摘要
The Gynecologic Oncology Group (GOG) has studied a number of drugs to determin e their activity in patients with previously treated squamous and nonsquamous ca ncer arising in the uterine cervix. A Phase II study with intravenous vinorelbin e was initiated for this purpose in patients with Stage IVB, recurrent, or persi stent nonsquamous carcinomas who had received one prior chemotherapy or were not eligible for other studies. Eligible patients had to have measurable disease, G OG performance status of 0-2 and adequate bone marrow, liver, and renal functio n. The treatment consisted of vinorelbine 30 mg/m2 on days 1 and 8, repeated eve ry 21 days. Tumor measurements and toxicities were recorded every treatment cycl e. Thirty patients were enrolled with 28 patients deemed eligible and evaluable. Only two confirmed partial responses (7.1%) were noted. Neutropenia was the mo st common toxicity with 9 of 28 (32%) experiencing either grade 3 or 4 changes. Anemia was severe in seven. Neuropathy was more than mild in three patients. Se vere events, such as fatigue, hypertension, or pulmonary changes attributed to d rug administration, occurred only in one or two instances. With the dose schedul e and assessment criteria employed, vinorelbine had only minimal activity in non squamous cancer of the cervix.
The Gynecologic Oncology Group (GOG) has studied a number of drugs to determin e their activity in patients with previously treated squamous and nonsquamous ca ncer arising in the uterine cervix. A Phase II study with intravenous vinorelbin e was initiated for this purpose in patients with Stage IVB, recurrent, or persi stent nonsquamous carcinomas who had received one prior chemotherapy or were not eligible for other studies. Eligible patients had to have measurable disease, G OG performance status of 0-2 and adequate bone marrow, liver, and renal functio n. The treatment consisted of vinorelbine 30 mg/m2 on days 1 and 8, repeated eve ry 21 days. Tumor measurements and toxicities were recorded every treatment cycl e. Thirty patients were enrolled with 28 patients deemed eligible and evaluable. Only two confirmed partial responses (7.1%) were noted. Neutropenia was the mo st common toxicity with 9 of 28 (32%) experiencing either grade 3 or 4 changes. Anemia was severe in seven. Neuropathy was more than mild in three patients. Se vere events, such as fatigue, hypertension, or pulmonary changes attributed to d rug administration, occurred only in one or two instances. With the dose schedul e and assessment criteria employed, vinorelbine had only minimal activity in non squamous cancer of the cervix.
