[Single-agent Xeloda in the treatment of recurrent and metastatic breast cancer].

OBJECTIVE: To evaluate the efficacy and adverse reactions of Xeloda in the treatment of recurrent and metastatic breast cancer. METHODS: This clinical study was designed to treat 69 patients with recurrent and metastatic breast cancer with Xeloda, 2500 mg/m(2)/d, twice daily for 2 weeks followed by a 1-week rest period, repeated every 3 weeks. RESULTS: Sixty-nine patients received Xeloda for more than 1 cycle. The overall response rate (CR + PR) was 16.0%, clinical benefit rate (CR + PR + SD > or = 24 months) was 27.5%, disease control rate (CR + PR + SD) was 75.4%. The median time to failure (TTF) was 3 months (range: 0.7 - 11 months). The median time to progression (TTP) was 2 months (range: 0.7 - 11 months). The median duration of response (CR + PR) was 6 months (range: 4 - 11 months). The most common treatment-related adverse events were hand-foot syndrome (HFS) that occurred in 60.8% (42/69) patients mostly as grade I-II. Fifty-five percent (22/40) of patients who had received high dose preventive Vit B6 developed HFS without grade III; while 69% (20/29) of patients who had not received such treatment did develop HFS including 2 patients with grade III. However, there was not significant difference between the two groups. CONCLUSION: Xeloda is an effective and well tolerated treatment in patients with recurrent and metastatic breast cancer. The symptoms of HFS may be relieved by high dose Vit B6 as prevention.

[Clinical trial on ibandronate in patients with tumor-associated hypercalcemia].

OBJECTIVE: Ibandronate, a third generation bisphosphonate, inhibits bone resorption in human and animal studies. This study is to evaluate the efficacy and safety of ibandronate as a single agent in patients with tumor-associated hypercalcemia. METHODS: An open, multicenter, non-controlled clinical trial was conducted in 22 patients. The patients received 2 mg ibandronate intravenously if the corrected calcium was less than 3.0 mmol/L but more than 2.7 mmol/L; they received 4 mg ibandronate iv if corrected calcium was more than 3.0 mmol/L. RESULTS: There was 100% efficacy in these two dose groups but the calcium correcting effect was more pronounced in the 4-mg dose group than the 2-mg dose group. The most common adverse reactions were fever and skin itching with an incidence of 4.5%. CONCLUSION: Ibandronate is active in patients with tumor-associated hypercalcemia and the adverse effects are well tolerated.

[Phase II clinical study of intratumoral H101, an E1B deleted adenovirus, in combination with chemotherapy in patients with cancer].

BACKGROUND & OBJECTIVE: In recent years,great development have been made in cancer therapeutics with replication-competent viruses (oncolytic viruses), E1B deleted adenovirus is one of promising viruses. The current study was designed to evaluate the efficacy and toxicity of intratumoral H101, a E1B-deleted adenovirus, in combination with chemotherapy on patients with cancer. METHODS: A total of 50 patients with malignant tumors in multiple centers clinical trial were treated with H101, 0.5ml 5x10(11) viral particle per day for 5 consecutive days every three weeks. Routine chemotherapy was performed at the same time. And the efficacy and toxicity were recorded. RESULTS: Among 46 valuable cases, the overall response rate was 30.4%. The response rate was 28.0% (14/50) among ITT population, including 3 complete response (CR) and 11 partial response (PR). The overall response rate of control lesion was 13.0%, including 1 case of CR and 5 cases of PR. Thus, the response rate in injected lesion is clearly higher than that in control lesion (P< 0.001). Main side effects were injection site pain (26.9%) and fever (30.2%). Grade 1 hepatic dysfunction was found in 4 patients, grade 2 in 1 patients, grade 4 in 1 patients. Grade 4 hematological toxicities were found in 4 patients. CONCLUSION: The study showed that the combination of genetically modified adenovirus (H101) and chemotherapy possessed some effect for treating the patients with refractory malignant tumors, and the toxicities were lower, well tolerated.