Background The efficacy and feasibility of chemotherapy in elderly metastatic breast cancer (MBC) patients (pts) have been studied in various phase II studies. However, results of prospective randomized studies in elderly MBC pts are scarce. Methods In this phase III multicenter study, MBC pts ≥ 65 years eligible for first-line chemotherapy were randomized between pegylated liposomal doxorubicin (PEGdoxo) (45mg/m2, IV, q 4 wks) or capecitabine (Cape) (1000 mg/m2 PO bid, days 1–14, q 3 wks). Other eligibility criteria were ECOG performance status (PS) ≤ 2 (3 allowed if due to pain or pre existing comorbidity), adequate bone marrow and organ functions. Stratification factors were PS (0–1 vs 2–3), HER2 status, visceral/non-visceral disease, adjuvant hormonal therapy (HTx), and HTx for MBC. Baseline geriatric assessment (GA) included functional status, instrumental activities of daily living, cognition, mood, comorbidity, polypharmacy and nutritional status. Chemotherapy was continued for 24 wks in the absence of progressive disease (PD) or unacceptable toxicity. Primary endpoint was progression-free survival (PFS), secondary endpoints were response rate, overall survival (OS), toxicity (CTC criteria) and compliance. Results Between April 2007 and August 2011, 78 pts were randomized to PEGdoxo (n = 40) or Cape (n = 38). The study was prematurely closed due to slow accrual and supply problems with PEGdoxo. Mean age was 74 years (range 65–86; 75+ 54%; 80+ 13%). Pt characteristics were balanced between the two arms: PS 0–1 77%, ER+ 68%, HER2+ 5%, visceral/non-visceral disease 76%/24%, adjuvant HTx 46%, HTx for MBC 56%, ≥ 3 metastatic sites 50%. Only 22 out of 75 pts with a baseline GA had no geriatric condition (29%), while 32 pts (43%) and 21 pts (28%) had one or ≥ 2 geriatric conditions, respectively. Chemotherapy was given for 6 months in 38%, with a mean dose intensity of 84% in both arms. Reasons for early treatment discontinuation were: PD (31%), toxicity (28%), pt withdrawal (3%). After a median follow up of 32 months, 74 pts had PD and 56 pts had died. The median PFS was 5.7 and 7.7 months with PEGdoxo and Cape (HR 0.68, 95% CI: 0.42–1.11, p = 0.12) and the median OS was 13.8 and 16.8 months, respectively (HR 0.84, 95% CI: 0.49–1.42, p = 0.51). Response was evaluable in 64 pts, with a partial response (PR) in 7 (21%) and 6 pts (19%), and stable disease in 21 (64%) and 17 pts (55%) for PEGdoxo and Cape, respectively. Toxicity was acceptable, mainly being grade 1–2, with for PEGdoxo/Cape grade 1 alopecia in 14/4 pts (grade 2 in 1 PEGdoxo pt), grade 3 fatigue in 5/5 pts, grade 3 HFS in 4/6 pts and grade 3 mucositis in 4/1 pts, respectively. Pts with ≥ 1 geriatric condition more frequently experienced grade 3–4 toxicity, after correcting for type of chemotherapy, age and PS (HR 2.24, 95% CI: 1.21–4.16). Pts aged 75+ had a twofold higher risk of dying, irrespective of treatment arm (HR 2.31, 95% CI: 1.31–4.07). Conclusions First-line chemotherapy with either PEGdoxo or Cape was feasible in elderly MBC pts, with adequate dose intensity and acceptable toxicity, even in non-fit pts or pts aged 75+. Baseline GA correlated with toxicity. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-12-05.
Background The value of magnetic resonance imaging (MRI) for patients with breast cancer remains under debate. Breast MRI may contribute to the planning of local therapy, but also bears the risk of overtreatment. We analyzed the use of MRI and its impact on surgical treatment and risk of detecting contralateral breast cancer in the Netherlands. Patients and methods All patients who underwent primary surgery for stage I-III invasive breast cancer in the years 2011-2013 were identified through the Netherlands Cancer Registry. The following data were documented: year of diagnosis, hospital type and volume, age at diagnosis, clinical T and N stage, histological type and grade, presence of multifocality in resection specimen, hormone receptor status, HER2 status and use of MRI. We analyzed whether MRI use was related to type of surgery (primary or secondary mastectomy or breast conserving surgery), surgical margin involvement, and diagnosis of synchronous contralateral breast cancer. Results MRI was performed in 10,819 (29,8%) out of 36,333 patients newly diagnosed with invasive breast cancer and treated with primary surgery in the years 2011-2013 in the Netherlands. Use of MRI did not clearly increase in this period. In the multivariate analysis, patients younger than 50 years of age compared to patients aged 70 years or older (OR 6.34, 95% CI 5.86-6.87), patients with lobular breast cancer compared to those with ductal carcinoma (OR 3.46; 95% CI 3.23-3.70) and patients with multifocal tumors compared to those without multifocality (OR 2.30, 95% CI 2.15-2.45) were more likely to undergo MRI. Hospital volume (<150 versus >150) was only marginally related to MRI use (OR 0.93; 95% CI 0.87-0.99). Patients with invasive breast cancer undergoing MRI were more likely to undergo primary mastectomy than those without MRI (OR 1.21; 95% CI 1.15-1.28), but the subgroup with invasive lobular cancer undergoing MRI were less likely to undergo primary mastectomy (OR 0.85; 95% CI 0.75-0.98). A significantly lower risk of positive surgical margins was seen in patients with lobular breast cancer and breast conserving surgery who had undergone MRI as compared to those without MRI (OR 0.58, 95% CI 0.44-0.78) and, consequently, also a lower risk of secondary mastectomy (OR 0.60, 95% CI 0.41-0.87). Risk of positive surgical margins was not reduced by MRI use in patients with invasive ductal carcinoma (OR 0.91; 95% CI 0.77-1.07). Patients who underwent MRI were almost four times more frequently diagnosed with contralateral breast cancer, compared to those in whom MRI was not performed (OR 3.60, 95% CI 3.06-4.24). Conclusion Breast MRI was significantly more often used in younger patients, patients with lobular and/or multifocal breast cancer. Interestingly, MRI use was associated with less primary and secundary mastectomies in lobular invasive breast cancer, in contrast to an increased number of primary mastectomies in patients with invasive ductal cancer. MRI was further associated with an almost fourfold higher incidence of contralateral breast cancer. Citation Format: Tjan-Heijnen VC, Lobbes MB, Vriens IJ, van Bommel AC, Nieuwenhuijzen GA, Smidt ML, Boersma LJ, van Dalen T, Smorenburg CH, Siesling S, Voogd AC. Only in lobular breast cancer MRI use is associated with a lower risk of positive surgical margins and a reduced number of mastectomies. A real-world analysis in The Netherlands. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-02-01.
Background: In early stage hormone receptor positive breast cancer, aromatase inhibitors (AIs) are established as adjuvant therapy for postmenopausal women. In daily practice AIs are also offered to patients with chemotherapy-induced amenorrhea (CIA). The impact of AIs on estrogen (E2) levels in these patients has not extensively been studied, although this could be very relevant for the efficacy and safety of the adjuvant hormonal treatment. The Dutch phase III DATA study is assessing the impact on disease-free survival of 3 vs. 6 years of anastrozole after 2–3 years of tamoxifen (N=1900 patients in total), and has included both postmenopausal patients and patients with CIA. The current analysis reports on the hormonal data in the CIA group. Patients and methods: We identified patients from the DATA study < 55 years of age at randomization who had received adjuvant chemotherapy and developed CIA, and excluded patients with ovariectomy or use of LHRH agonist. Patients were considered as having CIA if they were in amenorrhea since 3 months before start of chemotherapy up to 6 months after start of chemotherapy, and did not resume menses during tamoxifen therapy. Patients were eligible if postmenopausal E2 levels were confirmed within the last three months before randomization. Plasma FSH and E2 levels were serially determined at 6-month intervals. Results: A total of 285 patients with CIA were identified in the DATA study. Median age was 50.8 years (range 35.9 - 54.9). Results on E2 and FSH levels are presented in the Table. During treatment with anastrazole, FSH levels tended to increase over time and E2 levels didn't decline. Of note, FSH increased in nearly all patients with significantly elevated (premenopausal) E2 levels, in contrast to the pattern seen in spontaneous recovery of ovarian function. During follow-up, 4 patients had vaginal bleeding, 2 of them having postmenopausal E2 levels. In 8 (2.8%) patients E2 levels became ≥ 200 pmol/l (considered premenopausal) after 12–30 months use of AI. Using a more strict cutoff value of E2 (≥ 100 pmol/l), 62 (21.8%) patients had elevated levels of E2 during AI treatment. With 70 pmol/l as cutoff value, 117 (41.0%) patients had at some point during treatment an increased E2 level. Updated and detailed analyses will be presented at the meeting. Conclusion: In this first series of a large number of CIA patients with available data on E2 and FSH levels during anastrozole therapy, we observed high E2 levels in a substantial number of patients. The combination of increased E2 and FSH levels may indicate continuous stimulation of remaining ovarian follicles. The efficacy of AIs in women with CIA without strict E2 monitoring and adequate treatment modification in the presence of increasing E2 can be questioned. Further data hereon are warranted. Supported by: AstraZeneca NL and the Dutch Breast Cancer Trialists’ Group (BOOG). Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD04-02.
Background Breast cancer treatment is a multimodality effort to optimize outcome as well as to achieve the optimal cosmetic result. Various treatment strategies can be used for the latter goal: upfront breast conserving surgery (BCS), BCS after neoadjuvant therapy (NAC), and ablative surgery combined with immediate breast reconstruction. The rate of BCS is frequently used as a quality and trend indicator. The aim of the present study was to analyse the combined efforts expressed as the rate of breast contour preserving procedures (BCPP) and compare it to the rate of BCS. Material and methods All invasive M0 female breast cancer patients diagnosed and operated in one of the 89 hospitals in the Netherlands between January 2011 – December 2015 were selected from the national NABON Breast Cancer Audit. BCPP (defined as 'primary BCS', 'BCS after NAC', or 'ablative surgery combined with an immediate reconstruction') was calculated for the years of diagnosis, age groups (<30, 30-39, 40-49, 50-59, 60-69 and ≥ 70 years) and the individual hospitals. Results A total of 61,309 patients were identified. The rate of upfront BCS remained stable during the study period (52%), while the BCPP rate increased over the years (63% to 71%) due to an equal increase in the proportions of patients receiving NAC with BCS and undergoing ablative surgery with immediate breast reconstruction. While upfront BCS (with and without NAC) rates increased with age (30% in patients aged <30 years to 67% in patients aged 60-69), the rate of BCPP was more or less stable in these age groups, as the rate of ablative surgery with immediate reconstruction showed an inverse relationship with age, decreasing from 44% in patients <30 years to 1% in patients ≥70 years of age. The rate of BCS varied between hospitals in the Netherlands: 37% to 77%. Although BCPP is more often performed compared to BCS, the variation between hospitals remained (47% to 88%). Table. Percentage of patients treated with Breast Conserving Surgery (BCS), BCS after neo-adjuvant therapy and immediate breast reconstruction with ablative surgery resulting in total percentages of Breast Contour Preserving Procedures (BCPP). BCSBCSAblative surgeryBCPP Neo-adjuvant +IBR + Year of Diagnosis 201153%4%6%63%201253%4%7%64%201352%6%8%67%201452%8%9%69%201552%9%11%71%Age Group <3017%13%44%73%30-3927%14%26%67%40-4938%12%17%68%50-5956%7%11%75%60-6963%5%5%72%≥ 7049%2%1%52%Hospitals Mean52%6%8%67%Min34%0%0%47%Max66%26%28%88%BCS: Breast Conserving Surgery; IBR: Immediate Breast Reconstruction; BCPP: Breast Contour Preserving Procedures Conclusions While the rate of BCS remained stable over recent years, the rate of BCPP has increased significantly. Including immediate reconstruction into the BCPP rate annihilates observed age-dependent differences of the BCS-rates, while institutional differences remained. All in all, combining different treatment strategies into one parameter (BCPP) provides a more appropriate measure of maintaining the breast contour than BCS alone. Citation Format: van Bommel A, Spronk P, Vrancken Peeters M-J, Mureau M, Siesling S, Smorenburg C, van Dalen T. The concept of breast contour preserving surgery as parameter in breast cancer surgery [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-13-12.
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