Mediastinal L ymph N ode C learance A fter D ocetaxel-Cispla tin Neoadjuvant C hemotherapy I s P rognostic o f S urvival i n Patients W ith S tage I IIA p N2 N on-Small-Cell L ung C ancer: A M ulticenter P hase I I T rial

摘要: Purpose: A multicenter, phase II trial investigated the efficacy and toxicity of neoadjuvant docetaxel-cisplatin in locally advanced non‐small-cell lung cancer (NSCLC) examined prognostic factors for patients not benefiting from surgery. Patients Methods: Ninety with previously untreated, potentially operable stage IIIA (mediastinoscopically pN2) NSCLC received three cycles docetaxel 85 mg/m 2 day 1 plus cisplatin 40 days 2, subsequent surgical resection. Results: Administered dose-intensities were /3 weeks (range, 53 to 96) 95 0 104). The 265 well tolerated, overall response rate was 66% (95% confidence interval [CI], 55% 75%). Seventy-five underwent tumor resection positive margin involvement uppermost mediastinal lymph node 16% 35% patients, respectively (perioperative mortality, 3%; morbidity, 17%). Pathologic complete occurred 19% In resection, downstaging N0‐1 at surgery significantly prolonged eventfree survival (EFS) (OS; P .0001). At median follow-up 32 months, EFS OS 14.8 months 2.4 53.4) 33 53.4), respectively. Local relapse 27% distant metastases 37%. Multivariate analyses identified clearance (hazard ratio, 0.22; .0003) 0.26; .0006) as strongly increased survival. Conclusion: Neoadjuvant is effective tolerable pN2 NSCLC. Resection recommended only after chemotherapy. J Clin Oncol 21:1752-1759. © 2003 by American Society Clinical Oncology.