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Exclusion of Gastrointestinal Cancer Patients With Prior Cancer From Clinical Trials: Is This Justified?

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Date
2016-06
ICR Author
Smyth, Lizzy
Cunningham, David
Chau, Ian
Author
Smyth, EC
Tarazona, N
Peckitt, C
Armstrong, E
Mansukhani, S
Cunningham, D
Chau, I
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Type
Journal Article
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Abstract
Background Strict eligibility criteria are necessary to maintain patient safety and scientific validity in clinical trials. However, this may lead to impaired generalizability of results. As survival in gastrointestinal (GI) cancer relates mainly to the GI malignancy, we hypothesized that previous cancers do not impact on survival and are not a rational exclusion criterion.Materials and methods Patients treated with chemotherapy for a GI cancer in 2006 were identified from the electronic patient record at the Royal Marsden Hospital, London. Chart review was performed and patient age, gender, GI cancer stage, prior cancer stage, clinical trial availability/eligibility, and dates of cancer recurrence, death, and last follow-up were collated.Results A total of 697 patients were identified. Fifty-four patients (8%) had a prior cancer; commonly breast (26%), prostate (17%), or colon (9%); most were stage I (42%) or II (37%). Two hundred ninety-seven (65%) patients had GI cancer recurrence, 7 (12%) patients had relapse of a prior cancer. Five hundred four (72%) patients have died, 170 (24%) are alive with no cancer, and 23 (3%) patients are alive with cancer. A total of 476 (94%) died of GI cancer, 2 (0.3%) of their prior cancer. Of all patients, 489 (70%) had an available trial, but 30% of patients with a prior cancer were ineligible for this reason. Overall and GI-cancer-specific survival were comparable for patients with/without a prior cancer.Conclusions Survival for patients with a GI cancer requiring chemotherapy relates to the GI cancer and rarely a prior cancer. These patients should not be excluded from clinical trial participation.
URI
https://repository.icr.ac.uk/handle/internal/515
DOI
https://doi.org/10.1016/j.clcc.2015.11.003
Collections
  • Clinical Studies
Subject
Humans
Gastrointestinal Neoplasms
Neoplasms, Second Primary
Neoplasm Recurrence, Local
Treatment Outcome
Proportional Hazards Models
Retrospective Studies
Patient Selection
Aged
Middle Aged
Female
Male
Kaplan-Meier Estimate
Research team
Medicine (RMH Smith Cunningham)
Language
eng
Date accepted
2015-11-23
License start date
2016-06
Citation
Clinical colorectal cancer, 2016, 15 (2), pp. e53 - e59

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