Neoadjuvant carboplatin and weekly paclitaxel for stage Ib-IIIa non-small cell lung cancer (NSCLC): A Brown University Oncology Group (BrUOG) phase II study.

18502 Background: Achieving a pathologic complete response (pCR) to neoadjuvant chemotherapy is associated with improved survival in a number of solid tumors. SWOG 9900 demonstrated a 3% pCR rate following 3 cycles of q3week paclitaxel and carboplatin in resectable NSCLC. The BrUOG sought to determine if substituting more dose-intense weekly paclitaxel would increase the pCR rate. METHODS: Biopsy proven, consenting patients (pts) with stage IB-IIIA NSCLC and an adequate estimated post-resection FEV1 were eligible. Mediastinoscopy was performed on all patients prior to enrollment into the study. Patients received carboplatin AUC 6 q3weeks × 3 and weekly paclitaxel 80mg/m(2) × 9 weeks. RESULTS: Twenty pts with IB (n=17), IIB (n=1) and IIIA (n=2) were enrolled. Fourteen had a performance status (PS) of 0 and six a PS of 1. All pts completed the planned neoadjuvant therapy. Four pts (20%) had grade 4 neutropenia, one developed grade 3 neuropathy and one had grade 3 nausea. One patient refused surgery and received chemoradiation, one patient died unexpectedly of a non-treatment-related event, and surgery is pending for one patient. The other 17 patients underwent complete resection, either lobectomy (14) or pneumonectomy (3). There were no significant post-surgical complications. By intent to treat, the pCR rate was 16% (3/19); 5 additional pts (26%) had a radiographic partial response, but residual viable disease at surgery. No patient progressed during induction treatment. At median follow-up of 28 months the median survival has not been reached. Four pts have recurred; however, all pts who achieved a pCR with induction chemotherapy remain free of disease. CONCLUSIONS: Neoadjuvant weekly paclitaxel with q3week carboplatin is well tolerated in resectable NSCLC, with a pCR rate that compares favorably to other reported induction regimens and merits further investigation. No significant financial relationships to disclose.

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Author Neal Edward Ready Medicine, Medical Oncology