Abstract P5-15-04: The PROCEED trial KCSG BR11-01 phase III multicenter randomized open-label study of irinotecan plus capecitabine versus capecitabine in patients previously treated with anthracycline and taxane for HER2 negative metastatic breast cancer
Authors: Park IH , Im S-A , Jung KH , Sohn JH , Park YH , Park K-H , Nam B-H , Kim JH , Kim H-J , Lee S , Kim T-Y , Lee K-H , Kim S-B , Lee KS , Ro J 
Published: March 2017

Abstract
Purpose
We investigated whether the combination of irinotecan plus capecitabine improved progression free survival (PFS) compared with capecitabine alone in patients with HER2 negative MBC previously exposed to anthracyclines and taxanes.
Patients and methods
A total of 211 patients were randomly assigned to irinotecan (80mg/m2 on D1 and D8) and capecitabine (1,000mg/m2 bid on D1 to D14) or capecitabine alone (1,250mg/m2 bid on D1 to D14) every 3 weeks. The primary objective was PFS; secondary objectives included overall response rate, overall survival and safety.
Results
Both arms were well balanced in terms of age, hormone receptor status, visceral involvement, and number of previous treatment. There was no significant difference in PFS between the combination and capecitabine monotherapy arm (median, 6.6 vs. 5.3 months; HR=0.87; 95% CI, 0.65 to 1.16; P=0.33). In patients with triple negative breast cancer (N=87), the combination treatment significantly improved PFS (median, 4.8 vs. 2.8 months; HR=0.59 ; 95% CI, 0.37 to 0.94; P=0.03). Overall response rate was higher in the combination arm though it did not reach statistical significance (42.7% vs. 29.6%, P=0.06). Overall survival did not differ between two groups (median, 2.2 vs. 1.7 years; P=0.47). Grade 3 or 4 neutropenia occurred in 39.6% in the combination arm and 10% in the monotherapy arm. Hand-foot syndrome (≥ grade 2) was more common in the monotherapy arm (23.0% vs. 12.6%).
Table 1. Patient characteristics IX(N=111)X(N=100)p-valueAge (yr, median, range)50 (29-73)49 (30-80)0.47ECOG 0.80025 (22.5%)22 (22%) 185 (76.6%)76 (76%) 21 (0.9%)2 (2%) Pre-menopause28 (25.2%)29 (29%)0.64Post-menopause83 (74.8%)71 (71%) ER/PgR 0.16positive60 (54.1%)64 (64%) negative51 (45.9%)36 (36%) Adjuvant Chemotherapy86 (77.5%)72 (72%)0.43Adjuvant Endocrine46 (41.4%)39 (39%)0.78Visceral meta 1.0yes64 (57.7%)58 (58%) no47 (42.3%)42 (42%) Previous Chemotherapy 0.40012 (10.8%)12 (12%) 160 (54.1%)46 (46%) 232 (28.8%)34 (34%) 35 (4.5%)8 (8%) 42 (1.8%)0 IX, irinotecan plus capecitabine; X, capecitabine.
Conclusions
Irinotecan plus capecitabine did not demonstrate superior clinical activity in heavily treated HER2 negative MBC patients. The role of adding irinotecan to capecitabine in triple negative breast cancer remains to be elucidated.
Citation Format: Park IH, Im S-A, Jung KH, Sohn JH, Park YH, Park K-H, Nam B-H, Kim JH, Kim H-J, Lee S, Kim T-Y, Lee K-H, Kim S-B, Lee KS, Ro J. The PROCEED trial KCSG BR11-01 phase III multicenter randomized open-label study of irinotecan plus capecitabine versus capecitabine in patients previously treated with anthracycline and taxane for HER2 negative metastatic breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-15-04.