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285 Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-Cx11/GOG 3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in patients with high-risk locally advanced cervical cancer
  1. Sandro Pignata1,
  2. Vladyslav Sukhin2,
  3. Nicoletta Colombo3,
  4. Jacob Korach4,
  5. Takashi Matsumoto5,
  6. Susan Lalondrelle6,
  7. Julia Vizkeleti7,
  8. Leslie Randall8,
  9. Vanessa Samouelian9,
  10. Pamela Salman10,
  11. Angelica Nogueira-Rodrigues11,
  12. Ali Ayhan12,
  13. Juan F Cueva13,
  14. Yong Man Kim14,
  15. Edgar Petru15,
  16. Karin Yamada16,
  17. Kan Li16,
  18. Elizabeth Szamreta16,
  19. Allison Martin Nguyen16 and
  20. Domenica Lorusso17
  1. 1Department of Uro-Gynaecological Oncology, Instituto Nazionale Tumori IRCCS Fondazione G Pascale, Napoli, Italy
  2. 2Grigoriev Institute for Medical Radiology and Oncology NAMS Ukraine, Kharkiv, Ukraine
  3. 3University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy
  4. 4Gynecologic Oncology Department, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel
  5. 5Department of Obstetrics and Gynecology, Ehime University, Ehime, Japan
  6. 6Gynaecology Unit, Royal Marsden NHS Foundation Trust and Radiotherapy and Imaging Division, London, UK
  7. 7National Institute of Oncology, Centre of Radiotherapy, Budapest, Hungary
  8. 8School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA
  9. 9Centre de Recherche de l’Université de Montréal (CRCHUM), Université de Montréal, Montréal, Qc, Canada
  10. 10Oncovida Cancer Center, Providencia, Chile
  11. 11Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
  12. 12Turkish Society of Gynecologic Oncology (TRSGO), Baskent University, Ankara, Turkey
  13. 13Department of Medical Oncology, Hospital Clínico Universitario Santiago de Compostela, Santiago De Compostela, Spain
  14. 14Asan Medical Center, University of Ulsan, Seoul, South Korea
  15. 15Department of Gynecology and Obstetrics, Division of Gynecology, Medical University of Graz, Graz, Austria
  16. 16Merck and Co., Inc., Rahway, Nj, USA
  17. 17Catholic University of Sacred Heart; Gynecologic Oncology Unit Fondazione Policlinico Gemelli IRCCS, Rome, Italy


Introduction/Background We report prespecified patient-reported outcome (PRO) analyses from the phase 3 ENGOT-cx11/GOG 3047/KEYNOTE-A18 study (NCT04221945).

Methodology Patients with high-risk locally advanced cervical cancer (LACC; FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA) were randomized to 5 cycles of pembrolizumab 200 mg Q3W + CCRT (cisplatin 40 mg/m2 plus EBRT followed by brachytherapy) followed by 15 cycles of pembrolizumab 400 mg Q6W or 5 cycles of placebo Q3W + CCRT followed by 15 cycles of placebo Q6W. Changes from baseline to week 36 in QLQ-C30 global health status/quality of life (GHS/QoL) and physical functioning (PF) and QLQ-CX24 symptom-experience scale were secondary endpoints. Other PRO analyses were exploratory endpoints. PROs were classified as improved based on a ≥10-point change (QLQ-C30, QLQ-CX24) or ≥7-pt change (EQ-5D-5L). No alpha was assigned to PRO analyses.

Results Of 1060 patients in the intent-to-treat population, 1008 were included in PRO analyses (pembrolizumab+CCRT, n=502; placebo+CCRT, n=506). In both arms, QLQ-C30 GHS/QoL and QLQ-C30 PF and EQ-5D-5L VAS scores decreased from baseline at weeks 3 and 6 but improved relative to baseline at week 12 and subsequent weeks. A similar proportion of patients had improved/stable scores for the QLQ-C30 GHS/QoL (75.7% vs. 75.3%), QLQ-C30 PF (76.5% vs. 76.5%), QLQ-CX24 symptom experience (84.7% vs. 85.1%) and EQ-5D-5L VAS (73.3% vs. 75.6%) in both arms. There were no clinically meaningful between-group differences in changes in PRO scores from baseline to week 36 for QLQ-C30 GHS/QoL, QLQ-C30 PF, QLQ-CX24 symptom experience, or EQ-5D-5L VAS (table 1).

Abstract 285 Table 1

Conclusion Improvement in PFS with addition of pembrolizumab to CCRT in patients with high-risk LACC was accompanied by QoL changes similar to those in the placebo+CCRT group. These results support pembrolizumab+CCRT as a new standard of care for patients with high-risk LACC and support the positive benefit-risk profile of this combination.

Disclosures Disclosures are provided via the ESGO COI Disclosure form.

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