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 ORR was 8% for the DZ group (CR, N = 0; PR, N = 4; SD, N = 18; PD, N = 25; not evaluable, N = 1) and 4% for the D group (CR, N = 0; PR, N = 2; SD, N = 20; PD, N = 23; not evaluable, N = 1). The difference in ORR between the two groups was not statistically significant (P = 0.88). Median PFS was 2.7 (95% CI, 1.5–3.5) months for the DZ group and 2.6 (95% CI, 1.5–3.4) months for the D group (stratified log-rank test, P = 0.89; Fig. 2a). Median OS was 10.4 (95% CI, 7.0–15.8) months for the DZ group and 9.7 (95% CI, 6.1–12.5) months for the D group (stratified log-rank test, P = 0.62; Fig. 2b). No remarkable difference in PFS (Fig. 3a) or OS (Fig. 3b) was observed according to demographic characteristics (number of bone metastases, prior SRE, baseline urinary NTX and baseline serum I-CTP).
Affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.