Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402

Abstract

Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m2) was administered biweekly in a 28‐day cycle. The phase I portion was performed to determine the recommended phase II dose of nab‐PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression‐free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab‐PTX (100–150 mg/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%, and the median progression‐free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.

A Novel Microcrystalline BAY-876 Formulation Achieves Long-Acting Antitumor Activity Against Aerobic Glycolysis and Proliferation of Hepatocellular Carcinoma

“…Human malignacies are also considered to be chronic diseases, however, the recent research strategy of antitumor drug treatment has always been to try to achieve longterm oral anti-tumor drugs or to extend the cycle or time interval of intravenous drugs as much as possible (101)(102)(103). For example, albumin paclitaxel has been widely used clinically, and it can be injected once a week or a month in the treatment of breast cancer or lung cancer (104,105). Nevertheless, due to the high toxicity of anti-tumor drugs themselves, if oral administration or intravenous injection will cause the drug to be distributed throughout the body, on the one hand, other organs will be damaged, and on the other hand, the concentration of the drug in the lesion will be limited.…”