The regular email from “The Oncologist” arrived in my inbox this morning:
Editorial
Regarding “Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies”
Bruce A. ChabnerThis editorial reflects on improvements in the cancer drug approval process of the U.S. Food and Drug Administration.
Commentaries
ALK Fusion Detection in Circulating Free DNA: Finding an Important Needle in the Haystack
Meghan J. Mooradian, Justin F. GainorALK 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.
Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies
Gideon M. Blumenthal, Paul G. Kluetz, Julie Schneider, Kirsten B. Goldberg, Amy E. McKee, Richard PazdurWith 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.
Precision Medicine Clinic
A Case of Metastatic Atypical Neuroendocrine Tumor with ALK Translocation and Diffuse Brain Metastases
Victoria E. Wang, Lauren Young, Siraj Ali, Vincent A. Miller, Anatoly Urisman, John Wolfe, Trever G. Bivona, Bertil Damato, Shannon Fogh, Emily K. BergslandA 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.
Detection of an ALK Fusion in Colorectal Carcinoma by Hybrid Capture-Based Assay of Circulating Tumor DNA
Andrea Z. Lai, Alexa B. Schrock, Rachel L. Erlich, Jeffrey S. Ross, Vincent A. Miller, Evgeny Yakirevich, Siraj M. Ali, Fadi BraitehThe 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.
Clinical Trial Results
Phase II Study of First-Line Trebananib Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma
Ghassan K. Abou-Alfa, Jean-Frederic Blanc, Steven Miles, Tom Ganten, Jörg Trojan, Jonathan Cebon, Andre K. Liem, Lara Lipton, Charu Gupta, Benjamin Wu, Michael Bass, Ellen Hollywood, Jennifer Ma, Margaret Bradley, Jason Litten, Leonard B. SaltzMulticenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer
Marco Siano, Francesca Molinari, Vittoria Martin, Nicolas Mach, Martin Früh, Stefania Freguia, Irene Corradino, Michele Ghielmini, Milo Frattini, Vittoria EspeliA Phase II Study of Everolimus Plus Oral Prednisone in Patients with Metastatic Renal Cell Cancer
Cristian Lolli, Valentina Gallà, Giuseppe Schepisi, Domenico Barone, Salvatore Luca Burgio, Antonio Maugeri, Bernadette Vertogen, Dino Amadori, Ugo De GiorgiAcademia-Pharma Intersect: Lung Cancer
Targeting BRAF-Mutant Non-Small Cell Lung Cancer: From Molecular Profiling to Rationally Designed Therapy
Christina S. Baik, Nathaniel J. Myall, Heather A. WakeleeThis 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.
Breast Cancer
Clinical Variant Classification: A Comparison of Public Databases and a Commercial Testing Laboratory
William Gradishar, KariAnne Johnson, Krystal Brown, Erin Mundt, Susan ManleyPublic 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.
Gastrointestinal Cancer
Overall Survival and Clinical Characteristics of BRCA-Associated Cholangiocarcinoma: A Multicenter Retrospective Study
Talia Golan, Maria Raitses-Gurevich, Robin K. Kelley, Andrea G. Bocobo, Ayelet Borgida, Rachna T. Shroff, Spring Holter, Steven Gallinger, Daniel H. Ahn, Dan Aderka, Jain Apurva, Tanois Bekaii-Saab, Eitan Friedman, Milind JavleIt 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.
Global Health and Cancer
Implementing a Fee-for-Service Cervical Cancer Screening and Treatment Program in Cameroon: Challenges and Opportunities
Geneva DeGregorio, Simon Manga, Edith Kiyang, Florence Manjuh, Leslie Bradford, Preetam Cholli, Richard Wamai, Rebecca Ogembo, Zacharie Sando, Yuxin Liu, Lisa Kennedy Sheldon, Kathleen Nulah, Thomas Welty, Edith Welty, Javier Gordon OgemboThis 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.
Head and Neck Cancers
p16, HPV, and Cetuximab: What Is the Evidence?
James A. Bonner, Ricard Mesia, Jordi Giralt, Amanda Psyrri, Ulrich Keilholz, David I. Rosenthal, Frank Beier, Jeltje Schulten, Jan B. VermorkenThis 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.
Medical Ethics
Oncofertility: Fertile Ground for Conflict Between Patient Autonomy and Medical Values
Sarah K. Walsh, Elizabeth S. Ginsburg, Lisa Soleymani Lehmann, Ann H. PartridgeOncofertility 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.
Melanoma and Cutaneous Malignancies
Management of Treatment-Related Adverse Events with Agents Targeting the MAPK Pathway in Patients with Metastatic Melanoma
Adil Daud, Katy TsaiThis 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.
Neuro-Oncology
Comprehensive Genomic Profiling of Esthesioneuroblastoma Reveals Additional Treatment Options
Laurie M. Gay, Sungeun Kim, Kyle Fedorchak, Madappa Kundranda, Yazmin Odia, Chaitali Nangia, James Battiste, Gerardo Colon-Otero, Steven Powell, Jeffery Russell, Julia A. Elvin, Jo-Anne Vergilio, James Suh, Siraj M. Ali, Philip J. Stephens, Vincent A. Miller, Jeffrey S. RossComprehensive 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.
New Drug Development and Clinical Pharmacology
BRAF Mutations as Predictive Biomarker for Response to Anti-EGFR Monoclonal Antibodies
Emilie M. J. van Brummelen, Anthonius de Boer, Jos H. Beijnen, Jan H. M. SchellensThis 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.
Regulatory Issues: FDA
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy
Erin Larkins, Gideon M. Blumenthal, Weishi Yuan, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Hong Zhao, Chao Liu, Jingyu Yu, Kirsten B. Goldberg, Amy E. McKee, Patricia Keegan, Richard PazdurThis 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.
Symptom Management and Supportive Care
National Policies Fostering Hospice Care Increased Hospice Utilization and Reduced the Invasiveness of End-of-Life Care for Cancer Patients
Yu-Yun Shao, Emily Han-Chung Hsiue, Chih-Hung Hsu, Chien-An Yao, Ho-Min Chen, Mei-Shu Lai, Ann-Lii ChengThe 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.
Narratives in Oncology
Amani's Silence
Lea Baider, Lidia SchapiraThis 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.
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