Adult patients with histologically documented NSCLC who received ≥ 1 platinum-based chemotherapy regimen, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, were potentially eligible for this study. Patients were excluded if they had a life expectancy of less than 1 month or had an indication for liver, renal, or heart failure. Thirty-four eligible patients

were enrolled in this study and PCI32765 asked for written informed consent. Information collected at baseline included sex, age, ECOG performance status, tumor size, histology, disease stage, lung tumor–related chest pain or dyspnea, time since last chemotherapy (interval from last chemotherapy to inclusion), times of CT-PFNECII, and platinum resistance. Protocol design, data collection, and analysis were solely the responsibility of the authors. Eligible patients were randomly assigned to receive either CT-PFNECII combined with second-line chemotherapy (standard pemetrexed or docetaxel dosing schedule) (combination group, n = 17) or second-line chemotherapy (standard pemetrexed or docetaxel dosing schedule) alone (chemotherapy

group, n = 17). If a patient received prior taxane treatment, such as docetaxel or paclitaxel, pemetrexed was given as second-line chemotherapy. Otherwise, docetaxel was given as second-line chemotherapy. Ethanol-cisplatin (5%) was freshly prepared with 10 mg (2 ml) of cisplatin (Qilu Pharmaceutical Co, Ltd, Shandong, China) dissolved into an ethanol solution BMS-354825 nmr of 20 to 30 ml Sirolimus in vitro with the final ethanol concentration of 5% (vol/vol). Next, the freshly prepared 20 to 30 ml of 5% ethanol-cisplatin solution was percutaneously injected into the lung tumor individually with a 22-gauge fine needle (Gallini Medical Devices, Via Frattini, Italy) under CT (GE Healthcare, Waukesha, WI) guidance, once a week. This procedure was performed weekly for two consecutive weeks, and a third week with no treatment completed one cycle. Single chemotherapy agent pemetrexed (Alimta; Eli Lilly and Company,

Indianapolis, IN) (500 mg/m2 as a 10-minute IV infusion on day 1 of a 21-day cycle) or docetaxel (Taxotere; Aventis Pharmaceuticals, Bridgewater, NJ) (75 mg/m2 as a 1-hour IV infusion on day 1 of a 21-day cycle) was administered IV 1 day after CT-PFNECII every 3 weeks as a cycle. Each patient in the combination group received one to two cycles of CT-PFNECII and four cycles of pemetrexed/docetaxel, and each patient in the chemotherapy group received four cycles of pemetrexed/docetaxel. Patients on the pemetrexed arm were instructed to take folic acid (350-1000 μg) orally daily beginning approximately 1 to 2 weeks before the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. A 1000-μg vitamin B12 injection was administered intramuscularly 1 week before the first dose of pemetrexed and was repeated approximately every 9 weeks until after discontinuation.