Squamous cell carcinoma of the larynx is a major public health concern; it causes substantial morbidity and mortality, and arises chiefly as a result of tobacco and alcohol consumption. Early stage disease is best treated with radiation or surgery alone, but for patients with more locally advanced squamous cell carcinoma of the larynx, combined modality treatment has been shown to benefit selected patients, particularly when cisplatin-based chemotherapy and concurrent radiation therapy are employed, with or without altered fractionated radiation therapy. Substantial laryngectomy-associated quality-of-life decrements can be avoided in selected, potentially resectable patients with organ-sparing approaches, without sacrificing survival. Recently, trials have addressed the role of targeted systemic agents to the epidermal growth factor receptor, and other targets are under investigation. The addition of induction chemotherapy to concurrent chemoradiotherapy is a promising treatment strategy that warrants further evaluation, but has not yet emerged as a standard of care; the toxicity of such regimens must be balanced with the potential benefits on a case-by-case basis, and functional outcomes are often quite variable. Treatment planning, management and follow-up are complex, and thus should ideally be performed in a comprehensive, multidisciplinary fashion, in a center accustomed to a high volume of such cases. Future research directions are described herein.

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17072 Background: Published literature has demonstrated minimal activity for VNR in the salvage treatment of NSCLC, with response rates of only 0.8% (Fossella, et al, JCO 2000; 18(12), 2354–2362). However, in our clinical experience, we have observed a number of patients (pts) with clinical benefit. Methods: Retrospective evaluation was performed of all pts with NSCLC who had received VNR at FCCC from 6/02–6/05 in the salvage setting. Pts were evaluable if full medical records (including radiographic imaging for disease assessment) were available, had received ≥2 cycles of VNR, and had advanced, recurrent or metastatic NSCLC. Primary endpoint was response rate (RR); secondary endpoints included safety, median overall survival (OS), and median time to progression (TTP). Results: 52 pts were included, 28 pts were ultimately evaluable (13 pts received <2 cycles of VNR, 7 pts did not have NSCLC, and 4 pts received VNR with RT or other agents). Median age was 64 yrs, 64% were female; ECOG-PS 0–18%, 1–50%, 2–28.5%, 3–3.5%. 82% exhausted 2 lines of systemic therapy before VNR; 32% exhausted 3; 21.4% received prior EGFR-TKI; 18% received other prior protocol therapies. 96.3% of pts had stage IV, stage IIIB, or recurrent disease. 21.4% had bone mets; 25% had brain mets; and 42.8% had visceral metastases. 85.8% had significant comorbidities. Median number of VNR cycles was 4. RR:PR 10.7%, SD/MR 35.7%, and PD 50%. 25% required dose reductions, predominantly for gr 4 hematologic toxicities. Non-hematologic toxicities were generally mild, and included neuropathy, fatigue and GI distress; there were no Tx-related deaths. 32% were able to receive other systemic therapy after VNR. Median OS was 5 months, and median TTP was 3 months. Conclusions: Vinorelbine is active and relatively well-tolerated in the salvage treatment of NSCLC, including heavily pretreated pts. Response rates exceed that observed in the literature. [Table: see text]

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