Patient accrual into chemotherapy trials in non-small cell lung cancer
- Department of Oncology
- University of Edinburgh
- Western General Hospital
- Crewe Road
- Edinburgh, EH4 2XU, UK
- email A.Price@ed.ac.uk
In this edition of Thorax Spiro and colleagues1 report their perceived failure to recruit patients to the Big Lung trial (BLT). It is appropriate to consider why only 9% of eligible patients entered the trial and what impact this has on this important study.
BLT addresses the role of cisplatin-based combination chemotherapy in non-small cell lung cancer (NSCLC). This is not a trivial regime in a patient group with a median age of 67 years, many of whom will have major vascular co-morbidities. That fewer than one sixth of patients were deemed ineligible for these reasons is surprising. It is also noteworthy that 12% of patients had elective chemotherapy—presumably all with inoperable disease since there is no current evidence to justify routine postoperative adjuvant therapy. It is disappointing, but hardly surprising in the current UK research environment with its dependence on the pharmaceutical industry, that 13% of patients were treated in centres without the infrastructure for clinical research. It would be interesting to know how many of the 52 patients too late for consideration were postoperative referrals. It has been our experience, which is reflected in the poor accrual of subjects for LU22 (the MRC neoadjuvant chemotherapy trial), that it is extremely difficult to access patients fast tracked through surgery to discuss randomisation for chemotherapy trials.
Thus, the reality of this “failure” is that one quarter of eligible patients entered this study. How does this compare with other studies, particularly those with “no treatment” control arms? The authors compare their achievement unfavourably with …