Chemotherapy in non-small cell lung cancerBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7025.248c (Published 27 January 1996) Cite this as: BMJ 1996;312:248
Large trial will reduce uncertainty
- R J Stephens,
- M K B Parmar,
- R L Souhami,
- S Spiro
- On behalf of the steering committee of the big lung trial Statistician Statistician MRC Cancer Trials Office, Cambridge CB2 2BW
- Professor of clinical oncology Department of Oncology, University College London Medical School, Middlesex Hospital, London W1N 8AA
- Clinical director of medicine University College London Hospitals, Middlesex Hospital
EDITOR,—The recent meta-analysis of the role of chemotherapy in non-small cell lung cancer suggests that treatments containing cisplatin improved survival.1 The effect of chemotherapy seemed to be consistent across all subgroups (stage of disease, age, sex, performance status, and tumour histology). Because of the heterogeneity of the treatments used in the various trials, however, it was not possible to recommend a particular chemotherapy regimen or to be certain of the size of the benefit. Most importantly, it was not possible to state reliably whether a short course of a widely used cisplatin based treatment would improve survival, or by how much. The economic aspects and quality of life were also not addressed, for obvious reasons.
Considerable doubt therefore remains over the usefulness of combination chemotherapy in non-small cell lung cancer. To answer these questions we have designed a large randomised trial to compare chemotherapy with no chemotherapy in each of the four settings studied in the meta-analysis (surgery, surgery plus radiotherapy, radical radiotherapy, and supportive care). The recommended chemotherapy regimen is three cycles of either mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin.
Nine thousand patients will be required for the trial to give a reliable and clinically relevant result. Potentially all patients with non-small cell lung cancer will be eligible. Similar large trials have been conducted in breast and ovarian cancer, with considerable success. The “big lung trial” will be the first large scale randomised trial to ask this basic but important question about the treatment of this major disease.