Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: Implications for clinical trial design

7006 Background: Although objective response (CR/PR) & overall survival (OS) are typical efficacy measures for new treatments in advanced stage NSCLC, each has its limitations; e.g., some patients (pts) have no measurable disease or achieve only disease stabilization (SD) while OS is influenced by effective salvage therapies. Alternative methods of determining “clinical benefit” are needed. Methods: Pooled data from 984 pts entered onto 3 randomized SWOG trials of platinum-based chemotherapy (S9509: carbo/paclitaxel (CP) vs. cisplatin/vinorelbine; S9806: carbo/gemcitabine ->P or cisplatin/vinorelbine -> docetaxel; & S0003: CP ± tirapazamine) were analyzed for survival using the Landmark method. Results: Pt characteristics: median age = 62 years; male sex = 647 pts (66%); stage IV = 826 pts (84%); weight loss ≥ 5% = 404 pts (42%); performance status (PS) 0/≥1 = 340 (36%)/606 (64%). Tumor response was seen in 260 pts (26%). Median time to response (TTR), time to progression (TTP) & OS were 1.9, 4.3 and 8.9 ...