Abstract 2100
Background
In a phase I study, Afa (30 mg/body daily) plus Bev (15 mg/kg every 3 weeks) was well tolerated and had evidence of favorable disease control (Lung Cancer, 2018). We report an updated progression free survival (PFS), overall survival (OS) and tolerability analysis.
Methods
At first, pts received Afa at 40 mg/body daily and Bev intravenously at 15 mg/kg every 3 weeks (level 0) until progression of disease (PD) or occurrence of unacceptable toxicity and next, pts received Afa at 30 mg/body daily and Bev intravenously at 15 mg/kg every 3 weeks (level -1). The primary endpoint was set as rate of dose limiting toxicities. PFS, OS and tolerability of long term treatment were important key secondary end points. The cumulative survival rate will be estimated by the Kaplan-Meier method.
Results
Nineteen pts were enrolled (level 0: 5 and level -1: 14). At data cutoff (Oct 1, 2018; median follow-up, 27.4 months), 7 pts continued the treatment, 5 pts discontinued the treatment for progression of the lung cancer and 7 pts discontinued the treatment for toxicities (4 pts) or pts’ wish (3 pts). Median PFS was 23.4 months (95% CI: 17.7 months to not reached). In terms of OS, only two events have happened and median OS was not reached. Adverse events (AEs) happened in all pts. Severe AEs were shown in the table. Among 16 evaluable pts, the best response was PR (88%) and disease control rate was 100%. T790M were detected in two pts (a patient whose Afa was discontinued by progression and a patient after gefitinib whose Afa was discontinued by toxicities). Osimertinib were administered to these two pts.Table:
1525P
N = 19 | ||
---|---|---|
Grade 4 AE | 0 | |
Grade 3 AE | 15 | |
Grade 3 | Diarrhea | 4 |
Skin rash | 4 | |
Hypoxia | 1 | |
Stomatitis | 1 | |
Paronychia | 1 | |
Neutrpenia | 1 | |
Anorexia | 1 | |
Proteinuria | 1 | |
Hypertension | 1 |
Conclusions
This is the first report that PFS and OS of Afa plus Bev treatment were monitored for long term in chemo-naïve pts. With prolonged follow-up, first-line Afa plus Bev has very long PFS and OS. This therapy appears promising and we are doing a subsequent randomized trial (Afa plus Bev vs Afa alone, jRCTs061180006).
Clinical trial identification
UMIN000015944. Release date 16/Dec/2014.
Editorial acknowledgement
Legal entity responsible for the study
Okayama Lung Cancer Study Group.
Funding
Has not received any funding.
Disclosure
T. Ninomiya: Honoraria (self): Chugai Pharmaceutical Co.; Honoraria (self), Research grant / Funding (institution): Nippon Boehringer Ingerheim Co. N. Nogami: Honoraria (self): AstraZeneca; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): BMS; Honoraria (self): Kyowa Hakko Kirin; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Ono Pharmaceutical. T. Kozuki: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Nippon Boehringer Ingerheim Co.; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (institution): Chugai Pharmaceutical; Honoraria (self): Kyowa-Hakko Kirin; Honoraria (self), Research grant / Funding (institution): Eli Lilly Japan; Honoraria (self), Research grant / Funding (institution): Merck Biopharma; Honoraria (self), Research grant / Funding (institution): MSD; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Pfizer; Honoraria (self): Taiho Pharmaceutical. D. Harada: Honoraria (self): Ono Pharmaceutical; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Kyowa Hakko Kirin; Honoraria (self): AstraZeneca; Honoraria (self): Nippon Boehringer Ingelheim; Honoraria (self): Eli Lilly Japan; Honoraria (self): MSD KK. T. Kubo: Honoraria (self), Research grant / Funding (self): BMS; Honoraria (self): Taiho; Honoraria (self): AstraZeneca; Honoraria (self), Research grant / Funding (self): Ono Pharmaceutical; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Kyowa Hakko Kirin. K. Ohashi: Research grant / Funding (self): Nippon Boehringer Ingelheim; Research grant / Funding (self): Novartis. S. Kuyama: Honoraria (self): AstraZeneca; Honoraria (self): Meiji Seika Pharma; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Kyorin Pharma; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Novartis; Honoraria (self): BMS; Honoraria (self): Eli Lilly Japan. A. Bessho: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Chugai Pharma; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self): Bristol-Myers Squibb Japan; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Novartis; Honoraria (self): Eli Lilly Japan; Honoraria (self): Daiichi Sankyo; Honoraria (self), Research grant / Funding (institution): Kyorin; Research grant / Funding (institution): AbbVie. N. Fujimoto: Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Ono Pharmaceutical; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Hisamitsu Pharmaceutical; Honoraria (self): Eli Lilly Japan; Honoraria (self): Daiichi Sankyo; Honoraria (self): Astellas Pharma Inc. K. Aoe: Advisory / Consultancy: Boehlinger Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Ono Pharmaceutical; Speaker Bureau / Expert testimony, Research grant / Funding (self): BMS; Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Novartis. T. Shibayama: Honoraria (self): Ono Pharmaceutical; Honoraria (self): MSD KK; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Novartis; Honoraria (self): AstraZeneca. N. Ochi: Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Chugai Pharmaceutical. N. Takigawa: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Daiichi-Sankyo Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Chugai Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): MSD; Honoraria (self), Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Kyowa Hakko Kirin; Research grant / Funding (institution): Nippon Kayaku. K. Hotta: Honoraria (self), Research grant / Funding (self): Chugai Pharmaceutical; Honoraria (self): Nippon Boehringer Ingerheim Co. K. Kiura: Honoraria (self): AstraZeneca; Honoraria (self), Research grant / Funding (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Pfizer Japan; Honoraria (self): Eli Lilly Japan; Honoraria (self): MSD; Honoraria (self): Daiichi Sankyo; Honoraria (self): Novartis; Honoraria (self), Research grant / Funding (self): Boehringer Ingelheim. All other authors have declared no conflicts of interest.
Resources from the same session
5344 - Global trends in population-based survival for 303,169 adults diagnosed with glioblastoma in 44 countries during 2000-2014 (CONCORD-3)
Presenter: Fabio Girardi
Session: Poster Display session 1
Resources:
Abstract
3088 - Spanish Survey of treatment recommendations for elderley patients with glioblastoma
Presenter: María Ángeles Vaz Salgado
Session: Poster Display session 1
Resources:
Abstract
3484 - Updated analysis of the National Registry of Nervous System Tumors in Spain (RETSINE). RETSINE: National Registry of Nervous System Tumors of the Spanish Research Group in Neuro-oncology (GEINO) and Spanish Infrequent and Orphan Tumors Group (GETHI)
Presenter: Isaac Ceballos Lenza
Session: Poster Display session 1
Resources:
Abstract
4737 - Development and validation of novel nomograms predicting survival of malignant ependymoma patients: A population-based study
Presenter: Alzhraa Abbas
Session: Poster Display session 1
Resources:
Abstract
4740 - Characteristics, incidence, and survival of primary cerebral lymphoma: A population based study
Presenter: Sherief Ghozy
Session: Poster Display session 1
Resources:
Abstract
5362 - Trends in Incidence and Survival Analyses of Adult-onset Medulloblastoma
Presenter: Feifei Lin
Session: Poster Display session 1
Resources:
Abstract
3868 - Meta of classical chemotherapy compared with high-dose chemotherapy combined with autologous stem cell transplantation in newly diagnosed medulloblastoma patients after radiotherapy
Presenter: Mengting Zhang
Session: Poster Display session 1
Resources:
Abstract
4446 - Effect of cumulative dose of maintenance temozolomide on overall survival in patients with high grade glia tumors: a single institution analysis
Presenter: Marta Nerone
Session: Poster Display session 1
Resources:
Abstract
5119 - Markers of systemic inflammation correlate with survival prognosis in patients with newly diagnosed brain metastases
Presenter: Angelika Starzer
Session: Poster Display session 1
Resources:
Abstract
3882 - Venous Thromboembolism and Intracranial Hemorrhage in Patients with High-grade Glioma
Presenter: Clara Borges
Session: Poster Display session 1
Resources:
Abstract