Clinical Oncology - Scoring Treatment Effects

Outcome measures group

The aim of the outcome measures group is to develop a robust clinical tool to record and score acute and late normal-tissue effects of cancer treatments, specifically radiotherapy. Currently there is a recognized need for an international scoring system both in clinical trials (to facilitate accurate assessment of new technologies) and in clinical practice.

Background

Major advances in cancer prevention, early detection and treatment are resulting in longer survival. Cancer survivors can face a number of problems, which include the long-term effects of treatment on normal tissues and the likelihood of surviving with treatment effects is increased with combined modality treatment.

Improved measurement and assessment of the long-term burden of illness has been highlighted as important for future prospective research. Although tumour outcome and acute toxicity reporting is fairly standardized, there is no consensus as to how best to quantify late normal-tissue effects. The recognition and grading of toxicity caused by cancer treatment is a critical endpoint in clinical trials.

In 1995 the EORTC and RTOG published the late effects in normal tissues subjective, objective, management and analytic scales (LENT SOMA) in an attempt to devise an international scoring system. These scales were not ready to be adopted for widespread clinical use. To address this, the OM group established validation studies, produced user-friendly questionnaires to obtain normal tissue outcome data. In 2003 the NCI published the Common Terminology Criteria for Adverse Events (CTCAE) which incorporated the LENT SOMA items with early and late effects contained in one system.

Need for measurement and assessment of late effects

Measurement and assessment of late effects needs to be integrated into current patient management to:

  • Provide adequate information to the patient regarding complications associated with their treatment
  • Facilitate appropriate management for these complications
  • Improve multidisciplinary support for patients suffering from normal-tissue effects
  • Permit modification of treatment regimes to account for and reduce normal-tissue effects
  • Facilitate the development of predictive testing for normal-tissue effects

There is a need to ensure that any system developed for assessing late normal-tissue effects is appropriate for the disease site and treatment modality, and that it is feasible for use in a clinical setting.

The questionnaire approach is a practical and reliable way to use the toxicity scales. Work here to validate these questionnaires has been carried out with over 1000 patients to date at various disease sites : bladder, breast, cervix, head and neck, and prostate, These questionnaires are downloadable in pdf format. Part 1 (basic demographics) part 2 (subjective part) completed by patients in the clinic or by post and Part 3 (objective part) completed by clinician.

Collaborators

Søren M Bentzen, Ph.D., D.Sc.

Professor of Human Oncology, Professor of Medical Physics, 
Director of Research and Education of Human Oncology, 
University of Wisconsin School of Medicine and Public Health, 
Madison, WI 53792 
USA

Andy Trotti MD

Professor of Radiation Oncology
H Lee Moffitt Cancer Center at USF
Tampa, Florida 33612 
USA

Members of the outcome measures group

Project lead - Dr Susan E Davidson

Consultant and Honorary Senior Lecturer in Clinical Oncology 
The Christie NHS Foundation Trust 
Wilmslow Road Manchester M20 4BX

Statistician - Dr Damian Farnell

Academic Department of Radiation Oncology,
The Christie NHS Foundation Trust
Wilmslow Rd, Manchester M20 4BX.

Research Nurse - Jacki Routledge

Department of Clinical Oncology
The Christie NHS Foundation Trust 
Wilmslow Road Manchester M20 4BX