| General information |
| Database: | DB00737 |
| Objective: | Epidermal growth factor receptor (EGFR) mutation testing is standard practice after lung adenocarcinoma diagnosis, and provision of highquality tumor tissue is ideal. however, there are knowledge gaps regarding the utility of cytology or low tumor content histology samples to establish EGFR mutation status, particularly with regard to the proportion of testing performed using these sample types, and the lack of an established link with efficacy of treatment. |
| Authors: | Yang JC, et al |
| Title: | Epidermal growth factor receptor mutation analysis in previously unanalyzed histology samples and cytology samples from the phase III Iressa PanASia Study (IPASS). |
| Journal: | Lung Cancer. |
| Year: | 2014 |
| PMID: | 24361280 |
| Trial Design |
| Clinical Trial Id: | NCT00322452 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma (including bronchoalveolar carcinoma) |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | supplementary analysis of the randomizedphase III Iressa PanASia Study |
| Key Patients Feature: | Patients were eligible for inclusion into the study if they had histologically or cytologically confirmed stage IIIB or IV pulmonary adenocarcinoma (including bronchoalveolar carcinoma), were neversmokers (<100 cigarettes in their lifetime) or former light smokers (stopped smoking more than and equal to 15 years previously and smoked less than and equal to 10 packyears), and had received no prior chemotherapy, biologic therapy, or immunologic therapy. Patients provided written informed consent with separate consent for the optional assessment of EGFR biomarkers |
| Biomarker: | Epidermal growth factor receptor mutation |
| Biomark Analysis: | ORRs in mutationpositive cytology (83%) and histology (74%) subgroups were consistent with previous analyses (71%). Tumor size decrease was consistent across previously analyzed and unanalyzed samples (all mutation subgroups), with less consistency across ORRs in mutationnegative cytology (16%) and histology (25%) subgroups versus the previous analysis (1%). |
| Control Group Info: | gefitinib versus chemotherapy |
| Treatment Info: | This supplementary analysis assessed tumor content and mutation status of histology (n=99) and cytology samples (n=116) which were previously unanalyzed due to sample quality, type, and tumor content (<100 cells). |
| Primary End Point: | Objective response rate (ORR) and change in tumor size with gefitinib treatment were assessed. |
| Secondary End Point: | NA |
| Patients Number: | 215 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORRs in mutationpositive cytology (83%) and histology (74%) subgroups. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Histology samples with low tumor content and cytology samples can be used for EGFR mutation testing; patients whose mutation status was confirmed using these sample types achieved a response to treatment consistent with those confirmed using highquality histology samples. Better sample quantityquality can potentially reduce falsenegative results. |