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  • American Society of Clinical Oncology (ASCO)  (3)
  • Guastalla, Jean Paul  (3)
  • Scambia, Giovanni  (3)
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  • American Society of Clinical Oncology (ASCO)  (3)
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Subjects(RVK)
  • 1
    Online Resource
    Online Resource
    Impact of the trifunctional antibody catumaxomab followed by systemic chemotherapy (CTX) on overall survival (OS): Results of a subgroup analysis in patients (pts) with relapsed ovarian cancer (OC) and malignant ascites (MA).
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e16547-e16547
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e16547-e16547
    Abstract: e16547 Background: MA can compromise QoL in pts with OC. The safety and efficacy of catumaxomab in pts with MA due to EpCAM+ carcinomas where standard therapy was not available, not effective or no longer feasible was confirmed in a phase III trial comparing a 3-h intraperitoneal (i.p.) infusion with and without prednisolone premedication (Sehouli, ASCO 2012). Pts with OC who received subsequent CTX after treatment with catumaxomab (post-catumaxomab CTX) were analysed separately. Methods: OC pts in both treatment arms were pooled. The efficacy parameters time to next puncture (TTPu), puncture-free survival (PuFS) and OS were evaluated in relation to post-catumaxomab CTX. Results: 42/109 (39%) pts with MA due to OC received post-catumaxomab CTX, which included a platinum-containing regimen in 19 pts (17%). 21/109 (19%) received 〉 1 post-catumaxomab CTX regimen. Pts with any post-catumaxomab CTX compared with those without CTX had significantly prolonged OS (median 273 vs 81 d, HR 0.24, p 〈 0.0001) and PuFS (median 138 vs 43 d, HR 0.46, p = 0.0002). The difference in TTPu was not significant (223 vs 110 d, HR 0.68, p = 0.1788). Pts with 〉 1 post-catumaxomab CTX compared with 1 post-catumaxomab CTX had significantly prolonged OS (480 vs 167 d, HR 0.20, p 〈 0.0001). The difference between the groups with 1 and 〉 1 post-catumaxomab CTX in PuFS (153 vs 123 d, HR 0.64, p = 0.1804) and TTPu (153 vs 169 d, HR 1.52, p = 0.3600) was not significant. Pts who received platinum-containing post-catumaxomab CTX had significantly prolonged OS compared with those who received post-catumaxomab CTX without platinum (462 vs 169 d, HR 0.32, p = 0.0026). The difference between the groups with and without platinum in PuFS (153 vs 123 d, HR 0.76, p = 0.4448) and TTPu (153 vs 229 d, HR 1.68, p = 0.2373) was not significant. Conclusions: The data indicate that pts with MA due to OC who are able to receive CTX after catumaxomab treatment have significantly prolonged survival compared with pts who could not receive CTX. Further trials have been initiated to identify the best patient population to receive i.p. catumaxomab followed by subsequent CTX.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e16547
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Catumaxomab with and without prednisolone in patients with malignant ascites due to epithelial cancer: Results from the phase IIIb CASIMAS study.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e13097-e13097
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e13097-e13097
    Abstract: e13097^ Background: The primary objective of this study was to compare catumaxomab with prednisolone (CP) to catumaxomab without prednisolone (C) as 3-hour intraperitoneal (i.p.) infusion by demonstrating superiority for safety and non-inferiority for efficacy of the CP arm. Methods: 219 patients were randomized to catumaxomab plus premedication of 25 mg prednisolone (111 pts) or to catumaxomab alone (108 pts). The primary endpoint was the composite safety score (CSS) summarizing the worst CTCAE grades for the main TEAEs (pyrexia, nausea, vomiting, and abdominal pain). A potential impact of prednisolone on efficacy was assessed by the co-primary endpoint puncture-free survival (PuFS). Further parameters included overall survival (OS) and time to next therapeutic puncture (TTPu). Results: The superiority of CP for safety was not proven as the mean CSS was comparable in the two groups (CP: 4.1; C: 3.8 for; p= 0.383). The median PuFS was slightly lower in CP (30 days) compared to C (37 days). However the hazard ratio (HR) for PuFS (HR: 1.130, p=0.402) as well as the 75% quartiles (CP: 155 days, C: 92 days) were in favour of CP compared to C. The median TTPu was similar in both groups (CP: 78 days; C: 102 days, p= 0.599). The majority of patients (123 pts) had no therapeutic paracentesis prior to death (CP: 54.8%; C; 61.7%, p=0.297). Median OS was longer for CP (CP: 124 days; C: 86 days, p= 0.186) without statistical significance. Conclusions: The CASIMAS results are in concordance with the data of the pivotal study and thus confirm the robustness of the treatment effect of catumaxomab in malignant ascites. The administration of 25mg prednisolone as premedication prior to catumaxomab infusion did not change the safety profile and did not negatively impact the efficacy of catumaxomab. The composite safety score after 3-hour infusion time was comparable to that seen in the pivotal study using 6 hours.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e13097
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Quality of life in patients with malignant ascites during catumaxomab treatment: Results from the CASIMAS trial.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e13095-e13095
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e13095-e13095
    Abstract: e13095^ Background: Malignant Ascites (MA) is associated with a poor prognosis and limited palliative treatment options. To demonstrate the value of a new treatment the assessment of quality of life (QoL) is of particular importance. Following the demonstration of catumaxomab’s potential to stabilize QoL and prolong the time to first deterioration of QoL, results from CASIMAS give evidence that the QoL of patients remains unaffected during catumaxomab treatment Methods: In a two-arm, open-label, multicentre phase II/III study 219 patients were randomized to catumaxomab plus premedication of 25 mg prednisolone (111 pts) or to catumaxomab alone (108 pts) QoL was measured using the EQ-5D visual analogue scale (EQ-VAS). The EQ-VAS reports the respondent’s self-rated health on a vertical scale where the endpoints are labelled “Best imaginable health state” (100) and “Worst imaginable health state” (0). This information is used as a quantitative measure of health outcome. Patients were asked to complete EQ-VAS during the treatment period (d 0, 3 and 10) and follow-up (d8, 28). Descriptive analyses were performed according to EQ-5D User Guide (Version 4.0). Additionally ascites related symptoms were measured with a disease specific FACIT patient questionnaire. Results: For the pooled population (catumaxomab plus prednisolone and catumaxomab alone) longitudinal analysis of the EQ-VAS showed no relevant changes in mean score during the treatment period of catumaxomab (d0: 51.5; d3: 50.9; d10: 51.0) and compared to screening (52.7). An increase in mean values was observed in the follow-up period (d8: 53.9, d28: 57.1). Descriptive comparison of both treatment groups revealed no major differences in QoL and ascites related symptoms during the treatment and follow-up period, indicating that prednisolone has no impact on patient`s self-rated health. Conclusions: This analysis shows that QoL as measured by EQ-VAS remains unaltered during the treatment with catumaxomab and improves after the treatment period. The improvement is plausible due to the prolonged-puncture-free survival and is consistent with previous observations of QoL changes during and after intraperitoneal treatment with catumaxomab.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e13095
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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