Results of a phase I study of inhaled doxorubicin combined with docetaxel and cisplatin for advanced non-small cell lung cancer

7231 Background: The addition of targeted agents to the treatment of advanced NSCLC has failed to improve results seen with chemotherapy alone. Targeted delivery of agents to the lung through inhalation has shown promise. We have reported the results of a phase I study of inhaled doxorubicin (DOX) in patients with advanced cancers affecting the lungs. 7.5 mg/m2 was the recommended phase II dose, with minimal systemic toxicity. DLT was found in the lungs at higher doses. Using the Oncomyst delivery device we designed a combination trial of DOX, docetaxel (D) and cisplatin (P) administered every three weeks. Patients and Methods: Patients were required to have advanced, previously untreated NSCLC, acceptable organ function, including PFT criteria of ≥50% predicted FVC, FEV1 and DLCO, and resting and exercise oxygen saturation of ≥90% and 85%, respectively. D/P were administered at 75 mg/m2 in standard fashion. We performed a 2-level phase I portion starting at 6.0 mg/m2 of DOX, given prior to D/P, with esca...