Response to hormonal therapy as a prognostic factor for metastatic breast cancer treated with combination chemotherapy.

One hundred thirty-six patients with metastatic carcinoma of the breast who received adequate trials of hormonal therapy were evaluated in order to determine the relationship of response to prior hormonal therapy and the results achieved with combination chemotherapy. Fifty-three patients had shown objective responses and 83 had failed to respond to the commonly used modes of endocrine therapy for carcinoma of the breast. Distribution of patient characteristics known to influence the response to chemotherapy and the type of chemotherapy used were similar for both groups.

Causes of death in breast cancer: a clinicopathologic study.

Between January 1973 and October 1977, 166 patients who died of breast cancer were autopsied. The examination revealed consistently more tumor involvement than had been clinically suspected. Unsuspected areas of tumor involvement included the endocrine organs (40%), lungs (28%), cardiovascular system (21%), and the genitourinary system (21%).

A phase II study of peptichemio in advanced breast cancer.

A phase II trial of Peptichemio (PTC) was conducted on 56 patients with advanced breast cancer that had been resistant to treatment with cyclophosphamide. The overall response rate was 32%, with one complete remission, seven partial remissions, and ten instances of improved disease status. Soft tissue and bone lesions were the primary sites of response.

Alternating noncross-resistant combination chemotherapy and active nonspecific immunotherapy with BCG or MER-BCG for advanced breast carcinoma.

One hundred fifty-six evaluable patients with metastatic breast cancer were treated with vincristine, Adriamycin and cyclophosphamide alternating at fixed intervals with 5-FU and methotrexate. Immunotherapy with BCG or MER-BCG was administered to all patients in two consecutive treatment programs. Overall objective response rate and complete response rate were 67% and 20%, respectively.

Use of prognostic factors in analysis of historical control studies.

This paper considers the use of regression methods for the interpretation of comparative results between treatments in historical control studies. A logistic regression model is used for response rate studies and Cox's regression model for studies of disease-free or overall survival. For both models, stepwise regression procedures may be utilized to test for treatment differences adjusting for differences in patient characteristics between the treatment groups.

Immune-complex glomerulonephritis secondary to nonspecific immunotherapy.

Hematuria and renal failure developed in two patients with metastatic breast carcinoma while they were receiving nonspecific immunotherapy and chemotherapy. The electron microscopy picture was suggestive of immune-complex glomerulonephritis.

Pulmonary toxicity of mitomycin.

Six patients with breast cancer developed pulmonary toxicity following mitomycin therapy. The presenting symptoms were shortness of breath and a dry cough. The radiological pictures varied from a normal chest x-ray to extensive bilateral pneumonitis.

Knowledge acquisition from historical data: application to breast cancer patients.

The thesis of this paper is that knowledge acquired from historical data collected in a clinical research program may be used for planning future clinical trials and evaluating the effect of treatment. In a breast cancer study comparing adjuvant, treatment with FAC-BCG to control treatment Cox's regression model including number of involved nodes, stage of disease, and menopausal status was used to demonstrate that FAC-BCG patients have superior disease-free survival. A logistic regression model for acute leukemia involving age, cytogenetics, prior hematologic abnormality, temperature, serum creatinine, and hemoglobin was obtained by fitting to 325 previously untreated adult patients who received treatment between March, 1973 and April, 1977.

Chemoimmunotherapy for metastatic breast cancer with 5-fluorouracil, adriamycin, cyclophosphamide, methotrexate, L-asparaginase, Corynebacterium parvum, and Pseudomonas vaccine.

Moderate doses of methotrexate and L-asparaginase were added to standard doses fo 5-fluorouracil, Adriamycin, and cyclophosphamide in an attempt to improve the overall response rate and survival following chemotherapy. In addition, nonspecific immunotherapy with either Corynebacterium parvum or Pseudomonas vaccine was integrated into this prospective randomized clinical trial. The overall toxicity (degree of granulocytopenia and thrombocytopenia, length of myelosuppression, and incidence of myelosuppression-related infection and infectious deaths) increased considerably and led to the termination of patient accrual.

Complete remissions in metastatic breast cancer treated with combination drug therapy.

One hundred sixteen patients with metastatic breast cancer who achieved complete remission with combination chemotherapy were analyzed to ascertain the factors that affect the duration of complete remission and the patterns of relapse. The median duration of complete remission was 17 months. Disease recurred in 81 patients (70%) at periods ranging from 3 to 44 months after achievement of complete remission.

Pigmentation of the tongue and mucous membranes associated with cancer chemotherapy.

Hyperpigmentation of the tongue and buccal mucosa was observed after administration of conbination chemotherapy containing doxorubicin. The pigmentation lessened after discontinuation of doxorubicin, suggesting this drug as the possible causative agent.

Chemoimmunotherapy with or without oophorectomy in premenopausal patients with advanced breast cancer.

Ninety-eight premenopausal patients with stage IV breast cancer were treated with chemoimmunotherapy alone, or with combination oophorectomy-chemoimmunotherapy either simultaneously (chemoimmunotherapy within four weeks of oophorectomy) or sequentially (delayed chemoimmunotherapy until evidence of progressive disease or no response to oophorectomy). The chemoimmunotherapy consisted of a three-drug combination of Adriamycin, cyclophosphamide, and 5-fluorouracil or Ftorafur; immunotherapy consisted of either oral levamisole, BCG by scarification, or a combination of both. Forty patients underwent simultaneous oophorectomy-chemoimmunotherapy, with a response rate of 85% and a median duration of response of 25 months.

Phase II study of 4'-(9-acridinylamino)methanesulfon-m-anisidide (AMSA) in metastatic breast cancer.

A phase II study of 4'-(9-acridinylamino)methanesulfon-m-anisidide (AMSA) was carried out in previously treated patients with metastatic breast cancer. Four of 26 evaluable patients achieved partial responses and four showed minor responses. The maximum tolerated dose of AMSA was 30 mg/m2/day x 3 days and the dose-limiting toxic effect was myelosuppression.

Combination chemoimmunotherapy of metastatic breast cancer with 5-fluorouracil, adriamycin, cyclophosphamide, and BCG.

One hundred five patients with metastatic breast cancer were treated with 5-fluorouracil, Adriamycin, cyclophosphamide and BCG (FAC-BCG). The results were compared to those observed in a group of 44 patients treated with FAC chemotherapy alone. Although the overall response rates were similar (76% for FAC-BCG and 73% for FAC), the duration of remission was of 9 months for FAC and 14 months for FAC-BCG (p = 0.

Phase II study of hexamethylmelamine alone and in combination with mitomycin C and vincristine in advanced breast carcinoma.

Fifty-three patients with metastatic breast carcinoma were randomized to treatment with hexamethylmelamine (HMM) as a single agent versus a three-drug reimen of HMM, vincristine, and mitomycin C (HOM). All patients had received prior treatment with 5-fluorouracil, Adriamycin, and cyclophosphamide with or without methotrexate. HMM alone was used in a dose of 300 mg/m2/day x 14 days every 21 days.

Postoperative adjuvant chemotherapy with fluorouracil, doxorubicin, cyclophosphamide, and BCG vaccine. A follow-up report.

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.

Ftorafur, adriamycin, cyclophosphamide and BCG in the treatment of metastatic breast cancer.

Ftorafur is a 5-fluorouracil analogue which is slowly metabolized to 5-FU, resulting in prolonged therapeutic levels of this latter drug. Ninety-one evaluable patients with metastatic breast cancer were treated with Ftorafur, Adriamycin, cyclophosphamide, and BCG (ACFTOR-BCG), in an attempt to increase the effectiveness of the program or decrease its myelosuppressive toxicity. The results of this trial were compared to those previously reported with the combination of 5-FU, Adriamycin, cyclophosphamide, and BCG (FAC-BCG).

Tamoxifen. Use in treatment of metastatic breast cancer refractory to combination chemotherapy.

Tamoxifen citrate (Nolvadex [Great Britain]; no comparable US product) is a recently developed antiestrogen with significant activity against metastatic breast cancer in postmenopausal women. We investigated its usefulness in breast cancer patients after conventional endocrine therapy and combination chemotherapy had failed. Of the 50 evaluable patients, four (8%) achieved a complete remission, 14 (28%) achieved a partial remission, and ten showed a less than partial response or stabilization of their disease.

Combination chemotherapy with vincristine and methotrexate for advanced refractory breast cancer.

Eighteen patients with advanced breast cancer refractory to combination chemotherapy with 5-FU, Adriamycin, Cytoxan (FAC) were treated with methotrexate 30 to 40 mg/m2 iv and vincristing 1.5 mg/m2 iv at weekly intervals. Of 17 evaluable patients, 4 (23%) achieved a partial remission with a median duration of remission of 6 months and a median survival of 10 months.

Combination chemoimmunotherapy of metastatic breast cancer with 5-fluorouracil, adriamycin, cyclophosphamide, and BCG.

One hundred and five patients with metastatic breast cancer were treated with 5-fluorouracil, Adriamycin, cyclophosphamide and BCG (FAC-BCG). The results were compared to those observed in a group of 44 patients treated with FAC chemotherapy alone. Although the overall response rates were similar (76% for FAC-BCG and 73% for FAC), the duration of remission was of 9 months for FAC and 14 months for FAC-BCG (p = 0.

Combined chemoimmunotherapy for advanced breast cancer: a comparison of BCG and levamisole.

One hundred and fourteen evaluable patients with metastatic breast cancer were treated with a program consisting of 5-FU, Adriamycin, cyclophosphamide (FAC) and nonspecific immunotherapy with Levamisole. The results of this treatment program were compared to those observed with FAC and Bacillus Calmette Guerin (BCG) and FAC chemotherapy alone, both groups treated prior to the study reported in this paper. The overall response rates and complete response rates for all three treatment regimens were identical.