Volume 22, Issue 7, July 2017

This editorial reflects on improvements in the cancer drug approval process of the U.S. Food and Drug Administration.

ALK rearrangements have emerged as important therapeutic targets in oncology. This commentary, in light of recently reported cases, discusses the emerging role of liquid biopsies in molecular testing and new therapeutic options for oncology patients.

With the Breakthrough Therapy Designation program adding to the tools that the U.S. Food and Drug Administration (FDA) has for expediting drug development, the FDA reassessed the endpoints needed for approval of transformative therapies. Although the demonstration of an improvement in overall survival remains the gold standard for drug approval, innovation in cancer research has led to use of other endpoints in regulatory decision‐making. These endpoints include substantially delaying tumor progression or extending progression‐free survival, substantially reducing tumor size for a prolonged time, improving objective response rate and duration of response, or improving cancer‐related symptoms and patient function.

A challenge in precision medicine is the identification of actionable driver mutations. Alterations can be identified within the tumor tissue, by small biopsy or fine‐needle aspirates, or by noninvasive methods, such as circulating tumor cells or circulating tumor DNA. This article presents a case of atypical neuroendocrine tumor metastatic to the bone and brain for which circulating tumor DNA analysis found an ALK translocation.

The case of a patient with metastatic colorectal cancer is presented. This report is the first instance of an ALK fusion in colorectal cancer detected using a ctDNA assay.

This review provides a comprehensive overview of the clinical characteristics and prognostic implications for patients with BRAF‐mutant non‐small cell lung cancer and discusses therapeutic strategies that leverage experience from BRAF‐mutant metastatic melanoma. Practical considerations for oncologists are discussed, including considerations for molecular profiling and management of potential toxicities associated with targeted agents.

Public databases have been increasingly used in a clinical setting; however, the well‐documented limitations of these databases call into question how often clinicians will encounter discordant variant classifications that may introduce uncertainty into patient management. This study evaluated discordance in BRCA1 and BRCA2 variant classifications between a single commercial testing laboratory and a public database commonly consulted in clinical practice.

It is unknown if and to what extent the clinical course and therapeutic response of BRCA‐associated cholangiocarcinomas are distinct from non‐BRCA carriers. To gain insight, this multicenter retrospective study on BRCA‐associated cases was initiated and is reported here.

This report documents the strategies that led to the successful implementation of a nurse‐led cervical cancer screening program using visual inspection with acetic acid enhanced by digital cervicography, describes programmatic challenges, makes recommendations to optimize screening and treatment outcomes, and discusses the unique aspects of the Women's Health Program model developed in Cameroon.

This study reviews available methodologies for evaluating human papillomavirus (HPV) status, as well as current evidence involving the prognostic and potential predictive value of p16 and HPV status in patients with locoregionally advanced or recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with cetuximab combination regimens, with an emphasis placed on recent subgroup analyses of the phase III IMCL‐9815 and EXTREME trials.

Oncofertility is a relatively new field that serves to bridge the gap between available fertility resources and the special reproductive needs of cancer patients. Three cancer cases that illustrate ethical dilemmas in oncofertility practice are presented.

This review provides an overview of the adverse events associated with BRAFi and MEKi in melanoma, with a focus on the most commonly reported and serious adverse events, and offers practical guidance from a clinical perspective for optimal management.

Comprehensive genomic profiling (CGP) using next‐generation sequencing was performed on a series of 41 clinical esthesioneuroblastoma samples. This study provides a view into the genomic landscape of esthesioneuroblastoma and insight into the biological mechanisms underlying this tumor type.

This article summarizes the evidence for the impact of BRAF mutations on treatment outcome of anti‐EGFR monoclonal antibodies. Based on a review of literature, eight meta‐analyses were included in this study, which consistently show that patients with BRAF mutations have a lack of treatment benefit of anti‐EGFR monoclonal antibodies. Considering the quality and quantity of available evidence, current guidelines may be revised.

This article summarizes the evidence for the impact of BRAF mutations on treatment outcome of anti‐EGFR monoclonal antibodies. Based on a review of literature, eight meta‐analyses were included in this study, which consistently show that patients with BRAF mutations have a lack of treatment benefit of anti‐EGFR monoclonal antibodies. Considering the quality and quantity of available evidence, current guidelines may be revised.

The National Health Insurance (NHI) of Taiwan is a single‐payer, mandatory health insurance system. In 2011, two national policies fostering hospice services for terminal cancer patients took effect. This study explores the impact of these policy changes.

This narrative reflects on what it means to deliver compassionate and family‐centered care when cultural beliefs expose irreconcilable differences in goals, beliefs, and values among members of the multidisciplinary team and between professionals and patients and families.