Virtual Library
Start Your Search
Christoph Zielinski
Author of
-
+
P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
-
+
P2.12-04 - Liposomal Irinotecan vs Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed On/After Platinum-Based Therapy (ID 12768)
16:45 - 18:00 | Author(s): Christoph Zielinski
- Abstract
Background
Small Cell Lung Cancer (SCLC) accounts for ~15% of all lung cancers; it is an aggressive disease marked by rapid growth and early metastasis. Patients typically demonstrate initial sensitivity to chemotherapy and radiotherapy, followed by rapid relapse and development of drug resistance. Topotecan, a topoisomerase I (TOP1) inhibitor, is the only agent approved for second-line treatment in the United States and Europe. Liposomal irinotecan (nal-IRI) has demonstrated sustained TOP1 inhibition, with liposomal deposition in tumor tissue through leaky vasculature, followed by irinotecan release and subsequent conversion to the active metabolite SN-38. Pre-clinical data suggests that nal-IRI has improved anti-tumor activity compared to topotecan. The current trial (NCT03088813) is being undertaken to investigate the safety and efficacy of nal-IRI versus intravenous topotecan in patients with SCLC who have progressed on or after platinum-based first-line therapy.
a9ded1e5ce5d75814730bb4caaf49419 Method
There are two parts of this study: Part 1 is an open-label, single-arm, safety run-in phase and Part 2 is a randomized, controlled, efficacy assessment phase. Key inclusion criteria include ECOG performance status of 0–1, adequate organ function, histopathologically/cytologically confirmed SCLC, evaluable disease (RECIST v1.1), and life expectancy ≥12 weeks. Prior exposure of immuno-oncology therapies is allowed. Key exclusion criteria include a diagnosis of large cell neuroendocrine lung carcinoma, prior treatment regimens with TOP1 inhibitors, and retreatment with the same platinum-based regimen after relapse of first-line therapy. In Part 1, patients will be treated with different doses of nal-IRI to identify a tolerable dose level; this dose level will be expanded to include a total of 24 patients. The primary endpoint is safety and tolerability, with secondary endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
In Part 2, ~450 patients will be randomized in a 1:1 ratio between nal-IRI and IV topotecan. The primary endpoint is OS, followed by PFS, ORR, patient-reported outcomes, and exploratory analyses. Patients will be treated for a minimum of 3 cycles (1 cycle = 6 weeks) or until progressive disease or unacceptable toxicity. Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable - Trial in progress
8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable - Trial in progress
6f8b794f3246b0c1e1780bb4d4d5dc53
-
+
P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
-
+
P2.15-03 - Availability and Reimbursement of Diagnostic Testing and Novel Anti-Cancer Drugs for NSCLC in CEE: Results of a CECOG Survey (ID 13572)
16:45 - 18:00 | Author(s): Christoph Zielinski
- Abstract
Background
Current guidelines recommend routine molecular testing for EGFR, ALK, ROS1 and BRAF alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and in squamous NSCLC presenting specific clinical features. Precision medicine reflects the selection of appropriate targeted therapies (TTs) and immune-oncology (IO) treatment based on molecular testing.
a9ded1e5ce5d75814730bb4caaf49419 Method
To provide an overview of current situation, the Central European Cooperative Oncology Group (CECOG) has developed a survey with participation of national experts in the field of molecular pathology and oncology from 10 countries: Austria, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, and Slovenia. First part of the survey referred to availability and reimbursement of molecular diagnosis in NSCLC, including testing policy (“reflex” vs “on demand”, parallel vs subsequent) and turnaround times. The second part evaluated the access and reimbursement of targeted and IO therapies.
4c3880bb027f159e801041b1021e88e8 Result
There is large variability regarding molecular testing for NSCLC patients in CEE countries, both from access and reimbursement, and from the pattern of recommendation by oncologists. EGFR testing is reflex in Austria, Slovenia, Croatia, Czech Republic, and Slovakia and on demand in Bulgaria, Hungary, Poland, Romania, and Serbia, being fully covered by the public health system only in Austria and Slovenia. Similar situation is reported for ALK testing. ROS1, BRAF and PD-L1 are mainly tested on demand, once testing results for EGFR and ALK are found negative. Turnaround time ranges between 5 and 10 days for reflex testing influenced by technology, with delays for on demand testing.
In the first line, EGFR TKIs are available and reimbursed, while IO is reimbursed only in 5 out of 10 countries. The majority of second line TTs and IOs are registered, but not yet reimbursed in many CEE markets, despite the unmet medical need. Austria can be a model in CEE, having rapid access and implementation of the new standards in testing and treatment (all second line TTs and IO available). Slovenia and Hungary follow with 7 out of 10 second line available novel treatments. Time from registration to reimbursement of targeted treatment is usually long, lasting 1 year or more.
8eea62084ca7e541d918e823422bd82e Conclusion
This survey provides updated overview on availability and reimbursement of molecular diagnostic and precision medicines in CEE countries, for NSCLC patients. There is a strong need to standardize management and to facilitate access to novel therapies in routine clinical practice for better patient outcomes. Experts network, like CECOG, can facilitate regional dialogue.
6f8b794f3246b0c1e1780bb4d4d5dc53
