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

Masayuki Takeda, Takeharu Yamanaka, Takashi Seto, Hidetoshi Hayashi, Koichi Azuma, Morihito Okada, Shunichi Sugawara, Haruko Daga, Tomonori Hirashima, Kimio Yonesaka, Yoshiko Urata, Haruyasu Murakami, Haruhiro Saito, Akihito Kubo, Toshiyuki Sawa, Eiji Miyahara, Naoyuki Nogami, Kazuhiko Nakagawa, Yoichi Nakanishi, Isamu Okamoto

Research output: Contribution to journalArticle

28 Citations (Scopus)

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 languageEnglish
Pages (from-to)1050-1059
Number of pages10
JournalCancer
Volume122
Issue number7
DOIs
Publication statusPublished - Apr 1 2016

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docetaxel
Non-Small Cell Lung Carcinoma
Disease Progression
Japan
Drug Therapy
Platinum
Confidence Intervals
Therapeutics
Disease-Free Survival
Bevacizumab

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 journalArticle

Takeda, M, Yamanaka, T, Seto, T, Hayashi, H, Azuma, K, Okada, M, Sugawara, S, Daga, H, Hirashima, T, Yonesaka, K, Urata, Y, Murakami, H, Saito, H, Kubo, A, Sawa, T, Miyahara, E, Nogami, N, Nakagawa, K, Nakanishi, Y & Okamoto, I 2016, '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', Cancer, vol. 122, no. 7, pp. 1050-1059. https://doi.org/10.1002/cncr.29893
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. / 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. In: Cancer. 2016 ; Vol. 122, No. 7. pp. 1050-1059.
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title = "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",
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.",
author = "Masayuki Takeda and Takeharu Yamanaka and Takashi Seto and Hidetoshi Hayashi and Koichi Azuma and Morihito Okada and Shunichi Sugawara and Haruko Daga and Tomonori Hirashima and Kimio Yonesaka and Yoshiko Urata and Haruyasu Murakami and Haruhiro Saito and Akihito Kubo and Toshiyuki Sawa and Eiji Miyahara and Naoyuki Nogami and Kazuhiko Nakagawa and Yoichi Nakanishi and Isamu Okamoto",
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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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