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  • 1
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    Online Resource
    Medical treatment consensus in unresectable midgut gastrointestinal neuroendocrine tumors.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e14610-e14610
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e14610-e14610
    Abstract: e14610 Background: Neuroendocrine tumors (NETs) comprise mostly carcinoid or pancreatic NETs and are rare with symptoms that may be difficult to control. Current treatment guidelines lack some specificity. We summarize an expert panel consensus on medical treatment of well-differentiated unresectable midgut NETs. Methods: Consensus statements were developed via RAND/UCLA Delphi process, which involved a diverse group of physician experts (e.g., by specialty, geography, practice) developing comprehensive clinical patient scenarios and rating the scenarios on the appropriateness of various medical therapies before and after a face-to-face meeting. Experts and moderator were blinded to funding source. Scenarios were rated on a 1-9 scale and were labeled as appropriate, inappropriate, or uncertain. Scenarios with 〉 2 ratings in 1-3 and 〉 2 in 7-9 range were considered to have disagreement and were not assigned an appropriateness rating. Results: Panelists (age: 38-63 years) were from the northeast, midwest, south, and west regions. Specialties represented were medical and surgical oncology, interventional radiology, and gastroenterology. Panelists had practiced for a mean 15.5 years (range: 6-33). Panelists rated 202 scenarios. The proportion for which there was disagreement decreased from 11.7% (23 scenarios) before the meeting to 4.5% (9) after. Post-meeting, 49% (99 scenarios) were rated inappropriate, 29.7% (60) were uncertain, and 16.8% (34) were appropriate. Consensus statements from the scenarios included: 1) it is appropriate to use somatostatin analogs (SA) as 1 st -line therapy in all patients, 2) it is appropriate to increase the dose/frequency of octreotide-LAR as 2 nd -line therapy in patients with uncontrolled symptoms up to 60 mg every 4 weeks or up to 40 mg every 3 or 4 weeks for refractory carcinoid syndrome. Other treatment options may also be appropriate in 2 nd -line. Conclusions: Treatment consensus obtained in this study is concordant with NCCN recommendations. The Delphi process allowed quantification of ratings in a systematic and reliable way while improving consensus in a group of physicians on the appropriateness of medical therapies in midgut NETs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e14610
    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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  • 2
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    Small bowel carcinoid: Location isn’t everything.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 4_suppl ( 2013-02-01), p. 292-292
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 4_suppl ( 2013-02-01), p. 292-292
    Abstract: 292 Background: Contemporary data has revealed that small bowel carcinoid (SBC) accounts for the majority of gastrointestinal carcinoids. However, data remains limited regarding prognostic factors that impact survival for SBC patients. Using a population-based analysis, we investigate the significance of the primary site of disease for SBC. Methods: The Surveillance, Epidemiology, and End Results database was queried for histologically confirmed SBC between the years 1988 and 2009. Patients were excluded if adequate demographic and staging information was unknown. Overall and disease survival curves (OS and DSS respectively) were analyzed using the Kaplan-Meier method and compared using Log rank testing. Log rank and multivariate Cox regression analysis was used to identify predictors of survival using age, year of diagnosis, race, gender, tumor histology/size/location, TNM stage, number of lymph nodes (LNs) examined and percent of LNs with metastases. Results: Of the 3,834 patients analyzed, the mean age was 62.13 years and 51.2% were male. Median follow up was 50 months. The 10-year OS (63%) and DSS (91%) for duodenal primaries was statistically significant when compared to jejunal (53%, 74%), ileal (50%, 68%) and overlapping primaries (50%, 78%), (p = 0.0290 and 〈 0.0001, respectively). However, more the 90% of duodenal primaries had stage I and II disease only. On multivariate Cox regression analysis, after adjusting for multiple factors, primary site location was not a significant predictor of survival (p = 0.948 for OS and = 0.625 DSS) while TNM stage, age, tumor size and number of LNs examined portend improved OS and DSS. Conclusions: This population-based study of SBC over the past 30 years refutes the concept that the location of the SBC influences survival. A key element to consider is that more than 90% of duodenal primaries present at early stages. Further screening and diagnostic methods to detect other SBC primary sites could significantly impact survival.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.4_suppl.292
    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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  • 3
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    Online Resource
    Pharmacokinetic study of aldoxorubicin in patients with solid tumors
    Springer Science and Business Media LLC ; 2015
    In:  Investigational New Drugs Vol. 33, No. 2 ( 2015-04), p. 341-348
    Details
    In: Investigational New Drugs, Springer Science and Business Media LLC, Vol. 33, No. 2 ( 2015-04), p. 341-348
    Abstract: Introduction Aldoxorubicin, a prodrug of doxorubicin, binds covalently to serum albumin in the bloodstream and accumulates in tumors. Aldoxorubicin can be administered at doses several-fold higher than doxorubicin can, without associated acute cardiotoxicity. Purpose This study fully evaluated the pharmacokinetic profile of aldoxorubicin (serum and urine). Methods Eighteen patients with advanced solid tumors received aldoxorubicin 230 or 350 mg/m 2 (equivalent in drug load to doxorubicin at doses of 170 or 260 mg/m 2 , respectively) once every 21 days. Blood samples were taken in cycle 1 before aldoxorubicin infusion, and at 5, 15, 30, and 60 min, and at 2, 4, 8, 12, 16, 24, 48, and 72 h after infusion. Urine samples were taken in cycle 1 at 24, 48, and 72 h after infusion. Limited blood sampling was done in cycle 3, before aldoxorubicin infusion, and at 60 min and at 2, 4, and 8 h after infusion. Results The long mean half-life (20.1–21.1 h), narrow mean volume of distribution (3.96–4.08 L/m 2 ), and slow mean clearance rate (0.136–0.152 L/h/m 2 ) suggest that aldoxorubicin is stable in circulation and does not accumulate readily in body compartments outside of the bloodstream. Very little doxorubicin and its major metabolite doxorubicinol, which has been implicated in doxorubicin-associated cardiotoxicity, are excreted in urine. This might explain the lack of cardiotoxicity observed thus far with aldoxorubicin. Conclusions Our findings support dosing and administration schemas used in an ongoing phase 3 clinical study of aldoxorubicin in soft tissue sarcoma, and phase 2 clinical studies in small cell lung cancer, glioblastoma, and Kaposi’s sarcoma.
    Type of Medium: Online Resource
    ISSN: 0167-6997 , 1573-0646
    URL: Article
    DOI: 10.1007/s10637-014-0183-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2015
    detail.hit.zdb_id: 2009846-7
    SSG: 15,3
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  • 4
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    Everolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance)
    Bioscientifica ; 2022
    In:  Endocrine-Related Cancer Vol. 29, No. 6 ( 2022-06-01), p. 335-344
    Details
    In: Endocrine-Related Cancer, Bioscientifica, Vol. 29, No. 6 ( 2022-06-01), p. 335-344
    Abstract: Treatment with the MTOR inhibitor everolimus improves progression-free survival (PFS) in pancreatic neuroendocrine tumors (pNETs), but it is not known if the addition of a VEGF pathway inhibitor to an MTOR inhibitor enhances antitumor activity. We performed a randomized phase II study evaluating everolimus with or without bevacizumab in patients with advanced pNETs. One hundred and fifty patients were randomized to receive everolimus 10 mg daily with or without bevacizumab 10 mg/kg i.v. every 2 weeks. Patients also received standard dose of octreotide in both arms. The primary endpoint was PFS, based on local investigator review. Treatment with the combination of everolimus and bevacizumab resulted in improved progression-free survival compared to everolimus (16.7 months compared to 14.0 months; one-sided stratified log-rank P   = 0.1028; hazard ratio (HR) 0.80 (95% CI 0.56–1.13)), meeting the predefined primary endpoint. Confirmed tumor responses were observed in 31% (95% CI 20%, 41%) of patients receiving combination therapy, as compared to only 12% (95% CI 5%, 19%) of patients receiving treatment with everolimus ( P  = 0.0053). Median overall survival duration was similar in the everolimus and combination arm (42.5 and 42.1 months, respectively). Treatment-related toxicities were more common in the combination arm. In summary, treatment with everolimus and bevacizumab led to superior PFS and higher response rates compared to everolimus in patients with advanced pNETs. Although the higher rate of treatment-related adverse events may limit the use of this combination, our results support the continued evaluation of VEGF pathway inhibitors in pNETs.
    Type of Medium: Online Resource
    ISSN: 1351-0088 , 1479-6821
    URL: Article
    DOI: 10.1530/ERC-21-0239
    Language: Unknown
    Publisher: Bioscientifica
    Publication Date: 2022
    detail.hit.zdb_id: 2010895-3
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  • 5
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    Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE for Patients With Somatostatin Receptor–Expressing Neuroendocrine Tumors : The First US Phase 2 Experience
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Pancreas Vol. 43, No. 4 ( 2014-05), p. 518-525
    Details
    In: Pancreas, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. 4 ( 2014-05), p. 518-525
    Type of Medium: Online Resource
    ISSN: 0885-3177
    URL: Article
    DOI: 10.1097/MPA.0000000000000113
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 2053902-2
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  • 6
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    Online Resource
    Pharmacokinetic study of aldoxorubicin in solid tumor patients.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e13572-e13572
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e13572-e13572
    Abstract: e13572 Background: Aldoxorubicin consists of doxorubicin conjugated to a pH sensitive linker that binds covalently to circulating albumin. Previous studies demonstrated that aldoxorubicin can be administered at doses up to 350 mg/m 2 (260 mg/m 2 doxorubicin equivalents, DE) every 21 days for up to 8 cycles. We have investigated aldoxorubicin pharmacokinetics, including albumin-bound and free doxorubicin and doxorubicinol after administration of 2 dose levels of aldoxorubicin in patients with advanced solid tumors. Methods: Patients with solid tumors and no standard therapy were eligible. Other entry criteria: ECOG PS 0-2, LVEF 〉 45% of predicted normal for the site, adequate hematological status. Patients were administered either 230 mg/m 2 aldoxorubicin (165 mg/m 2 DE) or 350 mg/m 2 aldoxorubicin (260 mg/m 2 DE) iv over 30 minutes on day 1 of cycles 1 and 3. Blood samples were taken prior to administration and at multiple time points up to 72 hr post administration. Serum concentrations of albumin-bound doxorubicin, unbound doxorubicin and doxorubicinol were analyzed. Results: As of January 31, 7 subjects have been entered in the study. 6 subjects have received 230 mg/m 2 aldoxorubicin and 1 subject has received 350 mg/m 2 aldoxorubicin. No serious adverse events have been reported. Grade 3 or 4 adverse events include neutropenia, thrombocytopenia and anemia. A minor response (20% decrease) was observed in one subject (230 mg/m 2 aldoxorubicin) with small cell lung cancer who had received 3 prior chemotherapy regimens. For the 230 mg/m 2 cohort during cycle 1, median results for albumin-bound doxorubicin include C max = 64 µg/mL, t max = 0.25 hr, t 1/2 = 19.7 hr, AUC t- ∞ = 1500 h*µg/mL, CL pred = 0.153 L/h/m 2 , V ss pred = 3.91 L/m 2 . Results were similar for cycle 3. Free doxorubicin accounted for only 0.8% of total doxorubicin detected, and doxorubicinol less than 0.0007% of total drug. Results from the 350 mg/m 2 cohort are pending. Data from all 12 subjects will be available at presentation. Conclusions: Aldoxorubicin binds rapidly to albumin and is cleared slowly from the circulation. It possess a relatively narrow volume of distribution. These characteristics distinguish aldoxorubicin from published PK data for doxorubicin. Clinical trial information: NCT01706835.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e13572
    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
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    Phase I dose-escalation study of pasireotide LAR in patients with advanced neuroendocrine tumors.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e15126-e15126
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e15126-e15126
    Abstract: e15126 Background: Somastatin analogs (SSA), including octreotide and lanreotide, bind predominantly to somatostatin receptor (SSTR) 2 and form the foundation of treatment for symptomatic neuroendocrine tumors (NET). Pasireotide, a novel SSA with a broad binding affinity (SSTR 1-3 and 5), is being explored for treatment of NET. A phase 1 dose-escalation study (NCT01364415) of pasireotide long-acting release (LAR; starting dose of 80 mg) was designed to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) and to characterize safety, tolerability, pharmacokinetics, and efficacy in pts with advanced NET. Methods: Pts with advanced, well- or moderately differentiated NET received pasireotide LAR beginning at a dose of 80 mg q28d. Successive cohorts will receive doses (up to 220 mg) guided by a Bayesian logistic regression model until MTD/RP2D is reached. Results: To date, 15 pts have been treated at 80 mg (n=6) and 120 mg (n=9). Median age is 59 (44-76) years. Primary tumor sites include small intestine (40%), pancreas (20%), and lung (13.3%). All pts received prior antineoplastic therapy; 93% received prior SSA. Median number of cycles of pasireotide was 6.68 (2-14) (1 cycle=28 days). 10 (67%) pts remain on treatment: 3 on 80 mg and 7 on 120 mg. 5 (33%) have discontinued (disease progression, 2 pts; withdrew consent, 2 pts; adverse event [AE], 1 pt). Median plasma concentrations of pasireotide increased with dose. No dose-limiting toxicities have been reported. Most frequent AEs were similar in both dose groups and included hyperglycemia (87%), diarrhea (53%), abdominal pain (47%), nausea (40%), anemia (33%), and fatigue (33%). Most AEs were mild/moderate. 2 pts (1 in each group) had grade 3 hyperglycemia. 4 (27%) and 2 (13%) pts had HbA 1C increase from 〈 6.5% at baseline to 6.5- 〈 8% and ≥8%, respectively. 13 (87%) pts had radiographically stable disease as best response. More pts at 120 mg (50%) vs 80 mg (33%) achieved ≥50% reduction in chromogranin A. Conclusions: Pasireotide LAR up to 120 mg appears to be well tolerated in patients with advanced NET. The study is ongoing. Pasireotide represents a promising therapy for pts with NET. Clinical trial information: NCT01364415.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e15126
    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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  • 8
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    Pancreatic Neuroendocrine Tumors: Presentation, Management, and Outcomes
    SAGE Publications ; 2009
    In:  The American Surgeon Vol. 75, No. 10 ( 2009-10), p. 1025-1029
    Details
    In: The American Surgeon, SAGE Publications, Vol. 75, No. 10 ( 2009-10), p. 1025-1029
    Abstract: Pancreatic neuroendocrine tumors (pNETs) are an uncommon pancreatic neoplasm. We reviewed the presentation, management, and outcome of patients with pNETs treated at a single center by a multidisciplinary approach between 2004 and 2008. Over this time period, 154 patients with carcinoid and neuroendocrine tumors were treated, which included 46 patients (30% of total) with pNETs. The most common presentations included abdominal pain (20 of 46 [43%]), systemic symptoms such as hypoglycemia (15 of 46 [33%] ), and incidental mass (7 of 46 [15%]). Fourteen patients had functional tumors. At the time of diagnosis, 22 patients (48%) presented without metastases and 24 (52%) had metastatic disease. Median follow up for the entire group was 42 months. All patients with nonmetastatic pNET underwent pancreatic resection with 95 per cent postoperative survival. Overall survival in this group at 3 years was 86 per cent and disease-free survival was 81 per cent. In patients presenting with metastatic pNET, multiple treatment modalities were used, including liver resection or ablation (n = 15), hepatic chemoembolization (n = 17), pancreatic resection (n = 12), and systemic treatments (n = 7). Three-year survival was 70 per cent. Pancreatic resection results in greater than 80 per cent 3-year survival in nonmetastatic pNET. In patients presenting with metastatic pNET, excellent survival rates are also achievable using a multidisciplinary multimodal approach.
    Type of Medium: Online Resource
    ISSN: 0003-1348 , 1555-9823
    URL: Article
    DOI: 10.1177/000313480907501035
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2009
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  • 9
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    Online Resource
    Resection Prolongs Overall Survival for Nonmetastatic Midgut Small Bowel Neuroendocrine Tumors : A National Cancer Data Base Study
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Pancreas Vol. 51, No. 2 ( 2022-2), p. 171-176
    Details
    In: Pancreas, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. 2 ( 2022-2), p. 171-176
    Type of Medium: Online Resource
    ISSN: 1536-4828 , 0885-3177
    URL: Article
    DOI: 10.1097/MPA.0000000000001982
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2053902-2
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  • 10
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    Differential Diagnosis of Diarrhea in Patients With Neuroendocrine Tumors
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Pancreas Vol. 49, No. 9 ( 2020-10), p. 1123-1130
    Details
    In: Pancreas, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. 9 ( 2020-10), p. 1123-1130
    Abstract: Patients with neuroendocrine tumors (NETs) and carcinoid syndrome experience diarrhea that can have a debilitating effect on quality of life. Diarrhea also may develop in response to other hormonal syndromes associated with NETs, surgical complications, medical comorbidities, medications, or food sensitivities. Limited guidance on the practical approach to the differential diagnosis of diarrhea in these patients can lead to delays in appropriate treatment. This clinical review and commentary underscore the complexity in identifying the etiology of diarrhea in patients with NETs. Based on our collective experience and expertise, we offer a practical algorithm to guide medical oncologists and other care providers to expedite effective management of diarrhea and related symptoms in patients with NETs.
    Type of Medium: Online Resource
    ISSN: 1536-4828 , 0885-3177
    URL: Article
    DOI: 10.1097/MPA.0000000000001658
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2053902-2
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