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  • 1
    Electronic Resource
    Electronic Resource
    Keeping faith with trial volunteers (2007)
    [s.l.] : Nature Publishing Group
    Nature 446 (2007), S. 137-138 
    Details
    ISSN: 1476-4687
    Source: Nature Archives 1869 - 2009
    Topics: Biology , Chemistry and Pharmacology , Medicine , Natural Sciences in General , Physics
    Notes: [Auszug] ...How do patients who sign up for clinical trials know that the right questions are being asked and that the data support the reported answers to these questions? For many patient groups, transparency in study design, data collection and analysis, and full publication of results are issues of ...
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1038/446137a
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  • 2
    Electronic Resource
    Electronic Resource
    The Perceived Adjustment to Chronic Illness Scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials (1993)
    Springer
    Supportive care in cancer 1 (1993), S. 200-208 
    Details
    ISSN: 1433-7339
    Keywords: Quality of life ; Breast cancer ; Coping ; Single-item linear-analogue scale ; Validation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Subjective well-being is a major aspect of quality of life and is therefore increasingly used as an endpoint in clinical trials. It is influenced to a great extent by the complex process of coping with the disease and its treatment. Assessment of coping is methodologically demanding, especially in large clinical trials. We therefore developed a single-item measure, the Perceived Adjustment to Chronic Illness Scale (PACIS), as an indicator of coping, complementary to other scales related to quality of life. We sought to validate this instrument in a subgroup of 121 Swiss patients participating in the International Breast Cancer Study Group (IBCSG) adjuvant trials. At months 3 and 6 of adjuvant treatment PACIS showed a distinct pattern of highly significant rank correlations with several disease-and treatment-related problem areas from the Herschbach coping inventory (FBBK); 42% of the variance of PACIS at month 3 was explained by the FBBK (P=0.0001). The portion of explained variance was considerably higher for the Italian-(70%) than for the German-speaking (30%) subgroups. Patients who rated more effort to cope with their disease on PACIS indicated more frequent use of 3 of 15 coping strategies in relation to psychological distress. These were “crying and becoming desperate”, “taking tranquillizers and alcohol” and “other people are far worse off”. These three coping strategies may define a high-risk group for poor psychosocial outcome. Patients whose PACIS scores showed that it required less effort to cope tended to use the strategy “seeing a positive side of the problem”. We conclude that PACIS can be used as a global indicator of the coping process in large multicultural clinical trials of adjuvant therapy for breast cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00366447
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  • 3
    Electronic Resource
    Electronic Resource
    Levonantradol, a new antiemetic with a high rate of side-effects for the prevention of nausea and vomiting in patients receiving cancer chemotherapy (1982)
    Springer
    Cancer chemotherapy and pharmacology 9 (1982), S. 61-64 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Levonantradol, a new antiemetic compound pharmacologically related to the cannabinoids, was given to 17 patients who had experienced severe and protracted nausea and vomiting during previous courses of cancer chemotherapy, and to six patients receiving a first course of strongly emetic cytostatic treatment. Eight patients were partially protected from acute gastrointestinal disturbances. Of the 23 patients, 21 exhibited some toxicity, with six patients exhibiting major affective side-effects and 13 patients complaining of pain at the injection site. Levonantradol is an active antiemetic compound. Due to the rate of side-effects observed in our study however, we would not recommend use of this agent as an antiemetic drug.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00296765
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  • 4
    Electronic Resource
    Electronic Resource
    Pathologic data of prognostic significance for remission induction in advanced ovarian carcinoma (1984)
    Springer
    Journal of cancer research and clinical oncology 107 (1984), S. 106-110 
    Details
    ISSN: 1432-1335
    Keywords: Advanced ovarian carcinoma ; Phase-II trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Sixty-eight patients with “advanced ovarian carcinoma” were entered into an ongoing phase-II trial for remission induction with cis-platinum (DDP) 80 mg/m2 i.v. on day 1 followed by forced saline diuresis, melphalan (L-PAM) 12 mg/m2 i.v. on day 2 and hexamethylamine (HMM) 130 mg/m2 p.o. x 14 days from days 8–21 in six monthly cycles following operative resection and/or staging. Fifty-one patients were evaluable for response, ten had not completed six courses and could not be assessed, two patients died early (one probably of toxicity), and five patients refused treatment and follow-up. Thirty-Two patients had serous, endometrioid or undifferentiated carcinomas of the ovary. Of these, 11 (35%) achieved a pathologically proven complete remission (CR), five (16%) were NED after second-look (residual disease in ovary or removed omentum with all other biopsies and cytology washings negative), eight (32%) achieved a partial remission (PR), and three (12%) had progressive disease. None of the seven patients with clear-cell carcinoma and none of the three patients with mixed Mullerian tumor of the ovary responded. Six of nine patients with tumors of uncertain origin or proven metastasis to ovary did not respond to treatment. These preliminary results indicate that advanced ovarian carcinomas form a heterogeneous group of recognizable neoplastic diseases with striking variation in response to treatment.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00399381
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  • 5
    Electronic Resource
    Electronic Resource
    Interaction of tamoxifen with concurrent cytotoxic adjuvant treatment affects lymphocytes and lymphocyte subsets counts in breast cancer patients (1999)
    Springer
    Supportive care in cancer 7 (1999), S. 149-153 
    Details
    ISSN: 1433-7339
    Keywords: Key words Tamoxifen ; Cytotoxic treatment ; Cellular immunity ; Breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The effects and interaction of endocrine and cytotoxic adjuvant treatment on measures of cellular immunity were assessed in 41 stage I–II breast cancer patients from International Breast Cancer Study Group trials. Counts of lymphocytes and lymphocyte subsets [(T, T4, T8, B, natural killer (NK) and activated T (AT) cells] were assessed by flow cytometry immediately before adjuvant therapy at baseline and on day 1 of the 3rd cycle. Twenty-two patients received cyclophosphamide, methotrexate and 5-fluorouracil (CMF), 7 CMF and tamoxifen (TAM), and 12 TAM alone. On day 1 of the 3rd cycle the counts of total lymphocytes (P=0.003 ) and all lymphocyte subsets (P〈0.05) except AT cells were significantly lower than baseline in the CMF treatment group. There was no significant change in the CMF+TAM or in the TAM treatment group. The combination of CMF and TAM resulted in less pronounced decrease in lymphocyte and subset counts from baseline to day 1 of the 3rd cycle. It seems possible that there is an interaction between TAM with CMF that affects lymphocyte and lymphocyte subset counts during cytotoxic treatment.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s005200050245
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  • 6
    Electronic Resource
    Electronic Resource
    Effect of carboplatin on response and palliation in hormone-refractory prostate cancer (1998)
    Springer
    Supportive care in cancer 6 (1998), S. 462-468 
    Details
    ISSN: 1433-7339
    Keywords: Key words Hormone-refractory prostate cancer ; Carboplatin ; Prostate-specific antigen ; Palliative endpoints ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract To assess the efficacy of carboplatin in patients with hormone-refractory prostate cancer in terms of response rate and palliation, the Swiss Group for Clinical Cancer Research (SAKK) conducted this phase II clinical trial (SAKK 08/91). Carboplatin 400 mg/m2 was administered i.v. every 28 days to 27 patients. The prostate-specific antigen (PSA) level was monitored and compared with the clinical response. Tumour response was evaluated according to EORTC criteria. For patients with nonmeasurable disease, response was defined as the absence of progression in any tumour localization, with no increase in PSA and a decrease of at least 2 points in the WHO pain score. Selected aspects of quality of life (QL) and use of analgesics were assessed to describe patients' experience of toxicity and palliation. Only 1 patient with measurable and 2 patients with nonmeasurable disease achieved partial remission or a response according to our criteria. However, 13 of the 27 evaluable patients had some benefit from carboplatin therapy, as indicated by an improvement in performance status, reduction of pain, and stabilization of metastases. There was no clear-cut association between clinical response and PSA level. QL data suggested that carboplatin was relatively well tolerated and confirmed the clinically documented palliation. In particular, from baseline, for at least two consecutive cycles, 7 patients reported either an improvement in pain by 1 point or more on a 4-point scale (≥33%) without an increase in analgesic intake or a decrease by 50% or more in analgesic intake without an increase in pain. With the dose and schedule used in this study, carboplatin had only limited objective activity in advanced prostate cancer, but induced palliation in about half the patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s005200050195
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  • 7
    Electronic Resource
    Electronic Resource
    Association between immunity and prognostic factors in early stage breast cancer patients before adjuvant treatment (2000)
    Springer
    Breast cancer research and treatment 59 (2000), S. 279-287 
    Details
    ISSN: 1573-7217
    Keywords: breast cancer ; cellular immunity ; β2-microglobulin ; sIL-2r ; prognosis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: The association of known prognostic factors with immune cell counts and β2-microglobulin and soluble IL-2 receptor (sIL-2r) serum levels as markers of activation of the immune system was investigated in breastcancer. Methods: Two hundred thirty five operated stage I and II breast cancer patients to receive adjuvant treatment in IBSCG trials were assessed in a cross-sectional study immediately before the first treatment. Leukocytes, lymphocytes and lymphocyte subset counts, β2-microglobulin and sIL-2r serum levels were assessed as immunological parameters. Prognostic factors were tumor load, receptor status, patient characteristics, and contextual factors of the immune assessment (such as time of the day, time since surgery, type of surgery, concomitant medication, co-morbidity). Results: In an operated early stage breast cancer patient population, tumor load was not associated with immune cell counts, β2-microglobulin, or sIL-2r before adjuvant treatment. There was a pattern of association of prognostically favorable factors such as estrogen receptor (ER) positive tumor and older age with higher NK cell counts or with β2-microglobulin or sIL-2r. In addition, immune cell counts and the markers of activation of the immune system were affected by several contextual factors, such as diurnal variability, time since surgery, type of surgery, and the intake of concomitant medication. Conclusions: The association of NK cell counts and β2-microglobulin or sIL-2r serum levels with prognostically favorable factors such as ER positive tumor and older age supports the assumption that the immune system plays a role in the course of early breast cancer. The exact nature of this role requires furtherstudy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006379925343
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  • 8
    Electronic Resource
    Electronic Resource
    A Phase I trial of Cis-diammine-1,1-cyclobutane dicarboxylate platinum II (Carboplatin, CBDCA, JM-8) with a single dose every five week-schedule (1984)
    Springer
    Investigational new drugs 2 (1984), S. 297-304 
    Details
    ISSN: 1573-0646
    Keywords: Phase I trial ; Carboplatin ; CBDCA ; JM-8 ; Cis-diammine-1 ; 1-cyclobutane dicarboxylate platinum II ; platinum analogues
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Carboplatin, a new platinum analogue, was administered intravenously on a schedule of a single dose every five weeks to 23 patients with advanced malignant solid tumors. Patients were treated at six dosage levels ranging from 200–550 mg/m2 every five weeks. Thrombocytopenia was dose-limiting. At 550 mg/m2 Carboplatin, the median platelet nadir was 65 000/mm3. Leukopenia was common, but usually of mild to moderate degree. Gastrointestinal upset was commonly seen at all dose levels, but 35% of the patients experienced no vomiting. No significant increase of the serum creatinine following Carboplatin was seen. In 16 patients serial determinations of the creatinine clearance were performed. The median base line creatinine clearance was 87 (50–155) ml/min and dropped to a median lowest creatinine clearance of 69 (23–171) ml/min on day four (p 〈 0.05). The median creatinine clearance before the next Carboplatin treatment was 89 (42–155) ml/min. No significant proteinuria or electrolyte disturbances were noted. Carboplatin exhibited antitumor activity in ovarian, endometrial, thyroid and gastric carcinomas. The maximally tolerated dose appears to be 550 mg/m2 every five weeks. A starting dose of 450 mg/m2 seems to be appropriate for Phase II studies. In patients with impaired renal function and/or prior cis-Platin chemotherapy, Carboplatin at doses of 200–500
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00175380
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