Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study

Bendaly, Edmond; Dalal, Anand A.; Culver, Kenneth W.; Galebach, Philip; Будыкина, Т. С.; Foster, Rebekah; Sasané, Medha; Macalalad, Alexander R.; Guérin, Annie

doi:10.1007/s12325-017-0527-6

Cited by 17 publications

(28 citation statements)

References 19 publications

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“…Similar to results from previously conducted studies of real-world treatment patterns for ALK+ NSCLC [25,26,[36][37][38][39], we found that crizotinib was the most commonly prescribed first-line ALK TKI therapy in clinical practice. In the second-line ALK TKI setting (post crizotinib), our results showed that ceritinib was the most commonly prescribed therapy, which is consistent with the approval timelines and similar to the results of other real-world studies [24,25,[37][38][39][40][41][42]. These results are not surprising, as crizotinib was initially approved by the FDA in 2011 and was the first commercially available ALK TKI therapy in the U.S. [43].…”

Section: Discussionsupporting

confidence: 88%

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

et al. 2020

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Background. Little is known about real-world treatment and outcomes of patients with anaplastic lymphoma kinasepositive (ALK+) advanced non-small cell lung cancer (NSCLC). Patients and Methods. This retrospective study of the Flatiron Health EHR-derived deidentified database included patients with a lung cancer diagnosis and confirmed advanced NSCLC who received ALK tyrosine kinase inhibitor (TKI) therapy (January 1, 2011, through June 30, 2018). Patient characteristics and treatment patterns were characterized. Real-world progression-free survival (rwPFS) and time to discontinuation were calculated using the Kaplan-Meier method. Results. First-line ALK TKI therapy was administered to 581 patients (27.5% had brain metastasis on or prior to initiation) and second-line ALK TKI therapy to 254 patients post crizotinib (45.7% had brain metastasis on or prior to second-line ALK TKI initiation). Crizotinib (84.6%; n = 492) was the most commonly administered first-line ALK TKI therapy. For second-line ALK TKI post crizotinib (n = 254), 49.6% received ceritinib, 41.7% received alectinib, 5.9% received crizotinib retreatment, and 2.8% received brigatinib. Median (95% confidence interval [CI]) rwPFS was 7.47 (6.48-8.32) months for first-line and 7.30 (5.72-8.42) months for second-line ALK TKI. Median (95% CI) rwPFS was significantly longer among first-line ALK TKI patients without than with brain metastasis (8.52 [7.57-10.59] vs. 4.97 [3.75-5.99] months; p < .0001) and patients with brain metastasis on or prior to first-line ALK TKI therapy had a significantly increased risk of progression (hazard ratio AE SE, 1.976 AE 0.112; p < .0001). Conclusion. Median rwPFS in patients with advanced ALK+ NSCLC was < 8 months for firstand second-line ALK TKI therapy and was even shorter in patients with brain metastasis, highlighting the need for more effective treatments in this patient population. The Oncologist 2020;25:867-877 Implications for Practice: Results presented herein describe real-world treatment of advanced ALK+ NSCLC with ALK TKI therapies from January 2011 through June 2018. Crizotinib was the most commonly prescribed first-line ALK TKI therapy in this patient population, but the majority of data analyzed were obtained prior to Food and Drug Administration approval of alectinib and ceritinib in the first-line ALK TKI setting. Physicians should monitor patients closely to help identify when a change in treatment should occur.

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Section: Discussionsupporting

confidence: 88%

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

et al. 2020

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“…Din et al reported that crizotinib showed a 1 year survival rate of 71.2% and an objective response rate of 70.9% [34]. Bendaly et al reported that the ORR for ceritinib was 69% and median PFS was 12.9 months [6]. In a large, multi-country medical chart review (n = 1471) with seven countries, there was a significant improvement in complete response (odds ratio (OR), 2.65; 95% CI, 1.69-4.15) and a significant reduction in recurrence/progression (OR, 0.38; 95% CI, 0.24-0.59) [35].…”

Section: Comparison With Previous Studiesmentioning

confidence: 99%

“…One of them is crizotinib, initially designed for a mesenchymal-epithelial transition factor (MET) inhibitor in 2007, which prompted the development of anaplastic lymphoma kinase (ALK) target therapy [5]. It became the first ALK inhibitor to be approved by the Food and Drug Administration (FDA) in 2011 for standard first-line therapy in ALK-positive NSCLC, which accounts for approximately 2-7% of patients diagnosed with NSCLC [6]. However, the progression of brain metastases and resistance were the biggest challenges during crizotinib treatment [7].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Crizotinib, Ceritinib, and Alectinib in ALK-Positive Non-Small Cell Lung Cancer Treatment: A Meta-Analysis of Clinical Trials

Hoang

Myung

Pham

et al. 2020

Cancers

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This study aimed to evaluate the efficacy of anaplastic lymphoma kinase (ALK)-inhibitors in the treatment of ALK-positive non-small cell lung cancer (NSCLC) by using a meta-analysis of clinical trials. We searched PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov by using keywords related to the topic in August 2018. The pooled effect sizes were calculated based on a random-effects model. We also performed subgroup meta-analysis by types of ALK inhibitors (crizotinib, ceritinib, and alectinib). A total of 20 clinical trials with 10 single-arm trials and 10 double-arm trials were included in the final meta-analysis. The median overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), 1 year survival rate, and 2 year survival rate were 19.14 months, 8.47 months, 62%, 78%, 74%, and 62%, respectively. ALK inhibitors showed a significantly superior efficacy compared with chemotherapy (hazard ratio (HR) for OS, 0.83; HR for PFS, 0.43; rate difference (RD) for ORR, 0.23; and RD for DCR, 0.10). The current meta-analysis of clinical trials showed the significant efficacy of ALK inhibitors in the treatment of ALK-positive NSCLC. Further head-to-head trials are needed to compare their efficacy with other types of NSCLC treatment regimens. PROSPERO registration: CRD42018085987.

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“…97 It is worth noting that ceritinib may be highly effective in patients whose disease has progressed on crizotinib and has metastasized regardless of where the metastatic site is. 100…”

Section: Ceritinibmentioning

confidence: 99%

Metastasis manners and the underlying mechanisms of ALK and ROS1 rearrangement lung cancer and current possible therapeutic strategies

Chang

Man

et al. 2019

RSC Adv.

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Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study

Abstract: Novartis Pharmaceutical Corporation.

Cited by 17 publications

References 19 publications

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

Efficacy of Crizotinib, Ceritinib, and Alectinib in ALK-Positive Non-Small Cell Lung Cancer Treatment: A Meta-Analysis of Clinical Trials

Metastasis manners and the underlying mechanisms of ALK and ROS1 rearrangement lung cancer and current possible therapeutic strategies

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