First-line anlotinib-based combination treatment for patients with advanced non-small cell lung cancer: A three arms, prospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21073-e21073
Author(s):  
Baohui Han ◽  
Tianqing Chu ◽  
Wei Zhang ◽  
Bo Zhang ◽  
Xueyan Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Common Grade ◽  
Grade 3 ◽  
Egfr Mutated

e21073 Background: Anlotinib, a multi-target tyrosine kinase inhibitor antiangiogenic drug, had been recommended by guideline for the 3 lines or more treatment of non-small cell lung cancer (NSCLC) in China. However, data of anlotinib based combination in the first-line treatment remains unknown. Therefore, this study aims to evaluate efficacy and safety of the combination of erlotinib, chemotherapy or sintilimab with anlotinib respectively, in Chinese patients with locally advanced or metastatic NSCLC. Methods: In this open-label, three arms, prospective study, locally advanced or metastatic NSCLC patients with EGFR mutation (exon 19 deletion or L858R) (Cohort A) receive anlotinib (10 mg QD from day 1 to 14 of a 21-day cycle) and erlotinib (150 mg once daily) until disease progression or treatment intolerance. For patients with EGFR mutation negative, the treatment regimen was anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) in combination with chemotherapy (Cohort B) or sintilimab (Cohort C) according to investigator. The primary outcome was objective response (ORR), the secondary outcomes were progression free survival (PFS), disease control rate (DCR), overall survival (OS) and safety. Results: A total of 80 patients were enrolled with 30 patients in Cohort A, 28 patients in Cohort B, and 22 patients in Cohort C. Among these patients, 16 (57.1%), 7 (23.3%) and 1(4.5%) were female in Cohort A, B, and C, respectively. And 9 (32.1%) and 4 (18.2%) of them had brain metastasis in Cohort A and C, respectively. Till December 2020, all the patients received tumor assessment at least once. In Cohort A, 26 patients achieved confirmed PR, the ORR was 92.9%, and DCR was 96.4%. Median PFS was 20.53 months, and the 12-month PFS rate was 81.5%. In Cohort B, 17 patients achieved PR, the ORR was 60.0%, while DCR was 96.7%. Median PFS was 13.3 months, and the 12-month PFS rate was 55.5%. In Cohort C, medium PFS was 15.6 months. The 18- and 24-month PFS rate was 45.9% and 26.2%, respectively. The most common grade 3 adverse events (AEs) were rash (17.2%), oral mucositis (10.3%), diarrhea (6.9%) and proteinuria (6.9%) in Cohort A, and a grade 4 hypertension was observed. In Cohort B, the most common grade 3 AEs were platelet count decreased (20.0%), leucopenia (16.7%), hand-foot-skin reaction (10.0%), hypertriglyceridemia (10.0%), oral mucositis (6.7%) and thrombus (6.7%). Grade 4 platelet count decreased occurred in three patients (10.0%). Safety data of Cohort C had been published elsewhere. Conclusions: This study suggest that anlotinib-based combination treatment for patients with advanced non-small cell lung cancer might be new first-line therapy strategy. For EGFR-mutated positive patients, anlotinib plus erlotinib shows good efficacy and well tolerability. For EGFR-mutated negative patients, anlotinib combines with chemotherapy or sintilimab also may be a promising first-line treatment. Clinical trial information: NCT03628521.

scholarly journals Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: a meta-analysis of clinical trials

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hao-chuan Ma ◽  
Yi-hong Liu ◽  
Kai-lin Ding ◽  
Yu-feng Liu ◽  
Wen-jie Zhao ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Treatment Options ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
First Line ◽  
Grade 3

Abstract Background Whereas there are many pharmacological interventions prescribed for patients with advanced anaplastic lymphoma kinase (ALK)- rearranged non-small cell lung cancer (NSCLC), comparative data between novel generation ALK-tyrosine kinase inhibitors (TKIs) remain scant. Here, we indirectly compared the efficacy and safety of first-line systemic therapeutic options used for the treatment of ALK-rearranged NSCLC. Methods We included all phase 2 and 3 randomised controlled trials (RCTs) comparing any two or three treatment options. Eligible studies reported at least one of the following outcomes: progression free survival (PFS), overall survival (OS), objective response rate (ORR), or adverse events of grade 3 or higher (Grade ≥ 3 AEs). Subgroup analysis was conducted according to central nervous system (CNS) metastases. Results A total of 9 RCTs consisting of 2484 patients with 8 treatment options were included in the systematic review. Our analysis showed that alectinib (300 mg and 600 mg), brigatinib, lorlatinib and ensartinib yielded the most favorable PFS. Whereas there was no significant OS or ORR difference among the ALK-TKIs. According to Bayesian ranking profiles, lorlatinib, alectinib 600 mg and alectinib 300 mg had the best PFS (63.7%), OS (35.9%) and ORR (37%), respectively. On the other hand, ceritinib showed the highest rate of severe adverse events (60%). Conclusion Our analysis indicated that alectinib and lorlatinib might be associated with the best therapeutic efficacy in first-line treatment for major population of advanced NSCLC patients with ALK-rearrangement. However, since there is little comparative evidence on the treatment options, there is need for relative trials to fully determine the best treatment options as well as the rapidly evolving treatment landscape.

Gemcitabine-Induced Severe Peripheral Edema in a Patient With Lung Cancer

2012 ◽  
Vol 25 (3) ◽  
pp. 393-395 ◽  
Author(s):  
Stamatis Katsenos ◽  
Melita Nikolopoulou
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Liver Transaminase ◽  
Peripheral Edema ◽  
Significant Toxicity

Gemcitabine, alone or in combination with a platinum-based agent, is indicated for the first-line treatment of patients with locally advanced or metastatic non–small-cell lung cancer. It is generally a well-tolerated drug. Despite its lack of significant toxicity, the most commonly reported side effects include myelosuppression, gastrointestinal disturbances (eg, nausea and vomiting), influenza-like symptoms, skin rash with pruritus, and elevation of liver transaminase enzymes. Peripheral edema has rarely been described as an adverse effect. Herein, we report a patient with advanced non–small-cell lung cancer who experienced severe peripheral edema after gemcitabine administration. Immediate gemcitabine discontinuation and the administration of diuretics resulted in definite regression of peripheral edema.

Randomized Phase II Study of Bortezomib Alone and Bortezomib in Combination With Docetaxel in Previously Treated Advanced Non–Small-Cell Lung Cancer

2006 ◽  
Vol 24 (31) ◽  
pp. 5025-5033 ◽  
Author(s):  
Michael P. Fanucchi ◽  
Frank V. Fossella ◽  
Robert Belt ◽  
Ronald Natale ◽  
Panos Fidias ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Single Agent ◽  
Small Cell ◽  
Small Cell Lung ◽  
Randomized Phase Ii ◽  
Common Grade ◽  
Grade 3 ◽  
One Year

Purpose To evaluate the efficacy and toxicity of bortezomib ± docetaxel as second-line therapy in patients with relapsed or refractory advanced non–small-cell lung cancer (NSCLC). Patients and Methods Patients were randomly assigned to bortezomib 1.5 mg/m2 (arm A) or bortezomib 1.3 mg/m2 plus docetaxel 75 mg/m2 (arm B). A treatment cycle of 21 days comprised four bortezomib doses on days 1, 4, 8, and 11, plus, in arm B, docetaxel on day 1. Patients could receive unlimited cycles. The primary end point was response rate. Results A total of 155 patients were treated, 75 in arm A and 80 in arm B. Baseline characteristics were comparable. Investigator-assessed response rates were 8% in arm A and 9% in arm B. Disease control rates were 29% in arm A and 54% in arm B. Median time to progression was 1.5 months in arm A and 4.0 months in arm B. One-year survival was 39% and 33%, and median survival was 7.4 and 7.8 months in arms A and B, respectively. Adverse effect profiles were as expected in both arms, with no significant additivity. The most common grade ≥ 3 adverse events were neutropenia, fatigue, and dyspnea (4% and 53%, 19% and 26%, and 17% and 14% of patients in arms A and B, respectively). Conclusion Bortezomib has modest single-agent activity in patients with relapsed or refractory advanced NSCLC using this schedule, with minor enhancement in combination with docetaxel. Additional investigation of bortezomib in NSCLC is warranted in combination with other drugs known to be active, or using different schedules.

Two different schedules of docetaxel plus cisplatin as first-line therapy in advanced non-small cell lung cancer: A preliminary result from a randomized phase II study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7135-7135
Author(s):  
S. Park ◽  
S. Bang ◽  
E. Cho ◽  
D. Shin ◽  
J. Lee
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Randomized Phase Ii ◽  
Grade 3 ◽  
Line Chemotherapy

7135 Background: There has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of this randomized study is to evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced non-small cell lung cancer (NSCLC). Methods: Consenting patients with stage IIIB/IV or recurrent NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m2 on day 1, plus either weekly (35 mg/m2 on day 1, 8, 15 of a 4-week cycle) or 3-weekly (75 mg/m2 on day 1 of a 3-week cycle) docetaxel, both for up to 6 cycles. Objectives of this randomized phase II trial were response, toxicity and quality of life (QOL; measured with EORTC QLQ-C30). With a two-stage phase II design, the required number of patients was 39 per each arm. Results: Of 85 patients accrued, 71 patients were evaluable for response and 83 for safety. Baseline characteristics were well-balanced between the two arms: male (56 patients); median age (64 years); adenocarcinoma/squamous cell carcinoma (53/32); stage IIIB/IV/recurrent (12/63/10); ECOG performance status 0/1/2 (20/44/21). Median number of chemotherapy cycles was 3 (1–6) for both arms. Median dose intensities were docetaxel 88%, cisplatin 98% in weekly arm, and docetaxel 97%, cisplatin 98% in 3-weekly arm. The objective responses of weekly and 3-weekly arm were 38% (95% CI, 23–53) and 42% (95% CI, 27–57), respectively. There was significantly more grade 3/4 neutropenia (66% v 12%; P < .001) and febrile neutropenia (40% v 7%; P < .001) on 3-weekly arm but less grade 3/4 diarrhea (2% v 14%; P = .05) and severe skin/nail toxicity (5% v 29%; P = .003). No difference in the rates of treatment delay or dose reduction for both arms; however, 19% of day 15 docetaxel were omitted in weekly arm due to toxicity. Conclusions: Both weekly and 3-weekly docetaxel plus cisplatin appear to be active as first-line chemotherapy for advanced NSCLC, with different safety profiles. Updated results and QOL data, including a prolonged follow-up, will be presented. No significant financial relationships to disclose.

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