A. Goraya (Lahore, Pakistan)
Mayo HospitalAuthor Of 1 Presentation
105P - A comparative study of Cisplatin plus Adriamycin compared with Cyclophosphamide plus Adriamycin in patients with untreated metastatic triple negative Breast Cancer (TNBC)
Abstract
Background
Incidence of TNBC is much higher in developing countries like Pakistan. Although, new drugs like PARP inhibitors, Atezolizumab plus nab Paclitaxel, ipatisertib and Sacituzumab Govitecan are approved in metastatic TNBC, these are expensive and not readily available rendering chemotherapy remains main stay of treatment. BRCA mutations are often present in TNBC and Platinum drugs have shown their efficacy in BRCA mutated breast cancer. This study is aimed to look for response of platinum containing doublet in metastatic TNBC with unknown BRCA status as it’s cheaper and easily available.
Methods
A total of 290 patients (145 in each arm) of symptomatic metastatic TNBC were randomized in 2 groups.Group A received Adriamycin (60mg/m2) plus Cisplatin (75mg/m2) while Group B received Adriamycin (60mg/m2) plus Cyclophosphamide (600mg/m2) on day 1 of 21 days cycle for a total of 4 cycles. Response was assessed using RECIST criteria v.1.01. National Cancer Institute Common Toxicity Criteria version 4.03 (CTCAE) was used to document toxicities.Health related quality of life was determined using EORTC QLQ- C30 with a minimum decrease of ≥ 10 points considered significant. Data was analyzed using spss version 23. The quantitative variables were presented as mean ±SD while qualitative variables like tumor response as percentage and frequency. Independent sample t test with confidence interval of 95% was used for comparison between groups and p value of < 0.05 taken as significant.
Results
In group A, 33(22.8%) and 67(46.2%) showed complete and partial response respectively while stable and progressive disease was noted in 25(17.2%) and 20(13.8%). In group B, 23(15.9%) had complete response while 66(45.5%), 41(28.3%) and 15(10.3%), showed partial response, stable and progressive disease respectively (p=0.094) ORR between groups was 69.0% vs.61.4%.More grade ¾ neuropathy (p=0.004) and nephropathy (p=0.00007) was seen in group A. Quality of life was comparable in both groups(p=0.540).
Conclusions
No statistically significant difference in ORR seen in both groups. However, more Complete response was achieved in group A but at expense of more grade ¾ neuropathy and nephropathy.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.