Many patients will experience progression of the STS despite these current agents. At that juncture, life expectancy is approximately 6 months. When current chemotherapy agents (i.e. doxorubicin, ifosfamide and dacarbazine) are used in second-line, response rates are generally lower than when used as first-line treatment and clinical benefit is unproven [van Oosterom 2002]. Phase II studies with other agents have reported objective response rates of approximately 10% with no evidence of patient benefit (Table 4)1. As a result, in the last 30 years, no drugs have been approved in Europe or in the United States for the treatment of patients with STS (except for GIST), until now. See Novel Therapy section.
| Chemotherapy | No. of studies | No. of patients | Objective response rate |
|---|---|---|---|
| Paclitaxel | 2 | 101 | 8-13 |
| Docetaxel | 2 | 56 | 15-17 |
| Ixabepilone | 1 | 31 | 6 |
| Gemcitabine | 6 | 133 | 3-11 |
| Trofosfamide | 3 | 47 | 0-18 |
| Temozolomide | 3 | 91 | 0-5 |
| Topotecan | 2 | 37 | 0 |
| Irinotecan | 3 | 39 | 0-45 |
| Rubitecan | 2 | 55 | 0-8 |
| Vinorelbine | 1 | 14 | 0 |
| Raltitrexed | 1 | 22 | 0 |
There is, therefore, a clear need for effective salvage treatments, particularly for patients with advanced STS and for whom both doxorubicin and ifosfamide, administered either consecutively as first- and second-line therapy or in combination as first-line therapy, have failed1. See Novel Therapy section.
Reference:
1. Hartmann JT, Patel S. (2005) “Recent developments in salvage chemotherapy for patients with metastatic soft tissue sarcoma.” Drugs 65(2): 167–78.