CANCERS BRONCHIQUES NON A PETITES CELLULES AU STADE AVANCE
ESSAIS RANDOMISES TESTANT LES INHIBITEURS DE TYROSINE KINASE

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référence

chimiothérapie

n

 

% RO

p

SM

p

Fukuoka,

2003 (1)

I. gefinitib 250 mg/j

104

rattrapage

18,4

 

7,6 m

 

II. gefinitib 500 mg/j

106

19

8,9 m

Kris,

2003 (2)

I. gefinitib 250 mg/j

102

rattrapage

12

 

7 m

NS

II. gefinitib 500 mg/j

114

9

6 m

Giaccone,

2004 (3)

I. Gemcitabine (1,25 x 2) + cisplatine (50) + gefinitib 500 mg/j

365

1ère ligne

50

NS

9,9 m

NS

II. Gemcitabine (1,25 x 2) + cisplatine (50) + gefinitib 250 mg/j

365

51

9,9 m

III. Gemcitabine (1,25 x 2) + cisplatine (50) + placebo

363

47

10,9 m

Herbst,

2004 (4)

I. Paclitaxel (225) + carboplatine (AUC 6) + gefinitib 500 mg/j

347

1ère ligne

30

NS

8,7 m

NS

II. Paclitaxel (225) + carboplatine (AUC 6) + gefinitib 250 mg/j

345

30,4

9,8  m

III. Paclitaxel (225) + carboplatine (AUC 6) + placebo

345

28,7

9,9 m

Shepherd,

2005 (5)

I. erlotinib 150 mg/j

488

rattrapage

8,9

S

6,7 m

S

II. placebo

243

1

4,7 m

Herbst,

2005 (6)

I. Carbo-Paclitaxel

540

1ère ligne

19,3

NS

10,5 m

NS

II Carbo-Paclitaxel + erlotinib

539

21,5

10,6 m

Thatcher,

2005 (7)

1. Géfitibib 250 mg/j

1129

rattrapage

8

 

5,6 m

0,087

2. -

563

 

 

5,1 m

Gatzemeier,

2007 (8)

1. gemcitabine + cisplatine (80) +  erlotinib (150 mg/j)

580

1ère ligne

 

31,5

NS

43 s

NS

2. gemcitabine + cisplatine (80) + placebo

579

29,9

44,1 s

Lilenbaum,

2008 (9)

 

PS 2

1. erlotinib

52

PS 2

1ère ligne

2

 

6,6 m

0,018

2. carboplatine + paclitaxel

51

12

9,5 m

Kelly,

2008 (10) I

1. Gefitinib

118

Stade III en entretien après RT-CT d’induction (cisplatine – VP16) et docétaxel (consolidation)

 

 

17,3 m

0,013

2. Placebo

125

 

25,4 m

Crino,

2008 (11), I

1. Gefitinib

97

> 70 ans et non prétraité par chimio

3,1 %

NS

5,9 m

NS

2. Vinorelbine

99

5,1 %

8,0 m

Maruyama,

2008 (12), I

1. Geftinib

245

rattrapage

22,5 %

0,009

11,5 m

0,33

2. Docétaxel

244

12,8 %

14 m

Mok,

2009 (13) I

Gefitinib

609

1ère ligne

Asiatiques

Adénocarcinomes

Non ou ex-fumeurs

43 %

S

18,6 m

NS

Carbo + Paclitaxel

608

32 %

17,3 m

Mok,

2009 (14)  I

Gemci + platine + erlotinib

76

1ère ligne

Asiatiques

35 %

NS

74 s

NS

Gemci + platine + placebo

78

24 %

76 s

Takeda,

2010 (15)

gefitinib puis Doublet (séquentiel)

300

1ère ligne

Asiatiques

34 %

NS

13,7 m

NS

Doublet

298

29 %

12,9 m

Scagliotti,

2010 (16) I

Carboplatine + paclitaxel + sorafenib

464

1ère ligne

27 %

NS

10,7 m

NS

Carboplatine + paclitaxel + placebo

462

24 %

10,6 m

Maemondo,

2010 (17;18) A

Gefitinib

114

1ère ligne

Asiatiques

Tumeurs EGFR-mutées

73,7 %

S

27,7 m

NS

Carboplatine + paclitaxel

114

30,7 %

26,6 m

Cappuzzo,

2010 (19) I

Erlotinib

437

Entretien après 4 cycles chimio à base de platine (non progression)

 

 

12 m

S

Placebo

447

 

11 m

De Boer,

2011 (20)  I

Vandetanib

256

2ème ligne

19 %

S

10,9 m

NS

Pemetrexed

278

8 %

9,5 m

Natale,

2011 (21) I

Vandetanib

623

Rattrapage

12 %

NS

6,9 m

NS

Erlotinib

617

12 %

7,8 m

Gaafar,

2011 (22) I

Gefitinib

86

Entretien après 4 cycles chimio à base de platine (non progression

 

 

10,9 m

NS

Placebo

87

 

9,4 m

Zhou,

2011 (23) I

Erlotinib

83

1ère ligne, mutation activatrice EGFr

82 %

S

 

 

Gemcitabine + carboplatine

82

36 %

 

Han,

2012 (24) I

Gefitinib

159

1ère ligne, non fumeurs

55 %

NS

22,3 m

NS

Cisplatine + gemcitabine

150

46 %

22,9 m

Lee,

2012 (25) I

Vandetanib

617

Après échec ITK anti EGFr activé

2,6 %

S

8,5 m

NS

Placebo

307

0,7 %

7,8 m

Rosell,

2012 (26) I

Erlotinib

86

1ère ligne, mutation activatrice EGFr

58 %

S

19,3 m

NS

Chimiothérapie standard

87

15 %

19,5 m

Scagliotti,

2012 (27) I

Sunitinib + erlotinib

480

Rattrapage

10,6 %

0,047

9,0 m

NS

Erlotinib

480

6,9  %

8,5 m

Jänne,

2012 (28)

Erlotinib

81

Non fumeur (1ère ligne)

35 %

 

24,6 m

 

Erlotinib + Carbo + taxol

100

46 %

19,8 m

Gridelli,

2012 (29) I

Erlotinib

380

1ère ligne avec cross-over à la progression

20,3%

S

8,7 m

S

Cisplatine + gemcitabine

380

32,6%

11,6 m

Pas-Arez,

2012 (30) I

Cisplatine + gemcitabine + sorafenib

385

1ère ligne

28 %

NS

12,4 m

NS

Cisplatine + gemcitabine

387

 

26 %

12 ,5 m

Pérol,

2012 (31) I

Gemcitabine

155

Maintenance après 4 cycles cisplatine + gemcitabine

 

 

Valeur non rapportée

NS

Erlotinib

154

 

11,4 m

Observation

155

 

10,8 m

Scagliotti,

2012 (32) I

Carboplatine + paclitaxel + motesanib

541

1ère ligne, non épi épi

40 %

S

13 m

NS

Carboplatine + paclitaxel

549

26 %

11 m

Shaw,

2013 (33) I

Crizotinib

173

ALK positif et échec chimio à base platine

65 %

S

12,2 m

NS

Pemetrexed ou docétaxel

174

20 %

12,1 m

Sun,

2012 (34)

Gefitinib

68

2ème ligne

41 %

NS

22,2 m

NS

Pemetrexed

67

37 %

18,9 m

Miller,

2012 (35) I

Afatinib

390

Rattrapage échec ITK

7 %

 

10,8 m

NS

Placebo

195

 

12 m

Sequist,

2013 (36) I

Afatinib

230

1ère ligne avec mutation activatrice EGFr

56 %

0,001

 

 

Cisplatine + pémétrexed

115

23 %

 



Références

(1) Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003 Jun 15;21(12):2237-46.
(2) Kris MG, Natale RB, Herbst RS, Lynch TJ, Jr., Prager D, Belani CP, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003 Oct 22;290(16):2149-58.
(3) Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 1. J Clin Oncol 2004 Mar 1;22(5):777-84.
(4) Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 2. J Clin Oncol 2004 Mar 1;22(5):785-94.
(5) Shepherd FA, Rodrigues PJ, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005 Jul 14;353(2):123-32.
(6) Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2005 Sep 1;23(25):5892-9.
(7) Thatcher N, Chang A, Parikh P, Rodrigues PJ, Ciuleanu T, von Pawel J, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005 Oct 29;366(9496):1527-37.
(8) Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec J, De RF, et al. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol 2007 Apr 20;25(12):1545-52.
(9) Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, et al. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol 2008 Feb 20;26(6):863-9.
(10) Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023. J Clin Oncol 2008 May 20;26(15):2450-6.
(11) Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, et al. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol 2008 Sep 10;26(26):4253-60.
(12) Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 2008 Sep 10;26(26):4244-52.
(13) Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009 Sep 3;361(10):947-57.
(14) Mok TS, Wu YL, Yu CJ, Zhou C, Chen YM, Zhang L, et al. Randomized, placebo-controlled, phase II study of sequential erlotinib and chemotherapy as first-line treatment for advanced non-small-cell lung cancer. J Clin Oncol 2009 Oct 20;27(30):5080-7.
(15) Takeda K, Hida T, Sato T, Ando M, Seto T, Satouchi M, et al. Randomized phase III trial of platinum-doublet chemotherapy followed by gefitinib compared with continued platinum-doublet chemotherapy in japanese patients with advanced non-small-cell lung cancer: results of a west Japan thoracic oncology group trial (WJTOG0203). J Clin Oncol 2010 Feb 10;28(5):753-60.
(16) Scagliotti G, Novello S, von PJ, Reck M, Pereira JR, Thomas M, et al. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol 2010 Apr 10;28(11):1835-42.
(17) Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010 Jun 24;362(25):2380-8.
(18) Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol 2013 Jan;24(1):54-9.
(19) Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010 Jun;11(6):521-9.
(20) de Boer RH, Arrieta O, Yang CH, Gottfried M, Chan V, Raats J, et al. Vandetanib Plus Pemetrexed for the Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Phase III Trial. J Clin Oncol 2011 Mar 10;29(8):1067-74.
(21) Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, et al. Phase III Trial of Vandetanib Compared With Erlotinib in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2011 Mar 10;29(8):1059-66.
(22) Gaafar RM, Surmont VF, Scagliotti GV, van Klaveren RJ, Papamichael D, Welch JJ, et al. A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03). Eur J Cancer 2011 Oct;47(15):2331-40.
(23) Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011 Aug;12(8):735-42.
(24) Han JY, Park K, Kim SW, Lee DH, Kim HY, Kim HT, et al. First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung. J Clin Oncol 2012 Apr 1;30(10):1122-8.
(25) Lee JS, Hirsh V, Park K, Qin S, Blajman CR, Perng RP, et al. Vandetanib Versus Placebo in Patients With Advanced Non-Small-Cell Lung Cancer After Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor: A Randomized, Double-Blind Phase III Trial (ZEPHYR). J Clin Oncol 2012 Apr 1;30(10):1114-21.
(26) Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012 Mar;13(3):239-46.
(27) Scagliotti GV, Krzakowski M, Szczesna A, Strausz J, Makhson A, Reck M, et al. Sunitinib Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Phase III Trial. J Clin Oncol 2012 Jun 10;30(17):2070-8.
(28) Janne PA, Wang X, Socinski MA, Crawford J, Stinchcombe TE, Gu L, et al. Randomized Phase II Trial of Erlotinib Alone or With Carboplatin and Paclitaxel in Patients Who Were Never or Light Former Smokers With Advanced Lung Adenocarcinoma: CALGB 30406 Trial. J Clin Oncol 2012 Jun 10;30(17):2063-9.
(29) Gridelli C, Ciardiello F, Gallo C, Feld R, Butts C, Gebbia V, et al. First-Line Erlotinib Followed by Second-Line Cisplatin-Gemcitabine Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The TORCH Randomized Trial. J Clin Oncol 2012 Aug 20;30(24):3002-11.
(30) Paz-Ares LG, Biesma B, Heigener D, von PJ, Eisen T, Bennouna J, et al. Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Gemcitabine/Cisplatin Alone or With Sorafenib for the First-Line Treatment of Advanced, Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol 2012 Sep 1;30(25):3084-92.
(31) Perol M, Chouaid C, Perol D, Barlesi F, Gervais R, Westeel V, et al. Randomized, Phase III Study of Gemcitabine or Erlotinib Maintenance Therapy Versus Observation, With Predefined Second-Line Treatment, After Cisplatin-Gemcitabine Induction Chemotherapy in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2012 Oct 1;30(28):3516-24.
(32) Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, et al. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol 2012 Aug 10;30(23):2829-36.
(33) Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013 Jun 20;368(25):2385-94.
(34) Sun JM, Lee KH, Kim SW, Lee DH, Min YJ, Yun HJ, et al. Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01): an open-label, phase 3 trial. Cancer 2012 Dec 15;118(24):6234-42.
(35) Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, et al. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol 2012 May;13(5):528-38.
(36) Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. J Clin Oncol 2013 Jul 1.


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