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2022-RA-579-ESGO A phase II study assessing safety and efficacy of cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure (CABOCOL study)
  1. Elodie Coquan1,
  2. Justine Lequesne2,
  3. Emeline Colomba3,
  4. Jean-Sébastien Frenel4,
  5. Cyril Abdeddaim5,
  6. Véronique D’Hondt6,
  7. Marie Castera2,
  8. Sophie Abadie-Lacourtoisie7,
  9. Coraline Dubot8,
  10. Pierre-Emmanuel Brachet1,
  11. Alexandra Leconte2,
  12. Bénédicte Clarisse2 and
  13. Florence Joly1
  1. 1Medical Oncology Department, Centre François Baclesse, Caen, France
  2. 2Clinical Research Department, Centre François Baclesse, Caen, France
  3. 3Medical Oncology Department, Institut Gustave Roussy, Villejuif, France
  4. 4Medical Oncology Department, Institut de Cancérologie de l’Ouest, Saint Herblain, France
  5. 5Medical Oncology Department, Centre Oscar Lambret, Lille, France
  6. 6Medical Oncology Department, Institut du Cancer de Montpellier, Montpellier, France
  7. 7Medical Oncology Department, Institut de Cancérologie de l’Ouest, Angers, France
  8. 8Medical Oncology Department, Institut Curie, Saint Cloud, France


Introduction/Background The addition of bevacizumab and pembrolizumab to platinum-based chemotherapy improves survival in advanced/metastatic cervical cancer (a/m CC). However, few therapeutic options are available after progression, associated with a poor prognosis. Cabozantinib, an oral small molecule tyrosine kinase inhibitor targeting several receptor tyrosine kinases known to influence tumor growth, metastasis, and angiogenesis, represents a potential active treatment in CC. CABOCOL study concomitantly assessed the efficacy and safety of cabozantinib monotherapy in a/m CC after failure to platinum-chemotherapy (NCT04205799)

Methodology CABOCOL was a single-arm two-stage multicenter phase II trial. Using a Bryant-and-Day design, the primary endpoint was based on both clinical efficacy and safety: the 3-month disease control rate (DCR) and the proportion of patients experiencing gastro-intestinal (GI) or genito-urinary (GU) perforation/fistula grade ≥2 within 1 month after the end of treatment. Considering πEfficacy0=30%/πEfficacy1=50% the unacceptable/acceptable 3-month DCR, and πToxicity0=25%/πToxicity1=10% the unacceptable/acceptable perforation/fistula rate, and a 10% drop-out rate, 57 patients were needed (51 assessable): p_Efficacy ≥21/51 and p_Toxicity ≤9/51 will allow considering the study as positive. Cabozantinib was administered at the daily oral dose of 60 mg in a 4-week cycle, up to disease progression or unacceptable toxicity.

Results From January 2020 to December 2021, 57 patients were enrolled (54 assessable): median age 56 years, 28 (52%) pre-treated by bevacizumab, median follow-up 7.4 months. For primary endpoint, 25/54 (46.3%) patients had disease control at 3 months and 6/54 (11.1%) patients presented a Grade ≥2 GU/GI fistula/perforation (5 fistula/1 perforation). Overall response rate was 9.3% (5/54), with no complete response. Median progression-free and overall survivals were 2.8 [95%CI: 2.5–4.6] and 8.9 [6.7–14] months, respectively. Toxicity-related dose reduction was observed for 26 patients. Grade ≥3 treatment-related adverse events were GI toxicities (13% G3, 2% G5), hypertension (7.5% G3), asthenia (14.8% G3).

Conclusion Cabozantinib monotherapy showed promising efficacy with manageable toxicity in a/m CC.

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