Validation of breast cancer nomograms for predicting the non-sentinel lymph node metastases after a positive sentinel lymph node biopsy in a multi-center study.

OBJECTIVE: In the study, our aim was to evaluate the predictability of four different nomograms on non-sentinel lymph node metastases (NSLNM) in breast cancer (BC) patients with positive sentinel lymph node (SLN) biopsy in a multi-center study. METHODS: We identified 607 patients who had a positive SLN biopsy and completion axillary lymph node dissection (CALND) at seven different BC treatment centers in Turkey. The BC nomograms developed by the Memorial Sloan Kettering Cancer Center (MSKCC), Tenon Hospital, Cambridge University, and Stanford University were used to calculate the probability of NSLNM. Area under (AUC) Receiver Operating Characteristics Curve (ROC) was calculated for each nomogram and values greater than 0.70 were accepted as demonstrating good discrimination. RESULTS: Two hundred and eighty-seven patients (287) of 607 patients (47.2%) had a positive axillary NSLNM. The AUC values were 0.705, 0.711, 0.730, and 0.582 for the MSKCC, Cambridge, Stanford, and Tenon models, respectively. On the multivariate analysis; overall metastasis size (OMS), lymphovascular invasion (LVI), and proportion of positive SLN to total SLN were found statistically significant. We created a formula to predict the NSLNM in our patient population and the AUC value of this formula was 0.8023. CONCLUSIONS: The MSKCC, Cambridge, and Stanford nomograms were good discriminators of NSLNM in SLN positive BC patients in this study. A newly created formula in this study needs to be validated in prospective studies in different patient populations. A nomogram to predict NSLNM in patients with positive SLN biopsy developed at one institution should be used with caution.

Immunogenicity study of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine used to reconstitute a freeze-dried Haemophilus influenzae type b vaccine (DTaP-IPV//PRP-T) administered simultaneously with a hepatitis B vaccine at two, three and four months of life.

This study was designed to assess the immunogenicity of a vaccine combining diphtheria and tetanus toxoids, acellular pertussis vaccine, and inactivated poliovirus vaccine reconstituting Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (DTaP-IPV//PRP-T; Pasteur Mérieux Connaught, Lyon, France) administered simultaneously in association with hepatitis B vaccine (RECOMBIVAX (¿trade mark omitted¿) Merck, Sharp & Dohme, West Point, PA, USA) for the primary immunization of infants. The vaccines were administered at two, three and four months of age. One hundred and sixty-two healthy infants, aged 8-10 weeks, were enrolled in the study. Blood samples were taken before the first dose and 4 weeks after the third dose. The infants were observed for 15 minutes after vaccination for any immediate reaction. Adverse events requiring a medical consultation were recorded by the parents in a diary over the 7 days following vaccination. Four weeks after the third immunization, the percentages of infants fulfilling seroconversion criteria were 98.9% for pertussis toxin, 95.9% for filamentous haemagglutinin, 100.0% for tetanus, 100.0% for diphtheria, 99.3% for poliovirus type 1, 100.0% for both poliovirus types 2 and 3, 98.0% for Haemophilus influenzae type b, and 100% for hepatitis B surface antigen. No vaccine-related serious adverse event was reported. The simultaneous administration of DTaP-IPV//PRP-T and hepatitis B vaccines at two, three and four months of age yielded clinically satisfactory immune responses to all antigens compared with historical controls and gave a good safety profile.

Imipenem-cilastatin versus sulbactam-cefoperazone plus amikacin in the initial treatment of febrile neutropenic cancer patients.

The treatment of infectious complications in cancer patients has evolved as a consequence of the developments in the chemotherapy of cancer patients. In this prospective, randomized study, we compared imipenem-cilastatin and sulbactam-cefoperazone with amikacin in the empiric therapy of febrile neutropenic (< 1000/mm3) patients with liquids and solid tumours. Of 30 evaluable episodes, 15 were treated with imipenem-cilastatin and 15 were treated with sulbactam-cefoperazone plus amikacin. 73% of episodes were culture-positive: gram-positive pathogens accounted for 62% of the isolates. Bacteremia was the most frequent site of infection. The initial clinical response rate for both regimens was 60% (p > 0.05). No major adverse effects occurred. This study demonstrated that imipenem-cilastatin monotherapy and combination therapy of sulbactam-cefoperazone plus amikacin were equally effective empiric therapy for febrile granulocytopenic cancer patients.

Evaluation of vocal cord function after thyroid surgery.

OBJECTIVE: To compare clinical evaluation and indirect laryngoscopy with videolaryngostroboscopy (VLS), which is a new method of diagnosing abnormalities and dysfunction of the vocal folds. DESIGN: Prospective study. SETTING: Teaching hospital, Turkey. SUBJECTS: 218 patients who required thyroidectomy and who had no vocal abnormality preoperatively. INTERVENTIONS: Clinical evaluation, indirect laryngoscopy, and VLS before operation and on the second postoperative day. MAIN OUTCOME MEASURES: Sensitivity and specificity. RESULTS: The specificity of all three investigations was 100%. The sensitivity of VLS was 100%, of clinical evaluation 81%, and of indirect laryngoscopy 67%. CONCLUSIONS: Clinical evaluation and indirect laryngoscopy are safe ways of evaluating abnormalities of the vocal cords postoperatively. It would probably not be cost-effective to use VLS routinely, but for differential diagnosis and evaluation of prognosis of vocal abnormalities after thyroidectomy it is more accurate.