To evaluate the impact of adjuvant cisplatin-vinorelbine in completely resected non-small
cell lung cancer and identify patients likely to benefit from this regimen in the
Lung Adjuvant Cisplatin Evaluation (LACE) database. The overall LACE meta-analysis
showed survival benefit with cisplatin-based adjuvant chemotherapy (5-year survival
benefit of 5.4%, hazard ratio [HR] 0.89, p = 0.004). Subgroup analysis for the cisplatin-vinorelbine
regimen was prespecified in the LACE statistical analysis plan. Patients randomized
to cisplatin-vinorelbine or observation were the largest subgroup (41%) and the most
homogeneous in terms of drug doses and eligibility.
The LACE-vinorelbine cohort included trials evaluating cisplatin-vinorelbine versus
observation. Overall survival was the primary end point. Other studies randomizing
patients to other chemotherapy or observation (LACE-other) were also evaluated.
The LACE-vinorelbine cohort included 1888 patients from four studies (Adjuvant Navelbine
International Trialist Association, Big Lung Trial, International Adjuvant Lung Cancer
Trial, and National Cancer Institute of Canada Clinical Trials Group JBR.10). Baseline
characteristics were similar to the LACE-other but had fewer patients with stage IA
(2% versus 11%). Survival improvement at 5 years was 8.9% with cisplatin-vinorelbine
versus observation (HR 0.80, 95% confidence interval: 0.70-0.91, p <0.001). Stage
was a significant predictor for survival (test for trend, p = 0.02; benefit at 5 years:
14.7% [stage III], 11.6% [stage II], and 1.8% [stage I]). Similar benefits were seen
for disease-free survival (HR 0.75 [0.67-0.85, p <0.001], stage III [HR 0.62, 0.50-0.76],
stage II [HR 0.69, 0.57-0.83], and stage I [HR 0.95, 0.767-1.19]). The overall result
was statistically superior to LACE-other (LACE other HR 0.95, 0.86-1.05, interaction
p = 0.04).
In subgroup analyses, adjuvant cisplatin-vinorelbine provides a superior survival
benefit and can be recommended in completely resected stages II and III non-small
cell lung cancer.