Table 3. Trials of second-line chemotherapy in small-cell lung cancer.
| Author [Year] | Phase | Treatment free interval | Regimen | Number | ORR (%) | Median TTP or PFS (wks/mo.) | Median survival time (weeks/mo.) | Survival rates (%) |
|---|---|---|---|---|---|---|---|---|
| Von Pawel et al. [1999] (68) | III | >6 mo. | T vs. CAV | 107 | T: 24.3 CAV: 18.3 P=0.285 |
TTP T: 13.3 wks CAV: 12.3 wks P=0.552 |
T: 25 wks CAV: 24.7 wks P=0.795 |
NR |
| O’Brien et al. [2006] (69) | III | All relapsed SCLC | T (oral) vs. BSC | 141 | T: 7; (44 SD) | TTP T: 16.3 wks |
T: 25.9 wks BSC: 13.9 wks (P=0.01) |
6 month survival, T: 49 BSC, 26 |
| Eckhardt et al. [2007] (70) | III | ≥90 days | T (oral) vs. T (i.v.i.) | 309 | T (oral): 18.3 T (i.v.i.): 21.9 P value NR |
NR | T (oral): 33 wks T (i.v.i.): 35 wks |
1 yr survival, T (oral): 32.6, T (i.v.i.): 29.2 2 yr survival, T (oral): 12.4, T (i.v.i.): 7.1 |
| Onada et al. [2006] (79) | II | </>60 days | A | 60 (16 refractory, 44 sensitive) |
Refractory: 50 sensitive: 52 |
PFS refractory: 2.6 mo. sensitive: 4.2 mo. |
Refractory: 10.3 mo. sensitive: 11.6 mo. |
1 yr survival, refractory: 40, sensitive: 46 |
| Inoue et al. [2008] (80) | II | </>90 days | A vs. T | 59 evaluable (A=29, T=30) 23 refractory, 36 sensitive) |
A: 38 (Refractory 17, sensitive 53) T: 13 (refractory 0, sensitive 21) |
PFSA: 3.5 mo. (refractory 2.6 mo., sensitive 3.9 mo.) T: 2.2 mo. (refractory 1.5 mo., sensitive 3.0mo) |
A: 8.1 mo. (refractory 5.3 mo., sensitive 9.9 mo.) T: 8.4 mo. (refractory 5.4 mo., sensitive: 11.7 mo.) |
NR |
| Ettinger et al. [2010] (81) | II | <90 days | A | 75 | 21.3 (1.3 CR, 20 PR) | PFS: 3.2 mo. | 6.0 mo. | 6 month survival, 48; 1 yr survival, 15.7 |
| Jotte et al. [2011] (82) | II | ≥90 days | A vs. T | 76 (A=50, T=26) | A: 44 T: 15 P=0.021 |
PFS A: 4.5 mo. T: 3.3 mo. |
A: 9.2 mo. T: 7.6 mo. |
6 month survival, A: 60, T: 54 1 yr survival, A: 36, T: 33 |
| Jotte et al. [2011] (83) (ACT-1 study) | III | </>90 days | A vs. T | 637 (A=424, T=213) | A: 31 T: 17 P=0.0002 |
PFS A: 4.1 mo. T: 4.0 mo. P=0.98 |
A: 7.8 mo. T: 7.5 mo. refractory; A:6.2 mo., T: 5.7 mo., P=0.049) |
1 yr survival, A: 17, T: 8 (P=0.019) 18-month survival: A: 12, T: 0 (P=0.0006) |
| Treat et al. [2002] (84) | II | </>8 wks | PIC | 37 (13 resistant, 24 sensitive) |
Resistant: 15.4 sensitive: 8.3 |
NR | Resistant: 27.3 wks sensitive: 35.7 wks |
NR |
| Eckhardt et al. [2009] (85) | II | Refractory: PD through 1st line therapy Resistant: <90 days Sensitive: ≥91 days <180 days |
PIC | 77 (44 refractory, 27 resistant, 6 sensitive) |
4 | PFS: 9.1 wks | 26.9 wks | 6 month survival, 50.6 1 yr survival, 16.9 |
| Ciuleanu et al. [2010] (86) (SPEAR study) | III | <6 mo. | PIC + BSC vs. BSC | 401 (268 PIC + BSC, 133 BSC) |
NR | PFS refractory with no post study treatment) PIC + BSC: 9 wks BSC: 7 wks P=0.03 |
PIC + BSC: 21 wks BSC: 20 wks NS |
NR |
| Rhee et al. [2011] (87) | II | All relapsed SCLC | B | 25 | 24 | PFS: 2.2 mo. | 9.9 mo. | 1yr survival, 38.3 |
| Jeong et al. [2010] (88) | II | ≥3 mo. | B | 27 | 22 | PFS: 4.7 mo. | 13.1 mo. | NR |
| Kim et al. [2012] (89) | II | All relapsed SCLC (Platinum sensitivity not defined) | B | 50 (30 refractory, 20 sensitive) |
14 refractory: 10 sensitive: 20 |
PFS: 1.6 mo. refractory: 1.5 mo. sensitive: 2.8 mo. |
4.5 mo. refractory: 4.0 mo. sensitive: 6.5 mo. |
NR |
| Schmittel et al. [2007] (90) | II | ≥60 days | BEN | 21 | 29 | PFS 4.0 mo. | 7.0 mo. | 1 yr survival, 16 2 yr survival, 8 |
T, topetcan; CAV, cyclophosphamide/doxorubicin/vincristine; A, amrubicin; PIC, picoplatin; B, belotecan; BEN, bendamustine; BSC, best supportive care; NR, not reported