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Valery Breder
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-107 - Comparison of Outcomes in Responders and Nonresponders to Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts (ID 550)
08:00 - 18:00 | Author(s): Valery Breder
- Abstract
Background
The extent to which treatment response to immunotherapy translates into quality-adjusted survival time in NSCLC pts is worthwhile. We aimed to evaluate survival outcomes adjusted to quality of life (QoL) in NSCLC pts who are responders (Rs) and nonresponders (nRs) to nivolumab (Nivo) as 2+ line treatment within expanded access program and in a real-world practice.
Method
Adult pts with advanced platinum refractory NSCLC were enrolled in 11 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) – NCI CTCAE v3.0. Pts with complete/partial response or disease stabilization (CR/PR or SD) at first tumor evaluation were considered as Rs, with progression or early death due to disease – as nRs. For QoL assessment pts filled out RAND SF-36 at different times during Nivo treatment. Overall survival (OS) and progressive-free survival (PFS) curves were evaluated by the Kaplan-Meyer method and compared by the log-rank test. Quality-adjusted outcomes in Rs and nRs were compared using Q-TWiST method. UTWiST and UREL were calculated on the basis of SF6D.
Result
Overall, 200 pts were included in the analysis: 65% – males; median age – 62 y.o.; ECOG 0-1 – 81%; former/current smokers – 70.5%; non squamous NSCLC – 64%; ≥2 lines of previous treatment – 53%. Median follow-up – 7.5 mos; 195 pts completed Nivo treatment at cut-off. Out of 200 pts response was not evaluated in 7 pts; among 193 pts 58% were categorized as Rs, 42% – nRs (the median evaluation time – 2.1 mos). Responder status was not significantly associated with demographics, smoking status, or baseline ECOG. Median duration of PR/SD in Rs – 4.4 mos (CI 95% 0.7-33.4). Median follow-up in nRs – 1.8 mos (CI 95% 0.26-4.21). As compared with nRs, Rs had longer median OS (18.7 vs 3.5 mos, p<0.001) and PFS (9.1 vs 1.8 mos, p<0.001) as well as longer TWiST (mean 12.5 vs 1.9 mos, 95%CI of difference 8.4–12.9). Mean Q-TWiST in Rs was 11.8 mos vs 4.8 mos in nRs with 7.0 mos gain. Relative Q-TWiST gain is 88%.
Conclusion
The results obtained in this observational study demonstrate acceptable treatment outcomes of Nivo in advanced refractory NSCLC pts. Response to Nivo treatment is significantly associated with better median PFS and OS and accompanied with better quality-adjusted survival outcomes in this difficult patient cohort. The Q-TWiST provides a comprehensive assessment of the benefit of response to immunotherapy into quality-adjusted survival in NCSLC pts.
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EP1.14 - Targeted Therapy (ID 204)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.14-51 - Lorlatinib in Crisotinib-Resistant ALK+ NSCLC Patients. Our Experience (ID 1630)
08:00 - 18:00 | Author(s): Valery Breder
- Abstract
Background
Background: Lorlatinib is the third generation inhibitor of ALK and ROS1 tyrosine kinase has shown activity in patients with crisotinib-refractory ALK-positive NSCLC most of whom had CNS metastases . We report results of the overall and intracranial antitumor activity of patients with crisotinib-refractory ALK-positive NSCLC.
Method
Patients with ALK and ROS1-positive NSCLC who had progressed after crisotinib and at least one regimen of chemotherapy with or without CNS metastases with ECOG PS was 0-2 and adequate organ functions were given lorlatinib 100 mg orally once daily continuously. Primary endpoint - overall and intracranial objective response, secondary endpoint – safety of lorlatinib.
Since January 2017 to July 2018 39 patients were enrolled: ALK+- 36, ROS1+ - 3 pts. Median age 49 years. Patient characteristics summarised in Table 1.
Table 1. Baseline characteristics
Result
Objective response was achieved in 22 pts (56, 4%) – 3 complete (7,7%) and 19 partial (48,7%) responses. 16 pts( 41%) had stabilization as the best response, 1 ALK+ pt progressed. So disease control is 97,4%. Among 27 pts with brain metastases intracranial objective responses were observed in 20 pts (74%), included 8 complete (30%) and 12 patial responses (44%), 7 pts (26%) had stable disease . Thus all pts with intracranial lesions had disease control . 18 pts underwent previous brain radiotherapy of whom 12 pts received whole-brain radiotherapy, 5pts - stereotactic radiosurgery, and 1 received both. Their objective intracranial response was 61%. All patients without previous brain radiotherapy had objective intracranial response (100%).
At data cut-off (20.03.2019) median duration of treatment was 12 mon. 6 pts stopped receiving lorlatinib: 4 due to disease progression and 2 due to the deterioration of concurrent diseases.
Side effects of lorlatinib were mild or moderate. The most frequent events were hypercholesterolaemia (82%, 3-4 grade 25%), oedema ( 71,8%), weight increased ( 38.5%). Only 5 pts (12.8%) needed in dose reduction.
Conclusion
Our results confirmed that lorlatinib is an effective treatment option for pretreated ALK+/ROS1+ patients with high intracranial activity and good safety profile.
