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Perran Fulden Yumuk
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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
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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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): Perran Fulden Yumuk
- Abstract
Background
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.
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P2.06 - Mesothelioma (ID 170)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Mesothelioma
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.06-22 - Is Laboratory Prognostic Index a Valuable Prognostic Index for Malignant Pleural Mesothelioma? (Now Available) (ID 1445)
10:15 - 18:15 | Presenting Author(s): Perran Fulden Yumuk
- Abstract
Background
Prognostic significance of Laboratory Prognostic Index (LPI) was demonstrated in non-small cell lung cancer before. We aimed to assess the prognostic value of LPI in patients with malignant pleural mesothelioma (MPM).
Method
Records of MPM patients were examined retrospectively for serum laboratory results at diagnosis along with demographical and clinicopathological features. LPI is consisted of white blood cell count (>10000/mm3), albumin (<3.5 g/dL), lactate dehydrogenase (>248 U/L), alkalene phosphatase (>120 U/L) and calcium (>10.5 mg/dL) levels; and it is graded according to the number of abnormal parameters: 0 (none), 1 (one) and 2 (two or more). Kaplan-Meier method and stratified log-rank test were used in univariate analysis and a Cox regression model was conducted to determine independent predictors of overall survival (OS).
Result
Sixty-one patients were included in the study. Median age at diagnosis was 59 (51-66) years. 45 deaths (73.8%) have occurred at the time of final analysis and median OS was 19.5 months. One-year survival rates for patients with LPI 0, 1 and 2, were 82%, 61% and 59%; 2-year survival rates were 75%, 47% and 24%, respectively. Median OS of patients with LPI 0, 1 and 2 were 36.5, 21.7 and 15.6 months, respectively (p=0.007). Age, ECOG performance status, histology, hemoglobin level and LPI were found to effect OS significantly or to have a trend (p<0.1). In multivariate analysis, LPI (p=0.033) and ECOG performance status (p<0.001) were the independent prognostic factors.
Conclusion
The LPI may be a valuable prognostic factor in mesothelioma as well. Larger studies are needed to confirm this result.
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P2.17 - Treatment of Early Stage/Localized Disease (ID 189)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.17-23 - The Role Adjuvant Chemotherapy in Resected Stage 1 NSCLC with High Risk Factors: A Turkish Oncology Group Study (Now Available) (ID 2301)
10:15 - 18:15 | Author(s): Perran Fulden Yumuk
- Abstract
Background
Adjuvant chemotherapy is accepted as a standard treatment for suitable patients who have undergone surgery for T2N0 non-small cell lung cancer with tumors larger than 4 cm. Despite similar relapse rates, the benefit of adjuvant chemotherapy for smaller tumors with high risk features is not clear. In this retrospective analysis our aim was to evaluate the prognostic impact of adjuvant platin-based chemotherapy in high-risk stage 1 NSCLC patients.
Method
This cooperative group study included 250 NSCLC patients who underwent curative surgery for stage 1 NSCLC with tumor size 2-4 cm and adverse prognostic factors consisting of visceral pleural invasion(VPI), lympho-vascular invasion(LVI), high grade, presence of solid-micropapillary(SMP) components or STAS. Records of patients were analyzed to investigate the prognostic impact of adjuvant chemotherapy in this cohort. DFS was defined as the time from surgery to the last follow-up, until relapse or death, CSS;time from surgery to death related to cancer or last known contact, OS;time from diagnosis to death or last known contact. Statistical analysis was performed using SPSS 20.0 software(SPSSInc,Chicago,USA).
Result
Median age at presentation was 63 years (range 18-90). The mean tumor size was 29.4 ± 7.4 mm. The frequency of patients with specified risk factors were: VPI: n: 92 (36.8%); LVI: n: 91 (36.4%); Grade 3:n: 49 (19,6%); SMP:n: 76 (30.4%); STAS:n: 15 (6%). A total of 51 patients had received adjuvant platin-based chemotherapy. There were significantly more patients who received chemotherapy in the younger age group (<65 ears old, ≥65 years old) and those with larger tumors (2 – 3 cm, 3 – 4 cm).
During a median follow-up period of 91.8 months; 79 patients(31.6%) experienced recurrence, 62 patients(24.8%) have died, 144 patients(57.6%) were alive without disease and 24 patients (9.6%) were alive with disease.
5-year and 10-year OS rates were 72.7%(± 3,5) and 46.8%(± 8), respectively. There was a significant improvement in DFS with adjuvant chemotherapy, especially in groups with VPI (93.3% vs 53.6%, p:0.016) and SMP (92.3% vs 57.3%, p:0.03). There was also a non-significant trend for improved CSS and OS among patients who received CT.
Table 1. Effects of chemothrapy on survival. Chemotherapy Group
Events/N Median 5-years DFSNon - treatment Group
Events/N Median 5-years DFSP Value DFS 12/51 NE % 74.9 ± 6.3 81/190 71.1 months % 54 ± 4.2 0,032* CSS 4/49 NE % 89 ± 5 41/179 91.8 months % 76.9 ± 3.8 0,078 OS 10/49 NE %77.4 ± 6.4 51/179 88.9 months % 72.1 ± 4 0,541 *All values are stratified, respecting to significant confounding factors such as age, gender and tumor size.
Conclusion
Adjuvant platin-based chemotherapy should be considered for this subset of patients having high grade tumors, or those with VPI, LVI or solid-micropapillary components. Prospective, randomized trials incorporating clinical and molecular risk factors are required to clarify the role of adjuvant chemotherapy for stage 1 NSCLC patients.
