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452 Primary analysis of GEICO 120/DORA, a real-world multicentre study of dostarlimab in patients with recurrent or advanced DNA mismatch repair deficient/microsatellite instability-high (DMMR/MSI-H) endometrial cancer
  1. Alejandro Gallego1,
  2. Ainhoa Madariaga2,
  3. Purificación Estévez-García3,
  4. Facundo Albertí4,
  5. Anna Carbó5,
  6. Isabel Palacio6,
  7. Cristina Churruca7,
  8. Fernando Gálvez8,
  9. Mª Eugenia Ortega9,
  10. Paola Murata10,
  11. Aránzazu Manzano11,
  12. Maria Masvidal12,
  13. Cristina Martín-Lorente13,
  14. Blanca Hernando14,
  15. Inmaculada Lozano15,
  16. Juan F Cueva16,
  17. David Garcia-Illescas17,
  18. Esther Falcó18,
  19. Marta Mendiola19 and
  20. Andrés Redondo19
  1. 1Cancer Center Clínica Universidad de Navarra (CCUN), Madrid And Pamplona, Spain
  2. 2Hospital Universitario 12 de Octubre, Madrid, Spain
  3. 3Hospital Universitario Virgen del Rocío, Seville, Spain
  4. 4Hospital Regional Universitario de Málaga, Málaga, Spain
  5. 5Institut Català d’Oncologia/Hospital Universitari Dr. Josep Trueta, Barcelona, Spain
  6. 6Hospital Universitario Central de Asturias, Oviedo, Spain
  7. 7Hospital Universitario de Donostia, San Sebastián, Spain
  8. 8Complejo Hospitalario de Jaén, Jaén, Spain
  9. 9Hospital Universitario Miguel Servet, Zaragoza, Spain
  10. 10Hospital Universitari Arnau de Vilanova, Lleida, Spain
  11. 11Hospital Universitario Clínico San Carlos, Madrid, Spain
  12. 12Hospital Universitari Sant Joan de Reus, Reus, Spain
  13. 13Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  14. 14Hospital Universitario de Burgos, Burgos, Spain
  15. 15Hospital General Universitario Dr. Balmis, Alicante, Spain
  16. 16Hospital Clínico Universitario de Santiago, Santiago De Compostela, Spain
  17. 17Vall d’Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain
  18. 18Hospital Son Llàtzer, Palma De Mallorca, Spain
  19. 19Hospital Universitario La Paz, Madrid, Spain


Introduction/Background The efficacy and safety evidence of dostarlimab monotherapy in patients with MisMatch Repair deficient/MicroSatellite Instability-High (dMMR/MSI-H) endometrial cancer (EC) who progressed during or after a platinum-containing regimen, comes from the analysis of 143 patients who were enrolled in a phase I clinical trial (GARNET). Therefore, assessing dostarlimab in a real-world scenario is highly relevant.

Methodology GEICO 120/DORA is a multicentre, retrospective, observational study, in dMMR/MSI-H recurrent or advanced patients with EC treated in a real-world setting within the Spanish dostarlimab Expanded Access Program (EAP), conducted between January 2021 and February 2023. Included patients progressed to prior platinum-containing regimen and received at least 1 cycle of dostarlimab. The primary endpoint was overall response rate (ORR) per RECIST v1.1 and duration of response (DOR). Safety and tolerability of dostarlimab were key secondary endpoints.

Results Between March and September 2023, 129 patients were registered by 57 GEICO hospitals, 128 met inclusion criteria and 125 were evaluable for radiological response. Patients’ characteristics are described in Table 1. The median duration of dostarlimab administration was 8.8 months (IQR, 13.2) and 74 patients (57.4%) remained on therapy upon analysis. The median follow-up was 11.6 months. The best responses to dostarlimab were: 27 (21.1%) complete responses, 40 (31.3%) partial responses, 33 (25.8%) stabilizations, and 25 (19.5%) progressions, with a median time to response of 2.9 months (95% CI, 2.6–3.3). DOR at 6 and 12 months was 96.3 and 87.1%, while 66.4% and 42.2% patients were progression-free at 6 and 12 months, respectively. Only 4.7% of patients discontinued treatment due to toxicity. Asthenia (16.3%) and hypothyroidism (10.1%) were the most frequent dostarlimab-related adverse events.

Conclusion Dostarlimab monotherapy in dMMR/MSI-H EC in a real-world setting is associated to similar efficacy outcomes to those observed in GARNET trial. To our knowledge this is the largest series evaluating dostarlimab monotherapy after GARNET trial.

Disclosures Attached

Abstract 452 Table 1

Patient characteristics

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