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Randomized, placebo-controlled phase II study of vandetanib plus docetaxel in previously treated non small-cell lung
John V Heymach1, Bruce E Johnson, Diane Prager
1Dana-Farber Cancer Institute, Boston, MA, USA.
Purpose:
Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor-2 and epidermal growth factor receptor kinase activity. The activity of vandetanib plus docetaxel was assessed in patients with previously treated non-small-cell lung cancer (NSCLC).
Patients And Methods:
This two-part study comprised an open-label run-in phase and a double-blind randomized phase. Eligible patients had locally advanced or metastatic (stage IIIB/IV) NSCLC after failure of first-line platinum-based chemotherapy. The primary objective of the randomized phase was to prolong progression-free survival (PFS) in patients receiving vandetanib (100 or 300 mg/d) plus docetaxel (75 mg/m2 intravenous infusion every 21 days) versus placebo plus docetaxel. The study was designed to have more than 75% power to detect 50% prolongation at a one-sided significance level of P < .20. Secondary objectives included objective response rate, overall survival, safety and tolerability.
Results:
In the randomized phase (n = 127), median PFS was 18.7 weeks for vandetanib 100 mg plus docetaxel (n = 42; hazard ratio v docetaxel = 0.64; one-sided P = .037); 17.0 weeks for vandetanib 300 mg plus docetaxel (n = 44; hazard ratio v docetaxel = 0.83; one-sided P = .231); and 12 weeks for docetaxel (n = 41). There was no statistically significant difference in overall survival among the three treatment arms. Common adverse events included diarrhea, rash, and asymptomatic prolongation of corrected QT (QTC) interval.
Conclusion:
The primary objective was achieved, with vandetanib 100 mg plus docetaxel demonstrating a significant prolongation of PFS compared with docetaxel in relation to the prespecified significance level. On the basis of these encouraging data, phase III evaluation of vandetanib 100 mg plus docetaxel in second-line NSCLC has been initiated.
Insights
Vandetanib combined with docetaxel showed improved progression-free survival in non-small-cell lung cancer (NSCLC) patients. The 100 mg dose of vandetanib plus docetaxel significantly prolonged progression-free survival compared to docetaxel alone.
Area of Science:
- Oncology
- Pharmacology
Background:
- Non-small-cell lung cancer (NSCLC) is a leading cause of cancer-related deaths.
- Targeted therapies offer new treatment avenues for advanced NSCLC.
- Vandetanib inhibits key growth factor receptors implicated in cancer progression.
Purpose of the Study:
- To evaluate the efficacy and safety of vandetanib plus docetaxel in previously treated NSCLC patients.
- To determine if vandetanib enhances docetaxel's effectiveness in prolonging progression-free survival (PFS).
Main Methods:
- A two-part study including a run-in phase and a double-blind randomized controlled trial.
- Patients with advanced NSCLC who failed first-line chemotherapy were randomized.
- Treatment arms included vandetanib (100 or 300 mg/d) plus docetaxel versus placebo plus docetaxel.
Main Results:
- Vandetanib 100 mg plus docetaxel resulted in a median PFS of 18.7 weeks (hazard ratio=0.64, P=.037).
- Vandetanib 300 mg plus docetaxel showed a median PFS of 17.0 weeks (hazard ratio=0.83, P=.231).
- No significant difference in overall survival was observed; common adverse events included diarrhea and rash.
Conclusions:
- Vandetanib 100 mg plus docetaxel significantly prolonged PFS in previously treated NSCLC patients.
- These findings support further investigation of this combination in Phase III trials.
- Vandetanib 100 mg plus docetaxel represents a promising second-line treatment option for NSCLC.