Comparison between standard dose 75mg/m2 and fixed dose at 50mg of cisplatin in the treatment of non-small cell lung cancer patients in term of response rate and toxicity profile

BackgroundEGFR and ALK-negative non-small cell lung cancer (NSCLC) is treated by a platinum doublet chemotherapy in combination with paclitaxel, gemcitabine, pemetrexed or vinorelbine. Cisplatin can be nephrotoxic in standard doses in elderly patients.MethodsA phase II randomized clinical trial where we have recruited 120 patients with NSCLC randomly assigned into two groups in 1:1 model. 88 patients presented with stage IIIB disease while the remaining 32 patients with stage IV disease. Patients aged between 60-85 years (67 years in median). Group I included 60 patients who received cisplatin at a dose of 75mg/m2 and oral vinorelbine 80mg/m2 on weeks 1, 2 of a 21-day cycle in patients with adenocarcinoma and gemcitabine 1g/m2 on days 1, 8 in patients with squamous cell carcinoma. Group II included 60 who patients received cisplatin at a fixed dose of 50mg repeated every 14 days in a 28-day cycle plus vinorelbine in adenocarcinoma patients and gemcitabine in squamous cell carcinoma patients with the same schedule as group I. Patients received 3 cycles each in both groups and were evaluated with CT scan; responders continued the same protocol until progression or toxicity.ResultsThere was no complete responder in both groups. In group I, 33 patients demonstrated objective response 55% (95% CI: 47.4-61.2) versus 32 patients in group II 53.3% (95% CI: 46.6-58.3) (HR is 0.99, 95% CI:0.96-1.12) p value (0.05). CDDP at a fixed dose of 50mg is comparable to standard dose in term of response rate. Toxicity profile included nephrotoxicity which was documented more frequently in group I (20% versus 2% in group II (p value 0.004). hematologic toxicity such as neutropenia and anemia were more frequent in group I as well. In multivariate analysis, factor associated with better response was non-respiratory symptomatic patients at diagnosis, odds ratio 1.23 (95% CI:1.12-1.35). in univariate analysis, decreased platelet count during therapy was correlated with poor response in both groups, odds ratio 1.22 (95% CI: 1.08-1.33).ConclusionsCisplatin at low dose is more safe and comparable to the standard dose in term of objective response in patients with NSCLC treated with chemo-based platinum doublet with good toxicity profile.Legal entity responsible for the studyThe author.FundingHas not received any funding.DisclosureThe author has declared no conflicts of interest.