International Journal of Gynecological Cancer最新文献

{"title":"A cost-effectiveness analysis of sentinel lymph node biopsy compared with lymphadenectomy in intermediate- and high-risk endometrial carcinoma.","authors":"Pernille Bjerre Trent, Ane Gerda Eriksson, Anne Cathrine Staff, Knut Erling Juul-Hansen, Emily Annika Burger, Knut Reidar Wangen","doi":"10.1136/ijgc-2024-005906","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005906","url":null,"abstract":"<p><strong>Background: </strong>Sentinel lymph node biopsy (SLN) is increasingly used for surgical staging of endometrial carcinoma.</p><p><strong>Objective: </strong>To estimate the effect and cost-effectiveness of the implementation of an SLN algorithm for surgical staging in patients with intermediate- and high-risk endometrial carcinoma compared with lymphadenectomy.</p><p><strong>Methods: </strong>We performed a model-based, cost-effectiveness analysis using primary data from a tertiary referral hospital that included 829 patients with endometrial carcinoma undergoing surgical staging. We quantified the health and economic outcomes from two time periods, before and after implementation of the SLN algorithm by robotic surgery. Costs were measured directly from the hospital's financial department, while long-term health outcomes were estimated using self-reported lymphedema and health-related quality-of-life among survivors. Sensitivity analyses were conducted to evaluate uncertainty.</p><p><strong>Results: </strong>We projected that the SLN implementation period, predominately reflecting use of robotic SLN, simultaneously improved health outcomes (0.08 incremental quality-adjusted life-years) and lowered costs (US$1051) compared with the prior period involving robotic or open lymphadenectomy. SLN remained more beneficial and less costly across key sensitivity analyses-namely, varying the cost of the robotic platform, surgical equipment, number of yearly robotic procedures, percentage of robotic procedures versus percentage of laparotomies, length of stay, and lymphedema development. After 1000 simulations of the model, SLN implementation provided greater health benefits for lower costs (ie, cost saving) in 89% of simulations.</p><p><strong>Conclusion: </strong>Implementation of an SLN algorithm in the staging of intermediate- and high-risk endometrial carcinoma improved health outcomes for lower costs compared with lymphadenectomy. Cost-effectiveness could further improve by continuing to increase the proportion of robotic procedures.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464670","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}

{"title":"The association of the chemotherapy response score and homologous recombination deficiency in patients undergoing interval tumor reductive surgery following neoadjuvant chemotherapy.","authors":"Roni Nitecki Wilke, Jinsong Liu, Shannon Neville Westin, Bryan M Fellman, Travis T Sims, Melissa Pham, Kelly Rangel, Esther Sey, Jose Alejandro Rauh-Hain, Karen H Lu, Anil K Sood, Nicole D Fleming","doi":"10.1136/ijgc-2024-005893","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005893","url":null,"abstract":"<p><strong>Objectives: </strong>In patients undergoing interval tumor reductive surgery, a good response to neoadjuvant chemotherapy may limit available tumor for homologous recombination deficiency testing. The objective of this study was to assess whether the chemotherapy response score predicts homologous recombination status.</p><p><strong>Methods: </strong>We identified patients with advanced epithelial ovarian cancer (diagnosed January 2019 to 20 June 2023) who received neoadjuvant chemotherapy, underwent interval surgery, and for whom a chemotherapy response score was reported (1=no or minimal tumor response, 2=appreciable tumor response, 3=complete or near complete response with no residual tumor). Comparisons were made using ANOVAs or Kruskal-Wallis test for continuous variables and χ² or Fisher's exact test for categorical variables.</p><p><strong>Results: </strong>The cohort consisted of 234 patients with advanced ovarian cancer who underwent interval surgery following neoadjuvant chemotherapy. Of those who underwent germline genetic testing, 22% (51/232) had a pathogenic <i>BRCA1</i> or <i>BRCA2</i> mutation and of those with tumors sent for testing, 65% were found to have homologous recombination deficiency (66/146). With increasing chemotherapy response scores, a higher likelihood of a complete gross resection was observed (50% (chemotherapy response score, CRS 1) vs 77% (CRS 2) vs 88% (CRS 3), p<0.001). On multivariable analysis, CRS 2 (adjusted odds ratio=3.28, 95% CI 1.12 to 9.60, p=0.03) and CRS 3 (5.83, 1.79 to 18.93, p=0.003) were independently associated with homologous recombination deficiency compared with CRS 1.</p><p><strong>Conclusion: </strong>A positive response to chemotherapy at the time of interval tumor reductive surgery defined by the chemotherapy response score was associated with homologous recombination status and the likelihood of achieving a complete gross resection.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464676","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}

{"title":"Vaginal and pelvic recurrences and salvage treatments in a cohort of Danish endometrial cancer patients not given adjuvant radiotherapy.","authors":"Gitte Ørtoft, Lars Ulrick Fokdal, Claus Høgdall","doi":"10.1136/ijgc-2024-005772","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005772","url":null,"abstract":"<p><strong>Objective: </strong>In Denmark, adjuvant radiotherapy has gradually been omitted after surgery in endometrial cancer. This study analyses the impact of this strategy on patterns of recurrence and outcome after salvage radiotherapy. Moreover, the potential effect of adjuvant radiotherapy is estimated in the non-low-risk cohort.</p><p><strong>Methods: </strong>The cohort included 3723 consecutive Danish patients with endometrial cancer who had radical surgery without adjuvant treatment (2005-2012). The patients were divided into low-risk (stage 1A, endometrioid, grades 1, 2 and no lymph-vascular space invasion) and non-low-risk. Crude/actuarial recurrence rates evaluated the number of patients who might have benefited from additional adjuvant radiotherapy.</p><p><strong>Results: </strong>Within 9 years' observation time using crude recurrence rates, 13.4% recurred.The rate of isolated vaginal recurrences was 2.9% in low-risk compared with 6.7% in non-low-risk patients. Isolated pelvic recurrences were 0.8% in low-risk compared with 2.1% in non-low-risk patients. In all, 15.8% of non-low-risk patients died from endometrial cancer, mainly due to primary or secondary non-local recurrences (a later non-local recurrence after a primary isolated local recurrence). Only 0.6% and 1.1% of all non-low-risk patients died from an isolated vaginal or pelvic recurrence, respectively. In all, 86% of all patients with an isolated vaginal recurrence were treated with curative intent. Of these, 72% were given radiotherapy with a local control rate of 91% (crude rate). However, even though only 5.8% died of an unsuccessfully treated isolated vaginal recurrence after curative intended radiotherapy, 23.1% died from a secondary non-local recurrence, while 22.3% died from other causes.</p><p><strong>Conclusion: </strong>The Danish strategy of omitting adjuvant radiotherapy is safe. Adjuvant external beam radiotherapy may have prevented isolated local recurrences in 8.7% of the Danish non-low-risk patients, but a majority of these patients were salvaged by curative radiotherapy with 91% and 70% crude local control rates for isolated vaginal and isolated pelvic recurrences, respectively.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390437","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}

{"title":"Early non-compliance to ERAS in gynecological open surgery for malignancies, and post-operative complications: a multicenter, prospective, observational, cohort study.","authors":"Federico Ferrari, Nicolò Bizzarri, Anna Fagotti, Giovanni Scambia, Elisa Gozzini, Hooman Soleymani Majd, Matteo Rota, Franco Odicino","doi":"10.1136/ijgc-2024-005648","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005648","url":null,"abstract":"<p><strong>Background: </strong>Open surgical procedures for gynecological malignancies have a potential risk of post-operative complications and hence prolonged hospitalization, despite adherence to an Enhanced Recovery After Surgery (ERAS) protocol.</p><p><strong>Primary objective: </strong>To investigate the relationship between non-compliance to an ERAS protocol in the post-operative setting and the rate of post-operative complications, in women who underwent open surgery for gynecological malignancies.</p><p><strong>Study hypothesis: </strong>Early non-compliance with the ERAS protocol increases the risk of post-operative complications.</p><p><strong>Trial design: </strong>Multicenter, prospective, observational, cohort study.</p><p><strong>Major inclusion criteria: </strong>Patients with histologically proven gynecological cancer (endometrial, uterine, tubo-ovarian, and cervical) undergoing elective open surgery and managed according to ERAS guidelines.</p><p><strong>Exclusion criteria: </strong>Patients with post-operative recovery in an intensive care unit, undergoing anterior or total pelvic exenteration or intraperitoneal chemotherapy. Previous radiotherapy or previous non-gynecological major abdominal surgery.</p><p><strong>Primary endpoint: </strong>Association of non-compliance with the ERAS protocol using five selected indicators on post-operative day 2 with the rate of 30-day post-operative complications.</p><p><strong>Sample size: </strong>600 patients will be enrolled in the study.</p><p><strong>Estimated dates for completing accrual and presenting results: </strong>At present, 106 patients have been recruited. Based on this, the accrual should be completed in 2025. Results should be presented at the end of 2025.</p><p><strong>Trial registration: </strong>NCT05738902.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390427","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}

{"title":"Ten key steps for optimal robotic upper para-aortic lymph node dissection.","authors":"Jeeyeon Kim, Jiheum Paek","doi":"10.1136/ijgc-2024-005802","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005802","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390435","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}

{"title":"Para-aortic lymph node recurrence in surgically treated early-stage cervical cancer without para-aortic lymph node surgical staging.","authors":"Tullio Golia D'Augè, Giuseppe Caruso, Maria Elena Laudani, Ludovica Nazzaro, Luigi Antonio De Vitis, Nelia Marina Rosanu, Lucia Ribero, Sarah Alessi, Roberta Lazzari, Ilaria Betella, Giovanni Aletti, Vanna Zanagnolo, Nicoletta Colombo, Gabriella Schivardi, Francesco Multinu","doi":"10.1136/ijgc-2024-005950","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005950","url":null,"abstract":"<p><strong>Objective: </strong>The standard treatment for early-stage cervical cancer includes radical hysterectomy with pelvic lymph node staging ± bilateral salpingo-oophorectomy. Para-aortic lymphadenectomy may be considered; however, its role remains controversial. The objective of this study was to assess the para-aortic lymph node recurrence rate in patients undergoing surgery for apparent early-stage cervical cancer without para-aortic lymph node surgical staging.</p><p><strong>Methods: </strong>This is a retrospective cohort study including all consecutive patients with presumed early-stage (International Federation of Gynecology and Obstetrics (FIGO) 2018 IA1-IB2, IIA1) cervical cancer who underwent radical surgery at the European Institute of Oncology, Milan, Italy. Pelvic lymph node assessment included sentinel lymph node biopsy and/or systematic pelvic lymphadenectomy. Patients who underwent para-aortic lymphadenectomy or had an indication to receive adjuvant para-aortic radiotherapy were excluded. The Kaplan-Meier method was used to estimate 5-year recurrence-free survival.</p><p><strong>Results: </strong>Overall, 432 patients were included. The median age was 43.7 years (IQR 38.1-51.6). Sixteen (3.7%) patients were staged IA1 at diagnosis, 24 (5.6%) IA2, 208 (48.1%) IB1, 177 (41%) IB2, and 7 (1.6%) IIA1. At final pathology, the stage distribution was as follows: 36 (8.3%) stage IA1-IA2, 323 (74.8%) stage IB1-IB3, 17 (3.9%) stage II, and 56 (13%) stage IIIC1. Eighty-two patients (19%) underwent concurrent pelvic chemoradiotherapy, 20 (4.6%) radiotherapy alone, and 3 (0.7%) chemotherapy alone. Thirty-eight (8.8%) patients experienced a recurrence with a median time of 18 months (IQR 12-29). The median follow-up time for the remaining 394 (91.2%) patients was 70 months (IQR 36-98). Two patients (0.5%) had a recurrence in the para-aortic lymph nodes. The 5-year recurrence-free survival in the overall cohort was 90% (95% CI 87.4% to 93.3%).</p><p><strong>Conclusion: </strong>Given the low rate of para-aortic lymph node recurrence in surgically treated early-stage cervical cancer and the well-established peri-operative complications associated with para-aortic lymphadenectomy, our study aligns with recent evidence supporting the omission of this procedure in such patients.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390431","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}

{"title":"Proactive assessment of patient reported outcomes in ovarian cancer studies: a systematic review and call for action in future studies.","authors":"Ainhoa Madariaga, Rodrigo Sánchez-Bayona, Lawrence Kasherman, Jose Manuel Estrada-Lorenzo, Luis Manso, Pablo Tolosa, Manuel Alva, Laura Lema, Cristina González-Deza, Eva Ciruelos, David Valcarcel, Stephanie Lheureux, Amit M Oza","doi":"10.1136/ijgc-2024-005883","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005883","url":null,"abstract":"<p><strong>Objective: </strong>This systematic review aims to evaluate the proactive or real-time assessment of patient reported outcomes in studies involving patients with ovarian cancer undergoing systemic therapy.</p><p><strong>Methods: </strong>PubMed, Embase, and Cochrane databases were searched (from database inception until February 2022), and prospective ovarian cancer studies (experimental or observational) that incorporated patient reported outcomes, including quality of life, were included. The primary objective was to assess the ratio of studies incorporating real-time use of patient reported outcomes among those studies performing patient reported outcomes. A secondary objective was to describe the patient reported outcome reporting. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 checklist was followed. Descriptive statistics were used.</p><p><strong>Results: </strong>3071 articles were screened, with 117 included in the final analysis. Studies were published between 1990 and 2022, and consisted of 35 735 patients (median 140 patients per study; interquartile range 58-415). Median time from patient enrollment initiation to study publication was 7 years (range 1-15). Most studies were experimental/clinical trials (n=93, 79%) followed by observational (n=23, 20%). Therapeutic strategies were assessed in 98% (91/93) of experimental studies, most frequently chemotherapy (n=53, 58%), followed by antiangiogenics or poly-ADP ribose polymerase (PARP) inhibitors (n=8, 9%, each). Patient reported outcomes were the primary endpoint in 7.5% (7/93) and 83% (19/23) of experimental and observational studies, respectively. The ratio of real-time patient reported outcomes assessment/evaluation was 0.9% (1/117).</p><p><strong>Conclusions: </strong>Completion of patient reported outcome questionnaires involves time and effort for patients with ovarian cancer. Responses to these questionnaires were only assessed in real time in <1% of analyzed studies. Efforts should be made to incorporate proactive assessment of patient reported outcomes to optimize patient care and safety.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390432","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}

{"title":"2009 International Federation of Gynecology and Obstetrics (FIGO) stage IIIA endometrial cancer: oncologic outcomes based on involvement of adnexa, serosa, or both.","authors":"Eric Rios-Doria, Nadeem R Abu-Rustum, Gretchen Glaser, Michaela McGree, Ane Gerda Eriksson, Melissa Pham, Pamela Soliman, Beyhan Ataseven, Kaled Alektiar, Dmitriy Zamarin, Mario L Leitao, Jennifer Mueller","doi":"10.1136/ijgc-2024-005567","DOIUrl":"10.1136/ijgc-2024-005567","url":null,"abstract":"<p><strong>Objective: </strong>To assess clinicopathologic features and survival outcomes of patients with endometrial carcinoma involving adnexal, full-thickness serosal, or combined involvement.</p><p><strong>Methods: </strong>This international, multi-institutional, retrospective study examined patients with 2009 International Federation of Gynecology and Obstetrics (FIGO) stage IIIA endometrial cancer and tumors involving the uterine serosa and/or adnexa, who were surgically staged between 2000 and 2019. Patients with sarcoma histology, concurrent endometrial/ovarian malignancy, neoadjuvant treatment, positive lymph nodes, or peritoneal disease were excluded.</p><p><strong>Results: </strong>Of 185 patients identified, 139 had tumors with adnexal-only, 40 with serosal-only, and six with combined adnexal/serosal involvement. Median age at diagnosis was 60 years (range 23-89). Among tumors of endometrioid histology, 12 (48%) with serosal-only and 17 (19%) with adnexal-only involvement were FIGO grade 3 (p=0.007). Twenty-three tumors with serosal-only (64%) and 50 with adnexal-only (37%) involvement had lymphovascular invasion (p=0.004). Non-endometrioid histology was present in five tumors (83%) with combined adnexal/serosal, 15 (38%) with serosal-only, and 50 (36%) with adnexal-only involvement.Median follow-up was 77 months (range 0.6-254). Five-year progression-free survival and overall survival rates for all patients with stage IIIA disease were 73.8% (SE 3.5%) and 81.0% (SE 3.1%), respectively. For patients with adnexal-only, serosal-only, and combined adnexal/serosal involvement, 5-year progression-free survival rates were 80% (SE 3.8%), 61% (SE 8.3%), and 33% (SE 19.2%), respectively (p<0.01); 5-year overall survival rates were 85% (SE 3.3%), 70% (SE 7.8%), and 60% (SE 21.9%), respectively (p=0.09). On univariate analysis, tumors having serosal involvement with/without adnexal involvement, non-endometrioid histology, and lymphovascular invasion were significantly associated with progression. On multivariate analysis, tumors having serosal involvement with/without adnexal involvement remained significantly associated with recurrence (adjusted HR=2.2, 95% CI 1.2 to 4.3; p=0.01).</p><p><strong>Conclusions: </strong>Patients with 2009 FIGO stage IIIA endometrial cancer have distinct survival outcomes depending upon adnexal and/or serosal involvement. Progression-free survival was worse for patients with serosal involvement after adjusting for histology, adjuvant treatment, and lymphovascular space invasion.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1580-1587"},"PeriodicalIF":4.1,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792399","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}

{"title":"The evolving landscape of locally advanced cervical cancer treatment.","authors":"Mariana Carvalho Gouveia, Letícia de Mello Graziano, Letícia Vecchi Leis, Mariana Scaranti","doi":"10.1136/ijgc-2024-006128","DOIUrl":"https://doi.org/10.1136/ijgc-2024-006128","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390436","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}

{"title":"Effects of niraparib dose reduction on short-term outcomes in ovarian cancer patients.","authors":"Matteo Bruno, Adriana Ionelia Apostol, Serena Maria Boccia, Carolina Maria Sassu, Sara Lardino, Camilla Culcasi, Domenica Lorusso, Giovanni Scambia, Anna Fagotti, Claudia Marchetti","doi":"10.1136/ijgc-2024-005363","DOIUrl":"10.1136/ijgc-2024-005363","url":null,"abstract":"<p><strong>Objectives: </strong>Despite the individualized starting dose for maintenance therapy in ovarian cancer, the niraparib dose reduction rate remains high. The aim of this study was to evaluate the impact of niraparib dose reduction on progression-free survival in newly diagnosed primary advanced ovarian cancer and recurrent ovarian cancer patients. We also aimed to compare the reduction rates and the safety of niraparib on primary and relapse groups, and identify which factors may predict dose reduction.</p><p><strong>Methods: </strong>Patients with primary or recurrent ovarian cancer in maintenance who received niraparib between 2019 and 2022 were retrospectively evaluated. Niraparib dosing was based on individualized starting dose of 300 or 200 mg/day. The impact of niraparib dose reductions was focused on patients treated with 200 or 100 mg in both groups. Reduction rates, adverse events and predictive factors of reduction were assessed in each study group. The primary endpoint was progression-free survival in primary and relapse groups; the secondary endpoints were the reduction rates, the safety and tolerability of niraparib in both groups.</p><p><strong>Results: </strong>Of 215 patients identified, 124 (57.7%) primary and 91 (42.3%) recurrent ovarian cancer patients were included. The majority of patients started niraparib at 200 mg/day (92.7% primary and 80.2% relapse group); dose reductions from 300 or 200 mg/day to 200 or 100 mg/day occurred more frequently within cycles 1-3 (67% primary and 45% relapse group, p=0.001). Grade≥3 adverse events were lower in the relapse group (54.8% primary and 35.1% relapse, p=0.001). In both groups, dose modifications over the treatment did not significantly impair median progression-free survival. Univariate and multivariate analysis demonstrated that weight and platinum-doublets were possible risk factors for dose reduction.</p><p><strong>Conclusions: </strong>Niraparib dose reduction occurs in almost half of patients within cycles 1-3, although it is significantly more common in the first-line setting. Survival outcomes seem not to be impaired by dose reduction.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1588-1595"},"PeriodicalIF":4.1,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300625","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}