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R Margolese

Publications and source records attributed to R Margolese.

32 records · Page 2Linked to original sources
PubMed1985

Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer.

In 1976 we began a randomized trial to evaluate breast conservation by a segmental mastectomy in the treatment of Stage I and II breast tumors less than or equal to 4 cm in size. The operation removes only sufficient tissue to ensure that margins of resected specimens are free of tumor. Women were randomly assigned to total mastectomy, segmental mastectomy alone, or segmental mastectomy followed by breast irradiation. All patients had axillary dissections, and patients with positive nodes received chemotherapy. Life-table estimates based on data from 1843 women indicated that treatment by segmental mastectomy, with or without breast irradiation, resulted in disease-free, distant-disease-free, and overall survival at five years that was no worse than that after total breast removal. In fact, disease-free survival after segmental mastectomy plus radiation was better than disease-free survival after total mastectomy (P = 0.04), and overall survival after segmental mastectomy, with or without radiation, was better than overall survival after total mastectomy (P = 0.07, and 0.06, respectively). A total of 92.3 per cent of women treated with radiation remained free of breast tumor at five years, as compared with 72.1 per cent of those receiving no radiation (P less than 0.001). Among patients with positive nodes 97.9 per cent of women treated with radiation and 63.8 per cent of those receiving no radiation remained tumor-free (P less than 0.001), although both groups received chemotherapy. We conclude that segmental mastectomy, followed by breast irradiation in all patients and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for Stage I and II breast tumors less than or equal to 4 cm, provided that margins of resected specimens are free of tumor.

Breast Neoplasms↗
PubMed1985

Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation.

In 1971 we began a randomized trial to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative axillary nodes, with respect to disease-free survival, distant-disease--free survival, or overall survival (about 57 per cent) at 10 years. The patients were treated by radical mastectomy, total ("simple") mastectomy without axillary dissection but with regional irradiation, or total mastectomy without irradiation plus axillary dissection only if nodes were subsequently positive. Similarly, no differences were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without axillary dissection but with regional irradiation. Survival at 10 years was about 38 per cent in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. We conclude that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer.

Breast Neoplasms↗
PubMed1985

A phase II study of sequential methotrexate and fluorouracil in advanced colorectal cancer.

Twenty-nine patients with advanced colorectal cancer were treated with methotrexate (MTX) 200 mg/m2 followed 1 h later by fluorouracil (FU) (1000 mg/m2) and 24 h later by oral leucovorin 20 mg every 6 h for six doses. The cycle was repeated every 2 weeks. Among the 25 evaluable patients there were 2 complete responses (confirmed by liver scan) and 5 partial responses. Although hematological toxicity was mild, there were four episodes of nonfatal sepsis. The majority of patients developed an erythematous scaly rash on the palms and soles plus eye irritation after six courses of chemotherapy. In addition, the sequential MTX-FU had to be discontinued in 6 of the 7 responders because of (a) severe chills, (b) severe hyperpigmentation, or (c) neurologic complications (ataxic gait or disorientation). These results indicate that this sequential MTX-FU has modest activity in colorectal cancer but is associated with moderately severe toxicity. Only randomized trials of FU alone versus sequential MTX-FU can determine whether sequential MTX-FU has a therapeutic advantage over FU alone in the treatment of advanced colorectal cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1985

Alternating combination chemotherapy using cisplatin-bleomycin with sequential methotrexate-5-FU plus leucovorin rescue in patients with head and neck cancer.

Thirty-two patients (only two had previously untreated disease) with squamous cell carcinoma of the head and neck were treated with alternating combination chemotherapy. The regimen consisted of cisplatin (50 mg/m2) and bleomycin (30 units) given iv on Days 1 and 2, alternated with 1 hour of sequential methotrexate (200 mg/m2) and 5-FU (600 mg/m2) given iv, plus oral leucovorin rescue on Day 22. The entire cycle was repeated every 5 weeks (less than or equal to five cycles). Objective tumor regression was obtained in 33% of the 30 evaluable patients, with 13% complete regression. The median duration of response was only 3 months. Evidence of response occurred within one cycle, and was maximal after two cycles. Toxicity was very mild. Alternating combination chemotherapy is not more effective than either combination chemotherapy alone.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1983

Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update.

The current findings completely affirm the validity of our original observations indicating the appropriateness of grouping primary breast cancer patients into those with negative, 1 to 3, or greater than or equal to 4 positive nodes. Results, however, reveal that there is a risk in combining all patients with greater than or equal to 4 positive nodes into a single group. Since there was a 25% greater disease-free survival and an 18% greater survival in those with 4 to 6 than in those with greater than or equal to 13 positive axillary nodes, such a unification may provide misleading information regarding patient prognosis, as well as the worth of a therapeutic regimen when compared with another from a putatively similar patient population. Of particular interest were findings relating the conditional probability, i.e., the hazard rate, of a treatment failure or death each year during the 5-year period following operation to nodal involvement with tumor. Whereas the hazard rate for those with negative, or 1 to 3 positive nodes, was relatively low and constant, in those with greater than or equal to 4 positive nodes the risk in the early years was much greater, but by the fifth year it was similar to that occurring when 1-3 nodes were involved, and not much different from negative node patients. The same pattern existed whether 4 to 6 or greater than or equal to 13 nodes were positive. When the current findings are considered relative to other factors with predictive import, it is concluded that nodal status still remains the primary prognostic discriminant.

Axilla↗
PubMed1983

Breast cancer and thoracic metastases: review of 119 patients.

Review of the case notes of 660 patients with a diagnosis of breast cancer during a five-year period showed that in 119 cases there had been thoracic metastases. These were recorded as pleural or extrapleural metastases (79 patients), mediastinal tumour (46 patients), lymphangitic carcinoma (41 patients), pulmonary nodules (34 patients), and solitary pulmonary nodule (nine patients). Endobronchial metastases were present in seven patients and multiple pulmonary tumour emboli in two. The thorax was often the initial site of tumour recurrence. Most of these recurrences were present in several locations (intrathoracic or both intrathoracic and extrathoracic) simultaneously, facilitating the clinical diagnosis of metastatic breast cancer. Histopathological confirmation of metastasis was mandatory for the 10 patients who had a solitary intrathoracic abnormality without evidence of disease elsewhere. The median survival after diagnosis and treatment of a solitary thoracic metastasis was 42+ months and three of 10 patients are currently in remission (at 44, 87, and 121 months). The small tumour burden and early diagnosis giving lead time may explain the long survival in this group of patients.

Breast Neoplasms↗
PubMed1979

1-phenylalanine mustard (L-PAM) in the management of premenopausal patients with primary breast cancer: lack of association of disease-free survival with depression of ovarian function. National Surgical Adjuvant Project for Breast and Bowel Cancers.

Breast cancer patients participating in a prospective randomized clinical trial who were less than or equal to 49 years of age, had positive axillary nodes, and who received prolonged 1-phenylalanine mustard (L-PAM) as an adjuvant to mastectomy continue (after 4 years) to demonstrate a significantly greater disease-free survival (p = .007) than do patients who received placebo. Benefit was achieved in patients who were less than or equal to 39 years as well as those who were 40-49 years of age. Those in the younger age group showed a greater improvement in disease-free survival at 4 years relative to their controls (32% vs. 69%; p = .01) than did those in the older age group (48% vs. 61%; p = .09). When patients were examined relative to their nodal status, a highly favorable effect was found to have been achieved with L-PAM in those with 1-3 positive nodes (54% vs. 86%; p = .006). Results indicate that both age groups were benefited. When considered over time, they demonstrate that a relatively greater effect was achieved in the younger women. While L-PAM failed to significantly alter the disease-free survival of those with greater than or equal to 4 positive nodes a slightly better effect was achieved in the group less than or equal to 39 years. Since adjuvant chemotherapy has been found to be more effective in premenopausal than postmenopausal women, it has been presumed that decreased ovarian function, as a result of the chemotherapy, is responsible for the findings. To support or repudiate that concept, information regarding serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2), as well as menstrual function, has been obtained from women receiving L-PAM or L-PAM plus 5-FU therapy. In contrast to findings relative to disease-free survival, ovarian function and menses were most affected in patients 40-49 years of age. Amenorrhea occurred in 73% of patients in that age group and in only 22% of those less than or equal to 39 years (p less than .001). Similarly, a significant increase in LH and FSH and a decrease in E2, all indicative of ovarian suppression, was observed only in the older group of patients. Thus, it is concluded that while ovarian suppression may account for some of the adjuvant chemotherapeutic effect in premenopausal women, the dichotomy of findings in younger and older premenopausal women relative to therapeutic response and ovarian function indicates that other factors could be responsible.

Adult↗
PubMedDate not supplied

Acute toxicity during adjuvant chemotherapy for breast cancer: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience from 1717 patients receiving single and multiple agents.

Since 1972, the National Surgical Adjuvant Breast and Bowel Project (NSABP) has carried out a series of clinical trials evaluating the worth of adjuvant chemotherapy in the management of patients with primary breast cancer. This report provides information concerning (a) protocol compliance relative to drug administration and (b) acute toxicity encountered by patients in three separate trials who were given one-, two- or three-drug chemotherapy within 1 month of operation. The findings are derived from 1548 women who received 20,765 courses of chemotherapy, the most extensively documented experience yet reported. They indicate that despite the large number of physicians and the heterogeneity of the institutions participating, large cooperative efforts can be accomplished with credibility. Only 13 (0.8%) of the women failed to complete all courses of therapy for reasons directly related to nonprotocol compliance by physicians. Only 4.3% failed to complete therapy for miscellaneous reasons other than toxicity, treatment failure, occurrence of a second primary, or death unrelated to tumor. While almost all patients experienced toxic reactions during the therapy, only 3%--4% of recipients of melphalan (L-PAM; P) and 4%--5% of recipients of L-PAM + 5-FU(F)(PF) failed to complete 2 years of therapy because of toxicity. Of those patients receiving PF + methotrexate (MTX; M) (PMF), 15% did not finish their treatment for that reason. While there was little difference in hematologic and nonhematologic toxicity between those patients receiving P or PF, and such toxicity was generally acceptable to both patients and physicians, the addition of MTX (PMF) resulted in greater toxicity (vomiting, stomatitis, and alopecia) which was less readily accepted. Tolerance of any of these regimens was unrelated to patient age, despite the belief that older women are less tolerant of chemotherapy. The earlier toxicity occurred, the greater was the number of subsequent courses associated with toxicity, and the lower was the total amount of drug received. The extent of the toxicity produced by the NSABP regimens and the end results obtained with them, must be compared with the end results and toxicity obtained by other regimens before making a choice of the adjuvant therapy to be used.

Aged↗