PubMed Health⌕ Search

Biomedical subjects

C Redmond

Publications and source records attributed to C Redmond.

At least 37 records · Page 2Linked to original sources
PubMed1995

Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial.

BACKGROUND: The Breast Cancer Prevention Trial (BCPT) is a large, multicenter chemoprevention trial testing the efficacy of the antiestrogen drug tamoxifen for prevention of breast cancer and coronary heart disease in healthy women at high risk of breast cancer. The BCPT evolved from a series of prior studies in early stage breast cancer demonstrating the efficacy of tamoxifen in the prevention of systemic breast cancer recurrence and in the reduction of contralateral breast cancers. PURPOSE: The purpose of this article is to describe the methodologic considerations in the collection of health-related quality-of-life (HRQL) data in the BCPT and to present base-line HRQL data on the first 9749 participants. METHODS: An HRQL questionnaire that included the Center for Epidemiologic Studies-Depression Scale, a symptom checklist, the Medical Outcomes Study 36-item short form (MOS-SF-36), and the MOS sexual problems questions was completed by participants in the BCPT at base line (prior to random assignment). Medical and demographic information, as well as projected risk of breast cancer, were collected as part of study eligibility. Descriptive and correlational data were examined for these study participants. RESULTS: BCPT participants report high levels of functioning compared with U.S. general population norms but still report an average of 8.9 distinct symptoms during the past 4 weeks. Depression is less prevalent among the participants than in community samples, which reflects the exclusion of clinically depressed individuals. Sixty-five percent reported being sexually active in the past 6 months, with an age-related decline in sexual activity. Younger women reported fewer sexual problems than older women. There is a strong correlation between the two mental health measures, moderate to weak correlations between HRQL scales and levels of self-reported symptoms, and only weak correlations between measures of breast cancer risk and HRQL scales. The MOS-SF-36 scores were examined for three consecutive recruitment samples (0-6 months, 7-12 months, and 13-20 months), and the base-line scores were slightly better for the earliest group of participants. CONCLUSIONS: This article demonstrates the feasibility of collecting HRQL data in a large, multicenter, chemoprevention trial for women at high risk of breast cancer. The successful integration of HRQL data collection into this clinical trial attests to its value as a safety-monitoring end point and as an explicit and measurable outcome for the entire trial. IMPLICATIONS: HRQL data are important for studies in which healthy populations are involved and in which the potential for decrements in quality of life are real or perceived.

Adult↗
PubMed1995

Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) Protocol B-17. Intraductal carcinoma (ductal carcinoma in situ). The National Surgical Adjuvant Breast and Bowel Project Collaborating Investigators.

BACKGROUND: Controversy exists concerning the natural history of ductal carcinoma in situ (DCIS) of the breast, including its pathologic expression and treatment. This controversy has been fostered largely by the retrospective nature and limited sample sizes of extant studies. METHOD: Resolution of some of these issues was attempted by analyzing the pathologic features of 573 examples of DCIS obtained from a larger cohort of 790 women with DCIS enrolled in Protocol B-17 of the National Surgical Adjuvant Breast Project. This prospective randomized clinical trial was performed to assess the efficacy of local breast irradiation to reduce the incidence of second ipsilateral breast tumors (IBT) after lumpectomy. RESULTS: Tumor and patient characteristics, including significantly less IBT for those treated by lumpectomy and irradiation than lumpectomy alone, were almost identical for the subset comprising this analysis and the total B-17 cohort reported previously. The presence of moderate/marked comedo necrosis, which was evaluated as an independent parameter rather than as a specific histologic type of DCIS and uncertain/involved lumpectomy margins were the only statistically significant independent predictors of IBT for patients treated by lumpectomy as well as irradiation. The latter markedly reduced the annual hazard rates for the IBT associated with these indicators. CONCLUSIONS: Although not an endpoint of this study, the authors' findings suggest that the beneficial effect of irradiation in reducing IBT after lumpectomy for DCIS occurs with small (< 1.0 cm.) and larger lesions. Moderate/marked comedo necrosis and uncertain/involved lumpectomy margins represent independent predictors of IBT.

Adult↗
PubMed1994

Cause-specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy.

PURPOSE: To examine long-term cause-specific mortality in patients irradiated for breast cancer as part of a randomized clinical trial. PATIENTS AND METHODS: We studied all available information from randomized trials initiated before 1975 in which radiotherapy was the randomized option and surgery was the same for both treatment arms. Eight such trials were identified. RESULTS: The increased all-cause mortality rate in 10-year survivors previously reported is no longer significant, although a numerical difference in favor of non-irradiated patients remains. This result was strongly influenced by the earliest trials, and more recent trials have found a nonsignificant net benefit in overall mortality associated with radiation therapy. An excess of cardiac deaths was apparent in both early and more recent trials (P < .001), but this was offset by a reduced number of deaths due to breast cancer, especially in more recent trials. CONCLUSION: The reduction of breast cancer deaths suggests that radiation therapy may have a value beyond the clearly established improvements obtainable for local control. Use of techniques that minimize cardiac dose is important in reducing the risks of adjuvant radiotherapy, especially in good-prognosis patients.

Breast Neoplasms↗
PubMed1994

Histological characteristics of breast carcinoma in blacks and whites.

Tumor characteristics of 963 newly diagnosed invasive breast cancer cases from the population-based Black/White Cancer Survival Study were evaluated. Representative slides of the tumors were requested from all participating hospitals of three metropolitan areas and reviewed by one expert pathologist, blinded in regard to the age and race of patients. Nine tumor characteristics were evaluated for black and white patients. After adjusting for age, stage, and metropolitan area, blacks were significantly more likely to have high grade nuclear atypia [odds ratio (OR) = 1.97, 95% confidence interval (CI) = 1.27-3.04]; high mitotic activity (OR = 2.05, 95% CI = 1.34-3.14), grade 3 tumors (OR = 1.58, 95% CI = 1.02-2.45), and more necrosis (OR = 1.51, 95% CI = 1.16-1.98); and less likely to have well defined tubular formation (OR = 0.57, 95% CI = 0.42-0.77), marked fibrosis (OR = 0.65, 95% CI = 0.45-0.94), and positive estrogen receptor status (OR = 0.78, 95% CI = 0.58-1.05). These black/white differences remained after controlling for socioeconomic status (SES), body mass index, use of alcohol and tobacco, reproductive experience, and health care access and utilization. No significant racial differences were found for blood vessel invasion and lymphatic invasion. Although white women of high SES had more favorable tumors than those of low SES, the same pattern was not observed for blacks. High SES black women had statistically nonsignificant elevated ORs of a high mitotic index and tumor grade. These racial differences in tumor biology may have etiological and clinical implications.

Adult↗
PubMed1993

Lumpectomy compared with lumpectomy and radiation therapy for the treatment of intraductal breast cancer.

BACKGROUND AND METHODS: Women with ductal carcinoma in situ have been treated both by lumpectomy and by lumpectomy followed by radiation therapy, but the benefit of combined therapy is uncertain. A group of 818 women with ductal carcinoma in situ were randomly assigned to undergo lumpectomy or lumpectomy followed by breast irradiation (50 Gy). Sufficient tissue was removed that the margins of the resected specimens were histologically tumor-free. The mean duration of follow-up was 43 months (range, 11 to 86). The principal end point of the study was event-free survival, as defined by the presence of no new ipsilateral or contralateral breast cancers, regional or distant metastases, or other cancers and by no deaths from causes other than cancer. RESULTS: Five-year event-free survival was better in the women who received breast irradiation (84.4 percent, vs. 73.8 percent for the women treated by lumpectomy alone; P = 0.001). The improvement was due to a reduction in the occurrence of second ipsilateral breast cancers; the incidence of each of the other events was similar in the two groups. Of 391 women treated by lumpectomy alone, ipsilateral breast cancer developed in 64 (16.4 percent); it was noninvasive in 32 and invasive in the remaining 32. Of 399 women treated with lumpectomy and breast irradiation, ipsilateral breast cancer developed in 28 (7.0 percent) (noninvasive in 20 and invasive in 8). The five-year cumulative incidence of second cancers in the ipsilateral breast was reduced by irradiation from 10.4 percent to 7.5 percent for noninvasive cancers and from 10.5 percent to 2.9 percent for invasive cancers (P = 0.055 and P < 0.001, respectively). CONCLUSIONS: Breast irradiation after lumpectomy is more appropriate than lumpectomy alone for women with localized ductal carcinoma in situ.

Breast Neoplasms↗
PubMed1993

Pathologic findings from the National Surgical Adjuvant Breast Project protocol B-06. 10-year pathologic and clinical prognostic discriminants.

BACKGROUND: Prognostic pathologic and clinical features for 10-year survival were determined from 22 pathologic and 5 clinical variables encountered in 1090 node-negative and 651 node-positive patients enrolled in NSABP protocol B-06. METHODS: All factors were first screened univariately. Those exhibiting P values < 0.01 were entered into multivariate Cox regression models. The model with the best fit consisted of 951 negative-node and 496 node-positive patients. RESULTS: Better survival in node-negative patients was noted for whites rather than blacks, for patients with favorable tumor types (tubular, mucinous, papillary) rather than intermediate (lobular invasive, classical medullary, and not otherwise specified [NOS] combinations) or unfavorable forms (NOS pure and atypical medullary), and for tumors with good rather than poor nuclear grade. Number of nodal metastases, degree of tumor elastosis, and patient age younger than 40 years of age and 65 years of age and older in addition to nuclear grade and race were found significant for node-positive patients. Relative risks for combinations of these prognostic factors were multiplicative. CONCLUSIONS: The prognostic factors for node-negative patients were similar to those observed for this cohort at 8 years. Some differences noted between patients of both nodal groups in NSABP B-04 and B-06 may be related to selection requirements in the latter and hence different patient characteristics or more speculatively a change in tumor biology.

Adult↗
PubMed1993

Pathologic findings from the National Surgical Adjuvant Breast Project (Protocol 4). Discriminants for 15-year survival. National Surgical Adjuvant Breast and Bowel Project Investigators.

Twenty-one pathologic and five clinical features of Stage I and II invasive breast cancers from 620 patients enrolled in National Surgical Adjuvant Breast Project Protocol B-04 were analyzed to determine their predictive value for 15-year survival. Ten pathologic features had a statistically significant univariate prognostic relationship with long-term survival. These were analyzed further using a Cox regression model that found only the number of nodal metastases (0, 1-3, 4-9, or 10+), tumor size (< or = 2.0 cm versus 2.1-4 and 4.1 + cm), and the presence or absence of nipple involvement to be significant independent prognostic discriminants. Combinations of these three characteristics modestly increased their individual prognostic value. Differences in the findings in this study from those observed in the same patient population at 5 and 10 postoperative years and their relationship to other markers detected by ancillary pathologic techniques briefly are discussed.

Aged↗
PubMed1993

The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03.

PURPOSE: This study was designed to evaluate the efficacy of leucovorin-modulated fluorouracil (5-FU) as adjuvant therapy for patients with Dukes' stage B and C colon cancer. PATIENTS AND METHODS: Data are presented from 1,081 patients with Dukes' stage B and C carcinoma of the colon entered into National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol C-03 between August 1987 and April 1989. Patients were randomly assigned to receive either lomustine (MeCCNU), vincristine, and 5-FU (MOF), or leucovorin-modulated 5-FU (LV + 5-FU). The mean time on study was 47.6 months. RESULTS: Comparison between the two groups indicates a disease-free survival advantage for patients treated with LV + 5-FU (P = .0004). The 3-year disease-free survival rate for patients in this group was 73% (95% confidence interval, 69% to 77%), compared with 64% (95% confidence interval, 60% to 68%) for patients receiving MOF. The corresponding percentage of patients surviving was 84% for those randomized to receive LV + 5-FU and 77% for the MOF-treated cohort (P = .003). At 3 years of follow-up, patients treated with postoperative LV + 5-FU had a 30% reduction in the risk of developing a treatment failure and a 32% reduction in mortality risk compared with similar patients treated with MOF. CONCLUSION: Treatment with LV + 5-FU significantly prolongs disease-free survival and results in a significant benefit relative to overall survival. These findings, when considered together with results from a recent meta-analysis demonstrating a benefit from LV + 5-FU in advanced disease, provide evidence to support the concept of metabolic modulation of 5-FU.

Chemotherapy, Adjuvant↗
PubMed1992

A prospective study of the effectiveness of brief professionally-led support groups for infertility patients.

OBJECTIVE: This study prospectively evaluates the effectiveness and patient acceptability of professionally-led support groups in alleviating psychologic distress in infertility patients. METHOD: Sixty-four consecutive patients in a university hospital infertility program were administered a battery of psychologic tests before and after attendance at an 8 weekly session support group. The comparison group consisted of 35 consecutive infertility referrals to the same unit who were not initially offered the support group and were similarly tested over an 8 week period. RESULTS: Support group patients had significantly greater (p less than or equal to 0.01) entry than exit scores on several measures of psychologic distress and depression (the Beck Depression Inventory, the Hamilton Rating Scale for Depression, and the Global Severity Index, Anxiety, Depression, Hostility and Obsessive Compulsive Subscales of the Brief Symptom Inventory). The Avoidance Coping Style on the Moos Coping Responses Inventory was correlated with a higher Global Severity Index (p less than or equal to 0.01). Comparison group patients had similar psychometric scores to the support group patients at entry but showed no change over 8 weeks. Attenders expressed a high rate of satisfaction with the support group. CONCLUSIONS: Professionally-led support groups are a highly acceptable and effective intervention in self-referred patients in alleviating psychological distress related to infertility.

Adaptation, Psychological↗
PubMed1992

Prognostic factors in NSABP studies of women with node-negative breast cancer. National Surgical Adjuvant Breast and Bowel Project.

Twenty-two pathologic (including estrogen and progesterone receptor status) and four clinical features of 950 node-negative stage I invasive breast cancers from 950 women enrolled in the National Surgical Adjuvant Breast and Bowel Project protocol B-06 were analyzed for their possible prognostic significance. Univariate analyses revealed 10 characteristics that were significant at the 1% level. Only three of these--notably nuclear grade, histologic tumor type, and race--were found to be significant when entered into a Cox regression model. Patients whose tumors exhibited a good nuclear grade fared significantly better than those whose tumors were scored as poor. Similarly, a significantly better prognosis was noted when the histologic type of cancer was found to be "favorable" (mucinous, tubular, or papillary) than when it was "intermediate" (NOS, "Not Otherwise Specified," combination; typical medullary; and lobular invasive) or "unfavorable" (NOS pure and atypical medullary). Blacks exhibited a worse prognosis than whites. Survival was 94% at 8 years when the nuclear grade was good and the tumor type favorable, but only 54% when the nuclear grade was poor and tumor type unfavorable. Patients with one favorable and one unfavorable feature exhibited an intermediate survival. A brief overview as well as our own preliminary experience indicates that the combined use of these two prognostic pathologic parameters may be as good as and in some instances a better predictor of survival in node-negative patients than information derived from more "objective" methodologies such as flow cytometry, receptor analyses and tumor labeling indices or the demonstration of oncogene overexpression. Assessment of the pathologic parameters is simple, universally available, and quick and requires only modest training to be reproducible.

Breast Neoplasms↗
PubMed1992

Systemic therapy in node-negative patients: updated findings from NSABP clinical trials. National Surgical Adjuvant Breast and Bowel Project.

This report updates findings from two National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials conducted to evaluate the worth of systemic therapy for the treatment of node-negative breast cancer patients. In trial B-13, 737 women with estrogen receptor (ER)-negative tumors treated by sequential methotrexate and fluorouracil (MTX----5-FU) followed by leucovorin were compared with a control group treated by surgery alone. Findings for all patients through 5 years of follow-up indicate a 27% reduction in treatment failure as a result of MTX----5-FU (76% vs 67%). While patients 49 years old or less and 50 years old or more benefited significantly from MTX----5-FU, the effect on disease-free survival (DFS) was greatest in those 50 years or older, where a 50% reduction in treatment failure occurred (86% vs 72%). A 69% reduction in mortality resulting from MTX----5-FU was observed in the older group (95% vs 84%). Trial B-14 compared placebo with tamoxifen (TMX) in 2844 patients with ER-positive tumors. As originally reported, findings through 5 years of follow-up indicate a significant reduction (36%) in treatment failure as a result of the TMX (82% vs 72%). Improvement in DFS was highly significant in both age groups. In patients 49 years old or younger, there was a 44% reduction in DFS (81% vs 66%) and, in those 50 years old or more, a 31% reduction (82% vs 74%). A Cox proportional hazards model failed to indicate a benefit from MTX----5-FU and TMX in all patient subgroups. Both therapies reduced local-regional and distant recurrence, as well as breast tumor recurrence following lumpectomy. Updated findings from trials B-13 and B-14 continue to support our conclusions that (a) no subgroups of node-negative patients that we examined have such a good outcome as to preclude the use of effective systemic therapy in their treatment and (b) despite the benefits observed from MTX----5-FU and TMX, no subgroup of patients was so affected as to preclude use of a particular subgroup in assessing other therapy regimens in additional clinical trials. The identification and evaluation of markers to determine which patients should receive systemic therapy are of the highest priority. At present, however, the use of markers for therapeutic decision making regarding individual patients is tenuous.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

Lumpectomy for breast cancer: an update of the NSABP experience. National Surgical Adjuvant Breast and Bowel Project.

The data in this report continue to indicate, as first noted in 1985, that lumpectomy followed by breast irradiation in all patients, and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for negative- or positive-node patients with tumors 4 cm or less in size, provided that the margins of the resected specimens are free of tumor. The value of irradiation in reducing the incidence of tumor in the ipsilateral breast after lumpectomy continues to be significant in all patients regardless of nodal status, age, or tumor size. A multivariate analysis indicates that, in all patients, three covariates, ie, treatment, tumors with poor histologic type, and tumors with a maximum pathologic size greater than or equal to 2 cm, are significant predictors of breast tumor recurrence following lumpectomy. Of particular significance is the continuing observation that the distant disease-free survival (DDFS) and survival (S) of patients in the three treatment groups (total mastectomy, lumpectomy alone, and lumpectomy followed by breast irradiation) demonstrate no significant difference through 9 years of follow-up, despite the fact that the total mastectomy group (by virtue of breast removal) had no breast tumor recurrence, that lumpectomy patients treated with breast irradiation had a 10% ipsilateral tumor recurrence, and that patients treated by lumpectomy alone demonstrated a 40% recurrence of tumor.(ABSTRACT TRUNCATED AT 250 WORDS)

Breast Neoplasms↗
PubMed1991

DNA flow cytometric analysis of primary operable breast cancer. Relation of ploidy and S-phase fraction to outcome of patients in NSABP B-04.

Between 1971 and 1974, 1665 women with primary operable breast cancer were randomized into a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial (B-04) conducted to evaluate the effectiveness of several different regimens of surgical and radiation therapy. No systemic therapy was given. Cells from archival paraffin-embedded tumor tissue taken from 398 patients were analyzed for ploidy and S-phase fraction (SPF) using flow cytometry. Characteristics and outcome of patients with satisfactory DNA histograms were comparable to those from whom no satisfactory cytometric studies were available. In patients with diploid tumors (43%), the mean SPF was 3.4% +/- 2.3%; in the aneuploid population (57%), the SPF was 7.9% +/- 6.3%. Only 29.9% +/- 17.3% of cells in aneuploid tumors were aneuploid. Diploid tumors were more likely than aneuploid tumors to be of good nuclear grade (P less than 0.001) and smaller size (P equals 0.03). More tumors with high SPF were of poor nuclear grade than were tumors with low SPF (P equals 0.002). No significant difference in 10-year disease-free survival (P equals 0.3) or survival (P equals 0.1) was found between women with diploid or aneuploid tumors. Patients with low SPF tumors had a 13% better disease-free survival (P equals 0.0006) than those with a high SPF and a 14% better survival (P equals 0.007) at 10 years than patients with high SPF tumors. After adjustment for clinical tumor size, the difference in both disease-free survival and survival between patients with high and low SPF tumors was only 10% (P equals 0.04 and 0.08, respectively). Although SPF was found to be of independent prognostic significance for disease-free survival and marginal significance for survival, it did not detect patients with such a good prognosis as to preclude their receiving chemotherapy. The overall survival of patients with low SPF was only 53% at 10 years. These findings and those of others indicate that additional studies are necessary before tumor ploidy and SPF can be used to select patients who should or should not receive systemic therapy.

Breast Neoplasms↗
PubMed1991

Significance of ipsilateral breast tumour recurrence after lumpectomy.

Breast cancer treatment trials from the US National Surgical Adjuvant Breast and Bowel Project have established breast-conserving operations as a replacement for radical mastectomy (NSABP B-04), and have shown that in terms of survival free from distant disease there was no significant difference between lumpectomy, lumpectomy plus breast irradiation, and total mastectomy (NSABP B-06). 9-year follow-up data from B-06 are used here to address the issue of ipsilateral breast tumour recurrence (IBTR) and the development of distant disease, a question with important clinical and biological implications. A Cox regression model on fixed co-variates (ie, features such as tumour type or size present at surgery and not subsequently alterable) and on IBTR, which is time dependent and not fixed, revealed that the risk of distant disease was 3.41 times greater after adjustment for co-variates in patients in whom an IBTR developed. IBTR proved to be a powerful independent predictor of distant disease. However, it is a marker of risk for, not a cause of, distant metastasis. While mastectomy or breast irradiation following lumpectomy prevent expression of the marker they do not lower the risk of distant disease. These findings further justify the use of lumpectomy.

Breast Neoplasms↗
PubMed1991

Conservative management of intraductal carcinoma (DCIS) of the breast. Collaborating NSABP investigators.

Seventy-six patients with intraductal carcinoma (DCIS) of the breast have been observed for 83 months (range 50-141) following treatment by lumpectomy (L) only (21), L and breast irradiation (XRT) (27), or mastectomy (28). All represented examples of DCIS retrieved after pathologic examination of a much larger cohort of patients with stage I and II invasive breast cancer enrolled in NSABP protocol 6. Local breast recurrences were similar for women with DCIS and those from this cohort at a similar period of follow-up with invasive cancer treated by L only (43% vs. 39%) and L + XRT (7% vs. 10%). The presence of moderate/marked comedonecrosis was suggestively related to local breast recurrence (P = .07). This latter was significantly reduced for patients receiving post L XRT (P = .01). All local breast recurrences in this study and 29 of 31 recorded by others occurred at or close to the site of extirpation of the index cancer minimizing multicentricity as a contraindication for the conservative surgical treatment of DCIS. Survival rates which were similar for patients with DCIS regardless of form of local treatment were better than that observed for negative node patients with invasive cancer enrolled in protocol 6. Thus, DCIS is a less, not more, ominous disease than invasive cancer. This and other features of its natural history indicate that it would be a contradiction to treat invasive cancer but not DCIS conservatively.

Adult↗
PubMed1990

Effect of tamoxifen on serum insulinlike growth factor I levels in stage I breast cancer patients.

Insulinlike growth factor I (IGF-I) has been shown to be a potent mitogen for breast cancer cells in vitro, and IGF-I receptors have been demonstrated on human primary breast neoplasms. In a randomized, placebo-controlled study, we document that administration of the antiestrogen tamoxifen to patients with breast cancer was associated with a statistically significant (P = .002) reduction in the serum level of IGF-I. The mean IGF-I level was 1.4 U/mL in the placebo-treated group and 0.9 U/mL in the tamoxifen-treated group. Because serum IGF-I level is growth hormone (GH) dependent and because data suggest that the pubertal surge in GH and IGF-I levels is sex steroid dependent, we speculate that the mechanism underlying our observation may involve blockade by tamoxifen of estrogen action in the hypothalamic-pituitary axis. We conclude that tamoxifen treatment reduces IGF-I levels and that this reduction may contribute to the therapeutic effect of the drug.

Aged↗