ABSTRACT
INTRODUCTION: The role of primary prophylaxis (PP) with granulocyte colony-stimulating factor (G-CSF) for patients with metastatic pancreatic adenocarcinoma (MPA) treated with FOLFIRINOX is unknown. We aimed to compare the frequencies of grades 3 or 4 neutropenia (G3/4N) and febrile neutropenia (FN) and survival outcomes according to the use of PP. METHODS: This is a retrospective study. We included patients with pathologically confirmed MPA treated with FOLFIRINOX in first-line. Patients who received primary prophylaxis (PP group) were compared to patients who received secondary or no G-CSF (no-PP group). Overall survival (OS) and progression-free survival (PFS) were evaluated using the standard Cox proportional hazard model. To account for potential biases, we performed sensitivity analyses excluding patients who received secondary prophilaxis and treating G-CSF as a time-dependent covariate in extended Cox proportional hazard models. RESULTS: The study population consisted of 123 patients. PP was used by 75 patients (61.0%). G3/4 N occurred more frequently among patients without PP (10.7 vs 41.7%; P < .001). There was no difference in the frequency of FN between groups (5.3 vs 8.3%; P = .710). In multivariate analysis, PP was associated with a trend toward improved OS (HR = .66; 95% confidence interval [95% CI] .41 - 1.07; P = .094). In the multivariate model excluding patients with secondary prophylaxis (HR = .54; 95% CI 0.32 - .91; P = .022) and in the time-dependent model (HR = .47; 95% CI 0.28 - .80; P = .005), PP was associated with statistically superior OS. CONCLUSIONS: Despite the reduction in the frequency of G3/4N, the risk of FN among patients treated with FOLFIRINOX without G-CSF is too low to justify its use in a routine basis. However, given the potential of G-CSF to improve survival in this setting, further studies are warranted to assess its role during treatment with FOLFIRINOX for patients with MPA.
Subject(s)
Adenocarcinoma , Neutropenia , Pancreatic Neoplasms , Humans , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Retrospective Studies , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/etiology , Adenocarcinoma/drug therapy , Granulocyte Colony-Stimulating Factor/therapeutic use , Neutropenia/drug therapy , Neutropenia/etiology , Neutropenia/prevention & control , Pancreatic NeoplasmsABSTRACT
PURPOSE: This study evaluated the efficacy, safety, and immunogenicity of biosimilar pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 breast cancer. METHODS: This phase III randomized, multicenter, evaluator-blinded, noninferiority study recruited women with stage 2-4 breast cancer in Argentina who were scheduled to receive chemotherapy. Stratification was based on the breast cancer stage. The primary end point was the duration of severe neutropenia (DSN, noninferiority margin: 1 day) in the first chemotherapy cycle. Secondary end points assessed were incidence of severe neutropenia, grade 3 neutropenia, febrile neutropenia, infections, postchemotherapy hospitalization and duration, and the incidence of adverse drug reactions (ADRs). RESULTS: A total of 120 patients were randomly assigned to receive PegFilBS (58 patients) or PegFilOR (62 patients). Severe neutropenia occurred in 52 of 283 cycles (18.4%) for 27 patients who received PegFilBS and in 48 of 297 cycles (16.2%) for 20 patients who received PegFilOR (P = .48). During the first cycle, severe neutropenia occurred in 16 patients who received PegFilBS (DSN: 0.78 ± 1.53 days) and in 11 patients who received PegFilOR (DSN: 0.53 ± 1.25 days; 95% CI, -0.26 to 0.76 days). In the intention-to-treat analysis, the mean DSN values were 0.90 ± 1.79 days for the PegFilBS group and 0.50 ± 1.21 for the PegFilOR group (95% CI, -0.15 to 0.95 days). No significant differences were observed for the secondary efficacy end points. Three patients experienced seven ADRs in the PegFilBS group while 10 patients experienced 31 ADRs in the PegFilOR group. The most common ADR was myalgia. CONCLUSION: Relative to PegFilOR, PegFilBS provided noninferior efficacy outcomes in Argentinian women with stage 2-4 breast cancer who were treated using myelosuppressive chemotherapy.
Subject(s)
Antineoplastic Agents , Biosimilar Pharmaceuticals , Breast Neoplasms , Drug-Related Side Effects and Adverse Reactions , Neutropenia , Antineoplastic Agents/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biosimilar Pharmaceuticals/adverse effects , Breast Neoplasms/drug therapy , Drug-Related Side Effects and Adverse Reactions/drug therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Filgrastim , Granulocyte Colony-Stimulating Factor/adverse effects , Humans , Neutropenia/chemically induced , Neutropenia/drug therapy , Neutropenia/prevention & control , Polyethylene GlycolsABSTRACT
OBJECTIVE: The aim of this study was to evaluate the effects of the relaxation technique with guided imagery by means of virtual reality on health-related quality of life in patients undergoing hematopoietic stem cell transplantation. METHODS: A quasi-experiment conducted in a Bone Marrow Transplantation Service of a public hospital in southern Brazil. From October 2019 to October 2020, forty-two adult participants who underwent transplantation were included, 35 in the intervention group and seven in the control group. A guided imagery intervention, with audio guiding the relaxation associated with nature images in 360º, was performed during the hospitalization period. Data were collected on the first day of hospitalization, on the transplantation day, during the neutropenia stage, and at pre-hospital discharge. The Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Functional Assessment of Cancer Therapy-Neutropenia (FACT-N) were used to assess health-related quality of life, fatigue and neutropenia. Data were analyzed using the Generalized Linear Mixed Model for the evolution of the health-related quality of life assessments over time, considering the groups and stages. Pearson's correlation coefficient was adopted for the correlation analyses. RESULTS: Allogeneic transplantation was predominant: 28 (80%) in the intervention group and 5 (71.43%) in the control group. There were improvements in the health-related quality of life scores, although not significant. A significant difference was found among the stages (p <0.050) and a significant positive correlation (p <0.000) among the variables on general quality of life, additional concerns, fatigue and neutropenia in all stages. CONCLUSION: Patients undergoing hematopoietic stem cell transplantation suffer changes in their quality of life. Interventions based on integrative practices emerge as an option to minimize them.
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Subject(s)
Fatigue/prevention & control , Hematologic Neoplasms/therapy , Hematopoietic Stem Cell Transplantation/methods , Imagery, Psychotherapy/methods , Neutropenia/prevention & control , Quality of Life , Relaxation Therapy/methods , Adolescent , Adult , Aged , Case-Control Studies , Fatigue/psychology , Female , Follow-Up Studies , Hematologic Neoplasms/pathology , Hematologic Neoplasms/psychology , Humans , Male , Middle Aged , Neutropenia/psychology , Non-Randomized Controlled Trials as Topic , Prognosis , Surveys and Questionnaires , Survival Rate , Transplantation, Homologous , Young AdultABSTRACT
OBJECTIVES: to construct and assess bundle content for the prevention and management of complications in neutropenia in cancer patients. METHODS: a methodological study developed in four stages: scoping review; bundle construction; material assessment by experts (developed according to Pasquali's psychometry); pilot test in a High Complexity Assistance Unit in Oncology. For content assessment, the Delphi technique was applied in two rounds and those items with Content Validation Coefficient (CVC)> 0.78 and agreement> 80.0% were considered valid. Data were analyzed using descriptive and inferential statistics. RESULTS: all bundle requirements reached agreement between judges above 80.0%, in addition to statistically significant levels of assessment. At the end of the Delphi technique, bundle was significantly valid with CVC = 0.92 and CVC = 0.93, respectively. CONCLUSIONS: bundle content proved to be valid and highly credible.
Subject(s)
Neoplasms , Neutropenia , Delphi Technique , Humans , Neoplasms/complications , Neoplasms/therapy , Neutropenia/complications , Neutropenia/prevention & control , PsychometricsABSTRACT
OBJECTIVES: We aimed to determine whether carvacryl acetate acts as a TRPA1 receptor agonist and its effects against irinotecan (CPT-11) induced intestinal mucositis in mice. METHODS: TRPA1 structure was obtained from a protein databank, and the 3D structure of carvacryl acetate was determined. Appropriate binding conformations were discovered via automatic docking simulations. To determine the effect of carvacryl acetate in vivo, mice were treated with either DMSO 2%, CPT-11, carvacryl acetate followed by CPT-11, or HC-030031, a TRPA1 antagonist, followed by carvacryl acetate. Jejunum samples were taken and structural, inflammatory and antioxidant parameters were studied. KEY FINDINGS: Eight amino acids residues in TRPA1 established stable interactions with carvacryl acetate, which led to pharmacological efficacy against CPT-11-induced intestinal mucositis via reduction of both neutropenia and bacteremia, increase in villi height and crypt depth, decrease in pro-inflammatory cytokines (interleukin-1ß, keratinocyte chemoattractant and tumour necrosis factor-α) and decrease in malondialdehyde and nitric oxide metabolite levels in the jejunum. CONCLUSIONS: Carvacryl acetate is a promising anti-inflammatory and antioxidant agent, a fact confirmed through observations of its interactions with TRPA1 in CPT-11-induced intestinal mucositis in mice.
Subject(s)
Anti-Inflammatory Agents/pharmacology , Camptothecin/analogs & derivatives , Monoterpenes/pharmacology , Mucositis/prevention & control , Animals , Antineoplastic Agents, Phytogenic/toxicity , Antioxidants/pharmacology , Bacteremia/prevention & control , Camptothecin/toxicity , Cytokines/metabolism , Female , Intestinal Mucosa/drug effects , Intestinal Mucosa/pathology , Irinotecan , Jejunum/metabolism , Jejunum/pathology , Mice , Molecular Docking Simulation , Mucositis/chemically induced , Neutropenia/prevention & control , TRPA1 Cation Channel/agonistsABSTRACT
OBJECTIVES:: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS:: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS:: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION:: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima¯).
Subject(s)
Biosimilar Pharmaceuticals/therapeutic use , Breast Neoplasms/drug therapy , Filgrastim/therapeutic use , Hematologic Agents/therapeutic use , Neutropenia/chemically induced , Neutropenia/prevention & control , Adult , Antineoplastic Agents/adverse effects , Biosimilar Pharmaceuticals/pharmacokinetics , Female , Filgrastim/pharmacokinetics , Hematologic Agents/pharmacokinetics , Humans , Leukocyte Count , Middle Aged , Reference Values , Reproducibility of Results , Severity of Illness Index , Statistics, Nonparametric , Treatment OutcomeABSTRACT
OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa’s approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima¯).
Subject(s)
Humans , Female , Adult , Middle Aged , Biosimilar Pharmaceuticals/therapeutic use , Breast Neoplasms/drug therapy , Filgrastim/therapeutic use , Hematologic Agents/therapeutic use , Neutropenia/chemically induced , Neutropenia/prevention & control , Antineoplastic Agents/adverse effects , Biosimilar Pharmaceuticals/pharmacokinetics , Filgrastim/pharmacokinetics , Hematologic Agents/pharmacokinetics , Leukocyte Count , Reference Values , Reproducibility of Results , Severity of Illness Index , Statistics, Nonparametric , Treatment OutcomeABSTRACT
BACKGROUND: Previously, we validated the mouse thigh infection model to test the therapeutic equivalence of generic antibiotic products. Here, our aim was to compare the in vivo efficacy of amikacin products in clinical use in Colombia using this animal model. RESULTS: All except one generic product had the same in vitro potency, judging by the lack of differences on MIC and MBC compared with the innovator. However, eight of nine generic products failed in the neutropenic mouse thigh infection model to achieve the innovator's maximum effect (E max ≤ 5.65 for the generics vs. 6.58 log10 CFU/g for the innovator) against Escherichia coli SIG-1, after subcutaneous treatment every 6 h with doses ranging from 1.5 to 3072 mg/kg per day. CONCLUSION: As we demonstrated previously with other antibiotics such as vancomycin, gentamicin and oxacillin, the generic products of amikacin failed the in vivo efficacy testing. The therapeutic equivalence should be assessed in vivo before clinical approval of generic products.
Subject(s)
Amikacin/pharmacology , Anti-Bacterial Agents/pharmacology , Disease Models, Animal , Escherichia coli Infections/prevention & control , Neutropenia/prevention & control , Amikacin/therapeutic use , Animals , Anti-Bacterial Agents/therapeutic use , Escherichia coli Infections/drug therapy , Mice , Neutropenia/drug therapyABSTRACT
Se realizó una revisión bibliográfica con el objetivo de recomendar una estrategia de intervención educativa para prevenir la neutropenia febril en las personas con cáncer en adultos del municipio Ciego de Ávila. Se hizo una búsqueda en las diferentes bases de datos disponibles en Infomed, con el propósito de determinar tendencias a partir de la aplicación de determinados instrumentos y técnicas; estas se compararon con la literatura nacional y extranjera actualizada. La estrategia de intervención educativa recomendada ayudará al control y prevención de la neutropenia febril en las personas con cáncer mediante la prevención de problemas relacionados con esta dolencia. Se implementa una guía para su manejo inicial -al actuar enérgicamente para evitar la resistencia antimicrobiana- que constituye una guía práctica factible, avalada por el criterio de expertos (AU)
A bibliographical revision was carried out with the aim to recommend thean educational intervention strategy to prevent the febrile neutropenia in adult person with cancer in Ciego de Avila municipality. A search was carried out in different database available in Infomed, in order to determine tendencies from the application of certain instruments and techniques, these one were compared with national and foreigner updated literature. The recommended strategy of educational intervention will help to the control and prevention of febrile neutropenia in person with cancer by means of the prevention of problems related to this disease. It implements a guide for its initial handling, acting energetically in order to avoid the antimicrobial resistance that constitutes a feasible guide borne out by the experts' opinion (AU)
Subject(s)
Humans , Male , Female , Fever , Neoplasms/complications , Neutropenia/prevention & control , Review Literature as Topic , Early Medical Intervention/methodsABSTRACT
Neutropenia induced by chemotherapy (CT) is an infection risk factor associated to greater morbidity/mortality and dose-limiting toxicity that on many occasions requires a reduction of the dose of cytostatics or a delay in the administration of treatment. This may have a negative effect on the patient's quality of life and even diminish the efficacy of the treatment, especially when the intention is to cure or prolong survival. Management of treatment or prophylaxis of grade 3-4 neutropenia and febrile neutropenia with myeloid growth factors (CSF) varies very much in clinical practice, both in the time of starting treatment and the types of patients it is given to. The need to generalise and facilitate practice based on clinical evidence has led the Spanish Society of Medical Oncology (SEOM) to prepare clinical practice guidelines on the use of myeloid growth factors.
Subject(s)
Intercellular Signaling Peptides and Proteins/therapeutic use , Neutropenia/prevention & control , Practice Guidelines as Topic , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemoprevention/methods , Colony-Stimulating Factors/metabolism , Colony-Stimulating Factors/therapeutic use , Humans , Intercellular Signaling Peptides and Proteins/metabolism , Medical Oncology/legislation & jurisprudence , Medical Oncology/organization & administration , Myeloid Cells/metabolism , Neoplasms/drug therapy , Neutropenia/chemically induced , Palliative Care/methods , Societies, Medical/legislation & jurisprudence , Societies, Medical/organization & administration , SpainABSTRACT
PURPOSE OF REVIEW: To provide an update on the rational approach of febrile neutropenia in children with cancer and discuss future research aspects in the field. RECENT FINDINGS: Clinical and laboratory variables and new biomarkers associated with an increased risk for a severe outcome including invasive bacterial infection (IBI), sepsis, and mortality have been identified for children with cancer and febrile neutropenia. These variables and biomarkers are currently being used for an early risk assessment in order to identify children at low or high risk for IBI or at high risk for sepsis and death. Early identification of children with a differential risk has allowed the implementation of selective treatment regimens. More recently, host genetic differences have been associated with a differential risk for IBI. The individual gene profile based on selected polymorphisms could further fine-tune the early risk assessment allowing tailor-made management strategies. SUMMARY: In the last decades, efforts have focused on the stratification of the heterogeneous group of children with cancer and febrile neutropenia according to their risk for developing an IBI. This effort has allowed a less aggressive treatment strategy for children at low risk, including early hospital discharge and use of intravenous and oral antimicrobials at home. More recently, advances have been made in the early identification of children in the other spectrum of infection, those at high risk for sepsis and mortality, with the aim of rapid implementation of aggressive therapy.
Subject(s)
Bacterial Infections/prevention & control , Fever/prevention & control , Neoplasms/complications , Neutropenia/prevention & control , Bacterial Infections/complications , Child , Fever/complications , Humans , Neutropenia/complications , Patient Care Management/methods , Risk Assessment , Risk Factors , Survival AnalysisABSTRACT
El estudio identifica factores predictivos de infección o de complicaciones en pacientes pediátricos con neutropenia febril (NF), establece puntos clínicos decorte y destaca la importancia de la impresión clínica inicial y 24 horas de observación.
Subject(s)
Neutropenia/prevention & control , Neutropenia/therapyABSTRACT
Neutropenia is a common complication of cancer chemotherapy. Colony-stimulating factors (CSF) may be used to avoid neutropenia-associated complications. The Spanish Society of Medical Oncology (SEOM) recently constituted a working group to review the main issues concerning the use of CSF and carried out a consensus process about the use of CSF in cancer patients, held in Madrid on 26 May 2006. The group concluded the following recommendations: prophylactic use of CSF is recommended when a rate of febrile neutropenia (FN) higher than 20% is expected without the use of CSF or when additional risk factors for neutropenia exist; therapeutic use of CSF is recommended in order to treat FN episodes but not to treat afebrile neutropenic episodes. In addition, the use of CSF is considered effective when used to mobilise stem cells before high-dose chemotherapy and when used for chemotherapy schedule optimisation in dose-dense and in dose-intense regimens.
Subject(s)
Colony-Stimulating Factors/therapeutic use , Neoplasms/complications , Neutropenia/prevention & control , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Consensus , Drug Therapy, Combination , Humans , Medical Oncology , Neutropenia/drug therapy , Neutropenia/etiology , Neutropenia/urine , SpainABSTRACT
AIM: In several commonly used regimens, chemotherapy doses are split across different days of the cycle. We aimed to determine the feasibility of growth factor support with once-per-cycle pegfilgrastim in this setting. METHODS: This phase II study in breast cancer patients assessed the utility of a single 6 mg subcutaneous dose of pegfilgrastim administered on day 9 of an intravenous (IV) "split" CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2) and 5-fluorouracil 600 mg/m(2)) chemotherapy regimen administered on days 1 and 8 and repeated every 28 days for 6 cycles. RESULTS: Fifty-eight patients were enrolled, with 49 completing the study. For the primary endpoint, 48 patients (83%) received >or=85% of the relative dose intensity (RDI) of chemotherapy over all 6 cycles (95% confidence interval [CI], 71-91%). Across all chemotherapy cycles, 41 patients (71%) received all scheduled cycles on time and most patients (n=49, 84%) received >or=85% of the planned dose of all chemotherapy agents in all cycles. In total, 295/319 cycles (92%) were delivered on schedule and >or=85% of the planned dose of all chemotherapy agents were administered in 309/319 cycles (97%). Febrile neutropenia was reported in only 2 patients (3%). There were no grade 4 adverse events related to pegfilgrastim. DISCUSSION: Day 9 pegfilgrastim administration was well tolerated and provided effective protection against neutropenia in patients receiving IV CMF on days 1 and 8, allowing chemotherapy to be delivered on time and at the scheduled dose in most patients.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms, Male/drug therapy , Breast Neoplasms/drug therapy , Carcinoma/drug therapy , Granulocyte Colony-Stimulating Factor/administration & dosage , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Chemotherapy, Adjuvant , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Filgrastim , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Granulocyte Colony-Stimulating Factor/adverse effects , Humans , Injections, Intravenous , Male , Methotrexate/administration & dosage , Methotrexate/adverse effects , Middle Aged , Neutropenia/prevention & control , Polyethylene Glycols , Recombinant Proteins , Treatment OutcomeABSTRACT
INTRODUCTION: To evaluate the efficacy and safety profile of the concomitant dose-dense administration of doxorubicin and docetaxel as primary chemotherapy for patients with large or locally advanced breast cancer. MATERIALS AND METHODS: Forty-seven patients were included and received 50 mg/m(2) of doxorubicin and 75 mg/m(2) of docetaxel every two weeks for four cycles. Primary prophylaxis with granulocyte colony stimulating factor was administered. RESULTS: Patients included had mainly stage III disease (66%). Efficacy and toxicity analyses were carried out on an intention-to-treat basis. After study treatment, the rate of clinical responses was 85% (95% CI: 75-95) with 6% judged as clinical complete responses. Surgery was performed on 94% patients for whom the breast was conserved in 27%. Only one patient obtained a pathological complete response (with no evidence of invasive or non-invasive tumour in the breast and the lymph nodes). In three additional patients, malignant cells were detected only in one lymph node. The single severe haematological toxicity was neutropenia, occurring in one patient (2%) and two cycles (1%), being grade 3 in one and grade 4 in the other. Severe non-haematological toxicities were grade 3, and the most common was asthenia (8% of patients), followed by cutaneous toxicity, arthromyalgia and stomatitis, which occurred in fewer than 4% of patients in each case. CONCLUSIONS: The concomitant dose-dense administration of doxorubicin and docetaxel as neoadjuvant chemotherapy with granulocyte colony stimulating factor support is a feasible and effective schedule with a safe toxicity profile for women with large or locally advanced breast cancer.
Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Carcinoma/drug therapy , Granulocyte Colony-Stimulating Factor/therapeutic use , Neoadjuvant Therapy , Neutropenia/prevention & control , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Asthenia/chemically induced , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma/pathology , Carcinoma/surgery , Combined Modality Therapy , Docetaxel , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Drug Eruptions/etiology , Female , Humans , Mastectomy , Middle Aged , Neutropenia/chemically induced , Prospective Studies , Stomatitis/chemically induced , Taxoids/administration & dosage , Taxoids/adverse effectsABSTRACT
Fundamento: Neutropenia e infecciones son los efectos colaterales más limitantes de la aplicación de quimioterapia. El factor estimulante de colonias granulocíticas activa los neutrófilos, acorta el período neutropénico y puede ser efectivo contra el riesgo potencial de infección. Para su comercialización se necesitan estudios que avalen su efectividad y seguridad. Objetivo: Evaluar el impacto del G-CSF en profilaxis primaria, secundaria y episodios de neutropenia, en pacientes oncohematológicos de la provincia de Cienfuegos. Método: Se estudiaron 95 episodios neutropénicos recogidos en historias clínicas y cuadernos de recogida de datos, pertenecientes a 47 pacientes tratados en el Hospital Universitario Dr. Gustavo Aldereguía Lima de Cienfuegos y acaecidos durante un año (2005-2006). Se analizaron: datos demográficos, valores del conteo absoluto de neutrófilos, número de dosis administradas, régimen de tratamiento y posibles interrupciones de este. Resultados: El 50,5 por ciento recibió el tratamiento de forma ambulatoria. En 9 episodios hubo interrupción de tratamiento 9,5 por ciento y el número medio de dosis administradas para obtener la recuperación del conteo absoluto de neutrófilos fue de 6,69. Conclusiones: El producto resultó efectivo, pues pudo constatarse la disminución del número de episodios neutropénicos y la elevación de los valores de neutrófilos en aproximadamente una semana, lo que permitió un mejor seguimiento de la quimioterapia a los pacientes de la serie estudiada(AU)
Bakground: Neutropenia and infections are the most restrictive side effects in chemotherapy application. The granulocytic colonies stimulating factor activates the neutrophils, shortens the neutropenic period and can be effective against the potential risk of infection. There is a need of studies for its commercialization to endorse their effectiveness and security. Objective: To evaluate the impact of the G-CSF in primary and secondary prevention and neutropenia episodes, in onco-haematological patients in Cienfuegos. Method: 95 neutropenic episodes were studied, picked up in clinical histories and data collection notebooks belonging to 47 patients treated in the University Hospital Dr Gustavo Aldereguía Lima in Cienfuegos and happened during one year (2005-2006). It was analyzed: demographic data, absolute neutrophils count values, number of administered doses, treatment regime and possible treatment interruptions Results: 50, 5 percent received treatment in an ambulatory way. There was treatment interruption in 9 episodes, 9,5 percent and the mean dose number administered to obtain the recovery of neutrophils absolute count was 6,69. Conclusions: The product was effective, sine the decrease of neutropenic episodes could be verified, as the elevation of neutrophil values in approximately one week, what allowed a better pursuit of chemotherapy to patients of the studied series(AU)
Subject(s)
Humans , Neutropenia/prevention & control , Neutrophils , Radiation Oncology , Hematologic Diseases/drug therapy , Drug EvaluationABSTRACT
The routine use of granulocyte-colony stimulating factor (G-CSF) for 10 days during full-dose cyclophosphamide-doxorubicin-vincristine-prednisone (CHOP) chemotherapy in HIV-associated diffuse non-Hodgkin's lymphoma (NHL) patients is very expensive in developing countries. We treated 22 HIV-associated diffuse NHL patients with standard-dose CHOP and used G-CSF after an episode of febrile neutropenia until neutrophil count reached 1000/mm3. The clinical response was: complete response (36%), partial response (32%), stable disease (14%) and progression (18%). There were no toxicity-related deaths. Grade 3 or 4 neutropenia was observed in 16% of cycles, but only 8% were complicated with febrile neutropenia. Seventeen patients died (median survival 15 months; range 2-70). There are five patients alive (median survival 24+ months; range 17-36+). Our experience showed that we can treat HIV-related NHL patients with full-dose CHOP, achieve good responses and have an acceptable toxicity profile, with the use of G-CSF as needed.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Lymphoma, AIDS-Related/drug therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Female , Fever/chemically induced , Fever/prevention & control , Granulocyte Colony-Stimulating Factor/administration & dosage , Humans , Male , Maximum Tolerated Dose , Middle Aged , Neutropenia/chemically induced , Neutropenia/prevention & control , Prednisone/administration & dosage , Prednisone/adverse effects , Prospective Studies , Treatment Outcome , Vincristine/administration & dosage , Vincristine/adverse effectsABSTRACT
The hematopoietic growth factors (HGFs) are a family of glycoproteins which plays a major role in the proliferation, differentiation, and survival of primitive hematopoietic stem and progenitor cells, and in the functions of some mature cells. More than 20 different molecules of HGF have been identified. Among them, granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been demostrated to be effective in reducing the incidence of febrile neutropenia when administered inmediately after chemotherapy and as supportive therapy in patients undergoing bone marrow transplantation. Chemotherapy used for treatment of cancer often causes neutropenia, which may be profound, requiring hospitalization, and leading to potentially fatal infection. The uses of the recombinant human hematopoietic colony-stimulating factors G-CSF and GM-CSF for treatment and prophylaxis of chemotherapy-induced febrile neutropenia will be reviewed here.
Subject(s)
Antineoplastic Agents/adverse effects , Fever/chemically induced , Fever/prevention & control , Granulocyte Colony-Stimulating Factor/therapeutic use , Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use , Neutropenia/chemically induced , Neutropenia/drug therapy , Acute Disease , Aged , Antineoplastic Agents/administration & dosage , Bone Marrow Transplantation , Combined Modality Therapy , Data Interpretation, Statistical , Granulocyte Colony-Stimulating Factor/administration & dosage , Granulocyte Colony-Stimulating Factor/adverse effects , Granulocyte-Macrophage Colony-Stimulating Factor/administration & dosage , Granulocyte-Macrophage Colony-Stimulating Factor/adverse effects , Humans , Injections, Subcutaneous , Leukemia, Myeloid/drug therapy , Meta-Analysis as Topic , Neoplasms/drug therapy , Neoplasms/radiotherapy , Neutropenia/prevention & control , Practice Guidelines as Topic , Primary Prevention , Randomized Controlled Trials as Topic , Recombinant Proteins , Risk Factors , Time FactorsABSTRACT
The severity and duration of post chemotherapy neutropenia were recognized during the 1960s as main predisposing factors for infections in cancer patients. At the beginning of the 70's a standard management approach for all febrile neutropenia (FN) episodes was proposed, based on hospitalization and intravenous empirical broad spectrum antibiotic therapy. Widespread use of this approach resulted in a significant reduction in mortality attributable to bacterial infections. During the last 10 to 15 years, reappraisal of this standard approach has been done by several research groups who question the benefit of treating all FN patients similarly without taking in to consideration differences in severity of the FN episodes. This reappraisal has led during the 1990s to the development of the concept of high and low risk FN episodes that has been the base for the adoption of selective therapies based on the risk categorization of the individual patient. The Chilean Infectious Diseases Society called upon two government National Programs responsible for the appropriate distribution of chemotherapeutic drugs to all pediatric and adults cancer patients within the public health system, and upon the Chilean Hematology Society for the development of a Consensus on Diagnosis, Treatment and Prevention of Infections during FN Episodes in Cancer patients. The need for this Consensus is based on two main aspects: the new approaches proposed during the past year for management of these episodes, and the increasing population of cancer patients receiving improved chemotherapeutic agents that has increased there survival possibilities as well as there possibility to suffer a FN episode. The topics discussed in this document are based on an updated systematic and analytic review of the medical literature including epidemiology, laboratory diagnostics, risk categorization, treatment and prophylaxis. National data was included when available in order to provide the healthcare personnel that take care of these patients with best evidence based recommendations adjusted to the Chilean reality.
Subject(s)
Antineoplastic Agents/adverse effects , Fever , Neoplasms/drug therapy , Neutropenia , Opportunistic Infections , Bacterial Infections/diagnosis , Bacterial Infections/etiology , Bacterial Infections/prevention & control , Fever/diagnosis , Fever/etiology , Fever/prevention & control , Humans , Neoplasms/complications , Neutropenia/diagnosis , Neutropenia/etiology , Neutropenia/prevention & control , Opportunistic Infections/diagnosis , Opportunistic Infections/etiology , Opportunistic Infections/prevention & control , Risk AssessmentABSTRACT
Nowadays, the use of taxoid derivated compounds constitutes one of the main chemotherapeutic weapons against breast cancer, ovarian cancer and non-microcytic lung cancer. The limiting factor when determining the dose of taxoids to be administered is the occurrence of neutropenia which is a common side-effect of this therapy. That is why we propose this retrospective study in which we assessed docetaxel and paclitaxel induced neutropenia in oncologic patients by means of colony stimulating factors consumption. A systematic revision of filgastrin consumption by patients treated with taxoids during 2003 in the Infanta Cristina Hospital (Badajoz, Spain) was performed. Filgastrin consumption data were obtained individually, considering its dispensation to external patients as well as the possible administration during hospital stay. 22 out of the 140 patients treated with paclitaxel required colony stimulating factor. On the other hand, 27 out of 116 patients treated with docetaxel received filgastrin. The relation between filgastrin (micrograms) and taxoid consumption (milligrams) was 1.35 for paclitaxel and 4.17 for docetaxel. Taking into account each patient taxoids consumption (milligrams), the results were 7.09 for paclitaxel and 20.12 for docetaxel. When selecting the patients who suffer from breast cancer and lung cancer, these ratios were 0.76 for paclitaxel and 6.48 for docetaxel. The docetaxel group consumed 2.83 more colony stimulating factor than the pacitaxel group. This ratio was even greater (3.1) when ovarian cancer patients were excluded. These results showed an unfavorable relation for docetaxel, thus confirming that the use of docetaxel provokes a greater incidence and severity of neutropenia.