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The oncological role of resection in newly diagnosed diffuse adult-type glioma defined by the WHO 2021 classification: a Review by the RANO resect group. 根据世卫组织 2021 年分类法定义的新诊断弥漫成人型胶质瘤切除术的肿瘤学作用:RANO resect 小组综述。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00130-X
Philipp Karschnia, Jasper K W Gerritsen, Nico Teske, Daniel P Cahill, Asgeir S Jakola, Martin van den Bent, Michael Weller, Oliver Schnell, Einar O Vik-Mo, Niklas Thon, Arnaud J P E Vincent, Michelle M Kim, Guido Reifenberger, Susan M Chang, Shawn L Hervey-Jumper, Mitchel S Berger, Joerg-Christian Tonn

Glioma resection is associated with prolonged survival, but neuro-oncological trials have frequently refrained from quantifying the extent of resection. The Response Assessment in Neuro-Oncology (RANO) resect group is an international, multidisciplinary group that aims to standardise research practice by delineating the oncological role of surgery in diffuse adult-type gliomas as defined per WHO 2021 classification. Favourable survival effects of more extensive resection unfold over months to decades depending on the molecular tumour profile. In tumours with a more aggressive natural history, supramaximal resection might correlate with additional survival benefit. Weighing the expected survival benefits of resection as dictated by molecular tumour profiles against clinical factors, including the introduction of neurological deficits, we propose an algorithm to estimate the oncological effects of surgery for newly diagnosed gliomas. The algorithm serves to select patients who might benefit most from extensive resection and to emphasise the relevance of quantifying the extent of resection in clinical trials.

胶质瘤切除术与生存期延长有关,但神经肿瘤学试验往往不对切除范围进行量化。神经肿瘤学反应评估(RANO)切除小组是一个国际性的多学科小组,旨在通过界定手术在世界卫生组织 2021 年分类中定义的弥漫成人型胶质瘤中的肿瘤作用来规范研究实践。根据肿瘤分子特征的不同,大面积切除的有利生存效果可持续数月至数十年。对于侵袭性更强的肿瘤,最大限度的切除可能会带来额外的生存获益。在权衡肿瘤分子特征与临床因素(包括神经功能缺损的出现)所决定的切除术预期生存益处后,我们提出了一种算法,用于估算新诊断胶质瘤手术的肿瘤学效应。该算法用于选择可能从广泛切除术中获益最多的患者,并强调在临床试验中量化切除范围的意义。
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引用次数: 0
Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial. 完成腋窝淋巴结清扫以确定 pN2-3 状态作为 CDK4/6 抑制剂辅助治疗的适应症:SENOMAC 随机三期试验的事后分析。
IF 35.9 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-06 DOI: 10.1016/S1470-2045(24)00350-4
Jana de Boniface, Matilda Appelgren, Robert Szulkin, Sara Alkner, Yvette Andersson, Leif Bergkvist, Jan Frisell, Oreste Davide Gentilini, Michalis Kontos, Thorsten Kühn, Dan Lundstedt, Birgitte Vrou Offersen, Roger Olofsson Bagge, Toralf Reimer, Malin Sund, Peer Christiansen, Lisa Rydén, Tove Filtenborg Tvedskov
<p><strong>Background: </strong>In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.</p><p><strong>Methods: </strong>In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.</p><p><strong>Findings: </strong>Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6-59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84
背景:对于腔隙性乳腺癌,辅助CDK4/6抑制剂(如阿培莫司利)可提高无浸润生存率。对于T1-2、1-2级肿瘤和1或2个前哨淋巴结转移的患者,完成腋窝淋巴结清扫(cALND)是目前唯一能发现4个或更多结节转移(pN2-3)的预后工具,这也是在这种情况下辅助阿巴西利布的唯一适应症。然而,这项技术可能会导致患者的手臂发病率大幅上升。我们的目的是在正在进行的 SENOMAC 试验中,从患者个体层面务实地描述这一策略的潜在益处和害处:在 SENOMAC 随机三期试验中,来自五个欧洲国家(丹麦、德国、希腊、意大利和瑞典)67 个地点的临床结节阴性 T1-T3 乳腺癌且有一个或两个前哨淋巴结大转移的 18 岁或以上任何表现状态的患者通过按国家分层的包块随机化(随机包块大小为 2 和 4)被随机分配(1:1)到 cALND 或省略 cALND(即只进行前哨淋巴结活检)。主要结果是总生存期,尚未报告。在这项事后分析中,从SENOMAC按方案人群中挑选出了管腔雌激素受体阳性、HER2阴性、T1-2、组织学分级1-2级、肿瘤大小为5厘米或更小的乳腺癌患者,以符合monarchE试验队列1的特征,这些患者只有在发现有4个或更多结节转移时才有阿贝单抗辅助治疗的指征。主要研究目标是利用 monarchE 试验队列 1 中的侵袭性无疾病生存事件数据,确定 cALND 术后 1 年出现患者报告的严重或非常严重的手臂肢体功能障碍(以淋巴水肿功能、残疾和健康 [Lymph-ICF] 问卷测量)的患者人数,以避免在 5 年时发生一次侵袭性无疾病生存事件,并辅助阿贝昔单抗治疗 2 年。SENOMAC试验已在ClincialTrials.gov上注册,编号为NCT02240472,目前已结束注册,正在进行中:2015年1月31日至2021年12月31日期间,2766名患者加入SENOMAC,并被随机分配至cALND(1384人)或仅前哨节点活检(1382人),其中2540人被纳入按方案人群。2540名患者中有1705人(67%)符合这项事后研究的资格标准,其中802人(47%)进行了cALND,903人(53%)仅进行了前哨淋巴结活检。随机化时的中位年龄为 62 岁(IQR 52-71),1705 例患者中有 1699 例(>99%)为女性,6 例(2 例检验 p解释:作为一种可能确定阿巴西利适应症的方法,以及随后通过2年的阿巴西利辅助治疗避免5年无病生存事件的方法,cALND具有严重或非常严重的手臂发病率的巨大风险,因此不应鼓励为此目的进行cALND:瑞典研究理事会、瑞典癌症协会、北欧癌症联盟和瑞典乳腺癌协会。
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引用次数: 0
New immigration laws could undermine cancer research in the UK. 新移民法可能会削弱英国的癌症研究。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-01 DOI: 10.1016/S1470-2045(24)00436-4
Karl Gruber
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引用次数: 0
Ending financial discrimination for cancer survivors: embedding the Right to be Forgotten in legislation across Europe. 消除对癌症幸存者的经济歧视:将 "被遗忘权 "纳入欧洲各国立法。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-13 DOI: 10.1016/S1470-2045(24)00312-7
Mark Lawler, Grazia Scocca, Françoise Meunier
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引用次数: 0
Peru advances towards universal health care for patients with cancer. 秘鲁在为癌症患者提供全民医疗保健方面取得进展。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-16 DOI: 10.1016/S1470-2045(24)00445-5
Talha Burki
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引用次数: 0
Improving cancer control initiatives in Indigenous people. 改善土著居民的癌症控制措施。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-25 DOI: 10.1016/S1470-2045(24)00432-7
Karl Gruber
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引用次数: 0
Enhancing cardiovascular disease risk management in childhood cancer survivors. 加强儿童癌症幸存者的心血管疾病风险管理。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00346-2
Lan Yang, Jinlong Jiang, Shijie Guo
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引用次数: 0
Multimodality imaging of a large incidental papillary fibroelastoma. 偶发巨大乳头状纤维瘤的多模式成像。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00392-9
Wiaam Elkhatib, Prajwal Reddy
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引用次数: 0
Adaptive radiotherapy (up to 74 Gy) or standard radiotherapy (66 Gy) for patients with stage III non-small-cell lung cancer, according to [18F]FDG-PET tumour residual uptake at 42 Gy (RTEP7-IFCT-1402): a multicentre, randomised, controlled phase 2 trial. 根据 42 Gy 时[18F]FDG-PET 肿瘤残留摄取量,为 III 期非小细胞肺癌患者提供适应性放疗(最高 74 Gy)或标准放疗(66 Gy)(RTEP7-IFCT-1402):一项多中心、随机对照 2 期试验。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-09 DOI: 10.1016/S1470-2045(24)00320-6
Pierre Vera, Sébastien Thureau, Florence Le Tinier, Philippe Chaumet-Riffaud, Sébastien Hapdey, Hélène Kolesnikov-Gauthier, Etienne Martin, Alina Berriolo-Riedinger, Nicolas Pourel, Jean Marc Broglia, Pierre Boissellier, Sophie Guillemard, Naji Salem, Isabelle Brenot-Rossi, Cécile Le Péchoux, Céline Berthold, Etienne Giroux-Leprieur, Damien Moreau, Sophie Guillerm, Khadija Benali, Laurent Tessonnier, Clarisse Audigier-Valette, Delphine Lerouge, Elske Quak, Carole Massabeau, Frédéric Courbon, Patricia Moisson, Anne Larrouy, Romain Modzelewski, Pierrick Gouel, Nadia Ghazzar, Alexandra Langlais, Elodie Amour, Gérard Zalcman, Philippe Giraud

Background: Thoracic radiation intensification is debated in patients with stage III non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of a boost radiotherapy dose up to 74 Gy in a functional sub-volume given according to on-treatment [18F]fluorodeoxyglucose ([18F]FDG)-PET results.

Methods: In this multicentre, randomised, controlled non-comparative phase 2 trial, we recruited patients aged 18 years or older with inoperable stage III NSCLC without EGFR mutation or ALK rearrangement with an Eastern Cooperative Oncology Group performance status of 0-1, and who were affiliated with or a beneficiary of a social benefit system, with evaluable tumour or node lesions, preserved lung function, and who were amenable to curative-intent radiochemotherapy. Patients were randomly allocated using a central interactive web-response system in a non-masked method (1:1; minimisation method used [random factor of 0·8]; stratified by radiotherapy technique [intensity-modulated radiotherapy vs three-dimensional conformal radiotherapy] and by centre at which patients were treated) either to the experimental adaptive radiotherapy group A, in which only patients with positive residual metabolism on [18F]FDG-PET at 42 Gy received a boost radiotherapy (up to 74 Gy in 33 fractions), with all other patients receiving standard radiotherapy dosing (66 Gy in 33 fractions over 6·5 weeks), or to the standard radiotherapy group B (66 Gy in 33 fractions) over 6·5 weeks. All patients received two cycles of induction platinum-based chemotherapy cycles (paclitaxel 175 mg/m2 intravenously once every 3 weeks and carboplatin area under the curve [AUC]=6 once every 3 weeks, or cisplatin 80 mg/m2 intravenously once every 3 weeks and vinorelbine 30 mg/m2 intravenously on day 1 and 60 mg/m2 orally [or 30 mg/m2 intravenously] on day 8 once every 3 weeks). Then they concomitantly received radiochemotherapy with platinum-based chemotherapy (three cycles for 8 weeks, with once per week paclitaxel 40 mg/m2 intravenously and carboplatin AUC=2 or cisplatin 80 mg/m2 intravenously and vinorelbine 20 mg/m2 intravenously on day 1 and 40 mg/m2 orally (or 20 mg/m2 intravenously) on day 8 in 21-day cycles). The primary endpoint was the 15-month local control rate in the eligible patients who received at least one dose of concomitant radiochemotherapy. This RTEP7-IFCT-1402 trial is registered with ClinicalTrials.gov (NCT02473133), and is ongoing.

Findings: From Nov 12, 2015, to July 7, 2021, we randomly assigned 158 patients (47 [30%] women and 111 [70%] men) to either the boosted radiotherapy group A (81 [51%]) or to the standard radiotherapy group B (77 [49%)]. In group A, 80 (99%) patients received induction chemotherapy and 68 (84%) received radiochemotherapy, of whom

背景:对于III期非小细胞肺癌(NSCLC)患者的胸腔放射强化治疗存在争议。我们的目的是根据治疗时[18F]氟脱氧葡萄糖([18F]FDG)-PET的结果,评估在功能亚体积内给予最高74Gy增强放疗剂量的活性和安全性:在这项多中心、随机对照、非比较性2期试验中,我们招募了年龄在18岁或18岁以上、无法手术的III期NSCLC患者,这些患者没有表皮生长因子受体(EGFR)突变或ALK重排,东方合作肿瘤学组(Eastern Cooperative Oncology Group)的表现状态为0-1级,隶属于社会福利系统或为社会福利系统的受益人,有可评估的肿瘤或结节病变,肺功能保留,可接受以治愈为目的的放化疗。患者通过中央交互式网络应答系统以非掩蔽方式进行随机分配(1:1;采用最小化方法[随机因子为0-8];根据放疗技术[调强放疗与三维适形放疗]和患者接受治疗的中心进行分层)分配到实验性自适应放疗A组,其中只有[18F]FDG-PET检测结果为42 Gy的残留代谢阳性患者接受增强放疗(33次分次,每次最多74 Gy),其他患者接受标准放疗剂量(66 Gy,33次分次,每次6-5周);或分配到标准放疗B组(66 Gy,33次分次,每次6-5周)。所有患者均接受两个周期的铂类诱导化疗(紫杉醇 175 mg/m2 静脉注射,每 3 周一次,卡铂曲线下面积 [AUC]=6 每 3 周一次;或顺铂 80 mg/m2 静脉注射,每 3 周一次,长春瑞滨 30 mg/m2 静脉注射,第 1 天口服 60 mg/m2 [或 30 mg/m2 静脉注射],第 8 天口服 60 mg/m2 [或 30 mg/m2 静脉注射],每 3 周一次)。然后,他们同时接受放射化疗和铂类化疗(三个周期,共 8 周,每周一次,紫杉醇 40 毫克/平方米静脉注射,卡铂 AUC=2 或顺铂 80 毫克/平方米静脉注射,长春瑞滨 20 毫克/平方米静脉注射,第 1 天口服 40 毫克/平方米(或 20 毫克/平方米静脉注射),第 8 天口服 40 毫克/平方米(或 20 毫克/平方米静脉注射),21 天为一个周期)。主要终点是至少同时接受一次放化疗的合格患者15个月的局部控制率。这项RTEP7-IFCT-1402试验已在ClinicalTrials.gov(NCT02473133)注册,目前正在进行中:从2015年11月12日至2021年7月7日,我们将158名患者(女性47人[30%],男性111人[70%])随机分配到增强放疗A组(81人[51%])或标准放疗B组(77人[49%])。在 A 组中,80 名患者(99%)接受了诱导化疗,68 名患者(84%)接受了放化疗,其中 48 名患者(71%)在 42 Gy 后仍有[18F]FDG-PET 摄取,接受了增强放疗。在 B 组中,所有 77 名患者都接受了诱导化疗,73 人(95%)接受了放化疗。最终分析结果显示,接受放化疗的合格患者(n=140)的中位随访时间为 45-1 个月(95% CI 39-3-48-3)。A组68名患者中有20名(29%)和B组73名患者中有33名(45%)出现急性(放化疗开始后90天内)3-4级不良事件,其中A组有5名(7%)和B组有10名(14%)患者出现严重不良事件。最常见的 3-4 级不良事件是发热性中性粒细胞减少(A 组 68 人中有 7 人[10%],B 组 73 人中有 16 人[22%])和贫血(5 人[7%],9 人[12%])。在急性期,B组有两人死亡(3%)(一人死于与化疗有关的脓毒性休克,另一人死于与研究治疗无关的血型异常),A组无死亡病例。90天后,A组又有一人死于与治疗无关的疾病,B组有两人死亡(一人死于放射性肺炎,一人死于与治疗无关的肺炎):根据中期[18F]FDG-PET进行的胸部放疗增强可获得有意义的局部控制率,两组在危险器官的不良事件方面没有差异,这与之前的胸部放疗增强尝试不同,因此有必要对III期NSCLC患者在[18F]FDG-PET指导下的放疗剂量调整进行随机3期评估:2014年国家临床研究医院计划。
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引用次数: 0
Disappointment facing patients with breast cancer as trastuzumab deruxtecan too expensive for NHS. 由于曲妥珠单抗德鲁司坦对国民医疗服务体系而言过于昂贵,乳腺癌患者面临失望。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-08 DOI: 10.1016/S1470-2045(24)00446-7
Elizabeth Gourd
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引用次数: 0
期刊
Lancet Oncology
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