Transformation Into Small Cell Lung Cancer : a Mode of Resistance to Treatment (TransCPC)
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|ClinicalTrials.gov Identifier: NCT03419286|
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
|Condition or disease|
|Small Cell Lung Cancer|
An international multicentric retrospective collection of cases was performed between 2005 and 2017. A global e-mailing to a network of thoracic oncology centers in France and Italy called for the selection of retrospective cases. Consecutive non small cell lung cancer (NSCLC) patients with stage III or IV EGFR NSCLC with or without initial EGFR mutation with a secondary transformation to small cell lung cancer (SCLC) in participating centers in France and Italy were included. Patients with a previous history of SCLC or neuroendocrine tumor of the lung were excluded as well as patients with combined Small cell/ Non-small cell lung cancer on the initial pathology sample.
Study ethics approval was obtained on December 8th of 2015 (CECIC Rhône-Alpes-Auvergne, Clermont-Ferrand, IRB 5891). Anonymized data were collected at each center then centrally analyzed at the Albert Bonniot Institute, Inserm U 823, Grenoble Alpes University, in Grenoble, France.
The primary objective of this study was to analyze survival data after transformation to SCLC. The secondary objectives were to define: the epidemiological characteristics at the time of diagnosis of NSCLC, the histomolecular characteristics at the time of diagnosis of NSCLC and at the time of diagnosis of SCLC; the clinical characteristics at the time of diagnosis of NSCLC and SCLC and the treatment characteristics before and after transformation from NSCLC to SCLC.
All identified cases will be analyzed. This concerns about sixty two patients because the transformation into small cell lung cancer is a rare mechanism of resistance, it is for this reason that all the cases will be included in order to obtain the most exhaustive data possible.
Continuous variables were described as median (25%-75% interquartile range [IQR]) and categorical variables as number (%). Associations between categorical variables were compared using the chi-2 test or Fisher's exact test and those between continuous variables using the Wilcoxon test. Patients were followed until November of 2017. Overall survival (OS) is the time from the initial diagnosis of lung cancer to death and survival after SCLC transformation is from the rebiopsy to death. Kaplan-Meier plots of survival curves were compared between groups using the log-rank test. All tests were two-sided, and P values <0.05 were considered statistically significant. All statistical analyses were performed using SAS 9.3 (SAS Institute, Cary, NC, USA).
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||Retrospective Study of Cases of Small Cell Lung Cancer (SCLC) That Appeared During Treatment of Another Lung Carcinoma With or Without Oncogenic Activation (TransCPC)|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
patient with lung cancer with EGFR mutation before transformation into small cell lung cancer
EGFR NON MUTATED
patient with lung cancer without driver oncogenic before transformation into small cell lung cancer
- survival time after transformation to small cell lung cancer (SCLC) [ Time Frame: 2005 to 2017 ]months of survival after transformation into small cell lung cancer
- time from initial diagnosis of non small cell lung cancer (NSCLC) to small cell lung cancer transformation [ Time Frame: 2005 to 2017 ]median of months between initial diagnosis of non small cell lung cancer and small cell lung cancer transformation
- histology type at the time of diagnosis of NSCLC and at the time of diagnosis of small cell lung cancer (SCLC) [ Time Frame: 2005 to 2017 ]histology on biopsy at the initial diagnosis and at transformation according with OMS classification
- type of specific treatments administered before and after transformation from non small cell lung cancer into small cell lung cancer [ Time Frame: 2005 to 2017 ]The type of treatment administered before and after SCLC transformation. percentage of patients in each type of specific treatment used
- sexe of patients [ Time Frame: 2005 to 2017 ]sexe female or male in percentage of patients
- stage of NSCLC at initial diagnosis [ Time Frame: 2005 to 2017 ]percentage of patients with stage III and with IV of NSCLC
- smocking status at diagnosis initial of non small cell lung cancer [ Time Frame: 2005 to 2017 ]percentage of patients in never, former or active smokers
- type of mutations at the diagnostic initial NSCLC and at transformation [ Time Frame: 2005 to 2017 ]the mutation on initial biopsy and on biopsy at transformation in SCLC in percentage of patients
- treatment lines before transformation into small cell lung cancer (SCLC) [ Time Frame: 2005 to 2017 ]Median number of lines of treatment for the NSCLC before transformation into SCLC
- response rates to first line treatment after transformation into small cell lung cancer [ Time Frame: 2005 to 2017 ]response rate in percentage of patients after transformation into SCLC according with the RECIST criteria
- lines of treatment after transformation into SCLC [ Time Frame: 2005 to 2017 ]median number of lines of treatment after transformation into SCLC
- age of patients [ Time Frame: 2005 to 2017 ]the median in years at the he diagnosis initial of non small cell lung cancer
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419286
|Principal Investigator:||Denis Moro-Sibilot, MD-PHD||University Hospital, Grenoble|