Real-World Outcomes in Patients with Alk-Positive Non-Small Cell Lung Cancer Treated with Crizotinib

Davis, Kevin; Kaye, James A.; Masters, Elizabeth T.; Iyer, Shrividya

doi:10.3747/co.25.3723

Cited by 19 publications

(22 citation statements)

References 24 publications

(48 reference statements)

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“…Similar to results from previously conducted studies of real‐world treatment patterns for ALK + NSCLC [25, 26, 36–39], 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, 37–42].…”

Section: Discussionsupporting

confidence: 87%

“…The rwPFS for crizotinib as first line of ALK TKI therapy in our analysis (6.64 months) is similar to the results of previous real‐world analyses (6.1 to 9.5 months) [24–27] but is shorter than the PFS reported for crizotinib in the PROFILE 1007 (7.7 months), J‐ALEX (10.2 months), PROFILE 1014 (10.9 months), PROFILE 1029 (11.1 months), and ALEX (11.1 months) clinical trials [3, 4, 6, 28, 29]. However, clinical and radiologic tumor assessment of rwPFS is allowed during a wide range of timepoints (e.g., every 8–16 weeks) and patient population is less rigorously selected, so we expected variation between the results of our analysis and results from clinical trials.…”

Section: Discussionsupporting

confidence: 87%

See 1 more Smart Citation

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: 87%

Section: Discussionsupporting

confidence: 87%

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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“…We report a median OS of 31.0 months after initiation of crizotinib, which is comparable with the previous estimation of 33.8 months reported by the US retrospective observational study evaluating crizotinib in the first- and second-line settings. 10 However, the median OS time in these two studies was longer than the median OS time of 23.4 months in the retrospective medical record review conducted in the United States and Canada by Davis et al 11 Two hundred twelve patients were included in this review, and 65% of patients initiated crizotinib as first-line therapy. A majority of patients were men (69%), were current or former smokers (66.5%), and had not previously received other cancer-directed treatment (52.8%).…”

Section: Discussionmentioning

confidence: 92%

Overall Survival of Patients With ALK-Positive Metastatic Non–Small-Cell Lung Cancer in the Russian Federation: Nationwide Cohort Study

Tsimafeyeu¹,

Moiseenko

Орлов

et al. 2019

JGO

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PURPOSE The overall survival (OS) results in patients with ALK-positive metastatic non–small-cell lung cancer (NSCLC) have rarely been reported. The aim of this prospective-retrospective cohort study was to obtain real-world data on the use of crizotinib or chemotherapy in patients with ALK-positive metastatic NSCLC in Russia. PATIENTS AND METHODS Patients with epidermal growth factor receptor–negative metastatic NSCLC were screened in 23 cancer centers. To be eligible, patients were required to have confirmation of ALK rearrangement. Patients were treated with crizotinib (250 mg twice daily; n = 96) or the investigator’s choice of platinum-based chemotherapy (n = 53). The primary end point was OS. RESULTS A total of 149 ALK-positive patients were included. Mean age was 53 years in both groups. Patients were predominately women (59%) and never-smokers (74%), and most patients had adenocarcinoma histology (95%). At a median follow-up time of 15 months, 79 of the 149 patients included in the analysis had died. Median OS from the start of treatment was 31 months (95% CI, 28.5 to 33.5 months) in the crizotinib group and 15.0 months (95% CI, 9.0 to 21.0 months) in the chemotherapy group ( P < .001). The objective response rate was 34% in the crizotinib group. Among patients with brain metastasis, one complete response (6%) and five partial responses (31%) were achieved. Grade 3 adverse events were observed in three patients (3%) in the crizotinib group. CONCLUSION The improved OS observed in crizotinib clinical trials in ALK-positive NSCLC was also observed in the less selective patient populations treated in daily practice in Russia. The use of standard chemotherapy in these patients remains common but seems inappropriate as a result of the effectiveness of newer treatments, such as crizotinib.

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“…On the other hand, there was a report that the proportion of men was slightly higher than women (7). In addition, recent studies showed that 69% and 65.8% were male patients (9,11). Ke et al reported that the percentage of women was significantly higher in patients younger than 60 years compared to those older than 60 years (28).…”

Section: Discussionmentioning

confidence: 98%

“…Because of the rarity of ALK-rearranged NSCLC, it is important to collect and evaluate data in clinical practice in addition to the results of clinical trials to evaluate its significance. ALK rearranged gene mutation is an oncogenic driver of NSCLC and commonly associated with younger age (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). Although under a small number, however, elderly ALKrearranged NSCLC patients also have been reported (17)(18)(19).…”

mentioning

confidence: 99%

Clinicopathological Features in Elderly ALK-rearranged Non-small Cell Lung Cancer Patients

Miyazaki¹,

Sato²,

Kodama³

et al. 2020

In Vivo

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Aim: To clarify the clinicopathological features in elderly anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC) patients. Patients and Methods: A retrospective study was performed in 129 ALK rearranged NSCLC patients diagnosed between April 2008 and March 2019 in fifteen Institutions of the Ibaraki prefecture, Japan. Results: Median age of patients was 63 years. In 59 patients aged 65 and older, the proportions of patients with advanced stage and those treated with ALKtyrosine kinase inhibitor (TKI) were lower than those younger than 65 years. There was no difference in overall survival (OS) between the two age groups. Among the elderly patients, no difference was observed in OS between the patients aged 65-69 and those aged 70 and older. In 89 patients treated with TKI, no significant differences were observed in the progression-free survival of TKIs and OS between patients aged 65 and older and those younger than 65, respectively. Conclusion: Evaluation of ALK gene status and TKI treatment are desirable even for elderly patients. Advances in molecular biology have led to discovery of specific driver genes in certain cancer types and therefore to development of specific therapeutics (1, 2). This new trend is evident in the clinical practice of NSCLC patients. Mutations in the anaplastic lymphoma kinase (ALK) fusion gene is one such driver gene. Long-term survival can be expected in ALKrearranged NSCLC patients, but its frequency is very rare (1, 2001 This article is freely accessible online.

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Real-World Outcomes in Patients with Alk-Positive Non-Small Cell Lung Cancer Treated with Crizotinib

Abstract: Background Crizotinib has shown greater efficacy in clinical trials than chemotherapy in patients with anaplastic

Cited by 19 publications

References 24 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

Overall Survival of Patients With ALK-Positive Metastatic Non–Small-Cell Lung Cancer in the Russian Federation: Nationwide Cohort Study

Clinicopathological Features in Elderly ALK-rearranged Non-small Cell Lung Cancer Patients

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