Abstract
Objective: Doxorubicin has been the mainstay of treatment for advanced STS. However, the conventional formulation of doxorubicin has not been used clinically, due to poor penetration of the natural physiologic barriers, poor water solubility and high side effects profile. To overcome these obstacles authors compared the use of Specific conjugate particle doxorubicin (Group 1), a proven efficacious agent with advanced technical drug, and PEGylated liposomal Doxorubicin (Group 2) in a randomized prospective Phase III trial involving patients with advanced soft tissue sarcomas. Methods: We recruited eighty-four patients (32 males and 52 females) with histologically confirmed locally advanced or metastatic Soft Tissue Sarcoma (STS). The participants were between the ages of 18 and 70 years. Patients were randomized to receive either Specific Conjugate Particle Doxorubicin (SCP-Doxorubicin) and paclitaxel or the conventionally accepted PEGylated Liposomal Doxorubicin (PEGDoxorubicin) and paclitaxel. Patients received 45 mg/m2 of either PEG-Doxorubicin or SCP-Doxorubicin by an intravenous infusion over 30 minutes on day 1, followed by paclitaxel 150 mg/m2 as an intravenous infusion over three hours on day 1. We repeated treatment cycles every 28 days. Patients received a total of six cycles unless disease progression or unacceptable toxicity occurred.