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Research Article
Fen Wang
Peking University Shenzhen Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4876-710X
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Purpose: Anlotinib is an anti-angiogenetic multi-targeted tyrosine kinase inhibitor. This study aimed to evaluate the efficacy and safety of anlotinib in advanced non-small cell lung cancer (aNSCLC) in the real world.
Methods: Patients with aNSCLC receiving anlotinib were enrolled in two cohorts (treatment-naive and previously treated). The endpoints included progression-free survival (PFS), overall survival (OS) and anlotinib-related adverse events (ar-AEs).
Results: 203 patients accrued in the study. In the treatment-naïve cohort (n=80), the PFS was 7.4 (95% confidence interval [CI], 4.1-10.7) and OS was 10.8 (95% CI, 5.8-15.8) months of monotherapy group (immature survival for combination group). In previously treated cohort (n=123), The PFS was 8.0 months (95% CI, 6.1-9.9) in the combination group and 4.3 months (95% CI, 2.1-6.6) in the monotherapy group (hazard ratio [HR], 0.49; 95% CI, 0.29-0.83; p=0.007), respectively. The OS was 18.5 months (95% CI, 10.5- to 26.6) in the combination group and 7.8 months (95% CI, 7.1-8.4) in the monotherapy group (HR, 0.38; 95% CI, 0.22-0.66; p=0.001), respectively. The ar-AEs of grade ≥3 in the monotherapy and the combination groups were hypertension (9.0% and 8.7%), fatigue (8.1% and 7.6%), hand-foot syndrome (8.1% and 6.5%), diarrhea (5.4% and 8.7%), proteinuria (5.4% and 5.4%), and mucositis oral (6.3% and 8.7%).
Conclusion: In aNSCLC, anlotinib monotherapy has a promising efficacy in the first-line setting. It may be an option for those who are ineligible for chemotherapy; anlotinib combination therapy in a ≥ second-line setting showed manageable toxicities and encouraging efficacy, indicating a good application prospect.
Trial registration: This study was retrospectively registered with ISRCTN Registry (ID ISRCTN35543977) on January 26th, 2021 and Chinese Clinical Trial Register (ChiCTR2000032265) on April 4th, 2020.
Keywords
anlotinib, non-small cell lung cancer, real-world, tyrosine kinase inhibitor, anti-angiogenesis
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View the published article at Journal of Cancer Research and Clinical Oncology.
Version 1
Posted 11 Mar, 2021
No community comments so far
Reviews received
Received 02 Mar, 2021
Reviewers invited
Invitations sent on 01 Mar, 2021
Editor invited
On 28 Feb, 2021
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Journal of Cancer Research and Clinical Oncology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Fen Wang
Peking University Shenzhen Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4876-710X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Journal of Cancer Research and Clinical Oncology.
Version 1
Posted 11 Mar, 2021
No community comments so far
Reviews received
Received 02 Mar, 2021
Reviewers invited
Invitations sent on 01 Mar, 2021
Editor invited
On 28 Feb, 2021
Editor assigned
On 28 Feb, 2021
First submitted
On 26 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Journal of Cancer Research and Clinical Oncology.
Purpose: Anlotinib is an anti-angiogenetic multi-targeted tyrosine kinase inhibitor. This study aimed to evaluate the efficacy and safety of anlotinib in advanced non-small cell lung cancer (aNSCLC) in the real world.
Methods: Patients with aNSCLC receiving anlotinib were enrolled in two cohorts (treatment-naive and previously treated). The endpoints included progression-free survival (PFS), overall survival (OS) and anlotinib-related adverse events (ar-AEs).
Results: 203 patients accrued in the study. In the treatment-naïve cohort (n=80), the PFS was 7.4 (95% confidence interval [CI], 4.1-10.7) and OS was 10.8 (95% CI, 5.8-15.8) months of monotherapy group (immature survival for combination group). In previously treated cohort (n=123), The PFS was 8.0 months (95% CI, 6.1-9.9) in the combination group and 4.3 months (95% CI, 2.1-6.6) in the monotherapy group (hazard ratio [HR], 0.49; 95% CI, 0.29-0.83; p=0.007), respectively. The OS was 18.5 months (95% CI, 10.5- to 26.6) in the combination group and 7.8 months (95% CI, 7.1-8.4) in the monotherapy group (HR, 0.38; 95% CI, 0.22-0.66; p=0.001), respectively. The ar-AEs of grade ≥3 in the monotherapy and the combination groups were hypertension (9.0% and 8.7%), fatigue (8.1% and 7.6%), hand-foot syndrome (8.1% and 6.5%), diarrhea (5.4% and 8.7%), proteinuria (5.4% and 5.4%), and mucositis oral (6.3% and 8.7%).
Conclusion: In aNSCLC, anlotinib monotherapy has a promising efficacy in the first-line setting. It may be an option for those who are ineligible for chemotherapy; anlotinib combination therapy in a ≥ second-line setting showed manageable toxicities and encouraging efficacy, indicating a good application prospect.
Trial registration: This study was retrospectively registered with ISRCTN Registry (ID ISRCTN35543977) on January 26th, 2021 and Chinese Clinical Trial Register (ChiCTR2000032265) on April 4th, 2020.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
This is a list of supplementary files associated with this preprint. Click to download.
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