ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Phase II Study of Olaparib and Temozolomide for Advanced Uterine Leiomyosarcoma (NCI Protocol 10250).
Article 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. An erratum has been issued. Cited by 37 papers.
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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.
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Who cites it
37 citing papers in PubMed, 42 citations in OpenAlex.
- A Phase II Study of Berzosertib in Combination with Carboplatin Compared with Docetaxel with Carboplatin in Metastatic Castration-Resistant Prostate Cancer.Cancer research communications · 2026Trial
- Phase II study of rucaparib and nivolumab in patients with leiomyosarcoma.Journal for immunotherapy of cancer · 2025Trial
- Temozolomide and olaparib for the treatment of an ARID1A-mutated uterine carcinosarcoma: A case report.Gynecologic oncology reports · 2026Article
- Therapeutic Vulnerabilities of the Key Genetic Drivers in Leiomyosarcoma.Medical sciences (Basel, Switzerland) · 2026Review
- Article
- Use of Rucaparib Plus Temozolomide in Advanced Uterine Leiomyosarcoma: A Case Report From a Tertiary Centre in India.Cureus · 2026Article
- Liquid Biopsy in Uterine Leiomyosarcoma: Current Biomarkers, Emerging Technologies, and Future Perspectives.Current oncology reports · 2026Review
- Case Report: A case series on actionable genomic alterations guiding effective targeted therapy in rare sarcomas.Frontiers in oncology · 2026Article
- Article
- The PIK3CA/AKT pathway drives therapy resistance in rhabdomyosarcoma.Nature communications · 2025Article
- Genomics-led approach to drug testing in models of undifferentiated pleomorphic sarcoma.Molecular oncology · 2025Article
- Uterine leiomyosarcoma progression: A study of serial recurrences.Gynecologic oncology · 2025Article
- Leiomyosarcoma Therapeutic Approaches and Future Directions.Hematology/oncology clinics of North America · 2025Review
- Article
- Four-year recurrence-free survival in metastatic uterine adenosarcoma with somatic BRCA2 mutation on olaparib therapy: A case report.Gynecologic oncology reports · 2025Article
- Development of Antibody-Drug Conjugates for Malignancies of the Uterine Corpus: A Review.Cells · 2025Review
- Chronification of metastatic leiomyosarcoma in 9 lines of therapy by precision oncology: a case report and review of the literature.Frontiers in oncology · 2025Article
- Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review.Frontiers in oncology · 2025Article
- Novel Therapeutics in Soft Tissue Sarcoma.Cancers · 2024Review
- Next-Generation Sequencing-Guided Treatment of BRCA2-Mutant Metastatic Uterine Leiomyosarcoma With Poly(ADP-ribose) Polymerase Inhibitor Therapy.JCO precision oncology · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
22 authors at 15 institutions in 1 country.
Funding
Abstract
purposeUterine leiomyosarcoma (uLMS) is an aggressive subtype of soft-tissue sarcoma with frequent metastatic relapse after curative surgery. Chemotherapy provides limited benefit for advanced disease. Multiomics profiling studies have identified homologous recombination deficiency in uLMS. In preclinical studies where olaparib and temozolomide provided modest activity, the combination was highly effective for inhibiting uLMS tumor growth. PATIENTS AND
methodsNCI Protocol 10250 is a single-arm, open-label, multicenter, phase II study evaluating olaparib and temozolomide in advanced uLMS. Patients with progression on ≥1 prior line received temozolomide 75 mg/m
resultsTwenty-two patients were evaluable. The median age was 55 years, and 59% had received three or more prior lines. Best ORR within 6 months was 23% (5 of 22). The overall ORR was 27% (6 of 22). The median progression-free survival (mPFS) was 6.9 months (95% CI, 5.4 months to not estimable). Hematologic toxicity was common (grade 3/4 neutropenia: 75%; thrombocytopenia: 32%) but manageable with dose modification. Five of 16 (31%) of tumors contained a deleterious homologous recombination gene alteration by WES, and 9 of 18 (50%) were homologous recombination-deficient by the RAD51 assay. In an exploratory analysis, mPFS was prolonged for patients with homologous recombination-deficient versus homologous recombination-proficient tumors (11.2
conclusionOlaparib and temozolomide met the prespecified primary end point and provided meaningful clinical benefit in patients with advanced, pretreated uLMS.
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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.