A phase Ii clinical study of China-made paclitaxel in the treatment of cancer patients
Wu, H.; Guan, Z.; Lin, T.
Zhonghua Zhong Liu Za Zhi 20(2): 148-152
1998
ISSN/ISBN: 0253-3766 PMID: 10920970 Document Number: 494310
To evaluate the efficacy and toxicity of China-made paclitaxel in patients with a variety of advanced malignancies. 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. 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. At the above-mentioned dose and schedule, paclitaxel is effective with tolerable side effects.