQL in both arms during therapy.

Methods

The Functional Assessment Cancer Therapy-Prostate (FACT-P) questionnaire was collected at each visit and analyzed in all pts exposed to CBZ with evaluable HRQL at baseline and post-baseline. Higher values indicated better HRQL. Changes of ≥10 points in FACT-P total score and ≥2 points in Prostate Cancer Subscale (PCS)-pain score, confirmed by 2 consecutive evaluations were judged clinically meaningful.

Results

196 pts (median age, 74.6 yrs; ≥75 yrs, 49%; G8 <14, 20%; vulnerable or frail per SIOG guidelines, 30.1%; moderate to severe pain, 18%) previously treated with docetaxel and novel hormonal therapies (median 3 lines) were randomized to CBZ q3w (n=97) or q2w (n=99) + G-CSF. Median treatment duration was 19.0 and 20.1 weeks with CBZ q3w and q2w, respectively. HRQL was evaluable in 88 (90.7%) and 96 (97.0%) pts with CBZ q3w and q2w. PCS-pain improved in 35.2% vs 38.5% (CBZ q3w vs q2w). The probability of not having PCS-pain deterioration during treatment was 81.8% vs 75.0% with CBZ q3w vs q2w (HR=1.5 [95% CI, 0.80-2.9], p=0.2). Total FACT-P score improved from baseline in 17.0% vs 13.5% of pts with CBZ q3w vs q2w, respectively. FACT-P score was either stable or improved from baseline in 75.0% vs 74.0% of pts with CBZ q3w vs q2w. At 75% percentile, time to deterioration was 4.9 vs 3.3 months (HR: 1.2; p =0.57) with CBZ q3w vs q2w.

Conclusions

In this older and heavily pretreated mCRPC pts population, CBZ q3w and q2w + G-CSF similarly relieved pain and maintained or improved HRQL in 3 out of 4 pts with a comparable OS benefit. Since bi-weekly dosing induces less grade ≥3 neutropenia and/or neutropenic complications, it should be offered to pts unfit to receive the standard CBZ regimen.

Clinical trial identification

NCT02961257.

Editorial acknowledgement

Legal entity responsible for the study

ARTIC.

Funding

Sanofi.

Disclosure

S. Oudard: Financial Interests, Personal and Institutional, Advisory Board: Sanofi, Bayer, Janssen, AstraZeneca; Financial Interests, Personal, Advisory Board: Astellas, Pfizer. R. Ratta: Financial Interests, Personal, Invited Speaker: Ipsen, Astellas; Financial Interests, Personal, Advisory Board: Pfizer, Merck, BMS, AstraZeneca, Janssen. P. Barthelemy: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Pfizer, Ipsen, Bayer, Janssen Cilag, Astellas, Novartis, Amgen, Gilead; Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen. A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Board, & public speaking: Pfizer, AstraZeneca, Janssen, Ipsen, BMS; Financial Interests, Personal, Advisory Board: Sanofi, Novartis, Roche/Genentech, MSD, Astellas Pharma; Financial Interests, Personal, Full or part-time Employment, since 2023: BMS; Financial Interests, Institutional, Funding: Pfizer, Ipsen, Bayer; Financial Interests, Institutional, Local PI: Pfizer, AstraZeneca, Sanofi, JNJ, Novartis, Ipsen, Roche, BMS, MSD, Astellas Pharma, Excelixis, UNICANCER/GETUG, Incyte; Financial Interests, Steering Committee Member: AstraZeneca, Novartis, BMS; Non-Financial Interests, Member: ASCO, GETUG; Other, Other, Travel, Accommodations: Roche, MSD, JNJ, BMS, AstraZeneca, Pfizer, Astellas Pharma, Ipsen. K. Aldabbagh: Financial Interests, Personal, Advisory Board: Ipsen, Janssen, Novartis, Pfizer. C. Saldana: Financial Interests, Personal, Advisory Board: BMS, Ipsen, Pfizer, Bayer. G. Von Amsberg: Financial Interests, Personal, Advisory Board: Roche, BMS, Astellas, Sanofi, Janssen, MSD, Ipsen, Pfizer, AstraZeneca, Merck, Eisai. N. Houede: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, BMS, Merck, Pfizer, MSD, Janssen. D. Vernerey: Financial Interests, Personal, Advisory Board: SAS Novis, CellProtera SAS, Apmonia Therapeutics, Incyte, Veracyte SAS, INVECTYS, Novartis. C. Helissey: Financial Interests, Personal, Advisory Board: Janssen, Roche, Sanofi, Astellas, AstraZeneca. All other authors have declared no conflicts of interest.