Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study
Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recu...
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| Autor*in: |
Bang, Yung-Jue [verfasserIn] Kang, Yoon-Koo [verfasserIn] Catenacci, Daniel V. [verfasserIn] Muro, Kei [verfasserIn] Fuchs, Charles S. [verfasserIn] Geva, Ravit [verfasserIn] Hara, Hiroki [verfasserIn] Golan, Talia [verfasserIn] Garrido, Marcelo [verfasserIn] Jalal, Shadia I. [verfasserIn] Borg, Christophe [verfasserIn] Doi, Toshihiko [verfasserIn] Yoon, Harry H. [verfasserIn] Savage, Mary J. [verfasserIn] Wang, Jiangdian [verfasserIn] Dalal, Rita P. [verfasserIn] Shah, Sukrut [verfasserIn] Wainberg, Zev A. [verfasserIn] Chung, Hyun Cheol [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Übergeordnetes Werk: |
Enthalten in: Gastric Cancer - Springer-Verlag, 2002, 22(2019), 4 vom: 25. März, Seite 828-837 |
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| Übergeordnetes Werk: |
volume:22 ; year:2019 ; number:4 ; day:25 ; month:03 ; pages:828-837 |
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| DOI / URN: |
10.1007/s10120-018-00909-5 |
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SPR009350179 |
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| 245 | 1 | 0 | |a Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study |
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| 520 | |a Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 | ||
| 650 | 4 | |a Pembrolizumab |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Cisplatin |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a 5-Fluorouracil |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Capecitabine |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Gastric cancer |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Kang, Yoon-Koo |e verfasserin |4 aut | |
| 700 | 1 | |a Catenacci, Daniel V. |e verfasserin |4 aut | |
| 700 | 1 | |a Muro, Kei |e verfasserin |4 aut | |
| 700 | 1 | |a Fuchs, Charles S. |e verfasserin |4 aut | |
| 700 | 1 | |a Geva, Ravit |e verfasserin |4 aut | |
| 700 | 1 | |a Hara, Hiroki |e verfasserin |4 aut | |
| 700 | 1 | |a Golan, Talia |e verfasserin |4 aut | |
| 700 | 1 | |a Garrido, Marcelo |e verfasserin |4 aut | |
| 700 | 1 | |a Jalal, Shadia I. |e verfasserin |4 aut | |
| 700 | 1 | |a Borg, Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Doi, Toshihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Yoon, Harry H. |e verfasserin |4 aut | |
| 700 | 1 | |a Savage, Mary J. |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jiangdian |e verfasserin |4 aut | |
| 700 | 1 | |a Dalal, Rita P. |e verfasserin |4 aut | |
| 700 | 1 | |a Shah, Sukrut |e verfasserin |4 aut | |
| 700 | 1 | |a Wainberg, Zev A. |e verfasserin |4 aut | |
| 700 | 1 | |a Chung, Hyun Cheol |e verfasserin |4 aut | |
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10.1007/s10120-018-00909-5 doi (DE-627)SPR009350179 (SPR)s10120-018-00909-5-e DE-627 ger DE-627 rakwb eng Bang, Yung-Jue verfasserin aut Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 Kang, Yoon-Koo verfasserin aut Catenacci, Daniel V. verfasserin aut Muro, Kei verfasserin aut Fuchs, Charles S. verfasserin aut Geva, Ravit verfasserin aut Hara, Hiroki verfasserin aut Golan, Talia verfasserin aut Garrido, Marcelo verfasserin aut Jalal, Shadia I. verfasserin aut Borg, Christophe verfasserin aut Doi, Toshihiko verfasserin aut Yoon, Harry H. verfasserin aut Savage, Mary J. verfasserin aut Wang, Jiangdian verfasserin aut Dalal, Rita P. verfasserin aut Shah, Sukrut verfasserin aut Wainberg, Zev A. verfasserin aut Chung, Hyun Cheol verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 22(2019), 4 vom: 25. März, Seite 828-837 (DE-627)SPR009286586 nnns volume:22 year:2019 number:4 day:25 month:03 pages:828-837 https://dx.doi.org/10.1007/s10120-018-00909-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 22 2019 4 25 03 828-837 |
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10.1007/s10120-018-00909-5 doi (DE-627)SPR009350179 (SPR)s10120-018-00909-5-e DE-627 ger DE-627 rakwb eng Bang, Yung-Jue verfasserin aut Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 Kang, Yoon-Koo verfasserin aut Catenacci, Daniel V. verfasserin aut Muro, Kei verfasserin aut Fuchs, Charles S. verfasserin aut Geva, Ravit verfasserin aut Hara, Hiroki verfasserin aut Golan, Talia verfasserin aut Garrido, Marcelo verfasserin aut Jalal, Shadia I. verfasserin aut Borg, Christophe verfasserin aut Doi, Toshihiko verfasserin aut Yoon, Harry H. verfasserin aut Savage, Mary J. verfasserin aut Wang, Jiangdian verfasserin aut Dalal, Rita P. verfasserin aut Shah, Sukrut verfasserin aut Wainberg, Zev A. verfasserin aut Chung, Hyun Cheol verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 22(2019), 4 vom: 25. März, Seite 828-837 (DE-627)SPR009286586 nnns volume:22 year:2019 number:4 day:25 month:03 pages:828-837 https://dx.doi.org/10.1007/s10120-018-00909-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 22 2019 4 25 03 828-837 |
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10.1007/s10120-018-00909-5 doi (DE-627)SPR009350179 (SPR)s10120-018-00909-5-e DE-627 ger DE-627 rakwb eng Bang, Yung-Jue verfasserin aut Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 Kang, Yoon-Koo verfasserin aut Catenacci, Daniel V. verfasserin aut Muro, Kei verfasserin aut Fuchs, Charles S. verfasserin aut Geva, Ravit verfasserin aut Hara, Hiroki verfasserin aut Golan, Talia verfasserin aut Garrido, Marcelo verfasserin aut Jalal, Shadia I. verfasserin aut Borg, Christophe verfasserin aut Doi, Toshihiko verfasserin aut Yoon, Harry H. verfasserin aut Savage, Mary J. verfasserin aut Wang, Jiangdian verfasserin aut Dalal, Rita P. verfasserin aut Shah, Sukrut verfasserin aut Wainberg, Zev A. verfasserin aut Chung, Hyun Cheol verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 22(2019), 4 vom: 25. März, Seite 828-837 (DE-627)SPR009286586 nnns volume:22 year:2019 number:4 day:25 month:03 pages:828-837 https://dx.doi.org/10.1007/s10120-018-00909-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 22 2019 4 25 03 828-837 |
| allfieldsGer |
10.1007/s10120-018-00909-5 doi (DE-627)SPR009350179 (SPR)s10120-018-00909-5-e DE-627 ger DE-627 rakwb eng Bang, Yung-Jue verfasserin aut Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 Kang, Yoon-Koo verfasserin aut Catenacci, Daniel V. verfasserin aut Muro, Kei verfasserin aut Fuchs, Charles S. verfasserin aut Geva, Ravit verfasserin aut Hara, Hiroki verfasserin aut Golan, Talia verfasserin aut Garrido, Marcelo verfasserin aut Jalal, Shadia I. verfasserin aut Borg, Christophe verfasserin aut Doi, Toshihiko verfasserin aut Yoon, Harry H. verfasserin aut Savage, Mary J. verfasserin aut Wang, Jiangdian verfasserin aut Dalal, Rita P. verfasserin aut Shah, Sukrut verfasserin aut Wainberg, Zev A. verfasserin aut Chung, Hyun Cheol verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 22(2019), 4 vom: 25. März, Seite 828-837 (DE-627)SPR009286586 nnns volume:22 year:2019 number:4 day:25 month:03 pages:828-837 https://dx.doi.org/10.1007/s10120-018-00909-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 22 2019 4 25 03 828-837 |
| allfieldsSound |
10.1007/s10120-018-00909-5 doi (DE-627)SPR009350179 (SPR)s10120-018-00909-5-e DE-627 ger DE-627 rakwb eng Bang, Yung-Jue verfasserin aut Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 Kang, Yoon-Koo verfasserin aut Catenacci, Daniel V. verfasserin aut Muro, Kei verfasserin aut Fuchs, Charles S. verfasserin aut Geva, Ravit verfasserin aut Hara, Hiroki verfasserin aut Golan, Talia verfasserin aut Garrido, Marcelo verfasserin aut Jalal, Shadia I. verfasserin aut Borg, Christophe verfasserin aut Doi, Toshihiko verfasserin aut Yoon, Harry H. verfasserin aut Savage, Mary J. verfasserin aut Wang, Jiangdian verfasserin aut Dalal, Rita P. verfasserin aut Shah, Sukrut verfasserin aut Wainberg, Zev A. verfasserin aut Chung, Hyun Cheol verfasserin aut Enthalten in Gastric Cancer Springer-Verlag, 2002 22(2019), 4 vom: 25. März, Seite 828-837 (DE-627)SPR009286586 nnns volume:22 year:2019 number:4 day:25 month:03 pages:828-837 https://dx.doi.org/10.1007/s10120-018-00909-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 22 2019 4 25 03 828-837 |
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Bang, Yung-Jue @@aut@@ Kang, Yoon-Koo @@aut@@ Catenacci, Daniel V. @@aut@@ Muro, Kei @@aut@@ Fuchs, Charles S. @@aut@@ Geva, Ravit @@aut@@ Hara, Hiroki @@aut@@ Golan, Talia @@aut@@ Garrido, Marcelo @@aut@@ Jalal, Shadia I. @@aut@@ Borg, Christophe @@aut@@ Doi, Toshihiko @@aut@@ Yoon, Harry H. @@aut@@ Savage, Mary J. @@aut@@ Wang, Jiangdian @@aut@@ Dalal, Rita P. @@aut@@ Shah, Sukrut @@aut@@ Wainberg, Zev A. @@aut@@ Chung, Hyun Cheol @@aut@@ |
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Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. 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Bang, Yung-Jue |
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Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study Pembrolizumab (dpeaa)DE-He213 Cisplatin (dpeaa)DE-He213 5-Fluorouracil (dpeaa)DE-He213 Capecitabine (dpeaa)DE-He213 Gastric cancer (dpeaa)DE-He213 |
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Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study |
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Bang, Yung-Jue Kang, Yoon-Koo Catenacci, Daniel V. Muro, Kei Fuchs, Charles S. Geva, Ravit Hara, Hiroki Golan, Talia Garrido, Marcelo Jalal, Shadia I. Borg, Christophe Doi, Toshihiko Yoon, Harry H. Savage, Mary J. Wang, Jiangdian Dalal, Rita P. Shah, Sukrut Wainberg, Zev A. Chung, Hyun Cheol |
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pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase ii nonrandomized keynote-059 study |
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Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study |
| abstract |
Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 |
| abstractGer |
Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 |
| abstract_unstemmed |
Background The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. Clinical Trial ClinicalTrials.gov NCT02335411 |
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Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study |
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Kang, Yoon-Koo Catenacci, Daniel V. Muro, Kei Fuchs, Charles S. Geva, Ravit Hara, Hiroki Golan, Talia Garrido, Marcelo Jalal, Shadia I. Borg, Christophe Doi, Toshihiko Yoon, Harry H. Savage, Mary J. Wang, Jiangdian Dalal, Rita P. Shah, Sukrut Wainberg, Zev A. Chung, Hyun Cheol |
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Results from cohorts 2 and 3, evaluating first-line therapy, are presented. Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/$ m^{2} $ on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/$ m^{2} $ on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/$ m^{2} $ twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy). Results In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy). Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. 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