Abstract
BackgroundThe aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC).MethodsChemotherapy-naïve patients with advanced NSCLC were eligible. In the phase I dose-escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m2 given intravenously on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (75 mg/m2 given intravenously on day 1) every 4 weeks was selected for the phase II cohort. The primary endpoint was the objective response rate (ORR).ResultsTwenty-three patients (phase I, n = 6; phase II, n = 17) were enrolled, and 22 patients were eligible. The median age was 67.5 years (range 37–75), 90.9% were males, 45.5% had adenocarcinoma and 81.8% had stage IV disease. The ORR was 59.1% (90% confidence interval (CI); 41.8–74.4), and the disease control rate was 86.4% (95% CI; 66.7–95.3). The median progression-free survival was 5.1 months (95% CI; 4.0–6.7), and the median overall survival was 24.2 months (95% CI; 8.4 months to not estimable). The common grade ≥ 3 adverse events were neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one instance of grade 2 interstitial pneumonia and no treatment-related death.ConclusionsNab-paclitaxel plus cisplatin was well tolerated and associated with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted.Trial registrationUMIN Clinical Trials Registry: UMIN000011776; Date of registration: 17 September 2013; Date of enrolment of the first participant to the trial: 23 January 2014.
Highlights
The aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC)
In terms of toxicity, the incidence of peripheral neuropathy, which is a concern with sb-paclitaxel, was significantly lower with weekly nab-paclitaxel plus carboplatin than with sb-paclitaxel, and it resulted in a shorter time to recovery from grade ≥ 3 neuropathy to grade 1
If dose-limiting toxicity (DLT) was observed in 3/6 patients or more, we considered level 1 as the MTD, and we decided to examine level 0
Summary
The aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC). For patients in which the driver oncogene is negative or unknown, immune checkpoint inhibitors (ICIs) alone or in combination with cytotoxic drugs, depending on the programmed cell death-ligand 1 (PD-L1) status in the tumor and the tissue type, have been introduced as first-line treatments. Nab-paclitaxel is a 130 nm uniform nanoparticle paclitaxel formulation comprised of paclitaxel and human serum albumin It does not require Cremophor or anhydrous ethanol solvents to formulate, meaning that steroids or antihistamines do not necessarily have to be taken as pretreatments to suppress anaphylactic symptoms. It allows for quicker administration than solvent-based paclitaxel (sb-paclitaxel). In terms of toxicity, the incidence of peripheral neuropathy, which is a concern with sb-paclitaxel, was significantly lower with weekly nab-paclitaxel plus carboplatin than with sb-paclitaxel, and it resulted in a shorter time to recovery from grade ≥ 3 neuropathy to grade 1
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