P48.09 Anlotinib Plus Etoposide and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer: A Single Arm Phase II Trial

Han, Baohui; Zhang, W.; Zhang, B.; Chen, Y.; Zhang, Y.; Lou, Yang; Dong, Yi; Qian, Fen-Hong; Zhou, Wei; Yang, Zhiping

doi:10.1016/j.jtho.2021.01.879

Cited by 4 publications

(8 citation statements)

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“…The grade 3 and above adverse reactions were manageable with dose reduction or drug discontinuation. Similar to previous research, myelosuppression was the most frequent adverse reaction [13][14][15] . As the most common adverse reactions of anlotinib, the incidence of hypertension and hand-foot syndrome were 41.1% and 24.1%, respectively.…”

Section: Safetysupporting

confidence: 88%

“…In China, anlotinib has been approved by CFDA as the third-line and above treatment for SCLC based on the ALTER 1202 study [12] . Several small sample size single arm phase II clinical trials of anlotinib combined with platinum-etoposide chemotherapy as the rst-line treatment for ES-SCLC are being carried out in China and the preliminary results have shown the favorable clinical e cacy [13][14][15] .…”

Section: Safetymentioning

confidence: 99%

“…Based on ALTER 1202 study, anlotinib was approved by the China Food and Drug Administration (CFDA) in 2019 as the third-line and above treatment for SCLC [12] . Additionally, some small sample size clinical trials in China have shown the favorable e cacy of anlotinib combined with platinum-etoposide chemotherapy [13][14][15] . The 2021 American society of clinical oncology (ASCO) meeting announced the preliminary result of a phase II clinical study on the e cacy and safety of anlotinib combined with platinum-etoposide chemotherapy in the rst-line treatment of ES-SCLC.…”

Section: Introductionmentioning

confidence: 99%

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The Efficacy And Safety of Anlotinib Combined With Platinum-Etoposide Chemotherapy As First-Line Treatment For Extensive-Stage Small Cell Lung Cancer: A Chinese Multicenter Real-World Study

Zheng

Jiang

Gao

et al. 2022

Preprint

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Background: Anlotinib, an antiangiogenic multi-target tyrosine kinase inhibitor (TKI), was approved as the third-line and above treatment for small cell lung cancer (SCLC) in China. Some small sample size clinical trials have shown the favorable efficacy of anlotinib combined with platinum-etoposide chemotherapy as the first-line treatment for extensive-stage SCLC (ES-SCLC). This research aimed to explore the real-world efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy.Methods: Pathologically confirmed ES-SCLC patients receiving anlotinib plus platinum-etoposide chemotherapy as the first-line treatment were enrolled in this retrospective study. The primary endpoint of this study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse reactions.Results: In total, 58 patients were included in this study. The median PFS was 6.0 months [95% confidence interval (CI): 3.5-8.5], and the median OS was 10.5 months (95%CI 8.7-12.3). Thirty-four patients achieved partial response (PR), 18 patients achieved stable disease (SD), and 6 patients achieved progressive disease (PD). Respectively, the ORR and DCR were 58.6% and 89.6%. The main treatment-related adverse reactions were generally tolerated. The most common adverse reaction was myelosuppression (44.8%), followed by hypertension (41.4%), fatigue (34.5%), gastrointestinal reaction (32.7%), hand-foot syndrome (24.1%), and so on. Multivariate analysis showed that post-medication hand-foot syndrome [PFS 8.5 vs. 5.5 months, Hazards Ratio (HR)=0.23, 95%CI 0.07-0.72, P =0.012] was the independent predictor of PFS, and hypertension (OS 15.9 vs. 8.3 months, HR=0.18, 95%CI 0.05-0.58, P =0.005) was the independent predictor of OS.Conclusion: Anlotinib combined with platinum-etoposide chemotherapy as the first-line treatment for ES-SCLC appears to be effective and well-tolerated in the real-world. Patients with post-medication hypertension and hand-foot syndrome may confer superior prognosis. Further investigations are needed by prospective studies with larger sample size.

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Section: Safetysupporting

confidence: 88%

Section: Safetymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Efficacy And Safety of Anlotinib Combined With Platinum-Etoposide Chemotherapy As First-Line Treatment For Extensive-Stage Small Cell Lung Cancer: A Chinese Multicenter Real-World Study

Zheng

Jiang

Gao

et al. 2022

Preprint

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“… 11 Moreover, some small sample clinical trials found that the efficacy of anlotinib combined with chemotherapy was better than chemotherapy alone. 12 , 19 , 20 Nevertheless, the real-world efficacy and safety of anlotinib in ES-SCLC are still worthy of further exploration. Therefore, we conducted this multicenter real-world study to address this issue.…”

Section: Discussionmentioning

confidence: 99%

The Efficacy and Safety of Anlotinib in Extensive-Stage Small Cell Lung Cancer: A Multicenter Real-World Study

Zheng¹,

Jiang²,

Gao³

et al. 2022

CMAR

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Purpose Anlotinib, an antiangiogenic multi-target tyrosine kinase inhibitor (TKI), has shown favorable anticancer efficacy and acceptable safety in treating extensive-stage small cell lung cancer (ES-SCLC) in some clinical studies. This research aimed to explore the real-world efficacy and safety of anlotinib in ES-SCLC. Methods Pathologically confirmed ES-SCLC patients receiving anlotinib were enrolled for this retrospective study. The primary endpoint of this study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse reactions. Results In total, 202 patients were included in this study. The median PFS of all patients was 4.8 months [95% confidence interval (CI): 3.9–5.7], and the median OS was 7.6 months (95% CI 6.5–8.7). Respectively, the overall ORR and DCR were 30.2% and 87.1%. The univariate and multivariate Cox regression analyses revealed that patients with Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1, plus chemotherapy or immunotherapy, plus radiotherapy, and post-medication hypertension might have longer PFS and OS. The PFS and OS were significantly prolonged in combination group than that in monotherapy group [PFS 6.0 vs 3.6 months, hazards ratio (HR)=0.49, 95% CI 0.34–0.70, P < 0.001; OS 9.2 vs 4.8 months, HR = 0.48, 95% CI 0.32–0.72, P < 0.001]. The main treatment-related adverse reactions were generally tolerated. The incidence of adverse reactions in combination group was higher than that in monotherapy group (75.0% vs 52.6%, P = 0.001). The most common adverse reaction was hypertension, followed by hand-foot syndrome and fatigue, regardless of monotherapy or combination group. Conclusion Anlotinib is effective and well tolerated in patients with ES-SCLC in the real-world. The clinical efficacy of anlotinib combined with chemotherapy or immunotherapy is better than that of monotherapy. Further investigations are needed for prospective studies with larger sample size.

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“…Based on ALTER 1202 study, anlotinib was approved by the China Food and Drug Administration (CFDA) in 2019 as the third-line and above treatment for SCLC (17). Additionally, some small sample size clinical trials in China have shown the favorable efficacy of anlotinib combined with platinum-etoposide chemotherapy (18)(19)(20). The 2021 American society of clinical oncology (ASCO) meeting announced the preliminary result of a phase II clinical study on the efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy in the first-line treatment of ES-SCLC.…”

Section: Introductionmentioning

confidence: 99%

The efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A Chinese multicenter real-world study

Zheng

Jiang²,

Gao³

et al. 2022

Front. Oncol.

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BackgroundPatients with extensive-stage small-cell lung cancer (ES-SCLC) have high recurrence rates and bleak prognosis. This multicenter real-world study aimed to explore the efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy as the first-line treatment of ES-SCLC.MethodsPathologically confirmed ES-SCLC patients receiving anlotinib plus platinum-etoposide chemotherapy as the first-line treatment were enrolled in this retrospective study. The primary endpoint of this study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse reactions. The Cox regression analyses were employed to investigate the independent prognostic factors for OS and PFS of these individuals.ResultsIn total, 58 patients were included in this study. The median PFS was 6.0 months [95% confidence interval (CI): 3.5-8.5], and the median OS was 10.5 months (95%CI 8.7-12.3). Thirty-four patients achieved partial response (PR), 18 patients achieved stable disease (SD), and 6 patients achieved progressive disease (PD). The ORR and DCR were 58.6% and 89.6%. The main treatment-related adverse reactions were generally tolerated. Myelosuppression (44.8%) was the most common adverse reaction, followed by hypertension (41.4%), fatigue (34.5%), gastrointestinal reaction (32.7%), and hand-foot syndrome (24.1%). Multivariate analysis showed that post-medication hand-foot syndrome [PFS 8.5 vs. 5.5 months, Hazards Ratio (HR)=0.23, 95%CI 0.07-0.72, P =0.012] was the independent predictor of PFS, and hypertension (OS 15.9 vs. 8.3 months, HR=0.18, 95%CI 0.05-0.58, P =0.005) was the independent predictor of OS.ConclusionAnlotinib combined with platinum-etoposide chemotherapy as the first-line treatment for ES-SCLC appears to be effective and well-tolerated in the real-world. Well-designed large-scale prospective studies are urgently needed in the future to verify our findings.

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P48.09 Anlotinib Plus Etoposide and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer: A Single Arm Phase II Trial

Cited by 4 publications

References 0 publications

The Efficacy And Safety of Anlotinib Combined With Platinum-Etoposide Chemotherapy As First-Line Treatment For Extensive-Stage Small Cell Lung Cancer: A Chinese Multicenter Real-World Study

The Efficacy And Safety of Anlotinib Combined With Platinum-Etoposide Chemotherapy As First-Line Treatment For Extensive-Stage Small Cell Lung Cancer: A Chinese Multicenter Real-World Study

The Efficacy and Safety of Anlotinib in Extensive-Stage Small Cell Lung Cancer: A Multicenter Real-World Study

The efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A Chinese multicenter real-world study

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