Clinical observation of external compound Chinese herbal extract LC09 with capecitabine maintenance therapy after response to capecitabine-based combination chemotherapy in patients with metastatic breast cancer.

e12006 Background: Capecitabine(Cape) maintenance therapy after response to Cape-based combination chemotherapy(chemo) is one of the standard regimens recommended by NCCN for metastatic breast cancer(MBC) treatment. Hand-foot syndrome (HFS) induced by Cape may lead to dose modification or treatment interruption, even when the therapy may prove beneficial. The earlier-phase data of external compound Chinese herbal extract LC09 (Herba Geranii, etc.) has shown significant effective on treating HFS. This study aimed to evaluate the efficacy of LC09 with Cape maintenance therapy in MBC. Methods: MBC patients (pts) who responded to the first-line Cape-based combination chemo (docetaxel/navelbine/gemcitabine and cape, 6 cycles) were assigned to Cape maintenance therapy until disease progression or intolerable toxicity. Pts were randomly to receive LC09 and Cape (LC09 Group) versus single Cape (Control Group). Cape 1,000 mg/m2, PO, twice daily, d1-14, every 21 days. LC09 granules 10g was dissolved in 1,000ml of warm water (keep 34°C-37°C in a footbath), pts soaked their feet and hands in this lotion for 20 minutes, twice daily. The primary endpoint was progression-free survival (PFS) and secondary endpoints included HFS incidence rate, HFS NCI Grade as well as safety. Results: A total of 32 pts have been enrolled, all of them are Asian and female. The median age was 45.5yrs (range 27-70). The cycles of Cape maintenance chemo were 113 in LC09 group, 80 in control group. The LC09 group decreased the HFS incidence rate than control group (18.75% vs. 43.75%; p<0.01), and achieved longer median PFS (8.4 months vs. 7.35 months; p<0.05). NCI Grade for HFS as 1/2/3, Grade 2/1/0 in LC09 group (3/16), and 2/3/2 in control group (7/16). The cape withdrawal rate induced by HFS was 0 in LC09 group, 6.25% (1/16) in control group. Conclusions: Compound external Chinese herbal extract LC09 plus Cape maintenance therapy, could decrease the HFS incidence rate and cape withdrawal rate, and thus has shown the tendency to improve the PFS. Further research and overall survival (OS) should be observed. (Funded by No.2015BAI04B07)