International Journal of Radiation Oncology Biology Physics最新文献

{"title":"Effect of Cisplatin Cycles on Prognosis for Locally Advanced Cervical Cancer Patients Treated with Concurrent Chemoradiotherapy: A Long-Term Follow-Up, Large Cohort Study","authors":"","doi":"10.1016/j.ijrobp.2024.07.048","DOIUrl":"10.1016/j.ijrobp.2024.07.048","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>To assess the impact of cisplatin cycles on both overall survival (OS) and disease-free survival (DFS) in locally advanced cervical cancer (LACC) patients undergoing concurrent chemoradiotherapy (CCRT), and to build a nomogram-based prognostic stratification to identify LACC patients who might benefit from ≥ 5 cycles of cisplatin.</div></div><div><h3>Materials/Methods</h3><div>A total of 918 patients with LACC who underwent CCRT at our hospital were retrospectively enrolled. The difference in survival outcomes between the &lt; 5 cycles and ≥ 5 cycles groups were compared using the paired Log-rank test. Subgroup analysis was further conducted to explore the survival differences between the ≥ 5 cycles and &lt; 5 cycles groups in different subpopulations, including age, histology, tumor size, squamous cell carcinoma antigen (SCC Ag), and Federation International of Gynecology and Obstetrics (FIGO) stage. Univariate and multivariate Cox regression analyses were performed in the &lt; 5 cycles group to identify independent risk factors, and a nomogram was developed accordingly. The patients were divided into two risk subgroups according to the total points derived from the nomogram, and the survival outcomes between the &lt; 5 cycles and ≥ 5 cycles groups were compared in each risk strata.</div></div><div><h3>Results</h3><div>The 5-year OS and DFS were 76.7% (95% CI = 74.3–79.9%) and 86.1% (95% CI = 84.6–87.6%) (<em>P</em> = 0.002) and 68.7% (95% CI = 66.1%–71.3%) and 78.3% (95% CI = 76.6%–80.0%) (<em>P</em> = 0.0016) for the &lt; 5 and ≥ 5 cycles groups, respectively. In subgroup analysis, the survival benefit of ≥ 5 cycles could be maintained in patients with squamous disease (<em>P</em> = 0.0031 in OS; <em>P</em> = 0.0019 in DFS), patients with SCC &gt; 1.5 ng/mL (<em>P</em> = 0.0096 in OS; <em>P</em> = 0.019 in DFS), patients with tumor size &gt; 4 cm (<em>P</em> = 0.0036 in OS; <em>P</em> = 0.0011 in DFS), and patients with stage I/II disease (<em>P</em> = 0.0041 in OS; <em>P</em> = 0.014 in DFS). A nomogram incorporating size, SCCAg, and FIGO stage was constructed, and patients were divided into two risk groups (low-risk: total points &lt; 101; high-risk: total points ≥ 101). Receiving ≥ 5 cycles showed superiority in OS (<em>P</em> = 0.0025) and DFS (<em>P</em> = 0.008) over &lt; 5 cycles in the low-risk subgroup; however, this survival benefit could not be maintained in the high-risk subgroup (<em>P</em> = 0.130 in OS; <em>P</em> = 0.093 in DFS).</div></div><div><h3>Conclusion</h3><div>Receiving ≥ 5 cycles of cisplatin improved OS and DFS in LACC patients who received CCRT when compared with &lt; 5 cycles. A nomogram was constructed and the newly defined low-risk patients might gain significant OS and DFS benefit from receiving ≥ 5 cycles.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Prognostic Analysis of Chemoradiotherapy vs. Chemotherapy after D2 Resection for High-Risk Gastric Cancer: Results from a Prospective Randomized Control Study","authors":"","doi":"10.1016/j.ijrobp.2024.07.072","DOIUrl":"10.1016/j.ijrobp.2024.07.072","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.</div></div><div><h3>Results</h3><div>The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; <em>P</em> = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; <em>P</em> = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; <em>P</em> = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; <em>P</em> &lt; 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (<em>P</em> &lt; 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; <em>P</em> = 0.08), but the difference was not significant.</div></div><div><h3>Conclusion</h3><div>The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142359567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Multicenter Phase III Randomized Clinical Trial Comparing the Efficacy of an Adjuvant SOX Chemotherapy Regimen with SOX Combined with a Simultaneous Radiotherapy Regimen after D2 Radical Resection for Gastric Cancer","authors":"","doi":"10.1016/j.ijrobp.2024.08.018","DOIUrl":"10.1016/j.ijrobp.2024.08.018","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose/Objective(s)&lt;/h3&gt;&lt;div&gt;Adjuvant chemotherapy and chemoradiotherapy are both mainstream treatment modalities for gastric cancer, but whether to administer radiotherapy after gastric cancer D2 radical resection has been a focal point of discussion in recent years. This study compared the efficacy of chemotherapy alone and radiochemotherapy for adjuvant treatment in patients with stage T4 or positive lymph nodes after D2 resection.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials/Methods&lt;/h3&gt;&lt;div&gt;Researchers randomly assigned patients in a 1:1 ratio to either the concurrent chemoradiotherapy arm (SOXRT) or the chemotherapy-alone arm (SOX). In the SOXRT arm, patients received one cycle of induction chemotherapy with the SOX regimen 21 days before starting radiotherapy; the radiotherapy was at a total dose of 50.4Gy in 28 fractions, 1.8Gy per day, 5 fractions per week, simultaneously with concurrent chemotherapy with S-1 at a dose of 50 mg, bid. Three to four weeks after the completion of radiotherapy, three cycles of chemotherapy with the SOX regimen were administered, with the same dosage as the induction chemotherapy. The SOX arm received a total of six cycles of chemotherapy with the SOX regimen. The specific dosages for the SOX regimen were: S-1 30-40mg/m2 bid on days 1-14, and oxaliplatin 130mg/m2 on day 1, every 3 weeks. The primary endpoint of the study was disease-free survival (DFS). The double significance level is 0.05. Assuming that higher DFS can be achieved with simultaneous radiotherapy, the sample size needed for this project is 516 patients. Assuming that 20% of the patients need to be excluded from the statistics, the total number of patients that need to be enrolled in this project is 620.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 620 patients were randomized up to 16 August 2022. Patients had a median age of 54 years, 64% were male, 43% were stage T4 patients, and 72% were stage III (the eighth edition of the Cancer Staging Manual of AJCC). The baseline patient characteristics were balanced across treatment arms. The median DFS follow-up period was 64 months, with 263 DFS events observed. The 3-year DFS rates were 71.7% and 71.4%, and the 5-year DFS was 60.2% and 59.2% in the SOXRT and SOX arms, respectively. The median overall survival (OS) follow-up period was 69 months, with 188 OS events observed. The 3-year OS rates were 81.1% and 79.8%, and 5-year OS survival rates were 74.9% and 73.2% in the SOXRT and SOX arms, respectively. There was no statistically significant difference between the SOX arm and the SOXRT arm in both DFS (HR 0.930; P=0.56) and OS (HR 1.003; P=0.99). The incidence of adverse events in each treatment arm was as expected, and overall it was well tolerated with manageable toxicity.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;In T4 or lymph node-positive GC patients with D2 resection, the addition of radiation therapy to the postoperative adjuvant SOX regimen did not significantly improves the DFS or OS after D","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Phase II Trial of Camrelizumab in Combination with Concurrent Chemoradiotherapy as First-Line Treatment for Betel Nut-Related Locally Advanced Oral Squamous Cell Carcinoma","authors":"","doi":"10.1016/j.ijrobp.2024.07.049","DOIUrl":"10.1016/j.ijrobp.2024.07.049","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose/Objective(s)&lt;/h3&gt;&lt;div&gt;Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials/Methods&lt;/h3&gt;&lt;div&gt;This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m&lt;sup&gt;2&lt;/sup&gt; Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of &lt; 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, &lt;em&gt;P&lt;/em&gt; = 0.001), DFS (92.2% vs 55.5%, &lt;em&gt;P&lt;/em&gt; = 0.003), and OS (98.0% vs 77.8%, &lt;em&gt;P&lt;/em&gt; = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstr","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multi-Institutional Standardized Dosimetry Protocol for Preclinical Radiobiological Experiments","authors":"","doi":"10.1016/j.ijrobp.2024.07.022","DOIUrl":"10.1016/j.ijrobp.2024.07.022","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Commercial devices capable of delivering FLASH radiotherapy are being introduced into radiobiology research. There is a critical necessity for a unified dosimetric protocol to ensure dosimetric consistency across institutes. This work introduces a collaborative, multi-institutional dosimetry protocol designed to validate and standardize dosimetry across two research facilities using FLASH intraoperative systems.</div></div><div><h3>Materials/Methods</h3><div>Two independent institutes used the same collimator design (4x4 cm²) and same beam parameters to deliver 12 or 14 Gy with FLASH or conventional (CONV) dose rates. For dosimetry, replicates of a realistic anatomy 3D-printed mouse phantom with coronal or sagittal division allowing insertions of radiochromic films, and a set of films (sourced from a singular source) were sent from Institute 1 to Institute 2. The institutes independently calibrated the target doses for FLASH using films from the phantom against the associated measurements from the embedded toroid of the system, and for CONV against the total number of MU. Ultimately, 80 experimental toroid measurements for FLASH (40 per target dose) were acquired in 4 days, with 5 set of films per modality per day of measurement. The films were returned to Institute 1 for analysis and the experimental values for FLASH and CONV were calculated.</div></div><div><h3>Results</h3><div>For 12 Gy target dose, the toroid-derived FLASH doses combined for Institute 1 vs Institute 2 were 11.85 ± 0.11 Gy vs 12.32 ± 0.16 Gy, for 14 Gy were 14.12 ± 0.07 Gy vs 14.09 ± 0.01 Gy. for CONV 11.74 ± 0.23 Gy vs 12.19 ± 0.20 Gy and for 14 Gy were 13.86 ± 0.21 Gy vs 14.47 ± 0.31 Gy.</div></div><div><h3>Conclusion</h3><div>The differences between measured and target doses, as well as between FLASH and CONV doses, were within 3%, and the inter-institutional dose differences were under 5%. Enhancing the protocol could entail incorporating an extra calibration step before the experimental dates to fine tune dose alignment between institutions. The success of the collaborative, multi-institutional dosimetry protocol, using realistic anatomy 3D-printed mouse phantom, is evidenced by the demonstrated consistency in preclinical radiobiological experiments across distinct research facilities.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interim Futility Results of NRG-HN005, A Randomized, Phase II/III Non-Inferiority Trial for Non-Smoking p16+ Oropharyngeal Cancer Patients","authors":"","doi":"10.1016/j.ijrobp.2024.08.014","DOIUrl":"10.1016/j.ijrobp.2024.08.014","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose/Objective(s)&lt;/h3&gt;&lt;div&gt;NRG-HN005 was a phase II/III randomized study comparing each of two experimental arm(s) against a control arm from RTOG 1016, in patients with p16+, non-smoking associated, locoregionally advanced oropharyngeal cancer. The phase II primary endpoint was non-inferiority (NI) of progression-free survival (PFS). The phase III trial would have included the experimental arm(s) found to be NI in phase II, with co-primary endpoints of NI PFS and superior quality of life.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials/Methods&lt;/h3&gt;&lt;div&gt;Eligible patients had p16+ stage T1-2N1M0 or T3N0-N1M0 (AJCC 8&lt;sup&gt;th&lt;/sup&gt; edition) oropharyngeal squamous cell carcinoma and ≤10 pack-year smoking history. Patients were stratified by Zubrod performance status and randomized (1:1:1) to 70 Gy of intensity modulated radiation therapy (IMRT) over 6 weeks + Cisplatin at 100 mg/m&lt;sup&gt;2&lt;/sup&gt; every 3 weeks (Arm 1) vs 60 Gy IMRT over 6 weeks + Cisplatin at 100 mg/m&lt;sup&gt;2&lt;/sup&gt; every 3 weeks (Arm 2) vs 60 Gy IMRT over 5 weeks with nivolumab (Arm 3). For trial design, the assumed 9-month PFS was 96.5% and the lower threshold for Arms 2 and 3 was 91.8% (absolute NI margin 4.7%), for a hazard ratio (HR) boundary HR &lt; 2.4 required for noninferiority. With one-sided type I error rate of 10% per test and 80% power, a log-rank test required 22 events from 266 patients per comparison (requiring 133 patients per arm and a total sample size of 399). In phase II, a futility analysis would be triggered for each comparison after 50% of the PFS events (11/22) had been reported. If the observed HR exceeded the NI margin, accrual would be discontinued. All randomized patients were included in analysis.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Phase II accrued from 7/10/19 to 11/8/23. Accrual was suspended from 2/3/23 to 5/25/23, to discontinue Arm 2, after which randomization continued (1:1) to Arms 1 and 3 to complete the new phase II sample size of 382 patients. The median age was 60 years, 90.6% were male, 87.5% were White, and 84.9% had stage I disease. The first futility analysis was conducted after 11 PFS events (Arm 1: 2, Arm 2: 9) were reported, at a median follow-up of 1.1 years. The estimated HR was 4.34 (1-sided 90% upper confidence limit 11.83). The second futility analysis was triggered after 11 PFS events (Arm 1: 2, Arm 3: 9) were reported, at a median follow-up of 1.7 years. The estimated HR was 4.51 (1-sided 90% upper confidence limit 12.29). Accrual would have stopped but phase II had already completed. At present (median follow-up 2.2 years), 2-year PFS estimates are 98.1% (95% CI 95.4, 100) for Arm 1, 88.6% (95% CI 82.4, 94.7) for Arm 2, and 90.3% (95% CI 84.5, 96.1) for Arm 3. The 2-year overall survival estimates are 99.0% (95% CI 97.0, 100), 98.0% (95% CI 95.2, 100), and 96.1% (95% CI 92.3, 99.9), respectively.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The failure of the experimental arms to satisfy non-inferiority is due in part to the highly favorable ou","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concurrent Chemoradiation ± Atezolizumab (atezo) in Limited-Stage Small Cell Lung Cancer (LS-SCLC): Results of NRG Oncology/Alliance LU005","authors":"","doi":"10.1016/j.ijrobp.2024.08.013","DOIUrl":"10.1016/j.ijrobp.2024.08.013","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose/Objective(s)&lt;/h3&gt;&lt;div&gt;Concurrent chemoradiation (cCRT) followed by prophylactic cranial irradiation (PCI) has been the standard of care for LS-SCLC for decades. NRG-LU005 (NCT03811002) tested the addition of atezo to cCRT in this open label, randomized phase III international trial. Here, results of the 2nd planned interim analysis are reported as recommended by the Data Monitoring Committee.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials/Methods&lt;/h3&gt;&lt;div&gt;Patients (pts) with LS-SCLC, stage Tx-4, N0-3, M0 with ECOG performance status (PS) 0-2 were eligible. Pts received one cycle of chemotherapy (platinum/etoposide) prior to study registration and were randomized 1:1 to cCRT versus cCRT plus atezo, 1200 mg IV, every 3 weeks until investigator-assessed progression or intolerable side effects, for a maximum of 17 cycles. Pts were stratified by choice of chemotherapy (cisplatin vs. carboplatin), radiation fractionation schedule (66 Gy once daily vs. 45 Gy twice daily), sex, and PS (0/1 vs. 2). The primary endpoint was overall survival (OS). Secondary endpoints included investigator assessed progression-free survival (PFS), objective response rate (ORR), local control and distant-metastasis free survival (DMFS). PCI was recommended for pts achieving a complete or near-complete response. It was designed to detect an OS improvement with a hazard ratio (HR) of 0.71, at 1-sided alpha of 0.025 and 85% power.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;544 pts were randomized from May 2019 and December 2023. Baseline pt characteristics were well balanced. 47.2% of pts received twice daily radiation (BID). Median follow up was 21.0 months (mos) for all pts. The 1, 2 and 3-year OS rates were 82.6% (95% CI 77.2 - 86.9), 62.9% (95% CI 56.2 - 69.0) and 50.3% (95% CI 42.3 - 57.8) for cCRT, and 80.2% (95% CI 74.7 - 84.6), 58.6% (95% CI 52.1- 64.6) and 44.7% (95% CI 36.6 - 52.4) for atezo+cCRT. Median OS was 39.5 mos (95% CI 27.5 - Not reached) and 33.1 mos (95% CI 27.8 - 43.9) for cCRT and atezo+cCRT, respectively (HR= 1.11, 95% CI: 0.85-1.45). Median PFS was 11.5 mos (95% CI: 10.7- 13.4) and 12.0 mos (95% CI: 10.8-15.1) for cCRT and atezo+cCRT, respectively (HR=1.00, 95% CI: 0.80-1.25). Median DMFS was 13.2 mos (95% CI: 11.3-18.2) and 16.8 mos (95% CI: 12.0-23.5) for cCRT and atezo+cCRT, respectively (HR=0.95, 95% CI:0.75-1.21). Cumulative incidence of local failure at 24 mos was 14.4% (95% CI: 10.1 -19.5) and 13.1% (95% CI: 9.0 - 18.1) for cCRT and atezo+cCRT, respectively (HR=0.84, 95% CI: 0.50-1.40). Complete or partial response was achieved in 58.5% and 59.1% on cCRT and atezo+cCRT. Grade 3+ pneumonitis was 3.1% and 5.6% on cCRT and atezo+cCRT. There were no concerning safety signals for atezo +cCRT. Regardless of the receipt of atezo, pts treated with BID had higher survival (median OS 35.4 mos, 95% CI: 32.3 - not reached) than daily RT (median OS 28.3 mos 95% CI: 21.7 - 40.6; HR=1.44, 95% CI: 1.10-1.89).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Chemoradiation with ","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tribute to Paul Harari","authors":"","doi":"10.1016/j.ijrobp.2024.06.029","DOIUrl":"10.1016/j.ijrobp.2024.06.029","url":null,"abstract":"","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ASTRO Past Gold Medal Award Recipients","authors":"","doi":"10.1016/S0360-3016(24)03170-5","DOIUrl":"10.1016/S0360-3016(24)03170-5","url":null,"abstract":"","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Nurse-Led Multimodal Rehabilitation for Patients Undergoing Postoperative Radiotherapy of Esophageal Cancer: A Randomized Controlled Trial","authors":"","doi":"10.1016/j.ijrobp.2024.07.025","DOIUrl":"10.1016/j.ijrobp.2024.07.025","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>About 40% of patients develop serious complications after esophageal cancer surgery, which affects the quality of life. Symptoms such as fatigue and appetite loss caused by radiotherapy can also negatively impact the quality of life. However, rehabilitation exercises have been proven to significantly improve the quality of life. This study aimed to compare the effects of nurse-led multimodal rehabilitation versus conventional rehabilitation on physical recovery during adjuvant radiotherapy for postoperative esophageal cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized controlled trial recruited 70 patients who were randomized into the control group (CG, <em>N</em> = 35) and the intervention group (IG, <em>N</em> = 35). The CG received conventional care, and the IG received nurse-led multimodal rehabilitation. The patient’s quality of life, dyspnea index, fatigue, sleep quality, nutrition, anxiety, and depression were recorded before the start of radiotherapy (T0), after completion of radiotherapy (T1), and 6 months (T2) and 12 months (T3) after completion of radiotherapy. Data were analyzed following intention-to-treat principles. Linear mixed models were used to assess the effects of multimodal rehabilitation over time.</div></div><div><h3>Results</h3><div>The IG significantly increased the global health scores compared to the CG at T1 (difference = 26.19; 95% CI = 17.14 to 35.24; <em>P</em> &lt; 0.001), with differences remaining significant at T2 (difference = 21.43; 95% CI = 8.02 to 34.84; <em>P</em> = 0.002) and T3 (difference = 23.34; 95% CI = 7.31 to 39.36; <em>P</em> = 0.005). Compared with the CG, the weight of the IG was significantly higher at T1 (difference = 3.33; 95% CI = 0.89 to 5.77; <em>P</em> = 0.008), and the difference was still significant at T2 (difference = 3.13; 95% CI = 0.26 to 6.00; <em>P</em> = 0.033) and T3 (difference = 3.91; 95% CI = 0.64 to 7.19; <em>P</em> = 0.020). The fatigue score of the IG decreased significantly at T1(difference = -65.74; 95% CI = -90.74 to -40.75; <em>P</em> &lt; 0.001), and the difference remained statistically significant at T2 (difference = -64.86; 95% CI = -96.98 to -32.74; <em>P</em> &lt; 0.001) and T3 (difference = -48.80; 95% CI = -82.61 to -14.99; <em>P</em> = 0.005). The anxiety and depression status of the IG improved significantly at T1 (difference = -3.00; 95% CI = -4.99 to -1.01; <em>P</em> = 0.004) and (difference = -2.43; 95% CI = -4.48 to -0.38; <em>P</em> = 0.021), and the difference remained significant at T2 (difference = -3.63; 95% CI = -6.84 to -0.42; <em>P</em> = 0.027) and (difference = -3.66; 95% CI = -6.80 to -0.51; <em>P</em> = 0.023).</div></div><div><h3>Conclusion</h3><div>Nurse-led multimodal rehabilitation significantly improved the quality of life, sleep quality, nutrition, fatigue, anxiety, and depression status in patients undergoing postoperative radiotherapy for esophageal cancer.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}