Background
Phase III RCT, N=204, metastatic NSCLC progressing on ≥1 prior platinum-based regimen (1 prior 74%, 2 prior 14%, ≥3 prior 11%).
Interventions and follow up
Arm A: Docetaxel 75 mg/m2 q3wk
Arm B: Docetaxel 100 mg/m2 q3wk
Arm C: Best supportive care
Primary endpoint: OS
Arm B: Docetaxel 100 mg/m2 q3wk
Arm C: Best supportive care
Primary endpoint: OS
Results
mPFS (docetaxel vs BSC): 10.6 vs 6.7 weeks; P<.001
mOS (A vs B vs C): 7.5 vs 5.9 vs 4.6 mo; P=.01 for A vs C, P=.78 for B vs C
1-yr OS (A vs B vs C): 37% vs 19% vs 19%
mOS (A vs B vs C): 7.5 vs 5.9 vs 4.6 mo; P=.01 for A vs C, P=.78 for B vs C
1-yr OS (A vs B vs C): 37% vs 19% vs 19%
Adverse events
Hematologic: delayed myelosuppression; febrile neutropenia higher at 100 mg/m2
Dermatologic: maculopapular rash, hand-foot syndrome, nail changes
GI: mild nausea/vomiting
Other: fluid retention (premedicate with dexamethasone); minimal neurotoxicity
Dermatologic: maculopapular rash, hand-foot syndrome, nail changes
GI: mild nausea/vomiting
Other: fluid retention (premedicate with dexamethasone); minimal neurotoxicity
Conclusions
Docetaxel 75 mg/m2 (but not 100 mg/m2) improved survival and quality of life vs best supportive care, establishing it as the standard second-line agent for NSCLC.
Key Limitations
Small sample; 100 mg/m2 arm showed no OS benefit with more toxicity. Predates targeted therapy and immunotherapy era; the comparator (BSC) and prior-treatment landscape no longer reflect modern practice.
Clinical Context
Established docetaxel 75 mg/m2 as the historical second-line standard for NSCLC; FDA approved in this setting. In current ESMO practice, docetaxel (often with ramucirumab or nintedanib) is reserved for after first-line chemo-immunotherapy has been exhausted.