Efficacy And Safety Analysis Of Everoliums Combined Endocrine Therapy For Hormone Receptor Positive Advanced Breast Cancer

To retrospectively analyze the efficacy and toxicity of everolimus (EVE) combined with endocrine therapy in hormone receptor positive advanced breast cancer patients after adjuvant endocrine therapy or multi-line treatments.Methods:Collections of 32 patients after adjuvant endocrine therapy or heavily pretreated patients of the Affiliated Tumor Hospital of Guangxi Medical Uiversity from April 2013 to December 2015. Patients were treated with everolimus combined with endocrine therapy. The efficacy and adverse events were evaluated and the influence factors were analyzed.Results:32 patients received everolimus combined with endocrine therapy, 28 cases were assessable for efficacy, no cases achieved CR,6 cases(21.4%)got PR,18 cases(64.3%)were SD,4 cases(14.3%)had PD,The ORR was 22.4%, the CBR was 42.8%,and the mPFS 7.0 months(95%CI:6.5 to 7.5 months);as first-line therapy achieve the ORR was 28.6%,the CBR was 85.7%,and the mPFS11.3 months;and as second-line therapy achieve the ORR was 25%,the CBR was37.5%,and the mPFS7.1 months; as third-line and above therapy achieve ORR 15.4%,the CBR was23.1%,and the mPFS5.0 months.Univariate analysis showed that without visceral metastases and previously sensitive to endocrine therapy are the impactive factor of PFS, Patients with visceral metastases achieved mPFS 11.3 months and 5.7 months in those without visceral metastases, Patients with secondary resistance acheieved more benefit in mPFS than patients with primary resistance(8.3 months vs 4.8months), the difference was statistically significant.The multivariate analysis showed that the PR state、 without visceral metastases and previously sensitive to endocrine therapy are prognostic factors of PFS.Univariate and multivariate analysis showed that the benefit of mPFS is not affected by different endocrine drugs.And combination therapy can effectively reduce the level of CEA、 CA153 and CA125.The main toxic reactions weres tomatitis(93.3%),cough(53.3%), fatigue(40%), pneumonia(26.7%), elevated transaminase(26.7%), rash(20%), Anemia(20%), hyperglycemia(16.7%)and hyperlipidemia(13.3%).Most AEs were of grade I or II severity, grade Ⅲ or IV severity were not more common. In respect of sequelae,6 cases recovered with supportive care,22 cases had to reduce the dose and receive specific treatment;2cases improved after drug withdrawal.Conclusion:1. Combination of everolimus and endocrine therapy is effective in hormone receptor positive advanced breast cancer patients after adjuvant endocrine therapy or multi-line treatments and it also can prolong the progression, and the benefit of mPFS is not affected by different endocrine drugs,and with the increase of the number of treatment lines, CBR and ORR decreased, mPFS also shortened.2. Single factor and multivariate regression analysis showed that non visceral metastasis and previous sensitivity to endocrine therapy was an independent correlative factor to PFS.3. Combination of everolimus and endocrine therapy can effectively reduce the level of CEA、CA153 and CA125.4. The incidence of adverse events of combination therapy can not be ignored, and should emphasize the adverse event management of everolimus in the future, and should also weigh the efficacy and adverse, although reduction the dosage of everolimus allowed a better tolerance of everolimus, but whether it will effect the efficacy, further clinical trials is warranted.