Efficacy and safety of the combination of bevacizumab (BEV) and temsirolimus (TEM) in patients with metastatic renal cancer (mRCC) after first-line anti-VEGF treatment: A Hellenic Cooperative Oncology group (HeCOG) phase II trial

Date

09 Oct 2016

Session

Poster display

Presenters

Konstantinos Koutsoukos

Citation

Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373

Authors

K. Koutsoukos1, F. Zagouri1, K. Tzannis1, V. Karavasilis2, E. Samantas2, G. Aravantinos2, A. Koutras2, I. Gkerzelis2, E. Chamylos2, E. Kostouros1, M. Lykka1, G. Tsironis1, I. Dimitriadis1, M. Liontos1, G. Fountzilas2, M. Dimopoulos1, A. Bamias1

Author affiliations

  • 1 Oncology Unit, Department Of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 115 28 - Athens/GR
  • 2 Data Office, Hellenic Cooperative Oncology Group (HeCOG), 11524 - Athens/GR
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Background

Anti vascular endothelial growth factor (aVEGF) agents represent the standard 1st-line therapy for mRCC. Monotherapy with agents blocking VEGF, mTOR or PD1/PD-L1 interaction are approved therapies. Since post progression blockade of VEGF may be of value, we studied the combination of BEV+TEM in mRCC patients relapsing after 1st-line treatment.

Methods

A prospective, phase II, multicenter, trial evaluating the combination of BEV(10mg/kg, every 2 weeks) withTEM(25 mg weekly), until progression of the disease or unacceptable toxicity, was conducted in patients with mRCC who failed first-line aVEGF treatment. No previous therapy for relapsed disease was allowed. % of 6-month progression-free survival (PFS) was the primary end point.

Results

39 patients were enrolled and 37 of them were evaluable for response. 1st-line therapy included: sunitinib (16), bevacizumab/interferon (12), pazopanib (10), sorafenib (1). The median age was 67 (40-80) years. Clear cell histology was present in 97% of patients, while 69% had PS 0. 51% of patients were progression-free at 6 months (95% CIs: 34-66) and 20% (95% CIs: 9-34) at 12 months. The median time to progression was 6.8 months (95%CI 5.5-9.2) and the overall survival 18.2 months (95%CI 12.9-27.2). Best responses were: complete-1 (2.7%), partial-9(24.3%), stable disease-20 (54.1%), progression-7(18.9%). Worst toxicities were of grade: 1 in 1 case (3%), 2 in 20 (51%), 3 in 15 (38%), 4 in 2 (5%), 5 in 1 (3%). The most common adverse evets (AEs) were metabolic (44%), gastrointestinal (11%) and myelotoxicity (9%). The most common grade 3 and 4 AEs were infection (10%), hypertension (5%), hypertriglyceridemia (5%) and mucositis (5%).Toxicity was the most frequent cause of treatment discontinuation (33%).

Conclusions

The combination of BEV and TEMis active in mRCC patients relapsing after a VEGF 1st-line treatment. Our study confirms recent encouraging data of another anti-VEGF/anti-mTOR combination in this population. Nevertheless, toxicity was considerable leading to the discontinuation of therapy in 1/3 of patients.

Clinical trial identification

NCT01264341

EudraCT: 2010-020664-38

Legal entity responsible for the study

Hellenic Cooperative Oncology Group

Funding

Pfizer

Disclosure

K. Koutsoukos: Honoraria from Novartis. F. Zagouri: Honoraria from Novartis, Roche. E. Kostouros: Honoraria Janssen. M. Liontos: Janssen Honoraria. M. Dimopoulos: Honoraria from Celgene, Janssen, Takeda and Amgen. A. Bamias: Pfizer, Roche, Novartis, Bayer (Honoraria). All other authors have declared no conflicts of interest.

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