Comparing The Efficacy And Safety Of Albumin-bound Paclitaxel Plus Carboplatin With Gemcitabine And Carboplatin In The Treatment Of Advanced Squamous Cell Carcinoma Of The Lung Cancer

Objective: In this study,118 cases of squamous cell carcinoma of the lung cancer have been collected and analyzed to evaluate the efficacy and toxicity of albumin-bound paclitaxel plus carboplatin and gemcitabine plus carboplatin in the treatment of patients with advanced squamous cell carcinoma of the lung cancer.Methods: From January,2013 to August,2015,118 patients with locally advanced(stage IIIB)or metastatic(stage IV)SQCLC were enrolled into this study.According to the eligible and ineligible,one hundred and eighteen patients were randomly divided into two groups(group N and group G).Sixty patients received albumin-bound paclitaxel(130mg/m2,on day 1,8)and carboplatin(AUC 5 on day 1).Meanwhile,fifty and eight patients received gemcitabine(1000 mg/m2,on day 1,8)plus carboplatin(AUC 5 on day 1).The 3 week period was defined as a cycle of therapy.Each patient received a curative effect evaluation after two cycles of therapy.In this study,109 patients can evaluated the efficacy and safety of albumin-bound paclitaxel plus carboplatin and gemcitabine plus carboplatin.The objective response rate(ORR),disease control rate(DCR),progression free survival(PFS)and overall survival(OS)in two therapies are evaluated by the Response Evaluation criteria in Solid Tumors(RECIST).The toxic effect is assessed using the National Cancer Institute Common Toxicity Criteria(NCI~CTC 3.0).The SPSS 19.0 were used to data analyses.The difference of patient baseline characteristics,objective response rate(ORR),disease control rate(DCR)and toxicity reaction between two groups were determined by Chi squared test.PFS and OS were estimated by Kaplan–Meier models.Statistical comparisons between patients were conducted with a con-sided log-rank test(significance level 10%).The hazard ratio(HR)was estimated with a Cox proportional-hazards model,with 95% confidence intervals(95% CIs)and p values.Results: 1.In this study,109 patients were eligible for efficacy evaluation.The patients who were treated with nab-Paclitaxel plus carboplatin(group N)had an objective response rate of 44.4%(24/54);the disease control rates(DCR)was 75.9%(41/54)..Meanwhile,the patients who were treated with gemcitabine plus carboplatin(group G)had an objective response rate of 25.5%(14/55);the disease control rates(DCR)was 78.2%(43/55).Our results suggested that ORR improved 18.9% in group N,compared to that in group G.However,there was no significant difference in short~term efficacy between two groups(P > 0.05).2.The median progression~free survival(PFS)was 5.6 months in group N and 4.9 months in group G.Overall survival was 11.65 months in group N and 10.65 months in group G.There was no significant difference in PFS and OS between two treatment protocols(P > 0.05).3.Kaplan–Meier models showed there was a significant difference in PFS from 3 months and 6 months of the two groups.After at least two cycles of therapy,4 cases got stable disease,26 got partial response in group N.There was no case had progressive disease in this group.While,9 cases got partial response,12 cases got stable disease,and 5 got progressive disease in group G.At the same time,there was no case had complete response in two groups.Our results showed that the PFS in group N is much better than that in group G.4.In the two groups,the main hematologic toxic effects were anemia(94.4%vs 78.2%),thrombocytopenia(27.8%vs 90.9%),and neutropenia(55.6%vs 76.4%).Thrombocytopenia in group N was significantly lower than that in G group(27.8% vs 90.9%,P = 0.013).The incidence of anemia in group N was also higher than that in group G,but neutropenia was lower than that in group G,all of them had no significant difference in the two groups(P > 0.05).Two groups had non hematology toxicity reactions,including nausea/vomiting(46.3% vs36.4 %),diarrhea(42.6% vs20 %),liver function damage(9.3% vs12.7 %)and myalgia/arthralgia(7.4%vs3.6%),peripheral nerve toxicity(20.4% vs16.3 %),all of them no significant differences between the two groups(P > 0.05);No patients in N groups received skin rash,but the incidence of skin rash was 25.5% in group G,significantly higher than in N group(0 vs 25.5%,P = 0.000),the difference is statistically significant.The majority of the AEs in group N were mild(grade 1 or 2).Conclusion:The albumin-bound paclitaxel plus carboplatin had a similar curative effect in first-line treatment of advanced lung squamous carcinoma in elderly patients,compared to the combination of gemcitabine and carboplatin group.ORR was higher with albumin-bound paclitaxel than gemcitabine.There was no survival difference between albumin-bound paclitaxel and gemcitabine.But further subgroup analysis for patient baseline characteristics in group N indicated the significantly improved ORR/DCR in an age >70 years old,stage IIIB,and PS =0 ~ 1 of patients.Patients in group N versus group G resulted in a small improvement for PFS and OS that did not reach statistical significance.In the mediastinal lymph nodes ntumescentia subset of patients treated with albumin-bound paclitaxel versus gemcitabine resulted in a significance improvement for PFS.In general,albumin-bound paclitaxel plus carboplatin was better tolerated,and the majority of the AEs were mild(grade 1 or 2).Specifically,the lower incidences of thrombocytopenia and skin rash in the albumin-bound paclitaxel arm,indicate that the albumin-bound paclitaxel plus carboplatin is a well tolerated scheme in elderly patients.Taken together,the albumin-bound paclitaxel plus carboplatin regimen has a favorable risk-benefit profile compared with that of gemcitabine plus carboplatin as first-line therapy for elderly patients with SQCLC.