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  • American Society of Clinical Oncology (ASCO)  (4)
  • 1
    Online Resource
    Online Resource
    Chemotherapy induced peripheral neuropathy (CIPN) due to paclitaxel versus docetaxel in patients with early-stage breast cancer receiving taxane therapy: SWOG S1714.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 12003-12003
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 12003-12003
    Abstract: 12003 Background: Paclitaxel (Pac) and docetaxel (Doc) are used to treat early-stage breast cancer (BC). CIPN due to taxane therapy can cause sensory and motor deficits. CIPN symptoms caused by Pac versus Doc are not well described. Methods: SWOG S1714 enrolled patients ≥ 18 years with Stage I-III primary NSCLC, BC, or ovarian cancer starting treatment with a taxane-based regimen. CIPN was assessed by the patient-reported EORTC QLQ-CIPN20 (CIPN-20) and clinician-assessed NCI-CTCAE. Assessments occurred at baseline and 4, 8, 12, and 24 weeks after registration. Increase in CIPN-20 sensory subscale score ≥ 8 points was considered clinically meaningful. Chi-square and Fisher tests were used for baseline comparisons; logistic regression was used for multivariable analyses. Results: Among 1336 enrolled patients, 1106 of eligible patients had a diagnosis of BC, with median age 54.8 y (range 23.9-84.2 y), 99.3% female, and 72.3% White/11.3% Black/4.6% Asian/11.1% Hispanic/Latino. Pac was administered to 615 (55.6%) and Doc to 491(44.3%) patients. Between the Pac and Doc cohorts, there were significant baseline differences in median age, diabetes, and performance status. At 24 weeks, the proportion of patients with ≥8 point increase in CIPN-20 sensory score was lower for Doc (40.5%) vs Pac (50.2%) (odds ratio [OR] 0.64, 95% CI 0.50, 0.82; multivariable adjusted p 〈 .001). At nearly every timepoint through 24 weeks, patients treated with Pac had more sensory and motor neuropathy as measured by both the CIPN-20 and NCI-CTCAE (Table). Conclusions: In this diverse cohort of patients with BC, the frequency of CIPN was higher than expected for both Pac and Doc and more severe in patients receiving Pac. These findings based on CIPN-20 can assist in treatment decision-making about taxane therapy. Long term follow up will better characterize the differences in the trajectory of CIPN between Pac and Doc. Funding: NIH/NCI/NCORP grant UG1CA189974. Clinical trial information: NCT03939481. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.12003
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    RAD001-carboplatin combination in triple-negative metastatic breast cancer (TNMBC): A phase II trial.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 1042-1042
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 1042-1042
    Abstract: 1042 Background: Triple negative breast cancer cells often show genetic instability and inability to repair DNA damage rendering them sensitive to platinum agents. Rapamycin enhances platinum- induced apoptosis in breast cancer cell lines. We sought to explore the activity/toxicity of the of carboplatin with RAD001 in TNMBC. Methods: The primary objective of this study was to estimate clinical benefit rate/CBR (complete remission (CR) + partial remission (PR) + stable disease (SD) lasting 〉 6 months) and the toxicity of this combination in women with TNMBC who have had 0-3 prior chemoregimens for MBC. 25 subjects were recruited. This design had 〉 80% power to test the null hypothesis that the CBR is ≤10% vs. alternative hypothesis that CBR is ≥ 30% (≥6 would need to achieve a clinical benefit). Prior Carboplatin was allowed. Women with treated brain metastasis were eligible. Originally, Carboplatin AUC 6 was administered q3 weeks with daily 5mg of RAD001 with a 3 patient run-in, then 10 mg daily. Due to excessive thrombocytopenia, the dose of Carboplatin was first amended to AUC 5 and then to AUC 4 with 5 mg of RAD001 (no escalation to 10 mg). Results: All 25 patients have been recruited. Median age is 58.There have been 1 CR, 6 PR’s, 2 SD's lasting 〉 6 months and 6 PD’s. 3 patients were not evaluable. One SD achieved in a patient progressing on single agent Carboplatin. The estimated CBR is 36% (95% C.I.: 17%-55%). Median PFS is 3.3 months (95% C.I.: 2.4-7.7 months) from start of treatment. 7 patients (28%) had grade 3 or 4 thrombocytopenia and 3 (12%) had grade 3 neutropenia (no bleeding/ febrile neutropenia). Since amendment of Carboplatin to AUC 4 the regimen has been very well tolerated with only 11% grade 3 hemetoxicity. The grade 3 non-heme toxicities included nausea/ vomiting (n=1), mucositis (n=1) and dehydration (n=1). Grade 3 insomnia (n=1) and dyspnea (n=1) were thought to be unrelated to the treatment (no grade 3 fatigue/ interstitial lung disease). Conclusions: The study has achieved the primary end point of demonstrating clinical benefit in TNMBC. Dose limiting thrombocytopenia was an unexpected side effect requiring protocol amendment. Clinical trial information: NCT01127763.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.1042
    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
  • 3
    Online Resource
    Online Resource
    Efficacy of RAD001/carboplatin in triple-negative metastatic breast cancer: A phase II study.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 27_suppl ( 2012-09-20), p. 108-108
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 27_suppl ( 2012-09-20), p. 108-108
    Abstract: 108 Background: Triple-negative breast cancer cells are unable to repair double stranded DNA breaks and have sensitivity to platinum agents. Rapamycin acts synergistically with platinum agents to induce apoptosis and inhibit proliferation in breast cancer cell lines. RAD001 (oral mTOR inhibitor) and Carboplatin combination may have activity in triple-negative breast cancer. Methods: The primary objective is to estimate clinical benefit (complete remission (CR) + partial remission (PR) + stable disease (SD) lasting 〉 6 months) and toxicity of the combination in triple negative metastatic breast cancer patients who have had 0-3 prior chemotherapy regimens. This design has 〉 80% power to test the null hypothesis i.e. clinical benefit rate is ≤ 10% vs. alternative hypothesis that clinical benefit rate is ≥ 30%. Prior carboplatin is allowed. Women with treated brain metastasis are eligible. Originally, carboplatin AUC 6 was to be administered every 3 weeks along with daily 5mg of RAD001 with a 3 patient run-in and then 10 mg daily. Due to a surprising amount of thrombocytopenia, the dose of carboplatin was first amended to AUC 5 and most recently to AUC 4 with 5 mg of RAD001 (no escalation to 10 mg). Results: 23 out of 25 patients have been recruited. Median age is 59. Thus far, there have been 1 CR, 5 PR’s, 8 SD's and 6 PD’s. One SD was achieved in a patient progressing on single agent carboplatin at study entry. Median duration of response is 13 weeks (range: 6-74 weeks). 5 patients had grade 3/4 thrombocytopenia and 4 patients had grade 3 neutropenia (no febrile neutropenia). 13 patients had treatment held and/or dose reductions secondary to hematological toxicity. Since dosing amendment for carboplatin to AUC 4 the regimen has been well tolerated (only 1 patient with grade 3 neutropenia and thrombocytopenia). 1 patient had grade 3 dehydration. The estimated clinical benefit rate is 45% (95% C.I.: 23%, 67%). Median time to progression or death is 85 days from start of treatment. Conclusions: Our study has met the primary end point of demonstrating clinical benefit in triple-negative metastatic breast cancer. Dose-limiting thrombocytopenia was an unexpected side effect requiring protocol amendment. Patient accrual continues at the amended dosing.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.27_suppl.108
    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
  • 4
    Online Resource
    Online Resource
    Phase II trial of RAD001 plus carboplatin in patients with triple-negative metastatic breast cancer.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e11529-e11529
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e11529-e11529
    Abstract: e11529 Background: Triple negative breast cancer cells are unable to repair double stranded DNA breaks and hence have sensitivity to platinum agents. Rapamycin acts synergistically with platinum agents to induce apoptosis and inhibit proliferation in breast cancer cell lines. Combination of RAD001 (oral mTOR inhibitor) and Carboplatin may have activity in triple-negative breast cancer. Methods: The primary objective of the study was to estimate the clinical benefit (complete remission (CR) + partial remission (PR) + stable disease (SD) 〉 6 months) and the toxicity of this combination in women with triple negative metastatic breast cancer who have had 0-3 prior chemotherapy regimens for metastatic disease. 25 subjects were to be entered into a single stage open label Phase II study. Prior Carboplatin is allowed. Treated brain metastasis are eligible. The null hypothesis that the clinical benefit rate is ≤10% could be rejected if number of CR/PR/SD 〉 6 months was ≥6. Originally, intravenous Carboplatin AUC 6 was to be administered every 3 weeks along with daily 5mg of RAD001 with a 3 patient run-in and then 10 mg daily. Due to a surprising amount of thrombocytopenia with this combination, the dose of Carboplatin was first amended to AUC 5 and most recently to AUC 4 with 5 mg of RAD001. Results: 18 patients have been recruited thus far. Median age is 59. There have been 1 CR, 4 PR’s and 2 SD's lasting 〉 6 months. One SD was achieved in a patient progressing on single agent Carboplatin at study entry. Median duration of CR+ SD +PR thus far is 13 weeks (range: 6-60 weeks). 5 patients had grade 3/4 thrombocytopenia and 4 patients had grade 3 neutropenia (no febrile neutropenia). However, since amendment of Carboplatin dose to AUC 4 the regimen has been well tolerated. 1 patient suffered from grade 3 dehydration. The estimated clinical benefit rate is 50% (95% C.I.: 24%, 76%). Median time to progression or death is 87.5 days from start of treatment; there is only 1 death to date on this study. Conclusions: The study has achieved it’s primary objective of demonstrating clinical benefit of RAD 001-Carboplatin combination in triple negative metastatic breast cancer. Dose limiting thrombocytopenia was an unexpected side effect requiring protocol amendment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e11529
    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
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