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
5031 - Sarcoidosis-Like Reaction Mimics Progression in patients treated with immune checkpoint inhibitors
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract
5650 - Tissue-based activation of mucosal-associated invariant T (MAIT) cells in combination ipilimumab and nivolumab checkpoint inhibitor (CI) colitis.
Presenter: Sarah Sasson
Session: Poster Display session 3
Resources:
Abstract
5944 - Significance of severe immune-related adverse effects (irAE) on patients with advanced tumors treated with immune checkpoint inhibitors being admitted for secondary toxicity: Clinical relevance and next steps
Presenter: Leyre Zubiri
Session: Poster Display session 3
Resources:
Abstract
5989 - Implementation of a dedicated immuno-oncology toxicity service reduces the acute impact of immune-related adverse events
Presenter: Anna Olsson-Brown
Session: Poster Display session 3
Resources:
Abstract
3267 - Cardiotoxic and pro-inflammatory effects induced by the association of immune checkpoint inhibitor Pembrolizumab and Trastuzumab in preclinical models
Presenter: Nicola Maurea
Session: Poster Display session 3
Resources:
Abstract
3417 - Interstitial lung disease associated with immune-checkpoint inhibitors in malignant diseases
Presenter: Akira Yamagata
Session: Poster Display session 3
Resources:
Abstract
2071 - A Phase 1 Study of Intraperitoneal MCY-M11 Anti-Mesothelin CAR for Women with Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects with Peritoneal Mesothelioma with Recurrence after Prior Chemotherapy
Presenter: Christina Annunziata
Session: Poster Display session 3
Resources:
Abstract
4935 - Trial in progress: First-in-human study of a novel anti-NY-ESO-1–anti-CD3, TCR-based bispecific (IMCnyeso) as monotherapy in NY-ESO-1/LAGE-1A-positive advanced solid tumors (IMCnyeso-101)
Presenter: Juanita Lopez
Session: Poster Display session 3
Resources:
Abstract
5613 - Nimotuzumab-Cisplatin-Radiation versus Cisplatin-Radiation in HPV negative oropharyngeal cancer
Presenter: Kumar Prabhash
Session: Poster Display session 3
Resources:
Abstract
2576 - Interim analysis of a single arm phase 2 study of adjuvant nivolumab after salvage resection in head and neck squamous cell carcinoma patients previously treated with definitive therapy.
Presenter: Trisha Wise-draper
Session: Poster Display session 3
Resources:
Abstract