American Journal of Clinical Oncology-Cancer Clinical Trials最新文献

{"title":"Real-world Safety of Concurrent Pembrolizumab and Radiotherapy in Triple-negative Breast Cancer.","authors":"Assile El Fakih, Pierre Loap, Luc Cabel, Sofiane Allali, Kim Cao, Mariana Mirabel, Jean-Yves Pierga, Youlia Kirova","doi":"10.1097/COC.0000000000001236","DOIUrl":"https://doi.org/10.1097/COC.0000000000001236","url":null,"abstract":"<p><strong>Objectives: </strong>Triple-negative breast cancer (TNBC) accounts for ∼15% of invasive breast cancers and is associated with a poor prognosis. The introduction of pembrolizumab in both neoadjuvant and adjuvant settings, as established by the KEYNOTE-522 trial, has improved event-free survival and is now considered standard of care. Postoperative adjuvant radiotherapy remains essential in reducing recurrence and mortality. However, combining radiotherapy with pembrolizumab may increase the risk of toxicities, particularly cardiac, and its long-term safety profile remains poorly characterized. This study aims to assess the safety of this combination in TNBC patients.</p><p><strong>Methods: </strong>This monocentric retrospective study, conducted at Institut Curie in Paris, included patients with locally advanced TNBC treated according to the KEYNOTE-522 protocol-neoadjuvant chemotherapy and immunotherapy, followed by surgery and adjuvant therapy, including radiotherapy with or without pembrolizumab. Patients were divided into 2 groups: those receiving concurrent radiotherapy and pembrolizumab (RT-P), and those receiving radiotherapy alone (RT). The primary endpoint was treatment tolerance. Secondary endpoints included overall survival and cancer-specific survival. A P-value <0.05 was considered statistically significant.</p><p><strong>Results: </strong>A total of 89 patients were included, with a median follow-up of 16 months. Forty-one patients received radiotherapy alone, and 48 received concurrent radiotherapy and pembrolizumab. No significant differences were observed between groups in baseline characteristics or overall toxicity, except for grade 1 radiodermatitis, which was more frequent in the RT-P group (83.3% vs. 43.9%). No grade ≥3 toxicities were reported. Two cases of grade 1 pulmonary toxicity occurred in the RT-P group. The mean heart dose was 1.8 Gy (range: 0.01-7.9), with no cardiac toxicity attributable to radiotherapy.</p><p><strong>Conclusion: </strong>Adjuvant radiotherapy can be safely administered concurrently with pembrolizumab in TNBC patients without increasing radiation-related adverse events, supporting the continuation of systemic therapy in this high-risk population. Nevertheless, larger prospective studies are needed to assess long-term toxicity.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144800872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Intensive Multimodal Treatment on the Outcomes of Patients With Anaplastic Thyroid Cancer.","authors":"Bakr Alhayek, Firas Baidoun, Danny Hadidi, Muhamad Alhaj Moustafa, Omar Abdel-Rahman","doi":"10.1097/COC.0000000000001246","DOIUrl":"https://doi.org/10.1097/COC.0000000000001246","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Anaplastic thyroid cancer (ATC) is a rare and aggressive type of thyroid malignancy with a very poor prognosis and outcome despite therapy. The rarity of this disease and the poor functional status of ATC patients limit the ability to conduct clinical trials, thus there is a lack of large, controlled trials to guide treatment and evaluate the benefit of combined modality therapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The National Cancer Database (NCDB) was queried for patients diagnosed with ATC at age 18 or older between 2004 and 2018. After excluding patients with unknown number of treatment modalities, Charlson-Deyo score-a weighted summary of 17 chronic disease categories where higher scores denote greater baseline comorbidity burden-of 3 or more and patients lost for follow-up, we split the cohort into 3 groups according to the number of treatment modalities they received. Treatment modalities included surgery, radiation, and systemic therapy. Then, we evaluated the overall survival (OS) between the 3 groups. We studied the OS using Kaplan-Meier estimates and multivariate Cox regression analyses to evaluate factors associated with OS. In addition, propensity score matching (accounting for age, sex, race, Charlson-Deyo score, and clinical M stage) was used for more robust results.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 3460 patients with ATC were included in the analysis, of which 1472 (42.5%) either received one type of therapy or did not receive any therapy (group 1), 1092 (31.6%) received bimodal therapy (group 2), and 896 (25.9%) received trimodal therapy (group 3). We found that group 3 had better OS compared with group 1 and group 2 (median OS 9.1 vs. 1.7 and 4.9 mo, respectively, with P&lt;0.001 for all comparisons). Propensity score matching yielded 896 patients in each group. We found that group 3 had better OS compared with group 1 and group 2 (median OS 9.1 vs. 1.9 and 5.2 mo, respectively, with P&lt;0.001 for all comparisons). Same trend was found in subgroup analysis when we split the cohort according to the metastatic status; in M0 group (median OS was 10.4 vs. 1.9 and 6.1 mo, respectively, with P&lt;0.001 for all), in M1 group (median OS was 5.9 vs. 1.4 and 3.7 mo, respectively, with P&lt;0.001 for all). Modality-specific analyses further demonstrated that surgery, radiation, and systemic therapy each independently prolonged OS in both M0 and M1 cohorts (all P&lt;0.001). These individual benefits explain the additive advantage of trimodal therapy and underscore that offering at least one evidence-based modality is preferable when comprehensive treatment is infeasible. On multivariate analysis, group 1 and group 2 were associated with worse OS compared with trimodal treatment (HR: 2.721; 95% CI: 2.466-3.002 and HR: 1.434; 95% CI: 1.299-1.582, P&lt;0.001 for all).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Patients with ATC who were treated with intensive trimodal therapy had statistically significant improvement in OS compa","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144796017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Social Determinants of Health in the Receipt of Systemic Treatment for Metastatic Melanoma.","authors":"Hanna Kakish, Maira A Bhatty, Adam Wade, Hailey Seibert, Henry Herrera, Iris Sheng, Ankit Mangla, Richard S Hoehn, Luke D Rothermel","doi":"10.1097/COC.0000000000001198","DOIUrl":"10.1097/COC.0000000000001198","url":null,"abstract":"<p><strong>Simple summary: </strong>The development of contemporary immune and targeted therapies for patients with metastatic extended survival compared to the previous standard of care treatments. Therefore, equitable access to these therapies for all patients with advanced melanoma is of high importance. We aimed to understand the association between SES with treatment receipt and prognosis. Furthermore, we aimed to identify detailed reasons why patients with stage IV melanoma do not undergo systemic treatment. Our findings would help us understand what interventions are most helpful to improve the care of patients with advanced melanoma within our regional hospital system.</p><p><strong>Objectives: </strong>The Area Deprivation Index (ADI) has not been used to study the effects of socioeconomic status (SES) in the receipt of treatment in melanoma. We set out to understand the effect of SES on the receipt of systemic treatment upon diagnosis of stage IV melanoma patients within our health system.</p><p><strong>Methods: </strong>We queried patients with stage IV melanoma at our institution between 2010 and 2021. We defined SES based on ADI (highest quartile considered \"low SES\"). Multivariable regression analysis was performed to identify predictors of systemic therapy receipt. Additionally, we reviewed granular reasons for not receiving systemic treatment.</p><p><strong>Results: </strong>One hundred seventy-nine patients were included, of whom 119 (66.5%) received any type of systemic treatment. Patients were less likely to receive systemic therapy if they had worse performance status, low SES, or were diagnosed between 2010 and 2017. The majority of barriers to receiving systemic therapy included poor baseline medical condition and advanced disease with recommendation for hospice care (39 patients, 65%). Potentially modifiable reasons included refusal by the patient (5 patients, 8.3%), which did not differ between high and low SES patients, and occurred in only 1 patient ≥2018.</p><p><strong>Conclusions: </strong>Low SES predicted lower systemic treatment receipt for stage IV melanoma at our institution; however, most limitations to treatment came from nonmodifiable barriers to care at the time of diagnosis. These findings provide valuable insight into equity-focused programming at our institution and others.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"415-420"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"KRAS Mutations in Cancer: From Molecular Insights to Therapeutic Strategies.","authors":"Yuanzhu Zhang, Yujie Ma, Kexin Zhang, Yuqun Wang, Xiaodong Sun, Chengxia Kan, Fang Han","doi":"10.1097/COC.0000000000001192","DOIUrl":"10.1097/COC.0000000000001192","url":null,"abstract":"<p><p>The global burden of cancer remains a major public health challenge, with Kirsten rat sarcoma viral oncogene homolog (KRAS) emerging as the most common mutated oncogene across diverse malignancies. Once considered \"undruggable\" due to its unique structure, KRAS has garnered intense research focus, resulting in significant advancements. This paper aims to review recent developments in our understanding of KRAS biology, including its structural and functional aspects, and to explore the latest insights into its mutations across various cancer types. Emphasis is placed on prognosis, predictive roles, and emerging therapeutic strategies targeting KRAS. This review aspires to deepen our comprehension of KRAS and potentially enhance treatment outcomes for cancer patients harboring KRAS mutations in the future.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"383-391"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lack of Impact of Expansion Size From Gross Tumor Volume to Planning Target Volume on Control Rates and Patterns of Recurrence in Fractionated Radiotherapy for WHO Grade 1 Meningiomas.","authors":"Christopher R Weil, Calvin B Rock, Vikren Sarkar, Nicholas Gravbrot, Felicia H Lew, Christian B Rock, Lindsay M Burt, Cristina M DeCesaris, Randy L Jensen, Dennis C Shrieve, Donald M Cannon","doi":"10.1097/COC.0000000000001193","DOIUrl":"10.1097/COC.0000000000001193","url":null,"abstract":"<p><strong>Objectives: </strong>For single-fraction stereotactic radiosurgery (SRS) for WHO grade I meningiomas, no-GTV or minimal-GTV to PTV margin is an accepted practice. We evaluated whether there is a control difference based on GTV to PTV expansion size for fractionated RT.</p><p><strong>Methods: </strong>Eighty-seven patients with WHO grade 1 meningioma were identified from an institutional database, treated with either conventional immobilization and radiation treatment delivery techniques (cRT) with 5 to 20 mm PTV expansions or fractionated stereotactic radiotherapy (fSRT) with ≤3 mm GTV to PTV expansions. Kaplan-Meier estimators were used for local failure-free survival (LFFS), marginal-failure-free survival (MFFS), and distant failure-free survival (DFFS) analysis.</p><p><strong>Results: </strong>The median follow-up duration was 9.0 years. Twenty-five patients (29%) received cRT and 62 patients (71%) received fSRT. The median dose was 54 Gray. There were 4 local (5%), 1 marginal (1%), and 1 distant failure (1%). The fSRT and cRT groups each had 2 local failures; 3/4 local failures occurred in areas near critical organs at risk. For cRT versus fSRT, 5-year and 10-year LFFS were 100% versus 98% ( P =0.46) and 94% versus 96% ( P =0.34), 5-year and 10-year MFFS were 100% versus 100% and 100% versus 92% ( P =0.004), and 5-year and 10-year DFFS were 100% versus 98% at both time points ( P =0.65 and P =0.67, respectively).</p><p><strong>Conclusions: </strong>In this patient cohort, there was no local control benefit for larger GTV-to-PTV expansions. For patients with tumors not eligible for SRS, fractionated stereotactic treatment workflow with ≤3 mm PTV expansions is an effective approach for WHO grade 1 meningiomas.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"403-409"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proceedings of the American Radium Society® 107th Annual Meeting.","authors":"","doi":"10.1097/COC.0000000000001223","DOIUrl":"10.1097/COC.0000000000001223","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"S1-S39"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144286961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Best Interest.","authors":"Hilde M Buiting","doi":"10.1097/COC.0000000000001212","DOIUrl":"https://doi.org/10.1097/COC.0000000000001212","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":"48 8","pages":"381-382"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Practice Patterns of Surveillance in Sentinel Lymph Node-Positive Malignant Melanoma: An International Survey.","authors":"Paul Wong, Michael O'Leary, Kelly Mahuron, Hans F Schoellhammer, Moshe Faynsod, Benjamin Paz, Laleh G Melstrom","doi":"10.1097/COC.0000000000001196","DOIUrl":"10.1097/COC.0000000000001196","url":null,"abstract":"<p><strong>Objectives: </strong>To understand surveillance practice patterns in melanoma patients with a positive sentinel lymph node (SLN) biopsy.</p><p><strong>Methods: </strong>A survey was designed, tested for item relevance, readability, and content validity, and subsequently distributed to melanoma surgeons through institutional emails and international societies.</p><p><strong>Results: </strong>Majority of the 59 respondents were <10 years from training (59.3%), in academia (74.1%), or dedicated >25% of their practice to melanoma (50.8%). Nearly all surgeons (98.3%) would not recommend complete lymph node dissection (CLND) for a 2 mm melanoma with nodal metastasis <1 mm. 79.7% of surgeons claim a significant role in determining the surveillance regimen, and most (57.6%) opt for a combination of nodal basin ultrasound and CT or PET/CT, while 39.0% follow with ultrasound only. No difference in surveillance modality was seen when stratifying time since training (≤10 vs. >10 y; P =0.798). However, for those who dedicate >25% of their practice to melanoma, significantly fewer surgeons report use of ultrasound only (>25%: 13.3% vs. ≤25%: 65.5%; P <0.001). Whereas 33.9% of surgeons state their surveillance strategy is agnostic to patient factors, others claim adherence to appointments (30.5%), distance from hospital (18.9%), and insurance (15.8%) shift their management. Breslow depth >4 mm (27.4%), ulceration (22.2%), and mapping to >1 basin (16.2%) are the most common reasons surgeons obtain cross-sectional imaging. Reasons that deter surgeons against ultrasound as the surveillance modality of choice include reproducibility/interpretation of the results (42.6%), patient preference (25.0%), and medical oncology preference (22.1%).</p><p><strong>Conclusions: </strong>Despite trials aimed to inform the management of SLN-positive melanoma, surveillance strategies remain largely dependent on provider preference and individual patient factors.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"410-414"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144023964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Tolerability of Concurrent Radiotherapy and Sacituzumab Govitecan in Metastatic Breast Cancer.","authors":"Pierre Loap, Salma Chabli, Paul Cottu, Youlia Kirova","doi":"10.1097/COC.0000000000001195","DOIUrl":"10.1097/COC.0000000000001195","url":null,"abstract":"<p><strong>Objectives: </strong>Sacituzumab govitecan, an anti-TROP2 antibody-drug conjugate, is approved for metastatic triple-negative breast cancer (TNBC) from the second-line setting and for hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer from the third line. Radiotherapy is frequently required in metastatic settings for symptom control, but its combination with sacituzumab govitecan has not been formally evaluated. This study aims to assess the safety and tolerability of concurrent sacituzumab govitecan and radiotherapy in metastatic breast cancer patients.</p><p><strong>Methods: </strong>This retrospective, single-center study included all metastatic breast cancer patients who received sacituzumab govitecan and underwent external beam radiotherapy (EBRT) at Institut Curie. Clinical and pathologic data, treatment details, toxicities graded per CTCAE v5.0, and survival outcomes were analyzed. Overall survival (OS) was estimated using the Kaplan-Meier method.</p><p><strong>Results: </strong>Thirteen patients were included, with a mean age of 54 years. The majority (61.5%) had TNBC. A total of 19 metastatic sites were irradiated, including 10 brain and 9 bone metastases. No radiation-induced toxicity was observed, and no patients required treatment interruption. Grade 3 to 4 toxicities were limited to neutropenia (15.4%). The median OS from radiotherapy completion was 6 months, with a 6-month OS rate of 45.1% and a 12-month OS rate of 16.9%.</p><p><strong>Conclusions: </strong>The concurrent administration of sacituzumab govitecan and radiotherapy appears well tolerated, with no increased toxicity. This combination may be feasible in metastatic breast cancer patients when clinically indicated. Further studies with larger cohorts are necessary to confirm these findings.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"399-402"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Pegylated Filgrastim as Primary Prophylaxis Following Pediatric Dose-intensive Chemotherapy: A Randomized Controlled Trial.","authors":"Meena Haldorai, Jagdish P Meena, Aditya K Gupta, Ravindra M Pandey, Anita Chopra, Rachna Seth","doi":"10.1097/COC.0000000000001199","DOIUrl":"10.1097/COC.0000000000001199","url":null,"abstract":"<p><strong>Objectives: </strong>Large trials and meta-analyses in adults suggest a similar efficacy and safety of a single dose of peg-filgrastim compared with daily filgrastim in the prevention of chemotherapy-induced neutropenia. However, there is no large prospective data in the pediatric population. This trial was designed to demonstrate the efficacy and safety of peg-filgrastim in children.</p><p><strong>Methods: </strong>This was an open-labelled randomized trial. Children with solid tumors receiving chemotherapy in which growth factor support was indicated were screened before chemotherapy and randomized to either the filgrastim arm (5 mcg/kg daily) or peg-filgrastim arm (100 mcg/kg single dose 24 h postchemotherapy). Patients were followed up till absolute neutrophil count (ANC) recovery clinically as well as by thrice weekly complete blood counts. The primary outcome was the incidence of FN, and secondary outcomes included the reduction in the depth of ANC nadir, shortening of the duration of grade-4 neutropenia, reduction in ANC recovery time, and adverse events.</p><p><strong>Results: </strong>A total of 344 chemotherapy cycles were screened. After the exclusion of 29 cycles, 315 chemotherapy cycles in 61 patients were randomized to peg-filgrastim (n=160) and filgrastim arm (n=155). The median age of included patients was 3 years (2; 6.5), and males were predominant. The incidence of FN in peg-filgrastim and filgrastim arms was 8% and 18% ( P =0.01) (RR: 0.45; 95% CI: 0.24-0.84). Duration of ANC recovery, depth of ANC nadir, and adverse events reported were not significantly different in both arms.</p><p><strong>Conclusions: </strong>The incidence of FN in the peg-filgrastim arm was significantly lesser. No significant adverse events attributable to the study drug were reported.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"421-427"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}