Abstract
BACKGROUND Bevacizumab combined with platinum-based chemotherapy has been established as a standard treatment option in the first-line setting for advanced nonsquamous non-small cell lung cancer (NSCLC). However, there has been no evidence to support the use of bevacizumab beyond disease progression in such patients. METHODS West Japan Oncology Group 5910L was designed as a multicenter, open-label, randomized, phase 2 trial of docetaxel versus docetaxel plus bevacizumab every 3 weeks for patients with recurrent or metastatic nonsquamous NSCLC whose disease had progressed after first-line treatment with bevacizumab plus a platinum-based doublet. The primary endpoint was progression-free survival (PFS). RESULTS One hundred patients were randomly assigned to receive docetaxel (n = 50) or docetaxel plus bevacizumab (n = 50), and this yielded median PFS times of 3.4 and 4.4 months, respectively, with a hazard ratio (HR) of 0.71 and a stratified log-rank P value of.058, which met the predefined criterion for statistical significance (P <.2). The median overall survival also tended to be longer in the docetaxel plus bevacizumab group (13.1 months; 95% confidence interval [CI], 10.6-21.4 months) versus the docetaxel group (11.0 months; 95% CI, 7.6-16.1 months) with an HR of 0.74 (95% CI, 0.46-1.19; stratified log-rank P =.11). No unexpected or severe adverse events were recorded. CONCLUSIONS Further evaluation of bevacizumab beyond disease progression is warranted for patients with advanced NSCLC whose disease has progressed after treatment with bevacizumab plus a platinum-based doublet. Cancer 2016;122:1050-1059.
| Original language | English |
|---|---|
| Pages (from-to) | 1050-1059 |
| Number of pages | 10 |
| Journal | Cancer |
| Volume | 122 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Apr 1 2016 |
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All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research
Cite this
Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L) : An open-label, randomized, phase 2 trial. / Takeda, Masayuki; Yamanaka, Takeharu; Seto, Takashi; Hayashi, Hidetoshi; Azuma, Koichi; Okada, Morihito; Sugawara, Shunichi; Daga, Haruko; Hirashima, Tomonori; Yonesaka, Kimio; Urata, Yoshiko; Murakami, Haruyasu; Saito, Haruhiro; Kubo, Akihito; Sawa, Toshiyuki; Miyahara, Eiji; Nogami, Naoyuki; Nakagawa, Kazuhiko; Nakanishi, Yoichi; Okamoto, Isamu.
In: Cancer, Vol. 122, No. 7, 01.04.2016, p. 1050-1059.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L)
T2 - An open-label, randomized, phase 2 trial
AU - Takeda, Masayuki
AU - Yamanaka, Takeharu
AU - Seto, Takashi
AU - Hayashi, Hidetoshi
AU - Azuma, Koichi
AU - Okada, Morihito
AU - Sugawara, Shunichi
AU - Daga, Haruko
AU - Hirashima, Tomonori
AU - Yonesaka, Kimio
AU - Urata, Yoshiko
AU - Murakami, Haruyasu
AU - Saito, Haruhiro
AU - Kubo, Akihito
AU - Sawa, Toshiyuki
AU - Miyahara, Eiji
AU - Nogami, Naoyuki
AU - Nakagawa, Kazuhiko
AU - Nakanishi, Yoichi
AU - Okamoto, Isamu
PY - 2016/4/1
Y1 - 2016/4/1
N2 - BACKGROUND Bevacizumab combined with platinum-based chemotherapy has been established as a standard treatment option in the first-line setting for advanced nonsquamous non-small cell lung cancer (NSCLC). However, there has been no evidence to support the use of bevacizumab beyond disease progression in such patients. METHODS West Japan Oncology Group 5910L was designed as a multicenter, open-label, randomized, phase 2 trial of docetaxel versus docetaxel plus bevacizumab every 3 weeks for patients with recurrent or metastatic nonsquamous NSCLC whose disease had progressed after first-line treatment with bevacizumab plus a platinum-based doublet. The primary endpoint was progression-free survival (PFS). RESULTS One hundred patients were randomly assigned to receive docetaxel (n = 50) or docetaxel plus bevacizumab (n = 50), and this yielded median PFS times of 3.4 and 4.4 months, respectively, with a hazard ratio (HR) of 0.71 and a stratified log-rank P value of.058, which met the predefined criterion for statistical significance (P <.2). The median overall survival also tended to be longer in the docetaxel plus bevacizumab group (13.1 months; 95% confidence interval [CI], 10.6-21.4 months) versus the docetaxel group (11.0 months; 95% CI, 7.6-16.1 months) with an HR of 0.74 (95% CI, 0.46-1.19; stratified log-rank P =.11). No unexpected or severe adverse events were recorded. CONCLUSIONS Further evaluation of bevacizumab beyond disease progression is warranted for patients with advanced NSCLC whose disease has progressed after treatment with bevacizumab plus a platinum-based doublet. Cancer 2016;122:1050-1059.
AB - BACKGROUND Bevacizumab combined with platinum-based chemotherapy has been established as a standard treatment option in the first-line setting for advanced nonsquamous non-small cell lung cancer (NSCLC). However, there has been no evidence to support the use of bevacizumab beyond disease progression in such patients. METHODS West Japan Oncology Group 5910L was designed as a multicenter, open-label, randomized, phase 2 trial of docetaxel versus docetaxel plus bevacizumab every 3 weeks for patients with recurrent or metastatic nonsquamous NSCLC whose disease had progressed after first-line treatment with bevacizumab plus a platinum-based doublet. The primary endpoint was progression-free survival (PFS). RESULTS One hundred patients were randomly assigned to receive docetaxel (n = 50) or docetaxel plus bevacizumab (n = 50), and this yielded median PFS times of 3.4 and 4.4 months, respectively, with a hazard ratio (HR) of 0.71 and a stratified log-rank P value of.058, which met the predefined criterion for statistical significance (P <.2). The median overall survival also tended to be longer in the docetaxel plus bevacizumab group (13.1 months; 95% confidence interval [CI], 10.6-21.4 months) versus the docetaxel group (11.0 months; 95% CI, 7.6-16.1 months) with an HR of 0.74 (95% CI, 0.46-1.19; stratified log-rank P =.11). No unexpected or severe adverse events were recorded. CONCLUSIONS Further evaluation of bevacizumab beyond disease progression is warranted for patients with advanced NSCLC whose disease has progressed after treatment with bevacizumab plus a platinum-based doublet. Cancer 2016;122:1050-1059.
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U2 - 10.1002/cncr.29893
DO - 10.1002/cncr.29893
M3 - Article
VL - 122
SP - 1050
EP - 1059
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 7
ER -