Dabrafenib Versus Dabrafenib + Trametinib in -Mutated Radioactive Iodine Refractory Differentiated Thyroid Cancer: Results of a Randomized, Phase 2, Open-Label Multicenter Trial.

Oncogenic BRAF mutations are commonly found in advanced differentiated thyroid cancer (DTC), and reports have shown efficacy of BRAF inhibitors in these tumors. We investigated the difference in response between dabrafenib monotherapy and dabrafenib + trametinib therapy in patients with BRAF-mutated radioactive iodine refractory DTC. In this open-label randomized phase 2 multicenter trial, patients aged ≥18 years with BRAF-mutated radioactive iodine refractory DTC with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.

A phase I trial adding poly(ADP-ribose) polymerase inhibitor veliparib to induction carboplatin-paclitaxel in patients with head and neck squamous cell carcinoma: Alliance A091101.

Objectives: We report the results of this phase I study to evaluate the maximum tolerated dose (MTD) and safety of veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin and paclitaxel induction chemotherapy (IC) for locoregionally advanced head and neck squamous cell carcinoma (HNSCC).

Materials And Methods: In a 3 + 3 cohort design, patients with stage IVA-B human papillomavirus-negative HNSCC received 2 cycles of carboplatin (AUC 6, day 1), paclitaxel (100 mg/m, days 1, 8, 15) and veliparib (days 1-7) every 21 days followed by standard curative-intent chemoradiotherapy. Primary endpoint: MTD and recommended phase II dose (RP2D) as determined by the first IC cycle.

Incorporating Value-Based Care Into Oncology.

Value-based care within insurance design utilizes evidence-based medicine as a means of defining high-value versus low-value diagnostics and treatments. The goals of value-based care are to shift spending and coverage toward high-value care and reduce the use of low-value practices. Within oncology, several value-based methods have been proposed and implemented.

A pilot study of the pan-class I PI3K inhibitor buparlisib in combination with cetuximab in patients with recurrent or metastatic head and neck cancer.

Background: This study assessed the maximum tolerated dose (MTD) of the PI3K inhibitor buparlisib given concurrently with cetuximab in recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Methods: Twelve patients with R/M HNSCC were enrolled. Patients were given oral buparlisib starting day 7 and daily thereafter.

Challenges in the Clinical Application of the American Society of Clinical Oncology Value Framework: A Medicare Cost-Benefit Analysis in Chronic Lymphocytic Leukemia.

Purpose: The ASCO Value Framework calculates the value of cancer therapies. Given costly novel therapeutics for chronic lymphocytic leukemia, we used the framework to compare net health benefit (NHB) and cost within Medicare of all regimens listed in the National Comprehensive Cancer Network (NCCN) guidelines.

Methods: The current NCCN guidelines for chronic lymphocytic leukemia were reviewed.

Cabozantinib As Salvage Therapy for Patients With Tyrosine Kinase Inhibitor-Refractory Differentiated Thyroid Cancer: Results of a Multicenter Phase II International Thyroid Oncology Group Trial.

Purpose Sorafenib and lenvatinib are oral multikinase inhibitors targeting vascular endothelial growth factor receptor (VEGFR) and approved for radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). However, there are no approved second- or third-line therapies. MET is implicated in resistance to VEGFR inhibitors.

State insurance mandates and off-label use of chemotherapy.

Access to cancer drugs used off-label is important to cancer patients but may drive up healthcare costs with little evidence of clinical benefit. We hypothesized that state health insurance mandates for private insurers to provide coverage for off-label use of cancer drugs cause higher rates of off-label use. We used Truven MarketScan data from 1999 to 2007 on utilization of 35 infused chemotherapy drugs in private health plans in the United States, covering the period when eight states implemented off-label coverage laws.

Pilot Study of 99mTc-labeled Ethylene Dicysteine Deoxyglucose SPECT-CT Imaging in Treatment Response Evaluation in Patients with Locally Advanced Head and Neck Cancer.

Background: The purpose of this study is to describe the preliminary findings of 99mTc-labeled ethylene dicysteine deoxyglucose (99mTc-EC-DG) performed four weeks after chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma.

Methods: Review of nine patients with locally advanced head and neck squamous cell carcinomas imaged with 99mTc-EC-DG single photon emission computed tomography-computed tomography (SPECT-CT) at baseline before treatment and at four weeks after treatment completion was performed.

Results: At four weeks post-treatment, five patients had either decreased activity or no significant activity on 99mTc-EC-DG SPECT-CT and were considered to have responded to treatment, whereas four patients did not have significantly decreased uptake on 99mTc-EC-DG SPECT-CT and were considered to have not adequately responded to treatment.

Determinants of Patient-Centered Financial Stress in Patients With Locally Advanced Head and Neck Cancer.

Purpose: To prospectively estimate patient-centered financial stress and its relationship with health care utilization in patients with head and neck cancer. This was a survey-based, longitudinal, prospective study of treatment-naïve patients with stage III, IVa, or IVb locally advanced head and neck cancer at a single-institution tertiary care hospital from May 2013 to November 2014. With 121 patients approached, 73 (60%) agreed to participate.

Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

Background: Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress.

Methods: Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited.

Financial toxicity in cancer care.

The cost of cancer care is increasing, with important implications for the delivery of high-quality, patent-centered care. In the clinical setting, patents and physicians express a desire to discuss out-of-pocket costs. Nevertheless, both groups feel inadequately prepared to participate in these discussions, and perhaps not surprisingly, the integration of these discussions into clinical practice seems to be the exception rather than the rule.

Global Health Equity: Cancer Care Outcome Disparities in High-, Middle-, and Low-Income Countries.

Breakthroughs in our global fight against cancer have been achieved. However, this progress has been unequal. In low- and middle-income countries and for specific populations in high-income settings, many of these advancements are but an aspiration and hope for the future.

Economic analyses in squamous cell carcinoma of the head and neck: a review of the literature from a clinical perspective.

The purpose of this review was to describe cost-effectiveness and cost analysis studies across treatment modalities for squamous cell carcinoma of the head and neck (SCCHN), while placing their results in context of the current clinical practice. We performed a literature search in PubMed for English-language studies addressing economic analyses of treatment modalities for SCCHN published from January 2000 to March 2013. We also performed an additional search for related studies published by the National Institute for Health and Clinical Excellence in the United Kingdom.

The development of a financial toxicity patient-reported outcome in cancer: The COST measure.

Background: Considering patients' experience is essential for optimal decision-making. However, despite increasing recognition of the impact of costs on oncology care, there is no patient-reported outcome measure (PROM) that specifically describes the financial distress experienced by patients.

Methods: The content for a comprehensive score for financial toxicity (COST) was developed with a stepwise approach: step 1) a literature review and semistructured, qualitative interviews with patients for content generation; step 2) patients' assessment of the items for importance to their quality of life; step 3) pilot testing assessing interitem (IIC) and item-total (ITC) correlations to identify redundancy (Spearman rho, > 0.

A value framework in head and neck cancer care.

The care of head and neck squamous cell carcinoma has greatly evolved over the past 30 years. From single modality to a multidisciplinary care, there has also been a concurrent increase in treatment intensity, resulting, at many times, in more zealous regimens that patients must endure. In this article, we apply Porter's value model as a framework to balance survival, toxicities, cost, and trade-offs from a patient's perspective in head and neck cancer.

Financial Distress in Cancer Patients.

Novel diagnostic and therapeutic options offer hope to cancer patients with both localized and advanced disease. However, many of these treatments are often costly and even well-insured patients can face high out-of-pocket costs. Families may also be at risk of financial distress due to lost wages and other treatment-related expenses.

Access to cancer medications in low- and middle-income countries.

Major breakthroughs have been realized in controlling cancer in the past five decades. However, for patients in low- and middle-income countries (LMICs), many of these advances are nothing but an aspiration and hope for the future. Indeed, the greatest challenge we face in oncology today is how to reconcile small, incremental and significant improvements in the management of cancer with the exponentially increasing costs of new treatments.

Pharmacoeconomic issues in head and neck oncology.

Purpose Of Review: Despite medical advances, the global incidence, morbidity and mortality associated with head and neck cancer remain high. Pharmacoeconomic analyses of chemotherapeutic options commonly used by head and neck oncologists are reviewed in context with current clinical practice.

Recent Findings: From the British health system perspective, cetuximab with radiotherapy in locally advanced head and neck was found to be cost-effective compared to single modality radiotherapy in patients with a good performance status, and in whom platinum agents are contraindicated.

Unsupported off-label chemotherapy in metastatic colon cancer.

Background: Newer systemic therapies have the potential to decrease morbidity and mortality from metastatic colorectal cancer, yet such therapies are costly and have side effects. Little is known about their non-evidence-based use.

Methods: We conducted a retrospective cohort study using commercial insurance claims from UnitedHealthcare, and identified incident cases of metastatic colon cancer (mCC) from July 2007 through April 2010.