supple 3b. toxicity associated with carboplatin and paclitaxel

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Supple 3B. Toxicity associated with carboplatin and paclitaxel Reference Phas e Resear ch group Chemotherapy dose Median cycles No. of patie nts Median Age (year) PS0-1 or KPS 70 (%) Ethnicity (%) Toxicity criteria Grades 3-4 toxicity (%) MST (month) CBDCA (AUC) Paclita xel (mg/m 2 ) (range) Asian White Black Other Neutropen ia Anemia Thrombo cytopen ia 5 or 6 200-225 Day1 q3w Day1 q3w Belani et al 2005 III USA 6 225 4 (1-10) 188 61.3(28-80) 100 - 82 - 18 NCICTC 64.9 13.8 8 7.6 Lienbaum et al 2005 (CALGB9730) III USA 6 225 NR 284 64(39-83) 83 NR NR NR NR NR 62 13 12 8.8 Herbst et al 2005 (TRIBUTE) III USA 6 200 5 540 63(26-84) 99.8 2.4 89.4 6.1 2.1 NCICTC v.2 22.6 6.3 4.8 10.5 Herbst et al 2004 (INTACT2) III USA 6 225 6 345 63(31-85) 90.7 - 91.9 5.2 2.9 NCICTC v.2 5.9 0.6 NR 9.9 Lienbaum et al 2004 II USA 6 200 4 83 63(38-86) 84 NR NR NR NR NR 21.7 1.2 9.6 8.6 Schiller et al 2002 III ECOG 6 225 NR 290 63(30-85) 95 - 83 11 6 NR 63 10 10 8.1 Scagliotti et al 2002 III EU 6 225 NR (mean 4.2 cycles) 204 62(30-77) 92 NR NR NR NR NCICTC v.2 34.5 2.3 2.9 9.9 Kosmidis et al 2002 III EU 6 200 6 (1-9) 252 63(31-81) 86 NR NR NR NR WHO 15 5 2 10.4 Rosell et al 2002 III EU 6 200 4 (1-10) 306 58(27-76) 83 NR NR NR NR NR 51 9 2 8.5 Socinski et al 2002 (4cycles) † III USA 6 200 4 (0-6) 114 62(32-82) 100 - 74 24 3 NR 39 7 8 6.6 Socinski et al 2002 (until PD) † III USA 6 200 4 (0-19) 116 66(32-81) 100 - 73 23 4 NR 42 10 11 8.5 Kelly et al 2001 III SWOG 6 225 4 206 62(26-80) 100 NR NR NR NR NCICTC v.2 57 13 10 8 Abbreviations: MST, median survival time; NR, not reported; NCICTC v. , National Cancer Institute Common Toxicity Criteria Version; TRIBUTE, Tarceva responses in conjunction with paclitaxel and carboplatin; INTACT, ‘Iressa’ NSCLC Trial Assessing Combination Treatment; PD, progression disease; SWOG, South-west Oncology Group; HeCOG, Hellenic Cooperative Oncology Group The two reference were the same trial. One arm was received four cycles of carboplatin and paclitaxel, whereas one arm was received until disease progression.

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Page 1: Supple 3B. Toxicity associated with carboplatin and paclitaxel

Supple 3B. Toxicity associated with carboplatin and paclitaxel    

Reference Phase Research group

Chemotherapy dose  

Median cycles No. of patients

Median Age(year)

PS0-1 orKPS ≧70

(%)

Ethnicity (%) Toxicity criteria Grades 3-4 toxicity (%)  

MST(month)

CBDCA (AUC)

Paclitaxel (mg/m2)

(range) Asian White Black Other Neutropenia Anemia Thrombocytopenia

5 or 6 200-225

      Day1 q3w Day1 q3w                Belani et al 2005 III USA 6 225 4 (1-10) 188 61.3(28-80) 100 - 82 - 18 NCICTC 64.9 13.8 8 7.6

Lienbaum et al 2005 (CALGB9730)

III USA 6 225 NR 284 64(39-83) 83 NR NR NR NR NR 62 13 12 8.8

Herbst et al 2005 (TRIBUTE)

III USA 6 200 5 540 63(26-84) 99.8 2.4 89.4 6.1 2.1 NCICTC v.2 22.6 6.3 4.8 10.5

Herbst et al 2004 (INTACT2)

III USA 6 225 6 345 63(31-85) 90.7 - 91.9 5.2 2.9 NCICTC v.2 5.9 0.6 NR 9.9

Lienbaum et al 2004

II USA 6 200 4 83 63(38-86) 84 NR NR NR NR NR 21.7 1.2 9.6 8.6

Schiller et al 2002 III ECOG 6 225 NR 290 63(30-85) 95 - 83 11 6 NR 63 10 10 8.1

Scagliotti et al 2002

III EU 6 225 NR (mean 4.2 cycles)

204 62(30-77) 92 NR NR NR NR NCICTC v.2 34.5 2.3 2.9 9.9

Kosmidis et al 2002

III EU 6 200 6 (1-9) 252 63(31-81) 86 NR NR NR NR WHO 15 5 2 10.4

Rosell et al 2002 III EU 6 200 4 (1-10) 306 58(27-76) 83 NR NR NR NR NR 51 9 2 8.5

Socinski et al 2002 (4cycles) †

III USA 6 200 4 (0-6) 114 62(32-82) 100 - 74 24 3 NR 39 7 8 6.6

Socinski et al 2002 (until PD) †

III USA 6 200 4 (0-19) 116 66(32-81) 100 - 73 23 4 NR 42 10 11 8.5

Kelly et al 2001 III SWOG 6 225 4 206 62(26-80) 100 NR NR NR NR NCICTC v.2 57 13 10 8

Novello et al 2001 II EU 6 225 5 (1-6) 60 61(34-74) NR NR NR NR NR WHO 66 2 3 12.2

Glorieux et al 2001 II EU 6 200 4 (1-9) 99 64(47-77) 84.8 NR NR NR NR NCICTC 59.2 14.1 15.1 8.4

Kosmidis et al 2000

II HeCOGEU

6 225 5 99 59.4(31.5-73.8) 89 NR NR NR NR WHO 12.1 5.1 1 11.4

Abbreviations: MST, median survival time; NR, not reported; NCICTC v. , National Cancer Institute Common Toxicity Criteria Version; TRIBUTE, Tarceva responses in   conjunction with paclitaxel and carboplatin; INTACT, ‘Iressa’ NSCLC Trial Assessing Combination Treatment; PD, progression disease; SWOG, South-west Oncology Group; HeCOG, Hellenic Cooperative Oncology Group

†   The two reference were the same trial. One arm was received four cycles of carboplatin and paclitaxel, whereas one arm was received until disease progression.