Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer: West Japan Oncology Group.
Bottom Line: There were no clinically relevant differences in the frequencies of grade 3 or 4 adverse events between the two groups.No treatment-related deaths occurred in the DZ group.Zoledronic acid combined with docetaxel was well tolerated but did not meet the primary endpoint of demonstrating a longer progression-free survival in advanced NSCLC patients with bone metastases compared with docetaxel alone.
Affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.Show MeSH
Related in: MedlinePlus
Mentions: For the 94 patients included in the efficacy analysis, the cumulative incidence rates of an SRE at 3, 6, 9 and 12 months were 17%, 20%, 27% and 30%, respectively, for the DZ group, and 16%, 27%, 39% and 39%, respectively, for the D group (Fig. 4a). Median SRE-free survival was 7.2 (95% CI, 4.9–10.7) months for the DZ group and 6.0 (95% CI, 4.4–8.5) months for the D group (stratified log-rank test, P = 0.84). In subset analyses of the SRE rate according to baseline bone marker levels (Fig. 4b), the cumulative incidence rates of SRE at 12 months were 44% for the DZ group (N = 19) and 48% for the D group (N = 19) in patients with high baseline urinary NTX levels, 24% for the DZ group (N = 29) and 30% for the D group (N = 27) in patients with normal or unknown baseline urinary NTX levels, 43% for the DZ group (N = 34) and 38% for the D group (N = 32) in patients with high baseline serum I-CTP levels, and 7% for the DZ group (N = 14) and 37% for the D group (N = 14) in patients with normal or unknown baseline serum I-CTP levels.
Affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.