ABSTRACT
<p><b>OBJECTIVE</b>To investigate the efficacy, safety and the life quality improvement of uroacitides injection in the treatment for patients with advanced malignant tumors.</p><p><b>METHODS</b>A total of 160 patients with advanced stage cancers were enrolled into this multicenter, open and non-randomized phase II clinical trial, including cancers of the lung (33 cases), liver (45 cases), breast (17 cases), esophagus (11 cases), stomach (18 cases), colon (19 cases), pancreas (3 cases) and kidney (4 cases), and glioma (10 cases). Uroacitides was administrated in a dose of 300 ml daily via the superior vena cava catheter for consecutive 4-8 weeks.</p><p><b>RESULTS</b>Of the 160 patients, 21 dropped out and one patient died during the trial. Efficacy could be evaluated in 138 patients and safety in 160. The total objective response rate (ORR, CR + PR)) and tumor control rate (CR + PR + MR + SD) of the 138 evaluable patients were 5.8% and 65.2%, respectively. Clinical benefit response (CBR) rate was 57.2%. Major adverse effects were grade I - II and reversible nausea/vomiting (21.9%) and pain (6.3%).</p><p><b>CONCLUSION</b>Uroacitides injection is effective in the control for various kinds of advanced cancers with mild, reversible and tolerable adverse effects, and can also improve the patient's quality of life. It is worth being studied further.</p>
Subject(s)
Humans , Breast Neoplasms , Blood , Drug Therapy , Pathology , CA-19-9 Antigen , Blood , Carcinoembryonic Antigen , Blood , Carcinoma, Non-Small-Cell Lung , Blood , Drug Therapy , Pathology , Catheterization, Central Venous , Colorectal Neoplasms , Blood , Drug Therapy , Pathology , Liver Neoplasms , Blood , Drug Therapy , Pathology , Lung Neoplasms , Blood , Drug Therapy , Pathology , Methyltransferases , Therapeutic Uses , Nausea , Neoplasm Staging , Peptides , Therapeutic Uses , Phenylacetates , Therapeutic Uses , Quality of Life , Remission Induction , Salvage Therapy , Treatment Outcome , Vomiting , alpha-Fetoproteins , MetabolismABSTRACT
<p><b>OBJECTIVE</b>To evaluate the response rate and adverse reactions of exemestane (a new aromatase inactivator) in the treatment of postmenopausal women with advanced breast cancer.</p><p><b>METHODS</b>One hundred and seventy-three patients with advanced breast cancer entered this study with two patients excluded because of postmenopausal time being less than one year. Therefore, 173 patients could be evaluated for adverse events and 171 patients could be evaluated for efficacy. Exemestane, 25 mg orally daily for 4 weeks as one cycle was given.</p><p><b>RESULTS</b>In the 171 patients evaluated for efficacy, 4 (2.3%) experienced a complete response (CR) and 40 (23.4%) a partial response (PR), with the overall response rate of 25.7%. Ninety patients (52.6%) had stable disease (SD), with 25 having SD for at least 24 weeks. The clinical benefit (CR + PR + SD > or = 24 weeks) was shown in 69 (40.4%) patients. Progressive disease (PD) was shown in 37 (21.6%) patients. The untreated patients had a higher objective response rate (33.8%) than the retreated ones (18.1%) with significant difference (P = 0.019 7). The response rates for soft-tissue, bone involvement and visceral metastasis were 32.8%, 23.9%, and 12.4% (P = 0.002). There was no significant difference in different ages, time of menopause, disease-free interval or receptor status (P > 0.05). Drug-related adverse events were gastric discomfort (17.9%), malaise (17.9%), nausea (13.9%), hot flushes (11.0%) and dysphoria (5.8%). Other side reactions and abnormal laboratory parameters were observed occasionally which were irrelevant.</p><p><b>CONCLUSION</b>Exemestane can be used to treat postmenopausal women with advanced breast cancer giving only mild adverse reactions which are well tolerated.</p>