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1.
Artigo em Inglês | MEDLINE | ID: mdl-38940981

RESUMO

PURPOSE: Patients with chemotherapy-induced ovarian function failure (CIOFF) may experience ovarian function recovery (OFR). Earlier, we showed that OFR during treatment with anastrozole impacted the prognosis of hormone receptor-positive (HR+) breast cancer (BC) patients with CIOFF. Here, we present the long-term follow-up results. METHODS: Postmenopausal women with HR+ BC who were 45-57 years of age and received chemotherapy were identified from the phase 3 DATA study (NCT00301457) on the extended use of anastrozole. Eligible patients were categorised into two groups: patients with CIOFF and definitely postmenopausal patients. Patients with CIOFF were monitored for OFR. Disease-free survival (DFS), distant recurrence-free survival (DRFS), and overall survival (OS) were compared between patients with OFR and patients without OFR using multivariable Cox regression analyses, including OFR as a time-dependent covariate. BC-specific mortality (BCSM) was compared between groups using the Fine and Gray method. RESULTS: This study included 656 patients: 395 patients with CIOFF and 261 definitely postmenopausal patients. OFR occurred in 39 (12%) of 329 patients with CIOFF who were monitored for OFR. The median follow-up time was 13.3 years. Patients with OFR experienced a deterioration in DFS (hazard ratio (HR) = 1.54; 95% confidence interval (CI) 0.85-2.81), DRFS (HR = 1.51; 95% CI 0.73-3.11), OS (HR = 1.64; 95% CI 0.75-3.55), and BCSM (subdistribution HR = 1.98; 95% CI 0.84-4.63) when compared with patients without OFR. CONCLUSION: In patients with CIOFF, OFR during treatment with anastrozole was associated with a deterioration in BC outcomes. These findings underscore the importance of adequate ovarian function suppression in this subgroup of patients.

2.
Int J Cancer ; 151(4): 616-622, 2022 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-35403708

RESUMO

We investigated the effect of trastuzumab on cardiac function in a real-world historic cohort of patients with HER2-positive metastatic breast cancer (MBC) with reduced baseline left ventricular ejection fraction (LVEF). Thirty-seven patients with HER2-positive MBC and baseline LVEF of 40% to 49% were included. Median LVEF was 46% (interquartile range [IQR] 44%-48%) and median follow-up was 18 months (IQR 9-34 months). During this period, the LVEF did not worsen in 24/37 (65%) patients, while 13/37 (35%) patients developed severe cardiotoxicity defined as LVEF <40% with median time to severe cardiotoxicity of 7 months (IQR 4-10 months) after beginning trastuzumab. Severe cardiotoxicity was reversible (defined as LVEF increase to a value <5%-points below baseline value) in 7/13 (54%) patients, partly reversible (defined as absolute LVEF increase ≥10%-points from nadir to a value >5%-points below baseline) in 3/13 (23%) patients and irreversible (defined as absolute LVEF increase <10%-points from nadir and to a value >5%-points below baseline) in 3/13 (23%) patients. Likelihood of reversibility was numerically higher in patients who received cardio-protective medications (CPM), including ACE-inhibitors, beta-blockers and angiotensine-2 inhibitors, compared to those who did not receive any CPM (71% vs 13%, P = .091). Sixty-five percent of patients who received trastuzumab for HER2-positive MBC did not develop severe cardiotoxicity during a median follow-up of 18 months, despite having a compromised baseline LVEF. If severe cardiotoxicity occurred, it was at least partly reversible in more than two-thirds of the cases. Risks and benefits of trastuzumab use should be balanced carefully in this vulnerable population.


Assuntos
Neoplasias da Mama , Segunda Neoplasia Primária , Neoplasias da Mama/patologia , Cardiotoxicidade/tratamento farmacológico , Cardiotoxicidade/epidemiologia , Cardiotoxicidade/etiologia , Feminino , Humanos , Segunda Neoplasia Primária/induzido quimicamente , Receptor ErbB-2 , Volume Sistólico , Trastuzumab/efeitos adversos , Função Ventricular Esquerda
3.
Support Care Cancer ; 30(8): 6641-6648, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35501515

RESUMO

PURPOSE: Scalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45 and 20 min. Therefore, it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well. METHODS: Patients treated with weekly paclitaxel were included in this multi-centre trial and randomly assigned to a PICT of 45 or 20 min. The results were compared to a standard PICT of 90 min, derived from prospective collected data from the Dutch Scalp Cooling Registry. The primary endpoint was the percentage of patients who decide to not wear a wig or head covering. Secondary endpoints were the degree of CIA assessed with the Dean scale for assessment of hair loss; alopecia graded according to NCI CTC toxicity version 4.03 (CTCAE4.03); tolerance of scalp cooling and perceived distress of CIA. RESULTS: Ninety-one patients were enrolled in this study; 74 patients were evaluable for hair loss. Hair preservation was successful in 27 patients (75%) with a PICT of 45 min and in 31 patients (82%) with a PICT of 20 min. There was no difference in success rate with the standard PICT of 90 min (85%, p = 0.29). Similar success rates were seen when using the Dean scale and CTCAE assessment, with no differences between groups (p = 0.12 and p = 0.38). CONCLUSIONS: A 20 min PICT is as effective as 45 and 90 min to prevent weekly paclitaxel-induced alopecia and should be the new standard of care. TRIAL REGISTER: ClinicalTrials.gov Identifier: NCT03266185.


Assuntos
Antineoplásicos , Neoplasias da Mama , Hipotermia Induzida , Alopecia/induzido quimicamente , Alopecia/prevenção & controle , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/etiologia , Feminino , Humanos , Hipotermia Induzida/métodos , Paclitaxel/efeitos adversos , Estudos Prospectivos , Couro Cabeludo , Taxoides/efeitos adversos
4.
Breast Cancer Res Treat ; 180(3): 675-685, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32124136

RESUMO

PURPOSE: The phase III DATA study compared 6 and 3 years of adjuvant anastrozole following 2-3 years of tamoxifen in postmenopausal breast cancer patients. This pre-planned side-study assessed the relationship between a reduced bone mineral density (BMD) and distant recurrence-free survival (DRFS), and evaluated the effect of bisphosphonates on DRFS. METHODS: We selected all patients with a BMD measurement within 3 years after randomisation (landmark) without any DRFS events. Kaplan-Meier methods and Cox proportional hazards models were used for analyses. RESULTS: Of 1860 eligible patients, 1142 had a DEXA scan before the landmark. The BMD was normal in 436 (38.2%) and showed osteopenia in 565 (49.5%) and osteoporosis in 141 (12.3%) patients. After a median follow-up of 5.0 years from the landmark, neither osteopenia nor osteoporosis (compared with normal BMD) were associated with DRFS in both the 6-year [osteopenia HR 0.82 (95% CI 0.45-1.49), osteoporosis HR 1.10 (95% CI 0.26-4.67)] and the 3-year arm [osteopenia HR 0.75 (95% CI 0.40-1.42), osteoporosis HR 1.86 (95% CI 0.43-8.01)]. Moreover, bisphosphonate use did not impact DRFS. CONCLUSION: No association was observed between a reduced BMD and DRFS. Neither did we observe an impact of bisphosphonates on DRFS.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Doenças Ósseas Metabólicas/mortalidade , Neoplasias da Mama/tratamento farmacológico , Difosfonatos/uso terapêutico , Recidiva Local de Neoplasia/tratamento farmacológico , Osteoporose/mortalidade , Antineoplásicos Hormonais/efeitos adversos , Doenças Ósseas Metabólicas/induzido quimicamente , Doenças Ósseas Metabólicas/tratamento farmacológico , Doenças Ósseas Metabólicas/patologia , Neoplasias da Mama/patologia , Carcinoma Lobular/tratamento farmacológico , Carcinoma Lobular/patologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Osteoporose/induzido quimicamente , Osteoporose/tratamento farmacológico , Osteoporose/patologia , Prognóstico , Taxa de Sobrevida , Tamoxifeno/efeitos adversos
5.
Breast J ; 26(3): 433-439, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31538705

RESUMO

In the Netherlands, approximately 1300 women aged ≥75 years die every year of metastatic breast cancer (MBC). Data on palliative chemotherapy (CT) in very elderly patients are rare, and prospective studies appeared cumbersome. Therefore, we retrospectively analyzed the outcome and feasibility of chemotherapy in elderly MBC patients. Records of all patients with MBC aged ≥75 years who received first-line palliative chemotherapy between January 2000 and December 2014 at two large teaching hospitals in the Netherlands were reviewed. We registered patient and tumor characteristics together with data on previous adjuvant treatment, palliative endocrine treatment, comorbidities, clinical benefit (defined as ≥6 months progression-free survival), toxicity, and the reason for stopping chemotherapy. Patients with progressive disease (PD) or death within 30 days after starting CT were censored from analysis. A total of 54 patients with a median age of 77.6 years (range 75-90) were treated with palliative chemotherapy for MBC. Of them, 20 patients (37%) were aged ≥ 80 years. There was clinical benefit in 28 patients (52%). Median progression-free survival and median overall survival were 6.0 and 14.0 months, respectively. One year after the diagnosis of MBC, 27 patients (50%) were still alive and 15 patients (28%) lived longer than 2 years. Reasons for stopping CT were progressive disease (n = 32) or toxicity (n = 13). Most patients (n = 48) died of MBC while two patients died of toxicity. In selected patients with MBC aged 75 years or older, single-agent palliative chemotherapy is feasible and may have clinical benefit.


Assuntos
Neoplasias da Mama , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama/tratamento farmacológico , Estudos de Viabilidade , Feminino , Humanos , Metástase Neoplásica , Países Baixos , Cuidados Paliativos , Estudos Prospectivos , Receptor ErbB-2 , Estudos Retrospectivos , Resultado do Tratamento
6.
Int J Cancer ; 145(5): 1325-1333, 2019 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-30748011

RESUMO

The phase III DATA study investigates the efficacy of adjuvant anastrozole (6 vs. 3 year) in postmenopausal women with breast cancer previously treated with 2-3 years of tamoxifen. This planned side-study assessed patterns of care regarding detection and treatment of osteopenia/osteoporosis, and trends in bone mineral density (BMD) during and after therapy. We registered all BMD measurements and bisphosphonate-use. Time to osteopenia/osteoporosis was analysed by Kaplan Meier methodology. For the trend in T-scores we used linear mixed models with random patients effects. Of 1860 eligible DATA patients, 910 (48.9%) had a baseline BMD measurement. Among patients with a normal baseline BMD (n = 417), osteopenia was observed in 53.5% and 55.4% in the 6- and 3-year group respectively (p = 0.18), during follow-up. Only two patients (3-year group) developed osteoporosis. Of the patients with osteopenia at baseline (n = 408), 24.4% and 20.4% developed osteoporosis respectively (p = 0.89). Three years after randomisation 18.3% and 18.2% used bisphosphonates in the 6- and 3-year groups respectively and 6 years after randomisation this was 23.7% and 20.9% respectively (p = 0.90) of which the majority used oral bisphosphonates. The yearly mean BMD-change during anastrozole in the lumbar spine showed a T-score decline of 0.075. After bisphosphonate addition the decline became less prominent (0.047 (p < 0.001)) and after anastrozole cessation, while continuing bisphosphonates, the mean BMD yearly increased (0.047 (p < 0.001)). In conclusion, extended anastrozole therapy was not associated with a higher incidence of osteoporosis. Anastrozole-use was associated with a BMD decrease; however, the decline was modest and partially reversible after anastrozole cessation.


Assuntos
Anastrozol/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Osteoporose Pós-Menopausa/diagnóstico , Osteoporose Pós-Menopausa/terapia , Anastrozol/efeitos adversos , Antineoplásicos Hormonais/administração & dosagem , Antineoplásicos Hormonais/efeitos adversos , Densidade Óssea/efeitos dos fármacos , Feminino , Fraturas Ósseas , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Tamoxifeno/administração & dosagem , Tamoxifeno/efeitos adversos
7.
Int J Cancer ; 145(1): 274-283, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-30588619

RESUMO

The DATA study (NCT00301457) compared 6 and 3 years of anastrozole in postmenopausal women with hormone receptor-positive early breast cancer after 2-3 years of tamoxifen. Patients with chemotherapy-induced ovarian function failure (CIOFF) were also eligible, but could be at risk of ovarian function recovery (OFR). The current analysis compared the survival of women with CIOFF with definitely postmenopausal women and examined the influence of OFR on survival. Therefore, we selected patients from the DATA study aged 45-57 years at randomization who had received (neo)adjuvant chemotherapy. They were classified by reversibility of postmenopausal status: possibly reversible in case of CIOFF (n = 395) versus definitely postmenopausal (n = 261). The former were monitored by E2 measurements for OFR. The occurrence of OFR was incorporated as a time-dependent covariate in a Cox-regression model for calculating the hazard ratio (HR). We used the landmark method to calculate residual 5-year survival rates. When comparing CIOFF women with definitely postmenopausal women, the survival was not different. Among CIOFF women with available E2 follow-up values (n = 329), experiencing OFR (n = 39) had an unfavorable impact on distant recurrence-free survival (HR 2.27 [95% confidence interval [CI] 0.98-5.25; p = 0.05] and overall survival (HR 2.61 [95% CI 1.11-6.13; p = 0.03]). After adjusting for tumor features, the HRs became 2.11 (95% CI 0.89-5.02; p = 0.09) and 2.24 (95% CI 0.92-5.45; p = 0.07), respectively. The residual 5-year rate for distant recurrence-free survival was 76.9% for women with OFR and 92.1% for women without OFR, and for 5-year overall survival 80.8% and 94.4%, respectively. Women with CIOFF receiving anastrozole may be at increased risk of disease recurrence if experiencing OFR.


Assuntos
Anastrozol/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Ovário/efeitos dos fármacos , Tamoxifeno/administração & dosagem , Antineoplásicos Hormonais/administração & dosagem , Inibidores da Aromatase/administração & dosagem , Neoplasias da Mama/fisiopatologia , Intervalo Livre de Doença , Esquema de Medicação , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Ovário/fisiopatologia , Pós-Menopausa , Modelos de Riscos Proporcionais , Taxa de Sobrevida
8.
Support Care Cancer ; 27(5): 1919-1925, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30206728

RESUMO

PURPOSE: Scalp cooling as a method to reduce the incidence of chemotherapy-induced alopecia (CIA) is increasingly used in daily practice worldwide. However, in patients treated with 5-fluorouracil, epirubicin and cyclophosphamide (FEC), scalp cooling fails in 48-67% of patients. This study investigated the efficacy of extended duration of post-infusion scalp cooling in breast cancer patients treated with this regimen. METHODS: In this prospective multi-centre randomised study, 102 patients with early breast cancer treated with adjuvant FEC chemotherapy were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 90 or 150 min. The primary endpoint was the need to wear a wig or other head covering to mask visible hair loss. RESULTS: Sixteen out of 48 patients (33%) treated with 90 min of post-infusion cooling did not need any head covering, compared with 21 out of 46 patients (45%) treated with 150 min of post-infusion cooling (p = 0.2). WHO grades 2-3 (moderate-complete) alopecia were reported more often in patients treated with 90-min post-infusion cooling time (n = 25/51 (49%) versus n = 17/51 (33%); p = 0,02). Scalp cooling was well-tolerated (mean Visual Analogue Score 7.4) and only three patients (3%) stopped due to intolerance during treatment. CONCLUSIONS: Extending the duration of 90-min post-infusion scalp cooling to 150 min in patients treated with adjuvant FEC chemotherapy was well-tolerated but did not significantly diminish the need for head covering. However, grades 2-3 alopecia was seen less often with prolonged post-infusion scalp cooling.


Assuntos
Alopecia/induzido quimicamente , Alopecia/prevenção & controle , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Hipotermia Induzida/métodos , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Quimioterapia Adjuvante , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Epirubicina/administração & dosagem , Epirubicina/efeitos adversos , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Quimioterapia de Indução , Pessoa de Meia-Idade , Cuidados Paliativos/métodos , Estudos Prospectivos , Couro Cabeludo/efeitos dos fármacos , Couro Cabeludo/fisiopatologia , Taxoides/efeitos adversos
9.
Lancet Oncol ; 18(11): 1502-1511, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-29031778

RESUMO

BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequential endocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands. We randomly assigned postmenopausal women with hormone receptor-positive early breast cancer with no signs of disease recurrence after 2-3 years of adjuvant tamoxifen to either 3 or 6 years of anastrozole treatment (1 mg orally once a day) in a 1:1 ratio. We used TENALEA (Trans European Network for Clinical Trials Services) for the randomisation procedure. Stratification factors were nodal status, hormone receptor status, HER2 status, and tamoxifen treatment duration. The primary study endpoint of this analysis was disease-free survival starting beyond 3 years after randomisation (adapted disease-free survival). Here we report the final analysis from the DATA trial, which is registered with ClinicalTrials.gov, number NCT00301457. FINDINGS: Between June 28, 2006, and Aug 10, 2009, we screened 1912 patients of whom 955 were assigned to the 3-year group and 957 to the 6-year anastrozole treatment group. 1860 patients were eligible (931 in the 6-year group and 929 in the 3-year group) and 1660 were disease free 3 years after randomisation. The 5-year adapted disease-free survival was 83·1% (95% CI 80·0-86·3) in the 6-year group and 79·4% (76·1-82·8) in the 3-year group (hazard ratio [HR] 0·79 [95% CI 0·62-1·02]; p=0·066). Patients in the 6-year treatment group had more adverse events than those in the 3-year treatment group, including all-grade arthralgia or myalgia (478 [58%] of 827 in the 6-year treatment group vs 438 [53%] of 833 in the 3-year treatment group) and osteopenia or osteoporosis (173 [21%] vs 137 [16%]). INTERPRETATION: We cannot recommend the use of extended adjuvant aromatase inhibition after 5 years of sequential endocrine therapy in all postmenopausal women with hormone receptor-positive breast cancer. FUNDING: AstraZeneca.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Nitrilas/uso terapêutico , Tamoxifeno/uso terapêutico , Triazóis/uso terapêutico , Administração Oral , Adulto , Idoso , Anastrozol , Antineoplásicos Hormonais/efeitos adversos , Inibidores da Aromatase/efeitos adversos , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Quimioterapia Adjuvante , Intervalo Livre de Doença , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Estimativa de Kaplan-Meier , Mastectomia/métodos , Dose Máxima Tolerável , Pessoa de Meia-Idade , Países Baixos , Nitrilas/efeitos adversos , Pós-Menopausa/efeitos dos fármacos , Prognóstico , Estudos Prospectivos , Receptor ErbB-2/metabolismo , Análise de Sobrevida , Tamoxifeno/efeitos adversos , Resultado do Tratamento , Triazóis/efeitos adversos
10.
J Surg Oncol ; 115(3): 243-249, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27885679

RESUMO

BACKGROUND: In 2011, the NABON Breast Cancer Audit (NBCA) was instituted as a nation-wide audit to address quality of breast cancer care and guideline adherence in the Netherlands. The development of the NBCA and the results of 4 years of auditing are described. METHODS: Clinical and pathological characteristics of patients diagnosed with invasive breast cancer or in situ carcinoma (DCIS) and information regarding diagnosis and treatment are collected in all hospitals (n = 92) in the Netherlands. Thirty-two quality indicators measuring care structure, processes and outcomes were evaluated over time and compared between hospitals. RESULTS: The NBCA contains data of 56,927 patients (7,649 DCIS and 49,073 invasive cancers). Patients being discussed in pre- and post-operative multidisciplinary team meetings improved (2011: 83% and 91%; 2014: 98% and 99%, respectively) over the years. Tumour margin positivity rates after breast-conserving surgery for invasive cancer requiring re-operation were consistently low (∼5%). Other indicators, for example, the use of an MRI-scan prior to surgery or immediate breast reconstruction following mastectomy showed considerable hospital variation. CONCLUSIONS: Results shown an overall high quality of breast cancer care in all hospitals in the Netherlands. For most quality indicators improvement was seen over time, while some indicators showed yet unexplained variation. J. Surg. Oncol. 2017;115:243-249. © 2016 Wiley Periodicals, Inc.


Assuntos
Neoplasias da Mama Masculina/cirurgia , Neoplasias da Mama/cirurgia , Carcinoma in Situ/cirurgia , Auditoria Médica/métodos , Melhoria de Qualidade , Oncologia Cirúrgica/normas , Idoso , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Neoplasias da Mama Masculina/enzimologia , Neoplasias da Mama Masculina/patologia , Carcinoma in Situ/epidemiologia , Carcinoma in Situ/patologia , Prática Clínica Baseada em Evidências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica , Países Baixos/epidemiologia , Indicadores de Qualidade em Assistência à Saúde , Oncologia Cirúrgica/métodos , Oncologia Cirúrgica/estatística & dados numéricos
11.
Support Care Cancer ; 24(6): 2735-41, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-26805558

RESUMO

PURPOSE: For patients, chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of treatment. Scalp cooling can prevent or minimise CIA; the results may depend on the duration of cooling. Since a previous study on post-infusion cooling time in patients treated with docetaxel chemotherapy found no difference between 90 and 45 min, we investigated whether hair-preserving results could be maintained with a shorter post-infusion cooling time. METHODS: In this prospective, multi-centre randomised study, 134 patients who started treatment with docetaxel 75-100 mg/m(2) in a 3-weekly schedule were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 45 or 20 min. The primary end point was the need for a wig or other head covering as assessed by the patient. A visual analogue scale (VAS) with a range from 0 (not tolerable) to 10 (very tolerable) was used to measure tolerance. RESULTS: Scalp cooling results were similar for 45- and 20-min post-infusion cooling times. Thirty-three out of 45 patients (73 %) treated with 20 min of post-infusion cooling did not need a form of head covering, compared with 41 out of 52 patients (79 %) treated with 45 min of post-infusion cooling (p = 0.5). The procedure was well tolerated (mean visual analogue score 8.3). Six patients stopped due to intolerance during the first treatment cycle. CONCLUSIONS: A 20-min post-infusion cooling time is effective and tolerable for patients treated with scalp cooling to prevent docetaxel-induced alopecia. TRIAL REGISTRATION: Trialregister.nl Identifier, NTR 1856.


Assuntos
Alopecia/prevenção & controle , Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Hipotermia Induzida/métodos , Neoplasias/tratamento farmacológico , Couro Cabeludo , Taxoides/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Alopecia/induzido quimicamente , Docetaxel , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos
12.
Oncologist ; 18(7): 885-91, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23650021

RESUMO

The success of scalp cooling in preventing or reducing chemotherapy-induced alopecia (CIA) is highly variable between patients and chemotherapy regimens. The outcome of hair preservation is often unpredictable and depends on various factors. Methods. We performed a structured search of literature published from 1970 to February 2012 for articles that reported on factors influencing the effectiveness of scalp cooling to prevent CIA in patients with cancer. Results. The literature search identified 192 reports, of which 32 studies were considered relevant. Randomized studies on scalp cooling are scarce and there is little information on the determinants of the result. The effectiveness of scalp cooling for hair preservation depends on dose and type of chemotherapy, with less favorable results at higher doses. Temperature seems to be an important determinant. Various studies suggest that a subcutaneous scalp temperature less than 22 °C is required for hair preservation. Conclusions. The effectiveness of scalp cooling for hair preservation varies by chemotherapy type and dose, and probably by the degree and duration of cooling.


Assuntos
Alopecia/terapia , Hipotermia Induzida , Neoplasias/tratamento farmacológico , Couro Cabeludo , Alopecia/induzido quimicamente , Protocolos de Quimioterapia Combinada Antineoplásica , Tratamento Farmacológico , Feminino , Humanos , Neoplasias/patologia , Resultado do Tratamento
13.
Lancet Oncol ; 13(10): e437-44, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23026829

RESUMO

Comprehensive geriatric assessment (CGA) is done to detect vulnerability in elderly patients with cancer so that treatment can be adjusted accordingly; however, this process is time-consuming and pre-screening is often used to identify fit patients who are able to receive standard treatment versus those in whom a full CGA should be done. We aimed to assess which of the frailty screening methods available show the best sensitivity and specificity for predicting the presence of impairments on CGA in elderly patients with cancer. We did a systematic search of Medline and Embase, and a hand-search of conference abstracts, for studies on the association between frailty screening outcome and results of CGA in elderly patients with cancer. Our search identified 4440 reports, of which 22 publications from 14 studies, were included in this Review. Seven different frailty screening methods were assessed. The median sensitivity and specificity of each screening method for predicting frailty on CGA were as follows: Vulnerable Elders Survey-13 (VES-13), 68% and 78%; Geriatric 8 (G8), 87% and 61%; Triage Risk Screening Tool (TRST 1+; patient considered frail if one or more impairments present), 92% and 47%, Groningen Frailty Index (GFI) 57% and 86%, Fried frailty criteria 31% and 91%, Barber 59% and 79%, and abbreviated CGA (aCGA) 51% and 97%. However, even in case of the highest sensitivity, the negative predictive value was only roughly 60%. G8 and TRST 1+ had the highest sensitivity for frailty, but both had poor specificity and negative predictive value. These findings suggest that, for now, it might be beneficial for all elderly patients with cancer to receive a complete geriatric assessment, since available frailty screening methods have insufficient discriminative power to select patients for further assessment.


Assuntos
Idoso Fragilizado , Avaliação Geriátrica , Neoplasias/terapia , Idoso , Humanos , Resultado do Tratamento
14.
EClinicalMedicine ; 58: 101901, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36992863

RESUMO

Background: The DATA study evaluated the use of two different durations of anastrozole in patients with hormone receptor-positive breast cancer who were disease-free after 2-3 years of tamoxifen. We hereby present the follow-up analysis, which was performed after all patients reached a minimum follow-up of 10 years beyond treatment divergence. Methods: The open-label, randomised, phase 3 DATA study was performed in 79 hospitals in the Netherlands (ClinicalTrials.gov, number NCT00301457). Postmenopausal women with hormone receptor-positive breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen treatment were assigned to either 3 or 6 years of anastrozole (1 mg orally once a day). Randomisation (1:1) was stratified by hormone receptor status, nodal status, HER2 status, and prior tamoxifen duration. The primary outcome was adapted disease-free survival, defined as disease-free survival from 3 years after randomisation onwards. Adapted overall survival was assessed as a secondary outcome. Analyses were performed according to the intention-to-treat design. Findings: Between June 28, 2006, and August 10, 2009, 1912 patients were randomly assigned to 3 years (n = 955) or 6 years (n = 957) of anastrozole. Of these, 1660 patients were eligible and disease-free at 3 years after randomisation. The 10-year adapted disease-free survival was 69.2% (95% CI 55.8-72.3) in the 6-year group (n = 827) and 66.0% (95% CI 62.5-69.2) in the 3-year group (n = 833) (hazard ratio (HR) 0.86; 95% CI 0.72-1.01; p = 0.073). The 10-year adapted overall survival was 80.9% (95% CI 77.9-83.5) in the 6-year group and 79.2% (95% CI 76.2-81.9) in the 3-year group (HR 0.93; 95% CI 0.75-1.16; p = 0.53). Interpretation: Extended aromatase inhibition beyond 5 years of sequential endocrine therapy did not improve the adapted disease-free survival and adapted overall survival of postmenopausal women with hormone receptor-positive breast cancer. Funding: AstraZeneca.

15.
JNCI Cancer Spectr ; 7(6)2023 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-37991939

RESUMO

BACKGROUND: Obesity has been associated with an adverse prognosis and reduced efficacy of endocrine therapy in patients with hormone receptor-positive (HR+) breast cancer (BC). This study determines the prognostic and predictive effect of body mass index (BMI) on the disease-free survival (DFS) of postmenopausal HR+ BC patients. METHODS: Patients were identified from the DATA study (NCT00301457), a randomized controlled trial evaluating the efficacy of 6 vs 3 years of anastrozole after 2 to 3 years of adjuvant tamoxifen in postmenopausal women with HR+ BC. Patients were classified as normal weight (BMI: 18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2), or obese (≥30.0 kg/m2). The primary endpoint was DFS, evaluated from randomization (prognostic analyses) or 3 years after randomization onwards (predictive analyses; aDFS) using multivariable Cox regression analyses. P-values were 2-sided. RESULTS: This study included 678 normal weight, 712 overweight, and 391 obese patients. After a median follow-up of 13.1 years, overweight and obesity were identified as negative prognostic factors for DFS (hazard ratio (HR) = 1.16; 95% confidence interval (CI) = 0.97 to 1.38 and HR = 1.26; 95% CI = 1.03 to 1.54, respectively). The adverse prognostic effect of BMI was observed in women aged younger than 60 years, but not in women aged 60 years or older (P-interaction = .009). The effect of extended anastrozole on aDFS was similar in normal weight (HR = 1.00; 95% CI = 0.74 to 1.35), overweight (HR = 0.74; 95% CI = 0.56 to 0.98), and obese patients (HR = 0.97; 95% CI = 0.69 to 1.36) (P-interaction = .24). CONCLUSION: In this study among 1781 HR+ BC patients, overweight and obesity were adverse prognostic factors for DFS. BMI did not impact the efficacy of extended anastrozole.


Assuntos
Neoplasias da Mama , Humanos , Feminino , Anastrozol/uso terapêutico , Índice de Massa Corporal , Prognóstico , Sobrepeso/complicações , Obesidade/complicações
16.
Oncologist ; 17(11): 1439-49, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22941970

RESUMO

BACKGROUND: Awareness of the use of geriatric assessments for older patients with cancer is increasing. The aim of this review is to summarize all available evidence on the association between geriatric assessments and relevant oncologic outcomes. METHOD: A systematic search was conducted in Medline and Embase of studies on geriatric assessment in oncology, focusing on the association between baseline assessment and outcome. RESULTS: The literature search identified 2008 reports; 51 publications from 37 studies were selected for inclusion in the review. The quality of studies was heterogeneous and generally poor. A median of five geriatric conditions were assessed per study (interquartile range: 4-8). Little consistency was found in the results of the studies. Furthermore, different tools appear to be predictive depending on the outcome measure: frailty, nutritional status, and comorbidity assessed by the Cumulative Illness Rating Scale for Geriatrics were predictive for all-cause mortality; frailty was predictive for toxicity of chemotherapy; cognitive impairment and activities of daily living impairment were predictive for chemotherapy completion; and instrumental activities of daily living impairment was predictive for perioperative complications. CONCLUSION: Although various geriatric conditions appear to be of some value in predicting outcome in elderly patients with cancer, the results are too inconsistent to guide treatment decisions. Further research is needed to elucidate the role of geriatric assessments in the oncologic decision-making process for these patients.


Assuntos
Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Avaliação Geriátrica , Neoplasias/terapia , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Comorbidade , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/mortalidade , Neoplasias/radioterapia , Estado Nutricional
17.
Ned Tijdschr Geneeskd ; 1662022 09 26.
Artigo em Holandês | MEDLINE | ID: mdl-36300436

RESUMO

Breast cancer is the most commonly occurring malignancy in women. Every year, this type of cancer is newly diagnosed in almost 15,000 women and over 100 men in the Netherlands. Survival depends on the stage of disease and has improved over time. However, every year approximately 3100 women die of breast cancer in the Netherlands. Recent developments in breast cancer care focus on more breast and axilla conserving treatments, and the omission or more limited application of adjuvant chemotherapy or additional radiotherapy if it is deemed safe. In this educational article we discuss aspects of detection, diagnosis, treatment and follow-up of breast cancer.


Assuntos
Neoplasias da Mama , Mastectomia Segmentar , Feminino , Humanos , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Axila , Países Baixos , Radioterapia Adjuvante , Estadiamento de Neoplasias
18.
Oncologist ; 16(10): 1403-12, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21914699

RESUMO

INTRODUCTION: A comprehensive geriatric assessment systematically collects information on geriatric conditions and is propagated in oncology as a useful tool when assessing older cancer patients. OBJECTIVES: The objectives were: (a) to study the prevalence of geriatric conditions in cancer patients aged ≥ 65 years, acutely admitted to a general medicine ward; (b) to determine functional decline and mortality within 12 months after admission; and (c) to assess which geriatric conditions and cancer-related variables are associated with 12-month mortality. METHODS: This was an observational cohort study of 292 cancer patients aged ≥ 65 years, acutely admitted to the general medicine and oncology wards of two university hospitals and one secondary teaching hospital. Baseline assessments included patient characteristics, reason for admission, comorbidity, and geriatric conditions. Follow-up at 3 and 12 months was aimed at functional decline (loss of one or more activities of daily living [ADL]) and mortality. RESULTS: The median patient age was 74.9 years, and 95% lived independently; 126 patients (43%) had metastatic disease. A high prevalence of geriatric conditions was found for instrumental ADL impairment (78%), depressive symptoms (65%), pain (65%), impaired mobility (48%), malnutrition (46%), and ADL impairment (38%). Functional decline was observed in 8% and 33% of patients at 3 and 12 months, respectively. Mortality rates were 38% at 3 months and 64% at 12 months. Mortality was associated with cancer-related factors only. CONCLUSION: In these acutely hospitalized older cancer patients, mortality was only associated with cancer-related factors. The prevalence of geriatric conditions in this population was high. Future research is needed to elucidate if addressing these conditions can improve quality of life.


Assuntos
Avaliação Geriátrica/métodos , Neoplasias/terapia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Comorbidade , Feminino , Seguimentos , Geriatria/estatística & dados numéricos , Mortalidade Hospitalar , Hospitalização , Humanos , Masculino , Neoplasias/complicações , Neoplasias/epidemiologia , Países Baixos/epidemiologia , Estudos Prospectivos
19.
Breast J ; 15(1): 26-33, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19141131

RESUMO

We set out to investigate the level of accordance of diagnosis and treatment of elderly breast cancer patients with national guidelines and to study predictors of deviation. Data on patient and tumor variables were collected from charts of 166 patients aged 70 years and older, diagnosed at our hospital in 2002-2004. Diagnostic work-up and treatment were compared with guidelines and reasons for deviation were recorded; 122 (74%) patients were diagnosed and treated in accordance with guidelines. Diagnosis was incomplete in 19 patients (11%). Surgery, radiotherapy, and hormonal therapy were withheld in 19 (11%), 11 (7%), and 9 (5%) patients, respectively. Guideline deviation was motivated in 18 patients (11%) (comorbidity n=11, patients' preferences n=5, age n=2), unmotivated in 18 (11%), and undeliberate in 8 (5%). Our study demonstrates that deviation from guidelines in elderly breast cancer patients mainly occurs due to a deliberate adjustment to patient's comorbidity and preference.


Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/mortalidade , Estudos de Coortes , Comorbidade , Feminino , Humanos , Guias de Prática Clínica como Assunto , Estudos Retrospectivos
20.
Ned Tijdschr Geneeskd ; 1632019 05 31.
Artigo em Holandês | MEDLINE | ID: mdl-31187968

RESUMO

Breast cancer is the most commonly occurring malignancy in women. Every year, this type of cancer is newly diagnosed in almost 15,000 women and over 100 men in the Netherlands. The prognosis of breast cancer has improved considerably due to timely recognition using screening and particularly due to improved and multidisciplinary treatment. Nonetheless, annually more than 3100 women still die of breast cancer in the Netherlands. The latest developments in breast cancer care focus on more breast and axilla conserving treatments, and the omission or more limited application of adjuvant chemotherapy or additional radiotherapy if it is deemed safe. In this educational article we discuss aspects of detection, diagnosis, treatment and follow-up of breast cancer.


Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Detecção Precoce de Câncer/estatística & dados numéricos , Quimioterapia Adjuvante , Feminino , Humanos , Mastectomia Segmentar , Estadiamento de Neoplasias , Países Baixos , Prognóstico , Radioterapia Adjuvante , Medição de Risco
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