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1.
Am J Clin Oncol ; 22(5): 446-9, 1999 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-10521055

RESUMEN

The authors report a phase II pilot investigation in the Southwest Oncology Group examining a combination of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) incorporating modulated 5-FU in patients with poor-prognosis stage IV breast cancer. Patients with poor-prognosis stage IV breast cancer were treated with this "neo-FAC" as front-line therapy. The regimen consisted of 5-fluorouracil by continuous ambulatory infusion pump at 200 mg/m2/day for 42 days, repeated at 56-day intervals; doxorubicin at 20 mg/m2/week intravenously to a maximum cumulative total dose (including adjuvant therapy, if any) of 500 mg/m2; cyclophosphamide 60 mg/m2/day taken orally; methotrexate 15 mg/m2/week intravenously beginning 1 week after termination of doxorubicin; and oral prednisone decreasing from 60 mg/day on a tapering schedule for a total of 7 weeks of treatment. Treatment was continued until progression, unacceptable toxicity, or patient refusal. Twenty-four patients were accrued to this study. Of these, two were ineligible, and the remaining 22 were evaluable for response. Ten patients experienced grade 3 toxicity, and six had grade 4. There were no treatment-associated deaths. Best responses were a complete response in one patient (5%) and partial responses in 6, for an overall response rate of 32% (7/22 evaluable patients). Overall survival in five pilot studies in the Southwest Oncology Group in this poor-prognosis population are relatively superimposable. The present regimen, with its relatively poor outcome and the expense and inconvenience of administering chemotherapy by ambulatory infusion pump, will not be pursued further.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Humanos , Bombas de Infusión , Persona de Mediana Edad , Estadificación de Neoplasias , Tasa de Supervivencia , Estados Unidos/epidemiología
3.
Int J Biol Markers ; 11(4): 203-6, 1996.
Artículo en Inglés | MEDLINE | ID: mdl-9017443

RESUMEN

Breast cancer patients on dose-intensive chemotherapy often have elevated tumor markers during the course of treatment. Our objective was to estimate the incidence of a "false positive" tumor marker screen and to determine whether hand-foot epithelial damage was correlated. Data from 53 patients with high risk primary breast cancer who had undergone adjuvant or neoadjuvant 5FU-containing chemotherapy (FAC or FAC plus G-CSF) for 3 to 12 months were reviewed. The relationship between tumor marker elevation and disease recurrence, regimen intensity, and the occurrence of hand-foot syndrome was examined. Thirty-three of the 53 patients had elevated tumor markers in the absence of recurrent disease. The false positive rate was higher in patients who underwent FAC plus G-CSF chemotherapy than in patients who underwent FAC chemotherapy (92% vs 55%, p = .01). A false positive marker screen was associated with the occurrence of hand-foot syndrome even when the effect of regimen was accounted for by stratification (p = .01). Tumor marker screening of breast cancer patients on this type of adjuvant chemotherapy has poor specificity for recurrent malignancy. These data suggest tumor marker elevation may be an indicator of epithelial toxicity during chemotherapy, manifested clinically as hand-foot syndrome.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Biomarcadores de Tumor/análisis , Neoplasias de la Mama/tratamiento farmacológico , Erupciones por Medicamentos/etiología , Antígenos de Carbohidratos Asociados a Tumores/análisis , Neoplasias de la Mama/complicaciones , Antígeno Carcinoembrionario/análisis , Ciclofosfamida/efectos adversos , Doxorrubicina/efectos adversos , Reacciones Falso Positivas , Femenino , Fluorouracilo/efectos adversos , Pie , Mano , Humanos , Mucina-1/análisis , Recurrencia Local de Neoplasia/diagnóstico
4.
Cancer ; 71(2): 392-6, 1993 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-8422633

RESUMEN

BACKGROUND: Several studies support the belief that the efficacy of adjuvant chemotherapy in breast cancer is related to the dose intensity of the chemotherapy used (expressed in milligrams per square meter per week). Retrospective analyses indicate that the actual delivered dose intensity may correlate more strongly with efficacy than the intended dose delivery. METHODS: A doxorubicin-based adjuvant regimen was studied for breast cancer. It was modeled on the Southwest Oncology Group's regimen of cyclophosphamide, methotrexate, and 5-fluorouracil in that daily oral cyclophosphamide and weekly intravenous 5-fluorouracil were used, but weekly doxorubicin was substituted for methotrexate and administered in both the adjuvant and neoadjuvant setting to 29 patients. RESULTS: The actual dose delivery was 1.21-1.24-fold that calculated for the delivered dose in the two other adjuvant regimens using the same three drugs (5-fluorouracil, doxorubicin, and cyclophosphamide) for which this could be determined. This regimen was tolerated well. Toxicity was minimal and consisted largely of expected neutropenia. CONCLUSIONS: Whether improved dose intensity can be increased further with the use of growth factors or actually confers improved outcomes awaits the results of larger future trials.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Quimioterapia Adyuvante , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Estudios de Factibilidad , Femenino , Fluorouracilo/administración & dosificación , Humanos , Persona de Mediana Edad
5.
Cancer ; 68(5): 934-9, 1991 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-1913489

RESUMEN

Twenty-seven women with metastatic breast cancer were treated with doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH) every other week, alternating with 5-fluorouracil (5FU) and high-dose calcium leucovorin, for a 12-week induction regimen, followed by weekly doxorubicin and oral daily cyclophosphamide. Twenty-five women were eligible and evaluable. Of these, complete response occurred in two patients (8%) and partial response in six patients (24%), for a total response rate of 32%. Toxicity was similar to that seen in previous Southwest Oncology Group (SWOG) trials in this patient population. Response rates in this study were inferior, with comparable median survivals to those of previous SWOG studies that are reviewed. Additional, more dose-intensive approaches incorporating newer approaches to the administration of cancer chemotherapeutic agents are planned.


Asunto(s)
Adenocarcinoma/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adenocarcinoma/patología , Adulto , Anciano , Neoplasias de la Mama/patología , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Esquema de Medicación , Estrógenos , Femenino , Fluorouracilo/administración & dosificación , Humanos , Leucovorina/administración & dosificación , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Hormono-Dependientes/tratamiento farmacológico
6.
Cancer ; 67(12): 2969-73, 1991 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-1646065

RESUMEN

Novobiocin, a commercially available oral antibiotic, inhibits DNA topoisomerase II in a manner shown in cell culture to enhance the cytotoxicity of alkylating agents and cisplatin. Thirty-six patients were entered on a Phase II trial using high-dose cisplatin (100 mg/m2 on days 1 and 8 for four cycles) after steady-state dosing with novobiocin (1000 mg or four 250-mg capsules every 12 hours for six doses, four of which were administered before each dose of cisplatin). One patient remains on study and cannot be evaluated for response. No complete responses were seen. Three patients (8%) had partial responses and an additional patient had an unconfirmed partial response. The median survival time of all patients was just less than 7 months. These results are comparable with those of other concurrent Southwest Oncology Group (SWOG) Phase II and III trials of high-dose cisplatin in non-small cell lung cancer (NSCLC). Novobiocin plasma levels were obtained for three patients and were approximately 50% of the optimal concentration as reported in cell culture for potentiation of cytotoxicity. It was concluded that an optimum test of novobiocin as a modulator of cytotoxicity may require the availability of an intravenous preparation.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Cisplatino/administración & dosificación , Neoplasias Pulmonares/tratamiento farmacológico , Novobiocina/administración & dosificación , Administración Oral , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Cápsulas , Cisplatino/efectos adversos , Evaluación de Medicamentos , Femenino , Humanos , Infusiones Intravenosas , Riñón/efectos de los fármacos , Masculino , Persona de Mediana Edad , Novobiocina/efectos adversos , Novobiocina/sangre , Inducción de Remisión , Sudoeste de Estados Unidos
7.
Cancer ; 64(12): 2409-15, 1989 Dec 15.
Artículo en Inglés | MEDLINE | ID: mdl-2684382

RESUMEN

Thirty-seven patients with poor prognosis, metastatic breast cancer were treated with 5-fluorouracil, vinblastine, and Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) (FUVA) induction chemotherapy. All 26 patients (74%) with responsive or stable disease after induction chemotherapy received intensification with high-dose cyclophosphamide (120 mg/kg). Continued responders received additional FUVA as consolidation. The response rate to induction therapy was 54% (with complete response [CR] in 11%). With intensification, three patients (11%) showed improved response (partial response [PR] in one, PR to complete response [CR] in two); however, six patients (23%) progressed within 2 months of cyclophosphamide intensification, three within 1 month. The overall response rate to all three phases of the study was 69%, with CR in 23%. The median survival of all patients entered in this study was 15 months. For cyclophosphamide intensification, major toxicity consisted of leukopenia with fever requiring broad-spectrum antibiotics in 27%. The authors conclude that a single cycle of high-dose cyclophosphamide intensification in metastatic breast cancer does not result in significantly improved responses or prolonged survival.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Ciclofosfamida/uso terapéutico , Neoplasias Óseas/secundario , Neoplasias Encefálicas/prevención & control , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Ensayos Clínicos como Asunto , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Esquema de Medicación , Fluorouracilo/administración & dosificación , Humanos , Recurrencia Local de Neoplasia , Pronóstico , Vinblastina/administración & dosificación
8.
Cancer ; 59(7): 1249-54, 1987 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-3545430

RESUMEN

Seventy patients with poor prognosis, metastatic breast cancer were treated with FUVAC induction chemotherapy (5-fluorouracil, vinblastine, Adriamycin [doxorubicin] and cyclophosphamide). Consolidation therapy was given to 30 of 48 responders (63%), of whom 23 received sequential hemibody irradiation (HBI) at 8 cGy, corrected in the upper half for lung transmission. Seven received high dose cyclophosphamide and total body irradiation (TBI) with subsequent infusion of stored, cryopreserved autologous bone marrow. The response rate to induction therapy was 71% (complete [CR] in 21%). The median survival for all patients entered in this study is 12 months. With consolidation, one CR patient who received cyclophosphamide and TBI is disease free at 20+ months, off all treatment, while HBI did not produce longterm remissions. Of 17 partial response (PR) patients, two of 12 improved to CR with HBI, and one of five improved with cyclophosphamide plus TBI, but all ultimately relapsed. The main toxicity of sequential HBI was myelosuppression, with prolonged thrombocytopenia in 13%; only one case of radiation pneumonitis occurred (3%). Cyclophosphamide and TBI produced temporary, reversible marrow aplasia without other major toxicity. We recommend further investigation of Cytoxan (Bristol Myers Oncology Division, Evansville, IN) and TBI for breast cancer patients in remission after chemotherapy.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Trasplante de Médula Ósea , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/radioterapia , Terapia Combinada , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Enfermedades Hematológicas/inducido químicamente , Humanos , Metotrexato , Prednisona , Pronóstico , Vinblastina/administración & dosificación , Irradiación Corporal Total
9.
J Neurooncol ; 1(3): 269-73, 1983.
Artículo en Inglés | MEDLINE | ID: mdl-6088718

RESUMEN

Eleven patients with malignant gliomas recurring after surgery and radiation therapy, were treated with high dose BCNU 1 050-1 200 mg/M2 with autologous bone marrow rescue. Four patients also received concomitant 5-fluorouracil 1 000 mg/M2/24 hr daily for three days. Eight of ten evaluable patients demonstrated improvement on CAT scan as well as a decrease in steroid requirement. All patients surviving longer than two weeks after BCNU administration experienced full hematologic recovery. No delayed myelosuppression was seen after a single course of high dose therapy. Two patients died as a result of therapy, one following a second induction of BCNU for a total cumulative BCNU dose of 2 400 mg/M2 and one of infection while cytopenic. Additional toxicity includes one steroid-responsive interstitial pneumonitis, one centrilobular necrosis of the liver which spontaneously resolved and one episode of deep vein thrombosis. With limitation on the maximum BCNU dose and distribution of the total dose over three days, high dose BCNU can be administered with acceptable toxicity. This approach may offer a higher response rate than that expected for standard dose BCNU.


Asunto(s)
Trasplante de Médula Ósea , Neoplasias Encefálicas/tratamiento farmacológico , Carmustina/uso terapéutico , Glioblastoma/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Adulto , Carmustina/efectos adversos , Terapia Combinada , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Fluorouracilo/uso terapéutico , Estudios de Seguimiento , Humanos , Persona de Mediana Edad
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