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Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701) 地塞米松预防依维莫司诱导的口腔炎(Alliance MIST试验:A221701)
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.01.001
Kathryn J. Ruddy , David Zahrieh , Jun He , Blake Waechter , Julianne L. Holleran , Lionel D. Lewis , Selina Chow , Jan Beumer , Matthias Weiss , Nikolaos Trikalinos , Bryan Faller , Maryam Lustberg , Hope S. Rugo , Charles Loprinzi

mTOR inhibitors such as everolimus may cause oral stomatitis, often a dose-limiting toxicity. Prior clinical research has suggested that a dexamethasone mouth rinse might help prevent and/or treat this. Alliance A221701 was a randomized phase III trial of patients initiating 10 mg daily oral everolimus that compared dexamethasone mouthwash taken preventively (initial dexamethasone group) versus therapeutically (initial placebo group) to assess two coprimary endpoints: the incidence of mTOR inhibitor-associated stomatitis (mIAS), and the area under the curve (AUC) of mIAS-associated pain over an 8-week treatment period. A Fisher's exact test was used to compare the incidences while a Wilcoxon rank-sum test was used to compare the AUCs. In addition, we performed an exploratory analysis of the association of everolimus trough concentrations and toxicity using a Mann-Whitney U test. Due to slow accrual, this study closed after 39 patients were randomized (19 to upfront placebo and 20 to upfront dexamethasone). There were no significant differences between groups seen in either of the coprimary endpoints; furthermore, we found no association between whole blood everolimus trough concentrations and toxicity. Although limited by poor enrollment, the results of this study do not suggest that prophylactic dexamethasone mouthwash is superior to therapeutic dexamethasone mouthwash (initiated at the first sign of mouth pain) for reducing the incidence or severity of mIAS from everolimus.

mTOR抑制剂如依维莫司可能引起口腔口炎,通常是剂量限制性毒性。先前的临床研究表明,地塞米松漱口液可能有助于预防和/或治疗这种情况。Alliance A221701是一项针对开始每天口服10 mg依维莫司的患者的随机III期试验,该试验比较了预防性(初始地塞米松组)和治疗性(初始安慰剂组)使用的地塞米松漱口水,以及在8周治疗期内mIAS相关疼痛的曲线下面积(AUC)。Fisher精确检验用于比较发生率,而Wilcoxon秩和检验用于比较AUC。此外,我们使用Mann-Whitney U检验对依维莫司谷浓度和毒性的相关性进行了探索性分析。由于积累缓慢,这项研究在39名患者被随机分组后结束(19名患者接受安慰剂治疗,20名患者接受地塞米松治疗)。两组之间在任一共同主要终点方面均无显著差异;此外,我们发现全血依维莫司谷浓度与毒性之间没有关联。尽管受入选率低的限制,但本研究的结果并不表明,预防性地塞米松漱口水在降低依维莫司引起的mIAS的发生率或严重程度方面优于治疗性地塞米松漱漱口水(在出现口腔疼痛的第一个迹象时开始)。
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引用次数: 0
Non-pharmacologic interventions for improving cancer-related fatigue (CRF): A systematic review of systematic reviews and pooled meta-analysis 改善癌症相关疲劳(CRF)的非药物干预:系统综述和汇总荟萃分析的系统综述
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.004
Silvia Belloni , Cristina Arrigoni , Irene Baroni , Gianluca Conte , Federica Dellafiore , Greta Ghizzardi , Arianna Magon , Giulia Villa , Rosario Caruso

Introduction

Literature encloses numerous systematic reviews (SRs) on nonpharmacologic interventions for improving cancer-related fatigue (CRF). The effect of these interventions remains controversial, and the available SRs have not been synthesized yet. We conducted a systematic synthesis of SRs and meta-analysis to determine the effect of nonpharmacologic interventions on CRF in adults.

Material and methods

We systematically searched 4 databases. The effect sizes (standard mean difference) were quantitatively pooled using a random-effects model. Chi-squared (Q) and I-square statistics (I²) tested the heterogeneity.

Results

We selected 28 SRs, including 35 eligible meta-analyses. The pooled effect size (standard mean difference, 95% CI) was -0.67 (-1.16, -0.18). The subgroup analysis by types of interventions showed a significant effect in all the investigated approaches (complementary integrative medicine, physical exercise, self-management/e-health interventions).

Conclusions

There is evidence that nonpharmacologic interventions are associated with CRF reduction. Future research should focus on testing these interventions on specific population clusters and trajectories.

Prospero registration

CRD42020194258.

引言文献包括许多关于改善癌症相关疲劳(CRF)的非药物干预措施的系统综述(SR)。这些干预措施的效果仍然存在争议,可用的SRs尚未综合。我们对SRs和荟萃分析进行了系统综合,以确定非药物干预对成人CRF的影响。材料和方法我们系统地检索了4个数据库。使用随机效应模型对效应大小(标准平均差)进行定量汇总。卡方(Q)和I平方统计量(I²)检验了异质性。结果我们选择了28个SR,包括35个符合条件的荟萃分析。合并效应大小(标准平均差,95%CI)为-0.67(-1.16,-0.18)。按干预类型进行的亚组分析显示,所有研究方法(补充综合医学、体育锻炼、自我管理/电子健康干预)都有显著效果。结论有证据表明,非药物干预与CRF降低有关。未来的研究应侧重于在特定人群集群和轨迹上测试这些干预措施。Prospero注册CRD42020194258。
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引用次数: 0
Epidemiology and genetics of early onset colorectal cancer—African overview with a focus on Ethiopia 早期结直肠癌的流行病学和遗传学——以埃塞俄比亚为重点的非洲综述
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.007
Chimaobi Anugwom , Grace Braimoh , Amir Sultan , Willie Mohammed Johnson , Jose D. Debes , Abdulsemed Mohammed

Colorectal cancer (CRC) is a common cause of cancer-related death worldwide, with high rates of late diagnosis and increased mortality in sub-Saharan Africa. Furthermore, there is an alarming uptrend in the incidence of early onset colorectal cancer (EOCRC) across the globe, thus necessitating the need for early screening in general and special populations. There is, however, limited data available on the incidence and genetic characteristics of EOCRC from resource-poor countries, particularly Africa. Moreover, there is lack of clarity if recommendations and mechanisms proposed based on data from resource-rich countries applies to other regions of the world. In this review, we appraise the literature on EOCRC, its overall incidence, and genetic components as it pertains to sub-Saharan Africa. In addition, we highlight epidemiologic and epigenetic findings of our EOCRC cohort in Ethiopia.

结直肠癌癌症(CRC)是全球癌症相关死亡的常见原因,在撒哈拉以南非洲,晚期诊断率高,死亡率增加。此外,全球早发癌症(EOCRC)的发病率呈惊人的上升趋势,因此需要在一般和特殊人群中进行早期筛查。然而,关于资源贫乏国家,特别是非洲EOCRC的发病率和遗传特征的可用数据有限。此外,根据资源丰富国家的数据提出的建议和机制是否适用于世界其他地区也不明确。在这篇综述中,我们评估了有关EOCRC的文献、其总体发病率和遗传成分,因为它与撒哈拉以南非洲有关。此外,我们强调了埃塞俄比亚EOCRC队列的流行病学和表观遗传学发现。
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引用次数: 1
Battling chronic myeloid leukemia in a resource-constrained country: A case of public-private partnerships 在资源有限的国家抗击慢性粒细胞白血病:一个公私合作的案例
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.002
Rabbia Tariq , Irtebaat Fatima, Muhammad H. Shahid, Samiuddin Tariq, Faizan Niaz, Syed M. Hussain

Pakistan, where chronic myeloid leukemia constitutes around 80% of all myeloproliferative disorders, has been exploring multiple avenues in order to ensure the accessibility and affordability of imatinib and nilotinib. While most provinces of the country have joined hands with a pharmaceutical company to dispense free anti-CML medicines as part of a public-private partnership, the patients are still facing numerous challenges in the form of geographical disparity in the availability of these medicines, other out-of-pocket expenditures and most importantly, the uncertainty associated with the long-term continuation of this public-private endeavor due to procedural delays. In light of these predicaments, channeling resources towards research and development, fostering partnerships between government and NGOs and tapping into the domain of compulsory licensing appear to be the most sustainable solutions.

巴基斯坦的慢性粒细胞白血病约占所有骨髓增生性疾病的80%,该国一直在探索多种途径,以确保伊马替尼和尼洛替尼的可及性和可负担性。尽管作为公私合作的一部分,该国大多数省份都与一家制药公司联手免费发放抗慢性粒细胞白血病药物,但患者仍面临着许多挑战,这些挑战表现为这些药物的可用性存在地域差异,其他自付支出,最重要的是,由于程序延误,与这一公私合作的长期持续相关的不确定性。鉴于这些困境,将资源用于研发、促进政府和非政府组织之间的伙伴关系以及利用强制许可领域似乎是最可持续的解决方案。
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引用次数: 0
The flaws in assessing and reporting the toxicities of oral targeted therapies 评估和报告口服靶向疗法毒性的缺陷
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.04.001
Tito Fojo MD, PhD
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引用次数: 0
TOC TOC
IF 4 3区 医学 Q1 Medicine Pub Date : 2023-02-01 DOI: 10.1053/S0093-7754(23)00046-5
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引用次数: 0
Synchronous or metachronous presentation of pancreatic neuroendocrine tumor versus secondary lesion to pancreas in patients affected by renal cell carcinoma. Systematic review 肾细胞癌患者胰腺神经内分泌肿瘤的同步或异时表现与胰腺继发病变的比较。系统综述
IF 4 3区 医学 Q1 Medicine Pub Date : 2022-12-01 DOI: 10.1053/j.seminoncol.2023.01.007
Irene Persano , Elena Parlagreco , Anna La Salvia , Marco Audisio , Marco Volante , Consuelo Buttigliero , Giorgio Vittorio Scagliotti , Maria Pia Brizzi

The simultaneous or metachronous occurrence of pancreatic neuroendocrine tumor (panNET) and renal cell carcinoma (RCC) may represent a rare coincidence or a manifestation of von Hippel-Lindau disease (VHL). These two malignancies share both radiological and cytopathological features, making the differential diagnosis very challenging. In this review, we collected all cases of concurrent diagnosis of localized panNET and RCC, with or without VHL, as reported in the literature to date. We aimed to provide an insight into the differential diagnosis between panNET and RCC pancreatic metastasis with a focus on the optimal therapeutic algorithm depending on the diagnosis. We performed literature research in PubMed library databases for articles about coexisting panNET and RCC published from 2001 to 2018. We selected nine articles with a total of 13 patients, including one treated at our institution. Patients' median age was 49 years and eight out of 13 patients were women. VHL was diagnosed in nine cases. Most patients underwent radical nephrectomy for RCC (9/13) and a clear cell renal carcinoma variant was identified in six cases. The diagnosis of panNET was synchronous with RCC detection in nine cases and metachronous in four cases. The diameter of the pancreatic lesion was >2 cm in six cases. In two cases the panNET was misdiagnosed as metastatic RCC by radiological tests. Somatostatin receptor scanning was performed only in our patient (Octreoscan) showing intense uptake in the pancreatic mass. Endoscopic ultrasound fine needle aspiration of the pancreatic lesion was performed in four patients: in two cases the panNET was confused with metastatic RCC by cytological analysis. Most patients underwent pancreatic surgery (10/13) without histological confirmation. Clear cell panNET was recognized in six cases, while mixed neuroendocrine non-neuroendocrine neoplasm was diagnosed in one patient. Immunohistochemistry (IHC) staining showed positivity to typical neuroendocrine markers (chromogranin A and synaptophysin) in all reported tested cases (8/8). Three patients underwent systemic treatment: two patients received sunitinib and one patient interleukin-2 (IL-2). Other neoplasms were observed in seven patients, of whom six were affected by VHL syndrome. When neoplastic lesions are recognized in both the kidney and pancreas, panNET and RCC pancreatic metastasis are often misdiagnosed due to similar radiological and cytopathological features. An accurate differential diagnosis is crucial and IHC plays a central role in distinguishing the two entities. The therapeutic algorithm may change depending on the diagnosis: while pancreatic RCC metastases benefit from resection, in panNETs and VHL the indication for surgery must be carefully evaluated.

胰腺神经内分泌肿瘤(panNET)和肾细胞癌(RCC)同时或异时发生可能是一种罕见的巧合或冯希佩尔-林道病(VHL)的表现。这两种恶性肿瘤都具有放射学和细胞病理学特征,使得鉴别诊断非常具有挑战性。在本综述中,我们收集了迄今为止文献报道的所有同时诊断为局限性panNET和RCC的病例,无论是否伴有VHL。我们的目的是提供一个洞察panNET和RCC胰腺转移的鉴别诊断,重点是根据诊断的最佳治疗算法。我们在PubMed图书馆数据库中对2001年至2018年发表的关于panNET和RCC共存的文章进行了文献研究。我们选择了9篇文章,共13例患者,其中1例在我们的机构接受治疗。患者的中位年龄为49岁,13例患者中有8例为女性。VHL确诊9例。大多数患者接受根治性肾切除术治疗RCC(9/13), 6例发现透明细胞肾癌变异。panNET与RCC同步诊断9例,异时诊断4例。6例胰腺病变直径为2 cm。在两个病例中,panNET通过放射检查被误诊为转移性肾细胞癌。生长抑素受体扫描仅在我们的患者中进行(octrescan),显示胰腺肿块强烈摄取。4例患者行胰腺病变的内镜超声细针穿刺:其中2例panNET通过细胞学分析与转移性RCC混淆。多数患者(10/13)在没有组织学证实的情况下行胰腺手术。6例诊断为透明细胞panNET, 1例诊断为混合性神经内分泌非神经内分泌肿瘤。在所有报告的检测病例中,免疫组化(IHC)染色显示典型神经内分泌标志物(嗜铬粒蛋白A和突触素)阳性(8/8)。3例患者接受全身治疗:2例患者接受舒尼替尼治疗,1例患者接受白细胞介素-2 (IL-2)治疗。7例患者出现其他肿瘤,其中6例为VHL综合征。当在肾脏和胰腺均发现肿瘤病变时,panNET和RCC胰腺转移常因放射学和细胞病理学特征相似而被误诊。准确的鉴别诊断是至关重要的,免疫组化在区分两种实体方面起着核心作用。治疗方法可能会根据诊断而改变:虽然胰腺RCC转移可以从切除中获益,但panNETs和VHL的手术适应症必须仔细评估。
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引用次数: 0
Prevalence, mutational spectrum and clinical implications of clonal hematopoiesis of indeterminate potential in plasma cell dyscrasias 浆细胞异常中潜在不确定克隆造血的患病率、突变谱和临床意义
IF 4 3区 医学 Q1 Medicine Pub Date : 2022-12-01 DOI: 10.1053/j.seminoncol.2022.11.001
Stefano Testa , Jyoti Kumar , Alex J. Goodell , James L. Zehnder , Kevin M. Alexander , Surbhi Sidana , Sally Arai , Ronald M. Witteles , Michaela Liedtke

Clonal hematopoiesis of indeterminate potential (CHIP) is common both in healthy individuals and patients with hematological cancers. Recent studies have showed worse prognosis for patients with multiple myeloma (MM) and non-Hodgkin lymphoma undergoing stem cell transplant, that have concomitant presence of CHIP. Data regarding the clinical and biological role of CHIP in plasma cell dyscrasias (PCDs) is rapidly increasing. However, the prevalence and prognostic implication of CHIP in patients with MM outside of the transplant setting, and in those with other more indolent PCDs remains elusive. Here we explored the prevalence and clinical implications of CHIP detected through next-generation sequencing in 209 patients with PCDs including MM, light chain (AL) amyloidosis (ALA), monoclonal gammopathy of undetermined significance (MGUS), and smoldering multiple myeloma (SMM). To avoid attributing the mutations to the plasma cell clone, CHIP was defined as the presence of DNMT3A, TET2, or ASXL1 mutations in the peripheral blood or bone marrow (DTA-CH). The prevalence of DTA-CH was 19% in patients with PCDs, with no difference between each PCD. TET2 (23%) and DNMT3A (22%), were the most frequently mutated genes. DTA-CH correlated with older age in MM (P = .001) and MGUS/SMM (P = 0.0007), as well as with coronary artery disease or congestive heart failure in MM (P = .03). DTA-CH did not predict worse OS or PFS in either MM or ALA, nor it predict higher risk of progression to MM in patients with MGUS/SMM. Our results overall further elucidate the prevalence and mutational spectrum of CHIP in PCDs, providing more information regarding the clinical relevance of CHIP in this patient population.

克隆造血潜能不确定(CHIP)在健康个体和血液学癌症患者中都很常见。最近的研究表明,多发性骨髓瘤(MM)和非霍奇金淋巴瘤患者接受干细胞移植的预后较差,同时存在CHIP。关于CHIP在浆细胞异常(PCDs)中的临床和生物学作用的数据正在迅速增加。然而,CHIP在移植环境外的MM患者和其他较不活跃的PCDs患者中的患病率和预后意义仍然难以捉摸。在这里,我们探讨了通过下一代测序在209例PCDs患者中检测CHIP的患病率和临床意义,这些PCDs包括MM、轻链(AL)淀粉样变性(ALA)、未确定意义单克隆γ病(MGUS)和阴烧多发性骨髓瘤(SMM)。为了避免将突变归因于浆细胞克隆,CHIP被定义为外周血或骨髓中存在DNMT3A、TET2或ASXL1突变(DTA-CH)。PCD患者中DTA-CH的患病率为19%,每种PCD之间无差异。TET2(23%)和DNMT3A(22%)是最常见的突变基因。DTA-CH与MM的年龄(P = .001)和MGUS/SMM (P = 0.0007)以及MM的冠状动脉疾病或充血性心力衰竭(P = .03)相关。DTA-CH不能预测MM或ALA患者更差的OS或PFS,也不能预测MGUS/SMM患者进展为MM的更高风险。我们的研究结果进一步阐明了pcd中CHIP的患病率和突变谱,为该患者群体中CHIP的临床相关性提供了更多信息。
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引用次数: 5
A narrative review of the principal glucocorticoids employed in cancer 主要糖皮质激素用于癌症的叙述性回顾
IF 4 3区 医学 Q1 Medicine Pub Date : 2022-12-01 DOI: 10.1053/j.seminoncol.2023.01.004
Nerina Denaro , Ornella Garrone , Annamaria Morelli , Benedetta Pellegrino , Marco Carlo Merlano , Denise Vacca , Josie Pearce , Daniele Farci , Antonino Musolino , Mario Scartozzi , Chiara Tommasi , Cinzia Solinas

Glucocorticoids (GCs) are a pharmacological class of drugs widely used in oncology in both supportive and palliative settings. GCs differentially impact organs with immediate and long-term effects; with suppressive effect on the immune system anchoring their use to manage the toxicities of immune checkpoint inhibitors (ICIs).

In addition, GCs are often used in the management of symptoms related to cancer or chemotherapy and as adjuvants in the treatment of pain in the management of other. In the palliative setting, GCs, especially administered subcutaneously can be to assist in the control of nausea, dyspnea, asthenia, and anorexia-cachexia syndrome.

In this narrative review, we aim to summarize the role of GCs in the different settings (curative, supportive, and palliative) to help clinicians use these important drugs in their daily clinical practice with cancer patients.

糖皮质激素(GCs)是一类广泛应用于肿瘤学支持和姑息治疗的药物。gc对器官的影响不同,有即时和长期影响;对免疫系统具有抑制作用,因此它们被用于控制免疫检查点抑制剂(ICIs)的毒性。此外,GCs通常用于治疗与癌症或化疗相关的症状,并作为辅助治疗其他疾病的疼痛。在姑息治疗中,尤其是皮下注射GCs可帮助控制恶心、呼吸困难、虚弱和厌食症-恶病质综合征。在这篇叙述性综述中,我们旨在总结gc在不同情况下(治疗性、支持性和姑息性)的作用,以帮助临床医生在治疗癌症患者的日常临床实践中使用这些重要的药物。
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引用次数: 0
From doctors to ancillary staff: Regional and metropolitan cancer workforce perceptions and distress resulting from COVID-19 pandemic adaptations 从医生到辅助人员:区域和大都市癌症工作人员对COVID-19大流行适应的看法和困扰
IF 4 3区 医学 Q1 Medicine Pub Date : 2022-12-01 DOI: 10.1053/j.seminoncol.2023.01.008
Natasha A. Roberts , Elizabeth Ahern , Anita Pelecanos , Harry Gasper , Bryan Chan , Zarnie Lwin

Introduction

The declaration of the COVID-19 pandemic has resulted in necessary and rapid changes to health service delivery. In the Australian context, it has been broadly identified that these impacts have been felt by health care workers (HCW) providing care. We aimed to capture oncology HCW perceptions of support, stress, personal ability to meet needs and institutional preparedness across longitudinal periods of COVID-19 response in the early stages of the pandemic.

Methods and materials

An electronic survey was developed to measure the weekly impacts and distress experienced by HCW during the early phases of the pandemic. Hospital email communications relating to pandemic directives were noted. HCW included nursing, medical, ancillary staff and allied health team members at 2 study sites, 1 metropolitan and 1 regional center in Queensland, Australia. Descriptive statistics were applied to quantitative data, and a framework analysis for qualitative data. Key themes were synthesized using mixed methods approaches.

Results

A total of 176 HCW consented to participate. Four key themes were identified. Key theme 1 was strategies for protection, and included the subthemes of self-isolation, using personal protective equipment (PPE), protecting patients and families and each other. Key theme 2 was navigating rules and keeping up, and included the subthemes of compliance, exceptions, conflict and complex decision fatigue. Key theme 3 was tempered optimism, with subthemes including this is grief, pride in one's place and strategies for coping. Key theme 4 was framing the new normal, with subthemes including using technology, second wave and uncertainty.

Conclusion

Staff groups reported the emotional impacts of rapid change across clinical areas and centers. Distress corresponded to rapid change amid uncertainty, rather than reported infection rates. These findings give insight into the experiences of patient facing oncology HCW during periods of uncertainty, potentially informing policy in the future.

2019冠状病毒病大流行的宣布给卫生服务提供带来了必要和迅速的变化。在澳大利亚的情况下,人们普遍认为,提供护理的卫生保健工作者也感受到了这些影响。我们的目标是在大流行的早期阶段,跨越COVID-19应对的纵向阶段,捕捉肿瘤学HCW对支持、压力、个人满足需求的能力和机构准备的看法。方法和材料开展了一项电子调查,以衡量HCW在大流行早期阶段每周所遭受的影响和痛苦。注意到与大流行指令有关的医院电子邮件通信。HCW包括澳大利亚昆士兰州2个研究地点的护理、医疗、辅助人员和联合卫生团队成员,1个大都市中心和1个区域中心。定量数据采用描述性统计,定性数据采用框架分析。采用混合方法综合关键主题。结果共有176名HCW同意参与。确定了四个关键主题。关键主题1是保护战略,包括自我隔离、使用个人防护装备、保护患者和家属以及相互保护等分主题。关键主题2是导航规则和跟上,并包括合规性、例外、冲突和复杂决策疲劳等子主题。关键主题3是温和的乐观主义,副主题包括这是悲伤,一个人的地位和应对策略的骄傲。关键主题4是构建新常态,副主题包括使用技术、第二次浪潮和不确定性。结论工作人员小组报告了临床区域和中心的快速变化对情绪的影响。痛苦与不确定性中的快速变化相对应,而不是报告的感染率。这些发现让我们深入了解在不确定时期面临肿瘤HCW的患者的经历,可能为未来的政策提供信息。
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引用次数: 0
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Seminars in oncology
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