Elderly NSCLC/D vs DP (JCOG0207)

Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.

Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Inclusion Criteria:

1. histologically or cytologically proven non-small-cell lung cancer
2. stage IV, or stage III disease ineligible for definitive radiotherapy
3. 70 years or older
4. ECOG PS 0-1
5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7. No prior surgery within 4 weeks before enrollment
8. No prior radiotherapy for primary tumor
9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
10. Adequate organ function
11. Signed informed consent

Exclusion Criteria:

1. Symptomatic brain metastasis
2. Active another neoplasms
3. Severe SVC syndrome
4. Massive pericardial, pleural effusion, or ascites
5. Bone metastasis emergent for palliative radiotherapy or surgery
6. Uncontrollable systemic hypertension
7. Heart failure, Unstable angina, Myocardial infarction within 6 months
8. Uncontrollable diabetes
9. Active infection
10. Interstitial pneumonia/ Pulmonary fibrosis
11. Hypersensitivity for polysorbate 80
12. Systemic administration of corticosteroids