scholarly journals Adjuvant Cyclophosphamide, Methotrexate and 5-FluorouracilVersus Cyclophosphamide plus Futraful for Premenopausal Patients with Stage I-II and One- to Three-node-positive Breast Cancer: Results of A Prospective Randomized Study.

1996 ◽  
Vol 45 (1) ◽  
pp. 54-57
Author(s):  
Hideo Baba ◽  
Takashi Fukutomi ◽  
Sadako Akashi ◽  
Takeshi Nanasawa ◽  
Hiroshi Yamamoto
2002 ◽  
Vol 20 (24) ◽  
pp. 4628-4635 ◽  
Author(s):  
W. Jonat ◽  
M. Kaufmann ◽  
W. Sauerbrei ◽  
R. Blamey ◽  
J. Cuzick ◽  
...  

PURPOSE: Current adjuvant therapies have improved survival for premenopausal patients with breast cancer but may have short-term toxic effects and long-term effects associated with premature menopause. PATIENTS AND METHODS: The Zoladex Early Breast Cancer Research Association study assessed the efficacy and tolerability of goserelin (3.6 mg every 28 days for 2 years; n = 817) versus cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy (six 28-day cycles; n = 823) for adjuvant treatment in premenopausal patients with node-positive breast cancer. RESULTS: Analysis was performed when 684 events had been achieved, and the median follow-up was 6 years. A significant interaction between treatment and estrogen receptor (ER) status was found (P = .0016). In ER-positive patients (approximately 74%), goserelin was equivalent to CMF for disease-free survival (DFS) (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.84 to 1.20). In ER-negative patients, goserelin was inferior to CMF for DFS (HR, 1.76; 95% CI, 1.27 to 2.44). Amenorrhea occurred in more than 95% of goserelin patients by 6 months versus 58.6% of CMF patients. Menses returned in most goserelin patients after therapy stopped, whereas amenorrhea was generally permanent in CMF patients (22.6% v 76.9% amenorrheic at 3 years). Chemotherapy-related side effects such as nausea/vomiting, alopecia, and infection were higher with CMF than with goserelin during CMF treatment. Side effects related to estrogen suppression were initially higher with goserelin, but when goserelin treatment stopped, reduced to a level below that observed in the CMF group. CONCLUSION: Goserelin offers an effective, well-tolerated alternative to CMF in premenopausal patients with ER-positive and node-positive early breast cancer.


2007 ◽  
Vol 25 (18) ◽  
pp. 2509-2515 ◽  
Author(s):  
Peter Schmid ◽  
Michael Untch ◽  
Valentin Kossé ◽  
Grigorij Bondar ◽  
Leonid Vassiljev ◽  
...  

Purpose Ovarian suppression with luteinizing hormone–releasing hormone (LHRH) agonists is an effective adjuvant treatment for premenopausal women with estrogen receptor (ER) –positive breast cancer. Whereas monthly LHRH agonist therapy has been well established, the value of every-3-months (3-monthly) formulations is unclear. Patients and Methods This randomized phase III trial was performed to compare the 3-monthly depot LHRH agonist leuprorelin acetate (LAD-3M; n = 299) and chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF; n = 300) in pre- or perimenopausal patients with ER-positive, node-positive breast cancer. Results With a median follow-up of 5.8 years, recurrence-free survival was similar for patients treated with LAD-3M or CMF (hazard ratio [HR], 1.19; 95% CI, 0.94 to 1.51; P = .15). There was no substantial heterogeneity in the relative treatment effect among subgroups defined by age, progesterone receptor (PR) status, nodal status, hormone levels, or menstrual recovery after treatment. Exploratory overall survival analysis favored LAD-3M (HR, 1.50; 95% CI, 1.13 to 1.99; P = .005). Chemotherapy-related adverse effects such as nausea, vomiting, and alopecia were more common with CMF, whereas symptoms of estrogen suppression such as hot flushes and sweating were initially more pronounced with LAD-3M. Conclusion The 3-monthly depot LHRH-agonist leuprorelin acetate is an effective adjuvant treatment in premenopausal patients with hormone receptor–positive, node-positive breast cancer that is not inferior to CMF.


2005 ◽  
Vol 23 (28) ◽  
pp. 7089-7097 ◽  
Author(s):  
Günther Gruber ◽  
Marco Bonetti ◽  
M. Laura Nasi ◽  
Karen N. Price ◽  
Monica Castiglione-Gertsch ◽  
...  

Purpose We sought to determine retrospectively whether extracapsular spread (ECS) might identify a subgroup that could benefit from radiotherapy after mastectomy, especially patients with 1 to 3 positive lymph nodes (LN1-3+). Patients and Methods We randomized 1,475 premenopausal women with node-positive breast cancer to three, six, or nine courses of “classical” CMF (cyclophosphamide, methotrexate, and fluorouracil). After a review of all pathology forms, 933 patients (63%) had information on the presence or absence of ECS. ECS was present in 49.5%. The median follow-up was 10 years. Results In univariate analyses, ECS was associated with worse disease-free survival (DFS) and overall survival (OS). In multivariate analyses adjusting for tumor size, vessel invasion, surgery type, and age group, ECS remained significant (DFS: hazard ratio, 1.61; 95% CI, 1.34 to 1.93; P < .0001; OS: 1.67; 95% CI, 1.34 to 2.08; P < .0001). However, ECS was not significant when the number of positive nodes was added. The locoregional failure rate ± distant failure (LRF ± distant failure) within 10 years was estimated at 19% (± 2%) without ECS, versus 27% (± 2%) with ECS. The difference was statistically significant in univariate analyses, but not after adjusting for the number of positive nodes. No independent effect of ECS on DFS, OS, or LRF could be confirmed within the subgroup of 382 patients with LN1-3+ treated with mastectomy without radiotherapy. Conclusion Our results do not support an independent prognostic value of ECS, nor its use as an indication for irradiation in premenopausal patients with LN1-3+ treated with classical CMF. However, we could not examine whether extensive ECS is of prognostic importance.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12517-e12517
Author(s):  
Ericson Stoen ◽  
Jodi Kagihara ◽  
Peter Kabos ◽  
Christine M. Fisher ◽  
Jennifer Robinson Diamond

e12517 Background: HER2-positive breast cancers have a higher risk of recurrence, though systemic chemotherapy in combination with HER2-targeted agents significantly reduces this risk. Neratinib (N) is a small molecule inhibitor of HER2 that was shown in the ExteNET trial to improve invasive disease-free survival in patients with stage II-III breast cancer. The purpose of this study was to investigate factors associated with the use of adjuvant N in patients with HER2-positive breast cancer treated in the University of Colorado Health system (UCH). Methods: We performed a retrospective chart review of women diagnosed with stage I-III breast cancer who received adjuvant trastuzumab (T) between July 2016 and April 2019 at UCH to coincide with the approval of N in July 2017. We collected patient demographics, baseline characteristics, and cancer treatments. Results: A total of 350 patients were identified who received adjuvant T for treatment of stage I-III HER2-positive breast cancer within the inclusion timeframe. 234 patients (74.1%) were either ≥ T2 and/or node-positive at diagnosis as in the inclusion criteria of ExteNET. Of these, only 31 (13.3%) were prescribed adjuvant N within 2 months of completing adjuvant T. 81 (34.6%) received adjuvant pertuzumab (P) in addition to T. Of those who received N, 78.8% were ≥ T2 and 78.8% were node-positive. The average age of those receiving N was 49.3 versus 54.9 years in those not receiving N. Hormone receptor (HR)-positive disease was noted in 72.7% of those receiving N and 68.6% in those who did not (P = 0.624). The vast majority (97.0%) of patients were prescribed diarrheal prophylaxis with N. Patients receiving adjuvant N were less likely to have had a pathologic complete response (pCR) following neoadjuvant chemotherapy than those who did not receive N (23.1% versus 51.0%, P = 0.008). Of those who received N, 18 (54.5%) were treated at an academic hospital, where 34.2% of the total studied patient population was treated. Conclusions: The use of adjuvant N in patients with ≥ T2 or node-positive HER2-positive breast cancer in our patient population was low. Patients who did receive adjuvant N were more likely to have residual disease following adjuvant chemotherapy and be treated at an academic hospital. Despite the greater benefit of adjuvant N in HR-positive HER2-positive breast cancer in ExteNET, HR status did not correlate with the use of adjuvant N in our study. Trials assessing the additional benefit of adjuvant N in patients receiving adjuvant P or trastuzumab emtansine will likely be required prior to widespread use of adjuvant N.


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