Patrick J Stiff

Loyola University Medical Center, Maywood, Illinois, United States

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Publications (156)1053.54 Total impact

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    ABSTRACT: Umbilical cord blood (UCB) as an allogeneic transplant source is generally limited to units with pre-cryopreservation total nucleated cell (TNC) doses ⩾2.5 × 10(7) NC/kg. We prospectively investigated single UCB transplantation, with cord units as low as 1 × 10(7) NC/kg, all processed with post-thaw albumin-dextran dilution. We transplanted 104 adult patients with 84% having relapsed/refractory disease. The median TNC dose was 2.1 × 10(7) NC/kg (range: 1.0-4.4 × 10(7)) and median CD34+ cell dose was 1.0 × 10(5)/kg (range: 0.0-3.7 × 10(5)/kg). Post-manipulation cell recovery and viability were 96% and 99%, respectively. Median times to neutrophil and platelet engraftment were 16 and 43 days, respectively. Univariate factors predicting neutrophil engraftment included TNC (P=0.03) and CD34+ cell dose (P=0.01). CD34+ dose predicted platelet engraftment (P<0.001). In multivariate analysis, CD34+ dose remained significant for neutrophil and platelet engraftment (P<0.0001 and P<0.0001, respectively). The 100-day and 1-year overall survival were 70% and 46%, respectively (95% confidence interval: 36%-56% at 1 year). The subset transplanted with 1-1.5 × 10(7) NC/kg had similar 100-day and 1-year survivals of 73% and 45%, respectively. Single-unit UCB transplantation using small units, processed as described, leads to favorable engraftment and acceptable outcomes in poor prognosis patients. CD34+ cell dose (⩾1.5 × 10(5)/kg) helps predict faster engraftment and can aid in graft selection.Bone Marrow Transplantation advance online publication, 14 September 2015; doi:10.1038/bmt.2015.194.
    Bone marrow transplantation 09/2015; DOI:10.1038/bmt.2015.194 · 3.57 Impact Factor
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    ABSTRACT: To compare long-term safety outcomes (overall survival, disease progression, and incidence of secondary malignancies) between palifermin and placebo in the prevention of oral mucositis in patients with hematological malignancies undergoing autologous hematopoietic stem cell transplantation (HSCT). Patients were enrolled between 1997 and 2005 into 4 phase I-III studies (3 double-blind placebo-controlled, 1 open-label) conducted at 31 sites in Australia, Europe, and the United States. Survival outcomes (overall survival, progression-free survival) were compared using hazard ratios (HRs) estimated with a Cox model that included treatment group, baseline age, disease type, Eastern Cooperative Oncology Group (ECOG) performance status, country, and presence of prior radiotherapy as covariates. The incidence of secondary malignancies was compared with a chi-squared test. A total of 672 patients were randomized into the studies (428 palifermin, 244 placebo). The median follow-up time for subjects alive at last visit was 7.9 years (range 0.1-14.9) for palifermin and 8.8 years (0.1-14.8) for placebo. Palifermin-treated patients had comparable overall survival (HR, 1.01; 95% confidence interval [CI] 0.78-1.31; P = .921) and progression-free survival times (HR, 1.04; 95% CI, 0.83-1.31; P = .733) compared with placebo-treated patients. Secondary malignancies were reported by 13% of palifermin-treated patients vs 11% of placebo patients (P = .477). Breakdown into secondary hematological malignancies (7% vs 6%) or solid tumors (6% vs 6%) did not suggest any differences between the treatment groups. After a follow up of up to 15 years, comparable long-term safety outcomes (overall survival, progression-free survival, and incidence of secondary malignancies) were observed for palifermin- and placebo- treated patients undergoing autologous HSCT. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 08/2015; DOI:10.1016/j.bbmt.2015.08.018 · 3.40 Impact Factor
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    ABSTRACT: Assessment with (18)F-fluorodeoxy glucose-positron emission tomography (FDG-PET) prior to hematopoietic cell transplantation (HCT) for lymphoma may be prognostic for outcomes. Patients with chemotherapy-sensitive non-Hodgkin lymphoma (NHL) undergoing allogeneic HCT reported to the Center of International Blood and Marrow Transplantation Registry between 2007-2012 were included. Pre-HCT PET status (positive vs. negative) was determined by the reporting transplant centers. We analyzed 336 patients; median age was 55 years and 60% were males. Follicular lymphoma (n=104) was more common than large cell (n=85), mantle cell (n=69), and mature NK or T cell lymphoma (n=78); two-thirds of the cohort received reduced intensity conditioning; half had unrelated donor grafts. Patients underwent PET scanning a median of 1 month (range 0.07-2.83 months) before HCT; 159 were PET positive and 177 PET negative. At 3-years, relapse/progression, progression-free survival (PFS), and overall survival (OS) in PET-positive vs. PET-negative groups were 40% vs. 26%; p=0.007; 43% vs. 47%; p=0.47 and 58% vs. 60%; p=0.73, respectively. On multivariate analysis, a positive pre-transplant PET was associated with an increased risk of relapse/progression (risk ratio [RR] 1.86; p=0.001), but was not associated with worse OS (RR 1.29, 95% CI 0.96-1.7,p=0.08), PFS (RR 1.32, 95% CI 0.95-1.84,p=0.10) or NRM (RR 0.75 (0.48-1.18, p=0.22). PET status conferred no influence on graft-versus-host disease. A positive PET scan prior to HCT is associated with increased relapse risk but should not be interpreted as a barrier to a successful allograft. PET status does not appear to predict survival after allogeneic HCT for NHL. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 05/2015; 21(9). DOI:10.1016/j.bbmt.2015.05.007 · 3.40 Impact Factor
  • Cancer Research 05/2015; 75(9 Supplement):S4-03-S4-03. DOI:10.1158/1538-7445.SABCS14-S4-03 · 9.33 Impact Factor
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    ABSTRACT: The phase III North American Intergroup E2496 Trial (Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma) compared doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with mechlorethamine, doxorubicin, vincristine, bleomycin, vinblastine, etoposide, and prednisone (Stanford V). We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma (HL). Patients were randomly assigned to six to eight cycles of ABVD every 28 days or Stanford V once per week for 12 weeks. Two to 3 weeks after completion of chemotherapy, all patients received 36 Gy of modified involved field radiotherapy (IFRT) to the mediastinum, hila, and supraclavicular regions. Patients on the Stanford V arm received IFRT to additional sites ≥ 5 cm at diagnosis. Primary end points were failure-free survival (FFS) and overall survival (OS). Of 794 eligible patients, 264 had stage I or II bulky disease, 135 received ABVD, and 129 received Stanford V. Patient characteristics were matched. The overall response rate was 83% with ABVD and 88% with Stanford V. At a median follow-up of 6.5 years, the study excluded a difference of more than 21% in 5-year FFS and more than 16% in 5-year OS between ABVD and Stanford V (5-year FFS: 85% v 79%; HR, 0.68; 95% CI, 0.37 to 1.25; P = .22; 5-year OS: 96% v 92%; HR, 0.49; 95% CI, 0.16 to 1.47; P = .19). In-field relapses occurred in < 10% of the patients in each arm. For patients with stage I or II bulky mediastinal HL, no substantial statistically significant differences were detected between the two regimens, although power was limited. To the best of our knowledge, this is the first prospective trial reporting outcomes specific to this subgroup, and it sets a benchmark for comparison of ongoing and future studies. © 2015 by American Society of Clinical Oncology.
    Journal of Clinical Oncology 04/2015; 33(17). DOI:10.1200/JCO.2014.57.8138 · 18.43 Impact Factor
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    ABSTRACT: High-dose therapy followed by autologous stem-cell transplantation is standard of care for patients with relapsed or primary refractory Hodgkin's lymphoma. Roughly 50% of patients might be cured after autologous stem-cell transplantation; however, most patients with unfavourable risk factors progress after transplantation. We aimed to assess whether brentuximab vedotin improves progression-free survival when given as early consolidation after autologous stem-cell transplantation. We did this randomised, double-blind, placebo-controlled, phase 3 trial at 78 sites in North America and Europe. Patients with unfavourable-risk relapsed or primary refractory classic Hodgkin's lymphoma who had undergone autologous stem-cell transplantation were randomly assigned, by fixed-block randomisation with a computer-generated random number sequence, to receive 16 cycles of 1·8 mg/kg brentuximab vedotin or placebo intravenously every 3 weeks, starting 30-45 days after transplantation. Randomisation was stratified by best clinical response after completion of salvage chemotherapy (complete response vs partial response vs stable disease) and primary refractory Hodgkin's lymphoma versus relapsed disease less than 12 months after completion of frontline therapy versus relapse 12 months or more after treatment completion. Patients and study investigators were masked to treatment assignment. The primary endpoint was progression-free survival by independent review, defined as the time from randomisation to the first documentation of tumour progression or death. Analysis was by intention to treat. This trial is registered with, number NCT01100502. Between April 6, 2010, and Sept 21, 2012, we randomly assigned 329 patients to the brentuximab vedotin group (n=165) or the placebo group (n=164). Progression-free survival by independent review was significantly improved in patients in the brentuximab vedotin group compared with those in the placebo group (hazard ratio [HR] 0·57, 95% CI 0·40-0·81; p=0·0013). Median progression-free survival by independent review was 42·9 months (95% CI 30·4-42·9) for patients in the brentuximab vedotin group compared with 24·1 months (11·5-not estimable) for those in the placebo group. We recorded consistent benefit (HR <1) of brentuximab vedotin consolidation across subgroups. The most frequent adverse events in the brentuximab vedotin group were peripheral sensory neuropathy (94 [56%] of 167 patients vs 25 [16%] of 160 patients in the placebo group) and neutropenia (58 [35%] vs 19 [12%] patients). At time of analysis, 28 (17%) of 167 patients had died in the brentuximab vedotin group compared with 25 (16%) of 160 patients in the placebo group. Early consolidation with brentuximab vedotin after autologous stem-cell transplantation improved progression-free survival in patients with Hodgkin's lymphoma with risk factors for relapse or progression after transplantation. This treatment provides an important therapeutic option for patients undergoing autologous stem-cell transplantation. Seattle Genetics and Takeda Pharmaceuticals International. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 03/2015; 385(9980). DOI:10.1016/S0140-6736(15)60165-9 · 45.22 Impact Factor
  • Biology of Blood and Marrow Transplantation 02/2015; 21(2). DOI:10.1016/j.bbmt.2014.11.017 · 3.40 Impact Factor
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    ABSTRACT: The aim of this study was to describe the fate of patients with newly diagnosed acute myeloid leukemia (AML) who did not achieve an initial remission while being treated on a contemporary cooperative group trial. We analyzed the outcome of patients entered onto S0106, a recently reported cooperative group trial for patients with newly diagnosed AML. A total of 589 eligible patients were treated, of whom 150 (25%) did not achieve a remission while on study and were available for further analysis. The four-year survival for the entire cohort of 150 patients was 23%. Among the 64 patients who received an allogeneic hematopoietic cell transplant, the four-year survival rate was 48% compared to 4% for the 86 who did not undergo transplantation. Among those transplanted, we could not detect a difference in outcome according to remission status, donor source, type of preparative regimen, or cytogenetic risk category. More than 20% of patients with newly diagnosed AML who fail induction therapy can still be cured, particularly if they are able to receive an allogeneic hematopoietic cell transplant. These results suggest that early HLA-typing and donor identification are important components of the initial therapy of AML. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 12/2014; 21(3). DOI:10.1016/j.bbmt.2014.10.025 · 3.40 Impact Factor
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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. NCT01221857. Funding. Gamida Cell Ltd.
    Journal of Clinical Investigation 06/2014; 124(7). DOI:10.1172/JCI74556 · 13.22 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 06/2014; 55(6). DOI:10.3109/10428194.2013.838233 · 2.89 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.
    04/2014; 2014:153989. DOI:10.1155/2014/153989
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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 ( identifier: NCT00004031).
    The American journal of surgical pathology 04/2014; 38(4):494-501. DOI:10.1097/PAS.0000000000000147 · 5.15 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. DOI:10.1093/annonc/mdt594 · 7.04 Impact Factor
  • Patrick J Stiff · Joseph M Unger · Richard I Fisher
    New England Journal of Medicine 02/2014; 370(6):575-6. DOI:10.1056/NEJMc1314757 · 55.87 Impact Factor
  • Biology of Blood and Marrow Transplantation 02/2014; 20(2):S115-S116. DOI:10.1016/j.bbmt.2013.12.168 · 3.40 Impact Factor
  • 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. DOI:10.1016/B978-0-7020-4087-0.00073-5
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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: 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 12/2013; 88(12). · 3.80 Impact Factor
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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 number, NCT00004031.).
    New England Journal of Medicine 10/2013; 369(18):1681-90. DOI:10.1056/NEJMoa1301077 · 55.87 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; 88(12). DOI:10.1002/ajh.23561 · 3.80 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 Identifier: NCT00085709.
    Blood 04/2013; 121(24). DOI:10.1182/blood-2013-01-466706 · 10.45 Impact Factor

Publication Stats

5k Citations
1,053.54 Total Impact Points


  • 1994–2015
    • Loyola University Medical Center
      • • Department of Internal Medicine
      • • Department of Medicine
      • • Cardinal Bernardin Cancer Center
      • • Division of Hematology/Oncology
      Maywood, Illinois, United States
  • 2014
    • Fox Chase Cancer Center
      Filadelfia, Pennsylvania, United States
  • 1991–2014
    • Loyola University
      New Orleans, Louisiana, United States
  • 2000–2013
    • Loyola University Chicago
      • • Department of Medicine
      • • Cardinal Bernardin Cancer Center
      Chicago, Illinois, United States
  • 2010
    • Rush University Medical Center
      Chicago, Illinois, United States
  • 2009
    • Virginia Commonwealth University
      Ричмонд, Virginia, United States
  • 1999
    • University of California, Los Angeles
      Los Ángeles, California, United States