Neoadjuvant chemotherapy

新辅助化疗
  • 文章类型: Journal Article
    背景:新辅助化疗(NAC)对乳腺癌的手术治疗具有深远的影响。出于这个原因,意大利乳腺外科医师协会(ANISC)推动了关于这一主题的第三次全国共识会议,向多学科专家开放。
    方法:共识会议于2022年11月在线举行,在与五位核心团队专家进行了介绍性会议之后,参与者被要求就11个有争议的问题进行投票,而结果是用轮询系统实时收集的。
    结果:共有来自74个乳腺中心的164名专职人员参加。十一个问题中只有三个达成了共识,包括:1)磁共振成像评估反应的指征(79%);2)如果存在,需要重新评估残留肿瘤的生物学因素(96%);3)如果通过分析一个或多个前哨淋巴结(82%)证实了病理性完全缓解(pCR),则对cN1患者省略正式腋窝淋巴结清扫的可能性。大多数人投票赞成绘制NAC前的乳腺和淋巴结病变(59%),在病理或临床完全缓解的情况下,cN0患者不进行前哨淋巴结活检(69%)。在cT3/cN1+肿瘤伴pCR的情况下,只有8%的参与者认为适当省略乳房切除术后放射治疗.
    结论:在“现实世界”中,NAC后的手术方法仍然存在很大差异。随着NAC的使用越来越多,多学科小组应适应其程序以适应该领域的快速发展。
    BACKGROUND: Neoadjuvant chemotherapy (NAC) has a profound impact on surgical management of breast cancer. For this reason, the Italian Association of Breast Surgeons (ANISC) promoted the third national Consensus Conference on this subject, open to multidisciplinary specialists.
    METHODS: The Consensus Conference was held on-line in November 2022, and after an introductory session with five core-team experts, participants were asked to vote on eleven controversial issues, while results were collected in real-time with a polling system.
    RESULTS: A total of 164 dedicated specialists from 74 Breast Centers participated. Consensus was reached for only three of the eleven issues, including: 1) the indication to assess the response with Magnetic Resonance Imaging (79 %); 2) the need to re-assess the biological factors of the residual tumor if present (96 %); 3) the possibility of omitting a formal axillary node dissection for cN1 patients if a pathologic Complete Response (pCR) was confirmed with analysis of one or more sentinel lymph nodes (82 %). The majority voted in favor of mapping both the breast and nodal lesions pre-NAC (59 %), and against the omission of sentinel lymph node biopsy in cN0 patients in the case of pathologic or clinical Complete Response (69 %). In cases of cT3/cN1+ tumors with pCR, only 8 % of participants considered appropriate the omission of Post-Mastectomy Radiation Therapy.
    CONCLUSIONS: There is still a wide variability in surgical approaches after NAC in the \"real world\". As NAC is increasingly used, multidisciplinary teams should be attuned to conforming their procedures to the rapid advances in this field.
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  • 文章类型: Systematic Review
    基于紫杉烷的化疗的出现彻底改变了乳腺癌的治疗。这一进展有助于改善对可能无法手术的降分期肿瘤的反应。它还有助于使临床(cN)阳性淋巴结(LN)病理阴性(ypN0)。cN+患者的护理标准包括乳房切除术后放疗(PMRT),无论对新辅助化疗的反应如何。然而,1-3例LN阳性患者的PMRT仍然缺乏明确的指南。关于PMRT对1-3例LN阳性患者生存的益处,许多回顾性结果尚无定论。这种汇总分析试图达成共识。PubMed数据库在2023年10月进行了搜索。搜索产生了27篇论文,其中11人符合纳入标准。局部无复发生存率(LRRFS),无病生存率(DFS),每个研究的总生存期(OS)在给予时都列出,创建了两个小组,PMRT和NOPMRT,分别。然后将结果汇总用于分析。PMRT组患者总数为8340,4136,和4204在NOPMRT组中,分别。LRRFS,DFS,OS为96.9%,82.1%,PMRT组为87.3%,为93.2%,79.6%,NOPMRT组为84.8%,分别。LRFS无统计学意义,DFS,两组之间的OS(分别为p=0.61,p=0.61和p=0.38)。PMRT似乎不能为T1-3期pN1患者提供生存益处。该汇总分析的结果应通过更长的随访时间进行前瞻性确认。
    The advent of taxane-based chemotherapy has revolutionized breast cancer care. This advance has helped improve the response to downstaging tumors that might otherwise be inoperable. It has also helped in rendering clinically (cN+) positive lymph nodes (LNs) pathologically negative (ypN0). The standard of care for cN+ patients included post-mastectomy radiotherapy (PMRT), regardless of the response to neoadjuvant chemotherapy. However, PMRT in patients with 1-3 positive LNs still lacks definitive guidelines. Numerous retrospective results have been inconclusive about the benefit of PMRT on survival in patients with 1-3 positive LNs. This pooled analysis attempts to reach a consensus. The PubMed database was searched through October 2023. The search yielded 27 papers, of which 11 satisfied the inclusion criteria. The locoregional recurrence-free survival (LRRFS), disease-free survival (DFS), and overall survival (OS) for each study were tabulated when given, and two groups were created, the PMRT and NO PMRT, respectively. The results were then pooled for analysis. The total number of patients was 8340, 4136 in the PMRT group, and 4204 in the NO PMRT group, respectively. The LRRFS, DFS, and OS were 96.9%, 82.1%, and 87.3% for the PMRT group and 93.2%, 79.6%, and 84.8% for the NO PMRT group, respectively. There was no statistical significance in LRRFS, DFS, or OS between the two groups (p = 0.61, p = 0.61, and p = 0.38, respectively). PMRT does not seem to confer survival benefits in patients with pN1 rendered ypN0 for stages T1-3. This pooled analysis\'s findings should be confirmed prospectively with a longer period of follow-up.
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  • 文章类型: Journal Article
    局部晚期胃癌的治疗策略在世界范围内有所不同。新辅助化疗(NAC)被认为是局部晚期胃癌的有希望的治疗选择之一。即使在日本,临床试验已经进行或正在进行。2022年日本胃肠病外科学会第77届大会组织了一次共识会议,讨论了NAC治疗局部晚期胃癌的现状和未来前景。与会者期待着JCOG1509试验的结果,提供关于NAC的确凿证据。还讨论了NAC的最佳适应症和方案。在日本,cIII期胃癌患者是NAC的主要目标,参与者首选S-1和奥沙利铂的双重方案。然而,S-1,奥沙利铂三联方案的可行性,和多西他赛,有了5-FU,亚叶酸,奥沙利铂,多西他赛已经被证明,这些可能成为日本的治疗选择。其他讨论点包括围手术期化疗以避免腹膜复发和dMMR/MSI高肿瘤患者。小组认为NAC是一种有希望的治疗选择,如果正在进行的临床试验成功证明其疗效,NAC将成为日本cIII期胃癌的标准治疗方法。
    Treatment strategy for locally advanced gastric cancer differs worldwide. Neoadjuvant chemotherapy (NAC) is considered one of the promising treatment options for locally advanced gastric cancer, even in Japan, and clinical trials have been conducted or are ongoing. A consensus meeting was organized at the 77th general meeting of the Japanese Society of Gastroenterological Surgery in 2022, in which the current status and future prospects of NAC for locally advanced gastric cancer were discussed. Participants at the meeting looked forward to the results of the JCOG1509 trial, providing solid evidence regarding NAC. The optimal indications and regimens for NAC were also debated. Patients with cStage III gastric cancer are the main targets of NAC in Japan, and a doublet regimen of S-1 and oxaliplatin was preferred by the participants. However, the feasibility of a triplet regimen with S-1, oxaliplatin, and docetaxel, and that with 5-FU, leucovorin, oxaliplatin, and docetaxel has been demonstrated, and these could become treatment options in Japan. Other points of discussion include perioperative chemotherapy to avoid peritoneal recurrence and for patients with dMMR/MSI-high tumors. The panel regarded NAC as a promising treatment option, and NAC will become the standard treatment for cStage III gastric cancer in Japan if an ongoing clinical trial successfully demonstrates its efficacy.
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  • 文章类型: Journal Article
    背景:目前,没有潜在可切除的实际定义,边缘或不可切除的肝门部胆管癌(pCCA)是可用的。这项研究的目的是确定对患者进行分类的标准,以用于未来的新辅助或诱导治疗研究。
    方法:使用改进的DELPHI方法,荷兰所有三级转诊中心的肝胆外科医师均被邀请参加本研究.在五次在线会议中,讨论了决定可切除性的预定义因素以及有关手术可切除性和可操作性的其他因素。
    结果:五次在线会议产生了52份声明。经过两次调查,63%的问题达成了共识。主要共识包括关于潜在可切除性的定义。1)明确可切除:未来肝残端(FLR)无血管累及(≤90°),根治性胆道切除术的可行性。2)明显无法切除:FLR的不可重建的静脉和/或动脉受累或没有可行的根治性胆道切除术。3)边界可切除:所有患者在明确可切除和明确不可切除的疾病之间。
    结论:这项DELPHI研究得出了实用和适用的可切除性,或者更准确,探索性分类,可用于对患者进行分类,以用于未来的新辅助治疗研究。
    BACKGROUND: Currently, no practical definition of potentially resectable, borderline or unresectable perihilar cholangiocarcinoma (pCCA) is available. Aim of this study was to define criteria to categorize patients for use in a future neoadjuvant or induction therapy study.
    METHODS: Using the modified DELPHI method, hepatobiliary surgeons from all tertiary referral centers in the Netherlands were invited to participate in this study. During five online meetings, predefined factors determining resectability and additional factors regarding surgical resectability and operability were discussed.
    RESULTS: The five online meetings resulted in 52 statements. After two surveys, consensus was reached in 63% of the questions. The main consensus included a definition regarding potential resectability. 1) Clearly resectable: no vascular involvement (≤90°) of the future liver remnant (FLR) and expected feasibility of radical biliary resection. 2) Clearly unresectable: non-reconstructable venous and/or arterial involvement of the FLR or no feasible radical biliary resection. 3) Borderline resectable: all patients between clearly resectable and clearly unresectable disease.
    CONCLUSIONS: This DELPHI study resulted in a practical and applicable resectability, or more accurate, an explorability classification, which can be used to categorize patients for use in future neoadjuvant therapy studies.
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  • 文章类型: Consensus Development Conference
    On October 15th, 2020, the first Surgical National Consensus Conference on neoadjuvant chemotherapy (NACT) was promoted by the Italian Association of Breast Surgeons (ANISC).
    The Consensus Conference was entirely held online due to anti-Covid-19 restrictions and after an introductory four lectures held by national and international experts in the field, a total of nine questions were presented and a digital \"real-time\" voting system was obtained. A consensus was reached if 75% or more of all panelists agreed on a given question.
    A total of 202 physicians, from 76 different Italian Breast Centers homogeneously distributed throughout the Italian country, participated to the Conference. Most participants were surgeons (75%). Consensus was reached for seven out of the nine considered topics, including management of margins and lymph nodes at surgery, and there was good correspondence between the 32 \"Expert Panelists\" and the \"Participants\" to the Conference. Consensus was not achieved regarding the indications to NACT for high-grade luminal-like breast tumors, and the need to perform an axillary lymph node dissection in case of micrometastases in the sentinel lymph node after NACT.
    NACT is a topic of major interest among surgeons, and there is need to develop shared guidelines. While a Consensus was obtained for most issues presented at this Conference, controversies still exist regarding indications to NACT in luminal B-like tumors and management of lymph node micrometastases. There is need for clinical studies and analysis of large databases to improve our knowledge on this subject.
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  • 文章类型: Journal Article
    The first Swedish National Guidelines for Ovarian Cancer (NGOC) were published in 2012. We aimed to evaluate surgical outcomes and survival in patients with stage IIIC-IV disease, before and after the NGOC implementation.
    Women with primary epithelial ovarian cancer, FIGO stage IIIC-IV, registered in the Swedish Quality Registry for Gynecologic Cancer 2008-2011 and 2013-2016 were included. Surgical outcomes were analyzed, including frequency of complete cytoreduction (R0). Relative survival (RS) and excess mortality rate ratios (EMRRs) were computed as measures of survival. Univariable and multivariable regression (Poisson) were calculated.
    In total, 3728 women were identified, 1746 before and 1982 after NGOC. After adjusting for age and stage, survival was improved 2013-2016 vs. 2008-2011 (EMRR 0.89; 95%CI:0.82-0.96, p < 0.05). For women undergoing primary debulking surgery (PDS), R0 frequency (28.9% vs. 53.3%; p < 0.001) and 5-year RS (29.6% (95%CI:26.8-32.8) vs. 37.4% (95%CI:33.6-41.7)) were increased, but fewer patients (58% vs. 44%, p < 0.001) underwent PDS after NGOC implementation. Median survival for the PDS cohort increased from 35 months (95%CI,32.8-39.2) to 43 months (95%CI,40.9-46.4). In the neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) cohort, R0 increased (36.8% to 50.1%, p < 0.001), but not 5-year RS (17.5% vs. 20.7%, ns). Compared to PDS, the EMRR was 1.32 (95%CI,1.19-1.47, p < 0.001) for NACT+IDS and 3.00 (95%CI,2.66-3.38, p < 0.001) for chemotherapy alone. In multivariable analyses, PDS, R0, age ≤ 70 years, and stage IIIC were found to be independent factors for improved RS.
    Implementation of the first National Guidelines for Ovarian Cancer improved relative survival in advanced ovarian cancer.
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  • 文章类型: Journal Article
    Pertuzumab has improved pathologic complete response rates when compared with other chemotherapeutics in the treatment of HER-2 positive breast cancer patients.
    We sought to determine if axillary lymph node dissections (ALNDs) yielding at least the national standard of 10 lymph nodes is lower in patients who received neoadjuvant pertuzumab.
    A retrospective database identified patients who underwent ALND for breast cancer. We compared the axillary lymph node retrieval rates in those who received or did not receive neoadjuvant pertuzumab. Of 139 breast cancer patients who underwent ALND, fewer than 10 axillary lymph nodes were found in 41.7% of patients who received neoadjuvant pertuzumab (P < 0.01) and 18.6% of patients who received neoadjuvant therapy without pertuzumab (P = 0.01).
    Neoadjuvant chemotherapy was associated with a significantly lower rate of \"adequate\" ALNDs as defined by current guidelines. The patient subset that received neoadjuvant pertuzumab was more likely to have fewer than 10 axillary lymph nodes retrieved.
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  • 文章类型: Journal Article
    Osteosarcoma is the most common primary malignant bone tumor, occurring mainly in children and adolescents, and the limbs are the main affected sites. At present, limb-salvage treatment is considered as an effective basic standard treatment for osteosarcoma of the limb. China has a vast territory, but the development of technology is not balanced,which requires sufficient theoretical coverage, strong technical guidance and the application of limb-salvage treatment guidelines to the treatment of osteosarcoma. Therefore, to standardize and promote the development of limb-salvage surgery technology and improve the success rate of limb-salvage treatment, this guide systematically introduces limb-salvage techniques for the treatment of patients with limb osteosarcoma through definition of limb-salvage treatment, surgical methods, efficacy evaluation, postoperative treatment and prevention of complications, rehabilitation guidance, and follow-up advice.
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  • 文章类型: Journal Article
    局部晚期直肠癌(LARC)的标准方法是新辅助放化疗(nCRT),然后是全直肠系膜切除术(TME)。nCRT后,20%的患者达到临床完全缓解(pCR),可以通过非手术管理(NOM)进行治疗。
    意大利医学肿瘤协会(AIOM)直肠癌指南的小组采用了建议的分级,评估,开发和评估(等级)方法解决以下问题:NOM与TME可用于在nCRT后有临床完全缓解的直肠癌患者?确定了五个结果:无病生存(DFS),死亡率,局部复发,结肠造口术率,和功能结果。
    九项研究包括在分析中。另一方面,与TME组相比,NOM组的疾病复发风险更高(RR=1.69,95%CI1.08,2.64),我们观察到对NOM的死亡率有轻微的正效应,但不显著(RR=0.82,95%CI0.46,1.45).NOM组患者更有可能出现局部复发(RR=5.37,95%CI2.56,11.27),TME组患者更有可能进行永久性结肠造口术(RR=0.15,95%CI0.08,0.29)。只有一项研究评估了功能结果。证据的总体确定性被评为非常低。
    发现NOM与较高的局部复发风险相关,但未转化为较差的OS和较低的结肠造口术率。由于缺乏证据,没有建议是可能的。NOM仍然是一种实验性治疗;因此,接受NOM治疗的患者应纳入有专门随访时间表的临床试验.
    The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM).
    The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes.
    Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low.
    NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.
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  • 文章类型: Journal Article
    Gastric cancer is one of the most common digestive system tumors in China, and locally advanced gastric cancer (LAGC) accounts for a high proportion of newly diagnosed cases. Although surgery is the main treatment for gastric cancer, surgical excision alone cannot achieve satisfactory outcomes in LAGC patients. Neoadjuvant therapy (NAT) has gradually become the standard treatment for patients with LAGC, and this treatment can not only achieve tumor downstaging and improve surgical rate and the R0 resection rate, but it also significantly improves the long-term prognosis of patients. Peri/preoperative neoadjuvant chemotherapy and preoperative chemoradiotherapy are both recommended according to a large number of studies, and the regimens have also been evolved in the past decades. Since the NCCN guidelines for gastric cancer are one of the most authoritative evidence-based guidelines worldwide, here, we demonstrate the development course and major breakthroughs of NAT for gastric cancer based on the vicissitudes of the NCCN guidelines from 2007 to 2019, and also discuss the future of NAT.
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