Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

Tony S. Mok, Yi Long Wu, Myung Ju Ahn, Marina C. Garassino, Hye Ryoun Kim, Suresh S. Ramalingam, Frances A. Shepherd, Yong He, Hiroaki Akamatsu, Willemijn S. M. E. Theelen, Chee K. Lee, Martin Sebastian, Alison Templeton, Helen Mann, Marcelo Marotti, Serban Ghiorghiu, Vassiliki A. Papadimitrakopoulou

Research output: Contribution to journalArticle

918 Citations (Scopus)

Abstract

Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line
Original languageUndefined/Unknown
Pages (from-to)629-640
Number of pages12
JournalNew England Journal of Medicine
Volume376
Issue number7
DOIs
Publication statusPublished - Feb 1 2017

Keywords

  • Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy, Disease-Free Survival, Female, Humans, Lung Neoplasms/*drug therapy, Male, Middle Aged, Mutation, Pemetrexed/*administration dosage/adverse effects, Piperazines/*administration dosage/adverse effects, Platinum/administration dosage, Receptor, Epidermal Growth Factor/*antagonists inhibitors, Young Adult

Cite this

Mok, T. S., Wu, Y. L., Ahn, M. J., Garassino, M. C., Kim, H. R., Ramalingam, S. S., ... Papadimitrakopoulou, V. A. (2017). Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. New England Journal of Medicine, 376(7), 629-640. https://doi.org/10.1056/NEJMoa1612674

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. / Mok, Tony S.; Wu, Yi Long; Ahn, Myung Ju; Garassino, Marina C.; Kim, Hye Ryoun; Ramalingam, Suresh S.; Shepherd, Frances A.; He, Yong; Akamatsu, Hiroaki; Theelen, Willemijn S. M. E.; Lee, Chee K.; Sebastian, Martin; Templeton, Alison; Mann, Helen; Marotti, Marcelo; Ghiorghiu, Serban; Papadimitrakopoulou, Vassiliki A.

In: New England Journal of Medicine, Vol. 376, No. 7, 01.02.2017, p. 629-640.

Research output: Contribution to journalArticle

Mok, TS, Wu, YL, Ahn, MJ, Garassino, MC, Kim, HR, Ramalingam, SS, Shepherd, FA, He, Y, Akamatsu, H, Theelen, WSME, Lee, CK, Sebastian, M, Templeton, A, Mann, H, Marotti, M, Ghiorghiu, S & Papadimitrakopoulou, VA 2017, 'Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.', New England Journal of Medicine, vol. 376, no. 7, pp. 629-640. https://doi.org/10.1056/NEJMoa1612674
Mok, Tony S. ; Wu, Yi Long ; Ahn, Myung Ju ; Garassino, Marina C. ; Kim, Hye Ryoun ; Ramalingam, Suresh S. ; Shepherd, Frances A. ; He, Yong ; Akamatsu, Hiroaki ; Theelen, Willemijn S. M. E. ; Lee, Chee K. ; Sebastian, Martin ; Templeton, Alison ; Mann, Helen ; Marotti, Marcelo ; Ghiorghiu, Serban ; Papadimitrakopoulou, Vassiliki A. / Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 7. pp. 629-640.
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abstract = "Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line",
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T1 - Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

AU - Mok, Tony S.

AU - Wu, Yi Long

AU - Ahn, Myung Ju

AU - Garassino, Marina C.

AU - Kim, Hye Ryoun

AU - Ramalingam, Suresh S.

AU - Shepherd, Frances A.

AU - He, Yong

AU - Akamatsu, Hiroaki

AU - Theelen, Willemijn S. M. E.

AU - Lee, Chee K.

AU - Sebastian, Martin

AU - Templeton, Alison

AU - Mann, Helen

AU - Marotti, Marcelo

AU - Ghiorghiu, Serban

AU - Papadimitrakopoulou, Vassiliki A.

PY - 2017/2/1

Y1 - 2017/2/1

N2 - Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line

AB - Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line

KW - Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use, Carcinoma, Non-Small-Cell Lung/drug therapy, Disease-Free Survival, Female, Humans, Lung Neoplasms/drug therapy, Male, Middle Aged, Mutation, P

U2 - 10.1056/NEJMoa1612674

DO - 10.1056/NEJMoa1612674

M3 - Articolo

VL - 376

SP - 629

EP - 640

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

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ER -