Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study)
Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study...
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| Autor*in: |
Shen, Lin [verfasserIn] Li, Jin [verfasserIn] Xu, Jianming [verfasserIn] Pan, Hongming [verfasserIn] Dai, Guanghai [verfasserIn] Qin, Shukui [verfasserIn] Wang, Liwei [verfasserIn] Wang, Jinwan [verfasserIn] Yang, Zhenzhou [verfasserIn] Shu, Yongqian [verfasserIn] Xu, Ruihua [verfasserIn] Chen, Lei [verfasserIn] Liu, Yunpeng [verfasserIn] Yu, Shiying [verfasserIn] Bu, Lilian [verfasserIn] Piao, Yongzhe [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2014 |
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| Übergeordnetes Werk: |
Enthalten in: Gastric Cancer - Springer-Verlag, 2002, 18(2014), 1 vom: 21. Feb., Seite 168-176 |
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| Übergeordnetes Werk: |
volume:18 ; year:2014 ; number:1 ; day:21 ; month:02 ; pages:168-176 |
| Links: |
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| DOI / URN: |
10.1007/s10120-014-0351-5 |
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| Katalog-ID: |
SPR009320482 |
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| 245 | 1 | 0 | |a Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) |
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| 520 | |a Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. | ||
| 650 | 4 | |a Bevacizumab |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Gastric adenocarcinoma |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Li, Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Jianming |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, Hongming |e verfasserin |4 aut | |
| 700 | 1 | |a Dai, Guanghai |e verfasserin |4 aut | |
| 700 | 1 | |a Qin, Shukui |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Liwei |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jinwan |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Zhenzhou |e verfasserin |4 aut | |
| 700 | 1 | |a Shu, Yongqian |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Ruihua |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Lei |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Yunpeng |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Shiying |e verfasserin |4 aut | |
| 700 | 1 | |a Bu, Lilian |e verfasserin |4 aut | |
| 700 | 1 | |a Piao, Yongzhe |e verfasserin |4 aut | |
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10.1007/s10120-014-0351-5 doi (DE-627)SPR009320482 (SPR)s10120-014-0351-5-e DE-627 ger DE-627 rakwb eng Shen, Lin verfasserin aut Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 Li, Jin verfasserin aut Xu, Jianming verfasserin aut Pan, Hongming verfasserin aut Dai, Guanghai verfasserin aut Qin, Shukui verfasserin aut Wang, Liwei verfasserin aut Wang, Jinwan verfasserin aut Yang, Zhenzhou verfasserin aut Shu, Yongqian verfasserin aut Xu, Ruihua verfasserin aut Chen, Lei verfasserin aut Liu, Yunpeng verfasserin aut Yu, Shiying verfasserin aut Bu, Lilian verfasserin aut Piao, Yongzhe verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 18(2014), 1 vom: 21. Feb., Seite 168-176 (DE-627)SPR009286586 nnns volume:18 year:2014 number:1 day:21 month:02 pages:168-176 https://dx.doi.org/10.1007/s10120-014-0351-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 18 2014 1 21 02 168-176 |
| spelling |
10.1007/s10120-014-0351-5 doi (DE-627)SPR009320482 (SPR)s10120-014-0351-5-e DE-627 ger DE-627 rakwb eng Shen, Lin verfasserin aut Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 Li, Jin verfasserin aut Xu, Jianming verfasserin aut Pan, Hongming verfasserin aut Dai, Guanghai verfasserin aut Qin, Shukui verfasserin aut Wang, Liwei verfasserin aut Wang, Jinwan verfasserin aut Yang, Zhenzhou verfasserin aut Shu, Yongqian verfasserin aut Xu, Ruihua verfasserin aut Chen, Lei verfasserin aut Liu, Yunpeng verfasserin aut Yu, Shiying verfasserin aut Bu, Lilian verfasserin aut Piao, Yongzhe verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 18(2014), 1 vom: 21. Feb., Seite 168-176 (DE-627)SPR009286586 nnns volume:18 year:2014 number:1 day:21 month:02 pages:168-176 https://dx.doi.org/10.1007/s10120-014-0351-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 18 2014 1 21 02 168-176 |
| allfields_unstemmed |
10.1007/s10120-014-0351-5 doi (DE-627)SPR009320482 (SPR)s10120-014-0351-5-e DE-627 ger DE-627 rakwb eng Shen, Lin verfasserin aut Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 Li, Jin verfasserin aut Xu, Jianming verfasserin aut Pan, Hongming verfasserin aut Dai, Guanghai verfasserin aut Qin, Shukui verfasserin aut Wang, Liwei verfasserin aut Wang, Jinwan verfasserin aut Yang, Zhenzhou verfasserin aut Shu, Yongqian verfasserin aut Xu, Ruihua verfasserin aut Chen, Lei verfasserin aut Liu, Yunpeng verfasserin aut Yu, Shiying verfasserin aut Bu, Lilian verfasserin aut Piao, Yongzhe verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 18(2014), 1 vom: 21. Feb., Seite 168-176 (DE-627)SPR009286586 nnns volume:18 year:2014 number:1 day:21 month:02 pages:168-176 https://dx.doi.org/10.1007/s10120-014-0351-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 18 2014 1 21 02 168-176 |
| allfieldsGer |
10.1007/s10120-014-0351-5 doi (DE-627)SPR009320482 (SPR)s10120-014-0351-5-e DE-627 ger DE-627 rakwb eng Shen, Lin verfasserin aut Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 Li, Jin verfasserin aut Xu, Jianming verfasserin aut Pan, Hongming verfasserin aut Dai, Guanghai verfasserin aut Qin, Shukui verfasserin aut Wang, Liwei verfasserin aut Wang, Jinwan verfasserin aut Yang, Zhenzhou verfasserin aut Shu, Yongqian verfasserin aut Xu, Ruihua verfasserin aut Chen, Lei verfasserin aut Liu, Yunpeng verfasserin aut Yu, Shiying verfasserin aut Bu, Lilian verfasserin aut Piao, Yongzhe verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 18(2014), 1 vom: 21. Feb., Seite 168-176 (DE-627)SPR009286586 nnns volume:18 year:2014 number:1 day:21 month:02 pages:168-176 https://dx.doi.org/10.1007/s10120-014-0351-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 18 2014 1 21 02 168-176 |
| allfieldsSound |
10.1007/s10120-014-0351-5 doi (DE-627)SPR009320482 (SPR)s10120-014-0351-5-e DE-627 ger DE-627 rakwb eng Shen, Lin verfasserin aut Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 Li, Jin verfasserin aut Xu, Jianming verfasserin aut Pan, Hongming verfasserin aut Dai, Guanghai verfasserin aut Qin, Shukui verfasserin aut Wang, Liwei verfasserin aut Wang, Jinwan verfasserin aut Yang, Zhenzhou verfasserin aut Shu, Yongqian verfasserin aut Xu, Ruihua verfasserin aut Chen, Lei verfasserin aut Liu, Yunpeng verfasserin aut Yu, Shiying verfasserin aut Bu, Lilian verfasserin aut Piao, Yongzhe verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 18(2014), 1 vom: 21. Feb., Seite 168-176 (DE-627)SPR009286586 nnns volume:18 year:2014 number:1 day:21 month:02 pages:168-176 https://dx.doi.org/10.1007/s10120-014-0351-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 18 2014 1 21 02 168-176 |
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Enthalten in Gastric Cancer 18(2014), 1 vom: 21. Feb., Seite 168-176 volume:18 year:2014 number:1 day:21 month:02 pages:168-176 |
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Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. 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Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) Bevacizumab (dpeaa)DE-He213 Gastric adenocarcinoma (dpeaa)DE-He213 |
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Shen, Lin Li, Jin Xu, Jianming Pan, Hongming Dai, Guanghai Qin, Shukui Wang, Liwei Wang, Jinwan Yang, Zhenzhou Shu, Yongqian Xu, Ruihua Chen, Lei Liu, Yunpeng Yu, Shiying Bu, Lilian Piao, Yongzhe |
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bevacizumab plus capecitabine and cisplatin in chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase iii study (avatar study) |
| title_auth |
Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study) |
| abstract |
Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. |
| abstractGer |
Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. |
| abstract_unstemmed |
Background In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, double-blind, phase III study conducted in Chinese patients with advanced gastric cancer. Methods Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine–cisplatin plus either bevacizumab or placebo. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety. Results In total, 202 patients were included (placebo n = 102; bevacizumab n = 100). Baseline characteristics were well balanced. The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [hazard ratio, 1.11 (95 % CI, 0.79–1.56); P = 0.5567]. Median PFS was also similar in both arms. Bevacizumab plus capecitabine–cisplatin was well tolerated. Grade 3–5 adverse events (AEs) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients, respectively. Grade 3–5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients, mainly grade 3–5 hemorrhage (bevacizumab 4 %, placebo 12 %). Conclusions Addition of bevacizumab to capecitabine–cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS between the two arms and PFS was similar in both arms. Safety findings were as previously experienced with bevacizumab, including AVAGAST; no new safety signals were reported. |
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Li, Jin Xu, Jianming Pan, Hongming Dai, Guanghai Qin, Shukui Wang, Liwei Wang, Jinwan Yang, Zhenzhou Shu, Yongqian Xu, Ruihua Chen, Lei Liu, Yunpeng Yu, Shiying Bu, Lilian Piao, Yongzhe |
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Li, Jin Xu, Jianming Pan, Hongming Dai, Guanghai Qin, Shukui Wang, Liwei Wang, Jinwan Yang, Zhenzhou Shu, Yongqian Xu, Ruihua Chen, Lei Liu, Yunpeng Yu, Shiying Bu, Lilian Piao, Yongzhe |
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