Abstract
Nanosomal docetaxel lipid suspension (NDLS) was developed to overcome toxicity issues associated with conventional docetaxel. Conventional docetaxel carries a boxed warning of increased mortality with 100 mg/m2 dose in non-small cell lung cancer (NSCLC). We evaluated the efficacy and safety of NDLS monotherapy in patients with locally advanced (LA)/non-resectable/metastatic NSCLC after failure of prior platinum-based chemotherapy. In this two arm, randomized, multicentric, open label study, advanced NSCLC patients received NDLS 75 (T1 arm) or 100 mg/m2 (T2 arm) every 3 weeks for 6 cycles. Steroid premedication was not mandatory but could be administered as per institutional practice. Patients could be administered filgrastim support. Overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety were evaluated. Of 80 patients enrolled (T1: 39; T2: 41), 60 qualified as modified intent-to-treat (mITT) population (T1: 34; T2: 26). In the T1 and T2 arms, the ORRs were 2.9% and 15.4%, respectively (Table). At 1-year follow-up, median PFS in T1 and T2 arms was 8.07 and 8.13 months, respectively. The OS and PFS for both arms were 98.3% and 31.5%, respectively, at 1-year. The median OS was not reached for both arms. Most patients did not require steroid premedication. Anemia, leukopenia, abdominal pain, diarrhea, vomiting, asthenia, pyrexia, and anorexia were commonly reported (≥10% patients) adverse events. Only 2 events of grade 3 neutropenia (1 in each arm) were observed. Grade 3/4 hyperglycemia, infusion-related reactions, or neuropathy were not reported. No new safety concerns were observed.Table: 1038PResponse rateParametermITT (N=60)NDLS 75 mg/m2 (n=34)NDLS 100 mg/m2 (n=26)CR, n (%)0 (0.0)0 (0.0)PR, n (%)1 (2.9)4 (15.4)SD, n (%)26 (76.5)18 (69.2)ORR, n (%), [95% CI]1 (2.9) [0.07-15.33]4 (15.4) [4.36-34.87]DCR, n (%), [95% CI]27 (79.4) [62.10-91.30]21 (80.8) [60.65-93.45] Open table in a new tab NDLS monotherapy (75 or 100 mg/m2) was effective and well-tolerated in the treatment of advanced NSCLC. NDLS demonstrated a dose dependent increase in efficacy from 75 to 100 mg/m2.
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