Abstract 261P
Background
The addition of Carboplatin to standard chemotherapy for TNBC improves pCR and EFS but increases toxicity and reduces the delivery of all planned cycles. ddDCEP was designed to allow equal delivery of all the effective chemotherapy. Alternating use of non-cross-resistant chemotherapy with non-overlapping toxicity may improve treatment compliance and outcomes.
Methods
TNBC stage II/III were treated with Docetaxel 75mg/m2 and Cyclophosphamide 600 mg/m2 alternating with Epirubicin 90mg/m2 and Cisplatin 60mg/m2 every 2 weeks. In this early analysis, we report the pathological response, toxicity, completion rate of planned therapy, and event-free survival. All patients were treated using Indian made generics.
Results
116 women with high risk TNBC received ddDCEP. Median age was 44.5 years. 56.1% had stage III disease. Overall pCR (ypT0/Tis N0) was 55.2%(58 of 105 evaluable patients). pCR among stage II was 59.52% and stage III was 47.36%. Seven patients(stage II) had lumpectomy before NACT and were therefore excluded from pCR analysis. One patient refused surgery, 2 were operated at another center and 1 patient died before surgery. 60% of patients had breast-only pCR(ypT0/Tis). Good partial responses (Miller Payne 3,4) were observed in 31.7% of patients. Delivery of 6/8 planned doses was achieved in 98.3% of patients, and all 8 doses in 86%. Toxicity is detailed in the table. Blood transfusion was required prior to chemotherapy cycles in 39.8% of patients. ddDCEP produced low rates of gr 3/4 neuropathy, thrombocytopenia, and acute kidney injury as compared to published carboplatin/paclitaxel containing regimens. Median follow up currently is 13 months. 3 patients have recurred in the CNS, 2 have died. Table: 261P
| Adverse event | Grade 1/2 N (%) | Grade 3 N (%) | Grade 4 N (%) |
| Anemia | 55(47.4%) | 40(34.5%) | - |
| Thrombocytopenia | 64(55.2%) | 8(6.9%) | 2(1.7%) |
| Neutropenia | 22(18.9%) | 7(6%) | 12(10.3%) |
| Febrile neutropenia | - | 4(3.4%) | 1(0.9%) |
| Acute kidney injury | 9(7.8%) | - | - |
| Nausea and vomiting | 27(23.3%) | 3(2.6%) | - |
| Myalgia | 9(7.7%) | 1(0.9%) | - |
| Peripheral neuropathy | 7(6%) | - | - |
Conclusions
ddDCEP results in a high pCR rate of 55.2% and is well tolerated. This regimen allows equal and higher delivery of all important chemotherapy agents. Compared to Carboplatin containing regimens, ddDCEP reduces hospital visits, duration of treatment and the incidence of neuropathy, and thrombocytopenia.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Institutional Review Board of Christian Medical College Vellore, India.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.