Abstract 4256
Background
Novel therapies are needed as an initial or salvage treatment for patients with metastatic or locally advanced RCC. This study aimed to assess the safety and efficacy of everolimus in patients with metastatic recurrent and/or unresectable clear cell RCC.
Methods
EVERMORE is an open-label, multicenter, single-arm, phase 2 study (NCT01206764) that enrolled patients aged ≥ 18 yrs with advanced and histologically confirmed clear or non-clear cell RCC. Everolimus 10 mg/d was administered orally, as a first line or after cytokine therapy, until disease progression (PD), unacceptable toxicity, or study discontinuation for any other reason. The primary endpoint was progression-free survival (PFS) rate over time. The secondary endpoints were disease control rate (DCR; stable disease + partial response [PR] + complete response [CR]), objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.
Results
From 2009 to 2017, 142 patients with a mean age of 55.5 years from 10 countries were enrolled. Most of the patients (58.2%) have a clear cell adenocarcinoma as histology/cytology and 53.1% had stage IV disease at initial diagnosis. Of 142 patients, everolimus was received in 117 as first-line and in 25 as second-line treatment. The most common reason for early discontinuation of treatment was PD (n = 88, 62.0%). The median PFS for all assessed patients was 7.0 months (95% CI: 22.00, 37.29). The ORR was 12.0% (n = 17; 95% CI: 7.1, 18.5). The median DOR in patients who had either CR or PR was 39.0 months (n = 17). The DCR was 74.6% (n = 106; 95% CI: 66.7, 81.6). The median OS was not evaluable. The most commonly reported adverse events (AEs) of all grades were anemia (45.1%), stomatitis (29.6%), hyperglycemia (26.1%), and decreased appetite (22.5%). The most commonly reported serious AEs were pneumonia (n = 6), dyspnea (n = 4), urinary tract infection, decreased appetite, dehydration and diarrhea (n = 3 each). In the study, 33 deaths were reported, of which, 19 deaths were due to study indication.
Conclusions
The PFS and safety results of everolimus when administered in patients as first-line or after cytokine therapy are consistent with the previously published data (RECORD-3).
Clinical trial identification
NCT01206764.
Legal entity responsible for the study
Novartis Pharma AG.
Funding
Novartis Pharma AG.
Editorial Acknowledgement
Disclosure
D. Amokrane: Advisory board, Speaker or Grants for Clinical research: Novartis, Sanofi, Bayer, Ipsen, Amgen, Roche, Janssen, Pfizer MSD, Pierre Fabre. M. Ghosn: Grants-research support: Pfizer, Novartis. K. Slimane, V. Pilipovic: Employee and shareholder of Novartis. All other authors have declared no conflicts of interest.
Resources from the same session
2595 - Real-Life Utilization of Genomic testing for invasive Breast Cancer patients in Italy and France reduces Chemotherapy Recommendations
Presenter: Sandro Barni
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2343 - Benefit of adjuvant chemotherapy in hormone receptor-positive, HER2-negative, invasive lobular carcinoma of the breast
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2990 - Baseline lymphocyte counts predict distant recurrence in early breast cancer
Presenter: Gun Min Kim
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4532 - A propensity score analysis exploring the impact of the addition of adjuvant chemotherapy (aCT) to hormone therapy (aHT) in a multi-center series of resected luminal early stage pure Invasive Lobular Breast Carcinoma (ILC).
Presenter: Luisa Carbognin
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
2344 - Benefit of Adjuvant Systemic Therapies in HR+ HER2- pT1ab Node-Negative Breast Carcinomas
Presenter: Alexandre De Nonneville
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3525 - Anti-proliferative effect of oral metronomic vinorelbine in PAM50 Luminal/HER2-negative early breast cancer (SOLTI-1501 VENTANA): an open-label, randomized, three-arm, multicenter, window-of-opportunity study
Presenter: Aleix Prat
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3908 - Clinicopathologic significance of androgen receptor expression and discordant receptor status during progression in breast cancer
Presenter: Chan Heun Park
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
4075 - The outcomes of early breast cancers utilizing the Oncotype Dx Recurrence score (RS) instead of Clinico-pathological (CP) factors for prognostic risk assessment: A Single Institution Experience
Presenter: Adhar Alsayed
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
738 - Circulating tumor cells as a prognostic marker in non metastatic breast cancer patients.
Presenter: Summar Elmorshidy
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract
3151 - Molecular subtyping of breast cancer by dedicated breast PET
Presenter: Satoshi Sueoka
Session: Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Resources:
Abstract