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  • 1
    Online Resource
    Online Resource
    Everolimus Plus Octreotide Long-Acting Repeatable in Patients With Colorectal Neuroendocrine Tumors: A Subgroup Analysis of the Phase III RADIANT-2 Study
    Oxford University Press (OUP) ; 2013
    In:  The Oncologist Vol. 18, No. 1 ( 2013-01-01), p. 46-53
    Details
    In: The Oncologist, Oxford University Press (OUP), Vol. 18, No. 1 ( 2013-01-01), p. 46-53
    Abstract: The incidence of colorectal neuroendocrine tumors (NETs) is increasing, and patients with this disease have particularly poor prognoses. Treatment options are limited, and survival times have not improved in the past decade. Methods. A post hoc analysis of the efficacy and tolerability of everolimus plus octreotide long-acting repeatable (LAR) was conducted in patients with colorectal NETs enrolled in the phase III RAD001 in Advanced Neuroendocrine Tumors, Second Trial (RADIANT-2) study. The primary endpoint (progression-free survival [PFS]), secondary endpoints (including objective response rate), and safety were assessed. Results. Patients with colorectal NETs receiving everolimus plus octreotide LAR had a significantly longer median PFS (29.9 months; n = 19) than did those receiving placebo plus octreotide LAR (6.6 months; n = 20). Everolimus plus octreotide LAR treatment also significantly reduced the risk for disease progression (hazard ratio: 0.34; 95% confidence interval: 0.13–0.89; p = .011). Although no objective responses were observed, tumor shrinkage was more frequently noted in the everolimus plus octreotide LAR arm than in the placebo plus octreotide LAR arm (67% vs. 37%, respectively). The combination of everolimus plus octreotide LAR was generally well tolerated by patients with colorectal NETs; rash and stomatitis were the most commonly reported adverse events. Conclusions. Everolimus plus octreotide LAR treatment had significant benefits and improved outcomes for patients with advanced colorectal NETs compared with placebo plus octreotide LAR treatment. Results of this exploratory analysis are consistent with those reported from the RADIANT-2 primary analysis. These findings support additional investigations of everolimus plus octreotide LAR in patients with colorectal NETs.
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    URL: Article
    DOI: 10.1634/theoncologist.2012-0263
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2013
    detail.hit.zdb_id: 2023829-0
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  • 2
    Online Resource
    Online Resource
    Whole bone marrow irradiation for the treatment of multiple myeloma
    Wiley ; 1982
    In:  Cancer Vol. 49, No. 7 ( 1982-04-01), p. 1328-1333
    Details
    In: Cancer, Wiley, Vol. 49, No. 7 ( 1982-04-01), p. 1328-1333
    Type of Medium: Online Resource
    ISSN: 0008-543X , 1097-0142
    URL: Issue
    URL: Journal
    URL: Article
    DOI: 10.1002/1097-0142(19820401)49:7〈〉1.0.CO;2-9
    DOI: 10.1002/(ISSN)1097-0142
    DOI: 10.1002/1097-0142(19820401)49:7〈1328::AID-CNCR2820490703〉3.0.CO;2-4
    Language: English
    Publisher: Wiley
    Publication Date: 1982
    detail.hit.zdb_id: 1479932-7
    detail.hit.zdb_id: 2599218-1
    detail.hit.zdb_id: 2594979-2
    detail.hit.zdb_id: 1429-1
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  • 3
    Online Resource
    Online Resource
    Efficacy and Safety of Everolimus Plus Octreotide LAR in Patients With Colorectal Neuroendocrine Tumors (NET): Subgroup Analysis of the Phase III RADIANT-2 Trial : 394
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  American Journal of Gastroenterology Vol. 106 ( 2011-10), p. S154-S155
    Details
    In: American Journal of Gastroenterology, Ovid Technologies (Wolters Kluwer Health), Vol. 106 ( 2011-10), p. S154-S155
    Type of Medium: Online Resource
    ISSN: 0002-9270
    URL: Article
    DOI: 10.14309/00000434-201110002-00394
    RVK:
    XA 18920
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
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  • 4
    Online Resource
    Online Resource
    Localized Renal Aspergillosis with Hairy Cell Leukemia: A Review of Urinary Tract Aspergillosis in Malignant and Nonmalignant Conditions
    Informa UK Limited ; 1984
    In:  Cancer Investigation Vol. 2, No. 3 ( 1984-01), p. 199-202
    Details
    In: Cancer Investigation, Informa UK Limited, Vol. 2, No. 3 ( 1984-01), p. 199-202
    Type of Medium: Online Resource
    ISSN: 0735-7907 , 1532-4192
    URL: Article
    DOI: 10.3109/07357908409104372
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 1984
    detail.hit.zdb_id: 2043112-0
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  • 5
    Online Resource
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    Patterns of resource utilization and cost for postmenopausal women with hormone-receptor–positive (HR + ), HER2-negative (HER2 – ) advanced breast cancer (ABC) in Europe.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e17520-e17520
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e17520-e17520
    Abstract: e17520 Background: Healthcare resource utilization varies by disease stage and treatment choice. Notably, chemotherapy (CT) use is associated with extensive healthcare resource utilization and cost. This study reviews the direct and indirect cost implications of CT versus hormonal therapy (HT) in the ABC setting through the first 3 lines of treatment. Methods: A retrospective chart review of postmenopausal women diagnosed with HR + , HER2 – ABC in 5 European countries was conducted. Patients must have progressed on at least 1 line of HT and completed at least 1 line of CT in the ABC setting. Patient cohorts based on therapy received in each line were constructed (cohort A: HT 1st-line, CT 2nd-line, and any treatment 3rd-line; cohort B: HT 1st- and 2nd-line with CT 3rd-line; and cohort C: CT 1st-line with any 2nd- and 3rd-line). Costs of care based on resource utilization and country-specific cost were calculated by patient cohort and line of therapy. Working status was also assessed. Results: A total of 355 eligible patient charts between 2008 and 2012 were included in the analysis: cohort A, 218 (61%) patients; cohort B, 26 (7%) patients; and cohort C 111 (31%) patients. Total direct costs over all 3 treatment lines were €14,362 higher for CT versus HT as 1st-line therapy (cohort C vs A) and €10,368 higher for CT versus HT as 2nd-line (cohort A vs B). Monthly direct costs were €2,536 higher for CT versus HT for 1st-line therapy and €1,713 higher for CT versus HT in 2nd-line. Increased costs for CT were due to treatments to manage side effects, use of concomitant targeted therapies, and increased frequency of hospitalizations, healthcare provider visits, and monitoring tests. On switching from HT to CT, there was a doubling of the proportion of patients on sick leaves in both cohorts A and B. Conclusions: These results suggest an increased direct cost of care for CT relative to HT in European postmenopausal women with HR + , HER2 – ABC. Furthermore, CT-based therapy appears to be associated with lower productivity of working-age patients, potentially increasing overall indirect costs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e17520
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    Open-label, phase IIIb, multicenter, expanded access study of everolimus in patients with advanced neuroendocrine tumors (NET).
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 4138-4138
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 4138-4138
    Abstract: 4138 Background: Everolimus (EVE) antitumor efficacy in patients (pts) with advanced NET was demonstrated in 2 double-blind, placebo (P)–controlled, phase III trials (RADIANT-2 and RADIANT-3). Median PFS in pancreatic (pNET) pts was 11.0 months (EVE) vs. 4.6 months (P) (HR 0.35, 95% CI 0.27-0.45, P 〈 0.001) in RADIANT-3. Median EVE exposure in RADIANT-3 was 38 wks. EVE was approved for advanced pNET in the US and Europe in 2011. An expanded access protocol was launched to gather additional safety data and provide access to EVE for pts with advanced NET while awaiting regulatory approval. Methods: Pts aged ≥18 years with biopsy-proven NET; WHO performance status 0-2; and adequate bone, hepatic, and renal function were enrolled. Main exclusion criteria were poorly differentiated NET and cytotoxic therapy within 4 wks of enrollment. EVE (10 mg/d) was administered until disease progression, unacceptable toxicity, discontinuation, death, commercial availability of EVE, or until May 30, 2012. Pts were enrolled from April 21, 2011 to April 20, 2012. Primary objective was grade 3/4 and serious adverse events (AEs). Secondary objectives included investigator-assessed best overall response rate and PFS. Results: The full analysis set included 246 pts (pNET, n=126; non-pNET, n=120); the safety set included 240 pts (pNET, n=123; non-pNET, n=117). Median age was 61 and 66 years; 54% and 49% were male. Main primary tumor sites in non-pNET pts included small intestine (40%) and lung (22%). Median duration of EVE exposure was 12.1 wks and 24 wks in pNET and non-pNET. At data cutoff, there were 21 and 32 PFS events; 105 and 88 pts were censored. Grade 3/4 AEs were reported in 42.3% and 69.2% of pNET and non-pNET; those reported in ≥10% of pts in pNET and non-pNET included hyperglycemia (12.2% and 5.1%), diarrhea (10.6% and 31.6%), stomatitis (9.8% and 11.1%), nausea (8.1% and 10.3%), and anemia (5.7% and 11.1%). Median investigator-assessed PFS was 7.6 (95% CI 5.52-7.62) months and 10.8 (8.77-Not Estimable) months in pNET and non-pNET. Conclusions: EVE was well tolerated in pts with advanced NET. AEs were similar to those previously reported. Protocol-specified early termination of pts limits the interpretation of PFS medians. Clinical trial information: EudraCT Number: 2010-023032-17.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.4138
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    Multivariate analysis including biomarkers in the phase III RADIANT-2 study of octreotide LAR plus everolimus (E+O) or placebo (P+O) among patients with advanced neuroendocrine tumors (NET).
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 4_suppl ( 2012-02-01), p. 157-157
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 4_suppl ( 2012-02-01), p. 157-157
    Abstract: 157 Background: In this large phase III trial, median progression-free survival (PFS) improved by 5.1 mo with E+O compared to P+O in patients (pts) with NET associated with carcinoid syndrome. Randomization imbalances including WHO performance status (PS), and primary site favoring P+O confounded primary analysis. Chromogranin A (CgA) and 5-hydroxyindoleacetic acid (5-HIAA) are important biomarkers in NET. Analyses were performed to identify prognostic factors and adjust for randomization imbalances. Methods: Pts were randomized to E+O (n=216) or P+O (n=213). Potential prognostic factors including baseline CgA (≤2×ULN vs 〉 2×ULN), baseline 5-HIAA (≤median vs 〉 median), age ( 〈 65 vs ≥65), gender, race, WHO PS (0 vs 1, 2), primary site (lung vs other), prior somatostatin analog use (yes vs no), duration from diagnosis ( 〈 6 mo, 6-24 mo, 2-5 yr, 〉 5 yr), and organs involved (liver, bone) were assessed in univariate analysis using the log rank test and a stepwise regression using Cox proportional hazards model. Results: Randomization resulted in significant imbalance in baseline CgA (median [ng/mL], 251 E+O vs 137 P+O). Median PFS (mo) was significantly longer for pts with nonelevated CgA (27 vs 11; P 〈 .001) and nonelevated 5-HIAA (17 vs 11; P 〈 .001). Analyses also indicated age (14 vs 12; P=.01), WHO PS (17 vs 11; P=.004), liver involvement (14 vs not reached; P=.02), bone metastases (8 vs 15; P 〈 .001), and lung as primary site (11 vs 14; P=.06) as potentially prognostic. Multivariate analysis indicated that significant prognostic factors for PFS included baseline CgA (HR, 0.47; CI, 0.34-0.65; P 〈 .001), WHO PS (HR, 0.69; CI, 0.52-0.90; P=.006), bone involvement (HR, 1.52; CI, 1.06-2.18; P=.02), and lung as primary site (HR, 1.55; CI, 1.01-2.36; P=.04). Adjusted for covariates, a 38% reduction in risk of progression was observed for E+O (HR, 0.62; 95% CI, 0.51-0.87; P=.003). Conclusions: In the phase III RADIANT-2 trial, baseline CgA levels, WHO PS, lung as primary site, and bone involvement were important prognostic factors. Exploratory analysis adjusted for these prognostic factors indicated significant benefit for everolimus therapy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.4_suppl.157
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Online Resource
    Everolimus plus exemestane in patients with advanced invasive lobular carcinoma: Efficacy and safety results from BOLERO-2.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 26_suppl ( 2014-09-10), p. 152-152
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 26_suppl ( 2014-09-10), p. 152-152
    Abstract: 152 Background: In BOLERO-2 (NCT00863655), everolimus plus exemestane (EVE + EXE) more than doubled median progression-free survival (PFS) vs placebo (PBO) + EXE (by local assessment: 7.8 vs 3.2 mo; hazard ratio [HR], 0.45; P 〈 0.0001; by central assessment: 11.0 vs 4.1 mo; HR, 0.38; P 〈 0.0001) in patients (pts) with hormone-receptor–positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). This exploratory analysis assessed the efficacy and safety of EVE + EXE in a subset of pts with baseline invasive lobular carcinoma (ILC) (elderly pts with predominantly peritoneal, gastrointestinal, and ovarian metastases [mets]). Methods: Pts with HR+, HER2– ABC recurring or progressing on/after prior nonsteroidal aromatase inhibitor therapy were randomized 2:1 to receive EVE 10 mg/day + EXE 25 mg/day or PBO + EXE. Primary efficacy end point was PFS (by local assessment). Results: Of 724 pts, 77% (n = 556) had ductal carcinoma and 14% (n = 104; EVE + EXE, n = 64; PBO + EXE, n = 40) had ILC. In ILC subset, median age was 63 years, 47.1% had measurable disease, and majority of baseline characteristics were similar to overall study population with exception of main mets sites. In pts with ILC, 36% reported visceral mets (lung, liver, pleural, pleural effusions, peritoneum, and ascites), 10% lung mets, and 23% liver mets when compared with 59% visceral mets, 31% lung mets, and 33% liver mets in overall study population. Median PFS was higher with EVE + EXE vs PBO + EXE (6.9 vs 4.2 mo; HR, 0.59; 95% CI, 0.37-0.95). Objective response rates were 14.1% (EVE + EXE arm) and 0% (PBO + EXE arm) vs 12.6% and 1.7%, respectively, among overall study population. Clinical benefit rates were 45.3% (EVE + EXE arm) and 30.0% (PBO + EXE arm); 51.3% vs 26.4% in overall study population. The safety profile of EVE + EXE in pts with ILC was similar to overall study population. Most common adverse events (all grades) in EVE-treated pts with ILC were stomatitis (50%), diarrhea (41%), nausea (36%), fatigue (34%), and rash (33%). Conclusions: EVE + EXE prolonged PFS in pts with ILC who had different patterns of mets. Other outcomes were similar to those in overall study population. Clinical trial information: NCT00863655.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.26_suppl.152
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Development of everolimus, a novel oral mTOR inhibitor, across a spectrum of diseases
    Wiley ; 2013
    In:  Annals of the New York Academy of Sciences Vol. 1291, No. 1 ( 2013-07), p. 14-32
    Details
    In: Annals of the New York Academy of Sciences, Wiley, Vol. 1291, No. 1 ( 2013-07), p. 14-32
    Abstract: Everolimus is a potent, oral inhibitor of the mammalian target of rapamycin (mTOR) that has been investigated in multiple clinical development programs since 1996. A unique collaboration between academic and pharmaceutical experts fostered research that progressed rapidly, with simultaneous indication findings across numerous tumor types. Initially developed for the prophylaxis of organ transplant rejection, everolimus has demonstrated efficacy and safety for the treatment of patients with various types of cancer (renal cell carcinoma, neuroendocrine tumors of pancreatic origin, and breast cancer) and for adult and pediatric patients with tuberous sclerosis complex. The FDA approval of everolimus for these diseases has addressed several unmet medical needs and is widely accepted by the medical community where treatment options may be limited. An extensive clinical development program is ongoing to establish the role of everolimus as monotherapy, or in combination with other agents, in the treatment of a broad spectrum of malignancies.
    Type of Medium: Online Resource
    ISSN: 0077-8923 , 1749-6632
    URL: Issue
    URL: Article
    DOI: 10.1111/nyas.2013.1291.issue-1
    DOI: 10.1111/nyas.12122
    RVK:
    TD 7650
    Language: English
    Publisher: Wiley
    Publication Date: 2013
    detail.hit.zdb_id: 2834079-6
    detail.hit.zdb_id: 211003-9
    detail.hit.zdb_id: 2071584-5
    SSG: 11
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  • 10
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    BOLERO-4: Multicenter, open-label, phase II study of everolimus plus letrozole as first-line therapy in ER + , HER2 - metastatic breast cancer.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. TPS661-TPS661
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. TPS661-TPS661
    Abstract: TPS661 Background: Endocrine therapy (ET) is the standard of care for postmenopausal women with hormone receptor positive (HR + ; typically, estrogen receptor [ER] positive) advanced breast cancer (ABC). However, women with HR + ABC can progress while on ET. Crosstalk between ER signaling and the mammalian target of rapamycin (mTOR) pathway enhances tumor progression. Co-targeting these signaling pathways with the combination of everolimus (EVE), an orally bioavailable mTOR inhibitor, and ET (letrozole [LET] or tamoxifen) has been shown to significantly improve clinical outcomes in the neoadjuvant setting and in patients with HR + ABC progressing on/after nonsteroidal aromatase inhibitors. In a pivotal phase 3 trial in women with HR + ABC progressing on ET, EVE + exemestane (EXE) prolonged progression-free survival (PFS; local/central assessment: 7.8/11.0 mo [P 〈 .0001]) compared with EXE alone (3.2/4.1 mo [P 〈 .0001]). This study (BOLERO-4) will extend previous investigations to evaluate the safety and effectiveness of EVE+LET as first-line therapy in ER + HER2 – metastatic BC (mBC), and the potential benefits of continuing EVE+ET beyond initial progression. Methods: In this multicenter, open-label, international, single-arm, phase 2 study, 200 postmenopausal women age ≥18 y with ER + HER2 – mBC or locally ABC without prior therapy for advanced disease will receive EVE (10 mg/d) + LET (2.5 mg/d) until first disease progression. Upon disease progression, patients continuing in the trial will receive EVE+EXE (25 mg/d) until further disease progression. Patients who discontinue therapy in the first-line metastatic setting because of unacceptable toxicity will not be offered second-line therapy. The primary endpoint is PFS with EVE+LET in the first-line setting. Secondary endpoints include PFS in the second-line setting, overall survival, objective response rate, clinical benefit rate, safety, and the efficacy of oral dexamethasone solution to reduce the severity and/or duration of stomatitis using Oral Stomatitis Daily Questionnaire (OSDQ). Accrual across Europe, Asia, and the Americas begins Q1 2013. Estimated study completion is Q4 2015. Clinical trial information: NCT01698918.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.tps661
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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