Prospective study of transarterial infusion of docetaxel and cisplatin to treat non-small-cell lung cancer in patients contraindicated for standard chemotherapy.

Our previous retrospective study indicated a good response rate of non-small-cell lung carcinoma (NSCLC) to transarterial infusion chemotherapy, but the precise effect remains unresolved. This prospective study enrolled 25 patients with stage III or IV or recurrent NSCLC without distant metastasis (M1b) who were not candidates for either standard chemotherapy or chemoradiotherapy. The feeding arteries of each tumor detected by angiography were recorded and tumor staining was visually graded on a scale of I-IV. Docetaxel and cisplatin (25 and 25 mg/m(2), respectively) were administered by arterial infusion. The total dose of each was divided among feeding arteries according to the degree of tumor staining. The end points included response rate, progression-free survival (PFS), overall survival (OS) and toxicity. Correlations between effects and some clinical aspects were investigated. Of 25 patients enrolled between May 2007 and April 2011, 24 of them were evaluable. One complete response and 12 partial responses were achieved for an overall response rate of 52% (95% confidence interval [CI]: 35-69%). The median progression-free survival and overall survival periods were 6.5 (95% CI: 5.4-7.6) and 17.4 (95% CI: 14.2-20.6) months, respectively. The 1- and 2-year survival rates were 81% and 32%, respectively. Grade 3-4 hematological toxicity was not evident. Grade 3 general fatigue or appetite loss developed in patients with performance status (PS) ≥3. Neither grade 4 non-hematological toxicity nor treatment-related death occurred. Among various clinical aspects, ECOG PS significantly correlated with PFS and OS, whereas tumor staining significantly correlated with response. Survival was significantly better for patients with good PS (0 or 1) than poor PS (≥2) and those with, than without grade IV tumor staining. If a sufficient number of feeding arteries are detected and the tumor is appropriately stained, then arterial infusion chemotherapy has favorable response rates with less toxicity for patients with stage III or IV or recurrent NSCLC without distant metastasis (M1b) who cannot tolerate standard chemotherapy.