Purpose. To determine the efficacy and safety of capecitabine in women with inoperable, recurrent, or metastatic squamous cell cervical cancer. Patients and methods. In a phase II IRB approved trial, capecitabine was ...Purpose. To determine the efficacy and safety of capecitabine in women with inoperable, recurrent, or metastatic squamous cell cervical cancer. Patients and methods. In a phase II IRB approved trial, capecitabine was given at a dosage of 2000 mg/m2/day orally in a divided dose daily for 14 days followed by a 7- day rest period. A standard dose modification scheme was used with one allowed dose reduction or dose escalation. National Cancer Institute criteria for progression, response, and toxicity were utilized. Quality of life data were obtained using the Memorial Symptom Assessment Scale and Functional Assessment for Cancer Therapy, which included a subscale for cervical cancer. Results. Twenty of 23 enrolled patients were evaluable for response. Stable disease was noted in 5 patients, with a median duration of response of 3.5 months (range, 3- 6.5 months). No partial or complete responses were seen. Common grade 3 toxicities were fatigue (30.4% ); abdominal pain, constipation, hand-foot syndrome, nausea, and vomiting (8.7% each); as well as dyspnea, headache, and coagulopathy (4.3% each). There were no grade 4 toxicities. All patients with previous exposure to infused 5- FU had evidence of progression. No statistically significant changes in quality of life were noted from baseline to post-cycle 2. Conclusion. Single-agent capecitabine in patients with recurrent cervical cancer resulted in no objective responses. Although capecitabine is a welltolerated regimen, as a single agent, it offers minimal benefit in a poor-prognosis cervical cancer population.展开更多
Objective: Infliximab, a monoclonal antibody against tumor necrosis factor α , is approved by the US Food and Drug Administration for treatment of numerous autoimmune disorders. We conducted a prospective, open-label...Objective: Infliximab, a monoclonal antibody against tumor necrosis factor α , is approved by the US Food and Drug Administration for treatment of numerous autoimmune disorders. We conducted a prospective, open-label phase 2 clinical trial to assess the effectiveness of infliximab in treating refractory autoimmune uveitis. Methods: We prospectively enrolled 23 patients from the uveitis clinic of the Casey Eye Institute, Portland, Ore, into this trial. All patients meeting eligibility criteria received 3 infliximab infusions at weeks 0, 2, and 6. Clinical success was ascertained at week 10. Patients meeting initial criteria for success received an infusion at week 14 and every 8 weeks thereafter, with dose escalation permitted for breakthrough inflammation, and underwent outcome measurements at week 50. Results: All patients underwent outcome assessment at week 10. Eighteen (78% ) of these subjects met criteria for clinical success at this time. Success was judged by the composite clinical end point of visual acuity, control of intraocular inflammation, ability to taper concomitant medication therapy, and improvement in inflammatory signs on fluorescein angiography and/or ocular coherence tomography. Successful grading required improvement in at least 1 of 4 subcomponents and worsening in none. Seven of 14 patients enrolled for 1 year continued infliximab therapy and maintained their successful grading. Five did not complete 1 year of treatment because of significant adverse events, and 2 terminated treatment early for reasons unrelated to the study. Serious adverse events that were potentially related to infliximab included pulmonary embolus, congestive heart failure, lupus-like reaction in 2, and vitreous hemorrhage in 2 patients. Antinuclear antibodies developed in 15 of 20 enrolled patients receiving 3 or more infusions. Conclusions: Infliximab was an effective short-term immunosuppressive agent in most of the patients, with 18 of 23 meeting criteria for clinical success at week 10. Infliximab was effective in the long term in all patients able to complete 50 weeks of therapy. Although some patients achieved clear benefit, the rate of serious toxic effects was unexpectedly high. Further long-term studies are warranted to determine the safety and efficacy of infliximab in treating intraocular inflammation.展开更多
Pro Cyte Corp.(Kitkland,WA)正在欧洲扩展其抗秃头药物Triccomin^TM的二期临床试验。迄今为此的前临床及临床试验均表明这种肽-铜药物可增加男性脱发症患者的毛发数量。目前,获准进入美国市场的治脱发药物只有Rogaine^Tm一种。Tricomi...Pro Cyte Corp.(Kitkland,WA)正在欧洲扩展其抗秃头药物Triccomin^TM的二期临床试验。迄今为此的前临床及临床试验均表明这种肽-铜药物可增加男性脱发症患者的毛发数量。目前,获准进入美国市场的治脱发药物只有Rogaine^Tm一种。Tricomin将是第二种。不过,道路还长得很。ProCyte还必须在美国进行前临床试验,更不用提还有三期临床试验等在前面。在欧洲进行的第二期临床试验将在第一季度结束。据公司称,接受涂抹治疗的24名患者中,80%出现良好的毛发生长状况。展开更多
文摘Purpose. To determine the efficacy and safety of capecitabine in women with inoperable, recurrent, or metastatic squamous cell cervical cancer. Patients and methods. In a phase II IRB approved trial, capecitabine was given at a dosage of 2000 mg/m2/day orally in a divided dose daily for 14 days followed by a 7- day rest period. A standard dose modification scheme was used with one allowed dose reduction or dose escalation. National Cancer Institute criteria for progression, response, and toxicity were utilized. Quality of life data were obtained using the Memorial Symptom Assessment Scale and Functional Assessment for Cancer Therapy, which included a subscale for cervical cancer. Results. Twenty of 23 enrolled patients were evaluable for response. Stable disease was noted in 5 patients, with a median duration of response of 3.5 months (range, 3- 6.5 months). No partial or complete responses were seen. Common grade 3 toxicities were fatigue (30.4% ); abdominal pain, constipation, hand-foot syndrome, nausea, and vomiting (8.7% each); as well as dyspnea, headache, and coagulopathy (4.3% each). There were no grade 4 toxicities. All patients with previous exposure to infused 5- FU had evidence of progression. No statistically significant changes in quality of life were noted from baseline to post-cycle 2. Conclusion. Single-agent capecitabine in patients with recurrent cervical cancer resulted in no objective responses. Although capecitabine is a welltolerated regimen, as a single agent, it offers minimal benefit in a poor-prognosis cervical cancer population.
文摘Objective: Infliximab, a monoclonal antibody against tumor necrosis factor α , is approved by the US Food and Drug Administration for treatment of numerous autoimmune disorders. We conducted a prospective, open-label phase 2 clinical trial to assess the effectiveness of infliximab in treating refractory autoimmune uveitis. Methods: We prospectively enrolled 23 patients from the uveitis clinic of the Casey Eye Institute, Portland, Ore, into this trial. All patients meeting eligibility criteria received 3 infliximab infusions at weeks 0, 2, and 6. Clinical success was ascertained at week 10. Patients meeting initial criteria for success received an infusion at week 14 and every 8 weeks thereafter, with dose escalation permitted for breakthrough inflammation, and underwent outcome measurements at week 50. Results: All patients underwent outcome assessment at week 10. Eighteen (78% ) of these subjects met criteria for clinical success at this time. Success was judged by the composite clinical end point of visual acuity, control of intraocular inflammation, ability to taper concomitant medication therapy, and improvement in inflammatory signs on fluorescein angiography and/or ocular coherence tomography. Successful grading required improvement in at least 1 of 4 subcomponents and worsening in none. Seven of 14 patients enrolled for 1 year continued infliximab therapy and maintained their successful grading. Five did not complete 1 year of treatment because of significant adverse events, and 2 terminated treatment early for reasons unrelated to the study. Serious adverse events that were potentially related to infliximab included pulmonary embolus, congestive heart failure, lupus-like reaction in 2, and vitreous hemorrhage in 2 patients. Antinuclear antibodies developed in 15 of 20 enrolled patients receiving 3 or more infusions. Conclusions: Infliximab was an effective short-term immunosuppressive agent in most of the patients, with 18 of 23 meeting criteria for clinical success at week 10. Infliximab was effective in the long term in all patients able to complete 50 weeks of therapy. Although some patients achieved clear benefit, the rate of serious toxic effects was unexpectedly high. Further long-term studies are warranted to determine the safety and efficacy of infliximab in treating intraocular inflammation.
