First-line treatment outcomes of CML patients in a real-world data setting in Lebanon.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19031-e19031
Author(s):  
Fadi Nasr ◽  
Intissar Yehia ◽  
Reem El Khoury ◽  
Saada Diab ◽  
Ahmad Ghoche ◽  
...  

e19031 Background: BCR–ABL-targeting tyrosine kinase inhibitors (TKIs) constitute the cornerstone of treatment of CML leading to a life expectancy that is currently very close to that of age matched individuals in the general population. The aim of the current study was to describe aspects of CML in a real world data setting in Lebanon including responses to first lines with a specific focus on the impact of first-line treatment with imatinib compared to that of the second-generation TKI, dasatinib and nilotinib. We also evaluated what proportion of patients become eligible to attempt to stop their TKI treatment. Methods: Chronic myeloid leukemia registry was analyzed to evaluate response rates in the first line and eligibility for a treatment cessation attempt in adults diagnosed between 2003 and 2019. The registry covered 60 patients. 46 eligible patients were included in the study. BCR-ABL1 levels of ≤ 0.1%, ≤0.01% and ≤0.0032% on the international scale were defined as the molecular response end-points major molecular response(MMR), MR4.0 and MR,4.5 respectively. In the case of a switch in TKI therapy, the clinical chart was reviewed for the reason why the treating physician had changed the therapy (‘treatment failure’ or ‘TKI intolerance’). For the determination of eligibility to stop TKI, the inclusion criteria for the EURO-SKI trial were applied. Results: Seventy-two percent of the patients were treated with imatinib, 28% with a second-generation tyrosine kinase inhibitor (nilotinib and dasatinib). 15% of patients had discontinued their first-line treatment, mainly due to intolerance (10%) or treatment failure (5%). At 24 months, deep molecular response (MR 4.0 and MR4.5) were achieved at 16.7% and 38.9% respectively for imatinib, and at 22.2% and 33.3% respectively for second generation (p=1). The 5-year cumulative incidence of eligibility for a tyrosine kinase cessation attempt, according to EURO-SKI criteria, was 37%. Conclusions: In the current study we report the experience in CML from two health care institutions in Beirut, Lebanon. Our findings showed no statistically significant difference in response between the first and second generations. The criteria for an attempt to stop tyrosine kinase inhibitor therapy are met by a third of the patients.

2021 ◽  
Vol 21 ◽  
pp. S332-S333
Author(s):  
Fadi Nasr ◽  
Intissar Yehia ◽  
Reem El Khoury ◽  
Saada Diab ◽  
Ahmad Al Ghoche ◽  
...  

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2777-2777
Author(s):  
Dennis Dong Hwan Kim ◽  
Hong Gi Lee ◽  
Suzanne Kamel-Reid ◽  
Jeffrey H. Lipton

Abstract Abstract 2777 Background: The BCR/ABL transcript level at 3 months can predict long-term outcomes following frontline therapy with Imatinib or Dasatinib in chronic myeloid leukemia (CML) patients. However, data is lacking with second generation tyrosine kinase inhibitor (2GTKI) therapy after Imatinib failure. Methods: A total of 112 patients with CML in chronic phase (CP) receiving 2GTKI after Imatinib failure were reviewed. Treatment outcomes including complete cytogenetic (CCyR), major molecular (MMR) and molecular response 4.5 (MR4.5), treatment failure, progression-free (PFS) and overall survival (OS) were compared according to BCR/ABL transcript levels at 3 or 6 months, divided into <1%IS, 1–10%IS and °Ã10%IS. Results: Using cut off of 1%IS and 10%IS BCR/ABL transcript level, 70 patients (65%) showed <1%IS of BCR/ABL transcript level at 3 months, 16 patients (15%) between 1 and 10%IS, and 21 patients (20%), °Ã10%IS at 3 months. BCR/ABL transcript level at 3 months showed better correlation with OS (p<0.001) than that at 6 months (p=0.147). Better OS was also observed in the patients achieving <1%IS (100%) and 1–10%IS (100%) than those with °Ã10%IS at 3 months (70.6%, p<0.001). Those with <1%IS exhibited the best CCyR (100% at 12 months), MMR (93.1±3.2% at 18 months) and MR4.5 (80.2±6.3% at 3 years); those with 1–10%IS, intermediate (56.4±15.5% CCyR at 12 months; 22.1±14.1% MMR at 18 months; 10.0±9.5% MR4.5 at 3 years); and those with °Ã10%IS, the lowest CCyR (16.7±11.2% at 12 months), MMR (6.2±6.1% at 18 months) and MR4.5 rates (0%). Especially, in the subgroup of Imatinib resistant patients (n=59), none of them achieved MR4.5 if BCR/ABL transcript level is above 1% at 3 months (i.e. those with 1–10%IS or °Ã10%IS). Multivariate analysis confirmed strong correlation of BCR/ABL transcript level at 3 months with CCyR (HR 0.019), MMR (HR 0.047), MR4.5 (HR 0.057), treatment failure (HR 12.264), PFS (HR 7.754) and OS (HR 15.115). The group with <1%IS at 3 months maintained significantly lower BCR/ABL transcript level compared to other 2 groups. Conclusion: The BCR/ABL transcript level at 3 months is the most relevant surrogate for outcomes following 2GTKI therapy after Imatinib failure. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
pp. OP.20.00810
Author(s):  
Cheryl Ho ◽  
Brandon Chan ◽  
David Cameron ◽  
Aria Shokoohi ◽  
Dean A. Regier ◽  
...  

PURPOSE: Regulatory agencies such as the US Food and Drug Administration and health technology assessment bodies are increasingly using real-world evidence (RWE). The ability of healthcare systems to reliably generate response rate and progression-free survival from real-world data is unknown. We examined the capacity of a single-payer system to provide RWE by evaluating the frequency of computed tomography (CT) imaging during standard first-line metastatic systemic treatment of breast, colorectal, and lung cancer. METHODS: A 1-year cohort of patients with metastatic-at-diagnosis breast, colorectal, and lung cancer treated with first-line systemic therapy (excluding hormone therapy) referred to BC Cancer in 2016 was retrospectively reviewed for first-line treatment and CT imaging. Duration of first-line treatment was calculated from the first to the last dose of therapy. CT imaging was counted from the start of therapy to 8 weeks after the last therapy dose. RESULTS: A cohort of 664 patients was identified from the BC Cancer Registry. Distribution of metastatic disease at diagnosis was breast (n = 82), colorectal (n = 214), and lung (n = 368) cancer. For breast, colorectal, and lung cancer, there was a baseline CT within 4 weeks of treatment initiation in 59%, 51%, and 48% of patients, with median duration of first-line treatment of 14.6, 25.3, and 11.9 weeks and median CT imaging interval of 9.1, 9.0, and 6.1 weeks. CONCLUSION: In our publicly funded healthcare system, availability of baseline CT imaging was 48% to 59% and the frequency of assessment ranged from 6.1 to 9.1 weeks, subject to patterns of practice and resource availability. Our system was not capable of providing RWE for image-based end points. Alternative end points should be considered to capitalize on the wealth of real-world data.


2021 ◽  
Vol 21 ◽  
pp. S226
Author(s):  
Fadi Nasr ◽  
Intissar Yehia ◽  
Reem El Khoury ◽  
Saada Diab ◽  
Ahmad Al Ghoche ◽  
...  

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