Racial disparity in oncologic and quality-of-life outcomes in patients with locally advanced head and neck squamous cell carcinomas enrolled in a randomized phase 2 trial.

Background: To better understand patient-reported quality of life (PRQOL) for patients with head and neck cancer, PRQOL scores were collected in a clinical trial.

Methods: Patients were randomized to arm A (70 Gy of radiation with cisplatin) or arm B (70 Gy of radiation with cisplatin plus erlotinib at 150 mg daily). PRQOL scores were measured on days -7 (arm B only), 0, 30, and 180 with the University of Washington Quality of Life Questionnaire.

Treatment and outcomes of non-small-cell lung cancer patients with high comorbidity.

Background: The life expectancy of untreated non-small-cell lung cancer (NSCLC) is dismal, while treatment for NSCLC improves survival. The presence of comorbidities is thought to play a significant role in the decision to treat or not treat a given patient. We aim to evaluate the association of comorbidities with the survival of patients treated for NSCLC.

Phase II trial of eribulin mesylate in recurrent or metastatic salivary gland malignancies.

Background: This study examined the microtubule inhibitor eribulin in recurrent/metastatic salivary gland cancers (RMSGCs), a disease where no therapeutic standard exists.

Methods: This phase II clinical trial treated patients with progressive recurrent/metastatic salivary gland cancers with eribulin 1.4 mg/m i.

Survival Gains from First-Line Systemic Therapy in Metastatic Non-Small Cell Lung Cancer in the U.S., 1990-2015: Progress and Opportunities.

Background: Approximately 190,000 Americans are diagnosed with non-small cell lung cancer (NSCLC) annually, and about half have metastatic (Stage IV) disease. These patients have historically had poor survival prognosis, but several new therapies introduced since 2000 provide options for improved outcomes. The objectives of this study were to quantify survival gains from 1990, when best supportive care (BSC) only was standard, to 2015 and to estimate the impact of expanded use of systemic therapies in clinically appropriate patients.

Phase Ib Trial of the Toll-like Receptor 8 Agonist, Motolimod (VTX-2337), Combined with Cetuximab in Patients with Recurrent or Metastatic SCCHN.

As Toll-like receptors (TLR) are key mediators of immune responses, TLR agonists may be important for augmenting the efficacy of therapies for squamous cell carcinoma of the head and neck (SCCHN). Motolimod (VTX-2337), a selective small-molecule agonist of TLR8, stimulates natural killer (NK) cells, dendritic cells, and monocytes. A phase Ib clinical trial assessed the safety and antitumor activity of motolimod in combination with cetuximab in patients with SCCHN.

Value: The Next Frontier in Cancer Care.

Given the urgency to balance the delivery of high-quality cancer care with costs, stakeholders are developing new models of care delivery and reimbursement that emphasize value. The Value in Cancer Care series is a collection of 11 opinion-based articles that jointly aim to inform practicing oncologists about the pertinent facets of the value debate.

The Clinical and Economic Impacts of Skeletal-Related Events Among Medicare Enrollees With Prostate Cancer Metastatic to Bone.

Background: Approximately 40% of men diagnosed with metastatic prostate cancer experience one or more skeletal-related events (SREs), defined as a pathological fracture, spinal cord compression, or surgery or radiotherapy to the bone. Accurate assessment of their effect on survival, health care resource utilization (HCRU), and cost may elucidate the value of interventions to prevent SREs.

Materials And Methods: Men older than age 65 years with prostate cancer and bone metastasis diagnosed between 2004 and 2009 were identified from linked Surveillance Epidemiology and End Results-Medicare records.

The Value of Lung Cancer CT Screening: It Is All about Implementation.

Hospitals have been gradually implementing new lung cancer CT screening programs following the release of the U.S. Preventive Services Task Force grade B recommendation to screen individuals at high risk for lung cancer.

Projected Clinical, Resource Use, and Fiscal Impacts of Implementing Low-Dose Computed Tomography Lung Cancer Screening in Medicare.

Purpose: The Centers for Medicare and Medicaid Services (CMS) recently issued a national coverage determination that provides reimbursement for low-dose computed tomography (CT) lung cancer screening for enrollees age 55 to 77 years with ≥ 30-pack-year smoking history who currently smoke or quit in the last 15 years. The clinical, resource use, and fiscal impacts of this change in screening coverage policy remain uncertain.

Methods: We developed a simulation model to forecast the 5-year health outcome impacts of the CMS low-dose CT screening policy in Medicare compared with no screening.

Adjuvant Radiotherapy for Stages II and III Resected Thymoma: A Single-institutional Experience.

Introduction: The role of adjuvant radiation for Masaoka stages II and III thymoma remains controversial. The aim of this study was to evaluate the clinical benefit of radiation therapy for resected stages II and III thymoma patients.

Methods: We retrospectively reviewed the medical records of 175 thymoma patients treated from July 1996 to January 2013 at University of Washington Medical Center; 88 patients with adequate follow-up and who met histologic criteria were included.

Observational study designs for comparative effectiveness research: an alternative approach to close evidence gaps in head-and-neck cancer.

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H&N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects.

Moving beyond the national lung screening trial: discussing strategies for implementation of lung cancer screening programs.

The National Lung Screening Trial (NLST) has sparked new interest in the adoption of lung cancer screening using low-dose computed tomography (LDCT). If adopted at a national level, LDCT screening may prevent approximately 18,000 lung cancer deaths per year, potentially constituting a high-value public health intervention. Before incorporating LDCT screening into practice, health care institutions need to consider the risks associated with LDCT screening and the impact of LDCT screening on health care costs, as well as other remaining areas of uncertainty, including the unknown cost-effectiveness of LDCT screening.

Lung cancer screening with low-dose computed tomography: costs, national expenditures, and cost-effectiveness.

A recent randomized trial showed that low-dose CT (LDCT) screening reduces lung cancer mortality. Health care providers need an assessment of the national budget impact and cost-effectiveness of LDCT screening before this intervention is adopted in practice. Using data from the 2009 National Health Interview Survey, CMS, and the National Lung Screening Trial (NLST), the authors performed an economic analysis of LDCT screening that includes a budget impact model, an estimate of additional costs per lung cancer death avoided attributed to screening, and a literature search of cost-effectiveness analyses of LDCT screening.

Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation.

Purpose: We conducted a phase II study to assess the efficacy of continuous dosing of sunitinib in patients with flurodeoxyglucose positron emission tomography (FDG-PET)-avid, iodine-refractory well-differentiated thyroid carcinoma (WDTC) and medullary thyroid cancer (MTC) and to assess for early response per FDG-PET.

Experimental Design: Patients had metastatic, iodine-refractory WDTC or MTC with FDG-PET-avid disease. Sunitinib was administered at 37.

Medical interpreter knowledge of cancer and cancer clinical trials.

Background: Cancer patients with limited English proficiency may need specialized assistance to communicate with health professionals about cancer and clinical trials.

Methods: Medical interpreters working in several Boston-area hospitals were invited to participate in training sessions about cancer and cancer clinical trials. We did a pre and post survey-based assessment of knowledge of basic concepts in cancer and clinical trials, and post assessment of satisfaction, among 97 interpreters in cancer training and education sessions and 79 participants in clinical trial training and education sessions.

Long term survivors with metastatic pancreatic adenocarcinoma treated with gemcitabine: a retrospective analysis.

Background: Metastatic pancreatic adenocarcinoma has a short median overall survival (OS) of 5-6 months. However, a subgroup of patients survives more than 1 year. We analyzed the survival outcomes of this subgroup and evaluated clinical and pathological factors that might affect survival durations.

Trends in the use and role of biomarkers in phase I oncology trials.

Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the use of biomarkers and their contribution to the main goals of phase I trials.

Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to 2002 and the publications related to these abstracts.

Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials.

Context: In the past, cancer patients entering phase 1 studies confronted the prospects of high risk and unlikely benefit. Over the last decade, cancer drugs under development have become more targeted, and the clinical research environment has become more scrutinized. The impact of these changes on the risks and benefits to patients who participate in phase 1 cancer trials is unknown.