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1.
NCI Monogr ; (1): 81-5, 1986.
Artículo en Inglés | MEDLINE | ID: mdl-3534594

RESUMEN

Between 1974 and 1982, 796 patients with operable breast cancer following local therapy were treated with 3 consecutive doxorubicin-containing adjuvant therapy trials. The median follow-up of patients entered on the first trial was 102 months; the second trial, 71 months; and for the third trial, 41 months. The treatment program consisted of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). We altered the study designs to determine the role of nonspecific immunotherapy with BCG and postoperative irradiation in the second trial and the impact of additional chemotherapy with alternate drugs after completion of FAC in the third trial. In the first study, an overall 39% reduction in mortality was observed, and, in stage II disease, reductions of 54% and 37% in mortality were observed for patients less than 50 and greater than or equal to 50 years of age, respectively, in comparison to the historical control group. The data of the second trial illustrated that BCG and postoperative irradiation had no significant impact on the disease-free and overall survival. In the third trial, patients with estrogen receptor-positive tumor treated with additional chemotherapy with alternate drugs following completion of FAC had significantly superior disease-free survival compared with patients who did not receive additional chemotherapy. The results of 3 studies show that intensive combination chemotherapy significantly reduced the risk of recurrence and death in patients with breast cancer.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Vacuna BCG/uso terapéutico , Neoplasias de la Mama/inmunología , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/radioterapia , Ensayos Clínicos como Asunto , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Estudios de Seguimiento , Humanos , Ganglios Linfáticos/patología , Persona de Mediana Edad , Estadificación de Neoplasias , Prednisona/administración & dosificación , Receptores de Estrógenos/efectos de los fármacos , Receptores de Estrógenos/fisiología , Estados Unidos , Vincristina/administración & dosificación
2.
Breast Cancer Res Treat ; 2(2): 163-9, 1982.
Artículo en Inglés | MEDLINE | ID: mdl-6897369

RESUMEN

Four hundred and sixty patients with stage II or III breast cancer following regional therapy were treated with an adjuvant combination chemotherapy consisting of fluorouracil, doxorubicin, and cyclophosphamide (FAC). The relationship between the length of disease-free survival and length of delays in initiation of chemotherapy after surgery was evaluated. Patients were divided into four subgroups according to the length of delay in initiation of chemotherapy (less than 10 weeks, 10-13, 14-17, and greater than or equal to 18 weeks). Overall four year disease-free survival was 64%, 68%, 60%, and 63% for patient groups with delays of less than 10 weeks, 10-13, 14-17, or greater than or equal to 18 weeks respectively (p = 0.39). There was no trend for longer delay in treatment to be associated with shorter disease-free survival, except in poor prognosis patients.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de la Mama/terapia , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Fluorouracilo/administración & dosificación , Adulto , Vacuna BCG/uso terapéutico , Neoplasias de la Mama/mortalidad , Esquema de Medicación , Quimioterapia Combinada , Femenino , Humanos , Mastectomía , Persona de Mediana Edad , Pronóstico , Factores de Tiempo
3.
JAMA ; 242(14): 1509-13, 1979 Oct 05.
Artículo en Inglés | MEDLINE | ID: mdl-470088

RESUMEN

Two hundred twenty-two patients with stage II or III breast cancer following regional therapy were treated with a combination of fluorouracil, doxorubicin hydrochloride (Adrimycin), cyclophosphamide, and BCG vaccine. At 54 months of study (median follow-up, 30 months), the estimated proportions remaining disease-free two and three years after surgery were 83%and 78%, respectively, in the chemotherapy group and 64% and 55%, respectively, in 151 historical control patients. Estimated two- and three-year survival rates were 93% and 89%, respectively, in the chemotherapy group and 84% and 58%, respectively, in the control patients. Congestive heart failure has developed in three patients, possibly related to the use of doxorubicin. Adjuvant chemotherapy with these drugs was effective in prolonging the disease-free interval and survival of patients irrespective of menopausal status, degree of nodal involvement, or stage of the disease.


Asunto(s)
Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Vacuna BCG/uso terapéutico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/cirugía , Ciclofosfamida/uso terapéutico , Doxorrubicina/efectos adversos , Doxorrubicina/uso terapéutico , Quimioterapia Combinada , Femenino , Fluorouracilo/uso terapéutico , Insuficiencia Cardíaca/inducido químicamente , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia
4.
J Surg Oncol ; 12(1): 27-40, 1979.
Artículo en Inglés | MEDLINE | ID: mdl-480951

RESUMEN

A combination of 5-fluorouracil, Adriamycin, cyclophosphamide, and BCG (FAC-BCG) was evaluated as adjuvant treatment in breast cancer patients following surgical excision and/or radiation of first site of recurrent disease. In a group of 68 patients treated with FAC-BCG, the estimated proportion remaining free of disease at 2 years from first recurrence was 69%, compared to 24% in 60 historical control patients (P less than 0.01). Estimated 2-year survival rate from first recurrence was 85% for the FAC-BCG patients and 78% for the controls (P = 0.07). This regimen has significantly prolonged the disease-free interval from the first recurrence, but additional follow-up is needed to determine its effect on long-term survival.


Asunto(s)
Antineoplásicos/administración & dosificación , Vacuna BCG/uso terapéutico , Neoplasias de la Mama/terapia , Neoplasias de la Mama/mortalidad , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Quimioterapia Combinada , Femenino , Fluorouracilo/administración & dosificación , Humanos , Inmunoterapia , Metástasis Linfática , Persona de Mediana Edad , Neoplasias Torácicas/secundario , Neoplasias Torácicas/terapia
5.
Cancer ; 41(3): 1064-75, 1978 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-638948

RESUMEN

For the past 34 months, a combination of 5-fluorouracil, adriamycin, cyclophosphamide, and BCG (FAC-BCG) was evaluated as adjuvant treatment in stage II and III breast cancer patients with positive axillary nodes. In the group of 131 patients receiving FAC-BCG, the estimated proportion remaining disease-free at 2 years from surgery was 91% compared to an estimated 69% in a group of 151 historical control patients (p less than .01). This advantage was statistically significant in all subgroups except for patients with primary tumor less than 3 cm and for patients with less than 4 positive nodes. Estimated 2-year survival rates were 9,6% for FAC-BCG patients and 86% for control (p = .02). Treatment was well tolerated. Adjuvant FAC-BCG seems effective in prolonging disease-free interval and early survival in patients with stage II and III breast cancer. Its long term efficacy will require longer follow-ups.


Asunto(s)
Neoplasias de la Mama/terapia , Adulto , Anciano , Vacuna BCG/efectos adversos , Vacuna BCG/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Ciclofosfamida/uso terapéutico , Doxorrubicina/uso terapéutico , Quimioterapia Combinada/efectos adversos , Estudios de Evaluación como Asunto , Femenino , Fluorouracilo/uso terapéutico , Estudios de Seguimiento , Humanos , Inmunoterapia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Recurrencia
8.
J Bone Joint Surg Am ; 58(5): 629-33, 1976 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-1084348

RESUMEN

Forty-three patients with osteosarcoma were treated with amputation and adjuvant chemotherapy utilizing a four-drug combination of cyclophosphamide, vincristine, phenylalanine mustard, and adriamycin (CONPADRI-I regimen). Twenty-four patients (56 per cent) remained free of metastases twelve to sixty-one months after diagnosis. Ten of the twenty-four have been disease-free for more than three years. Another group of thirty patients was treated with amputation and a five-drug adjuvant chemotherapy program which included the administration of massive doses of methotrexate with citrovorum factor (COMPADRI-II regimen). Twenty of the thirty (67 per cent) remained free of metastases from twelve to twenty-six months after amputation (median, sixteen months). Two deaths related to methotrexate toxicity occurred. Late metastases developed in three patients (at sixteen, nineteen, and twenty-six months after operation) in the group treated with the COMPADRI-II regimen.


Asunto(s)
Antineoplásicos/uso terapéutico , Osteosarcoma/tratamiento farmacológico , Adolescente , Adulto , Antineoplásicos/administración & dosificación , Niño , Ciclofosfamida/efectos adversos , Ciclofosfamida/uso terapéutico , Doxorrubicina/efectos adversos , Doxorrubicina/uso terapéutico , Quimioterapia Combinada , Femenino , Humanos , Leucovorina/uso terapéutico , Masculino , Melfalán/uso terapéutico , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Metotrexato/uso terapéutico , Persona de Mediana Edad , Vincristina/uso terapéutico
9.
Lancet ; 1(7965): 871-6, 1976 Apr 24.
Artículo en Inglés | MEDLINE | ID: mdl-58143

RESUMEN

83 patients with colorectal carcinoma of the Dukes' C class were randomised to receive postoperative adjuvant therapy with B.C.G. alone or in combination with oral doses of 5-fluorouracil (5-F.U.), and have been followed for up to thirty months. Results were compared with carefully selected historical controls who were treated by surgery alone. A statistically significant prolongation of both disease-free interval and overall survival was observed in 50 patients receiving the combination of B.C.G. and 5-F.U. (P=0.03, P=0.01 respectively) as well as in 33 patients receiving B.C.G. alone (P=0.03, P=0.05 respectively). The efficacy of B.C.G.+5-F.U. was independent of the number of tumour-involved lymph-nodes in the surgical specimen. In contrast, B.C.G. given alone appears to be highly effective among 10 patients with 6 or more positive lymph-nodes (P less than 0.04) and ineffective (as yet) among 23 patients with 5 or less positive lymph-nodes. These results suggest that adjuvant immunotherapy, with or without chemotherapy, can improve the prognosis of surgically treated patients with colorectal carcinoma of the Dukes' C class.


Asunto(s)
Vacuna BCG/uso terapéutico , Neoplasias del Colon/terapia , Fluorouracilo/uso terapéutico , Cuidados Posoperatorios , Neoplasias del Recto/terapia , Administración Oral , Vacuna BCG/administración & dosificación , Neoplasias del Colon/mortalidad , Estudios de Evaluación como Asunto , Fluorouracilo/administración & dosificación , Estudios de Seguimiento , Humanos , Metástasis Linfática , Mesenterio , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Neoplasias del Recto/mortalidad , Factores de Tiempo
10.
Cancer ; 36(6 Suppl): 2421-7, 1975 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-1212660

RESUMEN

Fifty-eight patients with Dukes' C classification of carcinoma of the large bowel were placed on adjuvant immuno- or chemoimmunotherapy with Bacillus calmette guerin (BCG) or combination of 5-fluorouracil (5-FU) plus BCG following primary and definitive surgery, and were followed for up to 21 months. Of twenty-six patients receiving BCG alone by scarification, five have relapsed with 75% of freedom from disease estimated at 15.1 months compared with 10.1 months in a group of carefully selected historical controls who had surgery alone (p = 0.12). The survival of all patients receiving BCG alone has not reached the 75 percentile yet, and the difference from controls is currently estimated at the 18% level. The combination of 5-FU plus BCG (studied in 32 patients) may be superior to BCG alone at this time, in that it appears to more effectively protect against tumor recurrence (75 percentile not yet reached compared to control, (p = 0.08). The survival of patients on 5-FU plus BCG also appears to be improved (p = 0.09). No patients have expired compared to a 75 percentile survival of 16.6 months in the control. Serial determination of plasma CEA was crucial in the clinical follow-up of these patients. Frequent CEA detetminations have led to early detection of clinical relapse. In the elevation of CEA suggests tumor recurrence with a high degree of probability in patients with past history of cancer of the large bowel.


Asunto(s)
Vacuna BCG/uso terapéutico , Neoplasias del Colon/terapia , Fluorouracilo/uso terapéutico , Neoplasias del Recto/terapia , Antígeno Carcinoembrionario/análisis , Neoplasias del Colon/tratamiento farmacológico , Neoplasias del Colon/patología , Fluorouracilo/administración & dosificación , Humanos , Neoplasias del Recto/tratamiento farmacológico , Neoplasias del Recto/patología
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