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

Research output: Contribution to journalArticle

13 Citations (Scopus)

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 - Jan 1 2014

Fingerprint

zoledronic acid
docetaxel
Non-Small Cell Lung Carcinoma
Japan
Confidence Intervals
Neoplasm Metastasis
Disease-Free Survival
Bone Neoplasms
Safety
Bone and Bones
Information Services

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer : West Japan Oncology Group. / Murakami, Haruyasu; Yamanaka, Takeharu; Seto, Takashi; Sugio, Kenji; Okamoto, Isamu; Sawa, Toshiyuki; Hirashima, Tomonori; Takeda, Koji; Atagi, Shinji; Fukuoka, Masahiro; Nakanishi, Yoichi; Nakagawa, Kazuhiko; Yamamoto, Nobuyuki.

In: Cancer Science, Vol. 105, No. 8, 01.01.2014, p. 989-995.

Research output: Contribution to journalArticle

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, vol. 105, no. 8, pp. 989-995. https://doi.org/10.1111/cas.12448
Murakami, Haruyasu ; Yamanaka, Takeharu ; Seto, Takashi ; Sugio, Kenji ; Okamoto, Isamu ; Sawa, Toshiyuki ; Hirashima, Tomonori ; Takeda, Koji ; Atagi, Shinji ; Fukuoka, Masahiro ; Nakanishi, Yoichi ; Nakagawa, Kazuhiko ; Yamamoto, Nobuyuki. / Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer : West Japan Oncology Group. In: Cancer Science. 2014 ; Vol. 105, No. 8. pp. 989-995.
@article{1e3a96e13fa34f90bf99d5398da0b2aa,
title = "Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer: West Japan Oncology Group",
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.",
author = "Haruyasu Murakami and Takeharu Yamanaka and Takashi Seto and Kenji Sugio and Isamu Okamoto and Toshiyuki Sawa and Tomonori Hirashima and Koji Takeda and Shinji Atagi and Masahiro Fukuoka and Yoichi Nakanishi and Kazuhiko Nakagawa and Nobuyuki Yamamoto",
year = "2014",
month = "1",
day = "1",
doi = "10.1111/cas.12448",
language = "English",
volume = "105",
pages = "989--995",
journal = "Cancer Science",
issn = "1347-9032",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - Phase II study of zoledronic acid combined with docetaxel for non-small-cell lung cancer

T2 - West Japan Oncology Group

AU - Murakami, Haruyasu

AU - Yamanaka, Takeharu

AU - Seto, Takashi

AU - Sugio, Kenji

AU - Okamoto, Isamu

AU - Sawa, Toshiyuki

AU - Hirashima, Tomonori

AU - Takeda, Koji

AU - Atagi, Shinji

AU - Fukuoka, Masahiro

AU - Nakanishi, Yoichi

AU - Nakagawa, Kazuhiko

AU - Yamamoto, Nobuyuki

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84906794061&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84906794061&partnerID=8YFLogxK

U2 - 10.1111/cas.12448

DO - 10.1111/cas.12448

M3 - Article

VL - 105

SP - 989

EP - 995

JO - Cancer Science

JF - Cancer Science

SN - 1347-9032

IS - 8

ER -