A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer

Abstract

Background: Since lobaplatin (LBP) has been approved to treat metastatic breast cancer in China, this study aimed to evaluate the safety and efficacy of LBP-based chemotherapy in clinical practice. Methods: This trial was a prospective, open-label, multicenter phase IV clinical trial that enrolled patients with unresectable locally advanced or recurrent/metastatic breast cancer from 34 sites between July 2013 and March 2017. Patients were treated with LBP monotherapy or in combination for four to six cycles. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Results: A total of 1179 patients were analyzed; 59 (5.0%) were treated with LBP alone, 134 (11.4%) with LBP plus paclitaxel, 263 (22.3%) with LBP plus docetaxel, 237 (20.1%) with LBP plus gemcitabine, 403 (34.2%) with LBP plus vinorelbine, and 83 (7.0%) with other LBP-based regimens. The overall incidence of adverse events (AEs) was 95.2%, and 57.9% of patients had grade >3 AEs. The most common grade >3 AEs were neutropenia (43.9%), leukopenia (39.4%), anemia (17.8%), and thrombopenia (17.7%). LBP monotherapy showed the lowest incidence of grade >3 AEs (39.0%), followed by LBP plus docetaxel (52.9%), LBP plus paclitaxel (59.0%), LBP plus vinorelbine (62.5%), and LBP plus gemcitabine (62.9%). The ORR and DCR were 36.8 and 77.0%, respectively. The median PFS was 5.5 months (95% confidence interval: 5.2–5.9). Conclusion: LBP-based chemotherapy shows favorable efficacy in patients with advanced breast cancer, with manageable safety profile. Trial registration: This trial was registered with ChiCTR.org.cn, ChiCTR-ONC-13003471.

Safety and efficacy of anlotinib combined with taxane and lobaplatin in neoadjuvant treatment of clinical stage II/III triple-negative breast cancer in China (the neoALTAL trial): a single-arm, phase 2 trial

“…A phase IV clinical trial involving 1179 patients showed that the LBP-based chemotherapy had good efficacy and manageable toxicity in the treatment of advanced breast cancer. 5 Among the different chemotherapy regimens, such as LBP plus paclitaxel, LBP plus docetaxel, LBP plus gemcitabine, LBP plus vinorelbine, and other LBP-based regimens, LBP plus taxanes showed the highest ORR and DCR (LBP plus docetaxel: 51.7% and 84.6%; LBP plus paclitaxel: 49.6% and 85.6%). 5 In a phase III trial involving locoregionally advanced nasopharyngeal carcinoma patients, LBP-based induction chemotherapy combined with concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy.…”

“… 5 Among the different chemotherapy regimens, such as LBP plus paclitaxel, LBP plus docetaxel, LBP plus gemcitabine, LBP plus vinorelbine, and other LBP-based regimens, LBP plus taxanes showed the highest ORR and DCR (LBP plus docetaxel: 51.7% and 84.6%; LBP plus paclitaxel: 49.6% and 85.6%). 5 In a phase III trial involving locoregionally advanced nasopharyngeal carcinoma patients, LBP-based induction chemotherapy combined with concurrent chemoradiotherapy resulted in non-inferior survival and fewer toxic effects than cisplatin-based therapy. 6 In addition, a phase II randomized controlled clinical study of our group showed that neoadjuvant therapy with LBP can improve the pCR and ORR rates of TNBC, with tolerable side effects and a trend towards improving long-term survival.…”