[Multi-center prospective randomized trial on paclitaxel liposome and traditional taxol in the treatment of breast cancer and non-small-cell lung cancer].

Objective: To analyze the effects and side effects of paclitaxel liposome formula on breast cancer and non-small cell lung cancer, compared with traditional taxol.

Methods: 129 patients from multicenters were prospectively randomized into a test group, given paclitaxel liposome at 135 mg/m(2) each session, and a control group, given traditional taxol at 135 mg/m(2) each session. Both groups received these regimens combined with ADM or DDP for two cycles (3 weeks per cycle).

Results: Of 129 cases, 128 were eligible for the analysis of side effects and 126 for the overall response rate. The complete remission rate, partial remission rate and overall response rate were 1.6%, 33.3%, 34.9% in the test group and 6.3%, 22.2%, 28.6% in the control group. There was no significant difference between the two groups. Though there was no significant difference in hematological toxicity between the two groups, the toxicity from the mixed solvent of polyethoxylated castor oil and ethanol was significantly lower in the test group than that in the control group.

Conclusion: Paclitaxel liposome combined with ADM or DDP in the treatment of advanced breast cancer and non-small-cell lung cancer, being similarly effective as taxol, can significantly lower the incidence of serious hypersensitive reactions.