Clinical Benefit of Everolimus as Second-Line Therapy in Metastatic Renal Cell Carcinoma: The French Retrospective SECTOR Study.
Real-world data of everolimus after vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) therapy in metastatic renal cell carcinoma (mRCC) are limited.



The retrospective, noninterventional SECTOR (SECond line with afiniTOR) study (N = 165) assessed outcomes of second-line everolimus after initial VEGFR-TKI (TKI-everolimus, n = 144) and of third-line VEGFR-TKI after everolimus (TKI-everolimus-TKI, n = 59) in patients with mRCC. The primary end point was duration of everolimus therapy for both populations.



Median duration was 4.0 months (range, 0.0-33.0 months) for second-line everolimus and 18.0 months (range, 2-78 months) for sequential VEGFR-TKI and everolimus. Median overall survival (OS) for this sequence was 36.0 months (95% confidence interval [CI], 27.0-56.0 months) and was longer for patients who received a first-line TKI for ≥ 9 months (not reached) than for < 9 months (28.0 months; P < .001). During second-line everolimus treatment, commonly reported adverse events (all grades) were fatigue (n = 66, 40.7%), anemia (n = 58, 35.8%), and stomatitis (n = 41, 25.3%). Median duration from initiation of first-line TKI to the end of the third-line TKI was 24.0 months (95% CI, 19.0-29.0 months). Median OS for this sequence was 41.0 months (95% CI, 25.0-57.0 months) and was significantly longer for patients who received the first-line TKI for ≥ 9 months (37.5 months) than for < 9 months (19.0 months; P < .0001).



These results reflect clinical use of sequential TKI-everolimus and TKI-everolimus-TKI and provide additional evidence that everolimus could be an option in second-line therapy in mRCC. Results of the CheckMate-025 (Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma) and METEOR (Metastatic RCC Phase 3 Study Evaluating Cabozantinib versus Everolimus) studies might change the treatment landscape.
Université René Descartes, Immunothérapie et traitement antiangiogénique en pathologie cancérologique, and Hôpital Européen Georges Pompidou, Service de Cancérologie Médicale, Paris, France. Electronic address: stephane.oudard@aphp.fr.
Stéphane
S
Oudard
Centre François Baclesse-CHU, INSERM, Cancer et Préventions, Caen, France.
Florence
F
Joly
Institut de Cancérologie de Lorraine, Responsable du département d'Oncologie Médicale, Nancy, France.
Lionnel
L
Geoffrois
Centre Eugene Marquis, Medical Oncology Department, Rennes, France.
Brigitte
B
Laguerre
CHU Carémeau, Nimes and INSERM U1194, Institut de Recherche en Cancérologie de Montpellier, Department of Medical Oncology, Montpellier, France.
Nadine
N
Houede
Hôpitaux Universitaires de Strasbourg, Oncology and Hematology Department, Strasbourg, France.
Philippe
P
Barthelemy
CHU Bordeaux, Département d'Oncologie Médicale, Bordeaux, France.
Marine
M
Gross-Goupil
Université René Descartes, Immunothérapie et traitement antiangiogénique en pathologie cancérologique, and Hôpital Européen Georges Pompidou, Service de Cancérologie Médicale, Paris, France.
Yann
Y
Vano
Groupe Hospitalier Pitié Salpêtriére, Department of Radiology, Paris, France.
Oliver
O
Lucidarme
Gustave Roussy, Oncology Department, Villejuif, France.
Francois
F
Bidault
Novartis France, Oncology Department, Rueil-Malmaison, France.
Nadia
N
Kelkouli
Novartis France, Oncology Department, Rueil-Malmaison, France.
Khemaies
K
Slimane
Gustave Roussy, Oncology Department, Villejuif, France.
Bernard
B
Escudier
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D004334:Drug Administration Schedule; D000068338:Everolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005602:France; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000068338:Everolimus
Observational study; Real-world study; Sequential targeted therapy; VEGFR inhibitor; mTOR inhibitor