Ten-Year Follow-Up of 3 Years of Oral Adjuvant Clodronate Therapy Shows Significant Prevention of Osteoporosis in Early-Stage Breast Cancer

2008 ◽  
Vol 26 (26) ◽  
pp. 4289-4295 ◽  
Author(s):  
Tiina Saarto ◽  
Leena Vehmanen ◽  
Carl Blomqvist ◽  
Inkeri Elomaa

PurposeWe have previously reported that 3-year adjuvant clodronate treatment prevents bone loss in breast cancer patients. Here we report the 10-year follow-up data of clodronate in the prevention of treatment-related osteoporosis in women with early-stage breast cancer.Patients and MethodsTwo hundred sixty-eight pre- and postmenopausal, node-positive breast cancer patients were randomly assigned to clodronate, 1.6 g orally administered daily, or to control groups for 3 years. Premenopausal women were treated with adjuvant CMF chemotherapy; and postmenopausal women were treated with antiestrogens, either 20 mg tamoxifen or 60 mg toremifene, for 3 years. The bone mineral density (BMD) of the lumbar spine and hip was measured before treatment and at 1, 2, 3, 5, and 10 years after therapy.ResultsEighty-nine disease-free patients were included in the analyses of osteoporosis-free survival. During the 10-year period, 24 of 89 patients were diagnosed with osteoporosis. Fourteen patients developed spinal osteoporosis (three of 41 in the clodronate group, and 11 of 48 in the control group), and 14 of 89 patients were diagnosed with hip osteoporosis (seven of 41 in the clodronate group, and seven of 48 in the control group). The 10-year spinal, osteoporosis-free survival rate was 92.7% in the clodronate group, and 77.0% in the control group (P = .035). No difference was seen in the frequency of hip osteoporosis (85.4% v 82.9%; P = .92). Baseline BMD measurement had a predictive value of 18 of 24 patients (75%) who developed osteoporosis had osteopenia of the lumbar spine at baseline.ConclusionThree years of clodronate therapy significantly reduces the incidence of lumbar spine osteoporosis. Patients at risk of developing osteoporosis are among those who have pretreatment osteopenia, that is, baseline BMD measurement has predictive value.

2019 ◽  
Vol 10 (3) ◽  
pp. 1751-1755
Author(s):  
Hadeel Rashid Faraj

The most malicious tumor in women is breast cancer. Its treatment at the early stage of its recognition in a woman provides her multiple options for diagnosis. Physical inspection and mammography are helpful screening processes for the primary recognition of breast cancer, they are also labor dependent and need health specialists who are exceptionally prepared and skilled. This experiment was designed to estimate and compare the CA15-3 level, hormone, and Lactate dehydrogenase enzyme in Breast Cancer patients and in apparently healthier individuals. Blood CA15-3, hormone, and Lactate dehydrogenase enzyme levels were determined in 65 Women with Breast Cancer and 55 apparently healthy subjects. The levels of serum CA15-3, hormone, and Lactate dehydrogenase enzyme were showing a significant increase in women with Breast Cancer in comparison to the control group (P ≤ 0.05). The study also investigates the correlation between the concentrations of the CA15-3 and each of hormone, and Lactate dehydrogenase enzyme, However, we compared all measurement parameters according to the type of disease. In Breast cancer patients, we increase CA15-3, hormone, and Lactate dehydrogenase enzyme can clearly occur, and we positive correlation relationship between CA15-3 and each of PRL and LDH through coefficient correlation (r).


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12520-e12520
Author(s):  
Keerthi Tamragouri ◽  
Ethan M. Ritz ◽  
Ruta D. Rao ◽  
Cristina O'Donoghue

e12520 Background: Oncotype Dx (ODX) is a commercial diagnostic test primarily used to predict the likely benefit from chemotherapy in ER+, HER2-, and node negative breast cancer. The prognostic value (recurrence risk) has also been demonstrated to apply to early stage lymph node positive (LN+) disease in a number of retrospective and prospective studies. The ongoing RxPONDER trial aims to clarify the predictive value of RS in LN+ population. In light of the initial results, we analyzed the practice patterns and outcomes for HR+/Her2 -/node positive breast cancer patients receiving ODX testing in the years from 2010-2017 with RS 14-25 in a retrospective observational study of the NCDB. Methods: Women with HR+/Her2 -/node positive breast cancer receiving ODX testing from 2010-2017 were identified in the NCDB using TAILORx and RxPONDER patients’ inclusion criteria: ages 18-75, 6-50mm invasive tumors, N1, M0, ER+/HER2 -. The impact of ODX results in the high-intermediate range (14-25) and other clinico-pathologic variables on the receipt of chemotherapy were compared. Additionally, we examined the impact of chemotherapy on overall survival (OS). Frequencies, Kaplain-Meier analysis, and changepoint analysis using the Contal and O’Quigley method were utilized. Results: There were 109,652 T1-2 and N1 patients of whom 32,506 (29.6%) received ODX testing. 13,461 (41.4%%) women had scores in the high-intermediate (14-25) range. The majority tended to have only 1 LN involved (1LN: 77.2%, 2LNs: 17.5%, 3LNs: 5.3%), had a mean age of 57.8y, were Caucasian (86.4%), and were preferentially tested at academic or comprehensive community cancer programs (79.2%). 6,610 (49.3%) patients were recommended chemotherapy, the median ODX score for all women who were recommended chemotherapy was 20 compared to 17 for those whom chemotherapy was not recommended. 5,068 (76.7%) women had documentation of receiving chemotherapy which correlated with improved OS regardless of age. Conclusions: In the group of women with HR+/Her2 -/node positive breast cancer, clinicians appear to utilize ODX testing in less than one-third of patients, possibly finding RS to be most useful in guiding adjuvant therapy recommendations when only 1LN is involved. Both the recommendation and receipt of chemotherapy correlated linearly with increasing RS, as expected based on the current NCCN guideline recommendations. We identified an OS benefit when chemotherapy was administered, regardless of patient age. Long-term follow-up in the RxPONDER trial will likely continue to clarify the predictive value of RS < 25 in the ER+/HER2-/node positive breast cancer population.


1995 ◽  
Vol 13 (11) ◽  
pp. 2712-2721 ◽  
Author(s):  
M R Sertoli ◽  
P Bruzzi ◽  
P Pronzato ◽  
P Queirolo ◽  
D Amoroso ◽  
...  

PURPOSE The aim of this multicentric randomized trial was to determine whether reducing the interval between surgery and chemotherapy improves the outcome of breast cancer patients. PATIENTS AND METHODS Between June 1985 and July 1992, 600 breast cancer patients, clinical stages T1-3A,N0-2,M0 were randomly assigned to a perioperative cycle (PC) of cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF). Node-negative (N-) patients did not receive any further treatment. Node positive (N+) patients received 11 cycles if previously given PC, or 12 cycles of CEF alternated with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 (CMF). In addition, N+ patients received concomitant or sequential 5-year tamoxifen therapy. RESULTS At a median follow-up duration of 5.7 years, no significant difference in survival (88% v 84%, P = .3) between the two treatment arms was seen. However, a difference of borderline significance in relapse-free survival (RFS; 76% v 70%, P = .053) was evident. A significant survival advantage for the PC arm was detected only in the estrogen receptor-negative (ER-) patients (P = .003). RFS was significantly improved in N- patients, postmenopausal patients, and ER- patients. Multivariate analyses show that pathologic tumor size, nodal status, receptor status, and treatment (only in ER- patients) are significantly correlated with survival and RFS. PC toxicity did not influence wound healing. CONCLUSION This study provides preliminary evidence that PC positively affects relapse rate and survival in some subgroups, namely, ER- patients.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 676-676 ◽  
Author(s):  
T. Saarto ◽  
L. Vehmanen ◽  
C. Blomqvist ◽  
I. Elomaa

676 Background: We have previously reported that clodronate prevents bone loss in breast cancer patients (JCO 1997;15:1341, BJC 1997;75(4):602 and EJC 2001;37:2373). Here we report the 10-year follow-up data. Methods: 268 pre- (PRE) and postmenopausal (POST) node positive breast cancer patients were randomized to clodronate (CL), orally 1.6 g daily, or control groups for 3 years. PRE were treated with adjuvant chemotherapy and POST with antiestrogens (AE), tamoxifen 20 mg or toremifene 60 mg, for 3 years. The BMD of the lumbar vertebrae L1–4 (BMDLS) and femoral neck (BMDFN) was measured before the treatment and at 1, 2, 3, 5 and 10 years. 93 patients were eligible for 10-year analyses: 53 PRE and 40 POST. 132 patients had metastatic disease or died and 39 were either lost to follow-up or had to be excluded because having diseases or medications that influences bone metabolism. Results: PRE: BMDLS decreased -12.4% in the control and −8.7% in the CL group in 10 years: from 0 to 3 years −6.9 % vs. −4.2% and from 3 to 10 years −5.5% and −4.5%, respectively. BMDFN decreased −8.8% and −7.2%: from 0 to 3 years −2.9% vs. −2.6% and from 3 to 10 years −5.9% vs. −4.6%, respectively. POST: BMDLS decreased −3.0% in the AE and −1.7% in the AE+CL group in 10 years: from 0 to 3 years −1.5% vs. + 1.2% and from 3 to 10 years −1.5% vs. −2.9%, respectively. BMDFN decreased −7.7% and −6.0%: from 0 to 3 years −0.1% vs. +1.9% and from 3 to 10 years −7.6% vs. −7.9%, respectively. These differences do not reach statistical significance. At 10-years 18 patients had osteoporosis in LS and 15 in FN. Only 4 patients who had osteoporosis at 10 years had normal BMD before the therapy. Conclusions: As reported previously, clodronate prevents the bone loss during treatment in pre- and postmenopausal women. This beneficial effect seems to be maintained at least for 7 years after treatment termination in premenopausal. In postmenopausal women the effect seems to diminish within time. Due to small numbers of patients these differences are no longer statistically significant. Patients at risk of developing osteoporosis are among those who has pretreatment osteopenia i.e. baseline BMD measurement has predictive value. No significant financial relationships to disclose.


2015 ◽  
Vol 4 ◽  
pp. 284-289 ◽  
Author(s):  
Tomasz Nowikiewicz ◽  
Magdalena Wiśniewska ◽  
Michał Wiśniewski ◽  
Marta Biedka ◽  
Iwona Głowacka ◽  
...  

2000 ◽  
Vol 18 (12) ◽  
pp. 2406-2412 ◽  
Author(s):  
Edward Obedian ◽  
Diana B. Fischer ◽  
Bruce G. Haffty

PURPOSE: To determine the risk of second malignancies after lumpectomy and radiation therapy (LRT), and to compare it with that in a similar cohort of early-stage breast cancer patients undergoing mastectomy without radiation (MAST). PATIENTS AND METHODS: Between January 1970 and December 1990, 1,029 breast cancer patients at our institution underwent LRT. A cohort of 1,387 breast cancer patients who underwent surgical treatment by mastectomy (MAST), and who did not receive postoperative radiation during the same time period, served as a comparison group. Second malignancies were categorized as contralateral breast versus nonbreast. In the cohort of patients undergoing LRT, a detailed analysis was carried out with respect to age, disease stage, smoking history, radiation therapy technique, dose, the use of chemotherapy or hormone therapy, and other clinical and/or pathologic characteristics. RESULTS: As of March 1999, the median follow-up was 14.6 years for the LRT group and 16 years for the MAST group. The 15-year risk of any second malignancy was nearly identical for both cohorts (17.5% v 19%, respectively). The second breast malignancy rate at 15 years was 10% for both the MAST and LRT groups. The 15-year risk of a second nonbreast malignancy was 11% for the LRT and 10% for the MAST group. In the subset of patients 45 years of age or younger at the time of treatment, the second breast and nonbreast malignancy rates at 15 years were 10% and 5% for patients undergoing LRT versus 7% and 4% for patients undergoing mastectomy (P, not statistically significant). In the detailed analysis of LRT patients, second lung malignancies were associated with a history of tobacco use. There were fewer contralateral breast tumors in patients undergoing adjuvant hormone therapy, although this did not reach statistical significance. The adjuvant use of chemotherapy did not significantly affect the risk of second malignancies. CONCLUSION: There seems to be no increased risk of second malignancies in patients undergoing LRT using modern techniques, compared with MAST. Continued monitoring of these patient cohorts will be required in order to document that these findings are maintained with even longer follow-up periods. With nearly 15 years median follow-up periods, however, these data should be reassuring to women who are considering LRT as a treatment option.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 611-611
Author(s):  
B. Taback ◽  
N. Hansen ◽  
K. Conway ◽  
A. Giuliano

611 Background: It is estimated that approximately 10% of all breast cancer patients will develop local recurrence (LR) at 10 years. Routine surveillance for detection of early breast cancer recurrence is widely performed despite lack of conclusive evidence for an improvement in patient quality of life or potential for cure. A number of historical studies evaluating the effectiveness of routine screening for LR following treatment for early-stage breast cancer have suggested that the diagnosis of LR is more frequent during a routine visit and occurring in asymptomatic patients. However, differentiating the method of detection is not often elucidated. In this study we evaluated the manner in which patients presented with an isolated LR in clinical practice. Methods: Our routine patient follow-up consists of physical exam and mammogram every 6 mos for the first 2 years following breast conserving surgery (BCS) and yearly thereafter. We queried our prospectively collected breast cancer database (1632 patients from July 1986 - July 2004) for patients with an isolated LR following BCS (n=59 (3.6%); two patients had bilateral LRs). Medical records were not available for three patients. Results: At a median follow-up of 45 mos (range: 5–122 mos) there were 58 evaluable LRs: 15 DCIS, 31 infiltrating ductal carcinoma (IDC), 6 infiltrating lobular (ILC), 2 mixed IDC/ILC, 3 invasive cancers NOS and 1 unknown. Patient presentation was as follows: 25 were diagnosed by self-exam, 28 on screening mammogram, 2 were diagnosed by physician (includes one referral), and 3 unknown. Mammogram detected recurrences were more frequent among patients with DCIS whereas self-detected recurrences were more common in patients with IDC (79% vs 33% and 21% vs 67%, respectively; P<0.2). Mean tumor size was larger in self-presentation (2.1 cm; range: 0.8–4.5 cm) than in mammogram detected group (1.6 cm; range 0.4–6 cm). Conclusions: These findings demonstrate the value of mammography as compared to patient detected LRs. Whether a survival advantage exists remains uncertain. Nevertheless routine physician examination in this setting is highly insensitive and its further utility must be considered when devising cost-effective strategies for surveillance of breast cancer patients. No significant financial relationships to disclose.


2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 93-93
Author(s):  
Rebekah Young ◽  
Kimberly Gergelis ◽  
Shalom Kalnicki ◽  
Jana Lauren Fox

93 Background: Women with early-stage TN breast cancers are at increased risk for recurrence (RR) compared to other molecular subtypes, and are often treated with mastectomy without local adjuvant therapy. We wish to evaluate the RR for these women. Methods: In this single institution retrospective study, women with T1-2N0 TN breast cancer who underwent mastectomy between 2008-12 were identified from tumor registry. Adjuvant chemotherapy was allowed, but adjuvant radiotherapy (RT) was excluded. Of 3,000 cases reviewed, 52 women were identified. Median age was 58.5 (30–90). Lesions were high-grade (83%), and T1-2 (47%, 53%). 21 women (42%) had at least 1 risk factor. 5 women were BRCA+. Women underwent total mastectomy or modified radical mastectomy, and the majority (84%) had adjuvant chemotherapy. Results: At a median follow-up of 3.5 years (6-71 months), there were 8 recurrences (15.4%). 3 (5.8% of cohort) were locoregional (LR) only (2 chest wall (CW) and 1 ipsilateral axilla), 6 (11.5%) involved a concurrent LR and distant recurrence, and 2 (3.8%) were distant only. Median time to recurrence was 17.3 months. The isolated LR recurrences (LRR) were at 14, 15.6 and 15.1 months. Most women (41, 78.8%) were alive with NED. 3 were alive with disease, underdoing treatment, and 1 woman was disease free after treatment for CW recurrence. 8 patients (15.4%) are deceased, half from their cancer. On univariate analysis, there was no significant correlation (p>0.05) between age or high-risk features and RR (STATA v 11). Conclusions: T1-2N0 breast cancer patients are believed to have a low RR following mastectomy. TN disease, however, is more aggressive, and the question of irradiating early stage disease after mastectomy has arisen. A single institution, retrospective study found women with T1-2N0 TN disease fare better with BCT that includes RT, compared to mastectomy alone. Other studies have shown no statistical difference in RR between these 2 groups. We found an isolated LRR rate at 3.5 years of 5.8%. Follow-up and ultimately prospective data is needed to determine whether the isolated LRR warrants a change in treatment recommendations for this pt subset.


Biology ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 566
Author(s):  
Sherihan AbdelHamid ◽  
Hala El-Mesallamy ◽  
Hany Abdel Aziz ◽  
Abdel-Rahman Zekri

Evidence on the prognostic relevance of BRCA1/2 mutations on breast cancer survival is still debatable. To address this ambiguity, we sought to elucidate the impact of BRCA1/2 mutation carriership on long-term clinical outcomes for the first time in Egyptian female breast cancer patients. This study comprised 103 Egyptian female breast cancer patients previously tested for BRCA1/2 mutations. Clinicopathological characteristics and long-term follow-up data were retrieved from clinical records until death or loss to follow-up. Overall survival (OS), recurrence-free survival (RFS), disease-free survival (DFS), and metastasis-free survival (MFS) were compared in BRCA1/2 mutation carriers and non-carriers. Pathogenic variants (Class 5 according to ACMG/AMP guidelines) were observed in 29 cases. The profile of the detected variants was previously reported. After median follow-up time of 6.9 years (range, 4.2–24.4 years), BRCA1/2 carriers exhibited significantly worse RFS compared to non-carriers (p = 0.01; HR = 3.00 (95%CI 1.35–6.68)). However, we couldn’t demonstrate statistically significant difference between carriers of pathogenic mutations and non-carriers regarding MFS (p = 0.24; HR = 1.38 (95%CI 0.8–2.4)), DFS (p = 0.11; HR = 1.23 (95%CI 0.74–2.06)), or OS (p = 0.36; HR = 1.23 (95%CI 0.58–2.61)). Though no significant impact was observed in OS, yet BRCA1/2 mutation carriers were at high risk of recurrence, highlighting the importance of adopting BRCA screening strategies and prophylactic measures.


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