Prospective phase II study of capecitabine and temozolomide (CAPTEM) for progressive, moderately, and well-differentiated metastatic neuroendocrine tumors
| Autor: | Anna Oprescu, John A. Chabot, Jeffrey N. Bruce, Robert L. Fine, Anthony Paul Gulati, Kelley B. Mowatt, Dawn Tsushima |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Chemotherapy Temozolomide medicine.diagnostic_test business.industry medicine.medical_treatment Octreotide scan Phases of clinical research Neuroendocrine tumors medicine.disease Interim analysis Surgery Capecitabine Regimen Internal medicine medicine business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 32:179-179 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2014.32.3_suppl.179 |
| Popis: | 179 Background: We found in our lab that capecitabine (CAP), the prodrug of 5-FU, and temozolomide (TEM) were synergistic in inducing apoptosis in BON neuroendocrine tumor (NET) cell lines. We were the first to report in 2004 the use and mechanism of action of CAP and TEM (CAPTEM) in well differentiated NETs with promising results. Here we describe the interim analysis of an ongoing Phase II trial. Methods: 28 patients with metastatic well-moderately differentiated NET (ki-67 ≤20%) who had shown progression only on 60mg Sandostatin LAR (if octreotide scan positive) were treated with the following regimen: CAP 1,500mg/m2/day (PO divided BID, maximum 2,500 mg/day) on d1-14, and TEM 150-200mg/m2/day (PO divided BID, lower dose for patients who had prior chemotherapy or extensive radiation) on d10-14, with the next two weeks off, in a 28 day cycle. Primary objective was RR based upon RECIST, and secondary objectives included PFS, OS (from time of initiation of therapy), and toxicity evaluation. Other inclusion criteria were: age 20mo for all subtypes with 18/28 (64%) having progressed at this time. Twelve of 28 had died at this analysis with ongoing mOS of >25.3mo. The most common G3/4 toxicities were lymphopenia (32%), hyperglycemia (15%, unlikely related), thrombocytopenia (3%), and diarrhea (3%). No hospitalizations, opportunistic infections, or deaths occurred from CAPTEM. Conclusions: CAPTEM is an effective treatment for patients with progressive NET who failed high dose octreotide, with high PR and SD rates in carcinoids and insulinomas. The ongoing PFS in pancreatic NETs (>18.2 mo) is 150% greater than reported with everolimus and sutent. Clinical trial information: NCT00869050. [Table: see text] |
| Databáze: | OpenAIRE |
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