Virtual Library
Start Your Search
A. Sibau
Author of
-
+
P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
-
+
P2.07-011 - Maintenance with Lanreotide in SCLC Patients, Expressing Somatostatine Receptors, after Response to First Line Therapy (ID 2838)
09:30 - 09:30 | Author(s): A. Sibau
- Abstract
Background:
Small cell lung cancer (SCLC) is a rapidly progressive disease, characterized by rapid progression in spite of initial responsiveness to first-line chemotherapy. In this setting, an effective and safe maintenance therapy might result in improved disease control; to date, no maintenance strategy has been registered for SCLC yet. Since SCLC cells express a neuroendocrine phenotype, some tumors may express significant levels of somatostatin (SST) receptors; this feature might be exploited for new therapeutic approaches. The aim of our study is to investigate the activity of lanreotide, a SST analogue, as maintenance for patients with SCLC who have achieved a complete response (CR) or partial response (PR) to standard platinum-based chemotherapy (CHT) alone or combined with radiation therapy (RT) , in order to improve progression-free survival (PFS).
Methods:
In this prospective, open-label, multicenter, randomized phase III trial, patients with confirmed diagnosis of SCLC (limited or extended disease) expressing SST receptors (assessed by SST receptor scintigraphy) and with objective response (CR or PR) after CHT or CHT/RT are randomized (1:1) to one of the following arms: maintenance therapy/consolidation with 120 mg lanreotide, by deep subcutaneous injection, every 28 days up to progressive disease (PD) or one year (Arm A); or observation (Arm B). The patients were re-assessed every two months until documented PD during the first year after randomization, and then every three months. The planned enrollment period is 24 months, followed by a period of maintenance of 12 months and further 6 months for the completion of follow-up; the planned global period of the study is 3 years and a half.
Results:
This study is still ongoing; therefore, it is not possible to show its final results yet.. However, relevant preliminary data can be described. Currently, out of 76 expected patients, 53 were enrolled; of these, 11 patients (37.96%) in Arm A had limited disease and 18 (62.06%) extended disease. In Arm B, 11 patients had limited disease (45.83%) and 13 (54.17%) had extended disease. After one year of follow-up, among 29 patients randomized to Arm A, 1 patient died (3.45%), while 12 patients experienced PD (41.38%), and 16 are still on study (55.17%); among 24 patients randomized to Arm B, 2 deaths occurred (8.33%), while 11 patients experienced PD (45.83%) and 11 are still on study (45.83%). In Arm A, no significant adverse events were reported.
Conclusion:
This study will determine whether maintenance with lanreotide could prolong PFS of patients with SCLC expressing SST receptors and responsive to upfront CHT or CHT/RT. Moreover, the final results of this study might establish if this treatment could result in an improved overall survival rate after two years. To date, lanreotide has demonstrated an excellent safety profile in all the treated patients. On behalf of FONICAP (Forza Operativa Nazionale Interdisciplinare contro il Cancro del Polmone)
