The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.
The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.
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DOI：
10.1186/s41687-020-00255-0
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发表时间：
2020-10-30
影响因子：
2.7
通讯作者：
Pappot H
中科院分区：
文献类型：
--
作者：
Tolstrup LK;Bastholt L;Dieperink KB;Möller S;Zwisler AD;Pappot H
进行了一项随机对照试验，以评估接受免疫治疗的黑色素瘤患者在治疗期间使用定制的电子患者报告结果工具以及标准毒性监测与单独标准监测相比，是否将3级或4级不良事件的数量减少了50%。次要终点是：干预组是否报告了更多的不良事件，两组在电话咨询次数、额外门诊就诊次数、住院天数、类固醇治疗天数以及患者出现2级或更高毒性的时间方面是否存在差异。在丹麦欧登塞大学医院肿瘤科接受免疫治疗的黑色素瘤患者参与了研究。标准治疗包括临床医生在每个治疗周期前使用不良事件通用术语标准对不良事件进行评估。此外，随机分配到干预组的患者每周通过基于PRO-CTCAE平台的电子pro -工具报告他们的ae。146名黑色素瘤患者被随机分组。在本研究中，我们没有发现两组在3级或4级ae数量（P = 0.983）、ae总数量（P = 0.560）或两组患者出现2级或更高毒性的时间（0.516）方面存在差异。干预组患者的电话联系次数显著高于干预组（P = 0.009），干预组患者的额外就诊次数有增加的趋势（P = 0.156）。已经研究了接受免疫治疗的黑色素瘤患者的严重不良事件的数量是否可以通过让患者报告症状来减少。这些结果并不能证明将试点研究扩展到具有这种特殊设置的常规III期研究的合理性。然而，随着干预组患者打电话次数的增加，电话联系次数也有显著差异，这表明他们对不良事件的关注有所增加。即使电子PRO工具的使用不能减少该黑色素瘤人群中严重ae的数量，也不能排除对其他终点（如生活质量、沟通或治疗计划）的积极影响。Clinicaltrials.gov NCT03073031注册于2017年3月8日，回顾性注册。
A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156). It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.
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DOI：
10.1056/nejmoa1003466
发表时间：
2010-08-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Hodi FS;O'Day SJ;McDermott DF;Weber RW;Sosman JA;Haanen JB;Gonzalez R;Robert C;Schadendorf D;Hassel JC;Akerley W;van den Eertwegh AJ;Lutzky J;Lorigan P;Vaubel JM;Linette GP;Hogg D;Ottensmeier CH;Lebbé C;Peschel C;Quirt I;Clark JI;Wolchok JD;Weber JS;Tian J;Yellin MJ;Nichol GM;Hoos A;Urba WJ
通讯作者：
Urba WJ
DOI：
10.1056/nejmoa1504030
发表时间：
2015-07-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Larkin J;Chiarion-Sileni V;Gonzalez R;Grob JJ;Cowey CL;Lao CD;Schadendorf D;Dummer R;Smylie M;Rutkowski P;Ferrucci PF;Hill A;Wagstaff J;Carlino MS;Haanen JB;Maio M;Marquez-Rodas I;McArthur GA;Ascierto PA;Long GV;Callahan MK;Postow MA;Grossmann K;Sznol M;Dreno B;Bastholt L;Yang A;Rollin LM;Horak C;Hodi FS;Wolchok JD
通讯作者：
Wolchok JD
影响因子：
4.7
作者：
Baeksted, Christina;Nissen, Aase;Johansen, Christoffer
通讯作者：
Johansen, Christoffer
影响因子：
2.7
作者：
Mendoza, Tito R.;Dueck, Amylou C.;Basch, Ethan
通讯作者：
Basch, Ethan
影响因子：
3
作者：
Mooney, Kathi;Whisenant, Meagan S.;Beck, Susan L.
通讯作者：
Beck, Susan L.