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Micallef I.N.M.,Mayo Medical School | Ho A.D.,University of Heidelberg | Klein L.M.,Lutheran General Hospital | Marulkar S.,Genzyme | And 2 more authors.
Bone Marrow Transplantation | Year: 2011

Lenalidomide and other new agents have considerable activity in multiple myeloma (MM) and have changed the landscape of treatment. Data suggest that lenalidomide therapy before autologous hematopoietic stem cell transplantation has a detrimental effect on stem cell mobilization. This retrospective study examined the efficacy of plerixafor in combination with G-CSF among patients with MM previously treated with lenalidomide (median, 4 cycles; range, 1-20 cycles). Data were analyzed for 60 patients who received plerixafor plus G-CSF for frontline mobilization in a phase 3 clinical trial or an expanded access program (n20) or for remobilization in a compassionate use program (n40). The overall median number of CD34 cells collected was 5.6 × 10 6 per kg (range, 0.45 × 10 6-37.2 × 10 6). The minimum number of CD34 cells (2 × 10 6 per kg) was collected from 86.7% of patients in a median of 1 day. This minimum was collected from 100% of patients who underwent frontline mobilization and 80% of patients who underwent remobilization. These data suggest that CD34 hematopoietic stem cells can be successfully and predictably collected with combination plerixafor plus G-CSF for primary or secondary mobilization in the majority of patients with MM who have been previously treated with lenalidomide. © 2011 Macmillan Publishers Limited All rights reserved.

Sonpavde G.,Texas Oncology And Us Oncology Research | Matveev V.,Russian Academy of Medical Sciences | Burke J.M.,Rocky Mountain Cancer Centers | Caton J.R.,Willamette Valley Cancer Center | And 9 more authors.
Annals of Oncology | Year: 2012

Background: AT-101 (A), a small molecule oral inhibitor of the Bcl-2 family, has activity alone and in combination with docetaxel (Taxotere) and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). A randomized, double-blind, placebo-controlled phase II trial compared DP combined with either AT-101 (A) or placebo in chemonaive mCRPC.Patients and methods: Men with progressive mCRPC despite androgen deprivation were eligible and randomized 1 1. Patients received docetaxel (75 mg/m 2 day 1) and prednisone 5 mg orally twice daily every 21 days with either AT-101 (40 mg) or placebo twice daily orally on days 1-3. The primary end point was overall survival (OS).Results: Two hundred and twenty-one patients were randomly assigned. Median OS for AT-101 plus docetaxel-prednisone (ADP) and placebo-DP was 18.1 versus 17.8 months [hazard ratio (HR) 1.07, 95% confidence interval 0.72-1.55, P = 0.63]. Secondary end points were also not statistically different. Grade 3/4 toxic effects for ADP versus placebo-DP were cardiac events (5% versus 2%), lymphopenia (23% versus 16%), neutropenia (47% versus 40%), ileus (2% versus 0%) and pulmonary embolism (6% versus 2%). In a subgroup of high-risk mCRPC (n = 34), outcomes appeared to favor ADP (median OS 19 versus 14 months).Conclusions: AT-101 was tolerable but did not extend OS when combined with DP in mCRPC; a potential benefit was observed in high-risk patients. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Thomas V.T.,Rocky Mountain Cancer Centers | Hinson S.,Baylor University | Konduri K.,Baylor University
Therapeutic Advances in Medical Oncology | Year: 2012

Pulmonary carcinosarcoma is a rare and aggressive neoplasm that has both epithelial and mesenchymal components. We report on a 63-year-old woman who was found to have a right upper-lobe pulmonary carcinosarcoma with metastases to the liver and gastric fundus. There are currently no published guidelines on the treatment of pulmonary sarcomatoid carcinomas. However, with our expanding knowledge of cancer metastasis, cases of carcinosarcoma illustrate our current understanding of epithelial-mesenchymal transition in action. Here, we discuss the development and treatment of these biphasic tumors and the possible role of epithelial-mesenchymal transition. © 2011 The Author(s).

Flinn I.W.,Sarah Cannon Research Institute Tennessee Oncology | Van Der Jagt R.,University of Ottawa | Kahl B.S.,University of Wisconsin - Madison | Wood P.,Princess Alexandra Hospital | And 14 more authors.
Blood | Year: 2014

This randomized, noninferiority (NI), global, phase 3 study evaluated the efficacy and safety ofbendamustineplusrituximab(BR) vs a standard rituximab-chemotherapy regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] or rituximab plus cyclophosphamide, vincristine, and prednisone [R-CVP]) for treatmentnaive patients with indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Investigators preassigned the standard treatment regimen they considered most appropriate for each patient; patients were randomized to receive BR (n 5 224) or standard therapy (R-CHOP/R-CVP, n 5 223) for 6 cycles; 2 additional cycles were permitted at investigator discretion. Response was assessed by a blinded independent review committee. BR was noninferior to R-CHOP/R-CVP, as assessed by the primary end point of complete response rate (31% vs 25%, respectively; P 5 .0225 for NI [0.88 margin]). The overall response rates for BR and R-CHOP/R-CVP were 97% and 91%, respectively (P 5 .0102). Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05). These data indicate BR is noninferior to standard therapy with regard to clinical response with an acceptable safety profile. © 2014 by The American Society of Hematology.

Infante J.R.,Tennessee Oncology PLLC | Reid T.R.,University of California at San Diego | Cohn A.L.,Rocky Mountain Cancer Centers | Edenfield W.J.,Cancer Centers of the Carolinas | And 10 more authors.
Cancer | Year: 2013

BACKGROUND In this multicenter, open-label, randomized phase 2 trial, the authors evaluated the vascular endothelial growth factor receptor inhibitor axitinib, bevacizumab, or both in combination with chemotherapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS Patients with previously untreated mCRC were randomized 1:1:1 to receive continuous axitinib 5 mg twice daily, bevacizumab 5 mg/kg every 2 weeks, or axitinib 5 mg twice daily plus bevacizumab 2 mg/kg every 2 weeks, each in combination with modified 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX-6). The primary endpoint was the objective response rate (ORR). RESULTS In all, 126 patients were enrolled from August 2007 to September 2008. The ORR was numerically inferior in the axitinib arm (n = 42) versus the bevacizumab arm (n = 43; 28.6% vs 48.8%; 1-sided P =.97). Progression-free survival (PFS) (11.0 months vs 15.9 months; 1-sided P =.57) and overall survival (OS) (18.1 months vs 21.6 months; 1-sided P =.69) also were numerically inferior in the axitinib arm. Similarly, efficacy endpoints for the axitinib/bevacizumab arm (n = 41) were numerically inferior (ORR, 39%; PFS, 12.5 months; OS, 19.7 months). The patients who received axitinib had fewer treatment cycles compared with other arms. Common all-grade adverse events across all 3 treatment arms were fatigue, diarrhea, and nausea (all ≥49%). Hypertension and headache were more frequent in the patients who received axitinib. Patients in the bevacizumab arm had the longest treatment exposures and the highest rates of peripheral neuropathy. CONCLUSIONS Neither the addition of continuous axitinib nor the axitinib/bevacizumab combination to FOLFOX-6 improved ORR, PFS, or OS compared with bevacizumab as first-line treatment of mCRC. © 2013 American Cancer Society.

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