Abstract 1820
Background
Anlotinib is an oral tyrosine kinase inhibitor targeting VEGFR, FGFR, PDGFR and c-kit. Anlotinib showed significantly improvement in overall survival in ALTER0303 trial for refractory NSCLC, a randomized, double-blind, placebo-controlled phase III trial in China. This study reported the tolerance of anlotinib in the ALTER0303.
Methods
The adverse events (AEs), dose modification, and therapy interruption were collected from anlotinib group (n = 294) and placebo group (n = 143) that were enrolled in ALTER0303. AEs were graded using Common Terminology Criteria.
Results
The anlotinb related grade ≥3 AEs reported in ≥ 1% patients were hypertension (13.3%), hyponatremia (4.8%), hand-foot syndrome (HFS) (3.7%), hemoptysis (3.1%), GGT elevation (2.7%), hypertriglyceridemia (2.4%), QT interval prolongation (2.4%), lipase elevation (2.4%), proteinuria (2.4%), oral mucositis (1.0%), diarrhea (1.0%), and hyperbilirubinemia (1.0%). Grade ≥3 hypertension, HFS, and hypertriglyceridemia were significantly more frequent in the anlotinib group than in the control group. Dose reduction and drug interruption were required in 24 (8.16%) (Table) and 31 (10.54%) patients in anlotinib group, respectively. The most common anlotinib-related AEs causing interruption were hemoptysis (2.3%), venous thromboembolism (1.0%), proteinuria (0.7%), interstitial lung disease (0.7%), and pneumothorax (0.7%). Table: 1390P Dose nodification due to anlotinib-related adverse events
| Adverse events | No. (%) | Dose modification |
|---|---|---|
| Hand-foot syndrome | 7 (2.3) | 12mg→10mg |
| Hypertension | 3 (1.0) | 12mg→10mg |
| Hypertriglyceridemia | 2 (<1) | 12mg→10mg |
| Diarrhea | 1 (<1) 1 (<1) | 12mg→10mg 12mg→10mg→8mg |
| Liver dysfunction | 1 (<1) 1 (<1) | 12mg→10mg 12mg→10mg→8mg |
| Anorexia | 2 (<1) | 12mg→10mg |
| Oral mucositis | 2 (<1) | 12mg→10mg |
| Arrhythmia | 2 (<1) | 12mg→10mg |
| Fatigue | 1 (<1) | 12mg→10mg |
| Dyspnea | 1 (<1) | 12mg→10mg |
Conclusions
It was important to manage hand-foot syndrome, hypertension, diarrhea and hemoptysis, so that patients could benefit from anlotinib.
Clinical trial identification
NCT02388919.
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co., LTD.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., LTD.
Editorial Acknowledgement
Disclosure
All 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