Adenocarcinoma, Non-small-cell Lung Cancer
Conditions
Keywords
TS, polymorphism, lung cancer, adenocarcinoma, pemetrexed
Brief summary
The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
Detailed description
1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2. 2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks. 3. Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity. 4. The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment. 5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC(white blood cell)of all patients.
Interventions
'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks. 'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* histologic or cytologic proof of advanced lung adenocarcinoma * primary treatment * normal organ function * Eastern Cooperative Oncology Group performance status 0 to 2
Exclusion criteria
* Symptomatic patients with brain metastases * Major organ dysfunction and severe heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progress | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 1 year |
Countries
China