NE Oncology Issue – September 2014

Jackson LK et al. ASCO 2014:6050

Background

Symptom burden in patients with recurrent-metastatic head and neck cancer (RMHNC) is poorly described. Currently available patient-reported outcomes (PROs) do not incorporate measures that are specific to RMHNC and instead focus on acute and late effects of primary therapy. At ASCO 2014, Jackson and colleagues described the development and preliminary testing of the Vanderbilt Head and Neck Symptom Survey – Recurrent/ Metastatic (VHNSS-RM), a tool designed to assess RMHNC-related symptoms, residual toxicity from prior therapy, and side effects from current therapy.1

Study design

  • The objective of this study is to develop and perform preliminary testing of a PRO specifically designed to identify symptom burden and functional issues in RMHNC.
  • A list of items to include in the assessment was generated.
    • Investigators conducted 17 one-on-one interviews with patients with RMHNC.
    • A focus group consisting of 14 experts in the care of patients with head and neck cancer compiled a list of 104 symptoms and 63 psychosocial items.
    • Importance of items was rated by the experts and similar measures were combined.
  • A condensed list of 46 symptoms and 13 psychosocial issues was reviewed by 20 patients, who endorsed the items and ranked them by severity. (Table 1)
  • To develop the VHNSS-RM, investigators assembled a set of questions based on high-impact symptoms and symptoms that occurred at high frequency (endorsed by ≥35% of patients).
    • The VHNSS-RM contains 35 physical symptoms and 12 psychosocial issues that are scored on a scale from 0 to 10 (from none to severe).
    • Items included in the VHNSS-RM were compared to items in existing tools: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Core Module and Head and Neck Module (EORTC QLQ-C30 and QLQ-H&N35), Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N), MD Anderson Symptom Inventory- Head & Neck (MDASI-HN), VHNSS v2.0, and the University of Washington Quality of Life (UWQOL).
  • Pilot testing of the VHNSS-RM was completed by 50 consecutive patients with non-curable RMHNC.
    • The tool was administered online to patients during clinic visits.

Key findings

  • Patients testing the VHNSS-RM found the tool to be highly feasible and readable.
    • Investigators did not note any barriers to completion of the tool via computer interface.
    • In 92.4% of patients, the time required to complete the VHNSS-RM was ≤15 minutes.
    • A full range of scores was noted for 46 out of 47 questions.
  • The VHNSS-RM includes 12 novel symptom questions and 7 novel psychosocial issues. (Table 2)
  • Symptom burden was assessed as high in the pilot test.
    • Moderate to severe symptoms (VHNSS-RM ≥5) were identified in >30% of patients for 33 out of 47 questions (70.2%); of those, severe symptoms (VHNSS-RM ≥7) were found in 48.5% of patients.

Key conclusions

  • The VHNSS-RM is a feasible tool that can be completed in a timely manner.
  • The VHNSS-RM is able to:
    • Better identify actionable problems;
    • Allow for improved palliation in this cohort of patients;
    • Assess treatment response;
    • Assess treatment impact on overall symptom burden.
  • Since symptoms experienced by patients with RMHNC often differ at initial presentation and during primary treatment, the 19 novel questions included in the PRO may help to improve palliation in these patients.
  • The need for a directed assessment tool for symptoms and function deficits secondary to recurrent or metastatic disease was identified.
  • Studies to validate the VHNSS-RM and analyze its role in assessment of treatment response and impact on overall symptom burden are ongoing.

Reference: 1. Jackson LK, Deng J, Ridner SH, et al. Preliminary testing of a patient-reported outcome measure for recurrent or metastatic head and neck cancer. J Clin Oncol (ASCO Annual Meeting) 2014;32 (Suppl):abstr 6050.

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Canadian Perspectives

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Carolyn Owen, MD

Dr. Carolyn Owen completed postgraduate training in internal medicine and hematology at the University of Ottawa and the University of British Columbia, respectively, followed by a research fellowship in molecular genetics at Barts and the London School of Medicine and Dentistry in London, UK. Her research focused on familial myelodysplasia and acute myeloid leukemia. She is currently an Assistant Professor at the Foothills Medical Centre & Tom Baker Cancer Centre, and her clinical interests are low-grade lymphoma and chronic lymphocytic leukemia. She is also the local principal investigator in Calgary for several clinical trials in these areas.

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David Macdonald, MD, FRCPC

Dr. David Macdonald is a hematologist at the QEII Health Sciences Centre in Halifax, Nova Scotia, and Assistant Professor in the Division of Hematology at Dalhousie University’s Faculty of Medicine. Dr. Macdonald chairs the Hematology Cancer Site Team for Cancer Care Nova Scotia. His interests are in hematologic malignancies and, in particular, lymphoproliferative disorders. He has done a Clinical Trials Fellowship with the National Cancer Institute of Canada – Clinical Trials Groups and is actively engaged in clinical trials research. Dr. Macdonald has also completed a clinical fellowship in the lymphoma group at the British Columbia Cancer Agency in Vancouver, and he maintains a clinical research program in lymphoma.

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Jeffrey Rothenstein, MD, FRCPC

Dr. Jeffrey Rothenstein is a medical oncologist at the R.S. McLaughlin Durham Regional Cancer Centre in Oshawa and an Adjunct Assistant Professor in the Department of Oncology at Queen’s University in Kingston, Ontario. He completed his internal medicine and medical oncology training at the University of Toronto. Dr. Rothenstein’s main clinical focus is on the management of thoracic and gastrointestinal malignancies. He is the lung cancer site group leader at the R.S. McLaughlin Durham Regional Cancer Center.

Investigator Commentaries

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Stephan Stilgenbauer, MD

Dr. Stephan Stilgenbauer is Associate Professor and Deputy Chairman at the Department of Internal Medicine III (Hematology, Oncology, Rheumatology and Infectious Diseases) at Ulm University, Germany. He received his medical training at Heidelberg Medical School and was trained in internal medicine and hematology-oncology at the Universities of Heidelberg and Ulm. He spent a postdoctoral fellowship at the German Cancer Research Center (DKFZ) in Heidelberg. His research focus is on the molecular pathogenesis of hematological malignancies and translation of this research into novel treatment strategies. Dr. Stilgenbauer has authored or co-authored numerous original articles, reviews, and book chapters in journals such as The New England Journal of Medicine, The Lancet, Nature Medicine, the Proceedings of the National Academy of Sciences of the United States of America, Journal of Clinical Oncology, Blood, Leukemia, Haematologica, among others.

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C. Tom Kouroukis, MD

Dr. C. Tom Kouroukis graduated from the University of Toronto and completed training in Internal Medicine, Hematology and MSc (Health Research Methodology) training at McGill and McMaster Universities. He was awarded a National Cancer Institute of Canada Clinical Research Fellowship. He is a hematologist at the Juravinski Cancer Centre/Hamilton Health Science, Chair of the Hematology Disease Site Team, Head of the Division of Malignant Hematology, and Associate Professor in the Department of Oncology. He is Co-chair of the Hematology Cancer Disease Site Group of the Cancer Care Ontario Practice Guidelines Initiative and Chair of the Stem Cell Committee of Cancer Care Ontario. His research interests include the care of older patients with hematological cancers, the impact and evaluation of co-morbidity in older cancer patients, clinical trials, and practice guideline development.

Expert Commentaries

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Laurie H. Sehn, MD, MPH
Dr. Laurie H. Sehn is a Clinical Assistant Professor at the BC Cancer Agency and the University of British Columbia in Vancouver. She has been a medical oncologist and clinical investigator with the Lymphoma Tumour Group since 1998. Dr. Sehn has served on the Board of Directors of Lymphoma Foundation Canada (LFC) since 2002 and is currently Director of Research Fellowships for the LFC. Dr. Sehn’s research interests include all of the lymphoid cancers, with particular interest in the biology and treatment of large-cell lymphoma, the application of new imaging techniques such as PET scanning to lymphoma management, and innovative new approaches to treatment.

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Dietger Niederwieser, MD
Dr. Dietger Niederwieser is the Head of the Department of Hematology and Oncology at the University Hospital of Leipzig in Germany. He completed his medical degree and postgraduate training in internal medicine and hemato-oncology at the University of Innsbruck in Austria. His research interests include leukemia, myelodysplastic syndrome, renal cell carcinoma, Hodgkin lymphoma, allogeneic stem cell transplantation, and graft versus host disease and he is currently involved in a variety of clinical trials in these areas. Dr. Niederwieser is President of the Worldwide Network for Blood and Marrow Transplantation, past President of the European Group for Bone and Marrow Transplantation (EBMT), and a former Chair of the EBMT Chronic Leukemia Working Party. He is a member of several scientific societies, including the European Hematology Association, the American Society of Hematology, and the American Society of Clinical Oncology and he serves as an external reviewer for universities in Europe and the United States. Dr. Niederwieser is the author or co-author of numerous articles (<390) published in international peer-reviewed journals, such as The New England Journal of Medicine, Blood, the Journal of Clinical Oncology, the Journal of the American Medical Association, Nature Clinical Practice Oncology, Annals of Oncology, Leukemia, and Bone Marrow Transplantation.

Case Study

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Barbara Melosky, MD, FRCP(C)

Dr. Barbara Melosky is a Clinical Associate Professor of Medicine at the University of British Columbia and a medical oncologist at the British Columbia Cancer Agency in Vancouver. She graduated from medical school at the University of Manitoba, and did a residency in internal medicine and an oncology fellowship at the University of British Columbia. Dr. Melosky is currently working in the fields of lung and gastrointestinal malignancies with a special interest in the side effects of targeted therapy. She sits on the Executive Committee for the Lung Disease Site NCIC Clinical Trials Group and is the annual Chair of the Canadian Lung Cancer Conference.