Mostrando entradas con la etiqueta Bevacizumab; Triple-Negative Breast Cancer (BEATRICE); Dr. David Muñoz Carmona; Oncología Radioterápica; Breast cancer. Mostrar todas las entradas
Mostrando entradas con la etiqueta Bevacizumab; Triple-Negative Breast Cancer (BEATRICE); Dr. David Muñoz Carmona; Oncología Radioterápica; Breast cancer. Mostrar todas las entradas

sábado, 14 de mayo de 2016

Adjuvant RT Extends Survival in Elderly TNBC Patients

Adjuvant radiation therapy after lumpectomy improves survival for elderly women with early-stage, triple-negative breast cancer (TNBC), according to a new study to be presented at the 2015 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium in San Francisco (abstract 39).
Adjuvant radiation therapy may be omitted for elderly women with early-stage breast cancer who have favorable estrogen-receptor status. Some studies show that elderly women with TNBC have increased recurrence rates.
“Although the existing literature shows benefit from radiation, in the subgroup of elderly women with triple-negative breast cancer it does not provide a quantitative estimate on prolonged survival. Our study breaks ground by beginning to determine that exact amount,” lead author Sean Szeja, MD, radiation oncologist at the University of Texas Medical Branch at Galveston, Galveston, Texas, told Cancer Network.
The researchers conducted a retrospective analysis of the effect of adjuvant radiation therapy on the survival of elderly women with early-stage TNBC who underwent lumpectomy. Using the Surveillance, Epidemiology, and End Result (SEER) database, they evaluated how the addition of adjuvant radiation affected the survival of women ages 70 and above with T1-2, N0, M0 TNBC.
From 2010-2011, SEER data showed 12,620 triple-negative cases. Of these, 6,980 (55%) had stage T1-2, N0, M0. Lumpectomy was used in 4,002 of these cases, including 974 lumpectomy cases of women aged 70 and above. Adjuvant radiation therapy was given in 662 (68%) cases.
After 23 months, lumpectomy plus radiation therapy led to a statistically significant improvement in overall survival (98.2%) as compared with lumpectomy alone (85.6%). Similarly, disease-specific survival improved significantly for the combination (99%) over lumpectomy only (94%). Cox regression showed radiation demonstrated improved overall survival and disease-specific survival.
Breast cancer–related deaths were more common in the lumpectomy-only group (6%) compared with the lumpectomy and radiation group (1%). “The applicability of this is broad, considering that the life expectancy of the average 70-year-old female is 16 years. Therefore, our results will enable future treatment decisions to be made with more information,” said Dr. Szeja.
When other factors were considered, such as age, tumor size, and other treatment descriptions, the use of adjuvant radiation was associated with an overall sixfold decrease in any death, as well as death from breast cancer.
The researchers note that the difference in survival observed between those who did and did not receive adjuvant radiation could be explained by other factors, such as use of adjuvant chemotherapy.
Also, with a potential for selection bias in the study, the researchers suggest that future prospective studies are needed to better define the management of early-stage TNBC in elderly patients.
Dr. Szeja said “the oncologist should consider the patients’ life expectancy outside of the setting of their cancer, as well as comorbidities, often associated with age, that may impact their benefits as well as toxicity from any treatment. The elderly are also at risk for social factors, such as limited family support, that may impede their ability to comply with treatment as well as recover from its toxicities.”
He recommended oncologists perform a comprehensive geriatric assessment to evaluate functional, cognitive, and nutritional status as well as polypharmacy risks.
- See more at: http://www.cancernetwork.com/asco-2015-breast-cancer-symposium/adjuvant-rt-extends-survival-elderly-tnbc-patients#sthash.kaZvmRUi.dpuf

martes, 20 de agosto de 2013

Research August 14, 2013

Adjuvant Bevacizumab-Containing Therapy in Triple-Negative Breast Cancer (BEATRICE): Primary Results of a Randomised, Phase 3 Trial

Lancet Oncol. 2013 Aug 07;[EPub Ahead of Print], D Cameron, J Brown, R Dent, C Jackisch, J Mackey, X Pivot, GG Steger, TM Suter, M Toi, M Parmar, R Laeufle, Y-H Im, G Romieu, V Harvey, O Lipatov, T Pienkowski, P Cottu, A Chan, S-A Im, PS Hall, L Bubuteishvili-Pacaud, V Henschel, RJ Deurloo, C Pallaud, R Bell
   

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In women with triple-negative breast cancer, the addition of bevacizumab to adjuvant chemotherapy regimens did not reduce incidence of recurrent invasive disease or improve overall survival, and was associated with increased risk of hypertension and severe cardiac events.

ABSTRACT

Background:The addition of bevacizumab to chemotherapy improves progression-free survival in metastatic breast cancer and pathological complete response rates in the neoadjuvant setting. Micrometastases are dependent on angiogenesis, suggesting that patients might benefit from anti-angiogenic strategies in the adjuvant setting. We therefore assessed the addition of bevacizumab to chemotherapy in the adjuvant setting for women with triple-negative breast cancer.
Methods: For this open-label, randomised phase 3 trial we recruited patients with centrally confirmed triple-negative operable primary invasive breast cancer from 360 sites in 37 countries. We randomly allocated patients aged 18 years or older (1:1 with block randomisation; stratified by nodal status, chemotherapy [with an anthracycline, taxane, or both], hormone receptor status [negative vs low], and type of surgery) to receive a minimum of four cycles of chemotherapy either alone or with bevacizumab (equivalent of 5 mg/kg every week for 1 year). The primary endpoint was invasive disease-free survival (IDFS). Efficacy analyses were based on the intention-to-treat population, safety analyses were done on all patients who received at least one dose of study drug, and plasma biomarker analyses were done on all treated patients consenting to biomarker analyses and providing a measurable baseline plasma sample.
Findings: Between Dec 3, 2007, and March 8, 2010, we randomly assigned 1290 patients to receive chemotherapy alone and 1301 to receive bevacizumab plus chemotherapy. Most patients received anthracycline-containing therapy; 1638 (63%) of the 2591 patients had node-negative disease. At the time of analysis of IDFS, median follow-up was 31·5 months (IQR 25·6—36·8) in the chemotherapy-alone group and 32·0 months (27·5—36·9) in the bevacizumab group. At the time of the primary analysis, IDFS events had been reported in 205 patients (16%) in the chemotherapy-alone group and in 188 patients (14%) in the bevacizumab group (hazard ratio [HR] in stratified log-rank analysis 0·87, 95% CI 0·72—1·07; p=0·18). 3-year IDFS was 82·7% (95% CI 80·5—85·0) with chemotherapy alone and 83·7% (81·4—86·0) with bevacizumab and chemotherapy. After 200 deaths, no difference in overall survival was noted between the groups (HR 0·84, 95% CI 0·64—1·12; p=0·23). Exploratory biomarker assessment suggests that patients with high pre-treatment plasma VEGFR-2 might benefit from the addition of bevacizumab (Cox interaction test p=0·029). Use of bevacizumab versus chemotherapy alone was associated with increased incidences of grade 3 or worse hypertension (154 patients [12%] vs eight patients [1%]), severe cardiac events occurring at any point during the 18-month safety reporting period (19 [1%] vs two [<0 256="" and="" bevacizumab="" both="" chemotherapy="" discontinuation="" em="" nbsp="" or="" style="box-sizing: border-box; line-height: inherit;" treatment="">vs
 30 [2%]); we recorded no increase in fatal adverse events with bevacizumab (four [<0 em="" nbsp="" style="box-sizing: border-box; line-height: inherit;">vs three [<0 p="">
Interpretation: Bevacizumab cannot be recommended as adjuvant treatment in unselected patients with triple-negative breast cancer. Further follow-up is needed to assess the potential effect of bevacizumab on overall survival.

The Lancet Oncology
Adjuvant Bevacizumab-Containing Therapy in Triple-Negative Breast Cancer (BEATRICE): Primary Results of a Randomised, Phase 3 Trial
Lancet Oncol. 2013 Aug 07;[EPub Ahead of Print], D Cameron, J Brown, R Dent, C Jackisch, J Mackey, X Pivot, GG Steger, TM Suter, M Toi, M Parmar, R Laeufle, Y-H Im, G Romieu, V Harvey, O Lipatov, T Pienkowski, P Cottu, A Chan, S-A Im, PS Hall, L Bubuteishvili-Pacaud, V Henschel, RJ Deurloo, C Pallaud, R Bell