Clinical Trial: Retrospective Analysis of the Expression of the Neurotensin Receptor by Metastatic Lung Adenocarcinomas
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Retrospective Analysis of the Expression of the Neurotensin Receptor by Metastatic Lung Adenocarcinomas
Brief Summary:
Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients present themselves with a disease diagnosis immediately metastatic non curable. Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based chemotherapy with or without maintenance therapy. When there is to exhaust this first line, a second line treatment is offered to the patient. Three drugs are allowed in this situation: docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor for epidermal growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually standard in first online and in combination with platinum in all patients with non-squamous cancer, so that his place is in second line reduced facto). There is no recommendation for treatment in third line situation where only erlotinib is allowed.
Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3 trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and non-squamous. The very recent availability in France of the drug under an ATU fact that it will most likely become a standard second line, which will tend to place the third line docetaxel.
Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does not seem appropriate or even harmful. A selection of patients likely to benefit from the prescription of EGFR TKI-is essential.
Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central nervous system and the periphery. At the peripheral level, neurotensin
Detailed Summary:
The objectives of this work purely descriptive, are:
- Evaluate the expression by tumor cells of the neurotensin receptor on a retrospective series of patients:
- Consecutively treated between 2010 and 2015 at St. Joseph hospital (about a hundred patients) and the Saint-Antoine hospital (three hundred patients), holders of a metastatic and primary lung adenocarcinoma having received all even first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
- If possible, the records of patients treated at St. Joseph Hospital and Saint-Antoine Hospital between 2005 and 2010 as part of clinical trials evaluating the value of erlotinib will also be sought,
- Develop a score expression NTSR1 taking into account the percentage of tumor cells expressing the receptor and the intensity of the marking,
- Correlate labeling cells by NTSR1 with the clinical course of patients to see if expression NTSR1 is a factor of poor prognosis in metastatic patients.
Teams involved:
Services:
- Pharmacy that will establish the list of patients have been treated with the same chemotherapy,
- Pathological anatomy-to group blades and ensure immunohistochemical staining and reading,
- Pneumology and Thoracic Oncology to resume the clinical history of patients.
The scientific coordination of the study will be conducted by INSERM UMR-S 1007, cellular homeostasis and cancer - Reprogramming of biologic
Sponsor: Groupe Hospitalier Paris Saint Joseph
Current Primary Outcome: Number of patient expressing Neurotensin receptor ( NTSR1) in their tumor [ Time Frame: Day 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Groupe Hospitalier Paris Saint Joseph
Dates:
Date Received: August 24, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: September 1, 2016
Last Verified: September 2016
