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  • 1
    Electronic Resource
    Electronic Resource
    A phase I study of 5-fluorouracil, leucovorin and levamisole (1997)
    Springer
    Cancer chemotherapy and pharmacology 39 (1997), S. 300-306 
    Details
    ISSN: 1432-0843
    Keywords: Key words 5 Fluorourcil ; Leucovorin ; Levamisole ; Phase 1 ; Toxicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Purpose: The activity of 5-fluorouracil (5-FU) against colon cancer is enhanced by leucovorin and the combination of 5-FU and levamisole has activity in the adjuvant treatment of colonic malignancies. The combination of 5-FU with both leucovorin and levamisole may provide additional benefit in the treatment of colon cancer. Methods: A phase I study to assess qualitative and quantitative toxicities of this three-drug combination and to determine a dose for further phase II testing was undertaken. The role of levamisole as an immunomodulator was also assessed. Results: A group of 38 patients with incurable etastatic malignancies received 119 cycles of treatment at eight dose levels. 5-FU (375 mg/m2 per day) and leucovorin (200 mg/m2 per day) were administered intravenously (days 1–5). Levamisole was administered orally (days 1–3 and 15–17) at doses from 30 to 470 mg/m2 per day. Patients received both 5FU/leucovorin and 5-FU/leucovorin/levamisole in random order for their initial two cycles. All subsequent treatments were with the three-drug combination. Toxicities included nausea, vomiting, stomatitis, thrombocytopenia and granulocytopenia. Diarrhea was the dose-limiting toxicity at 470 mg/m2 per day levamisole. The addition of levamisole resulted in more toxicity than 5-FU and leucovorin alone. No clinical responses were seen with this regimen. The addition of levamisole resulted in more immunomodulation than 5-FU and leucovorin alone as evidenced by release of neopterin from monocytes. Conclusion: With this schedule and dose of 5-FU and leucovorin, the maximum tolerated dose of levamisole was 354 mg/m2. However, given the lack of response and the absence of dose-dependent immunomodulation, this may not be the appropriate dose for further phase 11 studies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050576
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  • 2
    Electronic Resource
    Electronic Resource
    Phase I trial of mitoxantrone and granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with advanced solid malignancies (1993)
    Springer
    Investigational new drugs 11 (1993), S. 291-300 
    Details
    ISSN: 1573-0646
    Keywords: granulocyte-macrophage colony-stimulating factor ; mitoxantrone ; clinical trials ; phase I trials
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Purpose To determine the maximally tolerated dose (MTD) and pharmacokinetics of high-dose mitoxantrone and document the toxicities and side effects of mitoxantrone when administered with GM-CSF. Patients and methods Twenty-three patients with advanced solid tumors were entered into a phase I and pharmacokinetic study. Mitoxantrone was administered at doses of 12, 21, 28, 32, 37, and 48 mg/m2 on day 1; GM-CSF (5 Μg/kg once or twice daily) was administered on days 2 to 14. Therapy was repeated every 3 weeks. Dose escalation continued in sets of three patients until the dose limiting toxicity (DLT) was observed. The DLT was based on hematologic, non-hematologic, and cardiac toxicity, and delay of therapy by more than 1 week due to toxicity. Plasma samples were assayed for mitoxantrone concentrations using high performance liquid chromatography (HPLC). Results Twelve patients required either mitoxantrone dose reductions or delays. DLT of neutropenia was observed at a mitoxantrone dose of 48 mg/m2/day. Therefore, we conclude the MTD was 37 mg/m2/day. Myelosuppression appeared to be cumulative. Two patients were withdrawn from the study due to a drop in left ventricular ejection fraction (LVEF). Two of 23 patients experienced a partial response. The mean area under the curve (AUC) and peak mitoxantrone levels increased linearly with dose; triexponential elimination of mitoxantrone was observed. No statistically significant correlation was observed between either peak mitoxantrone level or AUC and duration of absolute neutrophil count (ANC) 〈 500/mm3. Conclusion The use of GM-CSF allows administration of mitoxantrone at a dose greater than three times that given in standard therapy; treatment is well tolerated. Further studies are needed to determine whether mitoxantrone has cumulative cardiac or hematologic toxicity.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874427
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  • 3
    Electronic Resource
    Electronic Resource
    Weight change and risk of postmenopausal breast cancer (United States) (2000)
    Springer
    Cancer causes & control 11 (2000), S. 533-542 
    Details
    ISSN: 1573-7225
    Keywords: breast cancer ; body weight ; case–control study ; postmenopausal ; weight gain ; weight loss
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: Although many studies have shown that higher weight increases the risk of postmenopausal breast cancer, some aspects of this association are unclear. In order to examine the risk associated with different patterns of weight change, we analyzed data from a large case–control study of postmenopausal breast cancer. Methods: Participants included women aged 50–79 years (n = 5031) who are newly diagnosed with invasive breast cancer in Massachusetts, New Hampshire, and Wisconsin. Similarly-aged population controls (n = 5255) were selected at random from driver's license files and Medicare beneficiary lists. Height, weight, and information on other breast cancer risk factors were ascertained by structured telephone interviews from 1992 to 1995, and logistic regression was used to estimate multivariable-adjusted odds ratios (OR) and 95% confidence intervals (CI). Results: Women in the top quintile groups for height at age 20, recent weight, and recent body mass index had significantly increased risks of breast cancer. Among women who reached their highest adult weight at younger ages (≤45 years), increasing weight loss since that age was associated with a reduced risk of postmenopausal breast cancer (OR 0.90, CI 0.84–0.98, per 5 kg). However, weight loss among women whose highest weight occurred after age 45 was not associated with risk (OR 1.00, CI 0.95–1.05, per 5 kg). Weight gain since the lowest adult weight increased risk by 8% for each 5 kg of gain (OR 1.08, CI 1.06–1.11). Temporary weight cycling (weight loss followed by weight gain) was not associated with increased risk. Conclusions: Weight gain clearly increased risk of postmenopausal breast cancer. These data lend further support to efforts aimed at helping women avoid weight gain as they age.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008961931534
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  • 4
    Electronic Resource
    Electronic Resource
    The association of body size and large bowel cancer risk in Wisconsin (United States) women (1995)
    Springer
    Cancer causes & control 6 (1995), S. 30-36 
    Details
    ISSN: 1573-7225
    Keywords: Body mass index ; case-control study ; colorectal neoplasms ; height ; United States ; weight ; women
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Body size is associated with the risk of many diseases, including diabetes, heart disease, and some cancers. To evaluate the association of body size with large bowel cancer, height and weight measurements were ascertained by telephone interview from 779 Wisconsin (United States) women with newly reported diagnoses of carcinoma of the colon and rectum. Controls (n=2,315) interviewed for this case-control study were selected randomly from Wisconsin driver's license files and Health Care Financing Administration files. The effects of weight and height were examined using multiple logistic regression to control for potential confounding variables. In this study, weight adjusted for height increased the risk of colon cancer (odds ratio [OR] for 72.57–148.33 kg cf 36.29–58.05 kg=1.4,95 percent confidence interval [CI]=1.0–1.9) but did not increase the risk of rectal cancer. Height did not influence risk for cancer of either the colon or the rectum. Left-colon subsite analysis showed especially strong associations with current weight and with percent change in weight since age 18. These data suggest that a dose-response relationship exists between body size and risk of colon cancer in women; body size did not appear to influence risk of rectal cancer. Cancer Causes Control 1995, 6, 30–36
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00051678
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  • 5
    Electronic Resource
    Electronic Resource
    Recent oral contraceptive use and risk of breast cancer (United States) (1996)
    Springer
    Cancer causes & control 7 (1996), S. 525-532 
    Details
    ISSN: 1573-7225
    Keywords: Breast cancer ; oral contraceptives ; United States
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: We examined the association between recent oral contraceptive (OC) use and the risk of breast cancer in data from a large population-based case-control study in the United States. Cases (n=6,751) were women less than 75 years old who had breast cancer identified from statewide tumor registries in Wisconsin, Massachusetts, Maine, and New Hampshire. Controls (n=9,311) were selected randomly from lists of licensed drivers (if aged under 65 years) and from lists of Medicare beneficiaries (if aged 65 through 74 years). Information on OC use, reproductive experiences, and family and medical history was obtained by telephone interview. After adjustment for parity, age at first delivery, and other risk factors, women who had ever used OCs were at similar risk of breast cancer as never-users (relative risk [RR]=1.1, 95 percent confidence interval [CI]=10–1.2). Total duration of usealso was not related to risk. There was a suggestion that more recent use was associated with an increased risk of breast cancer; use less than two years ago was associated with an RR of 1.3 (CI=0.9–1.9). However, only among women aged 35 to 45 years at diagnosis was the increase in risk among recent users statistically significantly elevated (RR=2.0, CI=1.1–3.9). Use prior to the first pregnancy or among nulliparous women was not associated with increased risk. Among recent users of OCs, the risk associated with use was greatest among non-obese women, e.g., among women with body mass index (kg/m2) less than 20.4, RR=1.7, CI=1.1–2.8. While these results suggest that, in general, breast cancer risk is not increased substantially among women who have used OCs, they also are consistent with a slight increased risk among subgroups of recent users.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00051885
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  • 6
    Electronic Resource
    Electronic Resource
    Cancer of the large bowel in women in relation to alcohol consumption: a case-control study in Wisconsin (United States) (1993)
    Springer
    Cancer causes & control 4 (1993), S. 405-411 
    Details
    ISSN: 1573-7225
    Keywords: Alcohol drinking ; alcoholic beverages ; case-control study ; colorectal neoplasms ; United States ; women
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Age-specific consumption of beer, wine, and liquor was ascertained by telephone interview from 779 women in Wisconsin (United States) with newly reported diagnosis of carcinoma of the colon and rectum. Population controls (n=2,315) interviewed for this case-control study were randomly selected from Wisconsin driver's license files and Health Care Financing Administration files. Overall, there was a modest indication that high levels of alcohol consumption (11 or more drinks per week) were associated with increased risk of large bowel cancer (adjusted odds ratio [OR]=1.47,95 percent confidence interval [CI]=1.0–2.22). In site-specific analyses, only rectal cancer demonstrated a significant linear trend (P=0.01) with increasing consumption. Significant beverage-specific effects were observed for liquor and colon cancer: the adjusted ORs for 1–2, 3–5, and 6+ drinks per week were 1.12, 1.68, 1.51, respectively (P trend = 0.01). Beer was associated significantly with rectal cancer: the adjusted ORs for 1–2, 3–5, 6–10, and 11+ drinks per week were 1.25, 1.25, 1.58, 2.42, respectively (P trend = 0.02). Wine consumption was associated inversely with these cancers. These relationships appeared to be consistent for recent, past, and total lifetime consumption, and were not attributable to differences in dietary habits.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00050858
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