Laurence Albiges1, Aude Fléchon2, Christine Chevreau3, Delphine Topart4, Gwenaëlle Gravis5, Stéphane Oudard6, Jean M Tourani7, Lionnel Geoffrois8, Emeline Meriaux9, Antoine Thiery-Vuillemin10, Philippe Barthélémy11, Sylvain Ladoire12, Brigitte Laguerre13, Valérie Perrot14, Anaïs Billard14, Bernard Escudier15, Marine Gross-Goupil16. 1. Gustave Roussy, Villejuif, France. Electronic address: laurence.albiges@gustaveroussy.fr. 2. Centre Léon Bérard, Lyon, France. 3. IUCT Oncopole Institut Claudius Regaud, Toulouse, France. 4. Centre Hospitalier Universitaire, Montpellier, France. 5. Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille University, Inserm, CNRS, CRCM, Marseille, France. 6. Hôpital Européen Georges Pompidou, Paris, France. 7. Centre Hospitalier Universitaire, Poitiers, France. 8. Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France. 9. Centre François Baclesse, Caen, France. 10. Centre Hospitalier Universitaire Jean Minjoz, Besançon, France. 11. Centre Hospitalier Universitaire, Strasbourg, France. 12. Centre Georges François Leclerc, Dijon, France. 13. Centre Eugène Marquis, Rennes, France. 14. Ipsen, Boulogne-Billancourt, France. 15. Gustave Roussy, Villejuif, France. 16. Centre Hospitalier Universitaire Saint-André, Bordeaux, France.
Abstract
BACKGROUND: Real-world data on cabozantinib in metastatic renal cell carcinoma (mRCC) is limited. This study (CABOREAL) reports treatment patterns and outcomes for patients treated with cabozantinib through the French Early Access Program. PATIENTS AND METHODS: This multicentre (n = 26), observational, retrospective study enrolled patients with mRCC who had received ≥1 dose of cabozantinib. Overall survival (OS) was estimated using the Kaplan-Meier method; subgroups were compared using the log-rank test. A multiple Cox regression model assessed predictive factors of OS after cabozantinib initiation. RESULTS: Four hundred and ten recruited patients started treatment between September 2016 and February 2018: the Eastern Cooperative Oncology Group Performance Status ≥2, 39.3%; poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk, 31.7%; 0-1, 2 and ≥3 previous treatment lines, 25.3%, 33.4% and 41.2%, respectively; bone metastases, 55.9%; brain metastases, 16.8%. Median (min-max) follow-up was 14.4 (0-30) months. Overall, 57.0% of patients had a dose reduction, 15.6% an alternative dose schedule. The median average daily dose was 40.0 mg. Median (quartile [Q]1-Q3) treatment duration was 7.6 (0.1-29.1) months, median OS was 14.4 months, and the 12-month OS rate was 56.5% (95% confidence interval: 51.5-61.2). Most patients (54.4%) received subsequent treatment. Predictive factors associated with longer OS were body mass index ≥25 kg/m2 (p = 0.0021), prior nephrectomy (p = 0.0109), favourable or intermediate IMDC risk (p < 0.0001) and cabozantinib initiation at 60 mg/day (p = 0.0486). CONCLUSIONS: In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation at 60 mg/day was associated with improved outcomes. CLINICALTRIALS. GOV IDENTIFIER: NCT03744585.
BACKGROUND: Real-world data on cabozantinib in metastatic renal cell carcinoma (mRCC) is limited. This study (CABOREAL) reports treatment patterns and outcomes for patients treated with cabozantinib through the French Early Access Program. PATIENTS AND METHODS: This multicentre (n = 26), observational, retrospective study enrolled patients with mRCC who had received ≥1 dose of cabozantinib. Overall survival (OS) was estimated using the Kaplan-Meier method; subgroups were compared using the log-rank test. A multiple Cox regression model assessed predictive factors of OS after cabozantinib initiation. RESULTS: Four hundred and ten recruited patients started treatment between September 2016 and February 2018: the Eastern Cooperative Oncology Group Performance Status ≥2, 39.3%; poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk, 31.7%; 0-1, 2 and ≥3 previous treatment lines, 25.3%, 33.4% and 41.2%, respectively; bone metastases, 55.9%; brain metastases, 16.8%. Median (min-max) follow-up was 14.4 (0-30) months. Overall, 57.0% of patients had a dose reduction, 15.6% an alternative dose schedule. The median average daily dose was 40.0 mg. Median (quartile [Q]1-Q3) treatment duration was 7.6 (0.1-29.1) months, median OS was 14.4 months, and the 12-month OS rate was 56.5% (95% confidence interval: 51.5-61.2). Most patients (54.4%) received subsequent treatment. Predictive factors associated with longer OS were body mass index ≥25 kg/m2 (p = 0.0021), prior nephrectomy (p = 0.0109), favourable or intermediate IMDC risk (p < 0.0001) and cabozantinib initiation at 60 mg/day (p = 0.0486). CONCLUSIONS: In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation at 60 mg/day was associated with improved outcomes. CLINICALTRIALS. GOV IDENTIFIER: NCT03744585.
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