Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Perioperative Chemoimmunotherapy With Durvalumab for Muscle-Invasive Urothelial Carcinoma: Primary Analysis of the Single-Arm Phase II Trial SAKK 06/17.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 42 citations in OpenAlex.
- Avelumab-based neoadjuvant therapy in patients with muscle-invasive bladder cancer (AURA Oncodistinct-004): a phase 2 multicenter clinical trial.Journal for immunotherapy of cancer · 2025Trial
- Neoadjuvant gemcitabine-cisplatin plus tislelizumab in persons with resectable muscle-invasive bladder cancer: a multicenter, single-arm, phase 2 trial.Nature cancer · 2024Trial
- Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Response evaluation of neoadjuvant therapy in MIBC: clinical trial-derived evidence to guide practice.BJU international · 2026Review
- Immune Phenotype in Urothelial Carcinoma: From Tumor Biology to Therapeutic Stratification.Cancers · 2026Review
- Optimizing local control in the surgical management of bladder cancer.Nature reviews. Urology · 2026Review
- Novel Immune Checkpoint Inhibitor and Antibody-Drug Conjugate Approaches in the Perioperative Management of Muscle-Invasive Bladder Cancer.Current oncology (Toronto, Ont.) · 2026Review
- Perioperative immune-checkpoint inhibitors for muscle-invasive bladder cancer.Drugs in context · 2026Review
- Consolidative Radical Cystectomy Following Neoadjuvant Tislelizumab Plus Gemcitabine and Cisplatin in Clinically Lymph Node-positive Bladder Cancer: A Prospective Study.European urology open science · 2026Article
- Glutamine metabolism reprogramming promotes bladder cancer progression via PYCR1: a multi-omics and functional validation study.Journal of translational medicine · 2025Article
- End Points for the Next-Generation Bladder-Sparing Perioperative Trials for Patients With Muscle-Invasive Bladder Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Article
- Interferon Epsilon Loss Is Elusive 9p21 Link to Immune-Cold Tumors, Resistant to Immune Checkpoint Therapy, and Endogenous CXCL9/10 Induction.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025Review
- Neoadjuvant Immunotherapy in Bladder Cancer: Ushering in a New Era of Treatment-A Systematic Review of Current Evidence.European urology open science · 2025Review
- Perioperative durvalumab for muscle invasive bladder cancer: the start of a new chapter.Future oncology (London, England) · 2025Article
- Non-Invasive Tumor Budding Evaluation and Correlation with Treatment Response in Bladder Cancer: A Multi-Center Cohort Study.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Real-world comparison of neoadjuvant chemoimmunotherapy and chemotherapy in muscle-invasive bladder cancer.Scientific reports · 2025Article
- Clinical Effectiveness of Tislelizumab With Gemcitabine/Cisplatin Versus Gemcitabine/Cisplatin Alone as Adjuvant Therapy for High-Risk Muscle-Invasive Urothelial Carcinoma: A Real-World Study.Cancer medicine · 2025Article
- Real-world data on utilization of neoadjuvant chemotherapy for muscle invasive bladder cancer: impact on surgical complications and oncological efficacy.Acta oncologica (Stockholm, Sweden) · 2025Article
- The practical roadmap for peri-cystectomy approaches in muscle-invasive bladder cancer.Frontiers in oncology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe integration of immunotherapy in the perioperative setting of muscle-invasive urothelial carcinoma (MIUC) appears promising. SAKK 06/17 investigated the addition of neoadjuvant durvalumab to gemcitabine/cisplatin (GC) chemotherapy followed by radical surgery and adjuvant checkpoint inhibition with durvalumab. PATIENTS AND
methodsSAKK 06/17 was an investigator-initiated, open-label, single-arm phase II study including cisplatin-fit patients with stage cT2-T4a cN0-1 operable MIUC. Four cycles of neoadjuvant GC in combination with four cycles of durvalumab (start with GC cycle 2) were administered, followed by radical surgery. Adjuvant durvalumab was given for 10 cycles. The primary end point was event-free survival (EFS) at 2 years.
resultsSixty one patients were accrued at 12 sites. The full analysis set consisted of 57 patients, 54 (95%) had bladder cancer. Median follow-up was 40 months. The primary end point was met, with EFS at 2 years of 76% (one-sided 90% CI [lower bound], 67%; two-sided 95% CI, 62 to 85). EFS at 3 years was 73% (95% CI, 59 to 83). Complete pathologic response in resected patients (N = 52) was achieved in 17 patients (33%), and 31 (60%) had pathologic response <ypT2 ypN0. Overall survival (OS) was 85% (95% CI, 72 to 92) at 2 years and 81% (95% CI, 67 to 89) at 3 years. Grade 3 and 4 treatment-related adverse events (TRAEs) during neoadjuvant treatment occurred in 42% and 25%, respectively. TRAEs related to adjuvant durvalumab were grade 3 in 5 (11%) and grade 4 in 2 (4%) patients.
conclusionThe addition of perioperative durvalumab to the standard of care for patients with resectable MIUC results in a high EFS and OS at 2 years.
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