Table II.
Irinotecan studies in pretreated small cell lung cancer.
| First author/s, year | Type of study | Patients, n | Setting (%) | PS 0-1, % | Median age, years | Schedule, mg/m2 | OS, months | PFS, months | ORR, % | G3-4 anemia, % | G3-4 thrombocyt openia,% | FN,% | G3-4 neutropenia, % | (Refs.) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kondo, 2018 | Phase 2 | 30 | Sensitive (40); resistant (60) | 100 | 67 | CPT-11 100d1, 8 q21 | 10.4 | 4.1 | 43 | 13.3 | 3.3 | 6.6 | 36.7 | (15) |
| Trafalis, 2016 | Phase 2 | 32 | Resistant (100) | 82 | 63.5 | CPT-11 175 + bevacizumab 7.5 mg/kg q14 | 6 | 3 | 25 | 0 | 0 | 3.5 | 7.1 | (16) |
| Xenidis, 2011 | Phase 2 | 31 | Refractory (100) | 84 | 64 | CPT-11 125 + PLD 15 d1,14 q 28 | 3.16 | 1.86 | 12.9 | 3.2 | 0 | 6.5 | 0 | (17) |
| Ramalingam, 2010 | Phase 2 | 55 | Sensitive (51); refractory (49) | 95 | 61 | CPT-11 50 d1,8 + PAC 75 d1,8 q21 | 7.6 and 5.5a | 3 and 2a | 19.5 | 2 | 0 | 0 | 11 | (18) |
| Chen, 2009 | Phase 2 | 40 | Sensitive (100) | 85 | 65 | CPT-11 150 + CBDCA AUC5 d1 q 21 | 10 | - | 50 | 15 | 23 | 3 | 55 | (19) |
| Pallis, 2009 | Randomized phase 2 | 69 | Sensitive (52 vs. 35); refractory (47 vs. 64) | 85 vs. 94 | 60 vs. 65 | CPT-11 300 d8 + GEM 1000 d1, 8 q21 vs. CPT-11 300 d1 q21 | 8.6 and 5.7a (sensitive) vs. 8.6 and 3.8 (refractory) | 4.3 and 2.5 vs. 1.7 and 1.1 (sensitive and refractory) | 23.7 vs. 0 | 5.3 vs. 3.2 | 21 vs. 9.7 | 2.6 vs. 6.4 | 23 vs. 33 | (20) |
| Ohyanagi, 2008 | Phase 2 | 30 | Sensitive (66); refractory (34) | 65 | 90 | CPT-11 150 q21 + GEM 1000 d1,14 q21 | 14.4 | 3 | 36.7 | 3.3 | 3.3 | 0 | 43 | (21) |
| Rocha Lima, 2007 | Phase 2 | 71 | Sensitive (50); refractory (50) | 85 | 62 | CPT-11 100 d1,8 + GEM 1000 d1,8 q21 | 7.1 and 3.5a | 3.1. and 1.6 | 21 | 7.5 | 31 | 4.5 | 38.5 | (22) |
| Schuette, 2005 | Phase 2 | 35 | Sensitive (57); refractory (43) | 86 | 63 | CPT-11 100 d1,8 + GEM 1000 d1, 8 q 21 | 5.8 | 3.4 | 17 | 8.6 | 11.4 | 0 | 5.7 | (23) |
| Ichiki, 2003 | Phase 2 | 34 | Sensitive (71); refractory (29) | 68 | 69 | CPT-11 80 d1,8,15 + IFO 1,5 g/m2 d1-3 q 28 | 7.2 | - | 52.9 | 29.4 | 11.8 | 0 | 52.9 | (24) |
aSensitive and refractory disease. CPT-11, irinotecan; GEM, gemcitabine; IFO, Ifosfamide; CBDCA, carboplatin; PAC, paclitaxel; PDL, pegylated lyposomal doxorubicin; PS, performance status; OS, overall survival; PFS, progression-free survival; ORR, overall response rate; FN, febrile neutropenia.