Trial reportNeuro-oncology2020
Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer.
Trial report in Neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01645839 (Role of Intrathecal Chemotherapy With Liposomal Cytarabine), which is not on this map. Cited by 64 papers, 3 of them syntheses that pooled it.
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.
Role of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Patients Wih Leptomeningeal Metastasis of Breast Cancer. A Randomized Phase III Study.
Who cites it
64 citing papers in PubMed, 3 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7).Breast (Edinburgh, Scotland) · 2024Guideline
- Leptomeningeal metastasis from solid tumours: EANO-ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.ESMO open · 2023Guideline
- Current perspectives and trends in nanoparticle drug delivery systems in breast cancer: bibliometric analysis and review.Frontiers in bioengineering and biotechnology · 2023Pooled it
- Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in women with HER2Nature cancer · 2026Trial
- Phase II study of intrathecal administration of trastuzumab in patients with HER2-positive breast cancer with leptomeningeal metastasis.Neuro-oncology · 2023Trial
- Article
- Intrathecal nivolumab in metastatic solid tumors with leptomeningeal disease: dose escalation part of the multicenter IT-PD1/NOA-26 phase 1 trial.Nature cancer · 2026Article
- Advances in cerebrospinal fluid biomarkers for the diagnosis, treatment and monitoring of leptomeningeal metastases (Review).Oncology letters · 2026Review
- Novel treatment strategies and key research priorities for patients with breast cancer and central nervous system (CNS) metastases.NPJ breast cancer · 2025Review
- Point/Counterpoint: Intrathecal therapy for patients with leptomeningeal metastases from solid tumors.Neuro-oncology · 2025Article
- Chinese Expert Consensus on Leptomeningeal Metastases of Lung Cancer.Thoracic cancer · 2025Article
- Ara-C suppresses H3 K27-altered spinal cord diffuse midline glioma growth and enhances immune checkpoint blockade sensitivity.Science advances · 2025Article
- Leptomeningeal Disease: Current Approaches and Future Directions.Current neurology and neuroscience reports · 2025Review
- The research progress on meningeal metastasis in solid tumors.Discover oncology · 2025Review
- Leptomeningeal metastatic disease: new frontiers and future directions.Nature reviews. Clinical oncology · 2025Review
- Different methods of cerebrospinal fluid diversion in patients with leptomeningeal metastasis: A systematic review and meta-analysis.Surgical neurology international · 2025Review
- Leptomeningeal Carcinomatosis and Myelophthisic Anemia as Initial Manifestations of Metastatic Lobular Breast Cancer.Case reports in oncological medicine · 2025Article
- A review on intrathecal administration of medications for leptomeningeal metastases in solid tumors.Frontiers in pharmacology · 2025Review
- Central Nervous System Metastases in Breast Cancer.Current treatment options in oncology · 2025Review
- Development of a Prognostic Score in Patients With Advanced Breast Cancer Treated for Meningeal Carcinomatosis.The breast journal · 2025Article
4 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDEPOSEIN (NCT01645839) was a randomized open-label phase III study to explore the role of intrathecal chemotherapy in patients with newly diagnosed leptomeningeal metastasis (LM), a common manifestation of breast cancer.
methodsPatients with newly diagnosed LM defined by tumor cells in the cerebrospinal fluid or combination of clinical and neuroimaging signs of LM were randomized to receive systemic therapy alone (control group) or systemic therapy plus intrathecal liposomal cytarabine (experimental group). Progression-free survival related to LM (LM-PFS) was the primary endpoint.
resultsThirty-seven and 36 patients were assigned to the control and the experimental groups. Median number of liposomal cytarabine injections in the experimental group was 5 (range 1-20). Focal radiotherapy was performed in 6 (16%) and 3 (8%) patients in the control and experimental groups. In the intent-to-treat population, median LM-PFS was 2.2 months (95% CI: 1.3-3.1) in the control versus 3.8 months (95% CI: 2.3-6.8) in the experimental group (hazard ratio 0.61, 95% CI: 0.38-0.98) (P = 0.04). Seventy-one patients have died. Median overall survival was 4.0 months (95% CI: 2.2-6.3) in the control versus 7.3 months (95% CI: 3.9-9.6) in the experimental group (hazard ratio 0.85, 95% CI: 0.53-1.36) (P = 0.51). Serious adverse events were reported in 22 and 30 patients, respectively. Quality of life until progression did not differ between groups.
conclusionThe addition of intrathecal liposomal cytarabine to systemic treatment improves LM-related PFS. Confirmatory trials with optimized patient selection criteria and more active drugs may be required to demonstrate a survival benefit from intrathecal pharmacotherapy.
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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.