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Background: Chemotherapy (CT)-induced neutropenia and febrile neutropenia (FN) can lead to changes in the treatment plan, potentially worsening the cancer outcome. This study evaluated the effect of the glycopegylated granulocyte-colony stimulating factor lipegfilgrastim, used as primary (PP) or secondary prophylaxis (SP), on treatment modifications in adult patients receiving cytotoxic CT with or without biological/targeted therapy (BT) for solid and haematological tumours., Methods: This phase 4, prospective, observational study was conducted in eight centres in the Netherlands, in 2015-2017. Other study objectives were to characterise the population of cancer patients receiving lipegfilgrastim, to evaluate the incidence of CT-induced neutropenic events, and to assess safety., Results: Of 142 patients, 73.94% had breast cancer and 55.63% received CT in the adjuvant setting. Most patients received lipegfilgrastim as PP (74.65%) and were at low (34.51%) or high risk (39.44%) of FN. CT dose delays were recorded for 22.64% and 36.11% of patients receiving lipegfilgrastim for PP and SP, respectively. CT dose reductions were recorded for 2.11% of patients; no CT dose omissions and one BT dose omission occurred. FN and grade III/IV neutropenia were reported for 5.63% and 9.86% of patients, respectively; associated hospitalisations were rare. The most frequently lipegfilgrastimrelated adverse events (AE) were myalgia, bone pain, and back pain. Serious AEs (55) were reported for 30 (21.13%) patients. There were two deaths, unrelated to lipegfilgrastim administration., Conclusion: Administration of lipegfilgrastim in routine clinical practice in the Netherlands results in limited CT/BT dose modifications and low incidence of neutropenic events, with no new safety concerns.

Purpose: The Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on patients. The FACT-EGFR-18 was translated into Dutch and evaluated in order to document that the translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population., Method: Translation of the FACT-EGFRI-18 from English to Dutch was accomplished by employing the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation methodology. Ten native-speaking residents of the target country who reported EGFRI associated dermatological adverse events (dAEs) were asked to review the translation of the harmonized FACT-EGFRI-18., Results: Participants generally found the Dutch FACT-EGFRI-18 easy to understand and complete. In addition, the translation retained the original meaning of the FACT-EGFRI-18 items and instructions. Based on the results of the cognitive debriefing interviews, no changes to improve clarity and comprehension of translations were identified., Conclusions: The Dutch FACT-EGFRI-18 demonstrates content validity and linguistic validity, and was found conceptually equivalent to its English source, thus confirming linguistic validation. The results suggest that the Dutch FACT-EGFRI-18 can be applied to measure dAE related health related quality of life in Dutch-speaking patients undergoing EGFRI therapy. Formal validation of the Dutch FACT-EGFRI-18 is ongoing., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

As research continues to highlight the risks involved in handling antineoplastic drugs, the health services are giving increased attention to safety measures. In order to establish what protective measures nursing staff employ and what they know about antineoplastic drugs, a survey was carried out in The Netherlands. The questions were based on the self-study modules by Dunne and the (American) Oncology Nursing Society. A total of 1,373 questionnaires were distributed in 10 hospitals. Of these, 824 were returned, which represents a response rate of 60%. Over two-thirds (68%) of the nursing staff reported that they were involved, on a daily or weekly basis, in caring for patients being treated with antineoplastic drugs. In the view of 94% of the nurses, protective measures are effective. While administering antineoplastic drugs, 91% of the respondents said that they wore gloves, 21% said that they wore a gown, 18% wore a mask, and 3% used goggles. While handling excreta, fewer nurses applied safety measures. Thirty-nine percent of the respondents knew that latex gloves offer a greater degree of protection than PVC gloves. It appeared that there was not one Dutch hospital whose guidelines for the safe handling of antineoplastic material were completely up-to-date and that nurses do not always follow the guidelines established.