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Daily Oral Everolimus Activity in Patients With Metastatic Pancreatic Neuroendocrine Tumors After Failure of Cytotoxic Chemotherapy: A Phase II Trial
Open accessAbstract
Purpose: No established treatment exists for pancreatic neuroendocrine tumor (NET) progression after failure of chemotherapy. Everolimus (RAD001), an oral inhibitor of mammalian target of rapamycin, in combination with octreotide has demonstrated encouraging antitumor activity in patients with NETs. Patients and Methods: This open-label, phase II study assessed the clinical activity of everolimus in patients with metastatic pancreatic NETs who experienced progression on or after chemotherapy. Patients were stratified by prior octreotide therapy (stratum 1: everolimus 10 mg/d, n = 115; stratum 2: everolimus 10 mg/d plus octreotide long-acting release [LAR], n = 45). Tumor assessments (using Response Evaluation Criteria in Solid Tumors) were performed every 3 months. Chromogranin A (CgA) and neuron-specific enolase (NSE) were assessed monthly if elevated at baseline. Trough concentrations of everolimus and octreotide were assessed. Results: By central radiology review, in stratum 1, there were 11 partial responses (9.6%), 78 patients (67.8%) with stable disease (SD), and 16 patients (13.9%) with progressive disease; median progression-free survival (PFS) was 9.7 months. In stratum 2, there were two partial responses (4.4%), 36 patients (80%) with SD, and no patients with progressive disease; median PFS was 16.7 months. Patients with an early CgA or NSE response had a longer PFS compared with patients without an early response. Coadministration of octreotide LAR and everolimus did not impact exposure to either drug. Most adverse events were mild to moderate and were consistent with those previously seen with everolimus. Conclusion: Daily everolimus, with or without concomitant octreotide LAR, demonstrates antitumor activity as measured by objective response rate and PFS and is well tolerated in patients with advanced pancreatic NETs after failure of prior systemic chemotherapy.
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Metadata
- Authors
- Yao, J. C., Lombard-Bohas, C., Baudin, E., Kvols, L. K., Rougier, P., Ruszniewski, P., Hoosen, S., St. Peter, J., Haas, T., Lebwohl, D., Van Cutsem, E., Kulke, M. H., Hobday, T. J., O'Dorisio, T. M., Shah, M. H., Cadiot, G., Luppi, G., Posey, J. A., & Wiedenmann, B.
- Venue
- Journal of Clinical Oncology
- Published
- 2010-01-01
- Volume
- 28
- Issue
- 1
- Pages
- 69-76
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2128267006
- Cited by
- 647
- References
- 0
- FWCI
- 44.00
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Yao, J. C., Lombard-Bohas, C., Baudin, E., Kvols, L. K., Rougier, P., Ruszniewski, P., Hoosen, S., St. Peter, J., Haas, T., Lebwohl, D., Van Cutsem, E., Kulke, M. H., Hobday, T. J., O'Dorisio, T. M., Shah, M. H., Cadiot, G., Luppi, G., Posey, J. A., & Wiedenmann, B. (2010). Daily Oral Everolimus Activity in Patients With Metastatic Pancreatic Neuroendocrine Tumors After Failure of Cytotoxic Chemotherapy: A Phase II Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.24.2669
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
