LONDON, UK—Preliminary results of the Big Lung Trial in a supportive care setting found chemotherapy improved survival of patients with non-small-cell lung cancer (NSCLC) without diminishing their quality of life, according to a report presented by R.J. Stephens, MD, representing the CRC and UCL Cancer Trials Centre, London (ASCO abstract 1161).
"The [prior] meta-analysis included many small trials that used different measurements, different eligibility, and gave minimum information about toxicity and treatment-related deaths and no information at all about quality of life or health economics," Dr. Stephens said.
The aim of the Big Lung Trial was to conduct a single large, multicenter, randomized trial to determine the role of short-term cisplatin(Drug information on cisplatin)-based chemotherapy for all patients with NSCLC. Dr. Stephens reported on preliminary results for patients in a supportive care setting.
Broadly Inclusive Study
Investigators decided to be as inclusive as possible. The only eligibility criterion was having been recently diagnosed with NSCLC, at a time that was relatively late to consider chemotherapy or when there was uncertainty on the part of the patient or physician about the value of chemotherapy. Following primary treatment, which could include surgery, radical radiotherapy, or best supportive care, patients were randomized into two cohorts: chemotherapy or no chemotherapy.
"The design also allowed some flexibility in the choice of regimen," Dr. Stephens said. "Initially three regimens commonly used in the UK were permitted. But about half way through the trial, as new drugs became available, there was pressure to increase the choices."
The trial management group developed criteria for types of chemotherapy that would be allowed, such as evidence from a large, randomized trial that the new regimen was at least as good as the ones being used. At that time, NP (vinorelbine [Navelbine]/cisplatin [Platinol]) was added to the three existing regimens, which were CV (cisplatin/vindesine), MIC (mitomycin [Mutamycin]/ifosfamide [Ifex]/cisplatin) and MVP (mitomycin/vinblastine/cisplatin).
