JNCI Cancer Spectrum最新文献

{"title":"Menopausal hormone therapy: assessing associations with breast and colorectal cancers by familial risk.","authors":"Robert J MacInnis, Mark A Jenkins, Roger L Milne, Esther M John, Mary B Daly, Irene L Andrulis, Sarah V Colonna, Kelly-Anne Phillips, Loic Le Marchand, Polly A Newcomb, Amanda I Phipps, Stephanie L Schmit, Finlay A Macrae, Daniel D Buchanan, Steven Gallinger, Rish K Pai, Niloy J Samadder, Graham G Giles, Melissa C Southey, John L Hopper, Mary Beth Terry","doi":"10.1093/jncics/pkae121","DOIUrl":"10.1093/jncics/pkae121","url":null,"abstract":"<p><p>Menopausal users of hormone replacement therapy (HRT) are at increased breast cancer risk and decreased colorectal cancer (CRC) risk compared with individuals who have never used HRT, but these opposing associations may differ by familial risk of breast cancer and CRC. We harmonized data from 3 cohorts and generated separate breast cancer and CRC familial risk scores based on cancer family history. We defined moderate or strong family history as a risk score of 0.4 or higher, where 0.4 was equivalent to a 50-year-old woman with 1 parent diagnosed with either breast cancer or CRC at 55 years of age. Of 24 486 women assessed, 1243 and 405 were diagnosed with incident breast cancer and CRC, respectively. For breast cancer, menopausal HRT ever use versus never use hazard ratios were 1.27 (95% CI = 1.11 to 1.45) for a breast cancer familial risk score below 0.4 and 1.01 (95% CI = 0.82 to 1.25) for a breast cancer familial risk score of 0.4 or higher (Pdifference = .08). For CRC, menopausal HRT hazard ratios were 0.63 (95% CI = 0.50 to 0.78) for a CRC familial risk score below 0.4 and 1.21 (95% CI = 0.73 to 2.00) for a CRC familial risk score of 0.4 or higher (Pdifference = .03). Associations with menopausal HRT use that apply to the general population may not hold for women at moderate or strong familial risk of these cancers.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11700558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in breast cancer risk associated with benign breast disease from 1967 to 2013.","authors":"Amy C Degnim, Karthik Ghosh, Robert A Vierkant, Stacey J Winham, Tanya L Hoskin, Jodi M Carter, Bryan M McCauley, Matt R Jensen, Teresa Allers, Marlene Frost, Denice L Gehling, Jessica L Fischer, Lisa R Seymour, Laura M Pacheco-Spann, Philip S Rosenberg, Lori A Denison, Celine M Vachon, Lynn C Hartmann, Derek C Radisky, Mark E Sherman","doi":"10.1093/jncics/pkae128","DOIUrl":"10.1093/jncics/pkae128","url":null,"abstract":"<p><strong>Background: </strong>Benign breast disease (BBD) increases breast cancer (BC) risk progressively for women diagnosed with nonproliferative change, proliferative disease without atypia (PDWA), and atypical hyperplasia (AH). Leveraging data from 18 704 women in the Mayo BBD Cohort (1967-2013), we evaluated temporal trends in BBD diagnoses and how they have influenced associated BC risk over 4 decades.</p><p><strong>Methods: </strong>BC risk trends associated with BBD were evaluated using standardized incidence ratios (SIRs) and age-period-cohort modeling across 4 eras-premammogram (1967-1981), precore needle biopsy (CNB) (1982-1992), transition to CNB (1993-2001), and CNB era (2002-2013).</p><p><strong>Results: </strong>With a median follow-up of 15.8 years, 9.9% of women were diagnosed with BC (invasive and/or DCIS). From the premammogram era to the CNB era, we observed a significant increase in BC risk, rising from an SIR of 1.61 to 1.99. The proportion of proliferative BBD diagnoses (PDWA or AH) increased markedly over time (28.1%-49.7%), as did the proportion of DCIS events (11%-28%; χ2  P < .001). Within specific BBD categories, the risk of invasive BC increased modestly.</p><p><strong>Conclusions: </strong>Absolute risk of BC within BBD categories remained stable, but the relative risk of BC after BBD increased over time due to notable increases in higher risk BBD lesions, specifically PDWA and AH. These findings illustrate how evolving screening practices have changed the risk profile of BBD and should inform management strategies for patients with BBD in modern clinical settings.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RE: \"Narrative review of lifestyle interventions in breast cancer survivors: current evidence and future directions\".","authors":"Alain Braillon","doi":"10.1093/jncics/pkae125","DOIUrl":"10.1093/jncics/pkae125","url":null,"abstract":"","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11729713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142869322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the intersection of climate vulnerability and cancer burden in North Carolina.","authors":"Joyce Pak, Ngan Le, Eman M Metwally, Jeanny Wang, Arrianna Marie Planey, Amy M Lowman, Bradford E Jackson, Eboneé N Butler, Jennifer L Lund","doi":"10.1093/jncics/pkae124","DOIUrl":"10.1093/jncics/pkae124","url":null,"abstract":"<p><p>Climate-related extreme weather events disrupt health-care systems and exacerbate health disparities, particularly affecting individuals diagnosed with cancer. This study explores the intersection of climate vulnerability and cancer burden in North Carolina (NC). Using county-level data from the US Climate Vulnerability Index (CVI) and the NC Department of Health and Human Services, we analyzed cancer incidence and mortality rates from 2017 to 2021. Our findings reveal a robust correlation between CVI percentiles and cancer mortality (r = 0.72). Counties with high area deprivation like Scotland, Robeson, and Halifax had the highest CVI percentiles of 0.68, 0.67, and 0.66, with respective cancer mortality rates of 193, 195, and 196 per 100 000 person-years. Correlations between CVI and cancer incidence were modest (r = 0.22). These results underscore the need for targeted public health interventions to mitigate climate-related health disparities. Future work could focus on exploring specific climate hazards and cancer outcomes to enhance preparedness and resilience in cancer care.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Socioeconomic determinants of cancer screening adherence among cancer survivors: analysis from the 2020 Behavioral Risk Factor Surveillance System.","authors":"Edoardo Beatrici, Zhiyu Qian, Dejan K Filipas, Benjamin V Stone, Filippo Dagnino, Muhieddine Labban, Stuart R Lipsitz, Giovanni Lughezzani, Nicolò M Buffi, Alexander P Cole, Quoc-Dien Trinh","doi":"10.1093/jncics/pkae127","DOIUrl":"10.1093/jncics/pkae127","url":null,"abstract":"<p><strong>Background: </strong>Factors associated with cancer survivors' preventive health behaviors are understudied. We hypothesized that socioeconomic and health-care access factors may be associated with adherence to recommended cancer screenings.</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis using the 2020 Behavioral Risk Factor Surveillance System. Cancer survivors eligible for United States Preventive Services Task Force-recommended breast, cervical, prostate, and colorectal screenings were included. Multivariable logistic regression models were used to identify socioeconomic factors significantly associated with screening adherence.</p><p><strong>Results: </strong>Overall, 64 958 (weighted national estimate = 29 066 143) cancer survivors were included. Adherence rates varied across cancer types: 80.9% for breast, 88.9% for cervical, 54.1% for prostate, and 84.7% for colorectal cancer. Key predictors of low adherence included lower income (breast: adjusted odds ratio [aOR] = 0.56, 95% confidence interval [CI] = 0.43 to 0.74; cervical: aOR = 0.38, 95% CI = 0.24 to 0.59; prostate: aOR = 0.36, 95% CI = 0.24 to 0.52; colorectal: aOR = 0.74, 95% CI = 0.57 to 0.96), lack of health-care coverage for colorectal cancer (aOR = 0.51, 95% CI = 0.36 to 0.73), time since last checkup between 1 and 2 years prior for breast (aOR = 0.58, 95% CI = 0.45 to 0.75), prostate (aOR = 0.66, 95% CI = 0.47 to 0.91), and colorectal (aOR = 0.69, 95% CI = 0.56 to 0.86) cancer, and no health-care provider for breast (aOR = 0.68, 95% CI = 0.47 to 0.98), prostate (aOR = 0.45, 95% CI = 0.31 to 0.65), and colorectal (aOR = 0.51, 95% CI = 0.40 to 0.66) cancer.</p><p><strong>Conclusion: </strong>Cancer survivors' adherence to screening is associated with factors including lack of health-care coverage, lower income, time since the last exam, and having a personal provider. Targeted interventions accounting for such factors may help mitigate these disparities.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Indices of neighborhood disadvantage and individual cancer control behaviors among African American adults.","authors":"Bernard F Fuemmeler, Joseph Boyle, Carrie A Miller, Debarchana Ghosh, Cheryl L Knott","doi":"10.1093/jncics/pkaf015","DOIUrl":"10.1093/jncics/pkaf015","url":null,"abstract":"<p><strong>Background: </strong>Emerging literature notes the importance of neighborhood-level factors for cancer control behaviors beyond that of individual factors. Markers of neighborhood-level disadvantage have been linked to greater likelihood of nonsalutary cancer control behaviors. There has been less examination of many neighborhood factors simultaneously, which more accurately reflects individuals' daily experiences. We estimated associations of neighborhood deprivation indices with cancer control behaviors, identifying the relative importance of neighborhood-level deprivation index components for these outcomes.</p><p><strong>Methods: </strong>We used data from the Religion and Health in African Americans study, a national probability sample of African American adults. We separately considered 4 screening and 4 prevention behaviors as outcomes. We constructed neighborhood deprivation indices using census tract-level data and estimated their associations with outcomes using bayesian index models, adjusting for individual-level covariates. We reported odds ratios (ORs), credible intervals, and exceedance probabilities.</p><p><strong>Results: </strong>Participants in our sample engaged in relatively high levels of screening behaviors and lower levels of prevention behaviors. Neighborhood deprivation indices were statistically significantly associated with a greater likelihood of binge drinking (OR = 1.13, exceedance probability = 98.5%), smoking (OR = 1.07, exceedance probability = 99.4%), and insufficient colonoscopy (exceedance probability = 99.9%), Papanicolaou (exceedance probability = 99.7%), and prostate-specific antigen (exceedance probability = 99.1%) screening. Within neighborhood deprivation indices, median household income, percentage of individuals without some college education, and percentage of individuals unemployed received large estimated importance weights.</p><p><strong>Conclusion: </strong>We identified statistically significant associations between neighborhood disadvantage and nonsalutary cancer control behaviors as well as important neighborhood-level deprivation index components for each outcome. These and similar findings from future studies should be used to target specific neighborhood factors for specific cancer control behaviors rather than using a one-size-fits-all approach.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":"9 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11879093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A novel machine learning-based cancer-specific cardiovascular disease risk score among patients with breast, colorectal, or lung cancer.","authors":"Nickolas Stabellini, Omar M Makram, Harikrishnan Hyma Kunhiraman, Hisham Daoud, John Shanahan, Alberto J Montero, Roger S Blumenthal, Charu Aggarwal, Umang Swami, Salim S Virani, Vanita Noronha, Neeraj Agarwal, Susan Dent, Avirup Guha","doi":"10.1093/jncics/pkaf016","DOIUrl":"10.1093/jncics/pkaf016","url":null,"abstract":"<p><strong>Background: </strong>Cancer patients have up to a 3-fold higher risk for cardiovascular disease (CVD) than the general population. Traditional CVD risk scores may be less accurate for them. We aimed to develop cancer-specific CVD risk scores and compare them with conventional scores in predicting 10-year CVD risk for patients with breast cancer (BC), colorectal cancer (CRC), or lung cancer (LC).</p><p><strong>Methods: </strong>We analyzed adults diagnosed with BC, CRC, or LC between 2005 and 2012. An machine learning (ML) Extreme Gradient Boosting algorithm ranked 40-50 covariates for predicting CVD for each cancer type using SHapley Additive exPlanations values. The top 10 ML-predictors were used to create predictive equations using logistic regression and compared with American College of Cardiology (ACC)/American Heart Association (AHA) Pooled Cohort Equations (PCE), Predicting Risk of cardiovascular disease EVENTs (PREVENT), and Systematic COronary Risk Evaluation-2 (SCORE2) using the area under the curve (AUC).</p><p><strong>Results: </strong>We included 10 339 patients: 55.5% had BC, 15.6% had CRC, and 29.7% had LC. The actual 10-year CVD rates were: BC 21%, CRC 10%, and LC 28%. The predictors derived from the ML algorithm included cancer-specific and socioeconomic factors. The cancer-specific predictive scores achieved AUCs of 0.84, 0.76, and 0.83 for BC, CRC, and LC, respectively, and outperformed PCE, PREVENT, and SCORE2, increasing the absolute AUC values by up to 0.31 points (with AUC ranging from 0 to 1). Similar results were found when excluding patients with cardiac history or advanced cancer from the analysis.</p><p><strong>Conclusions: </strong>Cancer-specific CVD predictive scores outperform conventional scores and emphasize the importance of integrating cancer-related covariates for precise prediction.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11878632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Duration of aromatase inhibitor use and long-term cardiovascular risk in breast cancer survivors.","authors":"Yuhan Huang, Marilyn L Kwan, Susan R Heckbert, Nicholas L Smith, Megan Othus, Cecile A Laurent, Janise M Roh, Eileen Rillamas-Sun, Valerie S Lee, Tatjana Kolevska, Richard K Cheng, Carlos Irribarren, Mai Nguyen-Huynh, Dawn L Hershman, Lawrence H Kushi, Heather Greenlee","doi":"10.1093/jncics/pkaf009","DOIUrl":"10.1093/jncics/pkaf009","url":null,"abstract":"<p><strong>Background: </strong>There are limited data on duration of aromatase inhibitor (AI) and cardiovascular disease (CVD) risk in breast cancer (BC) survivors. We examined the risk of CVD and mortality associated with the duration of AI use in postmenopausal women with early stage hormone receptor-positive BC.</p><p><strong>Methods: </strong>Postmenopausal women diagnosed with hormone receptor-positive BC (n = 5853) who used an AI were included. Cause-specific hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between AI use duration (short term: >0 and <2 years; intermediate term: ≥2 and <5 years; long term: ≥5 years) and CVD and mortality outcomes. The landmark method was used to avoid immortal time bias; the selected landmark was 6 years after BC diagnosis.</p><p><strong>Results: </strong>Anastrozole was the AI predominantly prescribed (95.4%). Over a median follow-up of 3 years for women who survived 6 years after BC diagnosis, a lower risk of stroke was observed in intermediate-term AI users (HR = 0.60, 95% CI = 0.37 to 0.96) and long-term AI users (HR = 0.51, 95% CI = 0.30 to 0.85), than in short-term AI users. The longer duration of AI use was also associated with lower risk of all-cause mortality and non-CVD-related mortality. In addition, long-term AI users were at 37% lower risk of CVD-related mortality than short-term AI users. No statistically significant differences were observed in risks of major adverse cardiovascular events, ischemic heart disease, and heart failure across the 3 groups.</p><p><strong>Conclusion: </strong>Among postmenopausal women with early stage hormone receptor-positive BC who survived 6 years after BC diagnosis, longer duration of AI use was not associated with elevated CVD risk.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11879121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The need for a cancer exposome atlas: a scoping review.","authors":"Anna S Young, Catherine E Mullins, Neha Sehgal, Roel C H Vermeulen, P Martijn Kolijn, Jelle Vlaanderen, Mohammad L Rahman, Brenda M Birmann, Dinesh Barupal, Qing Lan, Nathaniel Rothman, Douglas I Walker","doi":"10.1093/jncics/pkae122","DOIUrl":"10.1093/jncics/pkae122","url":null,"abstract":"<p><strong>Background: </strong>Despite advances in understanding genetic susceptibility to cancer, much of cancer heritability remains unidentified. At the same time, the makeup of industrial chemicals in our environment only grows more complex. This gap in knowledge on cancer risk has prompted calls to expand cancer research to the comprehensive, discovery-based study of nongenetic environmental influences, conceptualized as the \"exposome.\"</p><p><strong>Methods: </strong>Our scoping review aimed to describe the exposome and its application to cancer epidemiology and to study design limitations, challenges in analytical methods, and major unmet opportunities in advanced exposome profiling methods that allow the quantification of complex chemical exposure profiles in biological matrices. To evaluate progress on incorporating measurements of the exposome into cancer research, we performed a review of such \"cancer exposome\" studies published through August 2023.</p><p><strong>Results: </strong>We found that only 1 study leveraged untargeted chemical profiling of the exposome as a method to measure tens of thousands of environmental chemicals and identify prospective associations with future cancer risk. The other 13 studies used hypothesis-driven exposome approaches that targeted a set of preselected lifestyle, occupational, air quality, social determinant, or other external risk factors. Many of the included studies could only leverage sample sizes with less than 400 cancer cases (67% of nonecologic studies) and exposures experienced after diagnosis (29% of studies). Six cancer types were covered, most commonly blood (43%), lung (21%), or breast (14%) cancer.</p><p><strong>Conclusion: </strong>The exposome is underutilized in cancer research, despite its potential to unravel complex relationships between environmental exposures and cancer and to inform primary prevention.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11729703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe).","authors":"Florence Joly, Fernando Bazan, Delphine Garbay, Yaelle Ouldbey, Philippe Follana, Élise Champeaux-Orange, Eric Legouffe, Pierre-Emmanuel Brachet, Dominique Spaeth, Pierre Combe, Anne-Claire Hardy-Bessard, Frédéric Selle, Julien Grenier, Coriolan Lebreton, Olfa Derbel, Elise Bonnet, Pierre Fournel, Yolanda Fernandez Diez, Valérie Delecroix, Sheik Emambux, Jérôme Alexandre, Thomas Grellety, Dominique Mille, Hubert Orfeuvre, Catherine Favier, Delphine Le Roux, Marie-Ange Mouret-Reynier, Stanislas Quesada, Jean-Emmanuel Kurtz","doi":"10.1093/jncics/pkae114","DOIUrl":"10.1093/jncics/pkae114","url":null,"abstract":"<p><strong>Background: </strong>Maintenance niraparib at an individualized starting dose (ISD) is established in platinum-sensitive recurrent ovarian cancer (PSROC). However, patients' perspectives on the burden of prolonged maintenance therapy have not been reported in prospective trials or routine practice.</p><p><strong>Methods: </strong>In the real-life multicenter NiQoLe study, patients with PSROC received ISD maintenance niraparib. The primary objective was to describe physician-reported adverse events (AEs) leading to treatment modification during the first 3 months. Secondary endpoints included patient-reported outcomes (symptomatic AEs using PRO-CTCAE, self-reported fatigue, and impact on daily activities/function using FACT-F) collected remotely weekly using a specifically designed electronic device.</p><p><strong>Results: </strong>Most (80%) of 139 treated patients (median age = 70 years) began niraparib at 200 mg/day. Median treatment duration was 5.7 (range = 0.2-21.4) months. During the first 3 months, 86 patients (62%) required treatment modification (median = 27 days to modification). Physician-reported grade ≥3 niraparib-related AEs occurred in 34 patients (24%); 68 patients (49%) had treatment modification for AEs, predominantly thrombocytopenia. The most frequent patient-reported AEs (PRO-CTCAE) were fatigue, insomnia, constipation, and dry mouth. Self-reported AEs were severe in 66% of patients. At baseline, 33% of patients reported severe fatigue (FACT-F), which generally persisted during niraparib. Physicians systematically underestimated major patient-reported symptoms.</p><p><strong>Conclusions: </strong>In routine practice, niraparib dose modification was often required during the first 3 months despite individualized dosing. Physicians underestimated the burden of fatigue and symptomatic AEs. Digital self-reporting of AEs is feasible, provides patient-centered information complementing physician-reported AEs, and allows fuller appreciation of toxicity in real-world studies.</p><p><strong>Clinical trial information: </strong>NCT03752216.</p>","PeriodicalId":14681,"journal":{"name":"JNCI Cancer Spectrum","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11878563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}