Abstract 5637
Background
Due to improved outcome in mCRPC, most prognostic models may not reflect the current treatment landscape. Recently, Armstrong et al (Ann Oncol 2018) published a prognostic model based on the phase III PREVAIL trial.
Methods
We applied the Armstrong prognostic model to patients (pts) treated in the COU-AA-302 trial. Variables included in the model: albumin, ALP, Hb, LDH, NLR, number of bone metastases, pain, pattern of spread, PSA, time from diagnosis. Pts were categorized into low ( < =3), intermediate (4-6) or high (7-10 risk factors) risk. A continuous score was calculated. Association with overall survival (OS), radiographic progression-free survival (rPFS) and time to PSA progression (TTPSAP) was calculated with Cox-regression models, with Kaplan Meier estimates for median values. C-indices were used to assess the performance of the continuous risk score.
Results
918 pts (84,4%) had data on all variables. Risk score (continuous) was associated with OS (HR 2.19; p < 0.001) with a c-index of 0.68 (se = 0.011). 483 (52.6%), 403 (43.9%) and 32 (3.5%) pts were classified as low-, intermediate- and high-risk. OS was longer in low- than in intermediate- (HR: 0.4; p < 0.001) and high-risk (HR: 0.24; p < 0.001) pts. rPFS was prolonged in low risk versus intermediate (HR: 0.57; p < 0.001) and high-risk (HR: 0.41; p < 0.001) pts. TTPSAP was also improved in low-risk vs intermediate (HR: 0.6; p < 0.001) and high-risk (HR: 0.41; p < 0.001) pts. The association of risk group with OS, rPFS and TTPSAP was independent of treatment arm (Table). KM estimates of median (95%CI) OS, rPFS and TTPSAP.Table:
864P
OS | rPFS | TTPSAP | |
---|---|---|---|
Low | 41.7m (38.7-46.8) | 16.4m (13.8-19.1) | 11.1m (8.3-11.2) |
Intermediate | 24.6m (23.1-26.8) | 8.3m (8-11) | 5.6m (5.5-8.2) |
High | 16.7m (11.7-30.2) | 3.9m (3.6-4.1) | 5.3m (3.7-8.3) |
Conclusions
The Armstrong model is valid for mCRPC pts treated with first-line abiraterone. Less pts with high-risk features were included in COU-AA-302 than PREVAIL. These results may improve individual prognostic estimation and patient stratification in clinical trials. Study carried out under YODA Project #2018-3813.
Clinical trial identification
NCT00887198.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
D. Lorente: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Janssen; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer. All other authors have declared no conflicts of interest.
Resources from the same session
1885 - Factors associated with disease progression in patients treated with trametinib in combination with dabrafenib for unresectable advanced BRAFV600-mutant melanoma: an open label, non randomized study
Presenter: Philippe Saiag
Session: Poster Display session 3
Resources:
Abstract
5259 - Integrative RNAseq and Target panel sequencing reveals common and distinct innate and adaptive resistance mechanisms to BRAF inhibitors
Presenter: Phil Cheng
Session: Poster Display session 3
Resources:
Abstract
5619 - Effective treatment with T-VEC monotherapy in Stage IIIB/C-IVM1a Melanoma of the Head & Neck Region
Presenter: Viola Franke
Session: Poster Display session 3
Resources:
Abstract
5666 - Re-introduction of T-VEC Monotherapy in Recurrent Stage IIIB/C-IVM1a melanoma is effective
Presenter: Viola Franke
Session: Poster Display session 3
Resources:
Abstract
4117 - Efficacy of talimogene laherparepvec (T-VEC) in melanoma patients (pts) with locoregional (LR) recurrence, including in-transit metastases (ITM): subgroup analysis of the phase 3 OPTiM study
Presenter: Mark Middleton
Session: Poster Display session 3
Resources:
Abstract
5303 - Real Life Use of Talimogene Laherparepvec in Melanoma in Centers in Austria and Switzeland
Presenter: Christoph Hoeller
Session: Poster Display session 3
Resources:
Abstract
4130 - Outcomes of advanced melanoma patients who discontinued pembrolizumab (pembro) after complete response (CR) in the French early access program (EAP)
Presenter: Philippe Saiag
Session: Poster Display session 3
Resources:
Abstract
2050 - Outcome of patients with elevated LDH treated with first-line targeted therapy (TT) or PD-1 based immune checkpoint inhibitors (ICI)
Presenter: Sarah Knispel
Session: Poster Display session 3
Resources:
Abstract
1618 - Comparative-Effectiveness of Pembrolizumab vs. Nivolumab for Patients with Metastatic Melanoma
Presenter: Justin Moser
Session: Poster Display session 3
Resources:
Abstract
3556 - Long-term efficacy of combination nivolumab and ipilimumab for first-line treatment of advanced melanoma: a network meta-analysis
Presenter: Peter Mohr
Session: Poster Display session 3
Resources:
Abstract