Lung Adenocarcinoma With Bronchiolo-alveolar Feature, Pneumonic-type Adenocarcinoma (P-ADC)
Conditions
Keywords
Adenocarcinoma, Bronchiolo-Alveolar
Brief summary
Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.
Detailed description
We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.
Interventions
DRUGGefitinib
Gefitinib 250 mg/day, until progression or severe toxicity
Sponsors
AstraZeneca
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically / cytologically proven ADC-P * Non-resectable disease * 3-month expected survival * No prior radiotherapy or chemotherapy * Age \>= 18 years old * Performance status \< 4 (WHO) * Adequate blood biological parameters
Exclusion criteria
* Abnormal initial fibroscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate after 3 months of treatment | Month |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | 3-month |
| Time to progression | month |
| Survival | month |
| Prediction disease control by clinical and biological markers | month |
Countries
France
Outcome results
None listed