Double-blind randomized study on the myeloprotective effect of melatonin in combination with carboplatin and etoposide in advanced lung cancer

A significant myeloprotective effect of melatonin in mice treated with etop oside, cyclophosphamide or carboplatin has been reported. The present study was designed to evaluate if the same effect could be observed in patients receiving chemotherapy Twenty previously untreated patients with inoperable lung cancer received two cycles of carboplatin (given at area under the cu rve 5 by the Calvert formula) on day 1 and etoposide (150 mg m(-2) i.v.) on days 1-3 every 4 weeks. Melatonin 40 mg or placebo (double-blind) was give n orally in the evening for 21 consecutive days, starting 2 days before che motherapy. Patients were randomized to receive melatonin either with the fi rst or the second cycle. Complete blood cell count with differential was do ne three times per week for 3 weeks. The median age of the cohort was 60 ye ars (range 42-69), 16 patients had non-small cell and four patients small-c ell lung cancer, 12 stage III and eight stage IV disease. In a multivariate analysis including age, sex, diagnosis, stage, performance status, doses o f carboplatin and etoposide, and concomitant treatment with melatonin or pl acebo, the haematological parameters - depth and duration of toxicity for h aemoglobin, platelets and neutrophils (ANC) - were not significantly differ ent between cycles with/without melatonin. The mean ANC nadir and the mean number of days with ANC < 0.5 x 10(9) l(-1) were 0.5 x 10(9) l(-1) and 2.5 days, respectively, with/without melatonin. We concluded that, in patients with lung cancer, melatonin given orally at a dose of 40 mg per day for 21 days in the evening, does not protect against the myelotoxic effect of carb oplatin and etoposide.