A Comparative Study of Cisplatin Plus Adriamycin Compared with Cyclophosphamide Plus Adriamycin in Patients with Untreated Metastatic TNBC

Abstract

Objective: To look for the response of platinum agents in BRCA unknown TNBC patients as it is a cheaper drug and readily available.
Material and Methods: This study was comparative, conducted in department of Medical Oncology and Radiotherapy from May 2019 to Februaray 2021 in which a total of 290 (145 in each arm) patients of metastatic TNBC were enrolled. A total of 290 patients (145 in each arm) of symptomatic metastatic TNBC were randomized into 2 groups. Group A received Adriamycin (60mg/m²) plus Cisplatin (75mg/m²) while GroupBreceivedAdriamycin (60mg/m²) plus Cyclophosphamide (600mg/m²) on day 1 of 21 days cycle for a total of 4 cycles. The 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. An Independent sample t-test with a confidence interval of 95% was used for comparison between groups and a p-value of < 0.05 was taken as significant.
Results: In group A, 33(22.8%) and 67(46.2%) showed complete and partial responses 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 noted between two treatment arms but patients in the Cisplatin arm experienced more neuropathy and nephropathy.