[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.


CONCLUSIONS
At the above-mentioned dose and schedule, paclitaxel is effective with tolerable side effects.
Department of Medical Oncology, Cancer Hospital, Sun Yat-sen University of Medical Sciences, Guangzhou.
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H
Wu
Z
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Guan
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Lin
D000293:Adolescent; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D018288:Carcinoma, Small Cell / Q000188:drug therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel