{"title":"[多药抢救治疗后用pegfilgrastim治疗复发/难治性淋巴瘤的门诊管理安全性和可行性:一项单中心、开放标签、非随机、前瞻性介入研究]。","authors":"Hiromi Iwasaki, Satoshi Yamasaki, Masanori Kadowaki, Mariko Minami, Tomoyuki Nukada, Ken Takase","doi":"10.11406/rinketsu.64.596","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>We sought to assess the safety and feasibility of outpatient management in Japanese patients with relapsed/refractory lymphoma who had received pegfilgrastim after salvage therapy.</p><p><strong>Method: </strong>This was a single-center, open-label, non-randomized, prospective interventional analysis. Patients were completely hospitalized for cycle 1 of chemotherapy. Those who met the outpatient management criteria (outpatient group) were subsequently admitted to the hospital for chemotherapy cycles but were discharged after each cycle was completed. The inpatient group was discharged when white blood cell and platelet counts improved. Pegfilgrastim was given as a single 3.6 mg dose by subcutaneous injection 2 days after the completion of each chemotherapy cycle.</p><p><strong>Results: </strong>The percentage of outpatient management days (primary endpoint) ranged from 68.2%-75.0% in the outpatient group and 28.6%-50.0% in the inpatient group. According to the secondary endpoints, there were no hospitalizations due to febrile neutropenia during the outpatient period. There were no major safety concerns raised.</p><p><strong>Conclusions: </strong>For patients with relapsed/refractory lymphoma, pegfilgrastim administration after salvage therapy in an outpatient setting was feasible and safe for those who satisfied the outpatient management criteria.</p>","PeriodicalId":6352,"journal":{"name":"[Rinsho ketsueki] The Japanese journal of clinical hematology","volume":"64 7","pages":"596-607"},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Safety and feasibility of outpatient management in relapsed/refractory lymphoma treated with pegfilgrastim after multi-agent salvage therapy: a single-center, open-label, non-randomized, prospective interventional study].\",\"authors\":\"Hiromi Iwasaki, Satoshi Yamasaki, Masanori Kadowaki, Mariko Minami, Tomoyuki Nukada, Ken Takase\",\"doi\":\"10.11406/rinketsu.64.596\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>We sought to assess the safety and feasibility of outpatient management in Japanese patients with relapsed/refractory lymphoma who had received pegfilgrastim after salvage therapy.</p><p><strong>Method: </strong>This was a single-center, open-label, non-randomized, prospective interventional analysis. Patients were completely hospitalized for cycle 1 of chemotherapy. Those who met the outpatient management criteria (outpatient group) were subsequently admitted to the hospital for chemotherapy cycles but were discharged after each cycle was completed. The inpatient group was discharged when white blood cell and platelet counts improved. Pegfilgrastim was given as a single 3.6 mg dose by subcutaneous injection 2 days after the completion of each chemotherapy cycle.</p><p><strong>Results: </strong>The percentage of outpatient management days (primary endpoint) ranged from 68.2%-75.0% in the outpatient group and 28.6%-50.0% in the inpatient group. According to the secondary endpoints, there were no hospitalizations due to febrile neutropenia during the outpatient period. There were no major safety concerns raised.</p><p><strong>Conclusions: </strong>For patients with relapsed/refractory lymphoma, pegfilgrastim administration after salvage therapy in an outpatient setting was feasible and safe for those who satisfied the outpatient management criteria.</p>\",\"PeriodicalId\":6352,\"journal\":{\"name\":\"[Rinsho ketsueki] The Japanese journal of clinical hematology\",\"volume\":\"64 7\",\"pages\":\"596-607\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"[Rinsho ketsueki] The Japanese journal of clinical hematology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.11406/rinketsu.64.596\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"[Rinsho ketsueki] The Japanese journal of clinical hematology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.11406/rinketsu.64.596","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[Safety and feasibility of outpatient management in relapsed/refractory lymphoma treated with pegfilgrastim after multi-agent salvage therapy: a single-center, open-label, non-randomized, prospective interventional study].
Objective: We sought to assess the safety and feasibility of outpatient management in Japanese patients with relapsed/refractory lymphoma who had received pegfilgrastim after salvage therapy.
Method: This was a single-center, open-label, non-randomized, prospective interventional analysis. Patients were completely hospitalized for cycle 1 of chemotherapy. Those who met the outpatient management criteria (outpatient group) were subsequently admitted to the hospital for chemotherapy cycles but were discharged after each cycle was completed. The inpatient group was discharged when white blood cell and platelet counts improved. Pegfilgrastim was given as a single 3.6 mg dose by subcutaneous injection 2 days after the completion of each chemotherapy cycle.
Results: The percentage of outpatient management days (primary endpoint) ranged from 68.2%-75.0% in the outpatient group and 28.6%-50.0% in the inpatient group. According to the secondary endpoints, there were no hospitalizations due to febrile neutropenia during the outpatient period. There were no major safety concerns raised.
Conclusions: For patients with relapsed/refractory lymphoma, pegfilgrastim administration after salvage therapy in an outpatient setting was feasible and safe for those who satisfied the outpatient management criteria.