Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
Inclusion Criteria:
- Male and female patients aged over 18 years
- Histologically proven lung adenocarcinoma
- clinical stage IIIB/IV
- ECOG performance status 0-2
- Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
- At least one measurable lesion (according to RECIST)
- Provision of written informed consent
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- History of malignant disease.
- Evidence of clinically active interstitial lung diseases (patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded)
- Expected life expectancy less than 2 months
- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal
disease)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x
ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women (women of child¬bearing potential). Women of
childbearing potential must practice acceptable methods of birth control to prevent
pregnancy.