Why the study?
Does DEB-BACE loaded with gemcitabine improve objective response rate in patients with NSCLC who are ineligible for standard treatment?
Observational (n=6)
Does DEB-BACE loaded with gemcitabine improve objective response rate in patients with NSCLC who are ineligible for standard treatment?
DEB-BACE with gemcitabine-loaded CalliSpheres beads is a feasible and well-tolerated treatment that may provide disease control in NSCLC patients ineligible for standard therapy.
BACKGROUND: Drug-eluting beads bronchial arterial chemoembolization (DEB-BACE) can embolize the tumor-feeding artery and also be loaded with antitumor drugs, which can be released slowly into the local tumor environment. The effect of DEB-BACE in patients with lung cancer remains unclear. We evaluated the efficacy and safety of DEB-BACE with gemcitabine-loaded CalliSpheres beads in patients with non-small cell lung cancer (NSCLC). METHODS: From May 2017 to December 2018, six patients with NSCLC who were ineligible or refused to receive standard treatment underwent DEB-BACE with gemcitabine-loaded CalliSpheres beads. The primary endpoint was the objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and quality of life. Safety was evaluated by the occurrences of adverse events and serious adverse events. RESULTS: All patients were treated with DEB-BACE loaded with gemcitabine (800 mg) using CalliSpheres beads. Five patients also received transarterial infusion with nedaplatin (80-100 mg). Of the six patients, five underwent a second session of DEB-BACE, with intervals of one month between the first and second session. The median follow-up time was 16.5 months (7.0-23.0 months). ORR and disease control rate were 50.0% and 100.0%, 50.0% and 83.3%, 50.0% and 66.7% respectively at 2, 4, and 6 months after DEB-BACE. One patient maintained a partial response and the other five had progressive disease, of whom two patients died and the other three remained alive receiving targeted therapy, radiotherapy, transarterial infusion or thermal ablation. The median PFS was 8.0 months (4-23 months), and the 6- and 12 month PFS rates were 66.7% and 16.7%, respectively. The median OS was 16.5 months (7-23 months), and the six and 12 month OS rates were 100.0% and 66.7%, respectively. Hemoptysis, cough and dyspnea disappeared after DEB-BACE in four patients. Global quality of life, physical and emotional functioning were all significantly improved at two months (P < 0.05). There were no serious adverse events. CONCLUSIONS: DEB-BACE with gemcitabine-loaded CalliSpheres beads is a feasible and well-tolerated treatment for patients with NSCLC who are ineligible or refuse to receive standard treatment.
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Bie et al. (2019) conducted an observational in non-small cell lung cancer (NSCLC) (n=6). Drug-eluting beads bronchial arterial chemoembolization (DEB-BACE) loaded with gemcitabine was evaluated on objective response rate (ORR).
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