医学ppt唑来膦酸的抗肿瘤特性.ppt

* * * * * * * * * * Addition of daily oral CLO 1600 mg/day did not provide DFS or OS benefit in BC patients The NSABP B-34 study examined the benefit of daily oral CLO in pre- and post-menopausal pts with non-metastatic BC stratified by HR and nodal status, and by age 50 or ≥50 Study Endpoints and Definitions: Primary Outcome Measures: Disease free survival (Time?Frame:?Time from randomization to breast cancer recurrence, second primary cancer, or death from any cause) Secondary Outcome Measures: Skeletal metastasis (Time?Frame:?Time from randomization to first diagnosis of skeletal metastasis) Overall survival (Time?Frame:?Time from randomization to death from any cause) Relapse free survival (Time?Frame:?Time from randomization to any local, regional, or distant recurrence of breast cancer) Incidence of non-skeletal metastasis (Time?Frame:?Time from randomization to incidence of non-skeletal metastasis) Study Population ~ 65% of pts were over 50 years of age Majority of pts had node negative (~76%) or ER+ disease (~78%) Median time on study was 8.4 years for both arms There was an issue of noncompliance with therapy (~40% of pts were noncompliant in the first 3 years) RESULTS The addition of CLO did not improve the primary endpoint of DFS; however, treatment with CLO was associated with ? in nBMFI (HR = 0.743; P = .046) CLO was well tolerated with diarrhea being the most common AE Only 1 case of ONJ was noted in the CLO arm EligibilityGenders Eligible for Study: ? Female Accepts Healthy Volunteers: ? No Criteria DISEASE CHARACTERISTICS: Histologically proven invasive adenocarcinoma of the breast Stage I or II (T1-3, N0-1, M0) Must have undergone total mastectomy OR lumpectomy with an axillary dissection or sentinel node biopsy If any sentinel node is proven histologically positive by hematoxylin-eosin stain (HE) or deemed suspicious by HE and confirmed positive by immunohistochemistry, axillary dissection is required No bilateral malignancy or mammograp