Patrick J Stiff

Mayo Clinic - Rochester, Rochester, Minnesota, United States

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Publications (151)833.85 Total impact

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    ABSTRACT: Background. Delayed hematopoietic recovery is a major drawback of umbilical cord blood (UCB) transplantation. Transplantation of ex vivo-expanded UCB shortens time to hematopoietic recovery, but long-term, robust engraftment by the expanded unit has yet to be demonstrated. We tested the hypothesis that a UCB-derived cell product consisting of stem cells expanded for 21 days in the presence of nicotinamide and a noncultured T cell fraction (NiCord) can accelerate hematopoietic recovery and provide long-term engraftment. Methods. In a phase I trial, 11 adults with hematologic malignancies received myeloablative bone marrow conditioning followed by transplantation with NiCord and a second unmanipulated UCB unit. Safety, hematopoietic recovery, and donor engraftment were assessed and compared with historical controls. Results. No adverse events were attributable to the infusion of NiCord. Complete or partial neutrophil and T cell engraftment derived from NiCord was observed in 8 patients, and NiCord engraftment remained stable in all patients, with a median follow-up of 21 months. Two patients achieved long-term engraftment with the unmanipulated unit. Patients transplanted with NiCord achieved earlier median neutrophil recovery (13 vs. 25 days, P < 0.001) compared with that seen in historical controls. The 1-year overall and progression-free survival rates were 82% and 73%, respectively. Conclusion. UCB-derived hematopoietic stem and progenitor cells expanded in the presence of nicotinamide and transplanted with a T cell-containing fraction contain both short-term and long-term repopulating cells. The results justify further study of NiCord transplantation as a single UCB graft. If long-term safety is confirmed, NiCord has the potential to broaden accessibility and reduce the toxicity of UCB transplantation. Trial Registration. Clinicaltrials.gov NCT01221857. Funding. Gamida Cell Ltd.
    The Journal of clinical investigation. 06/2014;
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    ABSTRACT: The clinicopathologic findings in Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL) may show significant overlap, and MYC abnormalities, found in all BLs, also occur in a subset of DLBCL. The 2008 World Health Organization classification introduced the category of "B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and BL" (BCLU) in recognition of this overlap, but the clinical significance of BCLU (ie, "high-grade") morphology and the relationship between BCLU morphology and MYC abnormalities remains unclear. In this study, we identified 260 cases of non-Burkitt, diffuse aggressive B-cell lymphomas from SWOG S9704, a phase 3 randomized study of standard immunochemotherapy versus autologous stem cell transplantation. Of these, 31 cases (12%) showed BCLU morphology, and 229 (88%) showed typical DLBCL morphology. Of 198, 27 (14%) were positive for MYC by immunohistochemistry. BCLU morphology was associated with an increased incidence of MYC expression but otherwise was not associated with distinct clinicopathologic features or significantly decreased survival. MYC-positive cases were morphologically and phenotypically heterogenous and were associated with poor progression-free and overall survival in multivariate analysis. These findings confirm that BCLU does not represent a distinct clinicopathologic entity and demonstrate that BCLU morphology alone does not significantly impact survival compared with typical DLBCL. In contrast, MYC protein expression is a poor prognostic factor that may be associated with either BCLU or DLBCL morphology, and MYC immunohistochemistry is suggested for routine prognostic evaluation (Clinicaltrials.gov identifier: NCT00004031).
    The American journal of surgical pathology 04/2014; 38(4):494-501. · 4.06 Impact Factor
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    ABSTRACT: The role of body mass index (BMI) in survival outcomes is controversial among lymphoma patients. We evaluated the association between BMI at study entry and failure-free survival (FFS) and overall survival (OS) in three phase III clinical trials, among patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and Hodgkin's lymphoma (HL). A total of 537, 730 and 282 patients with DLBCL, HL and FL were included in the analysis. Baseline patient and clinical characteristics, treatment received and clinical outcomes were compared across BMI categories. Among patients with DLBCL, HL and FL, the median age was 70, 33 and 56; 29%, 29% and 37% were obese and 38%, 27% and 37% were overweight, respectively. Age was significantly different among BMI groups in all three studies. Higher BMI groups tended to have more favorable prognosis factors at study entry among DLBCL and HL patients. BMI was not associated with clinical outcome with P-values of 0.89, 0.30 and 0.40 for FFS, and 0.64, 0.67 and 0.09 for OS, for patients with DLBCL, HL and FL, respectively. The association remains non-significant after adjusting for other clinical factors in the Cox model. A subset analysis of males with DLBCL treated on R-CHOP revealed no differences in FFS (P = 0.48) or OS (P = 0.58). BMI was not significantly associated with clinical outcomes among patients with DLBCL, HD or FL, in three prospective phase III clinical trials. The findings contradict some previous reports of similar investigations. Further work is required to understand the observed discrepancies.
    Annals of Oncology 03/2014; 25(3):669-74. · 7.38 Impact Factor
  • Patrick J Stiff, Joseph M Unger, Richard I Fisher
    New England Journal of Medicine 02/2014; 370(6):575-6. · 54.42 Impact Factor
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    ABSTRACT: Allogeneic transplant using reduced intensity conditioning is a therapeutic option for patients with Hodgkin lymphoma (HL) who relapse after an autograft. This was a prospective study of 31 consecutive eligible patients with HL who relapsed after an autograft and underwent an allograft using BEAM (BCNU, etoposide, cytarabine, melphalan) conditioning. At a median follow-up of 7 years the progression-free survival (PFS) was 36% (95% confidence interval [CI] 19–54%) and overall survival (OS) was 42% (95% CI 23–59%). In multivariate analysis only residual disease at the time of transplant predicted outcome, with a 4-year PFS and OS of 62% and 75% for patients with minimal residual disease versus 8% and 8% for patients with gross residual disease, respectively (p = 0.005 and p = 0.001, respectively). This benefit seemed to be irrespective of chemosensitivity, with an OS for patients with chemorefractory yet minimal disease of 71% at 4 years. BEAM allogeneic transplant is effective in producing long-term remissions after autograft failure. Regardless of chemosensitivity, minimizing tumor burden pre-transplant may improve long-term outcome.
    Leukemia and Lymphoma 01/2014; 55(6). · 2.61 Impact Factor
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    ABSTRACT: Donor cell derived malignancies are a rare and interesting complication of allogeneic bone marrow transplantation. We present a case of a 56-year-old male with donor cell myeloid sarcoma of the stomach and myocardium.
    Case reports in hematology. 01/2014; 2014:153989.
  • Urszula Sobol, Patrick Stiff
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    ABSTRACT: Plasma cell disorders make up a broad spectrum of diseases that are characterized by the appearance of an abnormal clone of plasma cells, which typically manifests as a production of monoclonal immunoglobulin protein (monoclonal gammopathy). The overproduction of plasma cells and subsequent monoclonal gammopathy may be malignant or a premalignant process. Monoclonal gammopathy of undetermined significance (MGUS) is an example of a benign process with a malignant potential. Multiple myeloma, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, and AL amyloidosis (immunoglobulin light chain amyloidosis) are examples of malignant plasma cell disorders which require treatment. Neurologic manifestations of an underlying plasma cell disorder can be variable and typically challenging to treat. They can range from mild symptoms resulting from therapy to treat the disorder to clinically significant and life-threatening complications related to the disease itself. The peripheral nervous system is more commonly affected than the central nervous system. Peripheral neuropathy is a frequent manifestation and is associated with all of the plasma cell disorders (MGUS, multiple myeloma, POEMS syndrome, Waldenström macroglobulinemia and AL amyloidosis) with notable differences in the signs and symptoms among the different groups. Examples of central nervous system manifestations include spinal cord pathology, such as spinal cord compression from vertebral collapse or plasmacytoma. Intracranial involvement is rare but can occur from brain parenchyma infiltration, leptomeningeal involvement, and tumor-like lesions, such as amyloidoma in AL amyloidosis and plasmacytoma in multiple myeloma. Encephalopathy can occur due to metabolic disturbances related to the underlying plasma cell disorder, including hypercalcemia and uremia in multiple myeloma and hyperviscosity in Waldenström macroglobulinemia. Included in this chapter is a detailed discussion of the various plasma cell disorders and their spectrum of neurologic manifestations.
    Handbook of Clinical Neurology 01/2014; 120:1083-99.
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    ABSTRACT: The efficacy of autologous stem-cell transplantation during the first remission in patients with diffuse, aggressive non-Hodgkin's lymphoma classified as high-intermediate risk or high risk on the International Prognostic Index remains controversial and is untested in the rituximab era. We treated 397 patients who had disease with an age-adjusted classification of high risk or high-intermediate risk with five cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP plus rituximab. Patients with a response were randomly assigned to receive three additional cycles of induction chemotherapy (control group) or one additional cycle of induction chemotherapy followed by autologous stem-cell transplantation (transplantation group). The primary efficacy end points were 2-year progression-free survival and overall survival. Of 370 induction-eligible patients, 253 were randomly assigned to the transplantation group (125) or the control group (128). Forty-six patients in the transplantation group and 68 in the control group had disease progression or died, with 2-year progression-free survival rates of 69 and 55%, respectively (hazard ratio in the control group vs. the transplantation group, 1.72; 95% confidence interval [CI], 1.18 to 2.51; P=0.005). Thirty-seven patients in the transplantation group and 47 in the control group died, with 2-year overall survival rates of 74 and 71%, respectively (hazard ratio, 1.26; 95% CI, 0.82 to 1.94; P=0.30). Exploratory analyses showed a differential treatment effect according to risk level for both progression-free survival (P=0.04 for interaction) and overall survival (P=0.01 for interaction). Among high-risk patients, the 2-year overall survival rate was 82% in the transplantation group and 64% in the control group. Early autologous stem-cell transplantation improved progression-free survival among patients with high-intermediate-risk or high-risk disease who had a response to induction therapy. Overall survival after transplantation was not improved, probably because of the effectiveness of salvage transplantation. (Funded by the National Cancer Institute, Department of Health and Human Services, and others; SWOG-9704 ClinicalTrials.gov number, NCT00004031.).
    New England Journal of Medicine 10/2013; 369(18):1681-90. · 54.42 Impact Factor
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    ABSTRACT: ABSTRACT Allogeneic transplantation using reduced intensity conditioning is a therapeutic option for patients with Hodgkin Lymphoma (HL) who relapse after an autograft. This is a prospective study of 31 consecutive eligible HL patients who have relapsed after an autograft and underwent an allograft using BEAM (BCNU, etoposide, cytosine arabinoside, melphalan) conditioning. At a median follow up of 7 years the progression-free survival (PFS) is 36% (95% CI 19-54%) and overall survival (OS) is 42% (95% CI 23-59%). In multivariate analysis only residual disease at time of transplantation predicted outcome, with a 4-year PFS and OS of 62% and 75% for patients with minimal residual disease versus 8% and 8% for patients with gross residual disease, respectively (p =0.005 and p=0.001, respectively). This benefit seemed to be irrespective of chemosensitivity, with an OS for chemorefractory yet minimal disease patients of 71% at 4 years. BEAM allogeneic transplantation is effective in producing long-term remissions after autograft failure. Regardless of chemosensitivity, minimizing tumor burden pre-transplant may improve long-term outcome.
    Leukemia & lymphoma 08/2013; · 2.61 Impact Factor
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    ABSTRACT: The efficacy and safety of plerixafor + G-CSF in enhancing hematopoietic stem cell mobilization and collection has been demonstrated in two phase III studies involving patients with NHL or MM. In these pivotal studies, plerixafor + G-CSF significantly increased the proportion of patients achieving target stem cell yields, compared to placebo + G-CSF. In this analysis, we compare the efficacy and safety of plerixafor + G-CSF vs. placebo + G-CSF in patients enrolled in the two phase III studies, stratified by age: ≥60 years of age and <60 years of age. The proportion of older patients who achieved target stem cell yields were significantly higher in the plerixafor group than in placebo group (NHL: 50.9% vs. 25.4%, P<0.001; MM: 69.6% vs. 23.7%, P<0.001). In this older cohort, the median times to neutrophil and to platelet engraftment following autologous stem cell transplant were comparable between the plerixafor and placebo groups. Similar efficacy findings were observed in the younger age group. The most common adverse events (all grades) reported among older patients in the plerixafor group included diarrhea (41.3%), nausea (38.9%), fatigue (30.2%), and injection-site reaction (29.4%). The frequency of adverse events was similar between the older and the younger age groups. Taken together, our subanalysis demonstrate that plerixafor + G-CSF can be safely and effectively used in adult patients of all ages, including those ≥60 years, to support optimal stem cell mobilization for autologous stem cell transplantation.
    American Journal of Hematology 08/2013; · 4.00 Impact Factor
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    ABSTRACT: This randomized phase III clinical trial evaluated the potential benefit of the addition of gemtuzumab ozogamicin (GO) to standard induction and post-consolidation therapy in patients with acute myeloid leukemia. Patients were randomized to receive daunorubicin (45 mg/m(2)/day on days 1,2,3) and cytarabine (100 mg/m(2)/day by continuous infusion (CI) days 1-7) and GO (6 mg/m(2) day 4) (DA+GO) versus standard induction therapy with daunorubicin (60 mg/m(2)/day on days 1,2,3) and cytarabine alone (DA). Patients who achieved a complete remission (CR) received 3 courses of high dose cytarabine. Those remaining in CR after consolidation were randomized to receive no additional therapy versus 3 doses of GO (5 mg/m(2) every 28 days). From August, 2004, until August, 2009, 637 patients were registered for induction. The CR rate was 69% for DA+GO and 70% for DA, p=0.59. Among those who achieved a CR, the 5 yr relapse-free survival rate was 43% in the DA+GO arm and 42% in the DA arm (p=0.40). The 5 yr overall survival (OS) was 46% in the DA+GO arm and 50% in the DA arm (p=0.85). One hundred seventy-four patients in CR after consolidation underwent the post-consolidation randomization. Disease-free survival (DFS) was not improved with post-consolidation GO (HR=1.48, p=0.97). In this study, the addition of GO to induction or post-consolidation therapy failed to show improvement in CR rate, DFS or OS. This trial is registered with ClinicalTrials.gov. Identifier: NCT00085709.
    Blood 04/2013; · 9.78 Impact Factor
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    ABSTRACT: Although the role of autologous hematopoietic cell transplantation (auto-HCT) is well established in neuroblastoma (NBL), the role of allogeneic HCT (allo-HCT) is controversial. The Center for International Blood and Marrow Transplant Research conducted a retrospective review of 143 allo-HCT for NBL reported in 1990-2007. Patients were categorized into two different groups: those who had not (Group 1) and had (Group 2) undergone a prior auto-HCT (n=46 and 97, respectively). One-year and five-year OS were 59% and 29% for Group 1 and 50% and 7% for Group 2, respectively. Among donor types, disease-free survival (DFS) and OS were significantly lower for unrelated transplants at 1 and 3 years but not at 5 years post HCT. Patients in CR or very good partial response (VGPR) at transplant had lower relapse rates and better DFS and OS, compared with those not in CR or VGPR. Our analysis indicates that allo-HCT can cure some neuroblastoma patients, with lower relapse rates and improved survival in patients without a history of prior auto-HCT as compared with those patients who had previously undergone auto-HCT. Although the data do not address why either strategy was chosen for patients, allo-HCT after a prior auto-HCT appears to offer minimal benefit. Disease recurrence remains the most common cause of treatment failure.Bone Marrow Transplantation advance online publication, 18 February 2013; doi:10.1038/bmt.2012.284.
    Bone marrow transplantation 02/2013; · 3.00 Impact Factor
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    ABSTRACT: Epstein-Barr virus (EBV) is associated with Hodgkin lymphoma (HL) and can be detected by in situ hybridization (ISH) of viral nucleic acid (EBER) in tumor cells. We sought to determine whether plasma EBV-DNA could serve as a surrogate for EBER-ISH and to explore its prognostic utility in HL. Specimens from a Cancer Cooperative Intergroup Trial (E2496/Stanford V versus ABVD for HL) were used to compare pre-treatment plasma EBV-DNA quantification with EBV tumor status by EBER-ISH. A cut-off of >60 viral copies/100 µL plasma yielded 96% concordance with EBER-ISH. Pre-treatment and month 6 plasma specimens were designated EBV(-) or EBV(+) by this cut-off. Patients with pre-treatment EBV(+) plasma (n=54) had inferior failure-free survival (FFS) compared to those with pre-treatment EBV(-) plasma (n=274), log-rank p=0.009. By contrast, no difference in FFS was observed when patients were stratified by EBER-ISH. Pre-treatment plasma EBV positivity was an independent predictor of treatment failure on multivariate analyses. At month 6, plasma EBV(+) patients (n=7) had inferior FFS compared to plasma EBV(-) patients (n=125), log-rank p=0.007. These results confirm that plasma EBV-DNA is highly concordant with EBER-ISH in HL and suggest that it may have prognostic utility at baseline and after 6 months of therapy for HL. (Clinical trial information: NCT00003389).
    Blood 02/2013; · 9.78 Impact Factor
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    ABSTRACT: There is a lack of contemporary prospective data examining the adriamycin, bleomycin, vinblastine, dacarbazine (ABVD) and Stanford V (SV; doxorubicin, vinblastine, mechlorethamine, vincristine, bleomycin, etoposide, prednisone) regimens in older Hodgkin lymphoma (HL) patients. Forty-four advanced-stage, older HL patients (aged ≥60 years) were treated on the randomized study, E2496. Toxicities were mostly similar between chemotherapy regimens, although 24% of older patients developed bleomycin lung toxicity (BLT), which occurred mainly with ABVD (91%). Further, the BLT-related mortality rate was 18%. The overall treatment-related mortality for older HL patients was 9% vs. 0·3% for patients aged <60 years (P < 0·001). Among older patients, there were no survival differences between ABVD and SV. According to age, outcomes were significantly inferior for older versus younger patients (5-year failure-free survival: 48% vs. 74%, respectively, P = 0·002; 5-year overall survival: 58% and 90%, respectively, P < 0·0001), although time-to-progression (TTP) was not significantly different (5-year TTP: 68% vs. 78%, respectively, P = 0·37). Furthermore, considering progression and death without progression as competing risks, the risk of progression was not different between older and younger HL patients (5 years: 30% and 23%, respectively, P = 0·30); however, the incidence of death without progression was significantly increased for older HL patients (22% vs. 9%, respectively, P < 0·0001). Altogether, the marked HL age-dependent survival differences appeared attributable primarily to non-HL events.
    British Journal of Haematology 01/2013; · 4.94 Impact Factor
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    ABSTRACT: Many institutions have adopted algorithms based on pre-apheresis circulating CD34(+) cell counts to optimize use of plerixafor. However, a circulating PB CD34(+) cell threshold that predicts mobilization failure has not been defined. The superiority of plerixafor + G-CSF over placebo + G-CSF for hematopoietic stem cell mobilization and collection was shown for patients with NHL in a phase 3, prospective, randomized, controlled study. The question remains as to which patients may benefit the most of all from the use of plerixafor. In this post hoc retrospective analysis, mobilization outcomes were compared between the two treatment arms in patients stratified by peripheral blood CD34(+) cell count (<5; 5-9; 10-14; 15-19; or ≥20 cells/μL) obtained before study treatment and apheresis. Compared with placebo plus GCSF, plerixafor plus GCSF significantly increased the peripheral blood CD34(+) cells/ μL over prior day levels in all five stratified groups. The probability of subsequent transplantation without a rescue mobilization was far greater in the plerixafor-treated patients for the lowest initial (Day 4) peripheral blood CD34(+) cells/μL groups (<5; 5-9; 10-14). Engraftment and durability were the same for the two treatment groups for all strata, but the effect in the lower strata could be altered by the addition of cells from rescue mobilizations. These findings may provide insight into the optimal use of plerixafor in all patients undergoing stem cell mobilization.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 01/2013; · 3.15 Impact Factor
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    ABSTRACT: BACKGROUND: Autologous hematopoietic cell transplantation (AHCT) as initial therapy of multiple myeloma improves survival. However, data to support this approach for relapsed/progressive disease following initial AHCT (AHCT1) are limited. METHODS: Using Center for International Blood and Marrow Transplant Research (CIBMTR) data, we report the outcomes of 187 patients who underwent a second AHCT (AHCT2) for the treatment of relapsed/progressive multiple myeloma (MM). Planned tandem AHCT was excluded. RESULTS: Median age at AHCT2 was 59 years (range: 28-72) and median patient follow-up was 47 months (range: 3-97). Non-relapse mortality (NRM) following AHCT2 was 2% at 1 year and 4% at 3 years. Median interval from AHCT1 to relapse/progression was 18 months and median interval between transplants was 32 months. After AHCT2, the incidence of relapse/progression at 1 and 3 years was 51% and 82% respectively. At 3 years after AHCT2, progression-free survival was 13% and overall survival was 46%. In multivariate analyses, those relapsing ≥ 36 months after AHCT1 had superior progression free (p = 0.045) and overall survival (p= 0.019). Patients who underwent AHCT2 after 2004 had superior survival (p = 0.026). CONCLUSION: AHCT2 is safe and feasible for disease progression after AHCT1. In this retrospective study, individuals relapsing ≥ 36 months from AHCT1 derived greater benefit from AHCT2 compared to those with a shorter disease-free interval. Storage of an adequate graft prior to AHCT1 will ensure that the option of a second autologous transplant is retained for patients with relapsed/progressive MM.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 01/2013; · 3.15 Impact Factor
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    ABSTRACT: Ovarian cancer is one of the most frequent gynecological malignancies. However, as there is no effective screening method to detect early disease, it is usually only diagnosed when already widespread in the abdomen. The majority of patients diagnosed with advanced-stage disease will relapse and require additional therapy. In the search for additional effective treatments for the management of recurrent disease, researchers have focused on the potential usefulness of immunotherapeutic modulation by administering autologous immune cells, such as dendritic cells (DCs), to stimulate antitumor host responses. With the ultimate goal of improved survival, this review addresses mechanisms in ovarian cancer that may limit the expansion of antitumor immunity, discusses the parameters to be considered for optimal DC immunotherapy, outlines evaluation methodology used to monitor the success of treatment regimens and reviews reported DC immunotherapy trials in ovarian cancer.
    Expert Review of Anti-infective Therapy 01/2013; 13(1):43-53. · 2.07 Impact Factor
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    ABSTRACT: The efficacy and safety of plerixafor + G‐CSF in enhancing hematopoietic stem cell mobilization and collection has been demonstrated in two phase III studies involving patients with NHL or MM. In these pivotal studies, plerixafor + G‐CSF significantly increased the proportion of patients achieving target stem cell yields, compared to placebo + G‐CSF. In this analysis, we compare the efficacy and safety of plerixafor + G‐CSF versus placebo + G‐CSF in patients enrolled in the two phase III studies, stratified by age: ≥60 years of age and P P Document Type: Research Article DOI: http://dx.doi.org/10.1002/ajh.23561 Publication date: December 1, 2013 $(document).ready(function() { var shortdescription = $(".originaldescription").text().replace(/\\&/g, '&').replace(/\\, '<').replace(/\\>/g, '>').replace(/\\t/g, ' ').replace(/\\n/g, ''); if (shortdescription.length > 350){ shortdescription = "" + shortdescription.substring(0,250) + "... more"; } $(".descriptionitem").prepend(shortdescription); $(".shortdescription a").click(function() { $(".shortdescription").hide(); $(".originaldescription").slideDown(); return false; }); }); Related content In this: publication By this: publisher By this author: Micallef, Ivana N. ; Stiff, Patrick J. ; Stadtmauer, Edward A. ; Bolwell, Brian J. ; Nademanee, Auayporn P. ; Maziarz, Richard T. ; Partisano, Angela M. ; Marulkar, Sachin ; DiPersio, John F. GA_googleFillSlot("Horizontal_banner_bottom");
    American Journal of Hematology 01/2013; 88(12). · 4.00 Impact Factor
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    ABSTRACT: PURPOSEAlthough ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) has been established as the standard of care in patients with advanced Hodgkin lymphoma, newer regimens have been investigated, which have appeared superior in early phase II studies. Our aim was to determine if failure-free survival was superior in patients treated with the Stanford V regimen compared with ABVD. PATIENTS AND METHODS The Eastern Cooperative Oncology Group, along with the Cancer and Leukemia Group B, the Southwest Oncology Group, and the Canadian NCIC Clinical Trials Group, conducted this randomized phase III trial in patients with advanced Hodgkin lymphoma. Stratification factors included extent of disease (localized v extensive) and International Prognostic Factors Project Score (0 to 2 v 3 to 7). The primary end point was failure-free survival (FFS), defined as the time from random assignment to progression, relapse, or death, whichever occurred first. Overall survival, a secondary end point, was measured from random assignment to death as a result of any cause. This design provided 87% power to detect a 33% reduction in FFS hazard rate, or a difference in 5-year FFS of 64% versus 74% at two-sided .05 significance level. RESULTS: 74% for ABVD and 71% for Stanford V at 5 years (P = .32). CONCLUSIONABVD remains the standard of care for patients with advanced Hodgkin lymphoma.
    Journal of Clinical Oncology 11/2012; · 18.04 Impact Factor
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    ABSTRACT: Before US regulatory approval, an expanded access program provided plerixafor to patients with non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma (MM) who had not previously failed mobilization and were otherwise candidates for auto-SCT. Patients received granulocyte-CSF (G-CSF) 10 mcg/kg daily and plerixafor 0.24 mg/kg starting on day 4 with apheresis on day 5; all repeated daily until collection was complete. Overall, 104 patients received 1 dose of plerixafor. The addition of plerixafor to G-CSF resulted in a median threefold increase in peripheral blood CD34+ cell count between days 4 and 5. Among 43 NHL patients, 74% met the target of 5 × 10(6) CD34+ cells/kg (median, 1 day apheresis, range 1-5 days); among 7 HD patients, 57% met the target of 5 × 10(6) CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of 6 × 10(6) CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had 2 × 10(6) CD34+ cells/kg collected within 1-3 days. Plerixafor-related toxicities were minimal. Engraftment kinetics, graft durability and transplant outcomes demonstrated no unexpected outcomes. Efficacy and safety results were similar to results in phase II and III clinical trials.Bone Marrow Transplantation advance online publication, 26 November 2012; doi:10.1038/bmt.2012.219.
    Bone marrow transplantation 11/2012; · 3.00 Impact Factor

Publication Stats

3k Citations
833.85 Total Impact Points

Institutions

  • 2013
    • Mayo Clinic - Rochester
      • Department of Hematology
      Rochester, Minnesota, United States
  • 2003–2013
    • Loyola University Chicago
      • • Department of Medicine
      • • Department of Microbiology and Immunology
      • • Cardinal Bernardin Cancer Center
      Chicago, IL, United States
  • 2012
    • Illinois Institute of Technology
      • College of Psychology
      Chicago, IL, United States
  • 1994–2012
    • Loyola University Medical Center
      • • Department of Medicine
      • • Stritch School of Medicine
      • • Division of Hematology/Oncology
      • • Cardinal Bernardin Cancer Center
      Maywood, Illinois, United States
  • 2000–2010
    • Loyola University
      New Orleans, Louisiana, United States
  • 2009
    • Washington University in St. Louis
      San Luis, Missouri, United States
    • Mayo Foundation for Medical Education and Research
      • Department of Internal Medicine
      Rochester, MI, United States
    • University of Washington Seattle
      • Division of Oncology
      Seattle, WA, United States
  • 2008
    • Johns Hopkins Medicine
      Baltimore, Maryland, United States
  • 2006–2007
    • The Ohio State University
      • Division of Hematology
      Columbus, Ohio, United States
  • 1991
    • Southern Illinois University School of Medicine
      Springfield, Illinois, United States
  • 1983
    • Memorial Sloan-Kettering Cancer Center
      • Department of Medicine
      New York City, NY, United States
    • University of Illinois Springfield
      Спрингфилд, Florida, United States