Selinexor in combination with weekly paclitaxel in patients with metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study with expansion phase in ovarian cancer.

Objective: Selinexor is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound which blocks Exportin-1 (XPO1). Our objective was to determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of selinexor and weekly paclitaxel.

Methods: This was an open label, single-center, multi-arm phase 1b study utilizing a "3 + 3" design and a "basket-type" expansion in recurrent solid tumors.

Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors.

Selinexor, an oral selective inhibitor of nuclear export (SINE), was demonstrated to hinder the DNA damage repair (DDR) system by reducing DDR proteins while enhancing the killing of cancer cells by DDR-based therapeutics in vivo studies. In this single-center, multi-arm phase 1b study, selinexor with carboplatin, doxorubicin and cyclophosphamide (DC), irinotecan with fluorouracil and folinic acid (FOLFIRI), irinotecan, and capecitabine and oxaliplatin (XELOX), were employed as separate parallel arms. Eligible patients have relapsed/ metastatic refractory solid tumors following standard therapy or addition of selinexor to systemic therapy was appropriate.

Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study.

Background: Carboplatin and paclitaxel (CT) is one of the standard chemotherapy regimens used in various tumor types. Preclinical models have suggested that selinexor, a first-in-class oral potent selective inhibitor of nuclear export Exportin-1, and CT exerts antitumor activity in multiple malignancies.

Methods: This was a single-center, multi-arm phase Ib study utilizing a "basket type" expansion.

Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study.

Background Selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound inhibits Exportin-1(XPO1), had demonstrated synergistic activity with many chemotherapies and conferred in vivo antitumor efficacy in hematologic as well as solid tumors. Methods This open-label, single-center, multi-arm phase 1b study used a standard 3 + 3 design and a "basket type" expansion. Selinexor with intravenous topotecan was given in one of the 13 parallel arms.

Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial.

Purpose Acute radiation-induced esophagitis (ARIE) leads to treatment delays, decreased quality of life (QOL), and secondary adverse events such as weight loss. Grade 3 ARIE occurs in 15%-30% of patients undergoing radiotherapy to the esophagus, leading to disruption or discontinuation of treatment. The purpose of this study was to assess the effects of glutamine, a common nutritional supplement, on ARIE in patients with thoracic malignancies.

Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory.

Introduction: Immunotherapies have revolutionized the treatment of various cancers, but little is known about their symptomatic toxicity. Assessing these symptoms is best accomplished by asking the patients themselves. However, such reports are subjective and may face challenges as bonafide scientific data.

Phase 2 study of pembrolizumab in patients with advanced rare cancers.

Background: Patients with advanced rare cancers have poor prognosis and few treatment options. As immunotherapy is effective across multiple cancer types, we aimed to assess pembrolizumab (programmed cell death 1 (PD-1) inhibitor) in patients with advanced rare cancers.

Methods: In this open-label, phase 2 trial, patients with advanced rare cancers whose tumors had progressed on standard therapies, if available, within the previous 6 months were enrolled in nine tumor-specific cohorts and a 10th cohort for other rare histologies.

Prevalence of Complementary Medicine Use in Patients With Cancer: A Turkish Comprehensive Cancer Center Experience.

Purpose: Complementary and alternative medicine (CAM) has been popular among patients with cancer for several decades. The objectives of this study were to evaluate the prevalence of CAM use and to identify the factors affecting CAM use in a large patient cohort seen at a comprehensive cancer center in Turkey.

Patients And Methods: An investigator-designed survey was completed by volunteer patients who visited the outpatient clinic in the medical oncology department.

Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced/refractory cancers.

Purpose: Mammalian target of rapamycin (mTOR) inhibitors like temsirolimus may result in undesirable AKT upregulation. Metformin inhibits mTOR through different mechanisms and may enhance temsirolimus's antitumor activity. We conducted an open-label phase I dose escalation trial of this drug combination in patients with advanced/refractory cancers.

Evaluation of a novel blood pressure scoring method and its association with clinical response in cancer patients treated with anti-vascular endothelial growth factor therapy.

Background: The purposes of this study were to establish a novel blood pressure (BP) scoring method and to correlate it with clinical response in advanced cancer patients treated with anti-vascular endothelial growth factor (VEGF) therapies.

Methods: We retrospectively analyzed data for 368 patients from 23 clinical trials that included at least one anti-VEGF agent. We determined BP scores using the traditional Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.

Mucositis may limit the therapeutic window for mammalian target of rapamycin inhibitor-based combination therapy, necessitating treatment interruptions and/or dose reductions. Optimizing treatment or prophylactic interventions for mucositis will enable patients to continue effective treatment while maintaining good quality of life.

Barriers to study enrollment in patients with advanced cancer referred to a phase I clinical trials unit.

Unlabelled: We conducted this retrospective study to identify reasons that patients referred to a phase I clinical trial failed to enroll or delayed enrollment onto the trial.

Materials And Methods: Outcome analyses were conducted independently on data collected from electronic medical records of two sets of consecutive patients referred to a phase I clinical trial facility at MD Anderson Cancer Center. Data from the first set of 300 patients were used to determine relevant variables affecting enrollment; data from the second set of 957 patients were then analyzed for these variables.

Preoperative factors predicting survival after secondary cytoreduction for recurrent ovarian cancer.

Objective: We evaluated preoperative data that may predict benefit from secondary cytoreductive surgery (CRS) to assist in selecting therapy for patients with platinum-sensitive recurrent epithelial ovarian cancer.

Materials And Methods: Inclusion criteria included recurrent epithelial or primary peritoneal carcinoma with an initial disease-free interval more than 6 months after chemotherapy, evidence of disease on imaging studies and indication for surgery being to debulk residual disease. Preoperative CA125 values, computed tomographic findings, and time to progression were evaluated as predictors of survival in addition to postoperative information and perioperative morbidity.

Role of appendectomy at the time of primary surgery in patients with early-stage ovarian cancer.

Objective: To determine whether appendectomy is warranted in patients with apparent early-stage ovarian cancer who undergo surgery for staging and cytoreduction and to determine the complication rate associated with appendectomy in such patients.

Methods: We reviewed the medical records of all patients who underwent appendectomy at the time of primary surgery for ovarian cancer at The University of Texas M. D.

Endoscopy of the upper gastrointestinal tract as a diagnostic tool for children with human immunodeficiency virus infection.

Objective: The purpose of this study was to determine the prevalence of upper gastrointestinal tract lesions in children with human immunodeficiency virus (HIV) infection who undergo endoscopy of the upper gastrointestinal tract and to identify important clinical predictors of abnormal endoscopic results.

Methods: All HIV-infected children who underwent endoscopy and were followed at Children's Hospital, Boston, from January 1985 to August 1994 were studied. The main outcome measure was endoscopic results, which were categorized into observational, histologic, and microbiologic findings.

Access to physicians, obstetric care use, and adequacy of prenatal care for Medicaid patients in Maine: 1985-1989.

Objective: To document trends in prenatal care utilization and provider participation in the Maine Medicaid program for the period 1985-1989, and to examine the effect of physician availability on adequacy of care.

Methods: Five years of Medicaid claims data and 3 years of claims data linked to birth certificates were analyzed.

Results: Large decreases in overall physician participation in the Medicaid program were due to reductions in the number of family physicians and general practitioners, whereas the number of obstetricians increased during this time.