Table 3. Clinical studies of targeted agents for the treatment of SCLC.
|
Result
|
||||||||
|---|---|---|---|---|---|---|---|---|
| Authors | Targeted agent | Combination regimen | Targeted population | Phase | Sample size | RR | OS/PFS (months) | Conclusion |
| TKs inhibitors | ||||||||
| Dy et al (2005) | Imatinib | — | Relapsed, resistant/sensitive [c-Kit +] | II | 29 | No PR No SD | OS: R=3.9 S=5.3 | No clinical activity |
| Krug et al (2005) | — | Relapsed, resistant/sensitive [c-Kit +] | II | 12 | No PR No SD | OS: 2 | No clinical activity | |
| Johnson et al (2003) | — | ES, untreated relapsed, sensitive | II | 19 | No PR | — | No clinical activity | |
| Schneider et al (2006) | — | ES, if no PD after I-line IP × 4 [c-Kit +] | II | 14 | No PR | OS: 10 | Disease stability not maintained | |
| Spigel et al (2007) | Carboplatin/irinotecan | ES, untreated | II | 69 | PR 66% | OS: 8.4 | No improvement in results from chemotherapy alone | |
| Moore et al (2006) | Gefitinib | — | Relapsed, resistant/sensitive | II | 19 | No PR 10% SD | OS: 206 days | No clinical activity |
| Anti-angiogenic agents | ||||||||
| Sandler et al (2007) | Bevacizumab | Cisplatin/etoposide | ES, untreated | II | 64 | OR 69% | PFS at 6 months: 33% | Promising results |
| Ready et al (2007) | Irinotecan/cisplatin | ES, untreated | II | 72 | CR 3% PR 71% | OS: 11.7 | Primary end point not reached | |
| Jalal et al (2008) | Paclitaxel | Relapsed, sensitive | II | 34 | PR 11% SD 55% | OS: 21 weeks | Active regimen | |
| Pujol et al (2007) | Thalidomide | PCDE | ES, after response to PCDE × 2 | III | 119 | — | OS: 11.7/8.7 (NS) | Thalidomide did not improve survival |
| Lee et al (2008) | Carboplatin/etoposide | ES and LS, untreated | III | 724 | — | OS: 10.2/10.5 (NS) | Thalidomide did not improve survival | |
| Gitlitz et al (2008) | Sorafenib | — | Relapsed (platinum-treated) | II | 81 | PR 4% SD 32% | −7, S −5, R | Clinical activity |
| Ramalingam et al (2008) | Cediranib (ZD2171) | — | Relapsed (platinum-treated) | II | 25 | PR: 1 patient SD: 9 patients | PFS 1.2 | No clinical activity |
| Arnold et al (2007) | Vandetanib (ZD6474) | — | ES and LS, untreated. If no PD after first-line platinum-based (and PCI/TRT) | II | 107 | — | PFS and OS NS | No efficacy as maintenance therapy |
Abbreviations: RR=response rate; PR=partial response; SD=stable disease; OS=overall survival; PD=progressive disease; ES=early-stage; PFS=progression-free survival; CR=complete response; PCDE=etoposide plus cisplatin and cyclophosphamide plus 4′-epidoxorubicin; LS=late stage; S=sensitive; R=resistant; NS=not significant; PCI=prophylactic cranial irradiation; TRT=thoracic radiotherapy; OR=overall response.