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  • non-small-cell lung cancer  (1)
  • objective response rate  (1)
  • 1
    Electronic Resource
    Electronic Resource
    Experience with independent radiological review during a topotecan trial in ovarian cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 463-468 
    Details
    ISSN: 1569-8041
    Keywords: independent radiological review ; measurable disease ; objective response rate ; ovarian carcinoma ; standard protocols
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The results of phase II clinical trials are usually based onresponse of tumours to new oncolytic agents as evidenced by radiologicalimaging techniques. In this trial, all claimed responders were reviewed at aspecially convened meeting by the peer group of study investigators and aradiologist, independent of the study institutions. Patients and methods: One hundred eleven patients with advanced epithelialovarian cancer who had previously been treated with a platinum based regimenand had subsequently relapsed and who had measurable disease were treated withtopotecan at a dose of 1.5 mg/m2/day i.v. on five consecutivedays repeated every 21 days to assess efficacy and tolerability. Ninety-threewere considered eligible for the study per protocol and lesions were assessedby either computerised tomography (CT) or ultrasound (US). At the meeting,scans from all 24 (25.8%) claimed responders were reviewed, lesionsremeasured by the radiologist and a group discussion led to a final responseclassification. Results: Ninety-two patients were found to be eligible for the study and14 (15.2%) were confirmed as responders. Ten were rejected asresponders, mainly because the lesion did not decrease in size by≤50%, but one patient failed to meet the entry criteria.Remeasurement of CT scans was more objective than US scans. Difficulties wereencountered during review of some CT scan sequences because of non-uniformimaging parameters. Conclusions: Independent radiological review in conjunction with the peerreview group in this trial enabled rigorous and consistent application ofresponse criteria. This decreased the response rate from 25.8% to15.2%, but this represents a more objective assessment. CT scanning isan objective technique for assessing response rates in phase II studieswhereas US is subjective and dose not necessarily allow accurate lesionassessment on subsequent examinations, nor allows independent review at alater date. For these reasons it should not be used in such studies foraccurate lesion assessment. Cross-sectional imaging techniques such as CT andmagnetic resonance imaging (MRI) do allow accurate lesion assessment andindependent review at a later date, but standard protocols need to beinstituted, to allow consistency and a comparison to be made with subsequentstudies using the same agent and a broad comparison to be made with otheragents.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008241127883
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Single-agent gemcitabine versus cisplatin–etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 525-529 
    Details
    ISSN: 1569-8041
    Keywords: cisplatin ; etoposide ; gemcitabine ; non-small-cell lung cancer ; randomised phase II study
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: This randomised study was designed to determine the responserate, survival and toxicity of single-agent gemcitabine andcisplatin–etoposide in chemo-naïve patients with locally advancedor metastatic non-small-cell lung cancer. Patients and methods: Gemcitabine 1,000 mg/m2 was given asa 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin100 mg/m2 on day 1, and etoposide 100 mg/m2on days 1 (following cisplatin), 2 and 3. Major eligibility criteria includedhistologically confirmed non-small-cell lung cancer, measurable disease,Zubrod PS 0–2; no prior chemotherapy, no prior radiation of the measuredlesion, and no CNS metastases. Results: 146 patients were enrolled, 71 patients on gemcitabine and 75patients on cisplatin–etoposide. Patient characteristics were wellmatched across both arms. Sixty-six gemcitabine patients and 72cisplatin–etoposidepatients were evaluable. Partial responses were seen in 12 gemcitabinepatients (18.2%; 95% CI: 9.8–30) and 11cisplatin–etoposide patients (15.3%; 95% CI:7.9–25.7).Early indications show no statistical differences between the two treatmentswith respect to time to disease progression or survival. Haematological andlaboratory toxicity were moderate and manageable. However, hospitalisationbecause of neutropenic fever was required for 6 (8%)cisplatin–etoposide patients but not for any gemcitabine patients.Non-haematological toxicity was more pronounced with significant differencesin nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29%cisplatin–etoposide; despite the allowance for 5-HT-3antiemetics during the first cycle of cisplatin–etoposide), and alopecia(grade 3 and 4: 3% gemcitabine vs. 62%cisplatin–etoposide). Conclusions: In this randomised study, single-agent gemcitabine was atleast as active but better tolerated than the combinationcisplatin–etoposide.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008207731111
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
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