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1.
J Matern Fetal Neonatal Med ; 29(22): 3629-33, 2016 Nov.
Article in English | MEDLINE | ID: mdl-26785972

ABSTRACT

OBJECTIVE: The objective of this study is to examine results of bacterial cultures of the cervix prior to cerclage placement and how these may be used to guide prophylactic antibiotics. METHODS: All patients undergoing cerclage between 2000 and 2003 in a single, large community hospital were evaluated for indication for cerclage, signs and symptoms on presentation, transvaginal ultrasound cervical length findings, type of cerclage placed, type of anesthesia used, cervical culture taken, tocolytics given, gestational age at delivery, and complications surrounding delivery. RESULTS: Sixty-five cerclages were performed between 2000 and 2003, 13 (20%) prophylactic, 47 (72%) therapeutic, and five (8%) emergent. Cervical cultures were obtained in 85% of patients, of which 40% were negative resulting in no antibiotics given. In the remaining 45%, one or more pathogens were isolated and antibiotics were given according to sensitivities reported. Fifty-five of 65 patients (84%) delivered after 32 weeks gestation and a latency > 60 d was seen in 84%. The incidence of chorioamnionitis and PPROM was low. CONCLUSION: Bacterial cultures of the cervix prior to cerclage show variable colonization and antibiotic sensitivities and, there is no single antibiotic, chosen empirically, that will cover all pathogens.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Cerclage, Cervical , Cervix Uteri/microbiology , Gram-Negative Bacterial Infections/prevention & control , Gram-Positive Bacterial Infections/prevention & control , Pregnancy Complications, Infectious/prevention & control , Adolescent , Adult , Cervix Uteri/surgery , Chorioamnionitis/epidemiology , Chorioamnionitis/microbiology , Chorioamnionitis/prevention & control , Female , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/microbiology , Fetal Membranes, Premature Rupture/prevention & control , Follow-Up Studies , Gram-Negative Bacteria/isolation & purification , Gram-Negative Bacterial Infections/epidemiology , Gram-Negative Bacterial Infections/microbiology , Gram-Positive Bacteria/isolation & purification , Gram-Positive Bacterial Infections/epidemiology , Gram-Positive Bacterial Infections/microbiology , Humans , Incidence , Microbial Sensitivity Tests , Perioperative Care/methods , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/microbiology , Preoperative Care/methods , Retrospective Studies , Treatment Outcome , Young Adult
2.
J Clin Oncol ; 27(12): 1999-2006, 2009 Apr 20.
Article in English | MEDLINE | ID: mdl-19289619

ABSTRACT

PURPOSE: Trastuzumab shows clinical activity in human epidermal growth factor receptor 2 (HER-2)-positive early and advanced breast cancer. In the German Breast Group 26/Breast International Group 03-05 trial, we investigated if trastuzumab treatment should be continued beyond progression. METHODS: Patients with HER-2-positive breast cancer that progresses during treatment with trastuzumab were randomly assigned to receive capecitabine (2,500 mg/m(2) body-surface area on days 1 through 14 [1,250 mg/m(2) semi-daily]) alone or with continuation of trastuzumab (6 mg/kg body weight) in 3-week cycles. The primary end point was time to progression. RESULTS: We randomly assigned 78 patients to capecitabine and 78 patients to capecitabine plus trastuzumab. Sixty-five events and 38 deaths in the capecitabine group and 62 events and 33 deaths in the capecitabine-plus-trastuzumab group occurred during 15.6 months of follow-up. Median times to progression were 5.6 months in the capecitabine group and 8.2 months in the capecitabine-plus-trastuzumab group with an unadjusted hazard ratio of 0.69 (95% CI, 0.48 to 0.97; two-sided log-rank P = .0338). Overall survival rates were 20.4 months (95% CI, 17.8 to 24.7) in the capecitabine group and 25.5 months (95% CI, 19.0 to 30.7) in the capecitabine-plus-trastuzumab group (P = .257). Overall response rates were 27.0% with capecitabine and 48.1% with capecitabine plus trastuzumab (odds ratio, 2.50; P = .0115). Continuation of trastuzumab beyond progression was not associated with increased toxicity. CONCLUSION: Continuation of trastuzumab plus capecitabine showed a significant improvement in overall response and time to progression compared with capecitabine alone in women with HER-2-positive breast cancer who experienced progression during trastuzumab treatment.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Receptor, ErbB-2/metabolism , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal, Humanized , Breast Neoplasms/pathology , Capecitabine , Chemotherapy, Adjuvant , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Disease Progression , Female , Fluorouracil/administration & dosage , Fluorouracil/analogs & derivatives , Follow-Up Studies , Humans , Immunoenzyme Techniques , International Agencies , Middle Aged , Neoplasm Staging , Prognosis , Risk Factors , Survival Rate , Time Factors , Trastuzumab , Treatment Outcome
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