Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
88 citing papers in PubMed, 3 syntheses or guidelines pooled it, 132 citations in OpenAlex.
- Protein-Based Predictive Biomarkers to Personalize Neoadjuvant Therapy for Bladder Cancer-A Systematic Review of the Current Status.International journal of molecular sciences · 2024Pooled it
- Efficacy and safety of neoadjuvant PD-1 inhibitors or PD-L1 inhibitors for muscle invasive bladder cancer: a systematic review and meta-analysis.Frontiers in immunology · 2023Pooled it
- Neoadjuvant immunotherapy and chemoimmunotherapy for stage II-III muscle invasive bladder cancer.Frontiers in immunology · 2022Pooled it
- Neoadjuvant Sintilimab Combined with Gemcitabine and Cisplatin for Muscle-Invasive Bladder Cancer Patients Followed by Selective Bladder Sparing Surgery: A Phase 2 Trial.Cancer research and treatment · 2026Trial
- Trial
- 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
- Treatment Efficacy and Molecular Dynamics of Neoadjuvant Durvalumab and Olaparib in Resectable Urothelial Bladder Cancer: The NEODURVARIB Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Neoadjuvant gemcitabine-cisplatin plus tislelizumab in persons with resectable muscle-invasive bladder cancer: a multicenter, single-arm, phase 2 trial.Nature cancer · 2024Trial
- Immune features are associated with response to neoadjuvant chemo-immunotherapy for muscle-invasive bladder cancer.Nature communications · 2024Trial
- Perioperative Chemoimmunotherapy With Durvalumab for Muscle-Invasive Urothelial Carcinoma: Primary Analysis of the Single-Arm Phase II Trial SAKK 06/17.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.Nature medicine · 2023Trial
- Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695).European urology · 2023Trial
- Neoadjuvant therapy with camrelizumab plus gemcitabine and cisplatin for patients with muscle-invasive bladder cancer: A multi-center, single-arm, phase 2 study.Cancer medicine · 2023Trial
- 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
- Response evaluation of neoadjuvant therapy in MIBC: clinical trial-derived evidence to guide practice.BJU international · 2026Review
- Post-Treatment NLR and SII Associations with Response and Progression-Free Survival After Neoadjuvant Disitamab Vedotin Plus PD-1 Blockade in Muscle-Invasive Bladder Cancer: A Real-World Cohort Study.Diagnostics (Basel, Switzerland) · 2026Article
- Review
- Radiotherapy for High-Risk Non-Muscle-Invasive Bladder Cancer: Current Evidence and Future Directions.Current oncology (Toronto, Ont.) · 2026Review
- Unequal Access to Novel Systemic Therapies for Bladder Cancer: A Global Analysis of Clinical Trials of Immune Checkpoint Inhibitors and Antibody-Drug Conjugates.Current urology reports · 2026Review
- The hypoxic ECM and neutrophils in MIBC immunotherapy resistance.Nature reviews. Urology · 2026Review
28 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
20 authors at 2 institutions in 1 country.
Funding
Abstract
purposeTo evaluate the safety and efficacy of gemcitabine and cisplatin in combination with the immune checkpoint inhibitor pembrolizumab as neoadjuvant therapy before radical cystectomy (RC) in muscle-invasive bladder cancer.
methodsPatients with clinical T2-4aN0/XM0 muscle-invasive bladder cancer eligible for RC were enrolled. The initial six patients received lead-in pembrolizumab 200 mg once 2 weeks prior to pembrolizumab 200 mg once on day 1, cisplatin 70 mg/m
resultsThirty-nine patients were enrolled between June 2016 and March 2020 (72% cT2, 23% cT3, and 5% cT4a). Patients received a median of four cycles of therapy. All patients underwent RC except one who declined. Twenty-two of 39 patients (56% [95% CI, 40 to 72]) achieved < pT2N0 and 14 of 39 (36% [95% CI, 21 to 53]) achieved pT0N0. Most common adverse events (AEs) of any grade were thrombocytopenia (74%), anemia (69%), neutropenia (67%), and hypomagnesemia (67%). One patient had new-onset type 1 diabetes mellitus with ketoacidosis related to pembrolizumab and no patients required steroids for immune-related AEs. Clinicians consistently under-reported AEs when compared with patients.
conclusionNeoadjuvant gemcitabine and cisplatin plus pembrolizumab met its primary end point for improved pathologic downstaging and was generally safe. A global study of perioperative chemotherapy plus pembrolizumab or placebo is ongoing.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.