Table 1.
Recent clinical studies conducted within the past 5 years on treatment with apatinib or vinorelbine in patients with TNBC pretreated with chemotherapy or radiotherapy
| Study | Design | Subjects | Assignment | Treatment | Outcome measures | Conclusion |
|---|---|---|---|---|---|---|
| Treatment with apatinib | ||||||
| Hu et al. [13] | Phase II cohort study | 84 patients previously treated with anthracycline and/or taxane: 25 in phase IIa trial: 59 in phase IIb trial | – |
Phase IIa trial: apatinib, daily dose of 750 mg Phase IIb trial: apatinib, daily dose of 500 mg |
ORR and CBR were 10.7% and 25.0%, respectively. Median PFS and OS were 3.3 and 10.6 months, respectively | An apatinib dose of 500 mg rather than 750 mg is the recommended starting dose for heavily pretreated patients with mTNBC with a measurable rate of partial response and PFS |
| Li et al. [22] | Retrospective analysis | 44 patients with advanced TNBC with failed first-line or second-line therapy | Apatinib + capecitabine or capecitabine alone | Apatinib (500 mg) was orally administered daily on days 1–28 of each 4-week cycle and/or capecitabine (12,500 mg/m2) was orally taken twice daily for 14 days followed by a 7-day rest period until disease progression |
PFS, ORR (CR + PR), DCR (CR + PR + SD), and toxicity For apatinib + capecitabine or capecitabine alone: PFS, 5.5, 3.5 months; ORR, 40.9%, 13.4%; DCR, 68.2%, 31.8% |
Treatment with a combination of apatinib and capecitabine can achieve a better efficacy and similar rate of serious adverse events compared with capecitabine alone, as the third-line treatment for advanced TNBC |
| Hu et al. [26] | Case report | A female patient with stage IV TNBC. She had previously undergone whole-brain radiation therapy. Paclitaxel, platinum, UTD1, capecitabine, gemcitabine, vinorelbine, and single-agent apatinib were then administered as first-line to fifth-line therapies | – | Treatment with apatinib + CPT-11 + S-1 as the sixth-line therapy | Alleviation of the brain edema was achieved, and this was maintained for 7 months | Apatinib in combination with CPT-11 + S-1 to treat refractory BMs in a patient with TNBC |
| Zhou et al. [27] | Case report | A female patient with triple-negative spindle cell carcinoma | – | After treatment failure with bevacizumab combined with albumin-bound paclitaxel and cisplatin, the patient was treated with apatinib | Apatinib was more effective than bevacizumab for this patient | Apatinib is a safe and effective drug for treating advanced spindle cell breast carcinoma, especially in patients who have a prior experience of chemotherapy failure, or a poor physical condition |
| Treatment with vinorelbine | ||||||
| Rodler et al. [20] | Phase I cohort study | 50 patients with advanced TNBC | – | A 3 + 3 dose escalation design evaluated veliparib and vinorelbine, followed by veliparib monotherapy | Median PFS in 50 patients was 5.5 months | Veliparib (300 mg, twice daily) combined with cisplatin and vinorelbine is well-tolerated with encouraging response rates |
| Zhang et al. [21] | Prospective cohort study | 44 patients with metastatic TNBC pretreated with anthracyclines and/or taxanes | – | Biweekly combination of vinorelbine and oxaliplatin (NVBOX) | ORR 31.6%, median PFS 4.3 months, OS 12.6 months | A biweekly NVBOX regimen is effective and well-tolerated as a second-line or third-line treatment for patients with mTNBC |
| Wang et al. [23] | Retrospective analysis | 48 female patients with TNBC | – | Patients were given vinorelbine plus cisplatin (NP group, n = 22) or gemcitabine plus cisplatin (GP group, n = 26) |
The ORR, DCR, and median TTP were 45.5%, 77.3%, and 5 months, respectively, in the NP group, and 46.2%, 80.8%, and 5.2 months, respectively, in the GP group A lower incidence of thrombocytopenia and rash, and a higher incidence of phlebitis was found in the NP group compared to the GP group |
Both the NP and GP regimens are active and tolerated in cases of metastatic TNBC with anthracycline and/or taxane resistance. These regimens may be used as a salvage treatment for metastatic TNBC |
| Du et al. [24] | Retrospective analysis | 48 patients with metastatic TNBC pretreated with anthracyclines and one taxane | – | 22 patients were treated with vinorelbine plus platinum (NP), and 26 patients with vinorelbine plus capecitabine (NX) |
Total: ORR, 20.8%; CBR, 43.8%; median PFS, 4.4 months; median OS, 15.5 months ORR and PFS were better in the NP arm versus NX |
Vinorelbine-based combination chemotherapy shows moderate efficacy in the treatment of metastatic TNBC, and has manageable toxicity. The NP regimen shows potential superiority over the NX regimen. |
| Li et al. [25] | Retrospective analysis | 41 patients with advanced TNBC (pretreated with anthracyclines and/or taxanes, before or after surgery) in whom disease progressed after a certain period of time | – | Treatment with vinorelbine plus platinum (NP) regimen | ORR, 34.1%; CR, 7.3%; partial response, 26.8%; stable disease, 34.1%; median OS, 18.9 months; PFS, 6.7 months | The NP regimen showed clinical activity in patients with metastatic TNBC, and the toxicity was acceptable and manageable |
PFS median progression-free survival, ORR objective response rate, DCR disease control rate, BM brain metastasis, TNBC triple-negative breast cancer, CBR clinical benefit rate, OS overall survival, CR complete response, PR partial response, SD stable disease, TTP time to progression