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1585 Breakthrough febrile neutropenia after the use of pegylated filgrastim (pegfilgrastim): Incidence and risk factors
Abstracts 1585 POSTER Breakthrough febrile neutropenia after the use of pegylated filgrastim (pegfilgrastim): Incidence and risk factors I. Ahmad1 , K. AbdulRahman2 , J. Zekri3 , S. Karim3 , E. AbdelGhany4 . 1 Al Faisal University Riyadh, King Faisal Specialist Hospital and Reseach Ctr Jeddah, Oncology, Jeddah, Saudi Arabia; 2 King AbdulAziz University Jeddah, Medicine, Jeddah, Saudi Arabia; 3 Al Faisal University Riyadh, King Faisal Specialist Hosp and research Ctr Jeddah, Oncology, Jeddah, Saudi Arabia; 4 National Cancer Institute, Cairo, Egypt. King Faisal Specialist Hosp and Research Ctr Jeddah, Oncology, Jeddah, Saudi Arabia Background: Haematopoietic growth factors (HGFs) reduces the risk of febrile neutropenia (FN) by about 50% in cancer patients receiving chemotherapy. However, breakthrough febrile neutropenia (BTFN) despite the use of HGFs is still a potentially serious complication. Pegfilgrastim, a long acting HGF predominantly eliminated through neutrophil-mediated clearance is increasingly used prophylactically due to its effectiveness and convenience. We aim to investigate the frequency of BTFN and its risk factors in Middle Eastern cancer patients receiving prophylactic Pegfilgrastim after cytotoxic chemotherapy. Materials and Methods: 183 consecutive patients with solid tumors who received Pegfilgrastim either in primary or secondary prophylaxis settings from Jan 2009-Dec 2010 were identified. Patients with leukemia, myeloma or undergoing hematopoietic stem cells transplantation were excluded. Pegfilgrastim was administered in a single subcutaneous injection (6 mg), 24−48 hours after completion of chemotherapy. Rate of BTFN was calculated as (number of episodes of BTFN/total number of injections of Pegfilgrastim x 100). Risk factors contributing to the development of BTFN were analyzed by chi-square test. 33% of patients had a diagnosis of breast cancer, 32% had lymphoma and 34% had miscellaneous other solid tumor. 183 patients had received total of 591 injections of Pegfilgrastim. Median age of patients was 45 yrs. (14−85 yrs.). 120 patients (65.5%) were female. Following variables were analyzed using chi-square test for their association with the development of BTFN: age, sex, comorbidities, type of cancer, stage of disease, curative vs. palliative treatment, single vs. combination chemotherapy, body mass index, serum hemoglobin and serum albumin. Results: 581 doses of Pegfilgrastim were administered to 183 patients. Median age of patients was 45 (14−85) years and 120 patients (65.5%) were females. 49 episodes of BTFN occurred after the use of 581 injections of Pegfilgrastim resulting in an incidence of 8.4%. Out of 183 patients, 40 (21.9%) developed one or more episode of BTFN. None of the above analyzed variables were found to be a significant risk factor for the development of BTFN. Only serum albumin level showed a trend towards significance. 37.5% patients with low serum albumin level developed BTFN c/w 20.3% patients with normal serum albumin (p = 0.06). Conclusion: Incidence of BTFN after the use of Pegfilgrastim in our Middle Eastern cancer patient population was found to be 8.4%. Low albumin level indicating malnutrition in cancer patients has shown a non-significant trend toward development of BTFN. No conflict of interest. 1586 POSTER Oral vs intravenous antibiotics in low risk paediatric febrile neutropenia: A meta-analysis of randomised controlled trials A. Vedi1 , R. Cohn2 . 1 Royal Marsden Hospital, Drug Development Unit, London, United Kingdom; 2 Sydney Children’s Hospital, Kids Cancer Centre, Sydney, Australia Background: Sepsis is a major cause of morbidity and mortality in paediatric oncology patients, particularly during periods of neutropenia, which is a well-recognised complication of immunosuppressive therapy. Stratification of patients into low and high-risk categories has facilitated a new tailored approach to empiric therapy. The availability of oral antimicrobial drugs with broad-spectrum activity against common pathogens may provide an attractive alternative. Aims/Objectives: To determine whether, in low-risk febrile neutropenic paediatric populations, oral antibiotics are as effective as intravenous antibiotics in obtaining resolution of the febrile neutropenic episode. Methods: A comprehensive literature search of MEDLINE, EMBASE and CENTRAL identified prospective, randomised controlled trials comparing oral antibiotics to intravenous antibiotics in the treatment of febrile neutropenic episodes in low-risk paediatric oncology patients. Outcomes assessed were mortality, rate of treatment failure, length of the febrile neutropenic episode and adverse events. The random effects model was used to calculate risk ratios (RR) for dichotomous data and mean difference with standard deviation for continuous data.
S233 Results: Seven trials were included in the overall analysis, which included 934 episodes of febrile neutropenia in 676 patients aged between 9 months and 20 years. The overall treatment failure rates were not significantly different between oral and intravenous antibiotics (RR: 1.02, 95% CI 0.78 to 1.32, p = 0.91). Conclusions: In carefully selected low-risk febrile neutropenic children, empiric treatment with oral antibiotics is a safe and effective alternative to intravenous antibiotics, as they lower the cost of treatment, and psychosocial burden on these children and their families. No conflict of interest. 1587 POSTER Ability of intranasal transmucosal fentanyl in pectin to prevent breakthrough pain episodes in patients with radiation-induced oropharyngeal mucositis ˜ 5 , A. De R. Moleron1 , L. Cerezo2 , A. Ruiz3 , A. Hervas4 , A. Manas la Torre1 . 1 Hospital Universitario Puerta De Hierro − Majadahonda, Department of Radiation Oncology, Madrid, Spain; 2 Hospital Universitario de la Princesa, Department of Radiation Oncology, Madrid, Spain; 3 Hospital Universitario 12 de Octubre, Department of Radiation Oncology, Madrid, Spain; 4 Hospital Universitario Ramon y Cajal, Department of Radiation Oncology, Madrid, Spain; 5 Hospital Universitario La Paz, Department of Radiation Oncology, Madrid, Spain Background: GICOR, Spanish Group of Clinical Investigation in Radiation Oncology, conducted this observational study to evaluate the efficacy, toxicity and quality of life associated with the administration of intranasal transmucosal fentanyl in pectin (ITFP) among patients with mucositis secondary to radiotherapy or chemoradiotherapy for head and neck tumors. Materials and Methods: This prospective observational study (NCT02050503) comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated. The effective dose was defined as the dose offering satisfactory relief from two consecutive episodes of breakthrough pain without unacceptable toxic effects, in the 30 minutes following drug administration and food intake. Patients reaching an effective dose in the titration phase continued in the treatment phase until completing the treatment of 10 (up to 12) consecutive episodes of breakthrough pain. Primary treatment efficacy has been estimated based on the number of patients achieving significant relief (decrease in the VAS score 2 points) when episodes in the treatment phase and during screening were compared. QoL was measured at the beginning of the screening phase and at the end of the study using EORTC QLQ-C30 questionnaire. Results: Fifty-five patients were enrolled of which 33 were evaluable, 20 male (66.6%), age 59.7±8.4 y.o. BMI 24.7±3.7 Kg/m2 . Concurrent cisplatin based chemotherapy (54.5%) or cetuximab (27%) or both (6%) have been administered. After the screening phase, 69.7% presented mucositis grade 3. A total of 448 episodes were analyzed within the treatment phase. Median VAS at baseline was 6 (p25=3 p75=7) and 3 (p25=2 p75=4) during treatment phase (p < 0.01). Sixteen (48.5%) patients reached a difference between VAS 30 min after starting food intake during the screening phase and 30 min after ITFP administration during the treatment phase 2. Median QLQ-C30 Score standardized at the beginning of the study was 51 and 60 after the treatment phase (p < 0.001). Though no enteral feeding was allowed during the study, weight remained stable through the study period (BMI 24.4 vs 24.2). One patient presented with respiratory depression after overdosing due to repeated administration needing Intensive Care Unit admission (grade 4). Two patients presented with nausea (grade 1) and one with hypotension (grade 1) after receiving ITFP. Conclusions: ITFP is an effective treatment for breakthrough pain related with oral intake in patients with radiation induced oral mucositis in selected patients that significantly improves their pain control. Proper patient training is mandatory. Improving breakthrough pain control could decrease the need of enteral feeding. Conflict of interest: Other Substantive Relationships: This study was funded with an unrestricted grant from Archimedes Pharma. 1588 POSTER Population pharmacokinetics of rolapitant in patients with chemotherapy-induced nausea and vomiting X. Wang1 , J. Wang1 , V. Kansra1 . 1 TESARO, Clinical Pharmacology, Waltham, MA, USA Background: Rolapitant is a selective and long acting Neurokinin-1 (NK-1) receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV). Objectives of this analysis were to describe the
S233 Results: Seven trials were included in the overall analysis, which included 934 episodes of febrile neutropenia in 676 patients aged between 9 months and 20 years. The overall treatment failure rates were not significantly different between oral and intravenous antibiotics (RR: 1.02, 95% CI 0.78 to 1.32, p = 0.91). Conclusions: In carefully selected low-risk febrile neutropenic children, empiric treatment with oral antibiotics is a safe and effective alternative to intravenous antibiotics, as they lower the cost of treatment, and psychosocial burden on these children and their families. No conflict of interest. 1587 POSTER Ability of intranasal transmucosal fentanyl in pectin to prevent breakthrough pain episodes in patients with radiation-induced oropharyngeal mucositis ˜ 5 , A. De R. Moleron1 , L. Cerezo2 , A. Ruiz3 , A. Hervas4 , A. Manas la Torre1 . 1 Hospital Universitario Puerta De Hierro − Majadahonda, Department of Radiation Oncology, Madrid, Spain; 2 Hospital Universitario de la Princesa, Department of Radiation Oncology, Madrid, Spain; 3 Hospital Universitario 12 de Octubre, Department of Radiation Oncology, Madrid, Spain; 4 Hospital Universitario Ramon y Cajal, Department of Radiation Oncology, Madrid, Spain; 5 Hospital Universitario La Paz, Department of Radiation Oncology, Madrid, Spain Background: GICOR, Spanish Group of Clinical Investigation in Radiation Oncology, conducted this observational study to evaluate the efficacy, toxicity and quality of life associated with the administration of intranasal transmucosal fentanyl in pectin (ITFP) among patients with mucositis secondary to radiotherapy or chemoradiotherapy for head and neck tumors. Materials and Methods: This prospective observational study (NCT02050503) comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated. The effective dose was defined as the dose offering satisfactory relief from two consecutive episodes of breakthrough pain without unacceptable toxic effects, in the 30 minutes following drug administration and food intake. Patients reaching an effective dose in the titration phase continued in the treatment phase until completing the treatment of 10 (up to 12) consecutive episodes of breakthrough pain. Primary treatment efficacy has been estimated based on the number of patients achieving significant relief (decrease in the VAS score 2 points) when episodes in the treatment phase and during screening were compared. QoL was measured at the beginning of the screening phase and at the end of the study using EORTC QLQ-C30 questionnaire. Results: Fifty-five patients were enrolled of which 33 were evaluable, 20 male (66.6%), age 59.7±8.4 y.o. BMI 24.7±3.7 Kg/m2 . Concurrent cisplatin based chemotherapy (54.5%) or cetuximab (27%) or both (6%) have been administered. After the screening phase, 69.7% presented mucositis grade 3. A total of 448 episodes were analyzed within the treatment phase. Median VAS at baseline was 6 (p25=3 p75=7) and 3 (p25=2 p75=4) during treatment phase (p < 0.01). Sixteen (48.5%) patients reached a difference between VAS 30 min after starting food intake during the screening phase and 30 min after ITFP administration during the treatment phase 2. Median QLQ-C30 Score standardized at the beginning of the study was 51 and 60 after the treatment phase (p < 0.001). Though no enteral feeding was allowed during the study, weight remained stable through the study period (BMI 24.4 vs 24.2). One patient presented with respiratory depression after overdosing due to repeated administration needing Intensive Care Unit admission (grade 4). Two patients presented with nausea (grade 1) and one with hypotension (grade 1) after receiving ITFP. Conclusions: ITFP is an effective treatment for breakthrough pain related with oral intake in patients with radiation induced oral mucositis in selected patients that significantly improves their pain control. Proper patient training is mandatory. Improving breakthrough pain control could decrease the need of enteral feeding. Conflict of interest: Other Substantive Relationships: This study was funded with an unrestricted grant from Archimedes Pharma. 1588 POSTER Population pharmacokinetics of rolapitant in patients with chemotherapy-induced nausea and vomiting X. Wang1 , J. Wang1 , V. Kansra1 . 1 TESARO, Clinical Pharmacology, Waltham, MA, USA Background: Rolapitant is a selective and long acting Neurokinin-1 (NK-1) receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV). Objectives of this analysis were to describe the