Carboplatin-Etoposide is a 1st-line (1L) option for patients (pts) with advanced EP-PD-NEC. Schedules with oral or IV ET are used in clinical practice. Data from randomised trials are lacking.
Records of pts diagnosed with advanced EP-PD-NEC and treated with CB/oral-ET and CB/IV-ET were reviewed retrospectively (09/96-02/17). First-line survival/activity/toxicity data are reported.
One-hundred-thirteen pts were identified: median (med) follow-up was 11.5 months (m); med age was 65.8 years (range 24-88); male=64%; ECOG performance status 0-1=81%; no/mild comorbidities=81%; gastro-entero-pancreatic origin=54%; stage IV = 90% (53% liver metastases). Median Ki-67=70% (95%CI 60-80%), Ki-67>55%=59%. A total of 123 courses of CB-ET were administered: 106 (86%) 1L, 16 (13%) 2nd-line (2L) and 1 (1%) 3rd-line; med cycles/line=4; oral-ET 45%, IV-ET 55%. Median CB-ET dose-intensity (available for 82 courses): 96% (1L), 90% (2L). Median 1L-progression free survival (PFS) was 5.9m (95%CI 5.0-7.1): oral-ET 5.6m, IV-ET 6.2m, hazard ratio (HR)=0.76 (95%CI 0.51-1.14). Median 1L-overall survival (OS) was 11.5m (95%CI 8.9-13.6): oral-ET 8.9m, IV-ET 12.1m, HR = 0.68 (95%CI 0.45-1.03), p = 0.07. Radiological response (assessed for 95 pts), 1L-disease control rate was 75.8% (95%CI 67.1-84.6): oral-ET 69.8% (95%CI 55.5-84.1), IV-ET 80.8% (95%CI 69.7-91.8). Liver metastases were the only independent factor related to worse 1L-PFS on multivariable analysis, HR = 1.71 (95%CI 1.11-2.63). Commonest 1L-grade 3-4 adverse event (AE) was myelosuppression (47.2%); no significant differences between oral-ET and IV-ET AEs, except for venous thromboembolism; oral-ET 12.5%, IV-ET 1.7% (p = 0.04).
This is one of the largest series of pts with advanced EP-PD-NEC treated with CB-ET in the current literature. Oral-ET and IV-ET schedules are associated with comparable 1L-PFS/activity/toxicity data. There is a trend towards better 1L-OS for IV-ET schedules; this, however, may be driven by differences in patient selection between the two subgroups.
Clinical trial identification
Legal entity responsible for the study
The Christie NHS Foundation Trust.
Has not received any funding.
All authors have declared no conflicts of interest.