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Mehmet Ali Nahit Sendur
EP1.04 - Immuno-oncology (ID 194)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
EP1.04-17 - The Association of Clinicopathologic Features and Peripheral Blood Parameters with High PD-L1 Expression in Non-Small Cell Lung Cancer (Now Available) (ID 2422)
08:00 - 18:00 | Author(s): Mehmet Ali Nahit Sendur
Programmed death ligand 1 (PD-L1) is a marker that widely used for prediction of response to immune check-point inhibitors (ICIs). Especially, PD-L1 tumor proportion score (TPS) of 50% or greater strongly predict the response of ICI in non-small cell lung cancer (NSCLC). However, dynamic alteration of PD-L1 expression are the major problems for reflection of the actual status of the PD-L1 expression level. Because of that, we aimed to investigate the factors that may be associated with PD-L1 TPS expression level for reflection of the actual status of PD-L1 TPS expression.Method
The patients who diagnosed with NSCLC and known PD-L1 expression level at the diagnosis were enrolled to study. The data was collected as retrospectively. PD-L1 expression was assessed by using PD-L1 IHC 22C3 pharmDx assay. The patients were stratified according to PD-L1TPS expression level as ≥ 50% and < 50%. For detection of PD-L1 related factors, clinicopathologic features and peripheral blood parameters which were obtained at the diagnosis and before the initiation of any treatment was used. Neutrophil-lymphocyte ratio (NLR) and the platelet-lymphocyte ratio (PLR) were calculated and also systemic immune-inflammation index was calculated by using formula as follow: (Neutrophil x Platelets)/ Lymphocyte.Result
Totally, 152 patients were enrolled to study. A hundred four of 152 patients (68.4%) were PD-L1 TPS expression level < 50% and 48 of 152 patients (31.6%) were also PD-L1 TPS expression level ≥ 50%.The clinicopathologic features were similar between TPS ≥ 50% and < 50% groups, except the amount of cigarette consumption. In univariate analyses; NLR, PLR, and SII were found significantly lower in patients with TPS ≥ 50% (p: 0.003 for NLR, p: 0.019 for PLR, p: 0.008 for SII).In correlation analyses NLR and PLR were found negatively correlated with PD-L1 TPS expression (r: -0.170, p:0.037 for NLR; r: -0.184, p: 0.024 for PLR).
The association of PD-L1 TPS expression and peripheral blood parameters
PD-L1 TPS < 50% (Median)
PD-L1 TPS ≥ 50% (Median)
According to the results of our study, NLR, PLR, and SII can be used to the prediction of the high PD-L1 expression level. In addition, NLR and PLR, easily accessible - assessable and also cheap markers, can be used for reflection of current PD-L1 expression status in the during the treatment with ICIs that targeted to PD-1/PD-L1.
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P1.14 - Targeted Therapy (ID 182)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
P1.14-15 - Lorlatinib in ALK- or ROS1-Positive Non-Small Cell Lung Cancer Patients: Experience from an Early Access Program in Turkey (ID 1971)
09:45 - 18:00 | Author(s): Mehmet Ali Nahit Sendur
Lorlatinib, a third generation ALK and ROS1 inhibitor, is indicated for the treatment of patients with ALK+ metastatic NSCLC whose disease has progressed on crizotinib and at least one second-generation ALK inhibitor. The aim of this study is to evaluate the efficacy and safety of lorlatinib in an Expanded Access Program (EAP) in Turkey.Method
The EAP was open-label, multicenter, and single-arm. Patients were eligible to receive lorlatinib (100 mg p.o/day) if they had advanced stage ALK- or ROS1-positive NSCLC and had progressed on crizotinib and/or second generation ALK inhibitors such as ceritinib or alectinib. The primary endpoint was PFS with lorlatinib. Secondary endpoints were objective response rate, overall survival, and safety.Result
Between February 2017 and December 2018, a total of 91 patients were admitted to the EAP at 27 oncology centers in Turkey. Eleven patients died before receiving the drug. Four patients were excluded from the EAP because of lost of the follow-up. Of the 76 patients who received drug, 13 were excluded from the analysis due to inability to access patient information. Six of these 13 patients were on lorlatinib treatment at the time of data collection. The median age of patients was 53.5 (17-84) years. Of 63 evaluable patients, 55 (87.3%) had ALK+ NSCLC and 8 (12.7%) had ROS1+ NSCLC. All patients had adenocarcinoma histology, and 54% (n=34) had brain metastasis before lorlatinib treatment. Twenty-one patients received lorlatinib as third-line treatment (mostly after chemotherapy and crizotinib). Median follow-up was 9.1 months. Five patients died before the first evaluation of response. In patients who received at least 1 dose of lorlatinib, median PFS was 12.6 months, and 1-year PFS rate was 53%. In ALK+ patients, median PFS was 14.7 months and 1-year PFS rate was 55%. In ROS1+ patients, median PFS was 9.1 months and 1-year PFS rate was 47%. In patients who received only crizotinib prior to lorlatinib, median PFS was 14.8 months and 1-year PFS rate was 59%. In patients who received ≥2 ALK inhibitors prior to lorlatinib, median PFS was 5.1 months and 1-year PFS rate was 27%. One-year OS rate was 65%. In response-evaluable patients (n=55), the ORR and DCR were 68.6% and 87.0% all patients. However, ORR and DCR were 69.6% and 87.0% for ALK+ and 62.5% and 87.5% for ROS1+ patients. Of response-evaluable 55 patients, the frequency of brain metastasis before lorlatinib was 54.5% (n=30). In only 7 patients (12.7%), brain metastasis developed under lorlatinib treatment. CNS control rate with lorlatinib was 87.3%. Dose reduction occurred in 9 patients (14.3%). Reasons for discontinuation of treatment were disease progression (n=17, 26.8%), adverse events (n=2, 3.2%), death (n=13, 20.6%), and unknown reasons (n=13, 20.6%).Conclusion
In this EAP, lorlatinib showed systemic activity in patients with advanced ALK+ or ROS1+ NSCLC, regardless of CNS metastases and previous TKI treatment.