Low-risk Febrile Neutropenia Patients Research Articles

1653. Cost effectiveness of Levofloxacin Vs Amoxicillin/Clavulanate And Ciprofloxacin In The Outpatient Management Of Low-Risk Febrile Neutropaenia In Children With Cancer: A Randomised Control Study.

Abstract Background outpatient management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible.In this study, we aimed to assess the efficacy and safety of single-agent Levofloxacin versus the Augmentin /ciprofloxacin regimen used in our institute. Methods This is a randomized prospective interventional 2 arm study of low-risk febrile neutropenia patients presenting to the emergency department at the National Cancer Institute, Cairo University starting from December 2021 to July 2022. Eligible patients were children< 18 years with Low-risk febrile neutropenia without an aetiological diagnosis.Patients were randomized to double-agent ciprofloxacin and amoxicillin-clavulanic acid in comparison to single-agent levofloxacin. Follow up of the outpatient cases on; Day 1, Day 3, and Day 7 for Resolution of infection and stopping of antibiotics regardless of neutropenia. Drug-related side effects encountered in both arms of the study were reported. A decision analytic model was created to compare the two different treatment strategies Outcome measures were quality-adjusted FN episodes, costs, and incremental cost-effectiveness ratios (ICER). The clinical parameters of the model were derived mainly from data collected at National Cancer Institute. Health effects were expressed in terms of QALY gain.One-way sensitivity analysis (DSA) was conducted. Results 200 patients (100 in each group) were enrolled. 100% of patients achieved marrow recovery in both arms by D7. Fever subsided in 100% on the Levofloxacin arm compared to 60% in the other group. only 1 patient on the double agent arm was upgraded to HR.Levofloxacin was tolerable in all patients with no significant side effects, while patients in the double agent arm; 4 had diarrhea, 2 nausea, and 2 complained of a bad drug taste. Levofloxacin is the dominant strategy versus Augmentin/ciprofloxacin with incremental QALY 0.0001and lower cost 62.4996 L.E in the treatment of home-based care of febrile neutropenia with a willingness to pay threshold of 77,520 LE per QALY (1 GDP/CAPITA) Figure 1 Conclusion Levofloxacin is cost effective and can be administered safely in children with low-risk FN, however close follow-up for long-term side effects and emerging bacterial resistance is warranted. Disclosures All Authors: No reported disclosures

Going local: Evaluating guideline adherence and appropriateness of antibiotic prescribing in patients with febrile neutropenia at an academic teaching hospital.

Febrile neutropenia (FN) is a medical emergency with significant morbidity and mortality for oncology patients, requiring comprehensive workup and timely antibiotic administration. We evaluated concordance with locally developed FN guidelines and outcomes of cancer patients admitted to general internal medicine at an academic teaching hospital. We conducted a retrospective observational cohort study of patients admitted between July 1, 2016, and June 30, 2017, for FN. Patients were classified as having low-risk or high-risk FN according to their malignancy and chemotherapy. Primary outcome was the proportion of patients receiving guideline-concordant antibiotics within 48 hours of admission to general internal medicine. Secondary outcomes were the proportion of patients in whom empirical antibiotics were active against pathogens isolated, rate of antibiotic-associated adverse events, and in-hospital mortality. We used logistic regression to model relationship between FN risk and guideline-concordant antibiotics. Among 100 patients included, 34 (34%) were low-risk FN and 66 (66%) were high-risk. Proportion of guideline-concordant empirical antibiotics was significantly lower among low-risk FN patients than high-risk patients: 12 (35%) of 34 versus 47 (71%) of 66 (P = .001). Empirical antibiotics were active against 17 (94%) of 18 isolated pathogens. The mortality rate was 3%, and 16% of patients experienced antibiotic-associated adverse events. Hematological malignancy and infectious diseases-trained physician involvement were associated with guideline-concordant prescribing, with adjusted odds ratios of 3.76 (95% CI, 1.46-9.70; P = .006) and 3.71 (95% CI, 1.49-9.23; P = .005), respectively. Guideline concordance was low compared to published reports. Factors influencing appropriate antimicrobial prescribing in patients with FN warrant further exploration.

Efficacy of Levofloxacin Versus Amoxicillin/Clavulanate and Ciprofloxacin in the Outpatient Management of Low-Risk Febrile Neutropenia in Children with Cancer; A Randomised Control Study

Background and Aims Outpatient management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible. the use of Amoxicillin/ Clavulanate plus ciprofloxacin, Levofloxacin, and Moxifloxacin for the treatment of low-risk febrile neutropenia. There are not enough studies assessing the tolerance, safety, and efficacy of these agents in children. In this study, we aimed to assess the efficacy and safety of single-agent Levofloxacin versus the Augmentin /ciprofloxacin regimen used in our institute. Methods This is a randomized prospective interventional 2 arm study of low-risk febrile neutropenia patients presenting to the emergency department at the National Cancer Institute, Cairo University starting from December 2021 to July 2022.Eligible patients were children<18 years with haematological malignancies or haemopoietic and Low-risk febrile neutropenia without aetiological diagnosis. Lottery method was used to randomly enrol patients (1:1) to both arms. Patients were randomized to double agent ciprofloxacin and amoxicillin-clavulanic acid in comparison to single-agent levofloxacin. Follow up of the outpatient cases at; Day 1: Start oral antibiotics, obtain guardians contacts, and assure compliance, Day 3: Follow up the patient clinically and follow up count, and Day 7: Resolution of infection and stopping of antibiotics regardless of neutropenia. Primary outcomes included Safe marrow recovery and improvement of fever in all eligible patients. Drug-related side effects encountered in both arms of the study were reported. Results A preliminary analysis of the first 120 patients (60 in each group) was done. 100% of patients achieved marrow recovery in both arms by D7. Fever subsided in 100% on the Levofloxacin arm compared to 60% in the group receiving Augmentin/Ciprofloxacin. only one patient on the double agent arm was upgraded to HR and admitted to the inpatient. Levofloxacin was tolerable in all patients with no significant side effects apart from insomnia reported by the parents in 1 patient, while patients in the double agent arm; 4 had diarrhoea, 2 nausea and 2 complained of bad drug taste. Conclusions Levofloxacin has better efficacy and can be administered safely in children with low-risk FN, however close follow-up for long-term side effects and monitoring of possible emerging bacterial resistance is warranted.

Efficacy and Safety of Sitafloxacin in Treating Low-risk Febrile Neutropenia in Patients with Lung Cancer.

Introduction: Febrile episodes in patients with cancer and chemotherapy-induced neutropenia can be life-threatening and generally require prompt administration of broad-spectrum antimicrobials. However, little evidence exists for treating patients with solid tumors and febrile neutropenia (FN) with oral antimicrobials. Methods: In this prospective study, we aimed to determine the efficacy and safety of sitafloxacin (STFX) for treating FN in lung cancer patients. In this prospective study, low-risk FN patients with lung cancer received STFX. The primary endpoint was response rate, defined as 5 sequential days of absence of fever without adverse events. The study was registered as UMIN000010911. Results: As a result, STFX was administered to 26 patients, all of whom survived during its administration. Of the 26, 14 completed primary endpoint (53.85%). The low response rate was attributed to occurrence of fevers of unknown cause rather than failure of FN treatment. Only two patients received antibacterial agents other than STFX. If response rate omitted absence of fever and been defined only as recovery from FN without changing microbial agents or serious complications, the response rate would have been 91.67%. Adverse events occurred in eight patients, none of which were serious. Conclusions: In conclusion, STFX might be used to treat low-risk FN in patients with lung cancer; however, a more detailed study will be required in future.

Scoring Systems Identifying the Low-Risk Febril Neutropenia Patients in the Emergency Department: Usefulness of MASCC, CISNE and qSOFA

Objective: We aimed to investigate the effectiveness of quick Sequential Organ Failure Assessment (qSOFA), Multinational Association for Supportive Care in Cancer (MASCC), and Clinical Index of Stable Febrile Neutropenia (CISNE) scores in identifying the low-risk febrile neutropenia patients among patients with chemotherapy-associated neutropenia in the emergency department setting.&#x0D; Material and Method: The risk scores of the patients were calculated and divided into low-risk and high-risk categories according to the guidelines. Serious complications and 30-day mortality were recorded. Patients who survived and did not develop any serious complications were defined as low risk FN.&#x0D; Results: The median age of the patients was 63 years, and 56.3% were male. Of all patients, 50.6% had hematological malignancy. Blood culture positivity was detected in 31% of the patients. Of all patients, 51 (58.6%) were low-risk FN. The complication rate in patients was 40.2%, while the mortality rate was 25.3%. When evaluated according to the risk scores, 69 (79.3%) patients with qSOFA, 40 (46%) patients with MASCC and 7 (8.1%) patients with CISNE were classified as low risk. The qSOFA score had the highest sensitivity with 96.08%, MASCC had the highest PPV with 85%, and the CISNE score had the highest specificity with 88.89% in patients with low-risk febrile neutropenia.&#x0D; Conclusion: MASCC, CISNE and qSOFA scores have reasonable discriminating power in identifying low-risk neutropenia patients. The combined use of scoring systems with the clinical gestalt and communication with oncologists will further increase the percentage of the recognized low-risk neutropenia patients in the emergency department.

1715P Plinabulin (Plin) is a more favorable option for the prevention of chemotherapy induced neutropenia (CIN) than pegfilgrastim (Peg) during the COVID-19 pandemic

Due to COVID-19, the NCCN Myeloid Growth Factor Panel expanded prophylactic G-CSF use to chemotherapy with Intermediate Risk (10%-20% risk) of Febrile Neutropenia (FN), and to Low Risk FN patients (pts) who previously developed FN. Preservation of resources for COVID-19 pts by reducing hospitalizations and emergency room visits by cancer chemotherapy pts is the intent of these changed recommendations. Other recommendations include use of self-injecting or on-body injector Peg, to minimize COVID-19 exposure at outpatient center by cancer pts and limiting prophylactic platelet transfusion to preserve blood product supply. Plin is an attractive alternative: it is a novel, non-G-CSF small molecule with CIN protection comparable to Peg, is given once 30 minutes after Chemo, and avoids the need for healthcare system touches on Day 1-3 for G-CSF administration. In contrast to Peg, Plin does not cause bone pain and thrombocytopenia and maintains quality of life. We compared the combined CIN data with single agent (SA) Plin 20 mg/m2 (n=29) vs. SA Peg 6mg (n=35) from 2 different phase II CIN studies over 4 cycles: 1. Study 105 in NSCLC pts given Intermediate FN Risk Docetaxel 75 mg/m2 (Doc) pts with risk factors), and 2. Study 106 in Breast cancer pts given High FN Risk Doc +Doxorubicin 50 mg/m2 + Cyclophosphamide 50mg/m2 (TAC). Plin was given as a single IV infusion on Day (D)1, 30 min after the last Chemo, and Peg 6mg given on D2 by SC injection. Grade 4 Neutropenia (Gr 4 N), Hospitalizations (Hosp), Infection rate (Inf), Sepsis (Sep), all Grade Thrombocytopenia (T) or Gr 2/3 T and Bone Pain (BoP) is summarized for SA Plin and SA Peg. (NS= non-significant). Table: 1715PGr 4 NHospInfSepAll Gr TGr 2/3 TGr 3 TBoPPegfilgrastim42.9%11.4%5.71%0%68.6%20%8.57%YesPlinabulin44.8%13.8%6.90%3.44%24.1%3.4%0%Nop-valueNSNSNSNS0.00020.0250.06- Open table in a new tab . Plin requires at least 50% fewer touches to the health care system and is equally effective as Peg for prevention of CIN and its clinical sequelae. Plin causes less thrombopenia and bone pain. Plin (given as a 40 mg fixed dose) is currently in two phase III trials for CIN.

Guideline adherence for the management of emergency department patients with febrile neutropenia and no infection source: Is there room for improvement?

Febrile neutropenia is an oncologic emergency associated with significant morbidity and mortality. The objective of our study was to assess guideline adherence and clinical outcomes associated with the management of high- and low-risk febrile neutropenia patients presenting to the emergency department. A retrospective observational cohort study was conducted at a 60,000-visit emergency department at an academically-affiliated tertiary referral hospital. Patients were identified as low- or high-risk using the guideline-recommended Multinational Association for Supportive Care in Cancer score. The primary outcome was the proportion of cases in which the management was concordant with applicable febrile neutropenia guidelines. Guideline adherence was defined as hospital admission and intravenous antimicrobial therapy for high-risk patients and discharge home with oral antimicrobial therapy for low-risk patients. Secondary outcomes included appropriate vancomycin administration, hospital length of stay, rates of acute kidney injury, in-hospital Clostridium difficile infection rates, and 30-day mortality. Of the 237 patients included, 94 (39.7%) were low-risk patients and 143 (60.3%) were high-risk patients. Guideline adherence occurred in 96.8% of high-risk patients and 0.4% of low-risk patients. Mean hospital length of stay of the low-risk group was 5 ± 5.0 days compared to 7.2 ± 7.3 days in the high-risk group. Vancomycin was often inappropriately given in 69.5% of high-risk patients. Clostridium difficile occurred in 15 (10.3%) adherent and 4 (4.4%) non-adherent patients. By 30 days, 4 (4.3%) low-risk and 15 (10.7%) high-risk patients died. Adherence to the febrile neutropenia guidelines was low resulting in unnecessary hospital admissions of low-risk patients and frequent over-prescription of empirical vancomycin.

Validation of the Clinical Index of Stable Febrile Neutropenia (CISNE) model in febrile neutropenia patients visiting the emergency department. Can it guide emergency physicians to a reasonable decision on outpatient vs. inpatient treatment?

Advances in oncology have enabled physicians to treat low-risk febrile neutropenia (FN) in outpatient settings. This study was aimed to explore the usefulness of the CISNE model and identify better triage in the emergency setting. This is a retrospective cohort study on 400 adult FN patients presenting to the Emergency Department of National Cancer Center, Korea from January 2010 to December 2016. All had been treated with cytotoxic chemotherapy for solid tumors in the previous 30 days. The primary outcome was the frequency of any serious complications during the duration of illness. Apparently stable patients numbered 299 (74.8%) of 400, and the remainder comprised clinically unstable patients. The stable patients fell into three cohorts according to the risk scores: CISNE I (low risk), 56 patients (18.7%); CISNE II (intermediate), 124 (41.5%) and CISNE III (high), 119 (39.8%). The primary outcome occurred in 10.7%, 19.4% and 33.6%, respectively, according to the cohort. Compared with the Multinational Association of Supportive Care in Cancer Risk Index Score (MASCC RIS), CISNE I stratum had significantly lower sensitivity (0.22 vs. 0.95 of MASCC low risk) but higher specificity (0.91 vs. 0.17) to predict zero occurrence of the primary outcome. The CISNE model was useful for identifying low-risk FN patients for outpatient treatment. The combination of the CISNE and MASCC RIS may help emergency physicians cope with FN more confidently.

A novel approach to improving ambulatory outpatient management of low risk febrile neutropenia: an Enhanced Supportive Care (ESC) clinic.

Outpatient management of low risk febrile neutropenia patients (LRFN) identified by the MASCC score is a safe and effective strategy. Early supportive care has been shown to improve outcomes in patients with care. We developed an innovative ambulatory outpatient "enhanced supportive care" (ESC) clinic combining emergency oncology and supportive care through which we incorporated the management of patients with LRFN. An ESC clinic was started in January 2017 at a tertiary cancer hospital in the North West of England. An integral part of the clinic was an ambulatory pathway for patients presenting with LRFN. Patients with a MASCC score ≥ 21 and an Early Warning Score ≤ 3 were potentially eligible for the pathway. Suitable patients were managed with oral amoxicillin/clavulanic acid (500/125mg TDS) and ciprofloxacin (500mg BD) or moxifloxacin 400mg OD if penicillin allergic. All patients had one dose of intravenous meropenem on arrival. In its first year, 68 patients with LRFN were managed through the clinic. Table 1 shows the demographic data of the patients. Six (8.8%) patients had a 7-day readmission. There were no serious complications in the cohort. The ESC clinic maybe an effective method for delivering outpatient ambulatory management of patients with LRFN.

A cohort study on protocol-based nurse-led out-patient management of post-chemotherapy low-risk febrile neutropenia.

International guidelines adopt risk stratification approach to manage patients with low-risk febrile neutropenia patients. We developed this out-patient program using shared-care model with professional input and patient empowerment, so as to reduce patients' psychological burden from hospitalization and to improve the cost-effectiveness of management. This is a prospective cohort study to compare the efficacy and safeness of the out-patient program when compared with traditional in-patient care. Patients with solid tumors, developed febrile neutropenia with Multinational Association of Supportive Care in Cancer score of at least 21, and good performance status were included. After initial assessment and the first dose of oral antibiotics, patients were observed in the ambulatory center. Stable patients were discharged home after 4h of observation and nurse counseling. Patients' condition and clinical progress were regularly reviewed by specialist nurses within the following week by telephone and nurse clinic follow-up. The primary objective of the study is success rate, which defined as the resolution of fever and infection, without hospitalization or any change in antibiotics. From September 2014 to December 2016, a total of 38 patients were enrolled. Majority were female with breast cancer (97%). Two patients required hospitalization due to persistent fever. The success rate of the out-patient program was not significantly different from the historical in-patient cohort (94.9 versus 97.4%, p = 0.053). No mortality was observed. Patients' compliance to the program was 100%, to telephone follow-up, nurse clinic visits, and daily temperature record. Out-patient management of patients with low-risk febrile neutropenia is effective and safe through implementation of a structured protocol with joint inputs and engagement from clinicians, oncology nurses, and patients.

Acute Oncology Care: A narrative review of the acute management of neutropenic sepsis and immune-related toxicities of checkpoint inhibitors

Cancer care has become increasingly specialized and advances in therapy have resulted in a larger number of patients receiving care. There has been a significant increase in the number of patients presenting with cancer related emergencies including treatment toxicities and those directly related to the malignancy.Suspected neutropenic sepsis is an acute medical emergency and empirical antibiotic therapy should be administered immediately. The goal of empirical therapy is to cover the most likely pathogens that will cause life-threatening infections in neutropenic patients.Patients with febrile neutropenia are a heterogeneous group with only a minority of treated patients developing significant medical complications. Outpatient management of low risk febrile neutropenia patients identified by the MASCC score is a safe and effective strategy.Immunotherapy with “checkpoint inhibitors” has significantly improved outcomes for patients with metastatic melanoma and evidence of benefit in a wide range of malignancies is developing. Despite these clinical benefits a number of immune related adverse events have been recognised which can affect virtually all organ systems and are potentially fatal. The timing of the onset of the adverse events is dependent on the organ system affected and unlike anti-neoplastic therapy can be delayed significantly after initiation or completion of therapy.The field of Acute Oncology is changing rapidly. Alongside, the traditional challenge of neutropenic sepsis there are many emerging toxicities. Further research into the optimal management, strategies and pathways of acutely unwell patients with cancer is required.

Therapeutic Use of Filgrastim for Established Febrile Neutropenia Is Cost Effective Among Patients With Solid Tumors and Lymphomas

PurposeWith the emergence of biosimilar filgrastim to the market, there is a gradual decrease in the listed price of the originator product of filgrastim over the years, and this could have an impact on the cost-effectiveness of filgrastim in the treatment of febrile neutropenia (FN). A cost-effectiveness analysis would allow clinicians to make informed decision when considering the therapeutic filgrastim among low-risk FN patients. This study aims to evaluate the cost-effectiveness of adding therapeutic filgrastim to antibiotics in the treatment of established FN among patients with solid tumors and lymphomas. MethodsA decision tree model was created to compare two treatment options for established FN as follows: (1) antibiotics alone (standard care) and (2) antibiotics with therapeutic filgrastim (comparator). The target population was a hypothetical cohort of adult cancer patients with solid tumors or lymphomas hospitalized with FN in Singapore. The analysis was performed from a hospital’s perspective over a 21-day time horizon. The main outcome measures included costs, quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to evaluate the robustness of the results. FindingsCompared with antibiotics alone, the treatment strategy of antibiotics with therapeutic filgrastim was a dominant choice, incurring a cost saving of US$125 per patient (comparator versus standard care: US$9110 versus US$9235) and additional health benefit of 0.0007 QALY gained per patient (comparator versus standard care: 0.0450 versus 0.0443). Model results were robust against the parameter variations in the one-way sensitivity analyses, but increasing the cost of filgrastim beyond US$87 per injection would increase the ICER to >US$50,000/QALY. Furthermore, the strategy of antibiotics with therapeutic filgrastim was the preferred choice (dominant or cost-effective) in 83.7% of the model iterations at a willingness-to-pay threshold of US$50,000/QALY. ImplicationsFrom a hospital’s perspective, the therapeutic filgrastim, in conjunction with antibiotics, in the treatment of FN is cost effective. This provides evidence to support the routine use of filgrastim for the treatment of FN among adult cancer patients with solid tumors and lymphomas.

The prognostic performance of adding patient-reported outcomes to the MASCC risk index to identify low-risk febrile neutropenia patients with solid tumors and lymphomas.

This study aims to develop and validate a prognostic model (PROMASCC) by incorporating the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N) elements, with the Multinational Association of Supportive Care in Cancer (MASCC) risk index, for identifying low-risk patients with febrile neutropenia (FN) for developing serious complications. This was a single-center, cross-sectional observational study. Either English or Chinese versions of the FACT-N were administered to the eligible patients according to their language preference within 7days of FN onset. Univariate analyses and multivariate analyses were performed to construct the PROMASCC model. The prognostic performance was compared between the PROMASCC model and MASCC risk index. The internal validation of the PROMASCC model was examined by bootstrapping technique. From August 2014 to April 2016, a total of 120 eligible patients were included in this study. In the univariate analyses, only the malaise subscale score has been significantly associated with the favorable outcome (without complications) (P=0.024). Compared to the MASCC risk index, the PROMASCC model has shown advantages on the improved specificity (64.3 vs. 38.1%) and positive predictive value (81.0 vs. 73.7%), lower misclassification rate (24.2 vs. 25.8%), and increased area under receiver-operating characteristic curve (0.732 vs. 0.658). The bootstrapping procedure estimates the optimism-corrected area for the PROMASCC model to be 0.731 (95% CI 0.648 to 0.814). This study has developed and validated a PROMASCC model and demonstrated that additional measurement on patient's fatigue level could improve the risk stratification of patients with FN.

ドセタキセルの外来化学療法時における発熱に対する経口抗菌剤のアドヒアランス

Febrile neutropenia (FN) is a critical condition in outpatient docetaxel chemotherapy. Many studies have provided evidence for the benefit of oral antibiotics in low risk FN patients and in December 2007, the National Cancer Center Hospital East started to use oral antibiotics routinely for the initial management of such patients. However, it is unclear whether oral antibiotics are being taken properly as initial treatment in the outpatient chemotherapy setting. In this study using patient records, we retrospectively investigated adherence in patients who had been prescribed oral antibiotics as needed during outpatient docetaxel chemotherapy between December 2007 and November 2009. Among the 335 subjects in our study, 87 (26%) developed fevers of above 38 degrees Celsius. Of these patients, 74 (85%) started taking oral antibiotics, and 60 patients finished the course of antibiotics as instructed. The frequency of proper use of oral antibiotics was significantly higher in patients who consulted the hospital by telephone than those who did not (88% vs. 51%, p < 0.001).The findings of this study show that most patients started taking oral antibiotics when they developed a fever of above 38 degrees Celsius, but many stopped taking them after the fever was resolved, and that telephone consultation could be beneficial in increasing adherence. However, few patients had to be admitted to the emergency department for treatment.

Management of febrile neutropenia: ESMO Clinical Practice Guidelines

Management of febrile neutropenia: ESMO Clinical Practice Guidelines J. de Naurois, I. Novitzky-Basso, M. J. Gill, F. Marti Marti, M. H. Cullen & F. Roila On behalf of the ESMO Guidelines Working Group* Department of Medical Oncology; Department of Haematology; Department of Clinical Microbiology, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK; Department of Medical Oncology, S. Maria Hospital, Terni, Italy

A randomized prospective open labeled study of oral amoxicillin-clavulanate with intravenous ceftriaxone and amikacin in low risk febrile neutropenia

18551 Background: Empiric oral antibiotic administration is a treatment option in low risk febrile neutropenia. Methods: Low risk febrile neutropenia patients (expected neutropenic duration &lt;7 days with no comorbid features) between 15 and 75 years of age were randomized to receive either oral amoxicillin-clavulanate 625 mg twice daily and levofloxacin 500 mg once daily or intravenous (i.v.) ceftriaxone 2 g and amikacin 15 mg/kg once daily. Most patients were treated on out patient basis. The primary end point was response to therapy- defervescence of fever within 72 hours with improvement in any clinical manifestation of infection and no recurrence of fever for 48 hours without use of antipyretics. Use of growth factors was not permitted except in treatment failure. The study was cleared by the institute ethics committee. Results: Sixty four episodes in 53 patients were evaluable, 33 in the i.v. group and 31 in the oral antibiotics group. The underlying diagnosis was bone and soft tissue sarcomas in 32 episodes, hematological cancers in 22 and other solid cancers in 10. The groups were equally matched for age (median 25 years in the i.v. arm and 19 years in the oral arm), gender, type of cancer, baseline absolute neutrophil count (median 200/μL in both arms) and duration of neutropenia (5 days and 4 days in the i.v. and oral groups respectively). A focus of infection was identified clinically in 15% of episodes and microbiologically in 11% of episodes; 57% of which were gram positive organisms and the rest gram negative. Seventy two percent (95% confidence interval 58% to 88%) in the i.v. arm and 77% (95% confidence interval 63% to 92%) in the oral arm responded to therapy. The only serious toxicity was one episode of convulsions in the i.v. group. All treatment failures received second line i.v. antibiotics. There was no mortality in either group. Comparing the two groups for equivalence (assuming a 25% difference between the two arms as unequal) the two groups were found to be equivalent with a power of 59% (p = 0.03). Conclusion: Oral antibiotics have comparable efficacy as intravenous antibiotics in the management of low risk febrile neutropenia. No significant financial relationships to disclose.