Abstract 2801
Background
The efficacy and safety of front-line BEV with carboplatin and paclitaxel (CP) for aOC were demonstrated in two randomised phase III trials (GOG-0218 and ICON7). OSCAR (NCT01863693; funded by Roche Products Ltd) evaluated front-line BEV-containing therapy in routine oncology practice in 29 UK centres.
Methods
Eligible patients received BEV (7.5 or 15 mg/kg q3w, typically for up to 12 months, per UK clinical practice) during and after front-line chemotherapy (physician’s choice) for high-risk stage IIIB–IV ovarian cancer. Co-primary endpoints were progression-free survival (PFS) and safety (NCI CTCAE v4.0). Patients were evaluated according to standard practice/physician’s discretion during BEV treatment, with an end-of-study assessment 12 months after the last BEV dose. We report post hoc subgroup analyses in populations defined by age and comorbidities.
Results
Of 299 patients starting treatment between May 2013 and Mar 2015, 80 were aged ≥70 years, of whom 9 were ≥80 years. Almost all patients (91%) had comorbidities (pre-existing medical condition at BEV initiation), most commonly hypertension/essential hypertension (27%), constipation (22%) or fatigue (22%). Most (93%) received BEV 7.5 mg/kg with CP; 22% had primary debulking surgery, 40% interval debulking surgery and 38% no surgery. Patient characteristics, treatment exposure, PFS and safety are summarised below. In multivariable Cox regression analysis, neither age nor number of comorbidities was prognostic for PFS.
Conclusions
Older patients were more likely to receive single-agent chemotherapy, have ongoing comorbidities and have worse surgical outcome than their younger counterparts. However, median BEV exposure, incidence of grade 3/4 AEs and median PFS were similar in younger and older patients. Grade ≥3 AEs were more common in patients with ≥3 than <3 comorbidities but PFS was similar.
Clinical trial identification
NCT01863693.
Legal entity responsible for the study
Roche Products Ltd.
Funding
Roche Products Ltd.
Editorial Acknowledgement
Medical writing assistance was provided by Jennifer Kelly, MA (Medi-Kelsey Ltd, Ashbourne, UK), funded by Roche Products Ltd.Table: 984P
| Characteristic, n (%) | Age, years | No. of comorbidities | |||
|---|---|---|---|---|---|
| <70 (n = 219) | ≥70 (n = 80) | <3 (n = 109) | ≥3 (n = 190) | ||
| Age, years | <65 ≥65 | 160 (73) 59 (27) | 0 80 (100) | 68 (62) 41 (38) | 92 (48) 98 (52) |
| High riska | 200 (91) | 70 (88) | 99 (91) | 171 (90) | |
| No microscopic residual disease | 11 (5) | 1 (1) | 6 (6) | 6 (3) | |
| ECOG PS | 0 1 2 Missing | 56 (26) 58 (26) 11 (5) 94 (43) | 13 (16) 27 (34) 6 (8) 34 (43) | 35 (32) 33 (30) 5 (5) 36 (33) | 46 (24) 66 (35) 15 (8) 63 (33) |
| Pre-existing hypertensionb | 49 (22) | 33 (41) | 13 (12) | 69 (36) | |
| Pre-existing proteinuriac | 11 (5) | 10 (13) | 4 (4) | 17 (9) | |
| Pre-existing diabetes | 13 (6) | 9 (11) | 2 (2) | 20 (11) | |
| Selected chemotherapy | CP Carboplatin alone Other | 214 (98) 2 (1) 3 (1) | 71 (89) 9 (11) 0 | 104 (95) 3 (3) 2 (2) | 181 (95) 8 (4) 1 (1) |
| AE leading to BEV discontinuation | 21 (10) | 12 (15) | 11 (10) | 22 (12) | |
| Median BEV duration, months (range) | 10.6 (<1–29.7) | 10.4 (≤1–41.4) | 10.9 (<1–29.7) | 10.3 (<1–41.4) | |
| Grade 3/4 AEs, n (%) | 118 (54) | 42 (53) | 50 (46) | 110 (58) | |
| Grade 5 AEs, n (%) | 5 (2)d | 2 (3)e | 1 (1) | 6 (3) | |
| Median PFS, months (95% CI) | 16.1 (14.5–18.5) | 14.8 (12.2–16.1) | 16.5 (14.7–18.0) | 14.9 (13.4–16.1) |
Stage III with ≥1 cm residuum, any stage IV, or no surgery.
bIncludes essential hypertension.
cIncludes high protein level in urine.
dGastrointestinal perforation, febrile neutropenia, cardiac arrest, pneumonia, metastases to meninges.
eAbdominal pain, pneumonia aspiration. AE=adverse event.
Disclosure
M. Hall: Advisory boards: Roche, Tesaro, Clovis Oncology, AstraZeneca. G. Bertelli: Advisory boards: Roche, Novartis, Genomic Health. J. Hasan: Advisory boards: Roche, AstraZeneca, Tesaro. A. Ograbek: Employee: Roche. T.J. Perren: Advisory boards: Roche, Novartis, Merck Sharp & Dohme Limited; Travel/accommodation: IGEA Medical. All other authors have declared no conflicts of interest.
Resources from the same session
5877 - TCR beta chain convergence defines the tumor infiltrating T cell repertoire of melanoma and non-small cell lung carcinoma.
Presenter: Timothy Looney
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
3212 - PI3K inhibition and modulation of immune and tumor microenvironment markers by copanlisib in patients with non-Hodgkin's lymphoma or advanced solid tumors
Presenter: Ahmad Awada
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
3574 - Pan-squamous genomic profiling stratified by anatomic tumor site and viral association
Presenter: Meagan Montesion
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
4113 - Toward the Standardization of Bioinformatics Methods for the Accurate Assessment of Tumor Mutational Burden (TMB)
Presenter: Han Chang
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
4468 - Prediction of primary resistance to anti-PD1 therapy (APD1) in 2nd line NSCLC
Presenter: Egbert Smit
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
4570 - Immunomodulatory germline variation impacts the development of multiple primary melanoma (MPM).
Presenter: Robert Ferguson
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
1169 - Leukocyte telomere length and recurrence risk after EGFR-TKIs therapy in patients with advanced lung adenocarcinoma
Presenter: Ming Yang
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
1707 - Gene embedding: a novel machine learning approach to identify gene candidates related to immunotherapy responsiveness
Presenter: Chi Tung Choy
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
2123 - Common and rare DPYD variants are predictive for 5FU/capecitabine (5FU) toxicity: The MRC COIN and COIN-B trials
Presenter: Ayman Madi
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract
5671 - The landscape of NTRK fusions in Chinese solid tumor patients
Presenter: Qi Ling
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Resources:
Abstract