New Tool Improves Participation in Mesothelioma Clinical Trials
Researchers in the United Kingdom devised a novel screening tool to better identify patients who will benefit the most from mesothelioma clinical trials.
The mesothelioma-specific tool should aid in the selection of suitable patients and minimize the inclusion of those who are unlikely to gain from a particular clinical trial.
Research was based on the analysis of patients involved in 38 different phase I clinical trials between 2003 and 2015. The clinical studies division of The Royal Marsden NHS Foundation Trust conducted the research.
“The process of allocating patients to suitable trials is likely to become increasingly biology driven,” lead author Dionysis Papadatos-Pastos wrote in the European Journal of Cancer. “A mesothelioma-specific, validated prognostic tool such as [the one] developed in this study, will aid in the optimal selection of patients.”
The program is based on three determining factors:
- Level of a blood protein called albumin
- Number of disease sites (including lymph nodes as a single site)
- Ratio of neutrophil to lymphocyte, which helps measure systemic inflammation
Each of the measurements has been used individually as a prognosticator of overall mesothelioma survival, but never as a combination to form a prognostic score involving clinical trials.
Benefit of Clinical Trials Can Vary Greatly
All three factors were assessed at the start of treatment and often reflect the disease state of an individual patient.
Researchers retrospectively measured the scores of 65 patients involved in the phase I trials and divided them into two classifications.
The first group with the lower scores had a median overall survival rate of 13.4 months.
None of the patients died within 90 days after their trials started.
The second group had an overall survival rate of just four months, and 10 of the 30 patients died within the 90-day window.
An estimated prognosis of at least three months is often a mandatory entry criterion in clinical trials. Identifying those patients beforehand would benefit all.
Of the 65 patients used in the study, 64 received at least one line of chemotherapy before their trial began, using the trial as potential second-line treatment.
The overall and progression-free survival median of all patients was eight months and 2.5 months, respectively.
Clinical Trial Participants Are Not Always Easy to Find
Enrolling enough patients in a clinical trial to make it meaningful is often difficult, which can lead to researchers lowering acceptance criteria.
Most patients involved in the clinical trials had few or no serious side effects and showed signs of some anti-tumor activity. Researchers believe this staging tool will lead to better selection.
The main objective of phase I trials is assessment of tolerability and safety, along with establishing recommended dosage levels for phase II.
Researchers believe this prognostic tool will become even more important in the future, improving the number of patients who benefit from molecular targeting agents used in clinical trials.
They also believe it will aid in the matching of mesothelioma patients with novel treatments and optimize the benefits of phase I trials.
“This scoring system now needs to be prospectively validated to serve as a clinical tool to aid in the selection of patients referred for participation in clinical trials,” Papadatos-Pastos wrote. “It also could be used as a prognostic tool in other treatment settings.”