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  • Gelber, RD  (2)
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  • 1
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 72, No. 24_Supplement ( 2012-12-15), p. S3-2-S3-2
    Abstract: Introduction Patients with isolated local and regional recurrences (ILRR) of breast cancer (BC) have a high risk of developing distant metastasis and dying from BC. We investigated the impact of chemotherapy (C) on disease-free survival (DFS) and overall survival (OS) after ILRR. Methods Patients with resected ILRR were stratified according to prior chemotherapy (yes vs. no), ER and/or PgR status of the recurrent tumor (both negative vs. either positive), and location of recurrence (breast vs. scar/chest wall vs. lymph nodes). Radiation, hormone and HER2 directed therapies were delineated in the protocol. Participants were randomly assigned to receive C or none. Multidrug C for at least 4 courses was recommended. Drug selection was at the discretion of the investigator. Slow accrual led to premature closure of the trial before achieving the planned sample size of 265. Results The trial accrued 162 patients (C, 85; control, 77) from 2002–2010. The groups were balanced in regard to the characteristics listed in the table below. At a median follow up of 4.9 years, there were 24 (28%) DFS events and 9 (11%) deaths in the C group compared with 34 (44%) DFS events and 21 (27%) deaths in the control group, corresponding to a 5-year DFS of 69% vs. 57%, [DFS HR (C/control) = 0.59, 95% CI (0.35, 0.99)], p =0.046] and a 5-year OS of 88% vs. 76%, [OS HR (C/control) = 0.41, 95% CI (0.19, 0.89)], p =0.02] . The results remained significant for both DFS and OS in multivariable Cox proportional hazards modeling controlling for ILRR location, disease-free interval, ER status and prior adjuvant chemotherapy. Adjuvant C was particularly effective for women with ER-negative ILRR: 5-year DFS 67% vs. 35%, [DFS HR (C/control) = 0.32, 95% CI (0.14, 0.73)], p =0.007] and OS 79% vs. 69%, [OS HR (C/control) = 0.43, 95% CI (0.15, 1.24)], p =0.12] . Results for the ER-positive ILRR cohort were: 5-year DFS 70% vs. 69%, [DFS HR (C/control) = 0.94, 95% CI (0.47, 1.89)], p =0.87] and OS 94% vs. 80%, [OS HR (C/control) = 0.40, 95% CI (0.12, 1.28)], p =0.12] . Conclusion Adjuvant chemotherapy should be recommended for patients with completely resected isolated loco-regional recurrences of breast cancer, in particular, if the recurrence is not sensitive to endocrine therapy. Funding NCI PHS grants U10-CA-37377, -69974, -12027, -69651, CA-75362. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S3-2.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    RVK:
    RVK:
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    American Association for Cancer Research (AACR) ; 2012
    In:  Cancer Research Vol. 72, No. 24_Supplement ( 2012-12-15), p. P6-07-06-P6-07-06
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 72, No. 24_Supplement ( 2012-12-15), p. P6-07-06-P6-07-06
    Abstract: Introduction: The risk of developing distant metastasis is elevated in patients (pts) who experience isolated locoregional recurrences (ILRR) after initial breast cancer treatment. Surgical resection of ILRR, radiation therapy (RT), and adjuvant hormonal therapy are common practice strategies. However, the role of chemotherapy (C) is unknown. Pts with complete excision of an ILRR were randomly assigned to C or no C. We report treatments, estrogen (ER) and progesterone receptor (PR) status in primary tumors and ILRR, incidence of second-ILRR failure events, and deaths. Methods: 162 pts were enrolled in IBCSG 27-02, BIG 1-02, NSABP B-37. RT was recommended but not required if a completion/salvage mastectomy was performed after an ipsilateral breast tumor recurrence. Hormonal therapy was required for ER+ and/or PR+ tumors and anti-HER2 therapy was given at investigator discretion. Stratification criteria were hormone receptor status of recurrence, site of recurrence (breast, mastectomy scar/chest, regional lymph nodes), and use of prior C. Results: Primary surgery was breast conserving: 98 (60%) and mastectomy: 64 (40%). Types of nodal surgery for primary cancer included sentinel node resection: 20 (12%), axillary node (AN) sampling: 37 (23%), AN dissection: 88 (54%), more extensive nodal surgery: 6 (4%), and no nodal surgery: 8 (5%). The sites of first ILRR were breast: 88 (54%), mastectomy scar/chest wall: 53 (33%), and regional lymph nodes: 21 (13%), and were similarly distributed by treatment arms. Of the 98 pts who originally had a lumpectomy, 92 (94%) received RT. Among these 92, ILRR were in-breast: 83 (90%), chest wall: 1 (1%), and regional node: 8 (9%). Salvage mastectomy was performed in 76/98 (78%) with prior lumpectomy. Of the other 22 pts, 17 had repeat lumpectomies and 5 had AN resection. Of the 64 who originally had mastectomy, 52 (81%) recurred in the scar/chest wall, 12 (19%) in the regional nodes and 15 pts (23%) received post-mastectomy RT, 4 of whom had regional nodal recurrences. Of the 143 pts who had ER status reported for the primary tumor, 21 (15%) had a different ER status reported for the ILRR (table). PR expression was discordant in 35 (26%) of the patients with known values. Average time from surgery for ILRR to surgery for second ILRR was 1.6 yrs (range: 0.08 -4.8). The average pt age for second LRR was 58.9 yrs versus 54.6 yrs for those who developed distant failures. At median follow up of 4.9 yrs, 15 pts developed a second ILRR (10 local, 5 regional), 7 (47%) of whom have died. Of the 37 (23%) pts who developed a distant failure 19 (51%) have died. Conclusions Similar to the effect observed in distant failure rates, a second ILRR following multimodality therapy for an ILRR is a strong prognostic indicator of subsequent death in this population. Funding: NCI PHS grants U10-CA-37377, -69974, -12027, -69651, 44066, and CA-75362. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-07-06.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    RVK:
    RVK:
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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