Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer: West Japan Oncology Group

Haruyasu Murakami, Takeharu Yamanaka, Takashi Seto, Kenji Sugio, Isamu Okamoto, Toshiyuki Sawa, Tomonori Hirashima, Koji Takeda, Shinji Atagi, Masahiro Fukuoka, Yoichi Nakanishi, Kazuhiko Nakagawa, Nobuyuki Yamamoto

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Abstract

The aim of this open-label, multicenter, randomized phase II trial was to evaluate the efficacy and safety of zoledronic acid in combination with docetaxel in previously treated patients with non-small-cell lung cancer (NSCLC) and bone metastases. In this study, patients randomly received docetaxel (60 mg/m2) with (group DZ) or without (group D) zoledronic acid every 21 days. There were 50 patients in each group, and the primary endpoint was progression-free survival. In an efficacy analysis of 94 patients (DZ, 48; D, 46), the median progression-free survival was 2.7 months (95% confidence interval [CI], 1.5-3.5 months) for the DZ group and 2.6 months (95% CI, 1.5-3.4 months) for the D group (stratified log-rank test, P = 0.89). The median overall survival was 10.4 months (95% CI, 7.0-15.8 months) for the DZ group and 9.7 months (95% CI, 6.1-12.5 months) for the D group (stratified log-rank test, P = 0.62). 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. This trial was registered with the University Hospital Medical Information Network (UMIN000001098). A randomized phase II study was evaluate the efficacy and safety of zoledronic acid in combination with docetaxel in previously treated patients with non-small cell lung cancer (NSCLC) and bone metastases. This study demonstrated the safety and tolerability of the combination of zoledronic acid and docetaxel but did not meet the primary endpoint of PFS in advanced NSCLC patients with bone metastasis.

Original languageEnglish
Pages (from-to)989-995
Number of pages7
JournalCancer Science
Volume105
Issue number8
DOIs
Publication statusPublished - Aug 2014

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Murakami, H., Yamanaka, T., Seto, T., Sugio, K., Okamoto, I., Sawa, T., Hirashima, T., Takeda, K., Atagi, S., Fukuoka, M., Nakanishi, Y., Nakagawa, K., & Yamamoto, N. (2014). Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer: West Japan Oncology Group. Cancer Science, 105(8), 989-995. https://doi.org/10.1111/cas.12448