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Pain progression at initiation of chemotherapy in metastatic Castration-Resistant Prostate Cancer (mCRPC) is associated with a poor prognosis: a post-hoc analysis of FIRSTANA

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Nicolas Delanoy

Citation

Annals of Oncology (2019) 30 (suppl_5): v325-v355. 10.1093/annonc/mdz248

Authors

N. Delanoy1, D. Robbrecht2, K. Fizazi3, F. Mercier4, O. sartor5, R. de Wit6, S. Oudard7

Author affiliations

  • 1 Medical Oncology, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Medical Oncology, Erasmus MC Cancer Institute, 3015 GD - Rotterdam/NL
  • 3 Cancer Medicine, Gustave Roussy, 94805 - Villejuif/FR
  • 4 Na, Stat process, 75003 - Paris/FR
  • 5 Cancer Center, Tulane University, 70112 - New Orleans/US
  • 6 Medical Oncology, Erasmus MC Daniel den Hoed Cancer Center, 3075EA - Rotterdam/NL
  • 7 Immunothérapie Et Traitement Antiangiogénique En Pathologie cancérologique, Hopital European George Pompidou, 75015 - Paris/FR
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Resources

Background

The FIRSTANA trial compared docetaxel 75mg/m2 Q3W (D75), cabazitaxel 20mg/m2 Q3W (C20) and cabazitaxel 25mg/m2 Q3W (C25) in patients with chemo-naive mCRPC (Oudard 2017). FIRSTANA enrolled patients regardless of presence of disease-related symptoms. This post-hoc analysis of FIRSTANA evaluates the influence of progression type on outcomes.

Methods

Patient outcomes (OS, PSA response [confirmed PSA decline from baseline ≥ 50%] and radiological PFS [rPFS]) were analyzed according to progression type at randomization. Progression at randomization was defined as follows: PSA progression only (PSA-p) with no radiological progression (Radio-p) and no pain, Radio-p (± PSA-p, no pain), pain progression (mean Present Pain Intensity ≥2 and/or mean analgesic score ≥ 10 over the 7 days prior to randomization (±PSA-p, ±Radio-p).

Results

PSA-p, Radio-p and Pain-p were present in 34.4%, 23.2% and 42.3% of patients at randomization, respectively. Pain progression at initiation of chemotherapy was associated with features of aggressive disease and a shorter OS. Lower activity of C20 than C25 and D75 was observed in patients with Pain-p.Table:

859P

Progression type
PSA-p N = 362Radio-p N = 244Pain-p N = 445Global p°
- PSA decrease ≥ 50% - Overall - D75 - C20 - C2569.0% 67.4% 71.0% 69.0%69.8% 65.8% 66.2% 78.3%58.0% 62.2% 49.3% 63.0%P = 0.003 P = 0.70 P = 0.002 P = 0.21
-rPFS, median [95% CI]* - Overall - D75 - C20 - C2516.5 [14.3; 18.9] 13.5 [11.3; 16.7] 19.7 [14.3; 26.5] 18.2 [14.2; 22.6]12.1 [11.2; 14.4] 11.3 [9.7; 14.4] 13.4 [10.6; 22.8] 11.4 [10.1; 15.7]10.8 [9.3;11.6] 11.4 [8.8; 13.9] 9.1 [7.6; 10.9] 11.1 [9.7; 12.8]p < 0.001 p = 0.13 p < 0.001 p = 0.001
OS, median [95% CI]* - Overall - D75 - C20 - C2527.7 [25.4;31.2] 29.0 [22.6; 36.6] 30.0 [24.9; NR] 26.5 [24.0; 31.6]30.6 [26.8;34.3] 28.4 [22.0; 34.1] 32.1 [27.9; 41.4] 29.7 [24.0; 38.5]18.5 [16.8; 20.6] 20.3[16.5;24.3] 16.5[14.3; 19.1] 20.4[17.0;25.3]p < 0.001 p = 0.003 p < 0.001 p = 0.031
*

in months, NR: not reached; °Log rank test for rPFS and OS, CMH test adjusted on stratification factors

Conclusions

Most patients in FIRSTANA had pain progression at randomization and this factor was associated with worse OS. In this post-hoc, subgroup analysis, C20 appeared less active than D75 and C25 in men with baseline pain progression.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Nicolas Delanoy.

Funding

Sanofi.

Disclosure

N. Delanoy: Travel / Accommodation / Expenses: Sanofi; Honoraria (self): Tesaro; Honoraria (self): MSD. D. Robbrecht: Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Bayer. K. Fizazi: Honoraria (self): Amgen; Honoraria (self): Astellas; Honoraria (self): AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Clovis; Honoraria (self): CureVac; Honoraria (self): Essa; Honoraria (self): Genentech; Honoraria (self): Janssen; Honoraria (self): MSD; Honoraria (self): Orion; Honoraria (self): Sanofi. F. Mercier: Honoraria (self): Sanofi; Honoraria (self): AstraZeneca; Shareholder / Stockholder / Stock options, Stat Process is a CRO providing statistical services to various companies: Stat Process. O. Sartor: Shareholder / Stockholder / Stock options: Eli Lilly; Shareholder / Stockholder / Stock options: GlaxoSmithKline; Shareholder / Stockholder / Stock options: Noria; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Bellicum; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Johnson &Johnson; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Dendreon; Advisory / Consultancy, Research grant / Funding (institution): Endocyte; Advisory / Consultancy: Constellation Pharmaceuticals; Advisory / Consultancy: Advanced Accelerator Applications; Advisory / Consultancy: Pfizer; Advisory / Consultancy: BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy: Bavarian Nordic; Advisory / Consultancy: Oncogenex; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Progenics. R. de Wit: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Sanofi; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Genentech. S. Oudard: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Janssen; Honoraria (self): Bayer; Honoraria (self): Pfizer; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): BMS; Honoraria (self): Ipsen.

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