Novel cisplatin nanoparticle safe as adjunctive treatment for solid tumours
Use of NC-6004, a novel cisplatin nanoparticle developed using micellar technology, as an adjunct to gemcitabine in the treatment of patients with advanced solid tumours appears to be well tolerated, and greater equivalent doses of cisplatin are achieved with no clinically significant neurotoxicity, ototoxicity or nephrotoxicity, as shown in a recent study.
A total of 22 patients with advanced solid tumours were given NC-6004 at 60–180 mg/m2 on day 1 and gemcitabine at 1,250 mg/m2 on days 1 and 8 every 3 weeks. Dose escalation of NC-6004 was initiated with a single patient run-in until a dose-limiting toxicity occurred at 180 mg/m2.
There were four cohorts of four patients enrolled at doses predicted by the Bayesian continual reassessment model (N-CRM). Maximum tolerated dose (MTD) was defined as having the greatest probability of target toxicity <25 percent. Quality of life was evaluated using the EORTC-QLQ-C30.
The most commonly reported grade III/IV haematologic adverse events were leukopaenia (68 percent) and thrombocytopaenia (59 percent). Of the 20 pretreated patients evaluable for response, 10 had previous exposure to a platinum agent. The MTD was 135 mg/m2.
A total of nine patients were treated at MTD, with treatment lasting a median of 15 weeks (range, 3–50). There were 11 patients (55 percent) who showed tumour shrinkage, three patients (15 percent) who had partial responses, and 14 patients (70 percent) who achieved stable disease.
EORTC QLC-C30 scores improved or remained stable in most patients.
The present data demonstrate the tolerability and promising activity of NC-6004 in combination with gemcitabine, researchers said, adding that the combination warrants further investigation in phase II trials enrolling nonsmall cell lung cancer, biliary tract and bladder cancer patients.