2009
DOI: 10.1016/s1359-6349(09)71801-4
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9088 Phase III study of Lipoplatin plus Gemcitabine versus Cisplatin plus Gemcitabine in advanced NSCLC; interim analysis

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Cited by 16 publications
(17 citation statements)
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“…Lipoplatin has received orphan drug status by the European Medicines Agency (EMA) for treatment of pancreatic adenocarcinoma [140]. Its efficacy has been subsequently demonstrated in various Phase II/III studies, such as NSCLC [141], HER2/neu negative metastatic breast cancer [142] and advanced gastric cancer [143]. In other human studies using Lipoplatin platinum accumulation in tumors and metastases was shown to be higher than that in adjacent normal tissue 20 h after i.v.…”
Section: Platinum Drug Delivery Using Nanocarriersmentioning
confidence: 99%
“…Lipoplatin has received orphan drug status by the European Medicines Agency (EMA) for treatment of pancreatic adenocarcinoma [140]. Its efficacy has been subsequently demonstrated in various Phase II/III studies, such as NSCLC [141], HER2/neu negative metastatic breast cancer [142] and advanced gastric cancer [143]. In other human studies using Lipoplatin platinum accumulation in tumors and metastases was shown to be higher than that in adjacent normal tissue 20 h after i.v.…”
Section: Platinum Drug Delivery Using Nanocarriersmentioning
confidence: 99%
“…230 A safety profile more favourable than cisplatin was also observed, with particular regard to nephrotoxicity, neurotoxicity and asthenia. 230 Lipoplatin has also been studied with gemcitabine for malignant pleural mesothelioma, where a response was observed in one patient. and reduced occurrence of ototoxicity.…”
mentioning
confidence: 93%
“…All the 5 trials allocated patients to treatment arms randomly, but most of them did not report how the sequences were generated except that Stathopoulos et al [14] clarified their randomization was carried out according to the method of random permuted blocks within strata. Otherwise, 2 of the 5 trials were open-label [7,17] and 2 did not publish information on blinding, [13,18] while only one was conducted with evaluators blinded to treatment assignment. [14] Three trials showed evidence of incomplete outcomes’ data [13,17,18] and 2 trials with reporting biases had no information for key outcome data for interventions.…”
Section: Resultsmentioning
confidence: 99%
“…1). One phase III clinical trial has shown lipoplatin appeared more effective than conventional cisplatin and had a more favorable safety profile, particularly regarding nephrotoxicity, neurotoxicity and asthenia, [13] whereas another phase III clinical study has demonstrated liposomal cisplatin reduced nephrotoxicity but had a similar antitumor efficacy compared with conventional formulation. [14] There is an urgent need to conduct a meta-analysis addressing pertinent evidence to evaluate whether liposomal cisplatin could enhance antitumor efficacy over conventional nonliposomal cisplatin.…”
Section: Introductionmentioning
confidence: 99%