Summary Background We compared standard adjuvant anthracycline chemotherapy with anthracycline–taxane combination chemotherapy in women with operable node-positive breast cancer. Here we report the ...final, 10-year follow-up analysis of disease-free survival, overall survival, and long-term safety. Methods BCIRG 001 was an open label, phase 3, multicentre trial in which 1491 patients aged 18–70 years with node-positive, early breast cancer and a Karnofsky score of 80% or more were randomly assigned to adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC) or fluorouracil, doxorubicin, and cyclophosphamide (FAC) every 3 weeks for six cycles. Randomisation was stratified according to institution and number of involved axillary lymph nodes per patient (one to three vs four or more). Disease-free survival was the primary endpoint and was defined as the interval between randomisation and breast cancer relapse, second primary cancer, or death, whichever occurred first. Efficacy analyses were based on the intention-to-treat principle. BCIRG 001 is registered with ClinicalTrials.gov , number NCT00688740. Findings Enrolement took place between June 11, 1997 and June 3, 1999; 745 patients were assigned to receive TAC and 746 patients were assigned to receive FAC. After a median follow-up of 124 months (IQR 90–126), disease-free survival was 62% (95% CI 58–65) for patients in the TAC group and 55% (51–59) for patients in the FAC group (hazard ratio HR 0·80, 95% CI 0·68–0·93; log-rank p=0·0043). 10-year overall survival was 76% (95% CI 72–79) for patients in the TAC group and 69% (65–72) for patients in the FAC group (HR 0·74, 0·61–0·90; log-rank p=0·0020). TAC improved disease-free survival relative to FAC irrespective of nodal, hormone receptor, and HER2 status, although not all differences were significant in these subgroup analyses. Grade 3–4 heart failure occurred in 26 (3%) patients in the TAC group and 17 (2%) patients in the FAC group, and caused death in two patients in the TAC group and four patients in the FAC group. A substantial decrease in left ventricular ejection fraction (defined as a relative decrease from baseline of 20% or more) was seen in 58 (17%) patients who received TAC and 41 (15%) patients who received FAC. Six patients who received TAC developed leukaemia or myelodysplasia, as did three patients who received FAC. Interpretation Our results provide evidence that the initial therapeutic outcomes seen at the 5-year follow-up with a docetaxel-containing adjuvant regimen are maintained at 10 years. However, a substantial percentage of patients had a decrease in left ventricular ejection fraction, probably caused by anthracycline therapy, which warrants further investigation. Funding Sanofi.
Topical hemostatic agents are used in conjunction with conventional procedures to reduce blood loss. They are often used in cardiothoracic surgery, which is particularly prone to bleeding risks. ...Variation in their use exists because detailed policy and practice guidelines reflecting the current medical evidence have not been developed to promote best surgical practice in this setting. To address this need, the Society for the Advancement of Blood Management convened an International Hemostatic Expert Panel. This article reviews the available literature and sets out evidence-based recommendations for the use of topical hemostatic agents in cardiothoracic surgery.
Purpose This study was conducted to evaluate the outcomes after treatment of fractures through the atrophic mandible using open reduction, internal fixation, and immediate bone grafting. Patients and ...Methods All patients treated surgically for fractures through an atrophic (<15 mm at the fracture site) mandible over a 17-year period were included if their records contained adequate information. Demographic data and details of treatment were tabulated, as were outcomes. Results A total of 32 patients (19 males, 13 females; age range, 43 to 92 years) met the inclusion criteria. Of the 32 cases, 26 were bilateral fractures, and most occurred through the region of the body of the mandible. Most patients had significant medical comorbidities. Most of the fractures were treated through an extraoral approach with a rigid internal fixation technique. Immediate bone grafts were used in 23 of the 32 patients. No intraoperative or postoperative complications occurred. All patients healed uneventfully. In 4 patients, plates had to be removed for various reasons after fracture healing was complete. Conclusions The use of a seemingly more aggressive approach for managing fractures through the atrophic mandible produced healing in all patients and, in the end, may be more “conservative” than a less aggressive approach. Despite the advanced age and medical comorbidities of most of the patients, all patients tolerated the surgery and did well postoperatively.
Posttransplant lymphoproliferative disorder (PTLD) is a well-recognized complication of long-term immunosuppression following hematopoietic or solid organ transplantation and is associated with ...significant morbidity and mortality. We present a unique case of PTLD that manifested with a nonhealing dental extraction socket 17 years after renal transplantation. We summarize the existing literature and present a review of an additional 25 cases. These highlight the variable clinical presentations of PTLD within the oral cavity and clear potential for delayed presentation at this anatomical subsite.
Background: Osteolytic lesions are present in 75% of patients with multiple myeloma (MM) and frequently require palliation with radiation therapy (RT). Prior case series of patients with MM with bone ...pain undergoing palliative RT suggests doses ≥12 Gy (equivalent dose in 2Gy fractions, EQD2) provide excellent bone pain relief. However, recent advances in care and novel biologic agents have significantly improved overall survival and quality of life for patients with MM. We hypothesized that lower-dose RT (LDRT, EQD2 <12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 ≥12 Gy) for palliation of painful, uncomplicated MM bone lesions. Methods: We retrospectively identified patients with MM treated with RT for uncomplicated, painful bone lesions and stratified by EQD2 ≥/< 12 Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. Results: Thirty-five patients with 70 treated lesions were included: 24 patients (48 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow-up was 14 and 16.89 months for HDRT and LDRT, respectively. The median dose of HDRT treatment was 20 Gy versus 4 Gy in the LDRT group. The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any-grade acute toxicity between the HDRT and LDRT cohorts (24.5% vs 9.1%, Χ2P = .20). Pain recurred in 10% of lesions (12% HDRT vs 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (P = .91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort, and 3 (6.3%) in the HDRT cohort. Conclusion: In this study, LDRT effectively palliated painful, uncomplicated MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful, uncomplicated MM bony lesions.
Abstract Purpose This study aims to validate the performance of the Sequential Organ Failure Assessment (SOFA) score to predict death of critically ill patients with cancer. Material and methods We ...conducted a retrospective observational study including adults admitted to the intensive care unit (ICU) between January 1, 2006, and December 31, 2008. We randomly selected training and validation samples in medical and surgical admissions to predict ICU and in-hospital mortality. By using logistic regression, we calculated the probabilities of death in the training samples and applied them to the validation samples to test the goodness-of-fit of the models, construct receiver operator characteristics curves, and calculate the areas under the curve (AUCs). Results In predicting mortality at discharge from the unit, the AUC from the validation group of medical admissions was 0.7851 (95% confidence interval CI, 0.7437-0.8264), and the AUC from the surgical admissions was 0.7847 (95% CI, 0.6319-0.937). The AUCs of the SOFA score to predict mortality in the hospital after ICU admission were 0.7789 (95% CI, 0.74-0.8177) and 0.7572 (95% CI, 0.6719-0.8424) for the medical and surgical validations groups, respectively. Conclusions The SOFA score had good discrimination to predict ICU and hospital mortality. However, the observed underestimation of ICU deaths and unsatisfactory goodness-of-fit test of the model in surgical patients to indicate calibration of the score to predict ICU mortality is advised in this group.
Abstract Purpose The aim of this study was to cross-validate an automated and customized severity of illness score as a means of predicting death among adult cancer patients admitted to the intensive ...care unit (ICU). Materials and Methods We conducted a retrospective study of ICU discharges between January 1, 2001, and December 31, 2005, in a university comprehensive cancer center. We randomly selected training and validation samples in 2 ICU groups (medical and surgical patients). We used logistic regression to calculate the probabilities of death in the ICU and in-hospital death in training samples and applied these probabilities to the validation samples to calculate sensitivity and specificity, construct curves, and determined the areas under the receiver operating characteristic curve (AUC). Results We included 6880 patients. In predicting ICU mortality, the AUC was 0.77 (95% confidence interval CI, 0.73-0.82) for the medical validation group and 0.8207 (95% CI, 0.7304-0.9109) for the surgical validation group. For in-hospital mortality, the AUCs for the groups of medical and surgical patients were 0.73 (95% CI, 0.69-0.76) and 0.77 (95% CI, 0.73-0.80), respectively. Conclusions The modified Sequential Organ Failure Assessment score is a good and valid predictor of cancer patients' risk of dying in the ICU and/or hospital despite the modifications needed to automate the score using existing electronic data.
Abstract Purpose The study aimed to evaluate the relative impact of clinical and demographic factors associated with the prevalence and incidence of anemia (hemoglobin Hb <12 g/dL) in critically ill ...patients with cancer. Materials and Methods We performed an electronic chart review for demographic and clinical data of adult patients with cancer with or without anemia admitted to the intensive care unit (ICU). Prevalence of anemia was determined at admission, and incidence determined if anemia developed during ICU stay. Anemia was classified as mild, moderate, or severe. The additive impact of clinical and demographic factors was evaluated by using a hierarchical linear regression model. Results A total of 4705 patients were included in the study. The prevalence and incidence of anemia were 68.0% and 46.6%, respectively. In prevalent cases, we found that the clinical covariates modified sequential organ failure assessment score, admission to the medical ICU, prior chemotherapy, diagnosis of hematologic cancer, and length of hospital stay before ICU admission explained 18.7% of the variance in the model, whereas the demographic covariates (age, sex, and race) explained only an additional 0.6%. The pattern was similar for incidence cases. Conclusions Clinical factors are more influential than demographic factors in the observed rates of prevalence and incidence of anemia in the ICU; thus, protocols are needed to identify subgroups of patients with cancer who could benefit from novel management strategies.
Antiangiogenic Therapy for von Hippel-Lindau Disease Madhusudan, Srinivasan; Deplanque, Gaël; Braybrooke, Jeremy P ...
JAMA : the journal of the American Medical Association,
02/2004, Letnik:
291, Številka:
8
Journal Article
PDF
