A phase IV study evaluating QT interval, pharmacokinetics, and safety following fractionated dosing of gemtuzumab ozogamicin in patients with relapsed/refractory CD33-positive acute myeloid leukemia.

Purpose: Gemtuzumab ozogamicin (GO) is indicated for treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). The QT interval, pharmacokinetics (PK), and immunogenicity following the fractionated GO dosing regimen have not been previously assessed. This phase IV study was designed to obtain this information in patients with R/R AML.

Farm size affects the use of agroecological practices on organic farms in the United States.

Organic agriculture outperforms conventional agriculture across several sustainability metrics due, in part, to more widespread use of agroecological practices. However, increased entry of large-scale farms into the organic sector has prompted concerns about 'conventionalization' through input substitution, agroecosystem simplification and other changes. We examined this shift in organic agriculture by estimating the use of agroecological practices across farm size and comparing indicators of conventionalization.

Outcomes following hematopoietic stem cell transplantation in patients treated with standard chemotherapy with or without gemtuzumab ozogamicin for acute myeloid leukemia.

The phase 3 ALFA-0701 trial demonstrated improved outcomes with fractionated-dose gemtuzumab ozogamicin (GO) combined with standard chemotherapy vs. standard chemotherapy alone in adults with de novo acute myeloid leukemia (AML). We examined post-transplant outcomes and occurrence of hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) in patients who received hematopoietic stem cell transplantation (HSCT) as follow-up therapy in ALFA-0701.

Bias in Obstetrician-Gynecologists' Workplaces.

Obstetrician-gynecologists (ob-gyns) face similar types of biases in the workplace as any people in society. In this first of three articles exploring this issue, we present the stories from ob-gyns who describe their experiences dealing with these biases. These stories serve to personalize the issue and to encourage us to personally face bias in the workplace to build our own resilience and strength, to support those who are personally attacked or diminished, and to develop workplace cultures that are inclusive, diverse, and strong.

Gemtuzumab ozogamicin for acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial.

The randomized, phase III ALFA-0701 trial showed that a reduced and fractionated dose of gemtuzumab ozogamicin added to standard front-line chemotherapy significantly improves event-free survival (EFS) in adults with acute myeloid leukemia (AML). Here we report an independent review of EFS, final overall survival (OS), and additional safety results from ALFA-0701. Patients (n=271) aged 50-70 years with AML were randomized to receive conventional front-line induction chemotherapy (3+7daunorubicin+cytarabine) with/without gemtuzumab ozogamicin 3 mg/m on days 1, 4, and 7 during induction.

Use of the STROBE Checklist to Evaluate the Reporting Quality of Observational Research in Obstetrics.

Objective: To evaluate observational research manuscripts submitted to Obstetrics & Gynecology to determine the level of adherence to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist and highlight specific areas that could be improved.

Methods: A scoring system based on the STROBE checklist was developed and validated for consistency by volunteer medical students or doctors. Using this scoring system, we performed a cross-sectional analysis on 198 observational research manuscripts submitted to Obstetrics & Gynecology from 2008 to 2016.

Subspecialty Influence on Scientific Peer Review for an Obstetrics and Gynecology Journal With a High Impact Factor.

Objective: To evaluate whether quality of peer review and reviewer recommendation differ based on reviewer subspecialty in obstetrics and gynecology and to determine the role of experience on reviewer recommendation.

Methods: We performed a retrospective cohort study of reviews submitted to Obstetrics & Gynecology between January 2010 and December 2014. Subspecialties were determined based on classification terms selected by each reviewer and included all major obstetrics and gynecology subspecialties, general obstetrics and gynecology, and nonobstetrics and gynecology categories.

Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer.

Purpose: Figitumumab (CP-751,871), a fully human immunoglobulin G2 monoclonal antibody, inhibits the insulin-like growth factor 1 receptor (IGF-1R). Our multicenter, randomized, phase III study compared figitumumab plus chemotherapy with chemotherapy alone as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC).

Patients And Methods: Patients with stage IIIB/IV or recurrent NSCLC disease with nonadenocarcinoma histology received open-label figitumumab (20 mg/kg) plus paclitaxel (200 mg/m(2)) and carboplatin (area under the concentration-time curve, 6 mg · min/mL) or paclitaxel and carboplatin alone once every 3 weeks for up to six cycles.

Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer.

This phase 2 study assessed PF-3512676 plus erlotinib in patients with epidermal growth factor receptor-positive advanced non-small cell lung cancer after prior chemotherapy failure. Patients were randomized 1:1 to PF-3512676 (0.20 mg/kg injected subcutaneously once weekly) plus erlotinib (150 mg daily) or erlotinib alone.

Randomized phase III trial of paclitaxel/carboplatin with or without PF-3512676 (Toll-like receptor 9 agonist) as first-line treatment for advanced non-small-cell lung cancer.

Purpose: This phase III study examined efficacy of the synthetic Toll-like receptor 9-activating oligodeoxynucleotide PF-3512676 in combination with standard paclitaxel/carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC).

Patients And Methods: Chemotherapy-naive patients with stage IIIB or IV NSCLC were randomly assigned (1:1) to receive up to six courses of paclitaxel/carboplatin (intravenous paclitaxel 200 mg/m(2) and carboplatin at area under the [concentration-time] curve 6 on day 1 of a 3-week cycle) alone (control arm) or in combination with 0.2 mg/kg subcutaneous PF-3512676 on days 8 and 15 (investigational arm).

Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine.

Purpose: To assess the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of orally administered irinotecan in the semi-solid matrix (SSM) formulation, both as a single agent and in sequential combination with capecitabine, in patients with advanced solid tumors.

Patients And Methods: Forty-three patients were treated with irinotecan given as a single oral daily dose on days 1-5 every three weeks. An additional forty patients were treated with sequential oral irinotecan given daily on days 1-5 followed by capecitabine given orally as a divided dose twice daily on days 6-14 of each three week cycle.

Differences in editorial board reviewer behavior based on gender.

Background: Reports indicate that there are gender-based differences in aspects of the peer-review process.

Methods: This is an analysis of editorial board members' reviews of original research submissions based on gender using the web-based management program, Editorial Manager, from January 1, 2002, through December 31, 2008. We evaluated recommendations of editorial board members for acceptance/rejection using a four-tier system, agreement with editor's final decision, turnaround time from review request to submission, and editors' grades of reviews on a 5-point scale.

Clinical pharmacokinetics and gastrointestinal tolerability of a novel extended-release microsphere formulation of azithromycin.

Background And Objective: A novel oral, extended-release, microsphere formulation of azithromycin (AZSR) was developed to improve the gastrointestinal tolerability profile while allowing administration of an entire treatment course of azithromycin in a single dose. Several phase I clinical pharmacology studies were conducted to (i) identify a well-tolerated single-dose formulation that met a predefined exposure target; and (ii) evaluate the effect of food and antacid on the absorption of this formulation. Of these, five pivotal studies are described here.

Metabolic syndrome, C-reactive protein, and prognosis in patients with established coronary artery disease.

Background: The prognosis associated with metabolic syndrome and high-sensitivity C-reactive protein (hs-CRP) in patients with stable coronary artery disease has not been well established.

Methods: The WIZARD study was to determine the effects of 12 weeks of antibiotic therapy on coronary heart disease events in patients with stable coronary artery disease and known Chlamydia pneumoniae exposure. Baseline metabolic risk factors were available for 3319 patients enrolled from 1997 to 1998.

A multicenter study of azithromycin, alone and in combination with chloroquine, for the treatment of acute uncomplicated Plasmodium falciparum malaria in India.

Background: Azithromycin has demonstrated in vitro and in vivo activity against Plasmodium falciparum, but small treatment studies have given mixed results.

Methods: Participants with fever and with both a blood smear and a rapid diagnostic test positive for falciparum malaria were randomly assigned to groups that were treated with either azithromycin or chloroquine or to matched groups receiving a placebo. After an interim analysis, open-label combination therapy with both drugs was initiated.

Azithromycin for the secondary prevention of coronary heart disease events: the WIZARD study: a randomized controlled trial.

Context: Several lines of evidence have implied an association between Chlamydia pneumoniae infection and atherogenesis.

Objective: To determine the effect of 12 weeks of antibiotic therapy on coronary heart disease events in patients with stable coronary artery disease and known C pneumoniae exposure.

Design, Setting, And Participants: Randomized, placebo-controlled trial of 7747 adults with previous myocardial infarction that had occurred at least 6 weeks previously (median, 2.