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Flavia Amaral Duarte
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P74 - Health Services Research/Health Economics - Real World Evidence (ID 246)
- Event: WCLC 2020
- Type: Posters
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P74.01 - Barries in Precision Medicine Implementation Among Advanced Nonsquamous Cell Lung Cancer-Patients: A Real-World Scenario (ID 2528)
00:00 - 00:00 | Presenting Author(s): Flavia Amaral Duarte
- Abstract
Introduction
Precision oncology has a prominent role in nonsquamous cell lung cancer (nsNSCLC) treatment progress. However, in a real-world scenario, there are still many challenges to derive the most benefit for patients, such as delays in the prompt identification of biomarkers, which may impact the clinical outcome. This study aimed to investigate not-cost related factors involved in the use of nsNSCLC molecular profile in clinical practice and the influence of its availability on clinical decisions.
Methods
We retrospectively collected clinicopathological data from advanced nsNSCLC-patients. Biomarker tests (EGFR, ALK, ROS1, BRAF, KRAS and PD-L1) were ordered by an assistant oncologist in a referral private clinic through pharmaceutical companies-sponsored programs, between January 2015 and February 2020. The interval from the diagnosis of advanced nsNSCLC to the characterization of the biomarker profile, as well as the time between the testing request and final report were recorded. We also investigated the choice of therapy and changes in the treatment upon the testing results. Descriptive statistics summarized the data. A normality test was performed for each continuous variable. For comparisons between dependent samples, the Wilcoxon Signed Ranks was used, and statistical significance assumed at p <0.05.
Results
In this cohort, 78 patients were included. The mean age at diagnosis was 68.9 years (SD ±11.70); the majority were female, former or current smokers. The median time between the advanced nsNSCLC diagnosis and biomarker characterization was 40.5 days (range, 29.5-68.5). The median time to the beginning of any treatment, was 40 days (range, 22.6-56.3). In 44.9% (n=35) of patients, an actionable alteration was identified. However, in 58% of them (n=18/31), patients ended up receiving cytotoxic chemotherapy as the first-line treatment. As soon as the molecular profile became available, the chemotherapy was replaced by a tyrosine kinase inhibitor (TKI) in 9 cases. Thus, the median time to the TKI initiation was longer, 92.0 days (range, 45.0-234.0). Considering only the EGRF and ALK-negative population, who would be candidates for immunotherapy ± chemotherapy, only 19.57% (n=9/46) underwent this treatment modality upfront. Finally, to evaluate in which step of biomarkers testing more time was spent, we compared the median interval between the diagnosis and the test request to the interval between the request and the results (respectively 29.0 versus 12.0 days; p<0.001).
Conclusion
Our data show a long median time from advanced nsNSCLC diagnosis and the availability of the biomarker testing in medical practice, which impacted the choice of a non-personalized therapy as first line and the necessity of treatment changes after the final report. Moreover, in this study, the time between diagnosis and test request was the longest step related to the delays in molecular characterization of these tumors. Together, these findings suggest that, even when reimbursement is not the main issue, other barriers in the implementation of precision oncology need to be faced, such as availability of tumor samples and optimization of the processes involved in test request, including education of the multidisciplinary care team.
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P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P84.21 - Treatment with Alectinib after Crizotinib-Induced Hepatitis in an ALK-Rearranged Advanced NSCLC-Patient (ID 1590)
00:00 - 00:00 | Presenting Author(s): Flavia Amaral Duarte
- Abstract
Introduction
The multitargeted tyrosine kinase inhibitors (TKI) directed to anaplastic lymphoma kinase (ALK) fusion gene represented a breakthrough in the treatment of non-small-cell lung cancer (NSCLC) harboring this driver mutation. Although the clinical benefits of crizotinib, the first-in-class, concerns about its hepatotoxicity have been araised. However, there is a lack of evidence supporting the treatment with another ALK-targeted TKI after liver injury induced by crizotinib. Herein, we report a case of successful treatment with a second-generation ALK inhibitor in an ALK-rearranged advanced NSCLC-patient after recovering from acute hepatitis induced by crizotinib.
Methods
This is a case report of a patient under treatment in referral private oncology center in Brazil. Data were extracted retrospectively from medical charts. Written informed consent was obtained from the patient.
Results
A 32-years-old female patient, non-smoker had a 3-months onset of dyspnea and cough. Her computer tomography scan showed multiple lung nodules, associated with lymphangitis signs and thoracic vertebral bone lesion. She underwent a right inferior lobe segmentectomy, whose path report showed a lung carcinoma.
As symptoms were getting worse, carboplatin plus paclitaxel were initiated, while complementary histophatologic and molecular investigations were being performed. After two cycles, the immunohistochemistry confirmed a pulmonary adenocarcinoma and an ALK rearrangement was detected.
The treatment was promptly adjusted for crizotinib on November 11th, 2018. After almost 60 days of therapy, despite symptoms improvement, the patient presented some non-specific complaints such as nausea and fatigue. By December 21st, her laboratory review demonstrated a severe liver dysfunction (shown graph in 1). Crizotinib therapy was halted. Viral involvement and other etiologies were then excluded. Thenceforth, a gradual liver function recovery was observed.
Meanwhile, during the period without specific oncology treatment, dyspnea and cough return and the patient developed a headache onset. Central nervous system (CNS) and lung progressions were detected.
Since then, she started on alectinib. In few weeks later, she completely recovered from her respiratory symptoms and no liver function alteration recurred.
The patient is still under alectinib therapy with excellent tolerability and no adverse effects. PET-CT performed in December, 2019 did not show any metabolic activity as well as the brain MRI did not evidence any CNS involvement.
Conclusion
This case suggests that alectinib, even belonging to the same drug class, could be used as an alternative agent when crizotinib is the etiology of the liver damage. While evidence from clinical trials are scarce, experiences like that, in a real-world scenario, may add in clinical decision.
