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Jiang, Ginger

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Jiang, Ginger

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    CNS Activity of Alectinib in Advanced ALK-Rearranged NSCLC: A Retrospective Review
    (2018-05-15) Jiang, Ginger
    Purpose: Central nervous system (CNS) metastases are a significant contributor to morbidity and mortality in ALK-rearranged non-small cell lung cancer (NSCLC). While the ability ofalectinib is known to have excellent CNS activity alectinib to control CNS disease in ALK-rearranged NSCLC has been demonstrated, clinical trial data in the literature are limited to patients with stable treated or asymptomatic untreated CNS metastases. Clinical oOutcomes of alectinib therapy in patients with untreated symptomatic, large CNS lesions have not previously been describedremain undetermined. There is significant need for a more complete understanding of the ability of alectinib to control symptoms and prevent disease progression in this important subset of patients. Materials and Methods: Database review identified a total of 68 patientsPatients with advanced ALK-rearranged NSCLC who were treated with alectinib at the Massachusetts General Hospital Cancer Center were eligible for this study. or alectinib and RT Patients must haveand had untreated, active CNS metastases prior to receiving treatment initiationstarting alectinib or RT followed by alectinib at Massachusetts General Hospital Cancer Center. Medical records were retrospectively reviewed to extract data on clinicopathologic features and treatment histories. Intracranial time to progression (TTP) and overall progression- free survival (PFS) were analyzed.were calculated from the alectinib start date until the date of intracranial or overall progression, defined as radiographic of clinical progression. Intracranial and overall PFS were determined using the Kaplan-Meier method. Log-rank testing will be used to assess differences in intracranial and overall PFS. Categorical variables were compared using a chi-square test. A 2-sided significance level of less than 0.05 was considered statistically significant. Results: We identified 68 patients eligible for this study. The overall median intracranial TTP after on alectinib was 19.8 months [(95% confidence interval (CI), 14.7- to 25.4 months]. Median overall PFS was 14.5 months (95% CI, 8.4- to 19.1 months). Overall and intracranial PFS were comparable in patients regardless of size of largest CNS metastasis, presence of symptoms, presence of radiographic edema, or steroid need for CNS disease. The CNS disease control rate at 12 weeks was 95%. Among 24 patients in this study with untreated, active CNS metastases that were 1 cm and/or symptomatic, the median overall PFS was 17.4 months (95% CI, 10.5-21.4 months) with a median intracranial TTP of 17.4 months (95% CI, 12.2.5-21.4 months). The intracranial TTP was comparable in patients regardless of the size of the largest CNS metastasis, presence of symptoms attributable to CNS disease, presence of associated radiographic edema, or steroid requirement for CNS disease. Conclusions: Alectinib alone in the absence of RT is an efficacious highly effective option for managementin the treatment of intracranial and overall diseaseCNS disease in patients with advanced ALK-rearranged NSCLC, including in those patients with symptomatic or severe large CNS disease. brain metastases. These findings suggest that CNS radiation could potentially be deferred in this patient population, and underscore the value of further development of ALK inhibitors with excellent CNS penetration.