Lipoplatin™ Monotherapy: A Phase II Trial of Second-Line Treatment of Metastatic Non-Small-Cell Lung Cancer

Abstract

Lipoplatin is a liposome encapsulated form of cisplatin. phase i studies on lipoplatin have demonstrated that the compound has an excellent toxicity profile. therefore we performed a phase ii trial in heavily pre-treated patients with advanced non-small-cell lung cancer (NSClC), performance status 0-2 in which the primary endpoint was response rate and secondary endpoints were safety and overall survival.Nineteen patients, average age 64 years old, with stage iV NSClC, were treated with lipoplatin 100 mg/m(2) every two weeks, as second line chemotherapy.We observed 1 partial remission (5.2%) and 3 stable diseases (15.9%). Time to progression (ttp) was 16 weeks and median overall survival (OS) was 31 weeks (7.2 months). We observed G1-G2 toxicity during chemotherapy, mainly gastrointestinal with nausea and vomiting (4 patients), asthenia (3 patients), mucositis (2 patients) and anemia (4 patients).Our phase ii study does not support a more extensive use of lipoplatin in phase III studies. An increase of dosage and a better selection of patients are mandatory to understand the real therapeutic activity of lipoplatin.

The status of platinum anticancer drugs in the clinic and in clinical trials

“…One such study did not recommend progression to Phase III studies, with only a 5% PR rate and 16% stable disease rate out of 19 pretreated patients. 228 Improved activity was shown when combining 120 mg m -2 Lipoplatin on days 1, 8 and 15 with gemcitabine 1000 mg m -2 on days 1 and 8 of a three-week cycle (LipoGem). This regime showed a disease control rate (DCR) of 71%.…”

Second and third line treatment in non-small cell lung cancer

“…Lipoplatin, 100 mg/m 2 every 14 days, is a new platinum analogue providing partial responses in 5% and stable diseases in 16% of patients with a median survival of 7 months [62]. Its toxicity profile leads to a dosage increase in further phase I-II trials.…”

Nanotechnology and human health: risks and benefits

“…A number of other nanoparticulate antineoplastic agents are available to avoid oto-and renal toxicity, in the case of cisplatin (Jehn et al, 2008;Ravaioli et al, 2009;Uchino et al, 2005), or to spare the viral carrier for nucleic acids and small interfering RNA (siRNA) (Bartlett and Davies, 2008). The liposomal cytarabine (DepoCyt), specifically designed for intrathecal use, is employed to treat neoplastic meningeal infiltrations (Bleyer, 1999).…”