There is no efficacy data available for VIDE induction alone as outcomes have only been assessed as part of the complete treatment regimen (VIDE induction followed by local treatment and VAC or VAI).
After a median follow-up of 5.9 years, the 3-year EFS was 75.4% with VAC and 78.2% with VAI. The VAC arm was statistically non- inferior to VAI in terms of EFS (HR 1.12; 91.4% CI 0.89 to 1.41) and OS (HR 1.09; 91.4% CI 0.84 to 1.42).r Considering the different types of events, HR for local recurrence was 1.0 (95% CI 0.69 to 1.46), HR for secondary metastases without local recurrence was 1.30 (95% CI 0.88 to 1.92), and HR for secondary malignancy was 0.69 (95% CI 0.23 to 2.07). 3-year EFS was 75.4% and 78.2% for VAC and VAI respectively. In the planned subgroup analysis, there was suggestion of an interaction between treatment and gender (p=0.083) with VAC being slightly less efficacious than VAI in men (HR 1.34; 95% CI 0.96 to 1.86). This effect was explored further in a subsequent analysis (see below).
Kaplan-Meier graph of event free survival (A) and overall survival (B)r
© Journal Clinical Oncology 2014
Gender and treatment choicer
In a later analysis, the impact of gender on treatment effect and acute toxicity following consolidation chemotherapy with VAC or VAI was examined. Multivariate analysis performed with respect to primary end-point EFS demonstrated a marginal interaction between gender and alkylating agent used (p=0.058). Treatment with VAC resulted in a poorer outcome than VAI for males, HR (VAC/VAI) = 1.37 (95% CI 0.98 – 1.90) compared with HR = 0.81 (95% CI 0.53 – 1.24) in females.
Kaplan Meier curves for unadjusted event free survival by gender and treatment group
© European Journal of Cancer 2015