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Prior malignancy should not exclude patients with gastrointestinal cancers from clinical trials
The decision to exclude patients with gastrointestinal cancers from clinical trials simply because they had a prior malignancy is unjustified, according to results of a retrospective observational study.
Survival among patients with gastrointestinal cancers who required chemotherapy typically was associated with the GI cancer rather than the prior malignancy, results showed.
“Governments worldwide include reducing barriers to participation in trials as a stated goal,” Elizabeth C. Smyth, MB, BCh, MSc, of the department of gastrointestinal cancer oncology at Royal Marsden Hospital in the United Kingdom, and colleagues wrote. “However, in order to improve on current recruitment rates to cancer clinical trials, it may be necessary to question the validity of commonly held beliefs regarding eligibility. Just as older patients should not be excluded by virtue of their age alone, we argue that neither should patients with a history of an adequately treated previous cancer.”
Smyth and colleagues reviewed data from 697 patients with gastrointestinal cancers treated in 2006 at Royal Marsden Hospital. The researchers then reviewed electronic records of the Gastrointestinal Clinical Trials Unit to determine opening and closing dates of relevant clinical trials during that time.
Fifty-four patients had undergone treatment for a previous malignancy, the most common of which were breast cancer (26%), prostate cancer (17%) or colon cancer (9%).
During the recruitment period, 489 patients (70%) had an available clinical trial at the time of gastrointestinal cancer treatment, and 113 (16%) enrolled onto a clinical trial. However, nearly one-third (30%) of patients with a prior cancer were deemed ineligible for a trial due to their previous malignancy.
Median follow-up was 83.2 months.
Researchers reported no statistically significant difference in median OS between patients who underwent prior treatment for malignancy and those who did not (37.4 months vs. 40.6 months).
Smyth and colleagues reported no statistically significant difference in median OS (35.4 months vs. 40 months, HR = 1; 95% CI, 0.78-1.29) or gastrointestinal cancer-specific survival (35.4 months vs. 41.5 months, HR = 1.06; 95% CI, 0.82-1.37) between study participants who did and did not participate in clinical trials.
Multivariate analysis showed age, cancer stage and non-colorectal cancer histology were independently associated with survival, whereas history of prior cancer was not.
“As significant health and socioeconomic inequalities have previously been identified for cancer survivors, to remedy this one by providing equal access to clinical trials seems both sensible and fair,” Smyth and colleagues wrote. – by Ryan McDonald
Disclosure: The researchers report no relevant financial disclosures.