RESUMEN
BACKGROUND: We aimed at investigating outcome of systemic treatments in advanced breast PT. METHODS: All cases of advanced breast PT treated with systemic treatments from 1999 to 2019, in one of the referral sarcoma centers involved in the study, were retrospectively reviewed. RESULTS: 56 female patients were identified. Median age was 52 (range of 25-76) years. Patients received a median number of 2 systemic treatments (range of 1-4). Best responses according to RECIST were 1 (3.7%) CR, 11 (40.7%) PR, 6 (22.2%) SD, 9 (33.3%) PD with anthracyclines plus ifosfamide (AI); 2 (16.7%) PR, 4 (33.3%) SD, 6 (50.0%) PD with anthracycline alone; 3 (18.8%) PR, 4 (25.0%) SD, 9 (56.3%) PD with high-dose ifosfamide given as a continuous infusion (HD-IFX); 3 (20.0%) SD, 12 (80.0%) PD with a gemcitabine-based regimen (with 2 patients not evaluable); 1 (8.3%) PR, 2 (16.7%) SD, 9 (75.0%) PD with trabectedin (with 1 patient not evaluable); 1 (16.7%) PR, 1 (16.7%) SD, 4 (66.7%) PD with tyrosine-kinase inhibitors (TKI). The median PFS were 5.7 (IQR 2.5-9.1) months with AI; 3.2 (IQR 2.2-5.0) months with anthracycline alone; 3.4 (IQR 1.4-6.7) months with HD-IFX; 2.1 (IQR 1.4-5.2) months with gemcitabine-based chemotherapy; 1.8 (IQR 0.7-6.6) months with trabectedin; 3.4 (IQR 3.1-3.8) months with TKI. With a median follow-up of 35.3 (IQR 17.6-66.9) months, OS from the start of first-line systemic treatment was 15.2 (IQR 7.6-39.6) months. CONCLUSION: In this series of advanced PT (to our knowledge, the largest reported so far), AI was associated with a high rate of responses, however, with a median PFS of 5.7 months. Other systemic treatments were poorly active.
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Neoplasias de la Mama , Sarcoma , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Humanos , Persona de Mediana Edad , Criterios de Evaluación de Respuesta en Tumores Sólidos , Estudios Retrospectivos , Sarcoma/patologíaRESUMEN
BACKGROUND: Previous analysis of COMBI-d (NCT01584648) demonstrated improved progression-free survival (PFS) and overall survival (OS) with combination dabrafenib and trametinib versus dabrafenib monotherapy in BRAF V600E/K-mutant metastatic melanoma. This study was continued to assess 3-year landmark efficacy and safety after ≥36-month follow-up for all living patients. PATIENTS AND METHODS: This double-blind, phase 3 study enrolled previously untreated patients with BRAF V600E/K-mutant unresectable stage IIIC or stage IV melanoma. Patients were randomized to receive dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or dabrafenib plus placebo. The primary endpoint was PFS; secondary endpoints were OS, overall response, duration of response, safety, and pharmacokinetics. RESULTS: Between 4 May and 30 November 2012, a total of 423 of 947 screened patients were randomly assigned to receive dabrafenib plus trametinib (n = 211) or dabrafenib monotherapy (n = 212). At data cut-off (15 February 2016), outcomes remained superior with the combination: 3-year PFS was 22% with dabrafenib plus trametinib versus 12% with monotherapy, and 3-year OS was 44% versus 32%, respectively. Twenty-five patients receiving monotherapy crossed over to combination therapy, with continued follow-up under the monotherapy arm (per intent-to-treat principle). Of combination-arm patients alive at 3 years, 58% remained on dabrafenib plus trametinib. Three-year OS with the combination reached 62% in the most favourable subgroup (normal lactate dehydrogenase and <3 organ sites with metastasis) versus only 25% in the unfavourable subgroup (elevated lactate dehydrogenase). The dabrafenib plus trametinib safety profile was consistent with previous clinical trial observations, and no new safety signals were detected with long-term use. CONCLUSIONS: These data demonstrate that durable (≥3 years) survival is achievable with dabrafenib plus trametinib in patients with BRAF V600-mutant metastatic melanoma and support long-term first-line use of the combination in this setting.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biomarcadores de Tumor/genética , Imidazoles/administración & dosificación , Melanoma/tratamiento farmacológico , Mutación , Oximas/administración & dosificación , Inhibidores de Proteínas Quinasas/administración & dosificación , Proteínas Proto-Oncogénicas B-raf/genética , Piridonas/administración & dosificación , Pirimidinonas/administración & dosificación , Neoplasias Cutáneas/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/farmacocinética , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Método Doble Ciego , Esquema de Medicación , Humanos , Imidazoles/efectos adversos , Imidazoles/farmacocinética , Estimación de Kaplan-Meier , Melanoma/genética , Melanoma/mortalidad , Melanoma/secundario , Oximas/efectos adversos , Oximas/farmacocinética , Inhibidores de Proteínas Quinasas/efectos adversos , Inhibidores de Proteínas Quinasas/farmacocinética , Piridonas/efectos adversos , Piridonas/farmacocinética , Pirimidinonas/efectos adversos , Pirimidinonas/farmacocinética , Factores de Riesgo , Neoplasias Cutáneas/genética , Neoplasias Cutáneas/mortalidad , Neoplasias Cutáneas/patología , Factores de Tiempo , Resultado del TratamientoAsunto(s)
Neoplasias Gastrointestinales , Tumores del Estroma Gastrointestinal , Sarcoma , Estudios de Seguimiento , Neoplasias Gastrointestinales/diagnóstico , Neoplasias Gastrointestinales/epidemiología , Neoplasias Gastrointestinales/terapia , Tumores del Estroma Gastrointestinal/diagnóstico , Tumores del Estroma Gastrointestinal/epidemiología , Tumores del Estroma Gastrointestinal/terapia , Humanos , Sarcoma/terapiaAsunto(s)
Neoplasias Óseas , Osteosarcoma , Sarcoma , Neoplasias Óseas/diagnóstico , Neoplasias Óseas/epidemiología , Neoplasias Óseas/terapia , Estudios de Seguimiento , Humanos , Osteosarcoma/diagnóstico , Osteosarcoma/epidemiología , Osteosarcoma/terapia , Sarcoma/diagnóstico , Sarcoma/epidemiología , Sarcoma/terapiaAsunto(s)
Neoplasias Óseas/terapia , Oncología Médica/normas , Osteosarcoma/terapia , Participación del Paciente , Adulto , Cuidados Posteriores/métodos , Cuidados Posteriores/normas , Factores de Edad , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biopsia , Neoplasias Óseas/diagnóstico , Neoplasias Óseas/epidemiología , Neoplasias Óseas/patología , Huesos/diagnóstico por imagen , Huesos/patología , Huesos/cirugía , Niño , Europa (Continente) , Humanos , Incidencia , Cuidados a Largo Plazo/métodos , Cuidados a Largo Plazo/normas , Imagen por Resonancia Magnética , Oncología Médica/métodos , Terapia Neoadyuvante/métodos , Terapia Neoadyuvante/normas , Estadificación de Neoplasias , Procedimientos Ortopédicos/métodos , Procedimientos Ortopédicos/normas , Osteosarcoma/diagnóstico , Osteosarcoma/epidemiología , Osteosarcoma/patología , Tomografía Computarizada por Tomografía de Emisión de Positrones , Cintigrafía , Radioterapia Adyuvante/métodos , Radioterapia Adyuvante/normas , Grupos de Autoayuda/normas , Sociedades Médicas/normas , Supervivencia , Resultado del TratamientoAsunto(s)
Oncología Médica/normas , Participación del Paciente , Sarcoma/terapia , Adulto , Cuidados Posteriores/métodos , Cuidados Posteriores/normas , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biopsia , Europa (Continente) , Humanos , Incidencia , Metástasis Linfática/diagnóstico por imagen , Metástasis Linfática/patología , Imagen por Resonancia Magnética/métodos , Imagen por Resonancia Magnética/normas , Oncología Médica/métodos , Terapia Neoadyuvante/métodos , Terapia Neoadyuvante/normas , Clasificación del Tumor , Estadificación de Neoplasias , Radioterapia Adyuvante/métodos , Radioterapia Adyuvante/normas , Sarcoma/diagnóstico , Sarcoma/epidemiología , Sarcoma/patología , Grupos de Autoayuda/normas , Sociedades Médicas/normas , Procedimientos Quirúrgicos Operativos/métodos , Procedimientos Quirúrgicos Operativos/normas , Tomografía Computarizada por Rayos X/métodos , Tomografía Computarizada por Rayos X/normas , Resultado del TratamientoAsunto(s)
Tumores del Estroma Gastrointestinal/terapia , Oncología Médica/normas , Participación del Paciente , Adulto , Cuidados Posteriores/métodos , Cuidados Posteriores/normas , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioterapia Adyuvante/métodos , Quimioterapia Adyuvante/normas , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Procedimientos Quirúrgicos del Sistema Digestivo/normas , Endosonografía , Europa (Continente) , Tumores del Estroma Gastrointestinal/diagnóstico , Tumores del Estroma Gastrointestinal/epidemiología , Tumores del Estroma Gastrointestinal/patología , Humanos , Biopsia Guiada por Imagen/métodos , Biopsia Guiada por Imagen/normas , Incidencia , Intestinos/diagnóstico por imagen , Intestinos/patología , Intestinos/cirugía , Laparoscopía/métodos , Laparoscopía/normas , Márgenes de Escisión , Oncología Médica/métodos , Estadificación de Neoplasias , Grupos de Autoayuda/normas , Sociedades Médicas/normas , Estómago/diagnóstico por imagen , Estómago/patología , Estómago/cirugía , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
BACKGROUND: Bone metastatic patients with osteosarcoma have a very poor prognosis. Targeted radiation therapy has been pursued as a valid alternative. The primary end point of this study was progression-free survival (PFS) at 4 months. PATIENTS AND METHODS: Twenty-two osteosarcoma patients were treated with Samarium-153 ethylenediaminetetramethylene phosphonic acid (153Sm-EDTMP) at various dosages. Administered activities ranged from 150 (3 mCi/kg) to 1140 MBq/kg (30 mCi/kg). Autologous hematopoietic stem cell infusion was carried out on day 14 after the (153)Sm-EDTMP infusion. RESULTS: The median PFS was 61 days (18-436 days) and the median overall survival (OS) was 189 days (31-1175 days). PFS and OS for the entire patient population were 32% [95% confidence interval (CI) 16-50] and 76% (95% CI 52-89) at 4 months, respectively. No statistical differences emerged according to 153Sm-EDTMP administered or 24-h retained activity. One-month pain palliation was only observed in a minority of subjects and in none at 4 months. CONCLUSIONS: Based on our series, the PFS is dramatically short even when higher activity of (153)Sm-EDTMP is administered. This would mean that, even at high level, 153Sm-EDTMP is itself ineffective against relapsed osteosarcoma or the residual activity is too low to be active on these particular subsets of patients.
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Neoplasias Óseas/terapia , Compuestos Organometálicos/administración & dosificación , Compuestos Organofosforados/administración & dosificación , Osteosarcoma/terapia , Radiofármacos/administración & dosificación , Adolescente , Adulto , Neoplasias Óseas/mortalidad , Neoplasias Óseas/patología , Niño , Terapia Combinada , Supervivencia sin Enfermedad , Femenino , Trasplante de Células Madre Hematopoyéticas , Humanos , Estimación de Kaplan-Meier , Masculino , Compuestos Organometálicos/efectos adversos , Compuestos Organometálicos/farmacocinética , Compuestos Organofosforados/efectos adversos , Compuestos Organofosforados/farmacocinética , Osteosarcoma/mortalidad , Osteosarcoma/secundario , Dosis de Radiación , Radiofármacos/efectos adversos , Radiofármacos/farmacocinética , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
In patients with osteosarcoma several causative factors are implicated in the occurrence of osteoporosis, such as no weight-bearing, pre- and post-surgical immobilization, and neoadjuvant and adjuvant chemotherapy. Nevertheless, osteoporotic fractures are a rare complication in young patients. We report the case of a spontaneous greenstick fracture of the distal tibia occurring during adjuvant chemotherapy in a 12-year-old Caucasian girl. Among the various drugs, the main role of methotrexate was investigated. A review of the literature is also presented along with a discussion about the role of preventive agents able to reduce the occurrence of osteopenia and/or osteoporosis following cancer treatment.
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Antimetabolitos Antineoplásicos/efectos adversos , Neoplasias Óseas/tratamiento farmacológico , Rodilla , Metotrexato/efectos adversos , Osteoporosis/inducido químicamente , Osteosarcoma/tratamiento farmacológico , Fracturas de la Tibia/inducido químicamente , Antimetabolitos Antineoplásicos/administración & dosificación , Neoplasias Óseas/diagnóstico por imagen , Niño , Femenino , Humanos , Metotrexato/administración & dosificación , Osteoporosis/diagnóstico por imagen , Osteoporosis/terapia , Osteosarcoma/diagnóstico por imagen , Radiografía , Fracturas de la Tibia/diagnóstico por imagen , Fracturas de la Tibia/terapiaRESUMEN
Epithelioid hemangioendothelioma (EHE) is an ultra-rare, translocated, vascular sarcoma. EHE clinical behavior is variable, ranging from that of a low-grade malignancy to that of a high-grade sarcoma and it is marked by a high propensity for systemic involvement. No active systemic agents are currently approved specifically for EHE, which is typically refractory to the antitumor drugs used in sarcomas. The degree of uncertainty in selecting the most appropriate therapy for EHE patients and the lack of guidelines on the clinical management of the disease make the adoption of new treatments inconsistent across the world, resulting in suboptimal outcomes for many EHE patients. To address the shortcoming, a global consensus meeting was organized in December 2020 under the umbrella of the European Society for Medical Oncology (ESMO) involving >80 experts from several disciplines from Europe, North America and Asia, together with a patient representative from the EHE Group, a global, disease-specific patient advocacy group, and Sarcoma Patient EuroNet (SPAEN). The meeting was aimed at defining, by consensus, evidence-based best practices for the optimal approach to primary and metastatic EHE. The consensus achieved during that meeting is the subject of the present publication.
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Hemangioendotelioma Epitelioide , Sarcoma , Adulto , Niño , Consenso , Hemangioendotelioma Epitelioide/diagnóstico , Hemangioendotelioma Epitelioide/tratamiento farmacológico , Humanos , Oncología Médica , Defensa del Paciente , Sarcoma/diagnóstico , Sarcoma/tratamiento farmacológicoRESUMEN
The aim of the study was to evaluate efficacy, safety and impact on life expectancy of levetiracetam (LEV), oxcarbazepine (OXC) and topiramate (TPM) monotherapy in patients with seizures related to brain metastases. We conducted a prospective observational study on 70 patients with brain metastases. Thirteen patients were excluded because they were in prophylactic therapy with antiepileptics, nine patients did not return to our Center. A total of 48 patients with epilepsy related to brain metastases were enrolled. Patients were treated with LEV, OXC and TPM in monotherapy and followed until their death. Eighteen patients dropped out. Therefore, we followed 30 patients. Mean duration of follow-up was 6.1 months. Upon visiting the patients prior to their death (i.e. last visit preceding the death of the patients), we observed a significant reduction (P < 0.001) in the mean monthly seizure frequency; with 19 patients (63.3%) obtaining complete seizure control in the whole population. A significant improvement of seizure frequency was also observed considering each antiepileptic treatment group separately. Median survival time was similar among the three groups of patients and was similar to Class I of prognostic factors of Radiation Therapy Oncology Group. Logistic regression showed that systemic treatments did not influence the antiepileptics' efficacy on seizure control (P = 0.614). In conclusion, regarding the use of newer antiepileptics in patients with seizures related to brain metastases, our data indicate that LEV, OXC and TPM significantly reduce seizure frequency (independently of systemic treatment), produce few side effects and appear not to affect life expectancy.
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Anticonvulsivantes/uso terapéutico , Neoplasias Encefálicas/complicaciones , Epilepsia/tratamiento farmacológico , Epilepsia/etiología , Esperanza de Vida , Adulto , Anciano , Anticonvulsivantes/efectos adversos , Neoplasias Encefálicas/mortalidad , Neoplasias Encefálicas/secundario , Evaluación de Medicamentos/métodos , Epilepsia/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Tumor necrosis factor-alpha (TNFalpha)-based hyperthermic isolated limb perfusion (HILP) is routinely carried out at most oncological institutions in the treatment of locally advanced soft tissue limb sarcoma (STS), employing high TNFalpha dosages. After a phase I-II study, the SITILO (Italian Society of Integrated Locoregional Therapies in Oncology) centers began to employ the lower dose of 1 mg of TNFalpha. The aim of this paper is to report on the results obtained in 75 patients with limb-threatening STS treated with a low TNFalpha dose and doxorubicin (Dx). PATIENTS AND METHODS: HILP with TNFalpha (at a dosage of either
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Doxorrubicina/administración & dosificación , Hipertermia Inducida , Sarcoma/tratamiento farmacológico , Neoplasias de los Tejidos Blandos/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia del Cáncer por Perfusión Regional/métodos , Supervivencia sin Enfermedad , Extremidades/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Perfusión , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: In isolated limb perfusion (ILP) with tumor necrosis factor-alpha (TNFalpha) and interferon (IFN)-gamma, pioneered by Lienard and Lejenne in 1988, TNFalpha was empirically employed at a dosage (3-4 mg) ten times higher than the systemic maximum tolerable dose (MTD). We previously conducted a phase I/II study in 20 patients with in-transit melanoma metastases, using a combination of melphalan and TNFalpha at dosages ranging from 0.5 to 3.3 mg. The dose of 1 mg of TNFalpha was identified as optimal in terms of both efficacy and toxicity. The aim of the present study was to describe our experience with 113 stage IIIA/IIIAB melanoma patients treated with a TNFalpha-based ILP and identify prognostic factors for response, locoregional control and survival. PATIENTS AND METHODS: Patients at stage IIIA-IIIAB (presence of in-transit metastases and/or regional node involvement) were considered eligible. The disease was bulky (>or=10 nodules
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Melanoma/tratamiento farmacológico , Melanoma/patología , Factor de Necrosis Tumoral alfa/metabolismo , Adulto , Anciano , Anciano de 80 o más Años , Extremidades , Femenino , Humanos , Masculino , Dosis Máxima Tolerada , Melanoma/mortalidad , Melfalán/farmacología , Persona de Mediana Edad , Metástasis de la Neoplasia , Perfusión , Pronóstico , Resultado del TratamientoRESUMEN
The aim of the current study was to evaluate the activity and toxicity of a combination of oxaliplatin with bolus fluorouracil and leucovorin in colorectal cancer (CRC) patients pretreated for advanced disease with various schedules including continuous fluorouracil infusion. Thirty consecutive patients with pretreated advanced CRC received oxaliplatin 130 mg/m2 by 2-h infusion dl, leucovorin 100 mg/m2 by 1-h infusion followed by fluorouracil 425 mg/m2 i.v. bolus from day 1 to 3 every 3 weeks for a maximum of 6 cycles. The best overall response rate in an intent-to-treat analysis was 13% (2 complete responses and 2 partial responses) (95% CI, 1.2-25.5%) and 37% of patients obtained stable disease with a tumor growth control rate of 50% (95% CI, 32.1-67.9%). The median progression-free survival was 4.0 months (95% CI, 1.4-6.5 months) and median overall survival was 12.0 months (95% CI, 9.9-14.1 months). The independent prognostic factors for improved overall survival were a good performance status and a response/stabilization of disease to chemotherapy. Severe neutropenia was quite common (43.3% of patients and 14.4% of cycles), although complicated by fever only in one case (3.3% of patients). There was one toxic death. In conclusion, the study combination showed an interesting rate of tumor growth control in a cohort of patients previously treated for advanced disease with various schedules including continuous fluorouracil infusion.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Fluorouracilo/toxicidad , Leucovorina/toxicidad , Compuestos Organoplatinos/toxicidad , Adulto , Anciano , Estudios de Cohortes , Neoplasias Colorrectales/mortalidad , Supervivencia sin Enfermedad , Femenino , Fluorouracilo/administración & dosificación , Humanos , Infusiones Intravenosas , Leucovorina/administración & dosificación , Masculino , Persona de Mediana Edad , Compuestos Organoplatinos/administración & dosificación , Oxaliplatino , Pronóstico , Factores de Tiempo , Resultado del TratamientoRESUMEN
Between February 1990 and December 1991 high-dose epirubicin (Epi)(120 mg/m2) plus cyclophosphamide (CTX)(600 mg/m2) were given every 3 weeks to 52 patients with locally advanced and metastatic breast cancer. 26 patients with locally advanced disease received four courses of this regimen before and after local treatments. 26 patients had metastatic disease: they received eight courses unless progression or unacceptable toxicity occurred. Responses were seen in 37/48 (77%) evaluable patients including 14 complete responses (CR), 23 partial responses (PR), nine stable disease, two progressive disease. Among the 25 evaluable patients with locally advanced disease, 9 had a CR and 11 a > 80% decrease in tumour volume. 6 patients (24%) had a pathologically confirmed complete response. 18 patients (72%) had a tumour reduction to 0-2 cm. The 3-year disease-free survival was 60%. Of the 23 evaluable patients with metastatic disease, 5 obtained a CR and 10 a PR, yielding an overall response rate of 65%. Myelosuppression was substantial with a grade 3-4 leucopenia in 76% of the patients even if neutropenic fever occurred in only 7% of the courses. A clinical congestive heart failure occurred in 1 patient following a total Epi dose of 960 mg/m2 and a bilateral quadrantectomy and radiotherapy. We conclude that (1) high-dose Epi + CTX is a very active regimen, in particular for the patients with locally advanced breast cancer; (2) breast conservation after this regimen in some of these patients may be considered; (3) neutropenia is the dose-limiting toxicity. Currently, a phase II study using the same combination given every 2 weeks together with r-methuG-CSF is ongoing.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Ciclofosfamida/administración & dosificación , Supervivencia sin Enfermedad , Epirrubicina/administración & dosificación , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Neutropenia/inducido químicamente , Resultado del TratamientoRESUMEN
Docetaxel has proven effective in advanced breast cancer. Myelosuppression and cumulative fluid retention syndrome are troublesome, potentially avoidable toxicities. In this consecutive cohort study, docetaxel (100 mg/m2 by 1 hour i.v. infusion, q3 weeks) activity and toxicity was explored in 56 anthracycline-pretreated patients (eligible: 55: median age: 51 years [range: 28-68 years]; median performance status: 0 [range: 0-3]) with metastatic breast cancer, using two different granulocyte colony-stimulating factor and steroid pre- and postmedication schedules. Twenty-nine patients (group A) received a 5-day oral prednisone premedication, and 26 (group B) received 4-day low-dose i.m. dexamethasone; group B patients also received prophylactic granulocyte colony-stimulating factor. All patients were evaluable for toxicity and 53 for response. Prophylactic granulocyte colony-stimulating factor significantly lowered the incidence of grade III-IV neutropenia and neutropenic fever (p = 0.0001 and 0.01, respectively). The incidence of moderate-severe fluid retention syndrome was lower in patients receiving i.m. dexamethasone (p = 0.08). Overall response rate was 53% (4 complete responses/24 partial responses, 95% confidence interval 39.4-66.2%); 32% have stable disease and 15% progressive disease. In 21 anthracycline-refractory/resistant patients, as well as in 10 paclitaxel-pretreated patients, the overall response rate was 50%. Docetaxel is highly active in anthracycline- and paclitaxel-pretreated metastatic breast cancer, with manageable toxicity. Optimal use of both granulocyte colony-stimulating factor support and steroid premedication deserves further investigation.