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Saadettin Kilickap
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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): Saadettin Kilickap
- 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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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-01 - Cemiplimab, a Human PD-1 Monoclonal Antibody, Versus Chemotherapy in First-Line Treatment of Advanced NSCLC with PD-L1 ≥50% (ID 1380)
10:15 - 18:15 | Author(s): Saadettin Kilickap
- Abstract
Background
Most patients (pts) with non-small cell lung cancer (NSCLC) present with advanced disease at diagnosis. Despite initial response to platinum-based doublet chemotherapy, an established first-line treatment for pts with advanced NSCLC whose tumours do not have EGFR, ALK, or ROS 1 mutations, pts often progress and require additional treatment options. In recent years, anti-programmed death-1 (anti–PD-1) therapies have emerged as an effective treatment option for advanced NSCLC, potentially allowing some patients with PD-L1 expression ≥50% to avoid chemotherapy. However, there is currently only one PD-1 inhibitor approved as monotherapy in first-line treatment of NSCLC. In a Phase 1 trial of pts with advanced malignancies, including NSCLC, cemiplimab exhibited anti-tumour activity with a safety profile similar to those described for other anti–PD-1 agents. Cemiplimab-rwlc is the only Food and Drug Administration-approved treatment for patients with advanced cutaneous squamous cell carcinoma.
Method
This is a randomised (1:1), multicentre, open-label, Phase 3 study of cemiplimab versus platinum‑based doublet chemotherapy in systemic treatment‑naïve pts (≥18 years) with stage IIIB, IIIC or IV squamous or non‑squamous NSCLC whose tumours express PD‑L1 in ≥50% of tumour cells (NCT03088540). Pts will be stratified by histology and geographic region. Pts will receive cemiplimab 350 mg every 3 weeks intravenously (for up to 108 weeks) or 4–6 cycles chemotherapy with (i) paclitaxel + cisplatin or carboplatin, (ii) pemetrexed + cisplatin or carboplatin with or without pemetrexed maintenance, (iii) or gemcitabine + cisplatin or carboplatin. Crossover from chemotherapy to cemiplimab and addition of chemotherapy to cemiplimab at the time of disease progression is allowed. The primary objective is to evaluate progression-free survival (PFS) as determined by blinded independent review committee. Key secondary objectives include assessment of overall survival and objective response rate. An independent data monitoring committee will monitor safety data during study conduct.
Result
Section not applicable
Conclusion
Section not applicable
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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): Saadettin Kilickap
- 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.
