Real World Study Of Albumin Paclitaxel In The Treatment Of HER2 Negative Advanced Breast Cancer

ObjectiveBreast cancer is the most common female malignant tumor in the world,while recurrence and metastasis are the main causes of death.Albumin paclitaxel,as a new cytotoxic drug of taxane family,has been proved to be effective in the treatment of advanced breast cancer in many clinical trials.However,real-world evidence on the impact of nab-paclitaxel in the treatment of(human epidermal growth factor receptor-2,HER2)negative advanced breast cancer is still limited.Hence,this study analyzed the efficacy and safety of albumin paclitaxel in the treatment of HER2 negative advanced breast cancer in the real world of China.MethodsIn this study,the clinicopathological data of 144 patients with HER2-negative advanced breast cancer treated with albumin paclitaxel between January 2015 and December 2020 in Zhejiang Cancer Hospital were collected and analyzed.The last follow-up time to December 2021.The efficacy,safety and prognostic factors of albumin paclitaxel treatment were evaluated.SPSS 25.0 and Graphpad Prism 7.0 software were used for statistical analysisResults1.Baseline characteristics:the median age of 144 patients to receive albumin paclitaxel was 53 years(29-73 years),all were female,79 patients(54.9%)were hormone receptor positive/HER2 negative(HR+/HER2-)breast cancer,and 65 patients(45.1%)were triple negative breast cancer(TNBC).2.Efficacy and differential analysis:1 patient obtained complete response(CR),52 patients obtained partial response(PR),82 patients obtained stable disease(SD),9 patients obtained progress disease(PD),the objective response rate(ORR)was 36.8%(53/144),while the clinical benefit rate(CBR)was 66.7%(96/144).3.Survival and prognosis analysis:the median progression-free survival(PFS)was 8.3 months(95%confidence interval(CI)7.3-9.3 months),the median overall survival(OS)was 20.9 months(95%CI 15.9-25.8 months).In multivariate Cox survival analysis,no visceral metastasis(HR=0.541,95%CI:0.362-0.809,P=0.003),no previous taxane treatment history(HR=0.633,95%CI:0.401-0.999,P=0.049)and combined treatment(HR=0.597,95%CI:0.405-0.882,P=0.009)were independent protective factors for PFS,TNBC(HR=1.805,95%CI:1.241-2.624,P=0.002)and more than third-line treatment(HR=2.000,95%CI:1.3542.954,P=0.000)were independent risk factors for PFS.Multivariate COX regression analysis,TNBC(HR=1.647,95%CI:1.085-2.500,P=0.019)and more than third-line treatment(HR=1.951,95%CI:1.273-2.990,P=0.002)were independent risk factors for OS.4.Safety analysis:The most common adverse reactions of these patients were myelosuppression and peripheral sensory neuropathy,the incidence rates were 95.1%and 50.7%respectively.Other adverse reaction including hepatic dysfunction,nausea,vomit,rash,etc.The overall grade 3-4 adverse incidence was 50.0%.Among them,grade 3-4 hematological toxicity including leukocytopenia(32.0%,46/144),neutropenia(29.8%,43/144),anaemia(24.3%,40/144),thrombopenia(6.3%,9/144).Grade 3-4 non-hematological toxicity including transaminase elevation(11.8%,17/144)and peripheral sensory neuropathy(6.3%,9/144).Conclusion1.Albumin paclitaxel has excellent clinical efficacy in the treatment of HER2-negative advanced breast cancer in the real world.2.No visceral metastasis,no previous taxane treatment history and combined treatment were independent protective factors for PFS,TNBC and more than third-line treatment were independent risk factors for PFS.TNBC and more than third-line treatment were independent risk factors for OS.3.The most common adverse reactions of these patients were myelosuppression and peripheral sensory neuropathy,were well tolerated and safety.