Abstract 4287
Background
For patients with mCRC that have failed a first-line oxaliplatin-based regimen, the preferred treatment option is an irinotecan-based regimen. In these secondary analyses of the OZONE study, aflibercept + FOLFIRI safety and efficacy was evaluated for sub-populations of patients with mCRC.
Methods
OZONE is a prospective, multicentre, observational, non-comparative study evaluating patients receiving aflibercept + FOLFIRI in the clinical setting, for 24 months from aflibercept initiation or until death. Patients were grouped according to: age (≥ 65 years vs < 65 years); renal (CrCl ≤ 80 mL/min) or hepatic (bilirubin > UNL or AST/ALT > 1.5 UNL) impairment; number and type of prior anti-cancer therapy.
Results
From the overall population (N = 766), there were 370 patients aged ≥ 65 years. All grade asthenia (43.5% vs 35.9%) and decreased appetite (25.4% vs 20.2%) occurred more frequently (≥ 5%) in patients aged ≥ 65 vs < 65 years. There were 256 patients with CrCl ≤ 80 mL/min, of which 43 had CrCl < 50 mL/min. Renal function did not influence treatment-emergent adverse events (TEAEs). Grade ≥ 3 TEAEs were reported in 76.7%, 67.1% and 67.9% of patients with CrCl < 50 mL/min, CrCl 50–80 mL/min, and CrCl > 80 mL/min, respectively. There were 129 patients with impaired liver function. All grade constipation and haemorrhage were more frequent in patients with impaired liver function vs those without (23.3% vs 14.2% and 37.2% vs 30.1%, respectively). There were 449 patients previously treated with bevacizumab. Only fatigue occurred more frequently in patients with prior bevacizumab vs those without (23.8% vs 17.0%). Efficacy multivariate analyses showed that treatment with aflibercept + FOLFIRI favoured patients without vs with hepatic impairment (median overall survival [OS] 13.7 vs 8.7 months; p < 0.001) and without vs with prior use of bevacizumab (median OS 16.6 vs 10.6 months; p < 0.001).
Conclusions
Subgroup analyses of the OZONE study did not reveal major differences in the safety profile according to age, renal or hepatic status, or prior bevacizumab status. These results suggest that aflibercept may be a treatment option for these subgroups of patients. Funding: Sanofi.
Clinical trial identification
ENCEPP/SDPP/4836.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Sanofi.
Disclosure
I. Chau: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Eli-Lilly; Advisory / Consultancy: Bristol Meyers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (self): Merck-Serono; Advisory / Consultancy: Five Prime Therapeutics; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Oncologie International; Advisory / Consultancy: Pierre Fabre; Research grant / Funding (self): Janssen-Cilag; Research grant / Funding (self): Sanofi Oncology. P. García-Alfonso: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bristol Meyers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: Merck-Serono; Advisory / Consultancy: Sanofi Oncology; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Servier. Z. Linke: Advisory / Consultancy, Advisory Board- Oncologic days in Bratislava, Slovakia, 2016, 2017, 2018 and Prague in 2018.: Sanofi; Speaker Bureau / Expert testimony, Lecture- Prague Onco 2019: Merck; Non-remunerated activity/ies, ESMO 2017: Roche. A. Ruiz-Casado: Research grant / Funding (self): Sanofi; Research grant / Funding (self): Servier; Research grant / Funding (self): Amgen; Research grant / Funding (self): Merck; Research grant / Funding (self): Lilly; Research grant / Funding (self): Roche; Research grant / Funding (self): Medtronic; Research grant / Funding (self): BTG. E. Polo Marques: Research grant / Funding (self): Roche; Research grant / Funding (self): Amgen; Research grant / Funding (self): Sanofi; Research grant / Funding (self): Merck. T. Cartwright: Research grant / Funding (self): Amgen; Research grant / Funding (self): Taiho. All other authors have declared no conflicts of interest.
Resources from the same session
3516 - Palbociclib Rechallenge in Hormone Receptor (HR)[+]/HER2[-] Advanced Breast Cancer (ABC). PALMIRA Trial
Presenter: Antonio Llombart Cussac
Session: Poster Display session 2
Resources:
Abstract
4616 - Alpelisib (ALP) + Endocrine Therapy (ET) by Last Prior Therapy in Patients (pts) With PIK3CA-Mutated Hormone-Receptor Positive (HR+) Human Epidermal Growth Factor Receptor-2-Negative (HER2–) Advanced Breast Cancer (ABC): Additional Study Cohort in BYLieve
Presenter: Eva Ciruelos
Session: Poster Display session 2
Resources:
Abstract
3592 - PRECYCLE: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy.
Presenter: Tom Degenhardt
Session: Poster Display session 2
Resources:
Abstract
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Presenter: Ning Li
Session: Poster Display session 2
Resources:
Abstract
2785 - Effect of response to last platinum-based chemotherapy in patients (pts) with platinum-sensitive, recurrent ovarian carcinoma in the phase 3 study ARIEL3 of rucaparib maintenance treatment
Presenter: Jonathan Ledermann
Session: Poster Display session 2
Resources:
Abstract
3496 - Integrated safety analysis of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with ovarian cancer in the treatment and maintenance settings
Presenter: Rebecca Kristeleit
Session: Poster Display session 2
Resources:
Abstract
2844 - Clinical factors associated with prolonged response and survival under olaparib as maintenance therapy in BRCA mutated ovarian cancers
Presenter: S.Intidhar Labidi-Galy
Session: Poster Display session 2
Resources:
Abstract
1955 - A Prospective Evaluation of Tolerability of Niraparib Dosing Based on Baseline Body Weight (BW) and Platelet (plt) Count: Blinded Pooled Interim Safety Data from the NORA Study
Presenter: Xiaohua Wu
Session: Poster Display session 2
Resources:
Abstract
2539 - Evaluation of Niraparib 200 mg/d as Maintenance Therapy in Recurrent Ovarian Cancer and Associated Thrombocytopenia in a Real-World US Setting
Presenter: Premal Thaker
Session: Poster Display session 2
Resources:
Abstract
1290 - Niraparib initial dose and its’ management in patients with recurrent high-grade serous ovarian cancer.
Presenter: Jacek Grabowski
Session: Poster Display session 2
Resources:
Abstract