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
"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-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).