Journal
CANCER MEDICINE
Volume -, Issue -, Pages -Publisher
WILEY
DOI: 10.1002/cam4.5652
Keywords
low dose; nab-paclitaxel; non-small cell lung cancer; phase II trial; previously treated
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A randomized phase II trial showed that both standard dose and low dose of nab-paclitaxel monotherapy had similar efficacy in previously treated advanced non-small cell lung cancer patients, with better safety profile in the low dose group.
BackgroundNab-paclitaxel (nab-PTX) has better transfer to tumor tissue than cremophor-based paclitaxel. It suggests that the optimum dose of nab-PTX might be lower than the dose and schedule that is widely used. We designed a randomized phase II trial to examine the clinical utility and safety of nab-PTX in patients with previously treated advanced non-small cell lung cancer (NSCLC). MethodsPatients were randomly allocated (1:1) to receive nab-PTX monotherapy at 100 mg/m(2) (group A) or 70 mg/m(2) (group B). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and adverse events (AEs). ResultsFinally, 81 patients were randomized. Similar results were observed in both groups for PFS (3.75 vs. 3.71 months), OS (13.50 vs. 16.13 months), or ORR (20.5% vs. 23.1%). The incidences of grade 3 or worse AEs were 57.5% in group A and 41.5% in group B. The proportion of serious side effects was 10.0% in group A and 4.9% in group B. ConclusionBoth standard dose and low dose of nab-PTX monotherapy are active for previously treated NSCLC patients with better safety profile. Therefore, nab-PTX 70 mg/m(2) dose and schedule in the trial would be a reasonable option.
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