Treatment of endotracheal or endobronchial obstruction by non-small cell lung cancer: Lack of patients in an MRC randomized trial leaves key questions unanswered

Symptoms of endotracheal or endobronchial obstruction caused by non-small c ell lung cancer (NSCLC) may be relieved with external beam radiotherapy (XR T) or endobronchial treatment. The comparative roles of these two methods n eed to be established. Patients with predominantly intraluminal obstruction of the trachea, a main bronchus or a lobar bronchus by unresectable NSCLC were randomized to XRT versus the clinician's choice of endobronchial treat ment with brachytherapy, laser resection or cryotherapy, according to local availability and practice. Clinicians' assessments included symptoms of ob struction, WHO performance status, lung function tests and adverse effects of treatment. Patients completed a Rotterdam Symptom Checklist at all asses sments and a daily diary card to record the severity of major symptoms duri ng the first 4 weeks. To show a difference of 15% in the relief of breathle ssness rates at 4 months (from 65% to 80%), 400 patients were required. In spite of our many previously successful lung cancer trials, and initial int erest from clinicians in 24 UK centres, who estimated they could randomize 200 patients per year into the present trial, only 75 patients were randomi zed from seven centres over 3.5 years. Intake to the trial was therefore ab andoned in November 1996 although an independent Data Monitoring and Ethics Committee had concluded in April 1996 that the scientific case for the tri al was still strong; there were no competing trials; there were no design p roblems; and much had been done to promote the trial. The main reasons give n by centres for the slow intake were: lack of referrals of untreated patie nts; patients being referred specifically for endobronchial treatment; pati ents having already received XRT; emergency endobronchial relief of obstruc tion being necessary; and XRT and endobronchial treatment being considered complementary and not as alternatives. The relative advantages and disadvan tages of XRT versus endobronchial treatment remain to be determined. The la ck of recruitment to this trial raises the issue of innovative techniques n ot being given the chance of proving their worth compared with traditional treatments.