Annals of Oncology最新文献

{"title":"Autoimmune bullous diseases induced by cyclin-dependent kinase 4/6 inhibitors—first cohort from the EADV Task Force ‘Dermatology for Cancer Patients’","authors":"","doi":"10.1016/j.annonc.2024.07.243","DOIUrl":"10.1016/j.annonc.2024.07.243","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142172379","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":"Optimizing Rectal Cancer Treatment: A Path Towards Personalization","authors":"","doi":"10.1016/j.annonc.2024.08.2349","DOIUrl":"10.1016/j.annonc.2024.08.2349","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142173089","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 Pooled Analysis of Trastuzumab Deruxtecan in Patients With HER2-Positive Metastatic Breast Cancer With Brain Metastases.","authors":"F André, J Cortés, G Curigliano, S Modi, W Li, Y H Park, W-P Chung, S-B Kim, T Yamashita, J L Pedrini, S-A Im, L-M Tseng, N Harbeck, I Krop, S Nakatani, K Tecson, S Ashfaque, A Egorov, S A Hurvitz","doi":"10.1016/j.annonc.2024.08.2347","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2347","url":null,"abstract":"<p><strong>Background: </strong>This exploratory pooled analysis investigated the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus comparator treatment in patients with HER2-positive metastatic breast cancer (mBC) with brain metastases (BMs) at baseline, categorized according to previous local treatment.</p><p><strong>Patients and methods: </strong>T-DXd data were pooled from DESTINY-Breast01/-02/-03. Comparator data, from patients receiving physician's choice therapy and trastuzumab emtansine, were pooled from DESTINY-Breast02 and -03, respectively. Baseline BM status was assessed according to US Food and Drug Administration criteria. Endpoints included intracranial objective response rate (ORR; complete or partial response in brain) per blinded independent central review (BICR) by RECIST v1.1, time to intracranial response, intracranial duration of response (DoR), central nervous system progression-free survival (CNS-PFS) by BICR, overall survival (OS), and safety.</p><p><strong>Results: </strong>148 patients who received T-DXd and 83 patients who received comparator treatment had BMs at baseline. In those who were treated with T-DXd, the intracranial ORR of patients with treated/stable and untreated/active BMs was 45.2% and 45.5%, respectively. The median (range) time to intracranial response was 2.8 months (1.1-13.9 months) and 1.5 months (1.2-13.7 months) in patients with treated/stable and untreated/active BMs, respectively. For those with treated/stable BMs, the median (95% CI) intracranial DoR was 12.3 months (9.1-17.9 months), and for those with untreated/active BMs it was 17.5 months (13.6-31.6 months). The median (95% CI) CNS-PFS and OS was 12.3 months (11.1-13.8 months) and not reached (22.1 months-not estimable [NE]) in those with treated/stable BMs, and 18.5 months (13.6-23.3 months) and 30.2 months (21.3 months-NE) in those with untreated/active BMs, respectively. Drug-related TEAEs grade ≥3 were experienced by 43.2% of patients with BMs and 46.4% without BMs with T-DXd.</p><p><strong>Conclusions: </strong>T-DXd demonstrated meaningful intracranial efficacy and clinical benefit in OS, with an acceptable and manageable safety profile in patients with HER2-positive mBC with treated/stable and untreated/active BMs.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144986","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":"Tocilizumab provides dual benefits in treating immune checkpoint inhibitor-associated arthritis and preventing relapse during ICI rechallenge: the TAPIR study.","authors":"P-F Petit, D Daoudlarian, S Latifyan, H Bouchaab, N Mederos, J Doms, K Abdelhamid, N Ferahta, L Mencarelli, V Joo, R Bartolini, A Stravodimou, K Shabafrouz, G Pantaleo, S Peters, M Obeid","doi":"10.1016/j.annonc.2024.08.2340","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2340","url":null,"abstract":"<p><strong>Background: </strong>The aim of this retrospective study was to evaluate the dual efficacy of tocilizumab (TCZ) in the treatment of ICI-related arthritis (ICI-AR) and the prevention of relapses after rechallenge.</p><p><strong>Patients and methods: </strong>We identified 26 patients with ICI-AR. The primary objectives were to evaluate TCZ efficacy in ICI-AR treatment and as secondary prophylaxis during ICI rechallenge in 11 of them. Patients received prednisone (CS) at 0.3 mg/kg tapered at 0.05 mg/kg weekly for six weeks. TCZ was administered at a dose of 8 mg/kg Q2w. In the subgroup receiving secondary prophylaxis (rechallenge n=11), TCZ was reintroduced with the same regimen concurrently with ICI rechallenge, and without the addition of CS. A control group of patients (rechallenge n=5) was rechallenged without TCZ. Secondary endpoints included post rechallenge evaluation of ICI duration, reintroduction of CS > 0.1 mg/kg/day, ICI-RA flares, and DCR.</p><p><strong>Results: </strong>The median age of the patients was 70 years. The median follow-up from ICI initiation was 864 days. Among the 20 patients treated with TCZ for ICI-AR, all (100%) achieved an ACR70 response rate, defined as greater than 70% improvement, at 10 weeks. 81% of these patients achieved steroid-free remission after 24 weeks on TCZ. The median follow-up period was 552 days in rechallenged patients. The results demonstrated a reduction in ICI-AR relapses upon ICI rechallenge in patients receiving TCZ prophylaxis as compared to patients who did not receive prophylaxis (17% vs 40%). The requirement for CS was completely abolished with prophylaxis (0% vs 20%), and the mean duration of ICI treatment was notably extended from 113 to 206 days. The 12-month post-rechallenge outcomes showed a disease control rate (DCR) of 77%. During TCZ prophylaxis, CXCL9 remained elevated, showing no decline from their levels at the onset of ICI-AR CONCLUSIONS: In addition to treating ICI-AR, TCZ demonstrated efficacy as a secondary prophylactic agent, preventing the recurrence symptoms and lengthening ICI treatment duration after ICI rechallenge.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144991","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 randomized study of 6 vs 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse.","authors":"J-Y Blay, C Schiffler, Olivier Bouché, Mehdi Brahmi, F Duffaud, M Toulmonde, B Landi, W Lahlou, D Pannier, E Bompas, F Bertucci, L Chaigneau, O Collard, M Pracht, C Henon, I Ray-Coquard, K Armoun, S Salas, M Spalato-Ceruso, A Adenis, B Verret, N Penel, C Moreau-Bachelard, A Italiano, A Dufresne, S Metzger, S Chabaud, D Perol, A Le Cesne","doi":"10.1016/j.annonc.2024.08.2343","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2343","url":null,"abstract":"<p><strong>Background: </strong>The administration of adjuvant imatinib during three years is indicated after resection of primary localized GIST at high risk of recurrence, but many patients relapse afterwards.</p><p><strong>Methods: </strong>IMADGIST (NCT02260505) was a multicenter open-label, randomized phase III study evaluating the maintenance of imatinib for 3 more years (6-years arm) compared to Interruption (3-years arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to treat disease-free survival (DFS). Secondary endpoints include overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, safety.</p><p><strong>Results: </strong>From December 24^th 2014 to April 4^th 2023; 136 patients aged ≥18, ECOG PS ≤2, with a localized GIST with a R0 or R1 surgery, and a risk of tumor recurrence ≥35% according to NCCN risk classification were randomized in 14 centers. Sixty-five patients were randomized to the 3-Years arm vs. 71 in the 6-Years arm. There were 68 males and females. Primary sites were gastric and small bowel in 60 (44%) and 64 (47%) patients respectively. Respectively 52 (38%) and 71 (52%) of patients had a risk of relapse of 35-70% and >70%.. With a median follow-up of 55 (IQR=46-59) months post randomization, DFS was significantly superior in the 6-Years arm (HR: 0.40 [0.20-0.69], p=0.0008). Time to imatinib resistance, survival, adverse events and quality of life are not different in the 2 arms.</p><p><strong>Conclusions: </strong>Three additional years of adjuvant imatinib reduces the risk of relapse in patients who have received 3 years of adjuvant imatinib with an acceptable tolerance.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144987","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":"Is adjuvant ribociclib ready for prime time?","authors":"A Natarajan, S M Tolaney","doi":"10.1016/j.annonc.2024.08.2341","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2341","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144990","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":"Gemcitabine, carboplatin, and Epstein Barr virus-specific autologous cytotoxic T lymphocytes for recurrent or metastatic nasopharyngeal carcinoma: VANCE, an international randomized Phase 3 trial.","authors":"H C Toh, M-H Yang, H-M Wang, C Y Hsieh, I Chitapanarux, K F Ho, R-L Hong, M K Ang, A D Colevas, E Sirachainan, C Lertbutsayanukul, G F Ho, E Nadler, A Algazi, P Lulla, L J Wirth, K Wirasorn, Y C Liu, S F Ang, S H J Low, L M Tho, H H Hasbullah, M K Brenner, W-W Wang, W S Ong, S H Tan, I Horak, C Ding, A Myo, J Samol","doi":"10.1016/j.annonc.2024.08.2344","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2344","url":null,"abstract":"<p><strong>Background: </strong>Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T cell immunotherapy generated from the blood of individuals and manufactured without genetic modification. In a previous Phase 2 trial of locally recurrent or metastatic nasopharyngeal cancer (R/M NPC) patients, first-line gemcitabine and carboplatin (GC) and EBV-CTL combination demonstrated objective anti-tumor EBV-CTL activity and a favorable safety profile. The present study explored whether this combined first-line chemo-immunotherapy strategy would produce superior clinical efficacy and better quality of life compared to conventional chemotherapy treatment.</p><p><strong>Patients and methods: </strong>This multicenter, randomized, Phase 3 trial evaluated the efficacy and safety of GC followed by EBV-CTL vs. GC alone as first-line treatment for R/M NPC patients. Thirty clinical sites in Singapore, Malaysia, Taiwan, Thailand, and the United States (US) were included. Subjects were randomized to first-line GC (4 cycles) and EBV-CTL (6 cycles) or GC (6 cycles) in a 1:1 ratio. The primary outcome was overall survival (OS) and secondary outcomes included progression-free survival, objective response rate, clinical benefit rate, quality of life, and safety.</p><p><strong>Clinicaltrials: </strong>gov identifier: NCT02578641.</p><p><strong>Results: </strong>330 subjects with NPC were enrolled. Most subjects in both treatment arms received ≥4 cycles of chemotherapy and most subjects in the GC+EBV-CTL group received ≥2 infusions of EBV-CTL. The central Good Manufacturing Practices (GMP) facility produced sufficient EBV-CTL for 94% of GC+EBV-CTL subjects. The median OS was 25.0 months in the GC+EBV-CTL group and 24.9 months in the GC group (hazard ratio = 1.19; 95% CI: 0.91, 1.56; P = 0.194). Only 1 subject experienced a Grade 2 serious adverse event related to EBV-CTL.</p><p><strong>Conclusion: </strong>GC+EBV-CTL in subjects with R/M NPC demonstrated a favorable safety profile but no overall improvement in OS vs. chemotherapy. This is the largest adoptive T cell therapy trial reported in solid tumors to date.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144989","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":"Does total neoadjuvant therapy improve overall survival in rectal cancer? Interpretation of the PRODIGE-23 and other studies.","authors":"J Socha, W Michalski, J P Gerard, K Bujko","doi":"10.1016/j.annonc.2024.08.2346","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2346","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144988","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":"Odronextamab against relapsed or refractory follicular lymphoma.","authors":"Yutaka Shimazu","doi":"10.1016/j.annonc.2024.08.2342","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2342","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139024","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":"Unlocking Methodological Insights on Oncology Efficacy Endpoints: from Statistical to Clinical and Vice Versa. Letter to the Editor regarding 'Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: Final overall survival results of MONARCH 3' by M. P. Goetz et al.","authors":"R De Sanctis, P Bruzzi, A Zambelli","doi":"10.1016/j.annonc.2024.08.2345","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.08.2345","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139025","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}