Volume 19, Issue 11, November 2014
Editorial
Defining a New Role for the National Cancer Institute Cooperative Groups: More Science, Fewer Trials
In the context of major changes, it is likely that the National Cancer Institute's Cooperative Groups will not have the resources to perform many of the traditional, definitive, randomized phase III trials of the past; industry will have to play a greater role in refining drug sequences or combinations. The new National Clinical Trials Network will have an opportunity to produce results with a major impact on cancer drug development.
Commentary
Drug Development for Hepatocellular Carcinoma: Knowing the Past Helps to Understand the Future
Hepatocellular carcinoma (HCC) is a highly complicated disease characterized by comorbid cirrhosis and disease heterogeneity. Given multiple failures in the past, we need to learn from previous experiences and generate novel ideas to increase the chance of success. More effort and patience should be exercised in the selection of a homogeneous patient population and identification of predictive markers during drug development for HCC.
Breast Cancer
Gene Status in HER2 Equivocal Breast Carcinomas: Impact of Distinct Recommendations and Contribution of a Polymerase Chain Reaction-Based Method
The authors sought to assess the impact of recommendations with regard to identifying patients eligible for anti-HER2 agents by fluorescence in situ hybridization and to elucidate whether multiplex ligation-dependent probe amplification (MLPA) may be of help in assessing HER2 gene status. Recent guidelines seem to improve the identification of HER2-positive carcinomas. MLPA can be of help if heterogeneous amplification has been ruled out.
Clinical Trial Results
A Pilot Study of Estradiol Followed by Exemestane for Reversing Endocrine Resistance in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer
A Phase II Study of Ifosfamide, Methotrexate, Etoposide, and Prednisolone for Previously Untreated Stage I/II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: A Multicenter Trial of the Korean Cancer Study Group
A Phase I/II Study of XELIRI Plus Bevacizumab as Second‐Line Chemotherapy for Japanese Patients With Metastatic Colorectal Cancer (BIX Study)
S-1 as Monotherapy or in Combination With Leucovorin as Second-Line Treatment in Gemcitabine-Refractory Advanced Pancreatic Cancer: A Randomized, Open-Label, Multicenter, Phase II Study
Economics of Oncology Practice
Patient Experience and Attitudes Toward Addressing the Cost of Breast Cancer Care
Most breast cancer patients want to discuss costs of care, but there is little consensus on the desired content or goal of these discussions. A self-administered, anonymous survey was given to breast cancer patients presenting for a routine visit within 5 years of diagnosis at an academic cancer center. Survey questions addressed experience and preferences concerning discussions of cost and views on cost control. Results are primarily descriptive.
Endocrinology
MicroRNA Expression Profiles in the Management of Papillary Thyroid Cancer
MicroRNAs (miRNAs) compose a class of molecules with promising applications for every stage of papillary thyroid cancer (PTC) management, including diagnosis, prognosis, treatment, and surveillance. This review is focused on the potential roles of miRNA in PTC management in the context of contemporary recommended clinical practice.
Novel Approaches in Anaplastic Thyroid Cancer Therapy
The purpose of this review is to summarize the promising preclinical and clinical studies in anaplastic thyroid cancer (ATC) treatment, as well as reveal new preclinical studies with novel approaches at genetic, organelle, cellular, and microenvironment levels. Because of the poor prognosis, all ATC patients should be referred to centers that participate in current clinical trials with new agents and delivery systems.
Gastrointestinal Cancer
Targeted Therapies in Metastatic Colorectal Cancer: A Systematic Review and Assessment of Currently Available Data
Novel molecular-targeted agents have recently been approved. This review summarizes and assesses the effects of molecular agents in metastatic colorectal cancer based on the available phase II and III trials, pooled analyses, and meta-analyses/systematic reviews. The future challenge will be a better selection of the population that will benefit the most from specific anti-vascular endothelial growth factor or anti- epidermal growth factor receptor treatment and a careful consideration of therapy sequence.
Hepatobiliary
Efficacy and Safety of the FOLFOX4 Regimen Versus Doxorubicin in Chinese Patients With Advanced Hepatocellular Carcinoma: A Subgroup Analysis of the EACH Study
The authors report the results of the EACH study for the subgroup of Chinese patients with advanced hepatocellular carcinoma (HCC) who are ineligible for curative resection or local treatment. FOLFOX4 significantly improved response and disease-control rates and prolonged survival compared with doxorubicin. Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC.
New Drug Development and Clinical Pharmacology
Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine's Workshop Series, “Implementing a National Cancer Clinical Trials System for the 21st Century”
This review, based on presentations and discussion during the Institute of Medicine and American Society of Clinical Oncology workshops, outlines the progress and challenges of collaborations among stakeholders in cancer research and drug development.
Symptom Management and Supportive Care
The Opioid Rotation Ratio of Hydrocodone to Strong Opioids in Cancer Patients
Cancer pain management guidelines recommend initial treatment with intermediate-strength analgesics such as hydrocodone and subsequent escalation to stronger opioids such as morphine. The aim of this study was to determine the opioid rotation ratio (ORR) of hydrocodone to morphine equivalent daily dose (MEDD) in cancer outpatients. An ORR of 1.5 is suggested to calculate the MEDD of hydrocodone for doses <40 mg/day, and an ORR of 1 is suggested for doses ≥40 mg/day.
A Prospective Study of Shortened Vitamin Supplementation Prior to Cisplatin–Pemetrexed Therapy for Non-Small Cell Lung Cancer
This study hypothesized that the lead-in time of folic acid and vitamin B12 supplementation prior to pemetrexed therapy could be shortened to 24 hours, enabling earlier commencement of chemotherapy. In this prospective study, the shortened vitamin supplementation was well tolerated and retained antitumor efficacy.
Sleep-Related Breathing Disorders in Patients With Tumors in the Head and Neck Region
This retrospective study demonstrates that patients with tumors in the head and neck region have significant sleep-related breathing disorders as judged by sleep-related complaints and polysomnographic data. Symptoms typically include daytime fatigue and sleepiness, and a heightened clinical suspicion is recommended for this cohort.
Letters to the Editor
Giant Cell Tumor of Bone
The role of enhanced fluorodeoxyglucose F 18 uptake of giant cell tumor of bone (GCTB) should be mentioned in an overview such as that reported by van der Heijden et al., with regard not only to the response to denosumab treatment for unresectable GCTB but also to the clinical implications for the diagnosis of this disease.
In Reply
The authors respond to the observations and remarks of Cavanna et al. concerning the clinical guidance paper on giant cell tumor of bone (GCTB) in the era of denosumab and update the paper with respect to the European Medicines Agency's recent positive opinion recommending denosumab for the treatment of adults and skeletally mature adolescents with GCTB that is unresectable or for which surgical resection is likely to result in severe morbidity
Updated Product Label Allows Home Administration of Omacetaxine Mepesuccinate
The U.S. Food and Drug Administration's accelerated approval of omacetaxine mepesuccinate for the treatment of chronic-phase or accelerated-phase chronic myeloid leukemia has been converted to full approval. Approved changes to the omacetaxine administration guidelines to allow home administration using syringes prepared by a health care professional will improve patient access to treatment by alleviating the need for daily visits to a medical facility during treatment, while also addressing concerns regarding the ability of patients or caregivers to accurately prepare and administer injections safely.