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A. Bearz
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-002 - Response Evaluation and Predictors in NSCLC During Treatment with AntiPD-L1 (ID 1264)
09:30 - 17:00 | Author(s): A. Bearz
- Abstract
Background:
Treatment of metastatic NSCLC patients with immune-checkpoint medicine is intriguing for the potential efficacy, even in difficult setting such as smokers or squamous-carcinoma; however it may be difficult to evaluate the clinical response due to the lack of reliable immuno-monitoring markers and the possibility of radiological pseudo-progression.
Methods:
not applicable
Results:
Herein we report five cases treated with antiPD-L1(MPDL3280A, Genentech): four patients were male and one female, all of them were ex-smokers, affected by metastatic NSCLC; 4 adeno- and 1 squamous cell carcinoma- in progression after one cycle of platin-based combined chemotherapy, median age 60 yrs (58-64), renal function after cisplatin was normal. They received anti-PD-L1 i.v. every 3 weeks in a clinical trial. Two patients had progression of disease, while 3 patients showed a clinical benefit. Patient #1 had stable disease at the pleural and right lung disease in the CT-scan after 6 weeks of treatment. He had low Magnesium values at basal and at every further control during PD-L1 therapy. Patient #2 showed progression of mediastinal lymph nodes and liver metastases in the CT scan after 6 weeks of treatment and progression was confirmed by CT-scans 4 and 8 weeks later; eventually a biopsy of the liver metastasis confirmed that there was a massive neoplastic invasion with tumor infiltrating lymphocytes (Tils) <5%. His basal Magnesium values were always normal. He stopped anti-PD-L1 therapy due to progression. Patient #3 had a volumetric increase of bilateral lung nodules in the CT-scan after 6 weeks while mediastinal lymph nodes were stable; lung nodules again and lymph nodes were both in progression 12 weeks later. His basal and further on Magnesium values were always normal. Patient #4 showed partial response in the CT-scan after 6 weeks of treatment, and benefit was confirmed later on by CT-scan after 12 weeks; he reported a clinical benefit for decrease of fatigue and chest pain; his basal Magnesium value was lower than normal and it has been always abnormal at every further blood check during PD-L1 treatment. Patient #5 showed partial response in the CT-scan after 6 weeks of treatment; she reported a clinical benefit for decrease of fatigue and increase of appetite; her basal Magnesium value was lower than normal and she continued to have low magnesemia at every further blood check during anti-PD-L1 treatment.
Conclusion:
Conclusion: evaluation of response may be difficult with immune checkpoint inhibitors and in one case we performed a biopsy to study tumor infiltrating lymphocytes to decide whether pseudoprogression or real progression. Data about PDL1 expression were not available because patients in a clinical trial. In our experience lower basal Magnesium value may predict a clinical benefit with anti-PD-L1, although we do not know its possible explanation.
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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)
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P2.07-011 - Maintenance with Lanreotide in SCLC Patients, Expressing Somatostatine Receptors, after Response to First Line Therapy (ID 2838)
09:30 - 17:00 | Author(s): A. Bearz
- 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)
