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1.  Phase I trial of capecitabine plus everolimus (RAD001) in patients with previously treated metastatic gastric cancer 
Purpose
Everolimus is a novel inhibitor of the mammalian target of rapamycin pathway, which is aberrantly activated in cancer cell. We conducted a phase I study of capecitabine plus everolimus (RAD001) in refractory gastric cancer patients.
Methods
Patients with metastatic gastric cancer and progression after prior chemotherapy were eligible. Four dose levels were planned as follows: Level 1, 5 mg bid/day of everolimus (D1-D21) and 500 mg/m2 bid/day of capecitabine (D1-14); Level 2, 5 mg bid/day of everolimus (D1-D21) and 750 mg/m2 bid/day of capecitabine (D1-14); Level 3, 5 mg bid/day of everolimus (D1-D21) and 1000 mg/m2 bid/day of capecitabine (D1-14); and Level 4, 10 mg bid/day of everolimus (D1-D21) and 1000 mg/m2 bid/day of capecitabine (D1-14). Treatment was repeated every 3 weeks until disease progression, patient refusal, or any serious adverse event.
Results
Fifteen patients were enrolled in this study between November 2009 and April 2010. Fifteen patients were enrolled (median age, 50 years; men, 9). Six patients had received two previous chemotherapy regimens; six patients had three previous chemotherapy regimens before the study treatment. Thus, the majority of patients were heavily pretreated. The dose-limiting toxicities were grade 3 infection, grade 3 mucositis, and grade 3 hyperglycemia and hyponatremia. After a median follow-up duration of 5.6 months (range, 2.3–8.1 months), median PFS was 1.8 months (95% CI, 0.8–2.8 months). The maximum best change observed was a 28.7% decrease in sum of longest diameters when compared with baseline.
Conclusions
The combination of capecitabine and everolimus showed satisfactory toxicity profile and modest clinical benefit in patients with refractory gastric cancer. The recommended dose of capecitabine and everolimus was 650 mg/m2 twice daily and 5 mg twice daily, respectively.
doi:10.1007/s00280-011-1653-5
PMCID: PMC3123695  PMID: 21526353
Gastric cancer; Everolimus; Capecitabine
2.  Primary CNS lymphoma other than DLBCL: a descriptive analysis of clinical features and treatment outcomes 
Annals of Hematology  2011;90(12):1391-1398.
Diffuse large B-cell lymphoma (DLBCL) constitutes most primary central nervous system (CNS) lymphoma (PCNSL), whereas T-cell, low-grade and Burkitt’s lymphomas (BL) are rarely encountered. Due to the paucity of cases, little is known about the clinical features and treatment outcomes of PCNSL other than DLBCL. The objective of this study was to describe the clinical characteristics and outcomes for patients with PCNSL other than DLBCL. Fifteen patients, newly diagnosed with PCNSLs other than DLBCL between 2000 and 2010, were included. The male to female ratio was 0.67:1 with a median age of diagnosis of 31 years (range 18–59). Pathologic distributions were as follows: peripheral T-cell lymphoma (PTCL; n = 7), marginal zone B-cell lymphoma (MZBCL; n = 1), lymphoplasmacytic lymphoma (LPL; n = 2), Burkitt’s lymphoma (n = 1), other unspecified (T-cell lineage, n = 2; B-cell lineage, n = 2). Thirteen patients (87%) showed Eastern Cooperative Oncology Group performance score (ECOG PS) 1–2. The remaining two were one PTCL patient and one Burkitt’s lymphoma patient. Of the nine patients with T-cell lymphoma, five (56%) had multifocal lesions, and one (20%) with LPL of the five patients with B-cell lymphoma showed a single lesion. Leptomeningeal lymphomatosis was identified in two patients (one with Burkitt’s lymphoma and one with unspecified B-cell lymphoma). Two patients (22%) with T-cell lymphoma died 7.7 and 23.3 months later, respectively, due to disease progression, despite HD-MTX-based therapy. Six patients with T-cell lymphoma (6/9, 66.7%) and four patients with low-grade B-cell lymphoma (4/5, 80%) achieved complete response and have survived without relapse (Table 3). One patient with Burkitt’s lymphoma showed poor clinical features with ECOG PS 3, deep structure, multifocal, and leptomeningeal lymphomatosis, and died 7.6 months after the initiation of treatment. In comparison with previously reported DLBCLs (median OS 6.4 years, 95% CI 3.7–9.1 years), T-cell lymphoma showed equivocal or favorable clinical outcomes and low-grade B-cell lymphomas, such as MZBCL and LPL, had a good prognosis. However, primary CNS Burkitt’s lymphoma presented poor clinical outcomes and showed a comparatively aggressive clinical course. In conclusion, primary CNS lymphoma other than DLBCL occurred more in younger patients and showed a generally good prognosis, except for Burkitt’s lymphoma. Further research on treatment strategies for Burkitt’s lymphoma is needed.
doi:10.1007/s00277-011-1225-0
PMCID: PMC3210363  PMID: 21479535
Primary CNS lymphoma; Diffuse large B-cell lymphoma

Results 1-2 (2)