[A phase II clinical study of China-made paclitaxel in the treatment of cancer patients].

OBJECTIVE: To evaluate the efficacy and toxicity of China-made paclitaxel in patients with a variety of advanced malignancies.

METHODS: Paclitaxel was administered by i.v. infusion at a dose of 175 mg/m2 in 3-hour every three weeks. All patients received premedication(dexamethasone, diphenhydramine and cimetidine) to prevent allergic reactions.

RESULTS: Of 116 patients, 114 patients received 2 to 3 courses of therapy and were evaluable for response. The overall response rate for ovarian cancer was 46.7%, for breast cancer 56.4%, for non-small-cell lung cancer 25.0%, for small-cell lung cancer 66.7%, and for nasopharyngeal cancer 41.7%. Responses were also achieved in patients who had failed to respond to prior chemotherapy, with the overall response rate of 42.9% for ovarian cancer, 57.6% for breast cancer, 33.3% for non-small-cell lung cancer, 25.0% for small-cell lung cancer, and 40.0% for nasopharyngeal cancer. Paclitaxel did not show cross-resistance with doxorubicin and cisplatin. The major toxicity associated with paclitaxel included neutropenia, arthralgia, myalgia, numbness of hands and feet and alopecia. No severe hypersensitivity reactions were observed.

CONCLUSION: At the above-mentioned dose and schedule, paclitaxel is effective with tolerable side effects.