Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer
(adenocarcinoma, large cell, squamous cell, or mixture) Stage IIIB due to any of the
following: Malignant pleural effusion Supraclavicular node involvement Contralateral hilar
node involvement Not eligible for CALGB protocols of combined therapy and chest
irradiation Stage IV Any stage that has recurred or progressed after surgery or
radiotherapy Measurable or evaluable disease Does not include the following: Bone
metastases Pleural or peritoneal effusions Irradiated lesions, unless progression
documented after radiation therapy No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times the upper limit
of normal (ULN) Renal: Creatinine no greater than 2 times ULN Other: No prior or
concurrent malignancy except: Curatively treated carcinoma in situ of the cervix
Curatively treated breast cancer Curatively treated basal cell or squamous cell skin
cancer At least 5 years since any nonrecurrent primary tumor surgically resected without
administration of adjuvant radiation therapy or chemotherapy HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones
except steroids for adrenal failure, hormones for nondisease related conditions (e.g.,
insulin for diabetes), or dexamethasone Radiotherapy: At least 2 weeks since prior
radiotherapy See Disease Characteristics Surgery: Prior surgery allowed See Disease
Characteristics