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3.
Ann Oncol ; 24(5): 1203-11, 2013 May.
Article in English | MEDLINE | ID: mdl-23293111

ABSTRACT

Background In women with node-positive breast cancer, the Breast International Group (BIG) 02-98 tested the incorporation of docetaxel (Taxotere) into doxorubicin (Adriamycin)-based chemotherapy, and compared sequential and concurrent docetaxel. At 5 years, there was a trend for improved disease-free survival (DFS) with docetaxel. We present results at 8-year median follow-up and exploratory analyses within biologically defined subtypes. Methods Patients were randomly assigned to one of four treatments: (i) sequential control: doxorubicin (A) (75 mg/m(2)) × 4 →classical cyclophosphamide, methotrexate, 5-fluorouracil (CMF); (ii) concurrent control: doxorubicin, cyclophosphamide (AC)(60/600 mg/m(2)) × 4 →CMF; (iii) sequential docetaxel: A (75 mg/m(2)) × 3 → docetaxel (T) (100 mg/m(2)) × 3 → CMF and (iv) concurrent docetaxel: AT(50/75 mg/m(2)) × 4 →CMF. The primary comparison evaluated docetaxel efficacy regardless of the schedule. Exploratory analyses were undertaken within biologically defined subtypes. Results Two thousand eight hundred and eighty-seven patients were enrolled. After 93.4 months of median follow-up, there were 916 DFS events. For the primary comparison, there was no significant improvement in DFS from docetaxel [hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.80-1.05, P = 0.187]. In secondary comparisons, sequential docetaxel significantly improved DFS compared with sequential control (HR = 0.81, 95% CI = 0.67-0.99, P = 0.036), and significantly improved DFS (HR = 0.84, 95% CI = 0.72-0.99, P = 0.035) and overall survival (OS) (HR = 0.79, 95% CI = 0.65-0.98, P = 0.028) compared with concurrent doxorubicin-docetaxel. Luminal-A disease had the best prognosis. HRs favored addition of sequential docetaxel in all subtypes, except luminal-A; but this observation was not statistically supported because of limited numbers. Conclusion With further follow-up, the sequential docetaxel schedule resulted in significantly better OS than concurrent doxorubicin-docetaxel, and continued to show better DFS than sequential doxorubicin-based control.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Doxorubicin/therapeutic use , Taxoids/therapeutic use , Adolescent , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/mortality , Cyclophosphamide/administration & dosage , Cyclophosphamide/therapeutic use , Disease-Free Survival , Docetaxel , Doxorubicin/administration & dosage , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/therapeutic use , Humans , Lymphatic Metastasis , Methotrexate/administration & dosage , Methotrexate/therapeutic use , Middle Aged , Taxoids/administration & dosage , Young Adult
4.
Br J Cancer ; 100(3): 442-9, 2009 Feb 10.
Article in English | MEDLINE | ID: mdl-19156139

ABSTRACT

To assess the efficacy of exemestane as neoadjuvant treatment, 55 postmenopausal women (mean age: 76 years; range: 66-86) with oestrogen-positive non-metastatic breast tumour and ineligible for conservative surgery were recruited into this phase II trial to receive oral exemestane (25 mg day(-1)) for 6 months. Tumour response was evaluated by clinical examination, mammography and breast ultrasound every 2 months (RECIST criteria). Overall clinical response to treatment was observed in 33/54 patients (61.1%; 95% CI: 48.1-74.0). Radiological responses in 45 evaluable patients were partial response in 23, stable disease in 21 and disease progression in one. Median time to surgery from the commencement of treatment was 7 months; conservative surgery in 24 patients (55.8%) and mastectomy in 19 patients (34.5%); no surgery (patient choice or considered not suitable by attending physician) in 12 patients. Pathologic complete response was observed in breast and axilla in one patient (2.3%) and different forms of persistent disease in 23 (53.5%) patients. Treatment tolerance was good. No patient withdrew from the study because of toxic events. We conclude that exemestane as a primary treatment is feasible and very active in elderly patients with large-sized breast cancer tumour. Conservative surgery is feasible in responding patients. No severe adverse events were detected. The optimal hormonal treatment schedule remains to be determined.


Subject(s)
Androstadienes/therapeutic use , Antineoplastic Agents/therapeutic use , Aromatase Inhibitors/therapeutic use , Breast Neoplasms/drug therapy , Postmenopause , Receptors, Estrogen/metabolism , Aged , Aged, 80 and over , Breast Neoplasms/metabolism , Breast Neoplasms/surgery , Combined Modality Therapy , Disease Progression , Female , Humans , Middle Aged , Survival Analysis
5.
Farm Hosp ; 31(5): 270-5, 2007.
Article in Spanish | MEDLINE | ID: mdl-18052629

ABSTRACT

OBJECTIVE: To know relative dose intensity (RDI) in patients with breast cancer treated with chemotherapy. To determine the number of patients where RDI was < 85% of that programmed and the possible cause. METHOD: Retrospective study, four-month selection period. The following were recorded: age, body surface, protocol applied, intention of treatment, frequency of administration of cycles, number of cytostatic treatments previously received and filgrastim administration. The average RDI per patient and protocol was calculated. RESULTS: 110 patients were analysed, the average age of them being 55.4 years (interval: 31-84), average body surface 1.7 m2 (1.3-2.4). Overall average RDI was 91.0% (SD 10.7). 93.8% (10.6), 95.8% (6.3) and 81.9% (18.5) in neoadjuvant, adjuvant and palliative treatments, respectively. 20% of the patients did not reach a RDI = 85% of that programmed, average RDI 69.5% (3.29). A delay in the administration of chemotherapy equal or greater than seven days occurred in 45.4% of the cases, average RDI 80.7% (16.0). In the episodes where the dose was reduced because of toxicity, the RDI was 75.6% (13.6). Significant inverse ratios were obtained with age (p = 0.02) and line of treatment (p = 0.03) with the RDI. In 36.8%, dose reduction was caused by neutropenia; 52.9% received filgrastim. CONCLUSIONS: Most patients received the appropriate RDI. Age, previous treatments and intention of treatment were the variables with the greatest impact on the dose received. The delay in administering the cycle was the most frequent act minimising the toxicity and which least affected the treatment.


Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/administration & dosage , Dose-Response Relationship, Drug , Drug Administration Schedule , Humans , Middle Aged , Retrospective Studies
6.
Farm. hosp ; 31(5): 270-275, sept.-oct. 2007. tab
Article in Es | IBECS | ID: ibc-63233

ABSTRACT

Objetivo: Conocer las intensidades de dosis relativas (IDR) enpacientes con cáncer de mama y tratamiento quimioterápico.Determinar el número de pacientes donde la IDR fue < 85% de laprogramada y posible causa.Método: Estudio retrospectivo, periodo de selección de 4 meses.Se registraron: edad, superficie corporal, protocolo administrado,intención de tratamiento, frecuencia de administración de ciclos,número de tratamientos citostáticos recibidos anteriormente y administraciónde filgrastim. Se calculó la IDR media por paciente y protocolo.Resultados: Se analizaron 110 pacientes, edad media 55,4años (intervalo: 31-84), superficie corporal media 1,7 m2 (1,3-2,4). La IDR media global fue 91,0% (DE 10,7). Del 93,8%(10,6), 95,8% (6,3) y 81,9% (18,5) en neoadyuvancia, adyuvanciay tratamiento paliativo, respectivamente. El 20% de pacientesno alcanzó una IDR >= 85% de la programada, IDR media 69,5%(3,29). Un retraso en la administración de quimioterapia igual osuperior a 7 días ocurrió en un 45,4% de los casos, IDR media80,7% (16,0). En los episodios donde se disminuyó la dosis portoxicidad la IDR media fue 75,6% (13,6). Se obtuvieron relacionesinversas significativas de la edad (p = 0,02) y línea de tratamiento(p = 0,03) con la IDR. En un 36,8% la reducción de dosisfue por neutropenia, recibiendo filgrastim el 52,9%.Conclusiones: La mayoría de pacientes recibió una IDR adecuada.La edad, tratamientos anteriores e intención de tratamientofueron las variables que más afectaron a la dosis recibida. Elretraso en la administración del ciclo fue la actuación más frecuentepara minimizar la toxicidad y que menos afectó al tratamiento


Objective: To know relative dose intensity (RDI) in patientswith breast cancer treated with chemotherapy. To determine thenumber of patients where RDI was < 85% of that programmedand the possible cause.Method: Retrospective study, four-month selection period.The following were recorded: age, body surface, protocol applied,intention of treatment, frequency of administration of cycles,number of cytostatic treatments previously received and filgrastimadministration. The average RDI per patient and protocol was calculated.Results: 110 patients were analysed, the average age of thembeing 55.4 years (interval: 31-84), average body surface 1.7 m2(1.3-2.4). Overall average RDI was 91.0% (SD 10.7). 93.8%(10.6), 95.8% (6.3) and 81.9% (18.5) in neoadjuvant, adjuvantand palliative treatments, respectively. 20% of the patients did notreach a RDI >= 85% of that programmed, average RDI 69.5%(3.29). A delay in the administration of chemotherapy equal orgreater than seven days occurred in 45.4% of the cases, averageRDI 80.7% (16.0). In the episodes where the dose was reducedbecause of toxicity, the RDI was 75.6% (13.6). Significant inverseratios were obtained with age (p = 0.02) and line of treatment(p = 0.03) with the RDI. In 36.8%, dose reduction was caused byneutropenia; 52.9% received filgrastim.Conclusions: Most patients received the appropriate RDI.Age, previous treatments and intention of treatment were thevariables with the greatest impact on the dose received. The delayin administering the cycle was the most frequent act minimisingthe toxicity and which least affected the treatment


Subject(s)
Humans , Female , Breast Neoplasms/drug therapy , Antineoplastic Agents/administration & dosage , Disease-Free Survival , Neutropenia/epidemiology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use
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