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Biomedical subjects

Jeff A Sloan

Publications and source records attributed to Jeff A Sloan.

At least 19 recordsLinked to original sources
PubMed2004

Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study.

PURPOSE: Few options are available for pain relief in patients with bone metastases who fail standard treatments. We sought to determine the benefit of radiofrequency ablation (RFA) in providing pain relief for patients with refractory pain secondary to metastases involving bone. PATIENTS AND METHODS: Thirty-one US and 12 European patients with painful osteolytic metastases involving bone were treated with image-guided RFA using a multitip needle. Treated patients had > or = 4/10 pain and had either failed or were poor candidates for standard treatments such as radiation or opioid analgesics. Using the Brief Pain Inventory-Short Form, worst pain intensity was the primary end point, with a 2-unit drop considered clinically significant. RESULTS: Forty-three patients were treated (median follow-up, 16 weeks). Before RFA, the mean score for worst pain was 7.9 (range, 4/10 to 10/10). Four, 12, and 24 weeks following treatment, worst pain decreased to 4.5 (P <.0001), 3.0 (P <.0001), and 1.4 (P =.0005), respectively. Ninety-five percent (41 of 43 patients) experienced a decrease in pain that was considered clinically significant. Opioid usage significantly decreased at weeks 8 and 12. Adverse events were seen in 3 patients and included (1) a second-degree skin burn at the grounding pad site, (2) transient bowel and bladder incontinence following treatment of a metastasis involving the sacrum, and (3) a fracture of the acetabulum following RFA of an acetabular lesion. CONCLUSION: RFA of painful osteolytic metastases provides significant pain relief for cancer patients who have failed standard treatments.

Adult↗
PubMed2003

Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy.

PURPOSE: A phase III, randomized, double-blind study was conducted by the North Central Cancer Treatment Group to determine the efficacy and toxicity of oral glutamine for the prevention of acute diarrhea in patients receiving pelvic radiation therapy (RT). PATIENTS AND METHODS: All 129 patients enrolled from 14 institutions between February 1998 and October 1999 were eligible. Patients received 4 g of glutamine or placebo orally, twice a day, beginning with the first or second day of RT and continuing for 2 weeks after RT. During treatment, patients were assessed weekly for toxicity, and a bowel function questionnaire was administered. The primary measures of treatment efficacy were diarrhea levels measured by maximum grade of diarrhea, incidence of diarrhea, and average diarrhea score. After completion of RT, the bowel function questionnaire was administered weekly for 4 weeks and at 12 and 24 months. Toxicity was measured by National Cancer Institute common toxicity criteria. RESULTS: The median age of patients was 69 years (range, 34 to 86 years). The two treatment arms were balanced with respect to all baseline factors. There were no significant differences in toxicity by treatment. Quality-of-life scores and the mean number of problems reported on the bowel function questionnaire were virtually identical for both treatment groups. The incidence of grade 3 or higher diarrhea was 20% for the glutamine arm and 19% for the placebo arm (P =.99). The maximum number of stools per day was 5.1 for the glutamine arm and 5.2 for the placebo arm (P =.99). CONCLUSION: There is no evidence of a beneficial effect of glutamine during pelvic RT.

Acute Disease↗
PubMed2003

A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma.

BACKGROUND: Recent laboratory and epidemiologic studies have suggested that green tea has antitumor effects in patients with prostate carcinoma. This Phase II trial explored green tea's antineoplastic effects in patients with androgen independent prostate carcinoma. METHODS: This study, which was conducted by the North Central Cancer Treatment Group, evaluated 42 patients who were asymptomatic and had manifested, progressive prostate specific antigen (PSA) elevation with hormone therapy. Continued use of luteinizing hormone-releasing hormone agonist was permitted; however, patients were ineligible if they had received other treatments for their disease in the preceding 4 weeks or if they had received a long-acting antiandrogen therapy in the preceding 6 weeks. Patients were instructed to take 6 grams of green tea per day orally in 6 divided doses. Each dose contained 100 calories and 46 mg of caffeine. Patients were monitored monthly for response and toxicity. RESULTS: Tumor response, defined as a decline >/= 50% in the baseline PSA value, occurred in a single patient, or 2% of the cohort (95% confidence interval, 1-14%). This one response was not sustained beyond 2 months. At the end of the first month, the median change in the PSA value from baseline for the cohort increased by 43%. Green tea toxicity, usually Grade 1 or 2, occurred in 69% of patients and included nausea, emesis, insomnia, fatigue, diarrhea, abdominal pain, and confusion. However, six episodes of Grade 3 toxicity and one episode of Grade 4 toxicity also occurred, with the latter manifesting as severe confusion. CONCLUSIONS: Green tea carries limited antineoplastic activity, as defined by a decline in PSA levels, among patients with androgen independent prostate carcinoma.

Aged↗
PubMed2003

Nicotine patch therapy based on smoking rate followed by bupropion for prevention of relapse to smoking.

PURPOSE: To determine whether (1) tailored nicotine patch therapy that is based on smoking rate can be carried out in a multisite oncology investigative group practice setting, (2) long-term use of bupropion reduces the rate of relapse to smoking in smokers who stop smoking with nicotine patch therapy, and (3) bupropion can initiate smoking abstinence among smokers who have failed to stop smoking after nicotine patch therapy. PARTICIPANTS AND METHODS: Fourteen North Central Cancer Treatment Group sites recruited generally healthy adult smokers from the general population for nicotine patch therapy and based the patch dosage on smoking rates. At completion of nicotine patch therapy, nonsmoking participants were eligible to be assigned to bupropion or placebo for 6 months (for relapse prevention). and smoking participants were eligible to be assigned to bupropion or placebo for 8 weeks of treatment. RESULTS: Of 578 subjects, 31% were abstinent from smoking at the end of nicotine patch therapy. Of those subjects not smoking at the end of nicotine patch therapy who entered the relapse prevention phase, 28% and 25% were not smoking at 6 months (the end of the medication phase) for bupropion and placebo, respectively (P =.73). For those still smoking at the end of nicotine patch therapy, 3.1% and 0.0% stopped smoking with bupropion or placebo, respectively (P =.12). CONCLUSION: Tailored nicotine patch therapy for the general population of smokers can be provided in a multisite oncology investigative group setting. Bupropion did not reduce relapse to smoking in smokers who stopped smoking with nicotine patch therapy. Bupropion did not initiate abstinence among smokers who failed to stop smoking with nicotine patch therapy.

Adolescent↗
PubMed2003

Lung cancer screening with CT: Mayo Clinic experience.

PURPOSE: To evaluate a large cohort of patients at high risk for lung cancer by using screening with low-dose spiral computed tomography (CT) of the chest. MATERIALS AND METHODS: A prospective cohort study was performed with 1,520 individuals aged 50 years or older who had smoked 20 pack-years or more. Participants underwent three annual low-dose CT examinations of the chest and upper abdomen. Characteristics of pulmonary nodules and additional findings were tabulated and analyzed. RESULTS: Two years after baseline CT scanning, 2,832 uncalcified pulmonary nodules were identified in 1,049 participants (69%). Forty cases of lung cancer were diagnosed: 26 at baseline (prevalence) CT examinations and 10 at subsequent annual (incidence) CT examinations. CT alone depicted 36 cases; sputum cytologic examination alone, two. There were two interval cancers. Cell types were as follows: squamous cell tumor, seven; adenocarcinoma or bronchioloalveolar carcinoma, 24; large cell tumor, two; non-small cell tumor, three; small cell tumor, four. The mean size of the non-small cell cancers detected at CT was 15.0 mm. The stages were as follows: IA, 22; IB, three; IIA, four; IIB, one; IIIA, five; IV, one; limited small cell tumor, four. Twenty-one (60%) of the 35 non-small cell cancers detected at CT were stage IA at diagnosis. Six hundred ninety-six additional findings of clinical importance were identified. CONCLUSION: CT can depict early-stage lung cancers. The rate of benign nodule detection is high.

Aged↗
PubMed2003

The hospice patient's primary caregiver. What is their quality of life?

OBJECTIVE: The purpose of this study was to (1) assess the quality of life (QOL) of the primary caregivers of hospice patients and (2) to analyze the ability of the hospice staff to accurately judge caregiver QOL. METHODS: A longitudinal pilot study of QOL of caregivers of patients entering hospice was undertaken. Caregivers and hospice personnel completed numerous questionnaires every 2 weeks until patient death. Global QOL and component constructs, as well as the demands of illness on the caregiver and profile of moods, were assessed. Simple descriptive statistics at each time point and summary measures (area under the curve) were calculated to describe the QOL profile of caregivers and staff perceptions of the caregivers. Cronbach's alpha coefficient was applied to verify tool internal consistency in a hospice population. Correlation coefficients were supplemented by Bland-Altman procedures for comparing scales measuring the same construct to compare the scores given by caregivers about themselves and staff ratings of the caregivers. The study had 80% power to detect an intracase difference between caregiver and staff ratings of the caregiver of 0.4 times the standard deviation using a two-sided paired t test with a 5% type I error rate. RESULTS: Caregiver QOL was relatively high and stable over time. Caregiver's QOL was correlated with the patient's overall QOL/hospice staff accurately evaluated caregiver QOL. CONCLUSIONS: By drawing attention to issues that affect the caregiver, we can improve delivery of hospice care and positively impact QOL for both caregiver and patient. Linear analog self-assessment scales are valuable tools for hospice staff to assess caregivers.

Caregivers↗
PubMed2003

TAP1, TAP2, and HLA-DR2 alleles are predictors of cervical cancer risk.

OBJECTIVE: The likelihood of developing cervical cancer has been shown to be increased in persons with certain HLA alleles. We evaluated immune response genes in the HLA region of chromosome 6 to see if individual or interactive associations with cervical cancer risk could be identified. METHODS: Tissue was obtained from 127 women undergoing surgical treatment for cervical cancer. Blood samples were obtained from 175 control subjects. A combination of polymerase chain reaction (PCR), sequence-specific PCR, and DNA sequencing was used to evaluate polymorphic alleles, including HLA class I B7, TNF alpha, HLA class II DR2, TAP1, and TAP2 genes. Fisher's exact test and logistic regression modeling were used for statistical analysis. RESULTS: A significantly greater proportion of the patients with cervical cancer were found to have the HLA class II DR2 1501 allele (P = 0.023) and the TAP2 A/B heterozygous pattern of alleles (P = 0.0006) than were women without cervical cancer. A proportion of patients with cervical cancer significantly smaller than that of the control women had a polymorphism at the -238 position of the TNF promoter and the TAP1 C/C homozygous pattern of alleles. With logistic modeling, the markers that showed consistent association with the occurrence of cervical cancer were TAP2 A/B, HLA-DR2 1501, and TAP1 C/C. CONCLUSIONS: We demonstrated a significant association between immune response genes and the risk of cervical cancer. Our data create a compelling argument for a gene or a cluster of genes in the HLA region of chromosome 6 that regulates host immune responses to human papillomavirus infection in a manner that results in inherited susceptibility or resistance to the transforming properties of oncogenic papillomaviruses.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed2003

Retrospective review of 208 patients with leiomyosarcoma of the uterus: prognostic indicators, surgical management, and adjuvant therapy.

OBJECTIVE: We evaluated the predictive value of several proposed prognostic indicators and the effect of surgical management and adjuvant therapy on clinical outcome associated with leiomyosarcoma (LMS) of the uterus. METHODS: A medical record search of patients treated at Mayo Clinic from 1976 through 1999 was performed using the International Classification of Diseases, Ninth Revision codes for LMS and malignant neoplasm of the uterus. Study inclusion criteria included confirmation of the diagnosis of LMS of the uterus by a pathologist at our institution. Survival curves were generated using the Kaplan-Meier method. Multivariate analysis was performed using the Cox proportional hazards model. A case-control investigation was also performed. RESULTS: A total of 208 patients met study requirements. The median follow-up for survivors was 7.7 years. Multivariate analysis showed that high grade, advanced stage, and oophorectomy were associated with significantly worse disease-specific survival. Case-control investigations suggested that ovarian preservation does not adversely affect survival and that adjuvant pelvic radiation therapy does not significantly improve survival. An LMS risk-assessment index that was generated is highly predictive of survival. CONCLUSION: Tumor grade and stage (using modified criteria for endometrial cancer) appear to be valid prognostic indicators for LMS of the uterus. Ovarian preservation may be considered in premenopausal patients with early-stage leiomyosarcoma of the uterus. Additionally, adjuvant therapy does not appear to significantly affect survival. Finally, our highly predictive LMS risk-assessment index may be useful for counseling patients.

Adult↗
PubMed2003

Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting.

This multicenter, randomized, open-label clinical trial was conducted to determine whether the combined use of nicotine patch therapy and a nicotine nasal spray would improve smoking abstinence rates compared to either treatment alone, without behavioral counseling. Data were collected at 15 regional cancer control oncology centers within the North Central Cancer Treatment Group. Of the 1384 smokers randomized to the study, 20% were abstinent from smoking at 6 weeks and 8% were abstinent at 6 months. At 6 weeks, the 7-day point prevalence smoking abstinence rate for the patch alone (21.1%) was superior to the spray (13.6%) but was significantly lower than the rate for combination therapy (27.1%). At 6 months, the 7-day point prevalence abstinence rates were not significantly different among the three groups. Combination nicotine nasal spray and nicotine patches were delivered safely in a nonspecialized outpatient clinical setting and enhanced short-term smoking abstinence rates, but these rates were not sustained at 6 months.

Administration, Cutaneous↗
PubMed2003

Randomized phase II study of daily versus continuous-infusion schedules of topotecan in the treatment of extensive-stage small cell lung cancers.

A randomized two-stage, phase II study was conducted to assess the antitumor activity of two different schedules of topotecan in the treatment of extensive-stage small-cell lung cancer (SCLC) in chemotherapy-naive patients. A total of 40 eligible patients were randomized to receive either the daily schedule, with topotecan being administered intravenously at 1.5 mg/m2 daily for 5 days every 3 weeks, or the continuous-infusion schedule, with topotecan administered intravenously at a dosage of 1.3 mg/m2 per day over 72 hours every 4 weeks. Randomization to the continuous-infusion schedule was discontinued due to inactivity, and an additional 20 patients were treated on the daily schedule. Patients received an average of 5 courses (range: 1-13) of the daily schedule compared to an average of 2 courses (range: 1-7) of the continuous-infusion schedule (p < 0.01). Confirmed response rates for the daily and continuous-infusion schedules are 62.5% (90% CI: 49-75%) and 15% (90% CI: 1-29%), respectively. Toxicity was predominantly hematologic with 92% (55/60) having greater than or equal to grade III neutropenia and 58% (35/60) reporting greater than or equal to grade III leukopenia for both IV schedules. Nonhematologic toxicity was very mild, with only 10% (6/60) patients experiencing grade IV toxicities. One patient died of infection on the continuous-infusion arm. Median times to progression for the daily and continuous-infusion schedules are 5 months (90% CI: 4.4-7.2) and 2 months (90% CI: 1.1-2.1), respectively. Estimated 1-year survival rates for patients receiving daily and continuous-infusion schedules are 63% (90% CI: 51-76%) and 55% (90% CI: 39-77%), respectively. Fifty percent (30/60) of patients received second-line therapy with etoposide and cisplatin. Forty-three percent (13/30) of patients who received second-line therapy achieved a confirmed response. Topotecan showed significant activity in the treatment of extensive stage SCLC when administered as a brief daily IV repeated every 3 weeks.

Adult↗
PubMed2003

A phase II study of the dolastatin 15 analogue LU 103793 in the treatment of advanced non-small-cell lung cancer.

A phase II study of the dolastatin 15 analog LU 103793 was conducted by the North Central Cancer Treatment Group in patients with advanced non-small-cell lung cancer (SCLC). Previously untreated patients received this agent at a dosage of 2.5 mg/m2 as a 5-minute intravenous infusion for 5 consecutive days every 3 weeks. Between September 1997 and July 1998, 17 patients were accrued in this study. Forty-two treatment cycles were administered with relatively modest toxicity. No responses were seen. This agent appears to be inactive in the treatment of advanced non-SCLC.

Aged↗
PubMed2003

Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation.

BACKGROUND: A number of studies have computed the minimally important difference (MID) for health-related quality of life instruments. OBJECTIVE: To determine whether there is consistency in the magnitude of MID estimates from different instruments. METHODS: We conducted a systematic review of the literature to identify studies that computed an MID and contained sufficient information to compute an effect size (ES). Thirty-eight studies fulfilled the criteria, resulting in 62 ESs. RESULTS: For all but 6 studies, the MID estimates were close to one half a SD (mean = 0.495, SD = 0.155). There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options. Negative changes were not associated with larger ESs. Population-based estimation procedures and brief follow-up were associated with smaller ESs, and acute conditions with larger ESs. An explanation for this consistency is that research in psychology has shown that the limit of people's ability to discriminate over a wide range of tasks is approximately 1 part in 7, which is very close to half a SD. CONCLUSION: In most circumstances, the threshold of discrimination for changes in health-related quality of life for chronic diseases appears to be approximately half a SD.

Chronic Disease↗
PubMed2003

A phase I trial of ISIS 2503, an antisense inhibitor of H-ras, in combination with gemcitabine in patients with advanced cancer.

PURPOSE: The purpose of this study was to define the toxicity, pharmacokinetics, and clinical activity of the combination of ISIS 2503, an oligodeoxynucleotide antisense inhibitor of H-ras, and gemcitabine in patients with advanced solid tumors. EXPERIMENTAL DESIGN: The target dose of ISIS 2503 on this study was 6 mg/kg/day. Twenty-seven patients (16 male, 11 female) received 97 treatment courses (median, 2; range, 1-13). Nineteen patients were treated with a fixed gemcitabine dose of 1000 mg/m(2) on days 1 and 8 and two escalating doses of ISIS 2503 (4 and 6 mg/kg/day) as a 14-day continuous infusion starting on day 1. In addition, 8 patients (5 male, 3 female) received a flat dose of ISIS 2503 based on ideal body weight. Cycles were repeated every 3 weeks. Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria, were recorded as maximum grade/patient for all treatment cycles. Pharmacokinetic analyses were performed to evaluate any interaction between these two agents. RESULTS: The most common nondose-limiting toxicity was hematological, manifested as neutropenia (5 grade 2, 7 grade 3, and 1 grade 4) and thrombocytopenia (10 grade 1, 5 grade 2, 5 grade 3, and 1 grade 4). Nonhematological toxicities included anorexia (7 grade 1, 3 grade 2, and 1 grade 3), nausea (10 grade 1 and 1 grade 3), fatigue (6 grade 1, 5 grade 2, and 3 grade 3), fever (6 grade 1, 2 grade 2, 1 and grade 3), and thrombosis associated with central lines (5). The plasma concentration of gemcitabine at the end of infusion was altered in the presence of ISIS 2503, leading to alterations on other pharmacokinetic parameters, but the observed differences were not clinically relevant. The plasma disposition of ISIS 2503 was not altered by gemcitabine coadministration. One partial response was documented in a heavily pretreated patient with metastatic breast cancer. Disease stabilization for greater than six cycles of treatment was observed in 5 patients. CONCLUSIONS: The combination of gemcitabine and ISIS 2503 was well tolerated and clinically active in this group of heavily pretreated patients. The recommended Phase II dose of gemcitabine (1000 mg/m(2)) and ISIS 2503 (6 mg/kg/day) warrants additional evaluation.

Adult↗