INTRODUCTION
toxicity, tumor, NSCLC
TUMOR, NSCLC
Traditionally, the dose of anti‐cancer agents has been decided based on the incidence of dose‐limiting toxicity (DLT) in a phase I clinical trial. Ideally, however, the optimum dose should be decided based on efficacy and toxicity. This is because following a dose recommendation based on DLT alone, rather than the optimal dose (which may be lower) can increase toxicity, cost, and could immunocompromise patients without additional benefit. Defining the optimum dose of cytotoxic chemotherapy is therefore critical to improve overall survival (OS) and patient quality of life.In chemotherapy for advanced NSCLC, administration of the optimal dose should improve outcomes. In the randomized phase II study of 1000 or 500 mg/mIn preclinical models of NSCLC, nab‐paclitaxel (nab‐PTX), an albumin bound and solvent free nanoparticle paclitaxel (PTX) formulation, has better transfer to tumor tissue than PTX. Compared with cremophor‐based PTX, nab‐PTX thus yielded higher mean intratumor and maximal circulating concentrations of free PTX in a xenograft model.A weekly (Days 1, 8, and 15 every 28 days) 70 mg/mWe designed a randomized phase II trial to determine the optimum dose, activity, and safety of weekly nab‐PTX (low dose 70 mg/m