To observe the clinical efficacy and
adverse effects of the domestic
paclitaxel developed by the Institute of Materia Medica, Chinese Academy of Medical Sciences,a prospective phase Ⅲ clinical trial of paclitaxel conducted by a study group of 16 hospitals was organized by us in 1996～1997. There were 243 patients with different advanced cancers confirmed by pathological or cytological examinations in the study. Paclitexal was administered as single agent in a dose 150～175 mg·m-2 iv (3～5 h) every 3～4 weeks, and 2～3 cycles as one course. Paclitexal was administered 135 mg·m-2 iv (3 h), every 3～4 weeks in combination chemotherapy in advanced refractory or recurrent patients after surgery, irradiation or chemotherapy. Cisplatin 80 mg·m-2 iv drip was added in
ovarian cancer and lung cancer; adriamycin 40 mg·m-2 iv was added in breast cancer; while cisplatin 80 mg·m-2 iv drip and pingyangmycin ( bleomycin A5) 8 mg im twice a week for two weeks were added in
esophageal cancer patients. All combination chemotherapy was administered every 3 weeks for 2～3 cycles as one course. After 2～3 cycles treatment in 190 evaluabe patients, there were 14 complete remission patients, 73 partial remission patients, 77 stable and 26 patients with progression. Total response rate (RR) was 45.8%. In ovarian cancer patients,
rr in single agent was 3/4, and 30% (6/20) in combination. In
breast cancer patients, RR was 62.5% (10/16) as single agent, and 60.0% (24/40) in combination. In esophageal cancer patients, RR was 4/5, and 43.4%(7/16) respectively; while RR were 3/4 and 34.4% (22/64) in
lung cancer respectively. Among 21 patient with other malignancies, the response rate was 38.1%(8/21). Analysis of the factors influencing prognosis showed that the performens status, pathology, prior chemotherapy and the stage of patients were most important. The major adverse effects were gastro-intestinal tract reactions, myopathy, alopecia, and bone marrow suppression. Few patients also had mild diarrhea, skin rash, folliculitis, peripheral neuritis. When used in combined with adriamycin or cisplatin, about 10% of patients had mild abnormal liver function. No severe hypersensitivity or SAE was observed. The current results are comparable with the results of the phase Ⅱ clinical trial and that of Taxol and Anzatax in efficacy and adverse effects.
More abstracts about the RESULTS OF PHASE Ⅲ STUDY OF PACLITAXEL IN THE MANAGEMENT OF ADVANCED CANCER PATIENTS