The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.
Efficacy of RAD001 (Everolimus) and Octreotide LAR in Advanced Low- to Intermediate-Grade Neuroendocrine Tumors: Results of a Phase II Study
Open accessAbstract
Purpose: Evaluate the activity of everolimus (RAD001) in combination with octreotide long-acting repeatable (LAR) in patients with advanced low- to intermediate-grade neuroendocrine tumors. Methods: Treatment consisted of RAD001 5 mg/d (30 patients) or 10 mg/d (30 patients) and octreotide LAR 30 mg every 28 days. Thirty carcinoid and 30 islet cell patients were enrolled. Results: Intent-to-treat response rate was 20%. Per protocol, there were 13 with partial responses (22%), 42 with stable disease (SD; 70%), and five patients with progressive disease (8%). Overall median progression-free survival (PFS) was 60 weeks. Median PFS for patients with known SD at entry was longer than for those who had progressive disease (74 v 50 weeks; P < .01). Median overall survival has not been reached. One-, 2-, and 3-year survival rates were 83%, 81%, and 78%, respectively. Among 37 patients with elevated chromogranin A, 26 (70%) achieved normalization or more than 50% reduction. Most common toxicity was mild aphthous ulceration. Grade 3/4 toxicities occurring in ≥ 10% of patients included hypophosphatemia (11%), fatigue (11%), and diarrhea (11%). Treatment was associated with a dose-dependent rise in lactate dehydrogenase (LDH). Those with lower than 109 U/L rise in LDH at week 4 had shorter PFS (38 v 69 weeks; P = .01). Treatment was also associated with a decrease in proliferation marker Ki-67 among patients who underwent optional paired pre- and post-treatment biopsy (P = .04). Conclusion: RAD001 at 5 or 10 mg/d was well tolerated in combination with octreotide LAR, with promising antitumor activity. Confirmatory studies are ongoing.
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Metadata
- Authors
- Yao, J. C., Phan, A. T., Chang, D. Z., Wolff, R. A., Hess, K., Gupta, S., Jacobs, C., Mares, J. E., Landgraf, A. N., Rashid, A., & Meric-Bernstam, F.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-09-10
- Volume
- 26
- Issue
- 26
- Pages
- 4311-4318
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2112064092
- Cited by
- 649
- References
- 24
- FWCI
- 43.58
- Type
- journal article
- Language
- en
- Open access
- green
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- Yao, J. C., Phan, A. T., Chang, D. Z., Wolff, R. A., Hess, K., Gupta, S., Jacobs, C., Mares, J. E., Landgraf, A. N., Rashid, A., & Meric-Bernstam, F. (2008). Efficacy of RAD001 (Everolimus) and Octreotide LAR in Advanced Low- to Intermediate-Grade Neuroendocrine Tumors: Results of a Phase II Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.16.7858
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