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  • 1
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 72, No. 24_Supplement ( 2012-12-15), p. PD07-04-PD07-04
    Abstract: Purpose: Neoadjuvant hormone therapy (HT) promotes breast-conserving surgery (BCS) and minimizes treatment-related toxicities for oestrogen receptor (ER)-positive HER2 negative breast cancer (BC). We aimed to evaluate the response rates to an AI (anastrozole) or an antioestrogen (fulvestrant) and to identify specific biomarkers of sensitivity to both treatments. Patients and Methods: A phase II multicentre, open-label trial was conducted to evaluate the efficacy of anastrozole and fulvestrant. 116 postmenopausal patients (pts) with ER positive, HER2 negative, operable BC were recruited in 6 centers and randomly assigned to receive either neoadjuvant anastrozole (arm A; 1mg/day) or fulvestrant (arm B; 500mg, with a loading dose during first month then q4w) for 4 months (mo). Pts with a good clinical response estimated by the clinician at 4 mo were allowed to pursue treatment for 2 more mo (i.e. up to 6 mo). The primary endpoint was to evaluate the best clinical response (by palpation) by RECIST criteria at 6 mo (or 4 mo). US and MR imaging were performed at baseline, after 1 mo treatment, and before surgery. Pathological response was evaluated using Sataloff classification. Follow-up is planned for 5 yrs. Results: Between Oct 2007 and Apr 2011, 59 pts were randomized to arm A and 57 to arm B. Main baseline characteristics were well-balanced between the 2 arms: Median age was 68 yrs-old (53–91) in arm A and 74 yrs-old (51–88) in arm B. Histological grades were EE I-II in 53 pts (89 %) and 49 pts (86%) and median clinical size before treatment was 41.5 mm and 42.3 mm in arm A and B respectively. Neither SAE nor grade 3/4 toxicity was reported. The most common treatment-related AEs were grade1/2 hot flushes (27% and 12% of pts in arm A and B respectively), and musculoskeletal symptoms (20% and 21%). 35 pts in arm A and 29 pts in arm B continued assigned treatment up to 6 mo depending on the clinical response evaluated at 4 mo. Also, the clinical response rate was estimated at 4 mo orat 6 mo. 1 death post-surgery was reported in arm B with no proven relationship with treatment. Overall clinical response rates (CR + PR) at 4 or 6 mo were 62% (CI 95% [49–75]) in arm A and 46% (CI 95% [32–59] ) in arm B. Clinical response rate amelioration at 6 mo was observed among 15% of pts in each arm. BCS was performed in 59% of pts in arm A and 49% in arm B. (1 pt from arm B refused surgery). Pathological response according to Sataloff classification: TA and TB tumor responses were observed in 17/59 pts (29%) in arm A vs 12/57 (21%) in arm B respectively. Conclusions: Both anastrozole and fulvestrant show excellent efficacy and tolerability as neoadjuvant therapy in post-menopausal pts with endocrine-dependent, HER2-negative BC. Objective response rates and improvement in surgical outcome seem to be more frequent with anastrozole. However disease stabilization and tolerability are in favour of fulvestrant. Our data suggest that neo-adjuvant HT improves surgical options for HR+ post-menopausal women. Correlation between clinical & pathological responses and outcome as well as the identification of markers of sensitivity to both treatments will be also studied. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr PD07-04.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
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  • 2
    Online Resource
    Online Resource
    American Association for Cancer Research (AACR) ; 2016
    In:  Cancer Research Vol. 76, No. 4_Supplement ( 2016-02-15), p. P1-07-02-P1-07-02
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 76, No. 4_Supplement ( 2016-02-15), p. P1-07-02-P1-07-02
    Abstract: Background: Breast cancer (BC) during pregnancy (BCP) is a rare situation that requires collaboration between oncologists, surgeons and obstetricians. The main objectives of this study were to compare the overall survival (OS) and disease free survival (DFS) of a multicenter cohort of pregnant patients (pts) with those of matched control pts. Methods: Patients from 27 centers and diagnosed between 2000 and 2006 with histological confirmed M0 invasive BC were included in this retrospective study. For the cohort of BCP, pts whose pregnancy was interrupted were not eligible. Controls were matched to BCP pts on 5 criteria: clinical T (of TNM), hormonal receptor (HR) status, HER2 status, administration of neo-adjuvant chemotherapy and pathological nodal status in the absence of neo-adjuvant chemotherapy. Survival times were estimated from the date of diagnosis using Kaplan-Meier method. OS was calculated until death from every cause, DFS was calculated until relapse or death from every cause; patients alive were censored at the date of last news. Results: 100 BCP pts were identified. Their clinical and pathological characteristics were described on a previous presentation (SABCS 2013 P6-06-07). Matched controls could not be found for 12 BCP pts. 88 BCP pts were matched with 204 controls. The only differences between the 2 populations in terms of characteristics or treatment were more radical mastectomy (p=0.036) and fewer taxane administrations in the BCP group (p=0.06). The median duration of follow-up was 8.2 years for cases and 7.7 years for controls. There were no differences between BCP pts and controls in 5-year OS: 83.4%, IC 95% (73.5-89.8) vs 83.8%, IC 95% (77.9-88.3) nor 7-year OS: 76.5% (65.5-84.4) vs 78.1% (71.5-83.3) (p=0.52). The 5-year DFS was 58.6% IC 95% (47.3-68.3) vs 67.2% IC 95% (60.2-73.2) (p= 0.16). However, 5-year DFS was lower in HR+ BCP pts subgroup than in HR+ control group (56.7% IC 95% (40.7-69.8) vs 70.9% IC 95% (61.4-78.5) (p=0.023). Conclusion: This multicenter French large study confirmed that there are no differences on OS and DFS between pregnant and no pregnant pts, though this might not be true for HR subgroup. Citation Format: Vanlemmens L, Ploquin A, Delaloge S, Rouzier R, Lesur A, Frenel J-S, Loustalot C, Bachelot T, Provansal M, Ferrero J-M, Coussy F, Debled M, Kerbrat P, Vinceneux A, Djelila A, Baron M, Jebert S, Decoupigny E, Tresch E, Bonneterre J. 5-year overall survival of early breast cancer during pregnancy: A multicenter French case control study. [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 P1-07-02.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2016
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 11, No. 1 ( 1993-01), p. 15-21
    Abstract: This study was designed to test the feasibility of administering doxorubicin at an optimal dose-intensity ( 〉 70 mg/m2 per 21 days) in combination with ifosfamide under recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) cover in patients with metastatic soft tissue sarcomas. PATIENTS AND METHODS One hundred four eligible patients (of 111 entered) in 16 centers received doxorubicin 75 mg/m2 plus ifosfamide 5 g/m2 every 3 weeks for up to seven cycles. rhGM-CSF (250 micrograms/m2) was administered once or twice daily by subcutaneous injections for up to 14 days between cycles of chemotherapy. RESULTS Full protocol dose-intensity of chemotherapy was administered to the majority of patients with only 15 of 293 cycles being complicated by febrile episodes that required hospitalization. There were two treatment-related deaths: one from septicemia and one from cardiac failure. The main toxicities attributed to rhGM-CSF were pruritus and rash. A 45% response rate (10% complete remission [CR]) was seen, with a median response duration of 9 months and median survival of 15 months. CONCLUSION This high-dose regimen of chemotherapy was feasible under rhGM-CSF cover and produced a higher response rate and median survival than previously seen by the European Organization for Research and Treatment of Cancer (EORTC) Soft Tissue Sarcoma Group. A randomized phase III study is now underway comparing this regimen with conventional-dose doxorubicin/ifosfamide to test the dose-response relationship.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 1993
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  • 4
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 73, No. 24_Supplement ( 2013-12-15), p. P6-06-07-P6-06-07
    Abstract: Background: Breast cancer (BC) during pregnancy (BCP) is a rare situation that requires multi-disciplinary management. The objectives of this study were to assess the tumor characteristics, clinical course and outcome of such patients (pts). Methods: French hospitals were invited to collect retrospective clinical, treatment and follow-up data of BCP managed between 2000 and 2006. Pts with histologically confirmed M0, invasive BC and pregnant at diagnosis were included. Pts whose pregnancy was interrupted were not eligible. Survival times were calculated from the date of diagnosis. Results: 100 BCP pts were identified. Median age was 32 years (24-42). Median gestational age at diagnosis was 25 weeks (3-38). 84% and 13% had palpable breast axillary mass respectively. Clinical stages were 1T0, 21T1, 39T2, 28T3, 6 T4A-C, 2 T4D, 3 TX, 56 N0, 39 N1, 5 NX. Histological analysis identified 85 ductal carcinomas, 4 lobular, 11 others. The histopathological grades was G1 in 4,3%, G2 in 29%, and G3 in 66,7%. Tumor subtype was luminal A in 3%, luminal B in 37% (24HER2-, 13HER2+), luminal undetermined in 6%, triple-negative in 45,9%, Her2 + in 21,3%, and not classified in 2% (HR -, HER 2 unknown). Median time interval between first observation and biopsy was 31 days (0-337), respectively 40 days (0-337) and 15 days (0-172) when the first observation was made by patients or physicians. Median time interval between pathologic diagnosis and treatment was 18 days (0-295). Treatment was initiated after pregnancy for 42 pts, with median time of 18 days after delivery. 97 pts received chemotherapy with a median number of 6 cycles (4-11), 92 with anthracyclin, 44 with taxanes. 53 chemotherapy were administered in neo adjuvant setting among which 25 during pregnancy), and 44 in adjuvant setting (23 during pregnancy). 98 pts underwent surgery (34 during pregnancy), with 57 conservations and 41 mastectomies, 93 pts received radiotherapy and 43 hormone therapy after pregnancy. 10 pts received Trastuzumab. The mean gestational age at delivery was 35 weeks (22-45). All children were alive, with a median weight of 2735 g at birth (550-3740). The 5-year Overall Survival rate is 83% (95%CI 74-89), while Disease Free Survival is 53% (95%CI 43-63). First recurrence site was metastasis in 28, locoregional in 13, controlateral in 9 and other cancers in 2. Conclusion: Biopsy and treatment intervals remain long among this population. In this large series BCP, there is an excess of triple-negative breast cancer. The 5-year OS rate is higher than previously reported but with DFS is lower. BCP remains an aggressive entity despite adapted treatment. Multivariate analysis will be presented. A comparison of this BCP population to matched controls is ongoing. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-07.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2013
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  • 5
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 1993
    In:  Journal of Clinical Oncology Vol. 11, No. 7 ( 1993-07), p. 1245-1252
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 11, No. 7 ( 1993-07), p. 1245-1252
    Abstract: This study investigated the therapeutic effects of single-agent intravenous (IV) weekly Navelbine (vinorelbine or 5'-nor-anhydro-vinblastine; Pierre Fabre Médicament, Boulogne, France), a semisynthetic vinca alkaloid, in women who had received no prior chemotherapy for locally advanced or metastatic breast cancer. PATIENTS AND METHODS One hundred fifty-seven patients with assessable advanced or metastatic breast cancer who had received no prior chemotherapy were entered onto the study. They were stratified into five groups according to the main assessable tumor target: lung, liver, lymph nodes, skin, and others. One hundred forty-five patients were assessable for toxicity and response using World Health Organization (WHO) criteria; the 12 patients who were not evaluated were excluded because they were found not to meet the eligibility criteria. Navelbine was administered as a weekly 30-mg/m2 short IV infusion, and treatment was continued until disease progression. RESULTS The overall response rate (WHO criteria) was 41% (complete response [CR], 7%; partial response [PR] , 34%; 95% confidence interval [CI], 33% to 49%). In addition, 30% of the patients had stable disease. The response rate according to target was lymph nodes (28 of 42), 67%; liver (nine of 39), 23%; lung (10 of 30), 33%; skin (21 of 30), 70%; primary tumor (10 of 16), 56%; and bone (three of 10), 30%. The median time to treatment failure was 6 months and the median survival was 18 months. A total of 1,673 cycles were given to 145 eligible patients. At least one episode of WHO grade 3 or 4 granulocytopenia was seen in 72% of the patients. Nausea and/or vomiting, anemia, and/or thrombocytopenia were seen in less than 1% of cycles. Other side effects were rare, and additional toxicities were documented in the following proportions of patients: grade 2 to 3 alopecia, 8%; infectious episodes, 6%; and peripheral neuropathy, 3%. CONCLUSION Our data confirm that Navelbine has major single-agent antitumor activity as front-line therapy in advanced breast cancer. Given its excellent tolerance profile and low toxicity, it should be considered for inclusion in first-line combination chemotherapy regimens.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 1993
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  • 6
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 72, No. 24_Supplement ( 2012-12-15), p. P1-13-04-P1-13-04
    Abstract: BACKGROUND: In 2000, the NIH Consensus meeting concluded that 4 to 6 cycles of adjuvant chemotherapy appeared to provide an optimal benefit; So, we underwent a prospective randomized trial comparing 4 and 6 cycles of FEC 100 (JCO 2005; 23: 2686–2693) for high risk node negative breast cancer patients. METHODS: This study enrolled 18–65 y women with operable breast cancer, without axillary lymph node involvement, or presence of isolated tumor cells, with size superior to 1 cm and another poor prognostic factor: T & gt; 2 cm, HR –, SBR grade II or III, age & lt; 35 y. After adequate breast surgery and axillary lymph node dissection or sentinel node technique, they were randomized between arm A, 6 cycles of FEC 100, and arm B, 4 cycles, every three weeks. The local regional treatment was completed following usual recommendations. All HR+ patients received hormonal therapy for 5 years. After August 2005, patients with HER2+ tumors were excluded from this study. The primary end point was PFS at 5 years. This study was powered to detect a 6% difference in favour of 6 cycles. Between August 2002 and September 2006, 1516 patients were randomized; 1515 are analysed in ITT. Three patients in the B group did not receive any chemotherapy. There is no significant difference between the two arms for tumor and patient characteristics. RESULTS At a median follow-up of 73 months we observed regarding PFS a low event rate, 197 for the entire population (13%) 91 in arm A median PFS, vs. 106 in arm B median PFS, without any difference between the two groups for DFS, DDFS, local relapse, overall survival. There was no unexpected toxicity. In the arm A we observed more grade III and IV neutropenia, without congestive heart failure. CONCLUSION At a follow-up of 73 months, we observed a low relapse rate, with no significant difference between the two arms. Duration of FEC100 does not induce different outcomes in this population. Question of length of adjuvant treatment is still open with and without taxanes. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-13-04.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    RVK:
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
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  • 7
    In: Anti-Cancer Drugs, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 2 ( 2001-02), p. 159-162
    Type of Medium: Online Resource
    ISSN: 0959-4973
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2001
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