Annals of Oncology最新文献

{"title":"Efficacy and safety of camrelizumab plus docetaxel and carboplatin as neoadjuvant therapy for stage II-III triple-negative breast cancer: the HELEN-Trio 011 randomized clinical trial.","authors":"D Jiao, X Sun, J Qiao, H Jia, X Liu, H Dai, C Zhang, Y Wei, B Chen, Y Sun, J Yu, L Zou, L Li, Y Feng, M Yan, L Liu, X Wang, Y Zhou, P Lu, W Wang, F Ji, L Jia, B Zhao, X Guo, Y Sun, T Huang, J Wu, M Lü, J Zhu, J Zhang, J Wang, H Yang, P Wang, L Niu, Z Pang, Y Xiang, Z Lu, X Chen, C Wang, Z Liu","doi":"10.1016/j.annonc.2026.10.102","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.102","url":null,"abstract":"<p><strong>Background: </strong>Neoadjuvant chemoimmunotherapy has become the standard-of-care for stage II-III triple-negative breast cancer (TNBC); however, anthracycline-containing regimens are associated with considerable toxicity. We evaluated camrelizumab combined with an anthracycline-free docetaxel-carboplatin regimen in this setting.</p><p><strong>Patients and methods: </strong>We performed a multicenter, randomized, open-label, phase 3 trial at 14 hospitals in China between December 2022 and June 2025. Eligible patients were women aged 18-70 years with previously untreated, stage II-III TNBC. Patients were randomized 2:1 to receive 6 cycles of neoadjuvant docetaxel (75 mg/m²) plus carboplatin (area under the curve [AUC]=6) on day 1, with or without camrelizumab (200 mg intravenously on day 3). The primary endpoint was pathological complete response (pCR), defined as ypT0/Tis ypN0, evaluated in the modified intention-to-treat (mITT) population (all patients who received at least one dose of study treatment).</p><p><strong>Results: </strong>A total of 369 patients were enrolled, and 352 comprised the mITT population for efficacy analysis. The pCR rate was 57.5% (134/233) in the camrelizumab-chemotherapy group and 45.4% (54/119) in the chemotherapy-alone group, corresponding to an absolute difference of 12.2% (95% CI, 1.4 to 22.9; one-sided P=0.014). Grade 3-4 treatment-related adverse events occurred in 24.9% (58/233) in the camrelizumab-chemotherapy group and 21.8% (26/119) in the chemotherapy-alone group. No treatment-related deaths were reported.</p><p><strong>Conclusion: </strong>The addition of camrelizumab to neoadjuvant docetaxel plus carboplatin significantly increased the pCR rate in patients with stage II-III TNBC, with a manageable safety profile. This regimen represents a promising anthracycline-free strategy that warrants comparison with current standard chemoimmunotherapy .</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149206521","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":"Gastric and oesophageal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.","authors":"S-E Al-Batran, M Bencivenga, T Crosby, M Dinis-Ribeiro, F Huguet, F Lordick, S Lorenzen, C Martinez Ciarpaglini, R L Obermannova, G Piessen, K Shitara, E Smyth, N C T van Grieken, A Zaanan, M Ducreux","doi":"10.1016/j.annonc.2026.09.015","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.015","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149190748","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":"Emerging Therapeutic targets and Early-phase drug Development in Gynecological Malignancies.","authors":"K Ouali, Dsp Tan, S Lheureux, C Massard","doi":"10.1016/j.annonc.2026.10.101","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.101","url":null,"abstract":"<p><p>Gynecological malignancies remain a major cause of cancer-related morbidity and mortality, particularly in recurrent and treatment-resistant settings. Advances in molecular profiling have accelerated the development of biomarker-driven therapies, expanding treatment options beyond conventional chemotherapy and first-generation targeted agents. Novel strategies targeting DNA damage response pathways, including WEE1, PKMYT1, and WRN, as well as vulnerabilities associated with CCNE1 amplification and actionable alterations such as TP53 Y220C, are showing encouraging clinical activity. Antibody-drug conjugates have emerged as a major therapeutic class, while immunotherapeutic approaches are evolving beyond immune checkpoint inhibitors to include bispecific antibodies, T-cell engagers, engineered T-cell receptor therapies, and CAR-T cells. Despite these advances, tumor heterogeneity, biomarker complexity, and acquired resistance remain major challenges. This review highlights recent developments in targeted and immune-based therapies across gynecological cancers and discusses future directions for biomarker-driven drug development and therapeutic sequencing.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178577","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":"Age 35 in SOFT: Prognostic Boundary, Treatment-Effect Modifier, or Surrogate of Clinical Risk?","authors":"R Kumar, L Costa, M J T F D Vrancken-Peeters, M E Cazzaniga, J Huober, A Vaid, C Garcia-Cantu, F J Esteva, M Toi, M Martin","doi":"10.1016/j.annonc.2026.10.099","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.099","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178581","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":"Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study.","authors":"I Ray-Coquard, D M O'Malley, A Oaknin, A Madariaga, N Lakhani, W McKean, A Perez-Fidalgo, M Okera, S Kitano, T Koyama, J S Frenel, G Curigliano, M R Khajawa, M Cheol Lim, D Lorusso, V Pilla Reddy, R M Speck, A M Gilligan, A M Szpurka, M Manvelyan, Y Wu, C Wang, E Avsar, C F Friedman, D Sachdeva, C Kyi, B Pothuri","doi":"10.1016/j.annonc.2026.10.001","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.001","url":null,"abstract":"<p><strong>Background: </strong>Folate receptor alpha (FRα) is overexpressed in most high-grade ovarian cancers (HGOC), but use of the FRα-targeting drug mirvetuximab soravtansine-gynx (MIRV) is limited by expression-level restrictions and toxicity profile. Sofetabart mipitecan (Sofe-M) is a novel FRα-targeting antibody-drug conjugate designed to overcome these barriers. Here we report safety, efficacy, and pharmacokinetics from the first-in-human phase 1 study.</p><p><strong>Patients and methods: </strong>This multicenter, open-label, phase 1 trial evaluated Sofe-M in patients with HGOC, regardless of FRα expression level. Prior MIRV treatment was permitted.</p><p><strong>Results: </strong>One-hundred-five patients with HGOC, the majority of whom were platinum resistant, received Sofe-M at 2, 3, 4 or 6 mg/kg every 21 days. Median age was 63.0 years, median number of prior treatments was 5.0 (1-11), 19 (18.1%) patients had prior MIRV, and 54 (51.4%) had tumor FRα expression <75% at ≥2+ intensity. Overall response rate was 50.5% (95% CI 40.5, 60.4) for all patients, 58.8% (95% CI 32.9, 81.6) at 3 mg/kg, 44.4% (95% CI 30.9, 58.6) for FRα <75%, 56.5% (95% CI, 41.1, 71.1) for FRα ≥75%, and 57.9% (95% CI 33.5, 79.7) for patients with prior MIRV exposure. Median progression-free survival was 8.1 months (95% CI 6.4, 8.5) and median follow-up was 12.9 months (95% CI 10.6, 15.2). Most common treatment-emergent adverse events (TEAEs) were nausea (64.8%), fatigue (56.2%), and anemia (47.6%). No keratopathies or grade ≥3 neuropathy were observed. At 3 and 4 mg/kg, the rate of Grade ≥3 treatment-related TEAEs was 35.3% and 56.4%, respectively. Treatment discontinuation due to TEAEs occurred in 11 patients (10.5%).</p><p><strong>Conclusions: </strong>Sofe-M demonstrated a favorable tolerability profile, notably absent of keratopathy and high-grade neuropathy, with durable clinical activity in heavily pretreated HGOC patients regardless of FRα expression level or prior MIRV. These data support 3 mg/kg as the recommended phase 3 dose and provide the basis for the FRAmework-01 trial.</p><p><strong>Clinical trial registration number: </strong>Phase 1 (NCT06400472); FRAmework-01 (NCT07213804).</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134659","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":"Postoperative ctDNA dynamics and eligibility for Treat-on-Molecular Result (TOMR) ALTAIR trial in colorectal cancer: insights from CIRCULATE-Japan.","authors":"Y Nakamura, H Bando, V N Aushev, J Watanabe, Y Takahashi, M Kotaka, N Matsuhashi, E Oki, Y Komatsu, M Shiozawa, K Hirata, Y Miyamoto, M Takahashi, K Yamazaki, D Manaka, A Kanazawa, Y-H Liang, K-H Yeh, C C Palsuledesai, R W Lentz, A Jurdi, M C Liu, M Rabinowitz, S Mishima, I Takemasa, D Kotani, A Sato, T Misumi, H Taniguchi, T Yoshino, T Kato","doi":"10.1016/j.annonc.2026.09.016","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.016","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149126194","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":"Efficacy of Cryotherapy in Preventing Taxane-Induced Neuropathy: The CryoPac Randomised Controlled Trial.","authors":"M E Lendorf, M B Bille, S M Krog, F L Kruse, L M Heining, C W Juul, R Gravesen, S Winther, E V Frandsen, A V Lendorf, H Danø, A S Knoop, H Pia, H Tankisi, S Birk, A B Jensen","doi":"10.1016/j.annonc.2026.09.014","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.014","url":null,"abstract":"<p><strong>Background: </strong>Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a common and debilitating adverse effect of taxane chemotherapy. Currently there is no established strategy for prevention or treatment. Smaller studies have suggested that cryotherapy may prevent CIPN.</p><p><strong>Design: </strong>We conducted a randomized controlled trial comparing usual care with cryotherapy using frozen gloves and socks during each taxane treatment. Participants were stratified by site and chemotherapy regiment and randomized 1:1 to cryotherapy or usual care. Eligible patients had a performance status of 0-1. Exclusion criteria included previous taxane chemotherapy, symptoms of CIPN, and a baseline Total Neuropathy Score (TNS) > 0. The primary endpoint was CIPN incidence at the End of Treatment (EoT) defined as TNS ≥2. Secondary endpoints included peripheral neuropathy evaluated with NCI-CTCAE v5.0, patient-reported outcomes using EORTC QLQ-CIPN20 and QLQ-C30, and quantitative sensory testing (QST).</p><p><strong>Results: </strong>A total of 268 patients were randomised; 51 dropped out, leaving 217 for analysis (cryotherapy 123, usual care 94 patients). CIPN incidence at EoT was 78% overall and did not differ significantly between the groups (cryotherapy: 91/123 [74%], 95% CI 0.65 to 0.81; control: 79/94 [84%], 95% CI 0.75 to 0.90; P= .071). Analysis of EORTC QLQ-CIPN20 subscales showed that the cryotherapy group had reduced tingling in hands (P=.025), numbness in hands (P=.025) and feet (p=0.0005), and less trouble manipulating small objects (P=.006). No difference was found in CTCAE grade ≥ 2 CIPN between groups (P = .2). QST showed that cryotherapy reduced tactile disturbance on the monofilament test (P=.006). No difference was observed in QLQ-C30 scores. Cryotherapy did not influence dose modifications. Compliance with cryotherapy was 67%.</p><p><strong>Conclusions: </strong>Cryotherapy did not significantly reduce CIPN incidence (TNS ≥2) at EoT, but cryotherapy treated patients reported fewer sensory symptoms and demonstrated reduced tactile disturbance. Longer follow-up may reveal benefits of cryotherapy for persistent CIPN, supporting possible clinical relevance.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT05928429.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103032","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 benefit from immune checkpoint inhibition in squamous esophageal cancer.","authors":"V E Blanco, E Smyth","doi":"10.1016/j.annonc.2026.09.001","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.001","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079480","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":"Final results and predictive biomarkers of response and long-term outcomes with first-line pembrolizumab monotherapy in advanced renal cell carcinoma in the phase II KEYNOTE-427 study.","authors":"D F McDermott, S Signoretti, J-L Lee, F Donskov, S S Tykodi, P Tomczak, G A Bjarnason, J M G Larkin, M D Kochenderfer, R A Gafanov, R Cristescu, J Markensohn, M Nebozhyn, Y Zhang, X Peng, K Rodriguez-Lopez, J Burgents, R F Perini, M B Atkins","doi":"10.1016/j.annonc.2026.09.011","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.011","url":null,"abstract":"<p><strong>Background: </strong>Previous results from the single-arm, phase II KEYNOTE-427 study showed antitumor activity with first-line pembrolizumab monotherapy in advanced clear cell renal cell carcinoma (ccRCC) and non-clear cell RCC (nccRCC). We report results of the final efficacy and safety analyses and exploratory, predictive biomarker analysis of KEYNOTE-427.</p><p><strong>Patients and methods: </strong>Eligible participants had histologically confirmed locally advanced, recurrent, or metastatic ccRCC (cohort A) or nccRCC (cohort B) with or without sarcomatoid features, measurable disease per RECIST v1.1, and no prior systemic therapy for advanced RCC. The primary end point was objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Prespecified biomarker objectives were to evaluate the association of clinical outcomes with a T-cell-inflamed gene expression profile (Tcell_infGEP), programmed cell death ligand 1 combined positive score (PD-L1 CPS), RCC driver gene mutations, and circulating tumor DNA (ctDNA; cohort A).</p><p><strong>Results: </strong>After a median (range) follow-up of 61.1 months (54.7-65.5) in cohort A and 56.7 months (47.9-64.0) in cohort B, ORRs were 36.4% and 26.7%, respectively. Continuous Tcell_infGEP was positively associated with ORR in cohort A (P=0.0208) and cohort B (P=0.0021). Continuous PD-L1 CPS was positively associated with ORR (P=0.0195) and progression-free survival (PFS; P=0.0307) in cohort A and ORR (P <0.0001), PFS (P=0.0002), and overall survival (OS; P=0.0014) in cohort B. RCC driver gene mutations showed no consistent patterns with ORR in either cohort. In cohort A, participants with detectable ctDNA at baseline had a shorter OS than participants with a ctDNA-negative status (median: 30.5 months [95% CI 18.1-56.4] vs 53.7 months [28.7-not reached]).</p><p><strong>Conclusions: </strong>These results show that pembrolizumab is a highly active agent in ccRCC and nccRCC. Insights from the comprehensive analysis of RCC tumor molecular components and ctDNA may facilitate progress toward effective, biomarker-driven precision treatment in advanced RCC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079468","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":"SKYSCRAPER-07: Falling Short of the Top.","authors":"S S Kim, N V Uboha","doi":"10.1016/j.annonc.2026.09.010","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.010","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149036059","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}