CANCERS BRONCHIQUES NON A PETITES CELLULES AU STADE AVANCE
ESSAIS TESTANT LE ROLE DE LA GEMCITABINE


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référence

chimiothérapie

n

(stIV)

% RO

p

SM

p

Manegold,

1997 (1)

I.         CDDP-VP16

75

 

15

 

NS

7,6 m

 

> 0,9

II.       Gemcitabine

71

 

18

6,6 m

Perng,

1997 (2)

I. CDDP-VP16

26

 

21

 

NS

48 s

 

0,65

II. Gemcitabine

27

 

19

37 s

Cardenal, 1999 (3)

I. Gemcitabine (1,25 g/m² J1+8) + CDDP (100 mg/m² J1)

69

 

36

 

41

 

 

 

0,02

9 m

 

 

 

NS

II. VP16 (100 mg/m² J1-3) + CDDP (100 mg/m² J1)

66

32

22

7 m

Comella,

1999 (4)

I. CDDP (50 mg/m² J1) + gemci (1,5 g/m² J1+8) + vinorelbine (25 mg/m² J1+8)

87

 

46

 

60

 

 

 

?

33 s

 

 

 

?

II. CDDP (80 mg/m²) + épirubicine (80 mg/m²) + vindésine (3 mg/m²) + lonidamine

54

32

37

32 s

Crino,

1999 (5)

I.CDDP (100 mg /m² J1) + gemci (1g/m² J1, 8, 15)

155

 

123

 

38

 

 

 

0,03

8,6 m

 

 

 

NS

II. CDDP (100 mg /m² J1) + Ifo (3g/m² J1) + MMC (6 mg/m² J1)

152

120

26

9,6 m

Rinaldi,

2000 (6)

GEM (1g/m2 d1 + 8) +

 

 

 

 

 

NS

 

 

 

0,14

1. CDDP 100 mg/m2 d2

45

 

42

15,4m

2. CDDP 70 mg/m2 d2

45

 

47

11,5m

Ricci,

2000 (7)

GEM (1g/m2 d1,8,15) +

 

 

 

 

 

NS

 

 

 

< 0,01

1. CDDP 80 d2

42

 

40

10 m

2. CDDP 80 d15

40

 

45

17 m

Comella,

2000 (8)

1. CDDP+GEM+VNR

60

 

47

 

 

?

51 s

 

 

?

2. CDDP+VNR

60

 

25

35 s

3. CDDP+GEM

60

 

30

42 s

Frasci,

2000 (9)

1. GEM+VNR

60

 

22

 

NS

29 s

 

< 0,01

2. VNR

60

 

15

18 s

Gridelli,

2001(10)

1. GEM+VNR

49

 

18

NS

?

 

2.  GEM

44

 

18

?

Georgoulias,

2001 (11)

I. CDDP (80 mg/m²)+docetaxel (100 mg/m²)

205

(129)

35

 

NS

10 m

 

NS

II. Gemci + docetaxel (100 mg/m²)

201

(130)

33

9,5 m

Vansteenkiste,

2001 (12)

I. gemcitabine

84

(58)

20

 

8 m

 

0,12

II. CDDP + VP16

85

(57)

20

6 m

Schiller,

2002 (13)

I.CDDP (75 mg/m²)+ paclitaxel (135 mg/m²)

303

89%

21

 

 

 

NS

7,8 m

 

 

 

NS

II.CDDP 100 + gemcitabine

301

86%

22

8,1 m

III.CDDP 75 + docetaxel (75 mg/m²)

304

86%

17

7,4 m

IV.Carboplatine  (AUC 6) + paclitaxel (225)

299

86%

17

8,1 m

Kosmidis,

2002 (14)

I. Paclitaxel (200 mg/m²) + Carbo (AUC 6)

252

(158)

28

 

0,12

10,4 m

 

0,32

II. Paclitaxel (200 mg/m²) + gemcitabine

257

(148)

35

9,8 m

Scagliotti,

2002 (15)

I. CDDP (75 mg/m²) + gemcitabine

205

81%

30

 


NS

9,8 m

 

 

NS

II. Carboplatine (AUC 6) + paclitaxel (225)

201

82%

32

9,9 m

III. CDDP (100 mg/m²) + VNR

201

81%

30

9,5 m

Greco,

2002(16)

I. CBDCA (AUC 5)+paclitaxel (200)+ gemci

71

(51)

37

 

 

 

NS

9,2 m

 

 

 

NS

II. CBDCA (AUC 6)+paclitaxel (200)+ VNR

65

(51)

45

8,6 m

III. paclitaxel (200)+ gemci

64

(53)

32

8,7 m

IV. Gemci + VNR

67

(49)

33

10,7 m

Chen,

2002 (17)

I. Carboplatine (AUC 7) + paclitaxel (175)

45

 

40

 

14,1 m

 

II. paclitaxel (175)+ gemci

45

 

40

12,6 m

Grigorescu,

2002 (18)

I. CDDP + VBL

99

 

10

 

S

7,9 m

 

0,0001

II. Carbo + gemcitabine

99

 

27

11,5 m

 

 

 

 

 

 

 

 

Soto Parra,

2002 (19)

I. CDDP  (70 mg/m² J2) + gemcitabine (1g/m² J1 + 8)

48

 

 

42

 

 

 

NS

367 j

 

 

 

NS

II. CDDP (70 mg/m² J2) + gemcitabine (1g/m² J1 + 8 + 15)

48

 

38

279 j

Gridelli,

2003 (20)

I. VNR

233

71%

18

 

 

NS

36 s

 

 

NS

II. gemcitabine

233

70%

16

28 s

III. VNR + gemcitabine

232

69%

21

30 s

Gebbia,

2003 (21)

I. CDDP + gemcitabine

138

(73)

34

 

 

 

0.007

8,2

 

NS

II. CDDP + vinorelbine

140

(75)

44

9,0

III. Ifo + gemcitabine puis CDDP + VNR

60

(33)

19

 

IV. CDDP + VNR puis Ifo + gemcitabine

60

(31)

31

 

Gridelli,

2003 (22)

I. CDDP (80) + VNR

126

80%

 

30

 

 

NS

 

38 s

 

 

0,08

II. CDDP (80) + gemcitabine

126

81%

III. VNR + gemcitabine

251

80%

25

32 s

Wachters,

2003 (23)

I. CDDP + gemcitabine

119

57%

46

NS

43 s

0,14

II. Epirubicine + gemcitabine

121

57%

36

36 s

Rocha-Lima,

2004 (24)

I. gemcitabine + irinotecan

39

(30)

12,8

 

8 m

 

II. gemcitabine + docétaxel

39

(31)

23,1

12,8 m

Comella,

2004 (25)

I. Gemcitabine + paclitaxel

65

(40)

32

 

 

 

0,01

9,2 m

 

 

 

NS

II. Gemcitabine + vinorelbine

68

(40)

23

9,7 m

III. Paclitaxel

63

(47)

13

6,4 m

IV. Gemcitabine

68

(44)

18

5,1 m

Rudd,

2005 (26)

I. Gemcitabine + carboplatine

212

(117)

42

 

NS

10 m

 

0,008

II. Cisplatine + MMC + ifosfamide

210

(105)

41

7,6 m

Martoni,

2005 (27)

I. CDDP (75) + VNR

137

65 %

32

NS

11 m

NS

II. CDDP (65) + gemcitabine

135

56 %

27

11 m

Quoix,

2005 (28)

I. Gemcitabine : 1 g/m² J1,8,15 ttes les 4 sem

42

62 %

14

 

154 j

 

II. Gemcitabine : 1,125 g/m² J1,8 ttes les 3 sem (sujets âgés : 70 à 90 ans)

39

72 %

28

205 j

Baka,

2005 (29)

I. Gemcitabine : 1 g/m² J1,8,15 ttes les 4 sem

87

58

5,5

NS

83 j

NS

II. Gemcitabine : 1,5 g/m² J1,8 ttes les 3 sem (PS ≤ 70)

87

54

9,9

65 j

Ma,

2005 (30)

I. pemetrexed J1 puis gemcitabine J 1 & 8

59

51

31

S

11,3 m

NS

II. gemci J1 puis pemetrexed J1 & gemci J8

31

28

6,5

10,4 m

III. gemci J1 puis pemetrexed J8 & gemci J8

62

53

16,1

11,8 m

Masters,

2006 (31)

I. gemci (1,1 J1 & 8) + carbo (AUC5 J8) ttes les 4 sem

48

41

23

0,08

8,7 m

NS

II. gemci (1 J1 & 8) + carbo (AUC5 J1) ttes les 3 sem

52

44

40

8 m

Soo,

2006 (32)

I. Carbo (AUC 5) + gemci 750 (en 75 min) J1&8

40

31

34

 

212 j

 

II. Carbo (AUC 5) + gemci 1000 (en 30 min) J1&8

38

31

42

287 j

Kim,

2006 (33)

I. gemcitabine + cisplatine (75)

40

(31)

53

0,002

18,3 m

0.059

II. étoposide + cisplatine (75)

42

(32)

19

10,9 m

Comella,

2007 (34)

Sujet âgé (70 ans)

I. paclitaxel (80 à 100) + gemcitabine (1 à 1,2) J1 et 8 (dose escaladée)

51

63

25

NS

9,7 m

NS

II. paclitaxel (80) + gemcitabine (1) J1 et 8 (dose fixe)

47

64

26

9,6 m

Helbekkmo,

2007 (35)

I . Carbo (AUC 4) + vinorelbine

218

70

 

 

7,3 m

0,89

II. Carbo (AUC 4) + gemcitabine

214

72

 

6,4 m

Zwitter,

2009 (36)

I. CDDP 75 + gemci 1,25 x 2

125

116

33 %

 

10,1 m

NS

II. CDDP 75 + gemci  0,25 en 6h x 2

124

113

47 %

10,0 m

Reynolds,

2009 (37) I

I. Gemcitabine

85

PS 2

6 %

S

5,1 m

NS

II. Carboplatine + gemcitabine

85

21 %

6,7 m

Treat,

2010 (38) I

I. Gemcitabine + carboplatine

379

90%

25 %

NS

7,9 m

NS

II. Gemcitabine + paclitaxel

377

90%

32 %

8,5 m

III. Paclitaxel + carboplatine

379

89%

30 %

8,9 m

Birsma,

2011 (39) A

I. Carbo + gemci

90

> 70 ANS

27 %

NS

8,6 m

NS

II. Carbo + paclitaxel

91

19 %

6,9 m



Références
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(2) Perng RP, Chen YM, Ming-Liu J, Tsai CM, Lin WC, Yang KY, et al. Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study. J Clin Oncol 1997 May;15(5):2097-102.
(3) Cardenal F, Lopez-Cabrerizo MP, Anton A, Alberola V, Massuti B, Carrato A, et al. Randomized phase III study of gemcitabine-cisplatin versus etoposide- cisplatin in the treatment of locally advanced or metastatic non-small- cell lung cancer. J Clin Oncol 1999 Jan;17(1):12-8.
(4) Comella P, Frasci G, Panza N, Manzione L, Lorusso V, Di Rienzo G, et al. Cisplatin, gemcitabine, and vinorelbine combination therapy in advanced non-small-cell lung cancer: a phase II randomized study of the Southern Italy Cooperative Oncology Group. J Clin Oncol 1999 May;17(5):1526-34.
(5) Crino L, Scagliotti GV, Ricci S, De Marinis F, Rinaldi M, Gridelli C, et al. Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project. J Clin Oncol 1999 Nov;17(11):3522-30.
(6) Rinaldi M, Crino L, Scagliotti GV, Mosconi AM, De Marinis F, Gridelli C, et al. A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: a phase II randomized trial. Ann Oncol 2000 Oct;11(10):1295-300.
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(10) Gridelli C, Cigolari S, Gallo C, Manzione L, Ianniello GP, Frontini L, et al. Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patients. Phase II data from the Multicenter Italian Lung Cancer in the Elderly Study (MILES) randomized trial. Lung Cancer 2001 Mar;31(2-3):277-84.
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(14) Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J, et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 2002 Sep 1;20(17):3578-85.
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(18) Grigorescu AC, Draghici IN, Nitipir C, Gutulescu N, Corlan E. Gemcitabine (GEM) and carboplatin (CBDCA) versus cisplatin (CDDP) and vinblastine (VLB) in advanced non-small-cell lung cancer (NSCLC) stages III and IV: a phase III randomised trial. Lung Cancer 2002 Jul;37(1):9-14.
(19) Soto PH, Cavina R, Latteri F, Sala A, Dambrosio M, Antonelli G, et al. Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study. Ann Oncol 2002 Jul;13(7):1080-6.
(20) Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 2003 Mar 5;95(5):362-72.
(21) Gebbia V, Galetta D, Caruso M, Verderame F, Pezzella G, Valdesi M, et al. Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and cisplatin followed by ifosfamide and gemcitabine in stage IIIB-IV non small cell lung carcinoma: a prospective randomized phase III trial of the Gruppo Oncologico Italia Meridionale. Lung Cancer 2003 Feb;39(2):179-89.
(22) Gridelli C, Gallo C, Shepherd FA, Illiano A, Piantedosi F, Robbiati SF, et al. Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2003 Aug 15;21(16):3025-34.
(23) Wachters FM, Van Putten JW, Kramer H, Erjavec Z, Eppinga P, Strijbos JH, et al. First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial. Br J Cancer 2003 Oct 6;89(7):1192-9.
(24) Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE, Crawford J, Govindan R, et al. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol 2004 Mar;15(3):410-8.
(25) Comella P, Frasci G, Carnicelli P, Massidda B, Buzzi F, Filippelli G, et al. Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients. Br J Cancer 2004 Aug 2;91(3):489-97.
(26) Rudd RM, Gower NH, Spiro SG, Eisen TG, Harper PG, Littler JA, et al. Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. J Clin Oncol 2005 Jan 1;23(1):142-53.
(27) Martoni A, Marino A, Sperandi F, Giaquinta S, Di Fabio F, Melotti B, et al. Multicentre randomised phase III study comparing the same dose and schedule of cisplatin plus the same schedule of vinorelbine or gemcitabine in advanced non-small cell lung cancer. Eur J Cancer 2005 Jan;41(1):81-92.
(28) Quoix E, Breton JL, Ducolone A, Mennecier B, Depierre A, Lemarie E, et al. First line chemotherapy with gemcitabine in advanced non-small cell lung cancer elderly patients: a randomized phase II study of 3-week versus 4-week schedule. Lung Cancer 2005 Mar;47(3):405-12.
(29) Baka S, Ashcroft L, Anderson H, Lind M, Burt P, Stout R, et al. Randomized phase II study of two gemcitabine schedules for patients with impaired performance status (Karnofsky performance status <= 70) and advanced non-small-cell lung cancer. J Clin Oncol 2005 Apr 1;23(10):2136-44.
(30) Ma CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, et al. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol 2005 Sep 1;23(25):5929-37.
(31) Masters GA, Argiris AE, Hahn E, Beck JT, Rausch G, Ye Z, et al. A randomized phase II trial using two different treatment schedules of gemcitabine and carboplatin in patients with advanced non-small-cell lung cancer. J Thorac Oncol 1, 19-24. 2006. Ref Type: Journal (Full)
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(35) Helbekkmo N, Sundstrom SH, Aasebo U, Brunsvig PF, von PC, Hjelde HH, et al. Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity. Br J Cancer 2007 Aug 6;97(3):283-9.
(36) Zwitter M, Kovac V, Smrdel U, Vrankar M, Zadnik V. Gemcitabine in brief versus prolonged low-dose infusion, both combined with cisplatin, for advanced non-small cell lung cancer: a randomized phase II clinical trial. J Thorac Oncol 2009 Sep;4(9):1148-55.
(37) Reynolds C, Obasaju C, Schell MJ, Li X, Zheng Z, Boulware D, et al. Randomized phase III trial of gemcitabine-based chemotherapy with in situ RRM1 and ERCC1 protein levels for response prediction in non-small-cell lung cancer. J Clin Oncol 2009 Dec 1;27(34):5808-15.
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(39) Biesma B, Wymenga AN, Vincent A, Dalesio O, Smit HJ, Stigt JA, et al. Quality of life, geriatric assessment and survival in elderly patients with non-small-cell lung cancer treated with carboplatin-gemcitabine or carboplatin-paclitaxel: NVALT-3 a phase III study. Ann Oncol 2011 Jul;22(7):1520-7.


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