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L D Case

Publications and source records attributed to L D Case.

At least 37 records · Page 2Linked to original sources

Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer.

PURPOSE: We prospectively assessed quality of life changes with time using validated instruments in men with clinically localized prostate cancer treated with permanent source interstitial brachytherapy. MATERIALS AND METHODS: A total of 46 men consecutively treated with permanent source interstitial brachytherapy between September 1997 and June 1998 completed quality of life (Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and urinary symptom (International Prostate Symptom Score [I-PSS]) questionnaires before (T0), and 1 (T1) and 3 (T3) months after treatment. All participants were treated with 125iodine alone. Repeated measures analyses of variance were conducted on all quality of life and urinary outcome measures for 44 patients with data at all 3 time points. RESULTS: Median patient age was 68 years (range 51 to 80). All men had clinical T1c to T2b prostate cancer, Gleason score was 6 or less in 36 (78%) and median pretreatment prostate specific antigen was 7 ng./ml. (range 1.1 to 20.6). Mean score (and standard deviation) at T0, T1 and T3 for each questionnaire was FACT-P 138.9 (14.4), 128.6 (19.4) and 136.7 (17.4), TO versus T1 p = 0.0005 and T0 versus T3 p = 0.6612, and I-PSS 8.3 (5.4), 19.7 (9.0) and 15.7 (7.2), T0 versus T1 p = 0.0001 and T0 versus T3 p = 0.0001. For the global test across time statistically significant differences were observed for the cumulative scores of FACT-P, I-PSS, physical well-being and prostate cancer subscales of the FACT-P and the Trial Outcome Index. By 3 months all quality of life measures had returned to baseline. Urinary symptoms as measured by I-PSS persisted for at least 3 months. CONCLUSIONS: Clinically meaningful decreases in quality of life, as measured by the FACT-P instrument, were evident within weeks after permanent source interstitial brachytherapy. However, by 3 months FACT-P scores returned to near baseline levels. A validated instrument designed to measure urinary symptoms (I-PSS) demonstrated that moderate to severe urinary symptoms persisted for at least 3 months following permanent source interstitial brachytherapy. An instrument specifically designed to measure urinary symptoms can provide additional clinical information when combined with FACT-P.

Aged↗

Health education to increase screening for cervical cancer among Lumbee Indian women in North Carolina.

Although age-adjusted mortality rates from cancer among Native-Americans are generally lower than for the US population as a whole, cervical cancer mortality rates are higher. This report presents results from a National Cancer Institute-funded health education program conducted among the Lumbee tribe in North Carolina that was designed to increase the proportion of women, age 18 and older, who receive Pap smears to screen for cervical cancer. The Solomon Four Group research design was used for this project. Participants were selected at random from the enrollment records of the Lumbee tribe and data collection was carried out during face-to-face interviews. The health education program was provided one-on-one in women's homes by a trained lay health educator and included verbal, print and videotape information. A total of 979 women were enrolled in the study, and 125 were lost to follow-up between the pre-test and post-test. Women who received the education program were found to be more likely to have knowledge of the Pap smear and to report a Pap smear in the past year at the post-test than those in the control group, regardless of whether they received the pre-test interview, P < 0.05. Women most likely to respond to the education program were also likely to have reported that they receive an annual physical examination. Women with better knowledge of the Pap smear tended to have more education, higher income and greater identification with Native-American culture than those with less knowledge. We conclude that the health education program was associated with greater knowledge about cervical cancer prevention and higher proportions of Lumbee women obtaining Pap smears in the past year.

Adolescent↗

Combination of fosinopril and pravastatin decreases platelet response to thrombin receptor agonist in monkeys.

Both angiotensin-converting enzyme (ACE) inhibitors and 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors have been shown to decrease cardiovascular morbidity and mortality. Results from clinical trials have suggested that HMG-CoA reductase inhibition might exert a beneficial effect independent of its lipid-lowering effect, and ACE inhibition may exert a benefit independent of blood-pressure lowering. To test the hypothesis that such an effect might be mediated by alteration in platelet reactivity, we studied 55 monkeys receiving both, 1, or neither of the ACE inhibitor fosinopril and the HMG-CoA reductase inhibitor pravastatin. Platelet responsiveness to collagen and to the thrombin receptor agonist (TRA) SFLRRN-NH2 was determined by aggregometry. For each agonist, the maximum rate and extent of aggregation were measured for each dose, and the concentration required for half-maximal response (C50) was determined. Each drug, when given alone, slightly decreased the dose of agonist required to produce 50% response in the rate and extent of platelet aggregation relative to control. The combination of the 2 drugs, however, produced a significant increase in the dose of TRA required to produce 50% response in the rate and extent of aggregation relative to either drug alone or the control group. This was not true for collagen. The magnitude of the change relative to the control group, 47% for rate and 30% for extent of aggregation, could confer considerable protection by changing the threshold for thrombin-induced platelet aggregation and, thus, decrease thrombosis.

Animals↗

Tamoxifen as initial endocrine therapy for metastatic breast cancer: long term follow-up of two Piedmont Oncology Association (POA) trials.

PURPOSE: To examine the outcomes of endocrine naive patients treated with tamoxifen as initial endocrine therapy for metastatic breast cancer. Data were obtained from the long-term follow-up of two previously published randomized trials. PATIENTS AND METHODS: All patients received tamoxifen 20 mg po in a single daily dose. Eligibility required patients to be age > or = 18, performance status 0-3, and estrogen or progesterone receptor positive or unknown. Patients were ineligible if they had any prior endocrine therapy in either the adjuvant or metastatic setting. RESULTS: 156 patients have been followed for a median of 8.3 years. Median age was 61 years, 83% were > or = 50 years, 84% performance status of 0-1, 43% were both ER and PR positive, 33% had prior chemotherapy, 62% had a disease-free interval of > 2 years, and 59% had only one metastatic site. The complete (14%) and partial (6%) response rate for 147 evaluable patients was 20% (95% CI for CR + PR of 14-27%). Multivariate analysis revealed that improved response was related to soft tissue involvement and positive PR status. The majority of patients with soft tissue, nodal or lung metastases had responses noted within three months. Median time to disease progression was 6.7 months. Multivariate analysis revealed that older patients, those with one metastatic site and those with positive PR status had the longest time to progression. Median survival was 27.2 months. Better performance status, fewer metastatic sites and being PR positive were associated with significantly improved survival. CONCLUSION: The patient population in this series is not likely to be studied in future trials because of the wide use of tamoxifen in the adjuvant setting. In a small percentage of patients with metastatic breast cancer, tamoxifen therapy is associated with prolonged remission and survival. Pretreatment characteristics can help identify such patients.

Adult↗

Effectiveness of health education to increase screening for cervical cancer among eastern-band Cherokee Indian women in North Carolina.

BACKGROUND: The North Carolina Native American Cervical Cancer Prevention Project was a 5-year, National Cancer Institute-funded trial of health education designed to increase screening for cervical cancer among Native-American women in North Carolina. PURPOSE: This study was conducted to evaluate the effectiveness of this education program in the Eastern-Band Cherokee target population. METHODS: Cherokee tribal lands were mapped and all households (N = 2223) were listed to ensure maximum coverage of the eligible population (women, aged 18 years and older, who were enrolled tribal members). Eligible women were identified by the use of a brief questionnaire administered to an adult member of the household. Of the 1279 households with eligible women, 1020 (79.8%) agreed to participate. The intervention was an individualized health education program delivered by female Cherokee lay health educators. The participants were randomly assigned to receive or not to receive the intervention (i.e., to program and control groups, respectively) by use of the Solomon Four-Group design. Data were collected in face-to-face interviews conducted in the participant's home. Of the 996 women who were ultimately enrolled, 540 were randomly assigned to receive a pretest (preintervention) interview that involved administration of a 96-item questionnaire designed to collect data on knowledge, intentions, and behaviors related to cervical cancer; of these 540 women, 263 were randomly assigned to receive the education program. The remaining 456 women did not receive the pretest, but 218 were randomly assigned to receive the education program. Six months after receiving the education program, the women in all four groups were administered a post-test that was identical to the pretest. Logistic regression was used to assess the effects of the pretest and the educational program. All P values resulted from two-sided statistical tests. RESULTS: Eight hundred and fifteen (81.8%) of the 996 participants completed the post-test interview. The remaining 181 women who were lost to follow-up were evenly distributed among the four study groups. At the post-test, 282 (73.2%) of the 385 women who received the education program reported having had a Pap smear following the intervention, compared with 275 (64%) of the 430 control subjects. Women who received the education program were more likely to answer all knowledge items correctly on the post-test (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.08-4.39) and to report having obtained a Pap smear in the past year (OR = 2.06, 95% CI = 1.14-3.72) than women in the control groups. CONCLUSION: Women who received the education program exhibited a greater knowledge about cervical cancer prevention and were more likely to have reported having had a Pap smear within the past year than women who did not receive the program.

Adult↗

Usefulness and limitations of serum and urine lysozyme levels in the classification of acute myeloid leukemia: an analysis of 208 cases.

The revised French-American-British (FAB) classification system for acute myeloid leukemia (AML) recommends the determination of serum lysozyme (SL) or urine lysozyme (UL) levels as an aid in distinguishing acute myeloblastic leukemia with maturation (FAB M2) from acute myelomonocytic leukemia (M4). We reviewed retrospectively 208 cases of adult leukemia in which SL and/or UL were obtained. Elevated lysozyme levels were not found in any of the M0, M3, or M7 cases, but were increased (false positive) in three (14%) M1 cases, 18 (19%) M2 cases and one (20%) M6 case. Although a UL value in excess of 3x normal was found in most cases of AML M4 and M5, only five (11%) M4 cases and three (20%) M5 cases had SL elevations of this magnitude. Lysozyme levels need to be interpreted in conjunction with other parameters for FAB classification.

Aged↗

Increasing influenza immunization among high-risk patients: education or financial incentive?

PURPOSE: To determine whether an educational brochure or a lottery-type incentive increases influenza immunization rates. PATIENTS AND METHODS: In a prospective, single-blind factorial design randomized trial at an urban community health center, all high-risk patients (n = 797) seen in the preceding 18 months were randomly assigned to one of four groups: a control group; a group mailed a large print, illustrated educational brochure emphasizing factors important to patients in making a decision about influenza immunization; a group mailed a lottery-type incentive announcing that all patients receiving influenza immunization would be eligible for grocery gift certificates; and a group mailed both educational brochure and incentive. Immunization was free, available without an appointment, and recorded by a computerized tracking system. RESULTS: The group mailed the brochure was more likely to be immunized than control (odds ratio [OR] = 2.29, 95% confidence interval [CI] 1.45 to 3.61), as was the group mailed the incentive (OR = 1.68, 95% CI 1.05 to 2.68), but there was no difference between the group mailed both interventions and the control group. The effectiveness of the brochure was more striking for individuals who had not accepted immunization in the prior year (OR = 4.21, 95% CI 2.48 to 7.14), suggesting a true educational effect rather than simply a reminder. CONCLUSION: In this community health center setting, an illustrated educational brochure increased influenza immunization among high-risk patients, a lottery-type incentive was much less effective, and both together was not effective.

Aged↗

Leucovorin and high-dose fluorouracil in metastatic prostate cancer. A phase II trial of the piedmont Oncology Association.

We performed a Phase II trial of oral leucovorin and high-dose fluorouracil (5FU) in hormone refractory patients with metastatic prostate cancer who had not had prior chemotherapy. 5FU was given as a 24-hour infusion at a dosage of 4 g/m2 and oral leucovorin at a dosage of 50 mg every 6 hours for four doses, starting with the infusion of 5FU. Fifteen patients were treated and three were not evaluable for response. There were no complete (CR) or partial responses (PR) in 12 evaluable patients (95% confidence interval for CR+PR of 0 to 26%). Three patients had stable disease and the remainder progressed. Toxicities were generally mild to moderate, but one patient died of sepsis while neutropenic. This dose and schedule of leucovorin and 5FU is not better than single-agent 5FU in patients with metastatic prostate cancer.

Aged↗

Validation of self-reported breast and cervical cancer screening tests among low-income minority women.

The objective of the Forsyth County Cancer Screening Project is to assess barriers to breast and cervical cancer screening among low-income women and to develop an educational program to address these barriers. To properly assess the barriers, it was first necessary to determine if self-reported rates of breast and cervical cancer screening were accurate. All women who participated in the baseline survey (n = 555) were asked to provide information regarding if, where, and when they had obtained mammograms and Pap smears. Identified health care facilities were then contacted to verify this information. Approximately 80% of responses were verified for at least one of the exams with the information provided. For mammography, 77% of self-reports were correct, whereas 67% of self-reports of Pap smear screening were correct (kappa = 0.54 and 0.15, respectively). For both tests, women thought they had received them more recently than they actually had, by an average of 3 months for mammography and 23 months for Pap smears. Using validated reports of screening did not substantially change identified predictors of screening for mammography. For Pap smear screening, however, most of the identified predictors of screening became nonsignificant when medical chart reports were used instead of self-reports, suggesting that caution should be used in relying on self-reports to design programs to improve cervical cancer screening practices.

Adult↗

GM-CSF and asparaginase potentiate ara-C cytotoxicity in HL-60 cells.

In preparation for a clinical trial using GM-CSF on days 4-10 of sequential high-dose cytarabine (ara-C) and asparaginase (ASNase) on days 1-3 and 8-10, potential interactions between the protein synthesis inhibitor ASNase and GM-CSF were evaluated. Granulocyte-macrophage colony-stimulating factor (GM-CSF) can stimulate acute myeloid leukemia (AML) cells to proliferate in vitro and in vivo. Log phase HL-60 cells were exposed to ara-C (10 microM x 3 h) and/or ASNase (10 U/ml during the last 2 h of ara-C). Ara-C and/or ASNase was removed and cells were incubated with or without GM-CSF (10 ng/ml). After 24, 48 and 72 h of GM-CSF there was no significant difference in the S phase fraction of cells exposed to ASNase prior to GM-CSF. Soft agar cloning efficiency was determined after retreatment with ara-C +/- ASNase 24 h into the GM-CSF incubation. GM-CSF enhanced cytotoxicity for all combinations, although this effect was of borderline significance (P = 0.0621); addition of ASNase to the treatment regimen significantly (P = 0.0229) enhanced cytotoxicity without any evidence of a negative interaction with GM-CSF. In addition, ara-C metabolism was assessed during simultaneous exposure to ara-C (10 microM x 3 h) +/- ASNase (10 U/ml the last 2 h) +/- GM-CSF (10 ng/ml beginning 24 h prior to ara-C). Ara-C incorporated into DNA (P = 0.0302) and ara-CTP formation (P = 0.0084 and P = 0.0003 at 2 and 3 h timepoints, respectively) were both increased significantly by GM-CSF, with modest non-significant increases with ASNase exposures. Neither ASNase nor GM-CSF inhibited the effects of the other in this in vitro model. Therefore, when appropriately scheduled, both GM-CSF and ASNase may potentiate ara-C cytotoxicity.

Arabinofuranosylcytosine Triphosphate↗

Occurrence, etiology, and clinical significance of extreme thrombocytosis: a study of 280 cases.

PURPOSE: To determine the etiology and to evaluate the clinical consequences of an extremely elevated platelet count. PATIENTS AND METHODS: A review of the medical records was performed on all patients encountered during a 5 1/2-year period who had at least one platelet count of 1,000 x 10(9)/L or greater. RESULTS: Of the total of 280 patients with extreme thrombocytosis (EXT), 231 (82%) had reactive thrombocytosis (RT), 38 (14%) had a myeloproliferative disorder (MPD), and 11 (4%) had cases of uncertain etiology. RT was more common than MPD in all age groups except those in the eighth decade and older. Symptoms of bleeding and/or vaso-occlusive phenomena were noted in association with EXT in 21 (56%) of the MPD patients but in only 10 (4%) of the RT patients. Treatment to lower the platelet count and/or inhibit platelet function was employed in 36 MPD patients and 23 RT patients. Eight patients with MPD and 34 with RT are known to have died, but no patient in either group is known to have died of a thrombotic or bleeding event when the platelet count was greater than or equal to 1,000 x 10(9)/L. CONCLUSIONS: Platelet counts greater than or equal to 1,000 x 10(9)/L should not be considered rare events in the general, acute-care hospital population, and usually represent a reactive phenomenon.

Adolescent↗

Hemorrhagic cystitis in bone marrow transplantation.

OBJECTIVES: Patients undergoing bone marrow transplantation are at risk for hemorrhagic cystitis despite appropriate preventive measures. This complication could have an impact on patient survival and other outcome variables. METHODS: A retrospective study of patients subjected to bone marrow transplantation was conducted to determine risk factors for hemorrhagic cystitis and evaluate the impact of hemorrhagic cystitis on certain outcome variables. Patients who experienced hemorrhagic cystitis received various forms of therapy, at the discretion of the treating physician. RESULTS: Hemorrhagic cystitis occurred more frequently in younger patients and those undergoing allogeneic transplantation. The occurrence of hemorrhagic cystitis was associated with increased hospital costs, length of hospitalization, and mortality. Gender, race, type of malignancy, other pretransplantation comorbidity, and the occurrence of other peritransplantation complications were not associated with occurrence of hemorrhagic cystitis. CONCLUSIONS: Hemorrhagic cystitis is a significant complication of bone marrow transplantation, which influences economic and survival outcome. Since the number of bone marrow transplants being performed is increasing, urologists should be prepared to play an active role in treating patients who experience this complication.

Adolescent↗

Breast cancer screening education in the workplace.

This study examined the use of breast cancer screening education programs in 102 of the major workplaces in Forsyth County, North Carolina. Characteristics of workplaces that had sponsored such programs within the preceding three years were identified. Eighteen percent of the workplaces surveyed had offered breast cancer screening education programs. Factors that were directly related to having sponsored a program included the size of the workforce, the number of female employees, and the proportion of female employees over 40 years old. Characteristics related to health service activities in the workplace were also predictive. Neither the type of industry nor the insurance status of the workplace was significantly related to having sponsored a program.

Adult↗

Tamoxifen versus high-dose oral medroxyprogesterone acetate as initial endocrine therapy for patients with metastatic breast cancer: a Piedmont Oncology Association study.

PURPOSE: To determine in a prospective randomized trial whether high-dose orally administered medroxy-progesterone acetate (MPA) was superior to tamoxifen in patients with recurrent or metastatic breast cancer who had received no prior endocrine therapy in either the adjuvant or advanced setting. PATIENTS AND METHODS: Patients initially received either tamoxifen 20 mg/d orally or MPA 1 g/d orally. At the time of disease progression, patients were crossed over to the other regimen. Eligibility required patients to be age > or = 18 years, performance status 0 to 3, and estrogen receptor (ER)- or progesterone receptor (PR)-positive or unknown. RESULTS: One hundred eighty-two eligible patients were entered and 166 were assessable for response. Complete plus partial response rates for tamoxifen and MPA were 17% and 34%, respectively (P = .01). Patients with bone metastases had a significantly higher partial response rate with MPA compared with tamoxifen (33% v 13%). Median time to treatment failure was 5.5 months for tamoxifen and 6.3 months for MPA (P = .48). The median survival duration was 24 months for tamoxifen and 33 months for MPA (P = .09). Multivariate analysis showed that treatment significantly influenced response rate, but not time to treatment failure or survival. After treatment failure following MPA, six of 42 patients (14%) treated with tamoxifen responded, compared with six of 49 (12%) treated with MPA following tamoxifen. Both agents were associated with minimal toxicity, but 35% of patients on MPA gained more than 20 lb as opposed to only 2% on tamoxifen. CONCLUSION: In this trial, initial treatment with MPA of endocrine-naive metastatic breast cancer patients was associated with a significantly higher response rate but not with improvement in time to treatment failure or survival, when compared with initial treatment with tamoxifen. Further randomized trials in patients with bone metastases are warranted to determine if high-dose progestin therapy is superior to tamoxifen in these patients.

Administration, Oral↗

Portable chest radiographs identify mechanical ventilator-associated hyperinflation.

OBJECTIVE: Portable chest radiographs (CRs) are obtained routinely in mechanically ventilated patients, but little is known about relationships between CR findings and ventilator parameters. It is unclear whether radiographically apparent hyperinflation correlates with tidal volume (VT), body weight (BW), VT/kg, or levels of peak airway pressure (PAP), positive end-expiratory pressure (PEEP), or pressure support (PS). DESIGN: Prospective comparison of CR and ventilator parameters in 62 mechanically ventilated patients in surgical and medical intensive care units of a university hospital. PATIENT SELECTION: All mechanically ventilated adults with portable CR on four separate dates. METHODS: Chest radiographs were classified by subjective assessments as hyperinflated (H+) or nonhyperinflated (H-), independent of knowledge of patients or their mechanical ventilation. Chest radiographs were reclassified independently as H+, H-, or indeterminate by a radiologist using objective criteria. Ventilator parameters recorded at the time of the CR were obtained and compared. RESULTS: Patients with CRs classified subjectively as H+ compared with patients with CRs classified as H- had a larger VT/kg (12.0 +/- 0.4 ml/kg [mean +/- SEM] vs 10.2 +/- 0.4; p = 0.004), lower BW (70.8 +/- 2.9 kg vs 81.5 +/- 3.8; p = 0.03), higher PEEP (6.5 +/- 0.5 cm H2O vs 5.0 +/- 0.4; p = 0.01), and higher PAP (38.2 +/- 2.1 cm H2O vs. 33.4 +/- 1.8; p = 0.06). Using objective CR classifications, patients with H+ CRs had a VT/kg of 12.6 +/- 0.4, larger than in the indeterminate (11.1 +/- 0.8) and H- (9.9 +/- 0.3) groups (p < 0.001). The BW differed among objectively classified groups (66.5 +/- 2.7 H+, 68.9 +/- 5.1 indeterminate, and 85.2 +/- 3.7 H-; p < 0.001), but other ventilator parameters did not correlate univariately with the degree of inflation on CR. Multivariate analysis showed that higher VT was predictive of H+ after adjusting for BW in subjective (p = 0.076) and objective (p = 0.017) classifications. PEEP (p = 0.004) and older age (p = 0.021) were also associated with H+ in multivariate analysis. Four of 25 (16 percent) patients with objectively H+ CRs developed barotrauma, while no patient with H- CR had this complication (p = 0.037). CONCLUSIONS: In mechanically ventilated patients, hyperinflation seen on portable CR is associated with higher VT, VT/kg, and lower BW, and may help predict subsequent barotrauma.

Adolescent↗

Cathepsin D as a prognostic indicator for node-negative breast cancer patients using both immunoassays and enzymatic assays.

This is a retrospective study on 162 node-negative patients, with both biochemical and clinical factors being measured for determination of prognostic markers. Steroid receptors were measured on all tumors, while tumor size, histological grade, ploidy status, and cell cycle kinetics indicators could not be found or measured on 25 or less of the patient group. The primary focus of this study was the measurement of cathepsin D, analyzed by two different procedures, and 161 of the 162 patients had at least one value. The antigenic assay was performed using the US-CIS kit, and it was sensitive and reproducible. A biochemical assay using the enzymatic activity of cathepsin D was developed, and it gave proportional values, compared to the antigenic assay values (r2 = 0.79). Our results indicated that the mean antigenic levels were 20% higher than the biochemical assay levels (P = 0.001). High levels of cathepsin D by the antigenic assay predicted poor relapse-free (P = 0.0001) and overall (P = 0.0004) survival. High levels of cathepsin D by the biochemical assay also predicted poor relapse-free (P = 0.031) and overall (P = 0.0013) survival. The cathepsin D values were still useful as predictors of outcome after multivariate analysis. Several other factors, such as grade and S phase, were useful as additional prognostic indicators. In conclusion, cathepsin D is the most useful marker in node-negative patients, and the analysis can be performed by both a biochemical and an antigenic assay.

Analysis of Variance↗

Chemotherapy of metastatic breast cancer in the elderly. The Piedmont Oncology Association experience [see comment].

OBJECTIVE: To determine the effect of age on treatment outcome in women with metastatic breast cancer treated with chemotherapy. DESIGN: Case-comparison study of patients with metastic breast cancer treated in five clinical trials of the Piedmont Oncology Association. SETTING: University and private practice physicians participating in the Piedmont Oncology Association clinical trials in the southeastern United States. PATIENTS: Seventy patients 70 years of age or older were compared with 60 patients aged 50 through 69 years and 40 patients less than 50 years of age. All patients were ambulatory or capable of self-care, with adequate hematologic, renal, and hepatic function. INTERVENTIONS: Treatment with multidrug chemotherapy regimens. MAIN OUTCOME MEASURES: Response to treatment, time to disease progression, survival, and toxic effects. RESULTS: Pretreatment characteristics including race, performance status, disease-free interval, prior therapy, sites of metastatic disease, and number and dominant sites of metastases were similar for the three age groups. The response rates for the younger-than-50, 50-through-69, and 70-or-older age groups were 40%, 31%, and 29%, respectively (P = .53). There were no significant differences in time to disease progression or survival for patients in the three age groups. Estimates for time to progression and survival were 9.1 and 17.9 months, 6.2 and 12.8 months, and 7.2 and 14.2 months, respectively. Toxic effects, dose delivery, and dose delays were also similar for all three age groups. CONCLUSIONS: Women 70 years of age or older who were enrolled in these trials were similar to their younger counterparts in response rates, time to disease progression, survival, and toxic effects. Women in this age group should not be excluded, based on age alone, from clinical trials involving chemotherapy for advanced breast cancer.

Age Factors↗