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Resisting RECIST—Uniformity Versus Clinical Validity
  1. Michelle K. Wilson, MBChB, FRACP*,
  2. Michael L. Friedlander, MD, PhD, FRACP,
  3. Stephanie Lheureux, MD, PhD,
  4. William Small, MD, FACRO, FACR, FASTRO§,
  5. Andrés Poveda, MD,
  6. Eric Pujade-Lauraine, MD, PhD,
  7. Katherine Karakasis, MSc,
  8. Monica Bacon, RN#,
  9. Valerie Bowering, RN,
  10. Tanya Chawla, MBBS, MRCP, FRCR, FRCP(C) and
  11. Amit M. Oza, BSc, MD, MBBS, FRCPC
  1. *Auckland City Hospital, Auckland, New Zealand;
  2. Prince of Wales Hospital, Sydney, Australia;
  3. Princess Margaret Cancer Centre, Toronto, Ontario Canada;
  4. §Department of Radiation Oncology, Loyol University, Chicago, IL;
  5. Instituto Valenciano de Oncologia, Valencia, Spain;
  6. Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and
  7. #Gynecologic Group Intergroup, Kingston, Canada.
  1. Address correspondence and reprint requests to Michelle K. Wilson, MBChB, FRACP, Cancer and Blood Services, Auckland City Hospital, Park Rd, Grafton, Auckland 1010, New Zealand. E-mail:


Objectives The Response Evaluation Criteria in Solid Tumors (RECIST) International Working Group developed criteria for tumor response and progression to standardize radiological assessment in patients receiving chemotherapy in phase 2 trials. However, it is unclear whether the defined percentage change in tumor size and volume reflects true clinical benefit for the patient. The RECIST criteria were designed to improve objectivity in trials, but not to replace clinical decision making. The aim of this study was to understand clinicians’ opinions about RECIST in current oncology practice.

Methods Using Web-based questionnaires, we investigated attitudes to the use of RECIST at a large comprehensive cancer center and in an international group of gynecologic cancer specialists through the Gynecologic Cancer InterGroup. The results reported here relate to the survey focusing on gynecologic cancer.

Results Sixty medical professionals from 13 countries responded to the survey. The majority of respondents worked at a tertiary or specialist cancer center (51; 86%). Overall, 66% of respondents felt RECIST increased trial objectivity and was a good measure of response. The majority of respondents (81%) reported that they infrequently challenged RECIST evaluation. Overall, 60% felt more than 10% of patients came off trial for clinical rather than radiological progression. In the context of a new small lesion, only 35% felt that should always be considered disease progression. The importance of both clinician and radiologist input was highlighted with nontarget progression. Nontarget progression and target progression were recognized as equally important for clinical decision making (72%).

Conclusions RECIST is a key criterion for endpoint assessment in clinical trials with its value recognized by clinicians. However, this survey also highlights the practical limitations of RECIST. Disconnect can be seen between the radiological result and the clinical picture—learning from these patients is critical. Continued efforts to improve metrics assessing patient benefit in trials remains a priority.

  • Gynecologic malignancies
  • Ovarian cancer
  • Response rate

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  • M.L.F. reports personal fees from ASTRA ZENECA, personal fees from PFIZER outside the submitted work. V.B. reports and received honorarium as member or Advisory Board for Olaparib with Astra Zeneca. M.K.W. reports travel support from Roche and MSD outside the published work.

  • The authors declare no conflicts of interest.

  • Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (