A prospective, open-label, multicenter, phase IV clinical study on the safety and efficacy of lobaplatin in the treatment of metastatic breast cancer.

Abstract

e13062 Background: Platinum-based chemotherapy is an important treatment for anthracycline- and taxane-resistant metastatic breast cancer(MBC), especially for triple-negative breast cancer(TNBC). Here, we presented the results of a phase IV clinical study of the third-generation platinum compound lobaplatin (LBP) in the treatment of MBC. Methods: Patients(Pts) diagnosed with MBC who had previously received chemotherapies containing anthracycline and/or taxane were recruited. The chemotherapy regimen was decided by the investigator but must include LBP. The primary endpoint was safety, the secondary study endpoints included PFS, OS, ORR, and DCR. Results: 1181 pts were enrolled from 34 research centers, 252 pts of them were TNBC. The main treatment regimens included LBP plus paclitaxel (134, 11.4%), LBP plus docetaxel(263,22.3%), LBP plus gemcitabine(235,19.9%) and LBP plus vinorelbine (404, 34.3%).The overall incidence of AE and grade III/IV(G3-4) incidence of AE were 95.00% and 58.10%, respectively. The most common AE were leukopenia (79.9%, G3-4: 39.5%), neutropenia(75.4%, G3-4: 43.8%), anemia(67.4%, G3-4: 17.8%), and thrombocytopenia(51.1%, G3-4: 17.8%). Creatinine clearance rate (Ccr) was the main influence factor for thrombocytopenia, the incidence of G3-4 thrombocytopenia in pts with Ccr < 60 ml/min were higher than that in pts with Ccr≥60 ml/min. Median follow-up was 36 months. The ORR and DCR were 36.8% and 76.9%, respectively. The mPFS and mOS were 5.5 months and 15.4 months, respectively. The efficacy of LBP combined with taxanes was significantly better than that of other regimens. Different sites of metastasis, ECOG score, clinical stage and age were the main factors influencing for efficacy. Conclusions: LBP-based regimens are effective and safe, and these regimens provide an alternatively treatment option for Chinese MBC pts. Clinical trial information: ChiCTR-ONC-13003471. Clinical trial information: ChiCTR-ONC-13003471 .