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Impact of smoking status on engagement in remote symptom monitoring after oncologic surgery: Implications for symptom management and readmission rates 吸烟状况对肿瘤手术后远程症状监测的影响:对症状管理和再入院率的影响。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-22 DOI: 10.1002/cncr.35708
Jennifer R. Cracchiolo MD, Yuelin Li PhD, Michelle L. Lui MPH, Sigrid V. Carlsson MD, PhD, MPH, Richard S. Matulewicz MD, Jamie S. Ostroff PhD

Background

Remote symptom monitoring (RSM) is an evidence-based strategy shown to mitigate postoperative morbidity; however, platform engagement is required to benefit from RSM. Patients who report current smoking are at high risk for postoperative complications, but it is unknown whether smoking status influences engagement with RSM, symptom severity, or unanticipated acute care visits.

Methods

This observational case–control study was conducted in patients undergoing ambulatory oncologic surgery at a large cancer center. The authors examined the effect of current smoking status on adherence to an electronically delivered postoperative recovery-assessment tool. Symptom severity and readmissions by smoking status were also analyzed.

Results

In total, 19,481 patients who underwent surgery and were enrolled in RSM were included. The nonresponse rate (28%) in current smokers was significantly greater than the rate observed in never smokers (21%; odds ratio, 1.38; 95% confidence interval, 1.17–1.63; p < .0001). Current smokers reported higher symptom scores for pain, wound swelling, constipation, and anxiety. The observed 30-day readmission rates were 3.6% for current smokers and 2.6% for never smokers, with overlapping confidence intervals.

Conclusions

Current smokers report higher symptom burden after surgery yet are less likely to adopt proactive digital postoperative recovery strategies like RSM. Implementation strategies are needed to improve the engagement of current smokers in RSM if benefits are to be realized in this high-risk population.

背景:远程症状监测(RSM)是一种基于证据的策略,可以减轻术后发病率;然而,要从RSM中获益,就需要平台粘性。报告目前吸烟的患者术后并发症的风险很高,但尚不清楚吸烟状况是否影响RSM的参与、症状严重程度或意外的急性护理就诊。方法:本观察性病例对照研究在一家大型癌症中心进行门诊肿瘤手术的患者中进行。作者检查了当前吸烟状况对电子交付的术后恢复评估工具的依从性的影响。并分析吸烟状况引起的症状严重程度和再入院情况。结果:共纳入19481例接受手术并纳入RSM的患者。当前吸烟者的无缓解率(28%)显著高于从不吸烟者(21%;优势比为1.38;95%置信区间为1.17-1.63;结论:目前吸烟者报告术后症状负担较高,但不太可能采取主动的数字术后恢复策略,如RSM。如果要在这一高危人群中实现益处,就需要实施战略来提高当前吸烟者参与RSM的程度。
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引用次数: 0
Overall survival benefit of pembrolizumab plus chemoradiotherapy for patients with high-risk locally advanced cervical cancer 派姆单抗联合放化疗治疗高危局部晚期宫颈癌患者的总生存获益
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-19 DOI: 10.1002/cncr.35688
Mary Beth Nierengarten
<p>The addition of pembrolizumab to chemoradiotherapy for patients with high-risk locally advanced cervical cancer significantly improved overall survival (OS), according to the second interim analysis of the phase 3 KEYNOTE-A18 trial published in <i>The Lancet</i>.<span><sup>1</sup></span> </p><p>The finding provides further support for adding pembrolizumab to chemoradiotherapy in this setting, and it builds on previously reported results showing a significant improvement in progression-free survival.<span><sup>2</sup></span> These latter findings resulted in the US Food and Drug Administration’s approval of this regimen for patients with high-risk, International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III–IVA cervical cancer.<span><sup>3</sup></span></p><p>Domenica Lorusso, MD, PhD, director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, Italy, and lead author of the study, first presented the results at the 2024 annual meeting of the European Society for Medical Oncology.<span><sup>4</sup></span> </p><p>At a median follow-up of 29.9 months, the 36-month OS rate was 82.6% for patients treated with pembrolizumab and chemoradiotherapy and 74.8% for patients treated with chemoradiotherapy alone, with a hazard ratio (HR) for death of 0.67 (95% CI, 0.50–0.90; <i>p</i> = .004).</p><p>The trial included 1060 newly diagnosed patients with high-risk locally advanced cervical cancer randomized 1:1 to five cycles of pembrolizumab (200 mg) with concurrent chemoradiotherapy followed by 15 cycles of pembrolizumab (400 mg) (the investigational arm) or five cycles of a placebo with concurrent chemoradiotherapy followed by 15 cycles of a placebo (the control arm). Chemoradiotherapy included five cycles of cisplatin (40 mg/m<sup>2</sup>) once weekly plus external-beam radiotherapy followed by brachytherapy.</p><p>At the time of randomization, patients were stratified by the planned type of external-beam radiotherapy (intensity-modulated radiotherapy [IMRT] or volumetric modulated arc therapy [VMAT] vs. non-IMRT or non-VMAT), the stage of cervical cancer at screening, and the planned total radiotherapy dose (<70 vs. ≥70 Gy).</p><p>The benefit of adding pembrolizumab to chemoradiotherapy generally was consistent among prespecified subgroups. For example, the HR for death was 0.89 (95% CI, 0.55–1.44) for patients at FIGO stages IB2–IIB and 0.57 (95% CI, 0.39–0.83) for patients at FIGO stages III–IVA.</p><p>Grade 3 or higher treatment-related adverse events were seen in 78% and 70% of the patients in the investigational and placebo arms, respectively. The most common event was anemia, with decreases in both white blood cell counts and neutrophil counts. Potential immune-mediated adverse events occurred in 39% and 17% of the patients, respectively.</p><p>“In the context of modern and high-quality radiotherapy that is curative in 75% of patients, the addition of pembrolizumab further increases
{"title":"Overall survival benefit of pembrolizumab plus chemoradiotherapy for patients with high-risk locally advanced cervical cancer","authors":"Mary Beth Nierengarten","doi":"10.1002/cncr.35688","DOIUrl":"10.1002/cncr.35688","url":null,"abstract":"&lt;p&gt;The addition of pembrolizumab to chemoradiotherapy for patients with high-risk locally advanced cervical cancer significantly improved overall survival (OS), according to the second interim analysis of the phase 3 KEYNOTE-A18 trial published in &lt;i&gt;The Lancet&lt;/i&gt;.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt;\u0000 &lt;/p&gt;&lt;p&gt;The finding provides further support for adding pembrolizumab to chemoradiotherapy in this setting, and it builds on previously reported results showing a significant improvement in progression-free survival.&lt;span&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;/span&gt; These latter findings resulted in the US Food and Drug Administration’s approval of this regimen for patients with high-risk, International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III–IVA cervical cancer.&lt;span&gt;&lt;sup&gt;3&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Domenica Lorusso, MD, PhD, director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, Italy, and lead author of the study, first presented the results at the 2024 annual meeting of the European Society for Medical Oncology.&lt;span&gt;&lt;sup&gt;4&lt;/sup&gt;&lt;/span&gt;\u0000 &lt;/p&gt;&lt;p&gt;At a median follow-up of 29.9 months, the 36-month OS rate was 82.6% for patients treated with pembrolizumab and chemoradiotherapy and 74.8% for patients treated with chemoradiotherapy alone, with a hazard ratio (HR) for death of 0.67 (95% CI, 0.50–0.90; &lt;i&gt;p&lt;/i&gt; = .004).&lt;/p&gt;&lt;p&gt;The trial included 1060 newly diagnosed patients with high-risk locally advanced cervical cancer randomized 1:1 to five cycles of pembrolizumab (200 mg) with concurrent chemoradiotherapy followed by 15 cycles of pembrolizumab (400 mg) (the investigational arm) or five cycles of a placebo with concurrent chemoradiotherapy followed by 15 cycles of a placebo (the control arm). Chemoradiotherapy included five cycles of cisplatin (40 mg/m&lt;sup&gt;2&lt;/sup&gt;) once weekly plus external-beam radiotherapy followed by brachytherapy.&lt;/p&gt;&lt;p&gt;At the time of randomization, patients were stratified by the planned type of external-beam radiotherapy (intensity-modulated radiotherapy [IMRT] or volumetric modulated arc therapy [VMAT] vs. non-IMRT or non-VMAT), the stage of cervical cancer at screening, and the planned total radiotherapy dose (&lt;70 vs. ≥70 Gy).&lt;/p&gt;&lt;p&gt;The benefit of adding pembrolizumab to chemoradiotherapy generally was consistent among prespecified subgroups. For example, the HR for death was 0.89 (95% CI, 0.55–1.44) for patients at FIGO stages IB2–IIB and 0.57 (95% CI, 0.39–0.83) for patients at FIGO stages III–IVA.&lt;/p&gt;&lt;p&gt;Grade 3 or higher treatment-related adverse events were seen in 78% and 70% of the patients in the investigational and placebo arms, respectively. The most common event was anemia, with decreases in both white blood cell counts and neutrophil counts. Potential immune-mediated adverse events occurred in 39% and 17% of the patients, respectively.&lt;/p&gt;&lt;p&gt;“In the context of modern and high-quality radiotherapy that is curative in 75% of patients, the addition of pembrolizumab further increases ","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":""},"PeriodicalIF":6.1,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncr.35688","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142996821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Potential new treatment approach for intermediate-stage hepatocellular carcinoma 潜在的治疗中期肝细胞癌的新方法。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-19 DOI: 10.1002/cncr.35687
Mary Beth Nierengarten
<p>The addition of lenvatinib and pembrolizumab to transarterial chemoembolization (TACE) significantly improved progression-free survival (PFS) in comparison with TACE alone for patients with intermediate-stage hepatocellular carcinoma (HCC) according to interim results of the prospective, phase 3 LEAP-012 study.<span><sup>1</sup></span> </p><p>The lead author of the study, Josep M. Llovet, MD, PhD, director of the Liver Cancer Program and professor of medicine in the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York, presented the results at the 2024 congress of the European Society for Medical Oncology in September.</p><p>At a median time of 25.6 months (from randomization to the data cutoff), the median PFS was 14.6 months for patients treated with the addition of lenvatinib and pembrolizumab to TACE and 10.0 months for patients treated with TACE alone, with a hazard ratio of 0.66 (95% CI, 0.51–0.84; <i>p</i> = .0002).</p><p>The finding indicates that the prespecified significant improvement in the PFS endpoint of the study was met. No significant improvement in overall survival (OS) was found, but the data are considered immature at this interim analysis.</p><p>Grade 3–5 treatment-related adverse events occurred in 71.3% of patients treated with lenvatinib and pembrolizumab plus TACE and in 31.5% of patients treated with TACE alone, and they led to treatment discontinuation in 8.4% and 1.2% of patients, respectively.</p><p>Commenting on the study, Kenneth K. Tanabe, MD, professor of surgery at Harvard Medical School and chief of the Division of Oncologic and Gastrointestinal Surgery at Massachusetts General Hospital, says that the findings suggest that lenvatinib and pembrolizumab plus TACE could be a new treatment approach for HCC in the future, but it is “too early to say with any degree of certainty.”</p><p>He notes the significantly greater toxicity with the addition of lenvatinib and pembrolizumab to TACE and points to several unknowns that still need answers. First, he questions the benefit of adding pembrolizumab to this regimen considering prior data from the LEAP-002 study that showed no benefit from adding pembrolizumab to lenvatinib in comparison with lenvatinib alone for advanced HCC.<span><sup>2</sup></span> </p><p>Also left unanswered, he says, is whether giving TACE alone followed by lenvatinib (sequential administration) at the time of disease progression would yield equivalent OS to that achieved with TACE alone despite the inferior PFS.</p><p>“This is not practice changing at this time,” he says, but he urges oncologists to “stay tuned to this channel.”</p><p>The LEAP-012 trial included 480 patients with HCC randomized 1:1 to lenvatinib (12 mg for a body weight ≥60 kg and 8 mg for a body weight <60 kg) and pembrolizumab (400 mg) or a placebo for up to 2 years. All patients in both groups received TACE, with the first administration occurring 2–4 weeks after the
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引用次数: 0
First person profile: Julie Brahmer, MD 第一人称简介:Julie Brahmer,医学博士:Brahmer博士的研究为首个获得美国食品和药物管理局批准用于治疗肺癌的免疫疗法铺平了道路。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-19 DOI: 10.1002/cncr.35686
Mary Beth Nierengarten
<p>A strong work ethic modeled after her father, who was a farmer, greased the tracks for Julie Brahmer, MD, and led her toward a career in oncology. She credits hard work for her many accomplishments as a clinician researcher of immunotherapy agents for thoracic cancers.</p><p>As a young investigator in her first faculty position at the Johns Hopkins University School of Medicine in the early 2000s, she performed research that paved the way for the first immunotherapy agent to receive approval from the US Food and Drug Administration for the treatment of lung cancer. The drug was nivolumab. Dr Brahmer led the first-in-human trial (phase 1) that showed the potential efficacy of nivolumab in lung cancer and co-led the phase 2 and 3 trials that eventually led to its approval as a second-line treatment for advanced non–small cell lung cancer (NSCLC).<span><sup>1, 2</sup></span> </p><p>Dr Brahmer called it a dream to be a part of developing a new drug for lung cancer. “My dream when starting out in drug development was to take a drug from its first-in-human trials and help it through its development and approval to help our lung cancer patients,” she says. “That dream was realized.”</p><p>Her vision was further realized with the subsequent approval of pembrolizumab for the treatment of lung cancer. She was the lead investigator on the KEYNOTE-024 trial, which was the first to show the superiority of pembrolizumab over chemotherapy for patients with previously untreated advanced NSCLC with programmed death ligand 1 expression. This led to the approval of pembrolizumab as a first-line treatment in this setting.<span><sup>3, 4</sup></span> </p><p>Thereafter, she mentored younger investigators whose research led to the approval of nivolumab in combination with chemotherapy for even early stages of lung cancer, such as the Checkmate 816 trial for neoadjuvant therapy of resectable NSCLC.</p><p>“It is amazing to see the changes in lung cancer treatment over the past 15 years,” she says. “We’re now talking about curing patients with immunotherapy and using it in multiple cancers, all the way from head and neck cancer to esophageal cancer and mesothelioma.”</p><p>Dr Brahmer’s leadership roles include serving as the director of the Thoracic Oncology Program and a professor of oncology at the Sidney Kimmel Comprehensive Cancer Center. She is also a coprincipal investigator of the Johns Hopkins National Clinical Trials Network. She oversees clinical trials of immunotherapies for lung cancer and drug development for thoracic malignancies and focuses on developing treatments for mesothelioma. She also serves as the chair of the Thoracic Cancer Committee of the ECOG–ACRIN National Cooperative Group.</p><p>Although hard work drove her younger years, Dr Brahmer now describes her work ethic as working efficiently—a necessary refinement when managing many tasks and juggling multiple leadership roles.</p><p>Among these roles, she receives the mos
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引用次数: 0
Reply to “Advancing trial recruitment science through enhanced study design” 回复“通过强化研究设计推进试验招募科学”。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-16 DOI: 10.1002/cncr.35705
Krupa K. Nathan MD, Angela B. Smith MD, MS
<p>We deeply appreciate the interest that Drs Lewicki and Stensland have taken to reflect on the operational tactics introduced in our recent <i>Cancer</i> article<span><sup>1</sup></span> and the demonstrable association between our centralized email, <i>CISTOquestion</i>, and patient accrual in the CISTO study (ClinicalTrials.gov identifier NCT03933826). Patient accrual remains the primary reason for failure or premature termination of clinical trials within urology and oncology at large, and reliable predictors of trial success have yet to be discretely identified.<span><sup>2-4</sup></span> Our goal is to share the strategies that we have found to maximize enrollment in the CISTO study so that these methods can be strategically used to optimize the success of future multi-institutional trials that strengthen evidence-based practices derived from these studies.</p><p>Among the engagement approaches used by the CISTO study team, our data suggest that CISTOquestion effectively contributed to increased and sustained enrollment and was unequivocally favored by CISTO site research coordinators, allowing for continual engagement. We agree that, from our analysis, causality between CISTOquestion and enrollment remains uncertain because of the nonrandomized rollout of CISTO study site participation and CISTOquestion. As Lewick and Stensland suggested, randomized, controlled methods for grouped site involvement and time-regulated CISTOquestion access would allow for determining a definitive effect of CISTOquestion on patient enrollment among different sites. Alternatively, it is important to consider that controlled access to CISTOquestion itself may limit site engagement, thereby counteracting enrollment for sites that rely on CISTOquestion for patient screening. This would be a tradeoff between site engagement/enrollment and determination of a true association between CISTOquestion and accrual. Such a compromise may be mitigated by allocating one half of the sites access to CISTOquestion for a brief period of time, as thoughtfully proposed.</p><p>Upon review of the feedback survey data administered to CISTO site research coordinators, CISTOquestion was regarded as a more beneficial resource versus all sites meetings, which aimed to facilitate structured engagement with CISTO study sites. Staffing and logistical coordination were substantial investments in the execution of all sites meetings, yet CISTOquestion was rated as more beneficial to CISTO site research coordinators given that principal investigators and CISTO study staff who responded to inquiries provided personalized, patient-specific responses. This was a testament to how CISTOquestion provided the most value given the resources used to initiate and maintain it. Considering the advancements in technology being integrated into trial design and clinical practice, the impact of CISTOquestion can be enhanced through the use of artificial intelligence with its capability of <i>learning</i> on a
{"title":"Reply to “Advancing trial recruitment science through enhanced study design”","authors":"Krupa K. Nathan MD,&nbsp;Angela B. Smith MD, MS","doi":"10.1002/cncr.35705","DOIUrl":"10.1002/cncr.35705","url":null,"abstract":"&lt;p&gt;We deeply appreciate the interest that Drs Lewicki and Stensland have taken to reflect on the operational tactics introduced in our recent &lt;i&gt;Cancer&lt;/i&gt; article&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; and the demonstrable association between our centralized email, &lt;i&gt;CISTOquestion&lt;/i&gt;, and patient accrual in the CISTO study (ClinicalTrials.gov identifier NCT03933826). Patient accrual remains the primary reason for failure or premature termination of clinical trials within urology and oncology at large, and reliable predictors of trial success have yet to be discretely identified.&lt;span&gt;&lt;sup&gt;2-4&lt;/sup&gt;&lt;/span&gt; Our goal is to share the strategies that we have found to maximize enrollment in the CISTO study so that these methods can be strategically used to optimize the success of future multi-institutional trials that strengthen evidence-based practices derived from these studies.&lt;/p&gt;&lt;p&gt;Among the engagement approaches used by the CISTO study team, our data suggest that CISTOquestion effectively contributed to increased and sustained enrollment and was unequivocally favored by CISTO site research coordinators, allowing for continual engagement. We agree that, from our analysis, causality between CISTOquestion and enrollment remains uncertain because of the nonrandomized rollout of CISTO study site participation and CISTOquestion. As Lewick and Stensland suggested, randomized, controlled methods for grouped site involvement and time-regulated CISTOquestion access would allow for determining a definitive effect of CISTOquestion on patient enrollment among different sites. Alternatively, it is important to consider that controlled access to CISTOquestion itself may limit site engagement, thereby counteracting enrollment for sites that rely on CISTOquestion for patient screening. This would be a tradeoff between site engagement/enrollment and determination of a true association between CISTOquestion and accrual. Such a compromise may be mitigated by allocating one half of the sites access to CISTOquestion for a brief period of time, as thoughtfully proposed.&lt;/p&gt;&lt;p&gt;Upon review of the feedback survey data administered to CISTO site research coordinators, CISTOquestion was regarded as a more beneficial resource versus all sites meetings, which aimed to facilitate structured engagement with CISTO study sites. Staffing and logistical coordination were substantial investments in the execution of all sites meetings, yet CISTOquestion was rated as more beneficial to CISTO site research coordinators given that principal investigators and CISTO study staff who responded to inquiries provided personalized, patient-specific responses. This was a testament to how CISTOquestion provided the most value given the resources used to initiate and maintain it. Considering the advancements in technology being integrated into trial design and clinical practice, the impact of CISTOquestion can be enhanced through the use of artificial intelligence with its capability of &lt;i&gt;learning&lt;/i&gt; on a","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":""},"PeriodicalIF":6.1,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142996823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Olaparib as treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency: Phase 2 LIGHT study final overall survival analysis 奥拉帕尼治疗BRCA突变和同源重组缺陷的铂敏感复发卵巢癌:2期LIGHT研究最终总生存分析
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-16 DOI: 10.1002/cncr.35707
Ying L. Liu MD, MPH, Cara A. Mathews MD, Fiona Simpkins MD, Karen A. Cadoo MD, Diane Provencher MD, Colleen C. McCormick MD, Adam C. ElNaggar MD, Alon D. Altman MD, Lucy Gilbert MD, Destin Black MD, Nashwa Kabil MD, PhD, Rosie N. Taylor MSc, Alan Barnicle PhD, Jiefen Y. Munley MD, Carol Aghajanian MD

Background

LIGHT (oLaparib In HRD-Grouped Tumor types; NCT02983799) prospectively evaluated olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer (PSROC) assigned to cohorts by known BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive non-BRCAm, and HRD-negative. At the primary analysis, olaparib treatment demonstrated activity across all cohorts, with greatest efficacy in terms of objective response rate and progression-free survival observed in the g/sBRCAm cohorts. The authors report final overall survival (OS).

Methods

In this phase 2, open-label, noncomparative study, patients with PSROC and one or more prior line of platinum-based chemotherapy were assigned to cohorts by BRCAm and HRD status. OS was a secondary end point. Tumors were analyzed using Myriad BRACAnalysis CDx and MyChoice CDx assays; HRD-positive tumors were defined using a genomic instability score of ≥42.

Results

Of 272 enrolled patients, 271 received olaparib and 270 met the inclusion criteria for the efficacy analysis. At data cutoff, 18-month OS rates in the gBRCAm, sBRCAm, HRD-positive non-BRCAm, and HRD-negative cohorts were 86.4%, 88.0%, 78.6%, and 59.6%, respectively. No new safety signals were observed. In a post hoc analysis, patients on treatment for >18 months were most frequently present in g/sBRCAm cohorts (31.0%).

Conclusions

Olaparib treatment continued to demonstrate benefit across all cohorts. Consistent with the primary analysis, the highest OS rates were observed in the BRCAm cohorts, regardless of g/sBRCAm. In patients without a BRCAm, a higher OS rate was observed in the HRD-positive non-BRCAm than the HRD-negative cohorts. These results highlight the importance of biomarker testing in this treatment setting.

背景:LIGHT(奥拉帕尼)治疗hrd分组肿瘤类型;NCT02983799)前瞻性评估了奥拉帕尼对铂敏感复发性卵巢癌(psproc)患者的治疗效果,psproc根据已知的BRCA突变(BRCAm)和同源重组缺陷(HRD)状态分为两组:种系BRCAm (gBRCAm)、体系BRCAm (sBRCAm)、HRD阳性非BRCAm和HRD阴性。在初步分析中,奥拉帕尼治疗在所有队列中都显示出活性,在g/sBRCAm队列中观察到的客观缓解率和无进展生存期方面疗效最大。作者报告了最终总生存期(OS)。方法:在这项开放标签、非比较的2期研究中,PSROC患者和一种或多种先前的铂类化疗药物被分配到BRCAm和HRD状态的队列中。OS是次要终点。肿瘤分析采用Myriad BRACAnalysis CDx和MyChoice CDx检测;hrd阳性肿瘤的定义采用≥42的基因组不稳定性评分。结果:272例入组患者中,271例接受奥拉帕尼治疗,270例符合疗效分析纳入标准。在数据截止时,gBRCAm、sBRCAm、hrd阳性非brcam和hrd阴性队列的18个月OS率分别为86.4%、88.0%、78.6%和59.6%。没有观察到新的安全信号。在一项事后分析中,g/sBRCAm队列中最常见的患者治疗时间为100 ~ 18个月(31.0%)。结论:奥拉帕尼治疗在所有队列中继续显示出益处。与初步分析一致,无论g/sBRCAm如何,在BRCAm队列中观察到最高的OS率。在没有BRCAm的患者中,hrd阳性的非BRCAm患者的OS率高于hrd阴性的患者。这些结果强调了生物标志物检测在这种治疗环境中的重要性。
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引用次数: 0
National survey of financial burden and experience among patients with cancer and autoimmune disease receiving charitable copay assistance 接受慈善共付援助的癌症和自身免疫性疾病患者的经济负担和经验的全国调查。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-15 DOI: 10.1002/cncr.35721
Jeffrey Peppercorn MD, MPH, Jill S. Hasler PhD, Bonnie Hu BA, Erin K. Tagai PhD, Greg J. Zahner MD, Anh Lam MD, Sarina Robbins BA, Stephanie B. Wheeler PhD, Ryan D. Nipp MD, MPH, Suzanne M. Miller PhD

Background

Little is known about the role that charitable copay assistance (CPA) plays in addressing access to care and financial distress. The study sought to evaluate financial distress and experience with CPA among patients with cancer and autoimmune disease.

Methods

This is a national cross-sectional self-administered anonymous electronic survey conducted among recipients of CPA to cover the costs of a drug for cancer or autoimmune disease. Self-reported financial distress as measured by Comprehensive Score for Financial Toxicity as well as health care spending and experience with financial barriers to care were evaluated, as were perspectives on policy questions related to CPA and costs of care.

Results

Among 1566 respondents (1108 with cancer and 458 with autoimmune disease, median age 71, 51% female, 89% White, 69% household income <$60,000), 53% reported mild and 31% moderate/severe financial distress, despite CPA. Eighteen percent reported missing recommended care because of costs. Most respondents (96%) had Medicare, 55% reported supplemental insurance, and 66% believed that insurance would prevent them from facing high costs of health care. A total of 52% reported paying more than $100 monthly in drug costs and 41% spending more than 10% of monthly income on health care. Financial distress was similar among patients with cancer and autoimmune diseases. In multivariable regression analysis, younger age, less education, unemployment, higher comorbidity, and lower income were independently associated with higher financial distress.

Conclusions

This study informs policy debate over the role of CPA foundations in the U.S. health insurance safety net and highlights the inadequacy of Medicare to guarantee access to care for older patients with chronic illness.

背景:很少知道的作用,慈善共付援助(CPA)在解决获得护理和财务困境。该研究旨在评估癌症和自身免疫性疾病患者的财务困境和CPA经历。方法:这是一项全国性的横断面自我管理的匿名电子调查,在CPA接受者中进行,以支付癌症或自身免疫性疾病的药物费用。通过财务毒性综合评分来衡量自我报告的财务困境,以及医疗保健支出和医疗保健财务障碍的经验,以及与CPA和护理成本相关的政策问题的观点进行了评估。结果:在1566名受访者中(1108名癌症患者和458名自身免疫性疾病患者),中位年龄71岁,51%女性,89%白人,69%家庭收入结论:本研究为CPA基金会在美国健康保险安全网中的作用提供了政策辩论,并强调了医疗保险在保证老年慢性病患者获得护理方面的不足。
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引用次数: 0
Advancing trial recruitment science through enhanced study design 通过改进研究设计推进试验招募科学。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-14 DOI: 10.1002/cncr.35703
Patrick Lewicki MD, MS, Kristian Stensland MD, MPH, MS
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引用次数: 0
Impact of obesity on outcome in children diagnosed with cancer in Canada: A report from Cancer in Young People in Canada 肥胖对加拿大儿童癌症诊断结果的影响:一份来自加拿大年轻人癌症的报告。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-13 DOI: 10.1002/cncr.35673
Samuel Sassine MD, MSc, André P. Ilinca MD, Hallie Coltin MD, MSc, Henrique Bittencourt MD, PhD, Uma Athale MD, Lynette Bowes MD, Josée Brossard MD, Sara Israels MD, Donna L. Johnston MD, Ketan Kulkarni MD, Sarah McKillop MD, Meera Rayar MD, Roona Sinha MD, Tony Truong MD, MPH, Catherine Vézina MD, Laura Wheaton MD, Alexandra P. Zorzi MD, Lillian Sung MD, PhD, Marie-Claude Pelland-Marcotte MD, PhD, Thai Hoa Tran MD

Background

Childhood obesity can result in adverse health outcomes. The objectives of this study were to describe the prevalence of obesity and determine the association between obesity at cancer diagnosis and event-free survival (EFS) and overall survival (OS) in children diagnosed with cancer in Canada.

Methods

The authors conducted a retrospective cohort study using the Cancer in Young People in Canada database, including all children with newly diagnosed cancer aged 2–18 years across Canada from 2001 to 2020. Obesity was defined as age-adjusted and sex-adjusted body mass index greater than or equal to the 95th percentile. Univariate and multivariable Cox proportional hazards models compared EFS and OS between patients with and without obesity at diagnosis.

Results

In total, 11,291 patients were included, of whom 10.5% were obese at diagnosis. In multivariable models controlling for age, sex, ethnicity, neighborhood income quintile, treatment era, and cancer categories, obesity at diagnosis was independently associated with inferior EFS (adjusted hazard ratio [aHR], 1.16; 95% confidence interval [CI], 1.02–1.32; p = .02) and OS (aHR, 1.29; 95% CI, 1.11–1.49; p = .001). The adverse prognostic impact of obesity was particularly notable for acute lymphoblastic leukemia (ALL) and central nervous system (CNS) tumors. In children with ALL (n = 3458), obesity remained associated with inferior EFS (aHR, 1.55; p = .002) and OS (aHR, 1.75; p = .002) in multivariable analysis. In patients with CNS tumors (n = 2458), obesity was also associated with inferior EFS (aHR, 1.38; p = .008) and OS (aHR, 1.47; p = .004).

Conclusions

In this population-based study, obesity at cancer diagnosis was independently associated with inferior survival across the entire cohort, and prominently in children with ALL and CNS tumors.

背景:儿童肥胖可导致不良的健康结果。本研究的目的是描述肥胖的患病率,并确定加拿大癌症诊断时肥胖与无事件生存期(EFS)和总生存期(OS)之间的关系。方法:作者使用加拿大年轻人癌症数据库进行了一项回顾性队列研究,包括2001年至2020年加拿大所有2-18岁新诊断癌症的儿童。肥胖被定义为年龄和性别调整后的体重指数大于或等于第95个百分位数。单变量和多变量Cox比例风险模型比较诊断时有无肥胖患者的EFS和OS。结果:共纳入11291例患者,其中10.5%的患者诊断为肥胖。在控制年龄、性别、种族、社区收入五分位数、治疗时间和癌症类别的多变量模型中,诊断时肥胖与较差的EFS独立相关(校正风险比[aHR], 1.16;95%置信区间[CI], 1.02-1.32;p = .02)和OS (aHR, 1.29;95% ci, 1.11-1.49;p = .001)。肥胖对急性淋巴细胞白血病(ALL)和中枢神经系统(CNS)肿瘤的不良预后影响尤为显著。在ALL患儿中(n = 3458),肥胖仍与较差的EFS相关(aHR, 1.55;p = .002)和OS (aHR, 1.75;P = .002)。在中枢神经系统肿瘤患者(n = 2458)中,肥胖也与较差的EFS相关(aHR, 1.38;p = 0.008)和OS (aHR, 1.47;p = .004)。结论:在这项基于人群的研究中,在整个队列中,癌症诊断时的肥胖与较差的生存率独立相关,在ALL和中枢神经系统肿瘤儿童中尤为突出。
{"title":"Impact of obesity on outcome in children diagnosed with cancer in Canada: A report from Cancer in Young People in Canada","authors":"Samuel Sassine MD, MSc,&nbsp;André P. Ilinca MD,&nbsp;Hallie Coltin MD, MSc,&nbsp;Henrique Bittencourt MD, PhD,&nbsp;Uma Athale MD,&nbsp;Lynette Bowes MD,&nbsp;Josée Brossard MD,&nbsp;Sara Israels MD,&nbsp;Donna L. Johnston MD,&nbsp;Ketan Kulkarni MD,&nbsp;Sarah McKillop MD,&nbsp;Meera Rayar MD,&nbsp;Roona Sinha MD,&nbsp;Tony Truong MD, MPH,&nbsp;Catherine Vézina MD,&nbsp;Laura Wheaton MD,&nbsp;Alexandra P. Zorzi MD,&nbsp;Lillian Sung MD, PhD,&nbsp;Marie-Claude Pelland-Marcotte MD, PhD,&nbsp;Thai Hoa Tran MD","doi":"10.1002/cncr.35673","DOIUrl":"10.1002/cncr.35673","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Childhood obesity can result in adverse health outcomes. The objectives of this study were to describe the prevalence of obesity and determine the association between obesity at cancer diagnosis and event-free survival (EFS) and overall survival (OS) in children diagnosed with cancer in Canada.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The authors conducted a retrospective cohort study using the Cancer in Young People in Canada database, including all children with newly diagnosed cancer aged 2–18 years across Canada from 2001 to 2020. Obesity was defined as age-adjusted and sex-adjusted body mass index greater than or equal to the 95th percentile. Univariate and multivariable Cox proportional hazards models compared EFS and OS between patients with and without obesity at diagnosis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 11,291 patients were included, of whom 10.5% were obese at diagnosis. In multivariable models controlling for age, sex, ethnicity, neighborhood income quintile, treatment era, and cancer categories, obesity at diagnosis was independently associated with inferior EFS (adjusted hazard ratio [aHR], 1.16; 95% confidence interval [CI], 1.02–1.32; <i>p</i> = .02) and OS (aHR, 1.29; 95% CI, 1.11–1.49; <i>p</i> = .001). The adverse prognostic impact of obesity was particularly notable for acute lymphoblastic leukemia (ALL) and central nervous system (CNS) tumors. In children with ALL (<i>n</i> = 3458), obesity remained associated with inferior EFS (aHR, 1.55; <i>p</i> = .002) and OS (aHR, 1.75; <i>p</i> = .002) in multivariable analysis. In patients with CNS tumors (<i>n</i> = 2458), obesity was also associated with inferior EFS (aHR, 1.38; <i>p</i> = .008) and OS (aHR, 1.47; <i>p</i> = .004).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>In this population-based study, obesity at cancer diagnosis was independently associated with inferior survival across the entire cohort, and prominently in children with ALL and CNS tumors.</p>\u0000 </section>\u0000 </div>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":""},"PeriodicalIF":6.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of focal anaplastic Wilms tumor: A report from the Children's Oncology Group AREN0321 and AREN03B2 studies 局灶性无细胞 Wilms 肿瘤的治疗:儿童肿瘤组织 AREN0321 和 AREN03B2 研究报告。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-13 DOI: 10.1002/cncr.35713
Amy E. Armstrong MD, Najat C. Daw MD, Lindsay A. Renfro PhD, James I. Geller MD, John A. Kalapurakal MD, Geetika Khanna MD, Arnold C. Paulino MD, Elizabeth J. Perlman MD, Peter F. Ehrlich MD, Kenneth W. Gow MD, Anne B. Warwick MS, MD, MPH, MSS, Colonel, Paul E. Grundy MD, Conrad V. Fernandez MD, Elizabeth A. Mullen MD, Jeffrey S. Dome MD, PhD, the Children's Oncology Group AREN0321 and AREN03B2 Study Committees

Background

In the fifth National Wilms Tumor Study, patients received vincristine and dactinomycin (VA) without radiation for stage I focal anaplastic Wilms tumor (FAWT) and VA plus doxorubicin (DD4A) and radiation for stage II–IV FAWT. Four-year event-free survival (EFS) and overall survival (OS) for stage I FAWT were 67.5% and 88.9% and for stage IV FAWT were 61.4% and 71.6%, respectively. Therapy intensification for stage I and IV FAWT was evaluated as secondary objectives in AREN0321.

Methods

Central review in the AREN03B2 Renal Tumors Classification, Biology, and Banking Study confirmed patient stage and tumor histology. Patients were then enrolled in AREN0321 and received DD4A with radiation for stage I–III FAWT and vincristine, doxorubicin, cyclophosphamide, carboplatin, and etoposide (UH-1/revised UH-1) with radiation for stage IV FAWT. Outcomes of patients with FAWT who were treated in AREN0321 (n = 25) and in AREN03B2 (n = 20) treated as per AREN0321 were analyzed.

Results

In the pooled data analysis from AREN0321 and AREN03B2, 4-year EFS and OS were both 100% for stage I–II FAWT (n = 21), 82.4% (95% CI, 66.1%–100%) and 87.8% (95% CI, 73.4%–100%) for stage III FAWT (n = 17), respectively, and both 85.7% (95% CI, 63.3%–100%) for stage IV FAWT (n = 7). Four patients enrolled in AREN0321 had events: treatment failure occurred in three patients with stage III FAWT, and one treatment-related death was observed in a patient with stage IV FAWT following revised UH-1. No EFS or OS events occurred in patients with FAWT enrolled in AREN03B2 only.

Conclusions

Patients with stage I and II FAWT have outstanding survival when treated with DD4A and radiation. Intensification of therapy may have improved survival for stage IV FAWT, albeit with an increased toxicity risk.

背景:在第五次国家肾母细胞瘤研究中,对于I期局灶性间变性肾母细胞瘤(FAWT)患者接受长春新碱和放线菌素(VA)不放疗,对于II-IV期肾母细胞瘤患者接受VA +阿霉素(DD4A)和放疗。I期FAWT的4年无事件生存率(EFS)和总生存率(OS)分别为67.5%和88.9%,IV期FAWT的4年无事件生存率(EFS)和总生存率(OS)分别为61.4%和71.6%。在AREN0321中,对I期和IV期FAWT的强化治疗被评估为次要目标。方法:AREN03B2肾肿瘤分类、生物学和银行研究的中心综述确定了患者的分期和肿瘤组织学。然后,患者被纳入AREN0321,接受DD4A放疗治疗I-III期FAWT,接受长春新碱、阿霉素、环磷酰胺、卡铂和依托泊苷(UH-1/修订UH-1)放疗治疗IV期FAWT。分析采用AREN0321治疗的FAWT患者(n = 25)和采用AREN03B2治疗的FAWT患者(n = 20)的结果。结果:在AREN0321和AREN03B2的汇总数据分析中,I-II期FAWT的4年EFS和OS均为100% (n = 21), III期FAWT (n = 17)的4年EFS和OS分别为82.4% (95% CI, 66.1%-100%)和87.8% (95% CI, 73.4%-100%), IV期FAWT (n = 7)的4年EFS和OS均为85.7% (95% CI, 63.3%-100%)。3例III期FAWT患者出现治疗失败,1例IV期FAWT患者在修订UH-1后出现治疗相关死亡。仅在AREN03B2中纳入的FAWT患者中没有发生EFS或OS事件。结论:ⅰ期和ⅱ期FAWT患者在DD4A和放疗的联合治疗下具有显著的生存率。强化治疗可能提高IV期FAWT的生存率,尽管毒性风险增加。
{"title":"Treatment of focal anaplastic Wilms tumor: A report from the Children's Oncology Group AREN0321 and AREN03B2 studies","authors":"Amy E. Armstrong MD,&nbsp;Najat C. Daw MD,&nbsp;Lindsay A. Renfro PhD,&nbsp;James I. Geller MD,&nbsp;John A. Kalapurakal MD,&nbsp;Geetika Khanna MD,&nbsp;Arnold C. Paulino MD,&nbsp;Elizabeth J. Perlman MD,&nbsp;Peter F. Ehrlich MD,&nbsp;Kenneth W. Gow MD,&nbsp;Anne B. Warwick MS, MD, MPH, MSS, Colonel,&nbsp;Paul E. Grundy MD,&nbsp;Conrad V. Fernandez MD,&nbsp;Elizabeth A. Mullen MD,&nbsp;Jeffrey S. Dome MD, PhD,&nbsp;the Children's Oncology Group AREN0321 and AREN03B2 Study Committees","doi":"10.1002/cncr.35713","DOIUrl":"10.1002/cncr.35713","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>In the fifth National Wilms Tumor Study, patients received vincristine and dactinomycin (VA) without radiation for stage I focal anaplastic Wilms tumor (FAWT) and VA plus doxorubicin (DD4A) and radiation for stage II–IV FAWT. Four-year event-free survival (EFS) and overall survival (OS) for stage I FAWT were 67.5% and 88.9% and for stage IV FAWT were 61.4% and 71.6%, respectively. Therapy intensification for stage I and IV FAWT was evaluated as secondary objectives in AREN0321.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Central review in the AREN03B2 Renal Tumors Classification, Biology, and Banking Study confirmed patient stage and tumor histology. Patients were then enrolled in AREN0321 and received DD4A with radiation for stage I–III FAWT and vincristine, doxorubicin, cyclophosphamide, carboplatin, and etoposide (UH-1/revised UH-1) with radiation for stage IV FAWT. Outcomes of patients with FAWT who were treated in AREN0321 (<i>n</i> = 25) and in AREN03B2 (<i>n</i> = 20) treated as per AREN0321 were analyzed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the pooled data analysis from AREN0321 and AREN03B2, 4-year EFS and OS were both 100% for stage I–II FAWT (<i>n</i> = 21), 82.4% (95% CI, 66.1%–100%) and 87.8% (95% CI, 73.4%–100%) for stage III FAWT (<i>n</i> = 17), respectively, and both 85.7% (95% CI, 63.3%–100%) for stage IV FAWT (<i>n</i> = 7). Four patients enrolled in AREN0321 had events: treatment failure occurred in three patients with stage III FAWT, and one treatment-related death was observed in a patient with stage IV FAWT following revised UH-1. No EFS or OS events occurred in patients with FAWT enrolled in AREN03B2 only.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Patients with stage I and II FAWT have outstanding survival when treated with DD4A and radiation. Intensification of therapy may have improved survival for stage IV FAWT, albeit with an increased toxicity risk.</p>\u0000 </section>\u0000 </div>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":""},"PeriodicalIF":6.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Cancer
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