First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Dong-Wan Kim; Yi-Long Wu; Jolanda Paolini; Tiziana Usari; Shrividya Iyer; Arlene Reisman; Keith D Wilner; Jennifer Tursi; M Boyer; V Ganju; B Hughes; N Pavlakis; B Solomon; S Varma; T Berghmans; J-L Canon; I Demedts; A Janssens; R Louis; T Pieters; D Schallier; V Surmont; C Maciel da Silva; C-G Moreira Ferreira; V Hirsh; A Joy; F Laberge; W Morzycki; R Wierzbicki; B Han; X Liu; S Qin; Y Shi; Y Wang; G Wu; Y-L Wu; C Zhou; J Ahvonen; F Barlesi; J Cadranel; E Dansin; J Fayette; J-F Morere; D Moro-Sibilot; J-L Pujol; E Quoix; G Zalcman; N Frickhofen; C-P Schneider; T Wehler; T Mok; P So; S Cuffe; A Bearz; C Boni; F Cappuzzo; F Cognetti; F De Braud; T De Pas; D Galetta; M Migliorino; D Rocco; G Scagliotti; P Tagliaferri; M Tiseo; K Aoe; T Hida; T Kato; T Kozuki; K Nakagawa; S Niho; M Nishio; H Nokihara; M Satouchi; T Seto; T Takahashi; J-S Ahn; D-W Kim; S-W Kim; G Berchem; O Arrieta Rodriguez; B Biesma; A-M Dingemans; E Smit; A Helland; F Barata; V Gorbunova; G Manikhas; S Orlov; S Leong; H-L Lim; R Soo; E-H Tan; A Nosworthy; M Codes Villena; E Felip; P Garrido Lopez; D Isla Casado; N Martinez Banaclocha; S Ponce Aix; N Reguart Aransay; D Rodriguez Abreu; J Trigo Perez; O Gautschi; M Pless; A Zippelius; G-C Chang; Y-H Tsai; Y Shparyk; F Blackhall; N Steele; V Armenio; K Dragnev; M Dugan; S Gadgeel; D Gerber; S Graziano; S Gurubhagavatula; L Horn; S Jalal; R Lauer; R Mehra; T Mekhail; H Mirshahidi; S Pakkala; J Polikoff; H Raftopoulos; M Saleh; R Salgia; S Waqar; Benjamin Solomon

doi:10.1056/NEJMoa1408440

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Dong-Wan Kim, Yi-Long Wu, Jolanda Paolini, Tiziana Usari, Shrividya Iyer, Arlene Reisman, Keith D Wilner, Jennifer Tursi, M Boyer (Collaborator), V Ganju (Collaborator), B Hughes (Collaborator), N Pavlakis (Collaborator), B Solomon (Collaborator), S Varma (Collaborator), T Berghmans (Collaborator), J-L Canon (Collaborator), I Demedts (Collaborator), A Janssens (Collaborator), R Louis (Collaborator), T Pieters (Collaborator)D Schallier (Collaborator), V Surmont (Collaborator), C Maciel da Silva (Collaborator), C-G Moreira Ferreira (Collaborator), V Hirsh (Collaborator), A Joy (Collaborator), F Laberge (Collaborator), W Morzycki (Collaborator), R Wierzbicki (Collaborator), B Han (Collaborator), X Liu (Collaborator), S Qin (Collaborator), Y Shi (Collaborator), Y Wang (Collaborator), G Wu (Collaborator), Y-L Wu (Collaborator), C Zhou (Collaborator), J Ahvonen (Collaborator), F Barlesi (Collaborator), J Cadranel (Collaborator), E Dansin (Collaborator), J Fayette (Collaborator), J-F Morere (Collaborator), D Moro-Sibilot (Collaborator), J-L Pujol (Collaborator), E Quoix (Collaborator), G Zalcman (Collaborator), N Frickhofen (Collaborator), C-P Schneider (Collaborator), T Wehler (Collaborator), T Mok (Collaborator), P So (Collaborator), S Cuffe (Collaborator), A Bearz (Collaborator), C Boni (Collaborator), F Cappuzzo (Collaborator), F Cognetti (Collaborator), F De Braud (Collaborator), T De Pas (Collaborator), D Galetta (Collaborator), M Migliorino (Collaborator), D Rocco (Collaborator), G Scagliotti (Collaborator), P Tagliaferri (Collaborator), M Tiseo (Collaborator), K Aoe (Collaborator), T Hida (Collaborator), T Kato (Collaborator), T Kozuki (Collaborator), K Nakagawa (Collaborator), S Niho (Collaborator), M Nishio (Collaborator), H Nokihara (Collaborator), M Satouchi (Collaborator), T Seto (Collaborator), T Takahashi (Collaborator), J-S Ahn (Collaborator), D-W Kim (Collaborator), S-W Kim (Collaborator), G Berchem (Collaborator), O Arrieta Rodriguez (Collaborator), B Biesma (Collaborator), A-M Dingemans (Collaborator), E Smit (Collaborator), A Helland (Collaborator), F Barata (Collaborator), V Gorbunova (Collaborator), G Manikhas (Collaborator), S Orlov (Collaborator), S Leong (Collaborator), H-L Lim (Collaborator), R Soo (Collaborator), E-H Tan (Collaborator), A Nosworthy (Collaborator), M Codes Villena (Collaborator), E Felip (Collaborator), P Garrido Lopez (Collaborator), D Isla Casado (Collaborator), N Martinez Banaclocha (Collaborator), S Ponce Aix (Collaborator), N Reguart Aransay (Collaborator), D Rodriguez Abreu (Collaborator), J Trigo Perez (Collaborator), O Gautschi (Collaborator), M Pless (Collaborator), A Zippelius (Collaborator), G-C Chang (Collaborator), Y-H Tsai (Collaborator), Y Shparyk (Collaborator), F Blackhall (Collaborator), N Steele (Collaborator), V Armenio (Collaborator), K Dragnev (Collaborator), M Dugan (Collaborator), S Gadgeel (Collaborator), D Gerber (Collaborator), S Graziano (Collaborator), S Gurubhagavatula (Collaborator), L Horn (Collaborator), S Jalal (Collaborator), R Lauer (Collaborator), R Mehra (Collaborator), T Mekhail (Collaborator), H Mirshahidi (Collaborator), S Pakkala (Collaborator), J Polikoff (Collaborator), H Raftopoulos (Collaborator), M Saleh (Collaborator), R Salgia (Collaborator), S Waqar (Collaborator), Benjamin Solomon (Collaborator)

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. METHODS: We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. RESULTS: Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P

Original language	English
Pages (from-to)	2167-2177
Journal	The New England Journal of Medicine
Volume	371
Issue number	23
DOIs	https://doi.org/10.1056/NEJMoa1408440
Publication status	Published - 4 Dec 2014

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10.1056/NEJMoa1408440

New targeted therapies in Non-Small Cell Lung Cancer improve patient outcomes
Blackhall, F. (Participant) & (Participant)
Impact: Health and wellbeing, Economic

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Kim, D.-W., Wu, Y.-L., Paolini, J., Usari, T., Iyer, S., Reisman, A., Wilner, K. D., Tursi, J., Boyer, M., Ganju, V., Hughes, B., Pavlakis, N., Solomon, B., Varma, S., Berghmans, T., Canon, J.-L., Demedts, I., Janssens, A., Louis, R., ... Solomon, B. (2014). First-line crizotinib versus chemotherapy in ALK-positive lung cancer. The New England Journal of Medicine, 371(23), 2167-2177. https://doi.org/10.1056/NEJMoa1408440

@article{6b9fcf57376a4ebd91b1fe1d03020d7e,

title = "First-line crizotinib versus chemotherapy in ALK-positive lung cancer.",

abstract = "BACKGROUND: The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. METHODS: We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. RESULTS: Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P",

author = "Dong-Wan Kim and Yi-Long Wu and Jolanda Paolini and Tiziana Usari and Shrividya Iyer and Arlene Reisman and Wilner, {Keith D} and Jennifer Tursi and M Boyer and V Ganju and B Hughes and N Pavlakis and B Solomon and S Varma and T Berghmans and J-L Canon and I Demedts and A Janssens and R Louis and T Pieters and D Schallier and V Surmont and {da Silva}, {C Maciel} and Ferreira, {C-G Moreira} and V Hirsh and A Joy and F Laberge and W Morzycki and R Wierzbicki and B Han and X Liu and S Qin and Y Shi and Y Wang and G Wu and Y-L Wu and C Zhou and J Ahvonen and F Barlesi and J Cadranel and E Dansin and J Fayette and J-F Morere and D Moro-Sibilot and J-L Pujol and E Quoix and G Zalcman and N Frickhofen and C-P Schneider and T Wehler and T Mok and P So and S Cuffe and A Bearz and C Boni and F Cappuzzo and F Cognetti and {De Braud}, F and {De Pas}, T and D Galetta and M Migliorino and D Rocco and G Scagliotti and P Tagliaferri and M Tiseo and K Aoe and T Hida and T Kato and T Kozuki and K Nakagawa and S Niho and M Nishio and H Nokihara and M Satouchi and T Seto and T Takahashi and J-S Ahn and D-W Kim and S-W Kim and G Berchem and Rodriguez, {O Arrieta} and B Biesma and A-M Dingemans and E Smit and A Helland and F Barata and V Gorbunova and G Manikhas and S Orlov and S Leong and H-L Lim and R Soo and E-H Tan and A Nosworthy and {Codes Villena}, M and E Felip and {Garrido Lopez}, P and {Isla Casado}, D and {Martinez Banaclocha}, N and {Ponce Aix}, S and {Reguart Aransay}, N and {Rodriguez Abreu}, D and {Trigo Perez}, J and O Gautschi and M Pless and A Zippelius and G-C Chang and Y-H Tsai and Y Shparyk and F Blackhall and N Steele and V Armenio and K Dragnev and M Dugan and S Gadgeel and D Gerber and S Graziano and S Gurubhagavatula and L Horn and S Jalal and R Lauer and R Mehra and T Mekhail and H Mirshahidi and S Pakkala and J Polikoff and H Raftopoulos and M Saleh and R Salgia and S Waqar and Benjamin Solomon",

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month = dec,

day = "4",

doi = "10.1056/NEJMoa1408440",

language = "English",

volume = "371",

pages = "2167--2177",

journal = "The New England Journal of Medicine",

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publisher = "Massachussetts Medical Society",

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Kim, D-W, Wu, Y-L, Paolini, J, Usari, T, Iyer, S, Reisman, A, Wilner, KD, Tursi, J, Boyer, M, Ganju, V, Hughes, B, Pavlakis, N, Solomon, B, Varma, S, Berghmans, T, Canon, J-L, Demedts, I, Janssens, A, Louis, R, Pieters, T, Schallier, D, Surmont, V, da Silva, CM, Ferreira, C-GM, Hirsh, V, Joy, A, Laberge, F, Morzycki, W, Wierzbicki, R, Han, B, Liu, X, Qin, S, Shi, Y, Wang, Y, Wu, G, Wu, Y-L, Zhou, C, Ahvonen, J, Barlesi, F, Cadranel, J, Dansin, E, Fayette, J, Morere, J-F, Moro-Sibilot, D, Pujol, J-L, Quoix, E, Zalcman, G, Frickhofen, N, Schneider, C-P, Wehler, T, Mok, T, So, P, Cuffe, S, Bearz, A, Boni, C, Cappuzzo, F, Cognetti, F, De Braud, F, De Pas, T, Galetta, D, Migliorino, M, Rocco, D, Scagliotti, G, Tagliaferri, P, Tiseo, M, Aoe, K, Hida, T, Kato, T, Kozuki, T, Nakagawa, K, Niho, S, Nishio, M, Nokihara, H, Satouchi, M, Seto, T, Takahashi, T, Ahn, J-S, Kim, D-W, Kim, S-W, Berchem, G, Rodriguez, OA, Biesma, B, Dingemans, A-M, Smit, E, Helland, A, Barata, F, Gorbunova, V, Manikhas, G, Orlov, S, Leong, S, Lim, H-L, Soo, R, Tan, E-H, Nosworthy, A, Codes Villena, M, Felip, E, Garrido Lopez, P, Isla Casado, D, Martinez Banaclocha, N, Ponce Aix, S, Reguart Aransay, N, Rodriguez Abreu, D, Trigo Perez, J, Gautschi, O, Pless, M, Zippelius, A, Chang, G-C, Tsai, Y-H, Shparyk, Y, Blackhall, F, Steele, N, Armenio, V, Dragnev, K, Dugan, M, Gadgeel, S, Gerber, D, Graziano, S, Gurubhagavatula, S, Horn, L, Jalal, S, Lauer, R, Mehra, R, Mekhail, T, Mirshahidi, H, Pakkala, S, Polikoff, J, Raftopoulos, H, Saleh, M, Salgia, R, Waqar, S & Solomon, B 2014, 'First-line crizotinib versus chemotherapy in ALK-positive lung cancer.', The New England Journal of Medicine, vol. 371, no. 23, pp. 2167-2177. https://doi.org/10.1056/NEJMoa1408440

TY - JOUR

T1 - First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

AU - Kim, Dong-Wan

AU - Wu, Yi-Long

AU - Paolini, Jolanda

AU - Usari, Tiziana

AU - Iyer, Shrividya

AU - Reisman, Arlene

AU - Wilner, Keith D

AU - Tursi, Jennifer

A2 - Boyer, M

A2 - Ganju, V

A2 - Hughes, B

A2 - Pavlakis, N

A2 - Solomon, B

A2 - Varma, S

A2 - Berghmans, T

A2 - Canon, J-L

A2 - Demedts, I

A2 - Janssens, A

A2 - Louis, R

A2 - Pieters, T

A2 - Schallier, D

A2 - Surmont, V

A2 - da Silva, C Maciel

A2 - Ferreira, C-G Moreira

A2 - Hirsh, V

A2 - Joy, A

A2 - Laberge, F

A2 - Morzycki, W

A2 - Wierzbicki, R

A2 - Han, B

A2 - Liu, X

A2 - Qin, S

A2 - Shi, Y

A2 - Wang, Y

A2 - Wu, G

A2 - Wu, Y-L

A2 - Zhou, C

A2 - Ahvonen, J

A2 - Barlesi, F

A2 - Cadranel, J

A2 - Dansin, E

A2 - Fayette, J

A2 - Morere, J-F

A2 - Moro-Sibilot, D

A2 - Pujol, J-L

A2 - Quoix, E

A2 - Zalcman, G

A2 - Frickhofen, N

A2 - Schneider, C-P

A2 - Wehler, T

A2 - Mok, T

A2 - So, P

A2 - Cuffe, S

A2 - Bearz, A

A2 - Boni, C

A2 - Cappuzzo, F

A2 - Cognetti, F

A2 - De Braud, F

A2 - De Pas, T

A2 - Galetta, D

A2 - Migliorino, M

A2 - Rocco, D

A2 - Scagliotti, G

A2 - Tagliaferri, P

A2 - Tiseo, M

A2 - Aoe, K

A2 - Hida, T

A2 - Kato, T

A2 - Kozuki, T

A2 - Nakagawa, K

A2 - Niho, S

A2 - Nishio, M

A2 - Nokihara, H

A2 - Satouchi, M

A2 - Seto, T

A2 - Takahashi, T

A2 - Ahn, J-S

A2 - Kim, D-W

A2 - Kim, S-W

A2 - Berchem, G

A2 - Rodriguez, O Arrieta

A2 - Biesma, B

A2 - Dingemans, A-M

A2 - Smit, E

A2 - Helland, A

A2 - Barata, F

A2 - Gorbunova, V

A2 - Manikhas, G

A2 - Orlov, S

A2 - Leong, S

A2 - Lim, H-L

A2 - Soo, R

A2 - Tan, E-H

A2 - Nosworthy, A

A2 - Codes Villena, M

A2 - Felip, E

A2 - Garrido Lopez, P

A2 - Isla Casado, D

A2 - Martinez Banaclocha, N

A2 - Ponce Aix, S

A2 - Reguart Aransay, N

A2 - Rodriguez Abreu, D

A2 - Trigo Perez, J

A2 - Gautschi, O

A2 - Pless, M

A2 - Zippelius, A

A2 - Chang, G-C

A2 - Tsai, Y-H

A2 - Shparyk, Y

A2 - Blackhall, F

A2 - Steele, N

A2 - Armenio, V

A2 - Dragnev, K

A2 - Dugan, M

A2 - Gadgeel, S

A2 - Gerber, D

A2 - Graziano, S

A2 - Gurubhagavatula, S

A2 - Horn, L

A2 - Jalal, S

A2 - Lauer, R

A2 - Mehra, R

A2 - Mekhail, T

A2 - Mirshahidi, H

A2 - Pakkala, S

A2 - Polikoff, J

A2 - Raftopoulos, H

A2 - Saleh, M

A2 - Salgia, R

A2 - Waqar, S

A2 - Solomon, Benjamin

PY - 2014/12/4

Y1 - 2014/12/4

N2 - BACKGROUND: The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. METHODS: We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. RESULTS: Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P

AB - BACKGROUND: The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. METHODS: We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. RESULTS: Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P

U2 - 10.1056/NEJMoa1408440

DO - 10.1056/NEJMoa1408440

M3 - Article

C2 - 25470694

SN - 1533-4406

VL - 371

SP - 2167

EP - 2177

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 23

ER -

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Abstract

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New targeted therapies in Non-Small Cell Lung Cancer improve patient outcomes

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