9 results on '"de Mendoza FH"'
Search Results
2. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial.
- Author
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Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, and Singer JW
- Abstract
BACKGROUND: Pixantrone dimaleate (pixantrone)-a novel aza-anthracenedione-was synthesised to reduce anthracycline-related cardiotoxicity without compromising antitumour efficacy. We aimed to assess the efficacy and safety of pixantrone versus an investigator's choice of a single-agent therapy in heavily pretreated patients with relapsed or refractory aggressive non-Hodgkin lymphoma. METHODS: In this phase 3, multicentre, open-label, randomised trial at 66 hospitals in Europe, India, Russia, South America, the UK, and the USA, patients with histologically confirmed aggressive non-Hodgkin lymphoma who had relapsed after two or more previous chemotherapy regimens were randomly assigned (1:1) by an interactive voice response system to treatment with pixantrone dimaleate (85 mg/m(2) intravenously on days 1, 8, and 15 of a 28-day cycle, for up to six cycles) or to a comparator (vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, or gemcitabine) given at prespecified standard doses and schedules. Patients were stratified by region, International Prognostic Index score, and previous stem-cell transplantation. Patients and investigators were not masked to treatment assignment; however, an independent assessment panel was masked. The primary endpoint was the proportion of patients with a complete or unconfirmed complete response in the intention-to-treat (ITT) population at the end of treatment. Primary analyses of efficacy were based on the independent assessment panel's data review. The study is registered at ClinicalTrials.gov, number NCT00088530. FINDINGS: The ITT population comprised 70 patients randomly assigned to the pixantrone group and 70 to the comparator. Five patients (two in the pixantrone group and three in the comparator group) dropped out before receiving their study drug. 14 patients (20·0% [95% CI 11·4-31·3]) who received pixantrone achieved a complete or unconfirmed complete response at end of treatment compared with four patients (5·7% [1·6-14·0]) in the comparator group (p = 0·021). The most common grade 3 or 4 adverse events in patients given pixantrone were uncomplicated, non-cumulative neutropenia (28 [41·2%] of 68 patients vs 13 [19·4%] of 67 patients in the comparator group), leucopenia (16 [23·5%] vs five [7·5%]), and thrombocytopenia (eight [11·8%] vs seven [10·4%]). INTERPRETATION: Pixantrone, given as a single-agent salvage therapy in heavily pretreated patients with relapsed or refractory aggressive non-Hodgkin lymphoma, is efficacious and tolerable. It could be a treatment option for patients whose aggressive non-Hodgkin lymphoma has failed to respond to at least two previous chemotherapy regimens. FUNDING: Cell Therapeutics, Inc. [ABSTRACT FROM AUTHOR]
- Published
- 2012
3. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial
- Author
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Paul Cernohous, Bertrand Coiffier, Raghunadharao Digumarti, Fernando Hurtado de Mendoza, David A. Rizzieri, Gary J. Schiller, Ruth Pettengell, Jack W. Singer, Geetha Narayanan, Giles W. Boland, Igor Gorbatchevsky, Henry L. Gomez, Lixia Wang, Pier Luigi Zinzani, Christine Kuepfer, Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani P.L., Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, and Singer JW.
- Subjects
Adult ,Male ,medicine.medical_specialty ,refractory aggressive non-Hodgkin lymphoma ,Adolescent ,salvage treatment ,Population ,Salvage therapy ,Antineoplastic Agents ,Aggressive Non-Hodgkin Lymphoma ,Vinorelbine ,Ventricular Function, Left ,chemistry.chemical_compound ,International Prognostic Index ,Internal medicine ,medicine ,Humans ,education ,Aged ,Aged, 80 and over ,Salvage Therapy ,education.field_of_study ,Ifosfamide ,Pixantrone ,business.industry ,Pixantrone dimaleate ,Lymphoma, Non-Hodgkin ,Middle Aged ,Isoquinolines ,Surgery ,Transplantation ,Oncology ,chemistry ,Female ,business ,medicine.drug - Abstract
Summary Background Pixantrone dimaleate (pixantrone)—a novel aza-anthracenedione—was synthesised to reduce anthracycline-related cardiotoxicity without compromising antitumour efficacy. We aimed to assess the efficacy and safety of pixantrone versus an investigator's choice of a single-agent therapy in heavily pretreated patients with relapsed or refractory aggressive non-Hodgkin lymphoma. Methods In this phase 3, multicentre, open-label, randomised trial at 66 hospitals in Europe, India, Russia, South America, the UK, and the USA, patients with histologically confirmed aggressive non-Hodgkin lymphoma who had relapsed after two or more previous chemotherapy regimens were randomly assigned (1:1) by an interactive voice response system to treatment with pixantrone dimaleate (85 mg/m 2 intravenously on days 1, 8, and 15 of a 28-day cycle, for up to six cycles) or to a comparator (vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, or gemcitabine) given at prespecified standard doses and schedules. Patients were stratified by region, International Prognostic Index score, and previous stem-cell transplantation. Patients and investigators were not masked to treatment assignment; however, an independent assessment panel was masked. The primary endpoint was the proportion of patients with a complete or unconfirmed complete response in the intention-to-treat (ITT) population at the end of treatment. Primary analyses of efficacy were based on the independent assessment panel's data review. The study is registered at ClinicalTrials.gov, number NCT00088530. Findings The ITT population comprised 70 patients randomly assigned to the pixantrone group and 70 to the comparator. Five patients (two in the pixantrone group and three in the comparator group) dropped out before receiving their study drug. 14 patients (20·0% [95% CI 11·4–31·3]) who received pixantrone achieved a complete or unconfirmed complete response at end of treatment compared with four patients (5·7% [1·6–14·0]) in the comparator group (p = 0·021). The most common grade 3 or 4 adverse events in patients given pixantrone were uncomplicated, non-cumulative neutropenia (28 [41·2%] of 68 patients vs 13 [19·4%] of 67 patients in the comparator group), leucopenia (16 [23·5%] vs five [7·5%]), and thrombocytopenia (eight [11·8%] vs seven [10·4%]). Interpretation Pixantrone, given as a single-agent salvage therapy in heavily pretreated patients with relapsed or refractory aggressive non-Hodgkin lymphoma, is efficacious and tolerable. It could be a treatment option for patients whose aggressive non-Hodgkin lymphoma has failed to respond to at least two previous chemotherapy regimens. Funding Cell Therapeutics, Inc.
- Published
- 2012
4. Randomised Phase II study of oral lapatinib combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck: rationale for future randomised trials in human papilloma virus-negative disease.
- Author
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Harrington K, Berrier A, Robinson M, Remenar E, Housset M, de Mendoza FH, Fayette J, Mehanna H, El-Hariry I, Compton N, Franklin N, Biswas-Baldwin N, Lau M, Legenne P, and Kumar R
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- Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Squamous Cell metabolism, Carcinoma, Squamous Cell pathology, Chemoradiotherapy adverse effects, Cisplatin administration & dosage, Cisplatin adverse effects, Cyclin-Dependent Kinase Inhibitor p16 analysis, Diarrhea etiology, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, ErbB Receptors analysis, Exanthema etiology, Female, Head and Neck Neoplasms metabolism, Head and Neck Neoplasms pathology, Humans, Immunohistochemistry, Lapatinib, Male, Middle Aged, Neoplasm Staging, Papillomaviridae physiology, Quinazolines administration & dosage, Quinazolines adverse effects, Radiotherapy Dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell therapy, Chemoradiotherapy methods, Head and Neck Neoplasms therapy, Quinazolines therapeutic use
- Abstract
Background: This randomised Phase II study assessed the activity and safety of concurrent chemoradiotherapy (CRT) and lapatinib followed by maintenance treatment in locally advanced, unresected stage III/IVA/IVB head and neck cancer., Patients and Methods: Patients were randomised 1:1 to concurrent CRT and placebo followed by placebo or concurrent CRT and lapatinib followed by lapatinib. Treatment continued until disease progression or study withdrawal. Primary end-point was complete response rate (CRR) by independent review 6 months post-CRT., Results: Sixty-seven patients (median age 56 years; 97% Eastern Cooperative Oncology Group performance status ≤1; 82% stage IV) were recruited. CRT dose intensities were unaffected by lapatinib: median radiation dose 70 Gy (lapatinib, placebo), duration 49 (lapatinib) and 50 days (placebo); median cisplatin dose 260 mg/m(2) (lapatinib) and 280 mg/m(2) (placebo). Lapatinib combined with CRT was well-tolerated. Grade 3/4 toxicities during CRT were balanced between arms, with the exception of an excess of grade 3 diarrhoea (6% versus 0%) and rash (9% versus 3%) and two grade 4 cardiac events in the lapatinib arm. CRR at 6 months post-CRT was 53% with lapatinib versus 36% with placebo in the intent-to-treat population. The progression-free survival (PFS) and overall survival rates at 18 months were 55% versus 41% and 68% versus 57% for the lapatinib and placebo arms, respectively. The difference between study arms was greatest in p16-negative disease (median PFS >20.4 months [lapatinib] versus 10.9 [placebo])., Conclusion: Lapatinib combined with CRT is well-tolerated with numeric increases in CRR at 6 months post-CRT and median PFS in p16-negative disease., (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Published
- 2013
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5. Addition of amifostine to the CHOP regimen in elderly patients with aggressive non-Hodgkin lymphoma: a phase II trial showing reduction in toxicity without altering long-term survival.
- Author
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Gómez HL, Samanéz C, Campana F, Neciosup SP, Vera L, Casanova L, Leon J, Flores C, de Mendoza FH, Casteñeda CA, Pinto JA, and Vallejos CS
- Subjects
- Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cyclophosphamide adverse effects, Cyclophosphamide therapeutic use, Disease-Free Survival, Doxorubicin adverse effects, Doxorubicin therapeutic use, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Leukopenia etiology, Lymphoma, Non-Hodgkin mortality, Male, Neutropenia etiology, Prednisone adverse effects, Prednisone therapeutic use, Prognosis, Vincristine adverse effects, Vincristine therapeutic use, Amifostine therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Lymphoma, Non-Hodgkin drug therapy, Radiation-Protective Agents therapeutic use
- Abstract
Background and Objectives: We report the 8-year follow-up of 34 patients aged ≥69 years old with NHL included in a phase IIb open-label randomized parallel groups study to evaluate the effectiveness of amifostine in preventing the toxicity of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP regime) ., Patients and Methods: Patients were randomized to receive classical CHOP (cyclophosphamide 750 mg/m(2), doxorubicin 50 mg/m(2), vincristine 1.4 mg/m(2) [maximum 2 mg] on day 1 and prednisone 100 mg/day for 5 days) or CHOP plus amifostine (6 cycles of amifostine 910 mg/m(2) on day 1). Efficacy (time to progression, TTP; disease-free survival, DFS; overall survival, OS) and toxicity endpoints were evaluated., Results: Thirty-four patients were randomized to A-CHOP (n=18) or CHOP (n=16). Patients with A-CHOP vs CHOP had significantly lower toxicity; neutropenia grade 4 ocurred in 13/92 (13%) vs 23/85 (27%, P=0.007) cycles, febrile neutropenia in 3/92 A-CHOP (3%) vs 8/85 (10%, P=.056) CHOP cycles, hospitalization for toxicity in 4/92 (4%) A-CHOP vs 11/85 (13%, P=.05) CHOP cycles. Median hospitalization stay for toxicity was 5 days with A-CHOP vs 8 days with CHOP (P=.05). There were no significant differences at 8 years in TTP (A-CHOP, 48.9% vs CHOP, 36.3%; P=.65), DFS (A-CHOP, 72.9% vs CHOP 55.6%; P=.50) and OS (A-CHOP, 44.3% vs CHOP, 54.4%). There was no long-term toxicity of clinical interest. The only prognostic factor identified to 8 years was the International Prognostic Index (IPI low/low intermediate risk vs high intermediate/high risk; HR=2.98; CI 95%:1.01-8.77; P=.048)., Conclusion: These results show that amifostine can be added to the standard CHOP treatment schedule with less acute toxicity and without influencing the outcome.
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- 2012
- Full Text
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6. EBV-positive diffuse large B-cell lymphoma of the elderly: a case series from Peru.
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Beltran BE, Castillo JJ, Morales D, de Mendoza FH, Quinones P, Miranda RN, Gallo A, Lopez-Ilasaca M, Butera JN, and Sotomayor EM
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- Age Factors, Aged, Aged, 80 and over, Antibodies, Monoclonal, Murine-Derived administration & dosage, Antibodies, Monoclonal, Murine-Derived therapeutic use, Antineoplastic Agents administration & dosage, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cyclophosphamide administration & dosage, Cyclophosphamide therapeutic use, Doxorubicin administration & dosage, Doxorubicin therapeutic use, Female, Humans, Lymphocyte Count, Lymphoma, Large B-Cell, Diffuse blood, Male, Middle Aged, Neoplasm Staging, Peru, Prednisone administration & dosage, Prednisone therapeutic use, Remission Induction, Retrospective Studies, Rituximab, Sex Distribution, Survival Analysis, Vincristine administration & dosage, Vincristine therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Herpesvirus 4, Human isolation & purification, Lymphoma, Large B-Cell, Diffuse drug therapy, Lymphoma, Large B-Cell, Diffuse virology
- Abstract
EBV-positive diffuse large B-cell lymphoma (DLBCL) of the elderly is an entity recently included in the WHO classification of lymphoid tumors. We have reviewed our experience and clinical outcomes of this distinct subtype of DLBCL. Between 2002 and 2009, cases of DLBCL were identified from medical records of the Hospital Nacional Edgardo Rebagliati Martins in Lima, Peru, and underwent pathological evaluation including immunohistochemistry for CD20, CD10, bcl-6, MUM1/IRF4, and EBV-encoded RNA in situ hybridization. Clinical data were gathered, tabulated, and reported descriptively. Survival analyses were performed using Kaplan-Meier estimates. Out of 199 cases of DLBCL, 28 cases of EBV-positive DLBCL of the elderly were identified. The median age was 75 years with male predominance (1.5:1). B-symptoms were present in 43%, advanced stage in 50% and International Prognostic Index (IPI) score > 2 in 57% of patients; 68% of patients had a nongerminal center (NGC) phenotype. The complete response rates to R-CHOP and CHOP were 63% and 33%, respectively. The median overall survival (OS) for the group was 5 months. In the univariate analysis, age ≥70 years, lymphocyte count <1.0 × 10(9) /L, and advanced clinical stage were associated with worse OS in patients treated with chemotherapy with and without rituximab. EBV-positive DLBCL of the elderly is a clinically aggressive entity with a short OS and typically presents with advanced stage, high IPI score, and a NGC phenotype. Further studies are needed to investigate if rituximab-containing regimens are associated with better response and OS rates in EBV-positive DLBCL of the elderly., (Copyright © 2011 Wiley-Liss, Inc.)
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- 2011
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7. Epstein-Barr virus as a prognostic factor in de novo nodal diffuse large B-cell lymphoma.
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Morales D, Beltran B, De Mendoza FH, Riva L, Yabar A, Quiñones P, Butera JN, and Castillo J
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- Adult, Aged, Aged, 80 and over, Antineoplastic Agents therapeutic use, Female, Humans, Male, Medical Oncology methods, Middle Aged, Prognosis, Treatment Outcome, Gene Expression Regulation, Neoplastic, Gene Expression Regulation, Viral, Herpesvirus 4, Human metabolism, Lymphoma, Large B-Cell, Diffuse diagnosis, Lymphoma, Large B-Cell, Diffuse virology
- Abstract
Although the International Prognostic Index (IPI) score is a valuable prognostic tool in diffuse large B-cell lymphoma (DLBCL), other risk-stratifying factors may be of value. The aim of this study was to define the prognostic value of EBV expression in de novo nodal DLBCL. Seventy-four cases were selected between January 2002 and December 2007. Clinical data were reviewed and tissue samples were evaluated for expression of CD20, CD10, bcl-6, MUM1, and EBV-encoded RNA (EBER). Of 74 evaluated cases, 53 cases (72%) were of non-germinal center-like subtype and 11 cases (15%) were positive for EBER. In a univariate analysis of the 57 patients who received chemotherapy, factors associated with survival were EBV status, performance status, LDH level, and IPI score. Using a multivariate analysis, a prognostic model was developed using IPI score and EBV status, which showed statistical significance. Our study supports EBV status as a powerful prognostic factor in de novo nodal DLBCL. Prospective studies should be carried to validate this hypothesis.
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- 2010
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8. Activity of ixabepilone in oestrogen receptor-negative and oestrogen receptor-progesterone receptor-human epidermal growth factor receptor 2-negative metastatic breast cancer.
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Pivot XB, Li RK, Thomas ES, Chung HC, Fein LE, Chan VF, Jassem J, de Mendoza FH, Mukhopadyay P, and Roché HH
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- Antimetabolites, Antineoplastic administration & dosage, Antimetabolites, Antineoplastic adverse effects, Antineoplastic Agents adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms chemistry, Capecitabine, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Drug Resistance, Neoplasm, Epidemiologic Methods, Epothilones adverse effects, ErbB Receptors analysis, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Fluorouracil analogs & derivatives, Humans, Liver Neoplasms drug therapy, Liver Neoplasms secondary, Lung Neoplasms drug therapy, Lung Neoplasms secondary, Receptors, Estrogen analysis, Treatment Outcome, Antineoplastic Agents administration & dosage, Biomarkers, Tumor analysis, Breast Neoplasms drug therapy, Epothilones administration & dosage, Receptors, Progesterone analysis
- Abstract
Oestrogen receptor (ER)-negative breast cancer, including oestrogen receptor-, progesterone receptor- and human epidermal growth factor receptor 2-negative (ER/PR/HER2-negative) breast cancer, is more aggressive than ER-positive disease. A major limitation in the treatment of ER-negative disease subtypes is the inherent insensitivity to hormonal agents (tamoxifen, aromatase inhibitors) that are widely used in the treatment of breast cancer. Thus, therapeutic options for poor prognosis patients with ER-negative breast cancer are limited to a handful of chemotherapeutic agents, and new agents are needed to improve the treatment of this disease. Ixabepilone, a novel epothilone B analogue with low susceptibility to cellular mechanisms that confer resistance to taxanes and other chemotherapeutic agents, has demonstrated potent preclinical antitumour activity in multiple models, including those with primary or acquired drug resistance. This review summarises the results of a prospective subset analysis from a phase III clinical trial evaluating ixabepilone for the treatment of metastatic breast cancer (MBC), in which efficacy and safety were evaluated in patients with ER-negative and ER/PR/HER2-negative disease.
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- 2009
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9. A phase II study of neoadjuvant gemcitabine plus doxorubicin in stage IIIB breast cancer: a preliminary report.
- Author
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Gomez H, Kahatt C, Falcon S, Santillana S, de Mendoza FH, Valdivia S, Vallejos C, Otero J, and Pen DL
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- Adult, Aged, Breast Neoplasms pathology, Breast Neoplasms radiotherapy, Breast Neoplasms surgery, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Doxorubicin administration & dosage, Female, Humans, Middle Aged, Neoadjuvant Therapy, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy
- Abstract
The purpose of this ongoing study is to determine the response and safety of a combination of gemcitabine (Gemzar; Eli Lilly and Company, Indianapolis, IN) plus doxorubicin as neoadjuvant therapy for stage IIIB breast cancer. Thirty-nine chemotherapy-naive patients were enrolled in the study. The median age was 54 years (range, 32 to 74 years), and the median Karnofsky performance status was 100. Gemcitabine 1,200 mg/m(2) was given on days 1 and 8, and doxorubicin 60 mg/m(2) on day 1, followed by surgery or radiotherapy. Ninety-seven of 117 cycles (83%) were administered at full dose. An overall response rate of 95% was obtained, with a complete response in 18% (seven patients) and a partial response in 77% (30 patients). Twenty-eight patients (72%) underwent breast surgery after a maximum of three cycles of neoadjuvant therapy. World Health Organization grade 3/4 toxicities included leukopenia in nine cycles (8%), neutropenia in 16 cycles (14%), febrile neutropenia in 11 cycles (9%), and anemia in two cycles (2%). The most important nonhematologic toxicity was grade 2/4 mucositis in 16 cycles (14%), and/or grade 2/3 diarrhea in 10 cycles (9%). Neoadjuvant therapy with gemcitabine plus doxorubicin results in a high tumor response rate with moderate oral and hematologic toxicity. Semin Oncol 28 (suppl 10):57-61., (Copyright 2001 by W.B. Saunders Company.)
- Published
- 2001
- Full Text
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