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对完成最初化疗方案后6～12个月内复发的卵巢癌患者进行卡培他滨治疗的Ⅱ期临床试验,并探讨TS、DDP、TP与治疗的关系:妇科肿瘤组的一项研究

世界核心医学期刊文摘（妇产科学分册） 2005年第7期1卷 42-43页

作者： Garcia A.A. blessing j.a. Lenz H.-j. 王婷婷 Breast Cancer Program Cedars Sinai Medical Center Women' s Cancer Research Institute 8700 Beverly Boulevard Los Angeles CA 90048 United States

Purpose. A phase II trial was conducted to evaluate the antitumor activity and adverse effects of capecitabine in women with measurable platinum- sensitive ovarian cancer or platinum- sensitive primary peritoneal cancer and to explore the ability of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) to predict response and toxicities. Experimental design. Patients were treated with a daily starting dose of 2500 mg/m2/day (divided in two doses given every 12 h) for 14 days of each 21- day cycle. Genotyping in the 5′ and 3′ ends of TS was performed in DNA from 23/23 pre- treatment blood specimens. Relative gene expression of TS, DPD, and TP was quantified in 18/21 paraffin- embedded tumor specimens. Results. Of the 27 patients enrolled on study, 2 were never treated leaving 25 patients evaluable. Two patients (8.0% ) achieved a partial response, 13 (52% ) exhibited stable disease, 5 (20% ) displayed increasing disease, and response could not be assessed in 5 (20% ). The median time to progression and survival was 3.9 and 21.2 months, respectively. The most common serious toxicities were nausea/vomiting, gastrointestinal, and dermatological. There was one treatment- related death. TS expression was associated with severe nausea/vomiting (P = 0.039), but not with other severe toxicities. TS genotype or expression of DPD or TP was not associated with any of the severe toxicities. Conclusions. Based on the low response rate, this trial was closed after the first stage of accrual, the drug was not selected for further study in this patient population, and biomarker associations with response could not be assessed.

关键词：妇科肿瘤卡培他滨 DDP TP TS Ⅱ期临床试验肿瘤标本毒性反应生物学指标磷酸化酶

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拓扑替康应用于子宫癌肉瘤的二期评价:一项妇科肿瘤组研究

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世界核心医学期刊文摘（妇产科学分册） 2005年第12期1卷 44-45页

作者： Miller D.S. blessing j.a. Schilder j. 张丽娟 Department of Obstetrics and Gynecology University of Texas Southwestern Medical Center at Dallas 5323 Harry Hines Blvd. J7.124 Dallas TX 75390- 9032 United States

Objectives. To estimate the antitumor activity of topotecan in patients with persistent or recurrent carcinosarcoma (malignant mixed mullerian tumors) of the uterus and to determine the nature and degree of toxicity of topotecan in this cohort of patients. Materials and methods. Eligible patients had measurable advanced or recurrent carcinosarcoma of the uterus. Topotecan at a target dose of 1.5 mg/m2 was administered IV daily for 5 days, every 3 weeks, until progression of disease or adverse affects prohibited further therapy. Results. Twenty-seven member institutions entered 51 patients. Of the patients entered, 48 were eligible. Patient characteristics included a median age of 65, with 33% having prior radiation and 92% having prior chemotherapy. Twenty-six patients (54% ) had a performance status (PS) of 0, 18 (38% ) had a PS of 1, and four (8% ) had a PS of 2. Patients received from 1 to 21 (with a median of 2) courses of treatment. The most frequently observed grade 4 toxicities were neutropenia seen in 35 (73% ) patients, leukopenia in 14 (29% ), and thrombocytopenia in 10 (21% ). Three (6% )- patients developed neutropenic sepsis and died shortly after their first treatment cycle. There were five (10% ) complete responses; 13 (27% ) patients maintained stable disease, 26 (54% ) experienced increasing disease, and reassessment did not occur in four (8% ). Conclusion. Topotecan at this dose and schedule does not appear to have major activity in patients with advanced or recurrent uterine carcinosarcoma previously treated with chemotherapy.

关键词：妇科肿瘤癌肉瘤拓扑替康靶剂量治疗周期毒性反应队列研究脓毒症白细胞减少抗肿瘤活性

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氮烯咪胺、丝裂霉素、阿霉素及顺铂与沙莫司亭治疗平滑肌肉瘤的Ⅱ期试验:妇科肿瘤协作组研究

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世界核心医学期刊文摘（妇产科学分册） 2006年第2期2卷 46-47页

作者： Long III H.j. blessing j.a. Sorosky j. 朱晓明 Department of Medical Oncology Mayo Clinic College of Medicine East 12B Mayo Building 200 First Street Southwest Rochester MN 55905-0001 United States

Objective. Following a reported 23%response rate (RR) for mitomycin (M), doxorubicin (A), and cisplatin (P) and preliminary data suggesting a superior RR for dacarbazine (D) +MAP +sargramostim, the Gynecologic Oncology Group (GOG) conducted a phase II trial of DMAP +sargramostim in patients with advanced uterine leiomyosarcoma. Methods. Eligibility required measurable disease, a GOG performance score of 0-2, and recovery from surgery/radiotherapy. Treatment consisted of sargramostim 250 μg/m2 SC q 12 h days -6 through -3, followed by D 750 mg/m2 IV over 2 h, M 6 mg/m2 IV, A 40 mg/m2 IV and P 60 mg/m2 IV over 2 h on day 1, followed by sargramostim 250 μg/m2 SC days 2-15. Cycles were repeated q 28 days (if ANC ≥1500/μl and platelets ≥100,000/μl) until disease progression or toxicity prevented further therapy. Doses were to be reduced by 20%for grade 4 neutropenia >7 days or any grade 4 thrombocytopenia and by 10%for a 1-to 2-week treatment delay for myelosuppression. Results. One of 19 patients who entered the study was ineligible. Eighteen patients received a median of 3.5 cycles (range: 1-6 cycles) of therapy. The overall RR was 27.8%(5.6%complete and 22.2%partial responses). Percent of patients with grade 3 or 4 toxicities included 78%neutropenia, 94%thrombocytopenia, 61%anemia, 44%GI, 28%infection, and 17%azotemia. Conclusions. DMAP +sargramostim produced a 27.8%RR, but its complexity and toxicity precluded further investigation, and the study was closed after the first stage of accrual.

关键词：平滑肌肉瘤妇科肿瘤氮烯咪胺氮质血症疾病恶化可测量中性粒细胞反应率

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顺铂与伊立替康联合治疗宫颈鳞状细胞癌:妇科肿瘤组Ⅱ期研究

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世界核心医学期刊文摘（妇产科学分册） 2005年第1期1卷 55-56页

作者： Muggia F.M. blessing j.a. McGehee R. Monk B.j. 安妮 Department of Medi cine Kaplan Cancer CenterDiv. Med. Oncol. New York Univ. M. New York NYUni ted States

Objective. To evaluate the combination of cisplatin and irinotecan as first-l ine treatment of patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Methods. Patients with no prior treatment for metastati c disease, presence of measurable tumors, performance status of 0 or 1, and adeq uate bone marrow, renal, and hepatic functions were potentially eligible for thi s trial. Cisplatin and irinotecan were givenweekly at starting doses of 25 and 6 5mg/m2, respectively, for three con secutive weeks. Cycles were to be repeated every 28 days with dose adjustments as required. Patient accrual was based on a two-stage design with at least sev en responses out of 28 patients in the first stage required to proceed to a seco nd stage of accrual seeking a response rate of 40%or better. Results. Of 34 pat ients entered onto the study, 31 were eligible and 27 were evaluable for respons e. Ten had received prior chemoradiation containing cisplatin. Among the five (t wo complete and three partial) observed responses, two were in the subset of pat ients who had received prior chemoradiation. This level of activity was deemed i nsufficient to warrant a second stage of accrual. Predominant toxicities were my elosuppression and gastroin-testinal symptoms, although six patients experience d none of these adverse effects. Conclusion. At these doses, weekly cisplatin an d irinotecan failed to demonstrate sufficient activity to undertake a phase III study. Although not apparent in this study, prior chemoradiation may affect resp onse to platinumbased combinations and its impact should be considered in the de sign of future trials.

关键词：宫颈鳞状细胞癌妇科肿瘤伊立替康化学放射疗法首次剂量化学放疗毒性反应耐受试验反应水平肾功能

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宫颈鳞状细胞癌的二线化疗药盐酸多柔比星脂质体(Doxil)的疗效评效:妇科肿瘤组的Ⅱ期研究

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世界核心医学期刊文摘（妇产科学分册） 2006年第12期2卷 32-33页

作者： Rose P.G. blessing j.a. Lele S. Abulafia O. 吕涛 Division of Gynecologic Oncology Case Western Reserve UniversityClevelandOH 44106United States

Objective.:Doxorubicin has reported activity in advanced and recurrent cervical cancer but hematologic toxicity has limited its use in some combinations. To determine the level of activity and potential for use in future combinations,a phase II trial of pegylated liposomal doxorubicin as second-line therapy in advanced and recurrent cervical cancer was performed. Methods.:Eligible patients had squamous cell carcinoma of the cervix,measurable disease,one prior chemotherapy regimen which did not include an anthracycline,absolute neutrophil count (ANC) > 1500/μl,platelet count > 100,000/μl,and adequate hepatic function. Pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously over 1 h every 4 weeks. Results.:Twenty-seven patients were entered on this study. All patients were evaluable for toxicity and 26 were evaluable for response. A median of 2 courses of therapy (range 1-10)-was given. No grade 4 toxicities were noted. Three patients (11.1%) had partial responses. Conclusion.:Liposomal doxorubicin has limited activity,at the dose and schedule employed in previously-treated cervical cancer.

关键词：宫颈鳞状细胞癌 Doxil 二线化疗妇科肿瘤盐酸多柔比星血液学毒性毒性反应联合方案 Ⅱ期临

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每4周40mg/m^2脂质体阿霉素治疗子宫内膜癌的Ⅱ期试验:一项妇科肿瘤组研究

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世界核心医学期刊文摘（妇产科学分册） 2005年第11期1卷 43-43页

作者： Homesley H.D. blessing j.a. Sorosky j. 刘亦恒 Department of Obstetrics and Gynecology Brody School of Medicine 272 Leo Jenkins Cancer Center Greenville NC 27858 United States

Objective. In patients with disseminated endometrial carcinoma, liposomal doxorubicin has possible advantages over doxorubicin which has proven single agent activity but well known cardiac toxicity. Before replacing doxorubicin in clinical trials, the Gynecologic Oncology Group (GOG) decided to conduct a phase Ⅱ clinical trial of liposomal doxorubicin (Ortho Biotech Products L. P., Raritan, Nj) in first-line therapy of patients with disseminated endometrial carcinoma. Methods. Patients with initial histologic confirmation of endometrial carcinoma presenting with disseminated or recurrent cancer who had not previously received cytotoxic drugs were considered for participation in this clinical trial. Eligible patients had measurable disease, GOG performance status 0-2, and adequate bone marrow, renal, and hepatic function according to standard criteria. Liposomal doxorubicin 40 mg/m2 was given by intravenous injection on an every 4-week cycle until toxicity or progression. Patients who remained free from tumor progression or intolerable toxicity received at least one to a maximum of 20 cycles of liposomal doxorubicin. Results. Fifty-six patients were registered, of whom three were determined ineligible (prior malignancy = 2, inadequate pathology material = 1). One patient never received therapy, leaving 52 evaluable patients. Two patients (3.8% ) achieved a complete response, four (7.7% ) exhibited a partial response, and 31 (59.7% ) had stable disease. The most common adverse events were constitutional (32/52), anemia (28/52), pain (27/52), dermatologic (25/52), and cardiovascular (12/52). Conclusions. In this trial, liposomal doxorubicin had a response rate of 11.5% in first-line treatment of disseminated endometrial carcinoma when given at 40 mg/m2 every 4 weeks. In view of the associated skin toxicity at this dose, liposomal doxorubicin does not appear to be a suitable replacement for the more active doxorubicin for therapy of endometrial carcinoma.

关键词： mg/m^2 妇科肿瘤毒性反应癌前病变复发性肿瘤播散性细胞毒性药物一线治疗药物肝功能状况用药史

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子宫内膜癌二线化疗药物HMR1275(flavopiridol)的Ⅱ期临床疗效评估:一项妇产科肿瘤组研究

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世界核心医学期刊文摘（妇产科学分册） 2005年第11期1卷 39-39页

作者： Grendys jr.E.C. blessing j.a. Burger R. Hoff-man j. 刘亦恒 Florida Gynecologic Oncolo-gy 2780 Cleveland AvenueFort MyersFL 33901Unit-ed States

Objective.A phase Ⅱ study was conducted to determ inethe efficacy of single agent flavopiridol therapy in patients with recurrent or persistent endometrial adenocarcinoma refractory to established treatments. Methods. Eligible patients with measurable disease who failed primary therapy including one cytotoxic regim en were eligible for the *** were treated with single agentflavopiridol (50mg/m2/day,Ⅳ bolus days 1,2,3).Treatm entwas repeatedevery 21days with dose adjustm ents made for *** were treated untilprogression ofdisease oradverseside effects precluded further ***.A totalof26patientswere enrolled in the study ofwhom ,23patientswere *** were no objective *** had stable disease (22%),15 (65%)had in-creasing disease,and response could notbe assessed in 3(13%).The mostfrequentside effects included anemia,neutropenia,and diarrhea,allofwhich appeared *** as a single agent in theabove dosing schedule appears to have minim alactivity assecond-line chem otherapy ofendom etrialadenocarcinoma.

关键词： HMR1275 flavopiridol 二线化疗临床疗效评估初始化疗细胞周期素快速静脉注射中性粒细胞

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Effects of environmental variability on superspreading transmission events in stochastic epidemic models

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Infectious Disease Modelling 2021年第1期6卷 560-583页

作者： Nika Shakiba Christina j.Edholm blessing O.Emerenini Anarina L.Murillo Angela Peace Omar Saucedo Xueying Wang Linda j.S.Allen School of Biomedical Engineering University of British ColumbiaVancouverBCCanada Department of Mathematics Scripps CollegeClaremontCAUSA Department of Mathematics Oregon State UniversityCorvallisORUSA Department of Pediatrics and Center for Statistical Sciences Brown UniversityProvidenceRIUSA Department of Mathematics and Statistics Texas Tech UniversityLubbockTXUSA Department of Mathematics Virginia Polytechnic Institute and State UniversityBlacksburgVAUSA Department of Mathematics and Statistics Washington State UniversityPullmanWAUSA School of Mathematical Sciences Rochester Institute of TechnologyRochesterNYUSA

Superspreaders(individuals with a high propensity for disease spread)have played a pivotal role in recent emerging and re-emerging *** disease outbreak studies,host heterogeneity based on demographic(***,sex,vaccination status)and environmental(***,urban/rural residence,clinics)factors are critical for the spread of infectious diseases,such as Ebola and Middle East Respiratory Syndrome(MERS).Transmission rates can vary as demographic and environmental factors are altered naturally or due to modified behaviors in response to the implementation of public health *** this work,we develop stochastic models to explore the effects of demographic and environmental variability on human-to-human disease transmission rates among superspreaders in the case of Ebola and *** show that the addition of environmental variability results in reduced probability of outbreak occurrence,however the severity of outbreaks that do occur *** observations have implications for public health strategies that aim to control environmental variables.

关键词： Superspreader MERS Ebola Environmental variability Stochastic models

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When evidence is lacking:a mixed-methods approach for the development of practice guidance in liver transplantation

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Gastroenterology Report 2021年第1期9卷 22-30,I0001页

作者： Lisa B.VanWagner blessing Aghaulor Tasmeen Hussain Megan Kosirog Patrick Campbell Stewart Pine Amna Daud Daniel j.Finn josh Levitsky Donald M.Lloyd-jones jane L.Holl Division of Gastroenterology and Hepatology Department of MedicineNorthwestern University Feinberg School of MedicineChicagoILUSA Department of Preventive Medicine Northwestern University Feinberg School of MedicineChicagoILUSA Comprehensive Transplant Center Northwestern University Feinberg School of MedicineChicagoILUSA Division of Cardiology Department of MedicineNorthwestern University Feinberg School of MedicineChicagoILUSA Department of Pediatrics Northwestern University Feinberg School of MedicineChicagoILUSA Center for Healthcare Delivery Science and Innovation and Department of Neurology Biological Sciences DivisionUniversity of ChicagoChicagoILUSA

Background Most interventions for conditions with a small cohort size,such as transplantation,are unlikely to be part of a clinical *** condition-specific evidence is lacking,expert consensus can offer more precise guidance to improve *** of cardiovascular risk in liver-transplant recipients is one example for which clinicians have,to date,adapted evidence-based guidelines from studies in the general ***,even when consensus is achieved,implementation of practice guidance is often inadequate and *** report on a novel mixed-methods approach,the Northwestern MethodVC,for the development of clinical-practice guidance when condition-specific evidence is *** illustrate the method through the development of practice guidance for managing cardiovascular risk in liver-transplant *** The Northwestern MethodVC consists of(i)adaptation of relevant,existing,evidence-based clinical-practice guidelines for the target population;(ii)consensus by experts of the proposed practice guidance;(iii)identification of barriers to guidance adherence in current practice;and(iv)recommendation for implementation and dissemination of the practice *** method is based on an iterative,user-centered approach in which the needs,wants,and limitations of all end users,including patients,are attended to at each stage of the design and development *** The Northwestern MethodVC for clinical-practice-guidance development uses a mixed-methods approach to bring together broad representation from multiple disciplines and practice settings to develop consensus considering the unique needs and preferences of patients,caregivers,and practitioners who are directly impacted by clinical-practice-guidance *** hypothesize that a priori involvement of end users in the guidance-development process will lead to sustainable implementation of guidance statements into clinical practice.

关键词： liver transplantation practice guideline consensus methodology

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替拉扎明加顺铂对铂敏感的复发卵巢癌或原发性腹膜癌治疗的二期评估:妇产科肿瘤协作组的研究

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世界核心医学期刊文摘（妇产科学分册） 2006年第6期2卷 54-55页

作者： Covens A. blessing j. BenderD. 吕涛 Division of Gynecology/Oncology Toronto-Sunny brook Regional Cancer Center 2075 Bayview Avenue Toronto Ont. M4N 3M5 Canada

Objectives. To estimate the anti- tumor activity, nature and degree of toxicity of tirapazamine in combination with cisplatin in patients with recurrent platinum- sensitive ovarian or primary peritoneal cancers. Methods. Eligible consenting patients had to have recurrent epithelial ovarian or primary peritoneal carcinoma with measurable disease. Patients were not allowed to have received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens. Patients must have been platinum- sensitive, meaning a treatment- free interval of >6 months after response to a platinum- based regimen. The RECIST criteria were used for parameters of response. Tirapazamine was administered at a dose of 390 mg/m2 IV over 2 h followed 1 h later by cisplatin 60 mg/m 2 IV every 3 weeks until disease progression or adverse effects prohibited further therapy. Results. Between june 2001 and February 2004, 65 patients were entered onto this study by 27 institutions; one patient was excluded due to ineligible tumor type. Twenty- six patients (41% ) received six or more cycles of therapy; however, 16 (25% ) received one course of therapy (mainly due to side effects or patient request). There were six (9% ) complete responders and 28 (44% ) partial responders for a total response rate of 53% . Only two patients (3% ) developed increasing disease on this protocol, and response could not be assessed in 18 patients (28% ). The median progression- free and overall survival for all patients is 10.9 and 26.4 months, respectively. The regimen did not cause major hematologic toxicity,however, it did cause frequent constitutional (23% ) and gastrointestinal (mostly nausea/vomiting) (44% ) grade 3 or 4 toxicity. Conclusions. The combination of tirapazamine and cisplatin has definite activity in the treatment of recurrent platinum- sensitive ovarian or primary peritoneal cancer. However, toxicity, primarily non- hematologic

关键词：原发性腹膜癌复发卵巢癌替拉扎明癌治疗妇产科肿瘤顺铂 RECIST标准静脉内给药协作

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