Table 2.
Pivotal Randomized Controlled Trials of Chemotherapy vs Biochemotherapy in Metastatic Melanoma
| Author | N | Regimen | ORR/CR | Median OS | Comments on Biochemotherapy Arm |
|---|---|---|---|---|---|
| Thomson,[37] 1993 | 170 | DTIC | 17% / 2% | 8.9 mo | No significant improvement in ORR or survival |
| DTIC + IFN | 21% / 7% | 7.6 mo | |||
| Bajetta,[38] 1994 | 266 | DTIC | 20% / 5% | 11 mo | Improved response duration; no significant improvement in ORR or survival |
| DTIC + IFN 9MU | 28% / 8% | 13 mo | |||
| DTIC + IFN 3MU | 23% / 7% | 11 mo | |||
| Falkson,[39] 1998 | 271 | DTIC ± tamoxifen | 16% / 4% | 8.4 mo | No significant improvement in ORR or survival |
| (DTIC ± tamoxifen) + IFN | 20% / 9% | 9.3 mo | |||
| Rosenberg,[40] 1999 | 102 | DTIC + cisplatin + tamoxifen | 27% / 8% | 15.8 mo | Trend toward improved ORR ; however, trend toward worsened OS |
| DTIC + cisplatin + tamoxifen + IL-2 + IFN | 44% / 6% | 10.7 mo | |||
| Eton,[41] 2002 | 183 | CVD (cisplatin + vinblastine + DTIC) | 25%a / 2% | 9.2 mo | Significantly improved ORR; trend toward improved OS; two patients with durable CRs (at > 75 mo and > 48 mo) |
| CVD + IL-2 + IFN (sequential biochemotherapy) | 48%a / 7% | 11.9 mo | |||
| Ridolfi,[42] 2002 | 176 | DTIC + cisplatin ± BCNU | 20% / 3% | 9.5 mo | No significant improvement in ORR or OS |
| (DTIC + cisplatin ± BCNU) + sc IL-2 + IFN | 25% / 3% | 11 mo | |||
| Kaufmann,[43] 2005 | 282 | Temozolomide | 13%a / 2% | 8.4 mo | Significantly improved ORR; however, no significant improvement in OS |
| Temozolomide + IFN | 24%a / 8% | 9.7 mo | |||
| Bajetta,[44] 2006 | 151 | CVD (cisplatin + vinblastine + DTIC) | 21%/0% | 12 mo | No significant improvement in ORR or OS |
| CVD + sc IL-2 + IFN | 33%/4% | 11 mo | |||
| Atkins,[45] 2008 | 395 | CVD (cisplatin + vinblastine + DTIC) | 14%/5% | 8.7 mo | No significant improvement in ORR or survival |
| CVD + IL-2 + IFN (concurrent biochemotherapy) | 19%/2% | 9.0 mo |
a
Statistically significant difference.
BCNU = carmustine; CR = complete response; DTIC = dacarbazine; IFN = interferon; IL = interleukin; MU = million units; ORR = objective response rate; OS = overall survival; sc = subcutaneous.