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Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.

BACKGROUNDAn earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiothera... Full description

Journal Title: The New England journal of medicine December 13, 2018, Vol.379(24), pp.2342-2350
Main Author: Antonia, Scott J
Other Authors: Villegas, Augusto , Daniel, Davey , Vicente, David , Murakami, Shuji , Hui, Rina , Kurata, Takayasu , Chiappori, Alberto , Lee, Ki H , de Wit, Maike , Cho, Byoung C , Bourhaba, Maryam , Quantin, Xavier , Tokito, Takaaki , Mekhail, Tarek , Planchard, David , Kim, Young-Chul , Karapetis, Christos S , Hiret, Sandrine , Ostoros
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1809697
Link: http://search.proquest.com/docview/2116125706/?pq-origsite=primo
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title: Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
format: Article
creator:
  • Antonia, Scott J
  • Villegas, Augusto
  • Daniel, Davey
  • Vicente, David
  • Murakami, Shuji
  • Hui, Rina
  • Kurata, Takayasu
  • Chiappori, Alberto
  • Lee, Ki H
  • de Wit, Maike
  • Cho, Byoung C
  • Bourhaba, Maryam
  • Quantin, Xavier
  • Tokito, Takaaki
  • Mekhail, Tarek
  • Planchard, David
  • Kim, Young-Chul
  • Karapetis, Christos S
  • Hiret, Sandrine
  • Ostoros
subjects:
  • Adult–Administration & Dosage
  • Aged–Adverse Effects
  • Aged, 80 and Over–Administration & Dosage
  • Antibodies, Monoclonal–Adverse Effects
  • Antineoplastic Agents, Immunological–Drug Therapy
  • Carcinoma, Non-Small-Cell Lung–Mortality
  • Chemoradiotherapy–Radiotherapy
  • Female–Drug Therapy
  • Humans–Mortality
  • Infusions, Intravenous–Radiotherapy
  • Intention to Treat Analysis–Radiotherapy
  • Kaplan-Meier Estimate–Radiotherapy
  • Lung Neoplasms–Radiotherapy
  • Male–Radiotherapy
  • Middle Aged–Radiotherapy
  • Survival Rate–Radiotherapy
  • Abridged
  • Antibodies, Monoclonal
ispartof: The New England journal of medicine, December 13, 2018, Vol.379(24), pp.2342-2350
description: BACKGROUNDAn earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODSWe randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTSOf the 713 patients who...
language: eng
source:
identifier: E-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1809697
fulltext: fulltext
issn:
  • 15334406
  • 1533-4406
url: Link


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titleOverall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
creatorAntonia, Scott J ; Villegas, Augusto ; Daniel, Davey ; Vicente, David ; Murakami, Shuji ; Hui, Rina ; Kurata, Takayasu ; Chiappori, Alberto ; Lee, Ki H ; de Wit, Maike ; Cho, Byoung C ; Bourhaba, Maryam ; Quantin, Xavier ; Tokito, Takaaki ; Mekhail, Tarek ; Planchard, David ; Kim, Young-Chul ; Karapetis, Christos S ; Hiret, Sandrine ; Ostoros
contributorHui, Rina (correspondence author) ; Karapetis, Chris (record owner) ; Jasas, Kevin ; Obyrne, Kenneth ; Houghton, Baerin ; Hughes, Brett ; Lewis, Craig ; Links, Matthew ; Ng, Say ; Parente, Phillip ; Gauden, Stanislaw ; Bourhaba, Maryam ; Forget, Frederic ; Vercauter, Piet ; Vansteenkiste, Johan ; Canon, Jean-Luc ; Cheema, Parneet ; Vincent, Mark ; Murray, Nevin ; Rothenstein
ispartofThe New England journal of medicine, December 13, 2018, Vol.379(24), pp.2342-2350
identifierE-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1809697
subjectAdult–Administration & Dosage ; Aged–Adverse Effects ; Aged, 80 and Over–Administration & Dosage ; Antibodies, Monoclonal–Adverse Effects ; Antineoplastic Agents, Immunological–Drug Therapy ; Carcinoma, Non-Small-Cell Lung–Mortality ; Chemoradiotherapy–Radiotherapy ; Female–Drug Therapy ; Humans–Mortality ; Infusions, Intravenous–Radiotherapy ; Intention to Treat Analysis–Radiotherapy ; Kaplan-Meier Estimate–Radiotherapy ; Lung Neoplasms–Radiotherapy ; Male–Radiotherapy ; Middle Aged–Radiotherapy ; Survival Rate–Radiotherapy ; Abridged ; Antibodies, Monoclonal
descriptionBACKGROUNDAn earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODSWe randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTSOf the 713 patients who...
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1Villegas, Augusto
2Daniel, Davey
3Vicente, David
4Murakami, Shuji
5Hui, Rina
6Kurata, Takayasu
7Chiappori, Alberto
8Lee, Ki H
9de Wit, Maike
10Cho, Byoung C
11Bourhaba, Maryam
12Quantin, Xavier
13Tokito, Takaaki
14Mekhail, Tarek
15Planchard, David
16Kim, Young-Chul
17Karapetis, Christos S
18Hiret, Sandrine
19Ostoros, Gyula
20Kubota, Kaoru
21Gray, Jhanelle E
22Paz-Ares, Luis
23de Castro Carpeño, Javier
24Faivre-Finn, Corinne
25Reck, Martin
26Vansteenkiste, Johan
27Spigel, David R
28Wadsworth, Catherine
29Melillo, Giovanni
30Taboada, Maria
31Dennis, Phillip A
32Özgüroğlu, Mustafa
titleOverall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
descriptionBACKGROUNDAn earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODSWe randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTSOf the 713 patients who...
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5Carcinoma, Non-Small-Cell Lung–Mortality
6Chemoradiotherapy–Radiotherapy
7Female–Drug Therapy
8Humans–Mortality
9Infusions, Intravenous–Radiotherapy
10Intention to Treat Analysis–Radiotherapy
11Kaplan-Meier Estimate–Radiotherapy
12Lung Neoplasms–Radiotherapy
13Male–Radiotherapy
14Middle Aged–Radiotherapy
15Survival Rate–Radiotherapy
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17Antibodies, Monoclonal
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8Ng, Say
9Parente, Phillip
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11Bourhaba, Maryam
12Forget, Frederic
13Vercauter, Piet
14Vansteenkiste, Johan
15Canon, Jean-Luc
16Cheema, Parneet
17Vincent, Mark
18Murray, Nevin
19Rothenstein, Jeffrey
20Zibdawi, Labib
21Bradbury, Penelope
22Butts, Charles
23El-Maraghi, Robert
24Bebb, Dafydd
25Acevedo Gaete, Alejandro
26Orellana, Eric
27Aren Frontera, Osvaldo Rudy
28Quantin, Xavier
29Hiret, Sandrine
30Planchard, David
31Mazières, Julien
32Renault, Aldo
33Robinet, Gilles
34Cortot, Alexis
35Hilgers, Werner
36Poudenx, Michel
37Barlesi, Fabrice
38El Kouri, Claude
39Perol, Maurice
40Lena, Herve
41Sabatini, Marielle
42de Wit, Maike
43Laack, Eckart
44Schulz, Christian
45Brugger, Wolfram
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57Ostoros, Gyula
58Sztancsik, Zsuzsanna
59Losonczy, Gyorgy
60Csanky, Eszter
61Nechushtan, Hovav
62Wollner, Mirjana
63Chella, Antonio
64Bearz, Alessandra
65Chiuri, Vincenzo Emanuele
66Garassino, Marina
67Gianni, Luca
68Brighenti, Matteo
69Ciardiello, Fortunato
70Milella, Michele
71Soto Parra, Hector
72Murakami, Shuji
73Yokoi, Takashi
74Tokito, Takaaki
75Kubota, Kaoru
76Sugawara, Shunichi
77Atagi, Shinji
78Hirashima, Tomonori
79Imamura, Fumio
80Iwamoto, Yasuo
81Kanda, Shintaro
82Masuda, Noriyuki
83Minato, Koichi
84Nakagawa, Kazuhiko
85Niho, Seiji
86Saka, Hideo
87Takahashi, Toshiaki
88Fujisaka, Yasuhito
89Sakai, Hiroshi
90Takahashi, Kazuhisa
91Baba, Tomohisa
92Harada, Masao
93Kasahara, Kazuo
94Maeda, Tadashi
95Maemondo, Makoto
96Okamoto, Isamu
97Takeda, Yuichiro
98Kobayashi, Kunihiko
99Nogami, Naoyuki
100...
startdate20181213
enddate20181213
citationpf 2342 pt 2350 vol 379 issue 24
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titleOverall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
authorAntonia, Scott J ; Villegas, Augusto ; Daniel, Davey ; Vicente, David ; Murakami, Shuji ; Hui, Rina ; Kurata, Takayasu ; Chiappori, Alberto ; Lee, Ki H ; de Wit, Maike ; Cho, Byoung C ; Bourhaba, Maryam ; Quantin, Xavier ; Tokito, Takaaki ; Mekhail, Tarek ; Planchard, David ; Kim, Young-Chul ; Karapetis, Christos S ; Hiret, Sandrine ; Ostoros
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1Aged–Adverse Effects
2Aged, 80 and Over–Administration & Dosage
3Antibodies, Monoclonal–Adverse Effects
4Antineoplastic Agents, Immunological–Drug Therapy
5Carcinoma, Non-Small-Cell Lung–Mortality
6Chemoradiotherapy–Radiotherapy
7Female–Drug Therapy
8Humans–Mortality
9Infusions, Intravenous–Radiotherapy
10Intention to Treat Analysis–Radiotherapy
11Kaplan-Meier Estimate–Radiotherapy
12Lung Neoplasms–Radiotherapy
13Male–Radiotherapy
14Middle Aged–Radiotherapy
15Survival Rate–Radiotherapy
16Abridged
17Antibodies, Monoclonal
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0Antonia, Scott J
1Villegas, Augusto
2Daniel, Davey
3Vicente, David
4Murakami, Shuji
5Hui, Rina
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7Chiappori, Alberto
8Lee, Ki H
9de Wit, Maike
10Cho, Byoung C
11Bourhaba, Maryam
12Quantin, Xavier
13Tokito, Takaaki
14Mekhail, Tarek
15Planchard, David
16Kim, Young-Chul
17Karapetis, Christos S
18Hiret, Sandrine
19Ostoros, Gyula
20Kubota, Kaoru
21Gray, Jhanelle E
22Paz-Ares, Luis
23de Castro Carpeño, Javier
24Faivre-Finn, Corinne
25Reck, Martin
26Vansteenkiste, Johan
27Spigel, David R
28Wadsworth, Catherine
29Melillo, Giovanni
30Taboada, Maria
31Dennis, Phillip A
32Özgüroğlu, Mustafa
33Karapetis, Chris
34Jasas, Kevin
35Obyrne, Kenneth
36Houghton, Baerin
37Hughes, Brett
38Lewis, Craig
39Links, Matthew
40Ng, Say
41Parente, Phillip
42Gauden, Stanislaw
43Forget, Frederic
44Vercauter, Piet
45Canon, Jean-Luc
46Cheema, Parneet
47Vincent, Mark
48Murray, Nevin
49Rothenstein, Jeffrey
50Zibdawi, Labib
51Bradbury, Penelope
52Butts, Charles
53El-Maraghi, Robert
54Bebb, Dafydd
55Acevedo Gaete, Alejandro
56Orellana, Eric
57Aren Frontera, Osvaldo Rudy
58Mazières, Julien
59Renault, Aldo
60Robinet, Gilles
61Cortot, Alexis
62Hilgers, Werner
63Poudenx, Michel
64Barlesi, Fabrice
65El Kouri, Claude
66Perol, Maurice
67Lena, Herve
68Sabatini, Marielle
69Laack, Eckart
70Schulz, Christian
71Brugger, Wolfram
72Faehling, Martin
73Wolff, Thomas
74Fischer, Juergen
75Emde, Till-Oliver
76Scholz, Christian
77Kalofonos, Haralabos
78Kotsakis, Athanasios
79Syrigos, Konstantinos
80Papazisis, Konstantinos
81Zarogoulidis, Kostantinos
82Sztancsik, Zsuzsanna
83Losonczy, Gyorgy
84Csanky, Eszter
85Nechushtan, Hovav
86Wollner, Mirjana
87Chella, Antonio
88Bearz, Alessandra
89Chiuri, Vincenzo Emanuele
90Garassino, Marina
91Gianni, Luca
92Brighenti, Matteo
93Ciardiello, Fortunato
94Milella, Michele
95Soto Parra, Hector
96Yokoi, Takashi
97Sugawara, Shunichi
98Atagi, Shinji
99Hirashima, Tomonori
100...
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29Melillo, Giovanni
30Taboada, Maria
31Dennis, Phillip A
32Özgüroğlu, Mustafa
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10Gauden, Stanislaw
11Bourhaba, Maryam
12Forget, Frederic
13Vercauter, Piet
14Vansteenkiste, Johan
15Canon, Jean-Luc
16Cheema, Parneet
17Vincent, Mark
18Murray, Nevin
19Rothenstein, Jeffrey
20Zibdawi, Labib
21Bradbury, Penelope
22Butts, Charles
23El-Maraghi, Robert
24Bebb, Dafydd
25Acevedo Gaete, Alejandro
26Orellana, Eric
27Aren Frontera, Osvaldo Rudy
28Quantin, Xavier
29Hiret, Sandrine
30Planchard, David
31Mazières, Julien
32Renault, Aldo
33Robinet, Gilles
34Cortot, Alexis
35Hilgers, Werner
36Poudenx, Michel
37Barlesi, Fabrice
38El Kouri, Claude
39Perol, Maurice
40Lena, Herve
41Sabatini, Marielle
42de Wit, Maike
43Laack, Eckart
44Schulz, Christian
45Brugger, Wolfram
46Faehling, Martin
47Reck, Martin
48Wolff, Thomas
49Fischer, Juergen
50Emde, Till-Oliver
51Scholz, Christian
52Kalofonos, Haralabos
53Kotsakis, Athanasios
54Syrigos, Konstantinos
55Papazisis, Konstantinos
56Zarogoulidis, Kostantinos
57Ostoros, Gyula
58Sztancsik, Zsuzsanna
59Losonczy, Gyorgy
60Csanky, Eszter
61Nechushtan, Hovav
62Wollner, Mirjana
63Chella, Antonio
64Bearz, Alessandra
65Chiuri, Vincenzo Emanuele
66Garassino, Marina
67Gianni, Luca
68Brighenti, Matteo
69Ciardiello, Fortunato
70Milella, Michele
71Soto Parra, Hector
72Murakami, Shuji
73Yokoi, Takashi
74Tokito, Takaaki
75Kubota, Kaoru
76Sugawara, Shunichi
77Atagi, Shinji
78Hirashima, Tomonori
79Imamura, Fumio
80Iwamoto, Yasuo
81Kanda, Shintaro
82Masuda, Noriyuki
83Minato, Koichi
84Nakagawa, Kazuhiko
85Niho, Seiji
86Saka, Hideo
87Takahashi, Toshiaki
88Fujisaka, Yasuhito
89Sakai, Hiroshi
90Takahashi, Kazuhisa
91Baba, Tomohisa
92Harada, Masao
93Kasahara, Kazuo
94Maeda, Tadashi
95Maemondo, Makoto
96Okamoto, Isamu
97Takeda, Yuichiro
98Kobayashi, Kunihiko
99Nogami, Naoyuki
100...
atitleOverall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC.
jtitleThe New England journal of medicine
risdate20181213
volume379
issue24
spage2342
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pages2342-2350
eissn1533-4406
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genrearticle
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abstractBACKGROUNDAn earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODSWe randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTSOf the 713 patients who...
doi10.1056/NEJMoa1809697
urlhttp://search.proquest.com/docview/2116125706/
issn00284793
date2018-12-13