Identification of newborns with birthweight ≥ 4,500g: Ultrasound within one- vs. two weeks of delivery.

OBJECTIVE: Our objective was to compare the diagnostic characteristics of sonographic estimated fetal weight (SEFW) done within 7 versus 8-14 days before delivery for detection of fetal macrosomia (birthweight ≥ 4500 g). STUDY DESIGN: We performed a multicenter, retrospective cohort study of all non-anomalous singletons with SEFW ≥ 4000 g by Registered Diagnostic Medical Sonographers conducted within 14 days of delivery. Cohorts were grouped by time interval between ultrasound and delivery: 0-7 days versus 8-14 days. The detection rate (DR) and false positive rate (FPR) for detection of birthweight (BW) ≥ 4500 g were compared between groups with subgroup analysis for diabetic women. Area under the receiver operator curve (AUC) was calculated to analyze all possible SEFW cutoffs within our cohort. RESULTS: A total of 330 patients met inclusion criteria with 250 (75.8 %) having SEFW within 7 days and 80 (24.2 %) with SEFW 8-14 days prior to delivery. The rate of macrosomia was 15.1 % (N = 51). The DR for macrosomia was significantly higher when SEFW was performed within 7 days of delivery compared to 8-14 days among non-diabetic (73.0 % vs 7.1 %; p < 0.001) and diabetic women (76.5 % vs 16.7 %; p = 0.02). There was no significant change in FPR in either group. The AUC for detection of macrosomia was significantly higher when SEFW was performed within 7 days versus 8-14 days (0.89 vs 0.63; p < 0.01). CONCLUSION: With SEFW ≥ 4000 g, the detection of BW ≥ 4500 g is significantly higher when the sonographic examination is within 7 days of birth irrespective of maternal diabetes.

A retrospective evaluation of activity of gemcitabine/platinum regimens in the treatment of recurrent ovarian cancer.

BACKGROUND: While many of these agents have been compared in prospective clinical trials, the gemcitabine/platinumbased regimens have not been compared in a prospective, randomized clinical trial. While bothgemcitabine/carboplatin and gemcitabine/cisplatin have a similar ORR in separate clinical trials, the tworegimens have never been directly been compared. With overlapping dose-limiting toxicity of thrombocytopenia, the gemcitabine/carboplatin regimen has been challenging to employ in the clinical setting in previously treated ovarian cancer patients and is often associated with treatment delays and/or dose reductions. Gemcitabine/cisplatin can also be a challenge due to its dose limiting neuropathy and renal toxicity, especially in previously treated patients. In the absence of any prospective, head to head comparison this retrospective study was embarked upon to compare the response rate and toxicity profiles of gemcitabine/cisplatin verses gemcitabine/carboplatin for the treatment of platinum-sensitive verses platinum-resistant recurrent ovarian cancer. METHODS: This was a retrospective chart review study that identified patients that had received either gemcitabine/cisplatin or gemcitabine/carboplatin for treatment of recurrent ovarian cancer and compared documented hematological and non-hematological toxicity and response based on RECIST (v1.1). Data was evaluated based upon platinum sensitivity/resistance as well. RESULTS: A total of 93 patients were identified that had received a gemcitabine/platinum regimen with 48 with recurrent ovarian cancer that were included in the study. There were 21 patients in the gemcitabine/cisplatin arm and 27 patients identified in the gemcitabine/carboplatin arm. Objective response rate (ORR) was greater in platinum-sensitive patients that received gemcitabine/carboplatin compared to gemcitabine/cisplatin (8 (67%) vs 2 (25%), p < 0.05). Conversely, ORR was greater in platinum-resistant patients treated with gemcitabine/cisplatin (4 (57%) vs 1 (25%), NS). Mean time to progression was greater in gemcitabine/cisplatin patients (7.2 vs 5.1 months, p < 0.03). Patients treated with gemcitabine/carboplatin discontinued due to toxicity at a greater rate (8 (33%) vs 5 (24%)). Specifically gemcitabine/carboplatin had a greater incidence (85%) of grade 2 or greater leukopenia, thrombocytopenia, and neutropenia compared to gemcitabine/cisplatin (19%) However, there was no significant difference in dose reductions, treatment delays, or granulocyte-colony stimulating factor (G-CSF) administration between regimens. CONCLUSIONS: Gemcitabine/cisplatin appears to have greater efficacy in platinum-resistant patients, while gemcitabine/carboplatin seems to have greater efficacy in platinum-sensitive patients. Overall, gemcitabine/carboplatin was associated with a greater incidence of myelosuppression and discontinuation due to toxicity. Similar to findings in endometrial cancer, gemcitabine/cisplatin may have benefit specifically in platinum-resistant ovarian cancer.

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy.

Objective The objective of this study was to observe the efficacy of antiemetic therapy (no emesis/retching episodes and no rescue medication use) when granisetron is administered via a transdermal patch system (TDS) in women who are 6 to 14 weeks pregnant when compared with oral ondansetron by evaluating the frequency of the use of rescue medications for control of nausea/vomiting of pregnancy (NVP). Methods This was an observational case series study to observe the potential benefits of granisetron TDS compared with oral ondansetron for management of NVP in pregnant patients during the first trimester. Dates of data collection were September 1, 2014, through December 31, 2015. There was no direct contact with patient. The oral ondansetron and granisetron TDS patients were matched by age, 4:1. The proportion of patients who received rescue antiemetics was calculated from those patients who continued to experience NVP. Risk factors for NVP were identified and compared between groups. Descriptive statistics were used to describe study results. Results Patients were prescribed rescue antiemetics in 0/3 patients in the granisetron TDS group compared with 2/12 patients in the oral ondansetron group. Conclusion Prospective efficacy studies on the use of granisetron TDS for management of NVP are needed to confirm this clinical observation.