Table 2.
Summary of phase II-III trials of Irinotecan-based doublet regimen on advanced NSCLC as first-line chemotherapy (2006–1990)*
| Author | N | Races | Regimen | Efficacy | Toxicity | |||
|---|---|---|---|---|---|---|---|---|
| Median OS (month) | Median PFS (month) | RR (%) | Grade 3/ 4 Neut. (%) | Grade 3/4 Diarrea (%) | ||||
| Asian trials | ||||||||
| Saito H et al.[23] 2006 | 27 | Japanese | Irinotecan 60 mg/m2 day 1, 8, Cisplatin 60 mg/ m2 day 1, q 21 days | 12.1 | NR | 30.0 | 60.0 | 22.0 |
| Hino M et a[l24] 2006 | 39 | Japanese | Irinotecan 60 mg/m2 on days 1, 8, 15, Cisplatin 30 mg/ m2 day 1, 8, 15, q 28 days | 12.8 | 2.1 | 33.3 | 15.4 | 15.4 |
| Zhang XR et al.[25] 2006 | 24 | Chinese | Irinotecan 60 mg/m2 day 1, 8, 15, Cisplatin 80 mg/ m2 day 1, q 28 days | NR | NR | 29.2 | 17.1 | 5.7 |
| Fukuda M et al.[26] 2004 | 59 | Japanese | Irinotecan 50 mg/m2 on days 1, 8 and 15, Carboplatin AUC 5, q 28 days | 10.0 | 4.0 | 34.0 | 60.0 | 7.0 |
| Yamamoto N et al.[14] 2004 | 57 | Japanese | Irinotecan 60mg/m2 day 1, 8, Docetaxel 60mg/m2 day 8, q 21 days | 10.7 | 4.2 | 32.0 | 84.0 | 16.0 |
| Ichiki M et al.[27] 2003 | 44 | Japanese | Irinotecan 80 mg/m2 day 1, 8, 15, Ifosfamide 1.5 g/m2 day 1 to 3, q 28 days | 12.5 | 5.3 | 29.5 | 38.6 | 6.8 |
| Negoro S et al.[13] 2003 | 133 | Japanese | Irinotecan 60 mg/m2 day 1, 8, 15, Cisplatin 80 mg/m2 day 1, q 28 days | 11.7 | 4.9 | 43.3 | 37.0 (grade 4) | 12.0 |
| Takeda K et al.[28] 2002 | 36 | Japanese | Irinotecan 50 mg/m2 day 1, 8, 15, Carboplatin AUC 5 day 1, q 28 days | 10.2 | NR | 25.0 | 76.5 | 5.9 |
| Ueoka H et al.[30] 2001 | 44 | Japanese | Irinotecan 50 mg/m2 day 1, 8, Cisplatin 60 mg/m2 day 1, 8, q 28days | 12.5 | NR | 48 | 70.5 | 25 |
| Nagao K et al.[29] 2000 | 69 | Japanese | Irinotecan 65 mg/m2 day 1, 8, 15, Cisplatin 80 mg/m2 day 1, q 28 days | 10.3 | NR | 47.8 | 80.3 | 18.8 |
| Takiguchi Y et al.[18] 2000 | 104 | Japanese | Irinotecan 60mg/m2 day 1, 8, 15, Cisplatin 80mg/m2 day 1, q 28 days | 10.5 | NR | 29.0 | 50.0 (grade 4) | 13.0 |
| Masuda N et al.[31] 1998 | 69 | Japanese | Irinotecan 60 mg/m2 day 1, 8, 15, Cisplatin 80 mg/m2 day 1, q 28 days | 10.3 | NR | 52.0 | 80 | 19 |
| Non-Asian trials | ||||||||
| Cardenal F et al.[37] 2003 | 73 | Spanish | Irinotecan 200 mg/m2 day 1, Cisplatin 80 mg/m2 day 1, q 21 days | 8.2 | 3.9 | 24.7 | NR | 29.0 |
| Jagasia MH et al.[38] 2001 | 50 | Americans | Irinotecan 65 mg/m2 and Cisplatin 30 mg/ m2 day 1, 8, 15, 21, q 42 days | 11.6 | 6.9 | 36.0 | 26.0 | 26.0 |
| DeVore RF et al.[39] 1999 | 52 | Americans | Irinotecan 60 mg/m2 day 1, 8, 15, Cisplatin 80 mg/m2 day 1, q 28 days | 9.9 | 5.1 | 28.8 | 46.1 | 17.3 |
| Pillot GA et al.[32] 2006 | 42 | Americans | Irinotecan 200 mg/m2 day 1 , Carboplatin AUC 5 day 1, q 21days | 11.7 | 6.9 | 14.0 | 62.0 | 5.0 |
| Ziotopoulos P et al.[33] 2005 | 39 | Greeks | Irinotecan 200 mg/m2 day 1, Docetaxel 80 mg/m2 day 1, q 21 days | 10.8 | 3.0 | 23.0 | 28.2 | 23.1 |
| Stathopoulos GP et al.[34] 2005 | 52 | Greeks | Irinotecan 125 mg/m2 day 1, 8, Paclitaxel 135 mg/m2 day 1, q 21 days | NR | 6.0 | 41.0 | NR | NR |
| Murren JR et al.[35] 2005 | 23 | Americans | Irinotecan 50 mg/m2 and Paclitaxel 75 mg/m2 on days 1 and 8 , q 21 days | 9.2 | 2.8 | 9.0 | 26.0 | 5.0 |
| Raez LE et al.[36] 2004 | 14 | Irish | Irinotecan 50mg/m2 day 1, 8, 15, Docetaxel 50mg/m2 day 2, q 28 days | 11.0 | NR | 7.0 | 21.0 | 0 |
| Rocha Lima CM et al.[19] 2004 | 39 | Americans | Irinotecan 100 mg/ m2 day 1, Gemcitabine 1000 mg/ m2 day 1, 8, q 21 days | 8.0 | 3.5 | 12.8 | 26.0 | 13.0 |
NR not reported, Ad. adenocarcinoma, Neut. neutropenia
*The literature was selected according to the criteria as follows: (1) NSCLC patients with previously untreated with chemotherapy; (2) treated with irinotecan-based doublet regimen; (3) prospective clinical trials Phase II and III.