Table 3. Clinical trials of systemic therapies without radiation therapy for patients with brain metastases from non-small-cell lung cancer.
| Study (year) | Phase | Patients (n) | Timing | Agents | Median OS | 1-year survival (%) | Intracranial TTP | Overall PFS | Cerebral RR (%) | Overall RR (%) | Ref. |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Wu et al. (2013) | II | 48 | Progressive BM | Erlotinib | 18.9 months | 73 | 10.1 months | 9.7 months | NA | 58.3 | [78] |
| Novello et al. (2011) | II | 64 | Progressive BM | Sunitinib | 25.1 weeks | NA | 15.4 weeks | 9.4 weeks | 4.3 | 1.6 | [79] |
| Barlesi et al. (2011) | II | 43 | Initial diagnosis of BM | Pemetrexed + cisplatin | 7.4 months | NA | 5.7 months | 4.0 months | 41.9 | 34.9 | [100] |
| Socinski et al. (2009) | II | 115 | Previously treated nonprogressive BM | Bevacizumab | NA | NA | NA | NA | NA | NA | [93] |
| Lee et al. (2008) | Randomized pilot | 48 | Initial diagnosis of synchronous BM | Gemcitabine + vinorelbine vs WBRT | 9.1 vs 9.9 months | NA | NA | 3.6 vs 4.4 months | NA | 28.0 vs 39.1 | [101] |
| Wu et al. (2007) | II | 40 | Patients with BM who had received prior chemotherapy | Gefitinib | 15.0 months | NA | NA | 9.0 months | 38 | 32 | [77] |
| Giorgio et al. (2005) | II | 30 | Progressive BM | Temozolomide | 6 months | 10 | NA | 3.6 months | 10 | NA | [81] |
| Chiu et al. (2005) | – | 11† | NA | Gefitinib | NA | NA | NA | NA | NA | NA | [76] |
| Ceresoli et al. (2004) | – | 41 | Newly diagnosed and progressive BM | Gefitinib | 5 months | NA | NA | 3 months | NA | 10 | [75] |
| Dziadziuszko et al. (2003) | II | 12‡ | BM with or without RT | Temozolomide | NA | NA | NA | NA | NA | 0 | [80] |
| Bernardo et al. (2002) | II | 22 | Newly diagnosed BM | Vinorelbine + gemcitabine + carboplatin | 33 weeks | NA | NA | NA | 45 | NA | [74] |
| Boogerd et al. (1999) | – | 13 | Newly diagnosed and progressive BM | Teniposide | NA | NA | NA | NA | 23 | NA | [102] |
| Minotti et al. (1998) | – | 23 | Newly diagnosed BM | Cisplatin + teniposide | 21 weeks | NA | NA | NA | 35 | NA | [73] |
| Lee et al. (1997) | – | 5§ | Newly diagnosed BM | Paclitaxel + carboplatin | – | – | – | – | 20 | 20 | [72] |
| Cotto et al. (1996) | II | 31 | NA | Fotemustine + cisplatin | 16 weeks | NA | NA | NA | NA | NA | [71] |
†21 patients had BM out of 76 total patients, 11 out of the 21 BM patients had chemotherapy without RT.
‡12 out of 25 patients had BM.
§Five patients enrolled at time of publication of preliminary results.
BM: Brain metastases; NA: Not available; OS: Overall survival; PFS: Progression-free survival; RR: Response rate; RT: Radiation therapy; TTP: Time to progression; WBRT: Whole-brain radiation therapy.