SUNNIFORECAST trial design supported by real-world data in papillary renal cell carcinoma We read with interest the recent report from the SUNNIFORESCAST trial (Bergmann et al. Ann Oncol. 2025), which compared ipilimumab–nivolumab with standard-of-care therapies in untreated non-clear cell renal cell carcinoma (nccRCC).1 We commend the authors for conducting a much-needed randomized trial in this understudied population and agree with their choice of control arm, given the absence of a universally accepted… Annals of Oncology November 7, 2025 Original source
Tailoring Treatment to Cancer Risk and Patient Preference: The 2025 St Gallen International Breast Cancer Consensus Statement on Individualizing Therapy for Patients With Early Breast Cancer Breast cancer is a global disease affecting millions of individuals. Ongoing advancements in multidisciplinary management of breast cancer patients warrant discussion and integration into standard treatment plans. Annals of Oncology November 7, 2025 Original source
Corrigendum to “Neo-adjuvant FOLFOX with and without panitumumab for patients with KRAS-wt locally advanced colon cancer: results following an extended biomarker panel on the FOxTROT trial embedded phase II population” The authors regret that in the Results section of the Abstract in the original publication, the number of KRAS-wt patients was incorrectly given. The correct Abstract should read as follows: Annals of Oncology November 7, 2025 Original source
Corrigendum to “Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3” The authors regret that in the originally published version of this article, there was an error in Figure 4. In the “Placebo + NSAI” arm, the number of events was incorrectly reported as 162. The correct number is 132. The corrected figure is given below. Annals of Oncology November 7, 2025 Original source
Corrigendum to “Sorafenib in patients with locally advanced and metastatic chordomas: a phase II trial of the French Sarcoma Group (GSF/GETO)” The authors regret that in the original publication some discrepancies had arisen between data reported in the text and in the figures. Annals of Oncology November 7, 2025 Original source
Palbociclib plus letrozole versus weekly paclitaxel, both in combination with trastuzumab plus pertuzumab, as neoadjuvant treatment for patients with HR+/HER2+ early breast cancer: primary results from the randomized phase II TOUCH trial (IBCSG 55-17) HR+/HER2+ breast cancer (BC) is a heterogeneous disease with low pathological complete response (pCR) to standard neoadjuvant treatment. CDK4/6 inhibitors with endocrine and anti-HER2 therapy have shown a potential for chemotherapy omission in this context. Annals of Oncology November 7, 2025 Original source
ALBAN (GETUG-AFU 37): a phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical Bacillus Calmette–Guérin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC)☆ Standard treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor is intravesical instillation with Bacillus Calmette–Guérin (BCG) (induction and maintenance regimens); however, BCG therapy still fails in 30%-40% of patients. Prior studies suggest that programmed death-ligand 1 (PD-L1) expression and alterations in immune infiltration might be associated with BCG failure. Annals of Oncology November 7, 2025 Original source
Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: final overall survival analysis of the phase III ALEX study☆ ALEX, a global, randomized, phase III trial evaluated alectinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). This final analysis provides mature overall survival (OS), duration of response (DOR) and long-term safety data. Annals of Oncology November 7, 2025 Original source
Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274☆ Despite surgery, recurrence rates remain high in muscle-invasive urothelial carcinoma (MIUC). The phase III randomized, double-blind, multicenter CheckMate 274 trial comparing adjuvant nivolumab versus placebo in patients with high-risk MIUC after radical surgery demonstrated that adjuvant nivolumab improved disease-free survival (DFS) versus placebo. We report results with 5-year minimum follow-up including exploratory analyses of circulating tumor DNA (ctDNA). Annals of Oncology November 7, 2025 Original source
TRADE: a phase II trial to assess the tolerability of abemaciclib dose escalation in early-stage HR-positive/HER2-negative breast cancer☆ Adjuvant abemaciclib with endocrine therapy (ET) improves clinical outcomes in patients with high-risk node-positive early-stage hormone receptor-positive/HER2-negative (HR-positive/HER2-negative) breast cancer (BC), based on the monarchE trial. Patients may experience tolerability issues at the standard abemaciclib dose [150 mg twice daily (b.i.d.)], potentially leading to early treatment discontinuation, particularly within the initial weeks of therapy. TRADE is a prospective, single-arm, phase… Annals of Oncology November 7, 2025 Original source
Long-term survival in the ALEX trial: a milestone in improving the prognosis of patients with ALK-positive non-small-cell lung cancer Recent progress in the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) has changed outcomes remarkably. Nowadays, the median progression-free survival (PFS) on first-line treatment with the third-generation ALK tyrosine kinase inhibitor (TKI) lorlatinib exceeds 5 years, which has not been reported before in metastatic lung cancer.1,2 The practice-changing ALEX study investigated alectinib versus crizotinib in… Annals of Oncology November 7, 2025 Original source
Palbociclib with adjuvant endocrine therapy in early breast cancer: 5-year follow-up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13) In the phase III PALLAS trial, the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) did not improve short-term invasive disease-free survival (iDFS) compared with ET alone in high-risk early-stage hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. In this article, we report 5-year efficacy outcomes, including updated iDFS and overall survival (OS). Annals of Oncology November 7, 2025 Original source
Overall survival with abemaciclib in early breast cancer☆ Adjuvant abemaciclib combined with endocrine therapy (ET) significantly improved invasive disease-free survival (IDFS) in patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node-positive, high-risk early breast cancer (EBC). The impact on overall survival (OS) remained unknown. Annals of Oncology November 7, 2025 Original source
A multicenter randomized phase II trial of lenvatinib plus everolimus versus cabozantinib in patients with metastatic clear cell RCC that progressed on PD-1 immune checkpoint inhibition (LenCabo) First-line treatments for metastatic clear cell renal cell carcinoma (ccRCC) combine PD-1 immune checkpoint inhibition (ICI) with CTLA-4 ICI or angiogenesis targeted therapy (TT). Upon progression, common options include cabozantinib or lenvatinib + everolimus, although these regimens have never been directly compared. We hypothesized that lenvatinib + everolimus will improve progression-free survival (PFS) compared to cabozantinib after progression on PD-1… Annals of Oncology November 7, 2025 Original source
Novel pembrolizumab-based treatments as first-line therapy in advanced clear cell renal cell carcinoma: Substudy 03A of the open-label, umbrella platform, phase I/II KEYMAKER-U03 trial First-line triplet therapy may expand clinical benefit for advanced clear cell renal cell carcinoma (ccRCC). The phase Ib/II KEYMAKER-U03 Substudy 03A (NCT04626479) investigated novel pembrolizumab (pembro)-based regimens in this setting. Annals of Oncology November 7, 2025 Original source
Three versus six cycles of platinum-based chemotherapy followed by avelumab maintenance as first-line treatment for advanced urothelial cancer: the phase II DISCUS trial Six cycles of platinum-based chemotherapy followed by avelumab continues to be used in some circumstances in advanced/metastatic urothelial cancer (mUC). To investigate whether shorter chemotherapy duration improves quality of life (QoL) without worsening efficacy, this study compared 3 vs 6 cycles followed by avelumab. Annals of Oncology November 7, 2025 Original source
Long-term outcomes with adjuvant CDK4/6 inhibitors: who benefits most? Hormone receptor-positive (HR-positive), HER2-negative breast cancers comprise the majority of breast cancer diagnoses and display wide variation in recurrence risk.1 The adjuvant use of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) can reduce recurrences in higher-risk HR-positive tumors with axillary lymph node involvement and/or biologically aggressive features.2,3 In adjuvant trials, the monarchE (abemaciclib) and NATALEE (ribociclib) studies demonstrated improved invasive disease-free survival… Annals of Oncology November 7, 2025 Original source
Combination with BCG induction and maintenance therapy for high-risk non-muscle invasive bladder cancer. For over 50 years, intravesical Bacillus Calmette-Guérin (BCG) has been the standard of care for high-risk non-muscle invasive bladder cancer (HR-NMIBC)1. Historically, patients with HR-NMIBC treated with BCG have a 50 and 76% chance of disease-free survival at three years depending on the amount of maintenance BCG given2. Recurrent disease often requires more aggressive treatment, such as bladder instillation of… Annals of Oncology November 7, 2025 Original source
Personalised antiemetic prophylaxis with NEPA for patients at high risk of chemotherapy-induced nausea and vomiting receiving moderately emetogenic chemotherapy: results from the randomised, multinational MyRisk trial☆ Patients receiving moderately emetogenic chemotherapy (MEC) are commonly prescribed a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist (RA) and dexamethasone (DEX) as standard-of-care (SOC) antiemetic prophylaxis. However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK1) RA-containing regimen may optimise their antiemetic prevention. To address this unmet need for a… Annals of Oncology November 7, 2025 Original source
177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase III trial☆ The phase III trial, XT-XTR008-3-01, was a randomised controlled trial (RCT) that evaluated the efficacy and safety of XTR008, a novel no-carrier-added lutetium-177 (177Lu)–Dotatate, for the first time in a later-line therapy setting for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of all origins. Annals of Oncology November 7, 2025 Original source