851P - Prospective observational study on the evaluation of everolimus adverse events (AEs) in metastatic renal cell carcinoma (mRCC) after first-line ant...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Florence Joly Lobbedez
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors F. Joly Lobbedez1, J. Eymard2, L. Albiges3, T. Nguyen4, A. Guillot5, F. Rolland6, D. Spaeth7, B. Laguerre8, P. Colin9, T. Lebret10, K. Slimane11, N. Kelkouli12, A. Ravaud13
  • 1Medocal Oncology, Centre Francois Baclesse, 14076 - Caen CEDEX /FR
  • 2Oncology, Institut Jean Godinot, FR-51056 - Reims/FR
  • 3Dept. Of Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 4Service Oncologie Medicale, University Hospital of Besançon, 25000 - Besançon/FR
  • 5Medical Oncology, INSTITUT DE CANCÉROLOGIE DE LA LOIRE, 42271 - SAINT PRIEST EN JAREZ CEDEX/FR
  • 6Oncology, RENE GAUDUCHEAU INSTITUT, SAINT HERBLAIN/FR
  • 7Medical Oncology, Centre d'Oncologie de Gentilly, 54100 - Nancy/FR
  • 8Medical Oncology, Centre Eugène Marquis, Rennes/FR
  • 9Oncology, ICC REIMS, REIMS/FR
  • 10Urology, Hôpital Foch, 92150 - Suresnes/FR
  • 11Oncology, NOVARTIS PHARMA, RUEIL MALMAISON/FR
  • 12Oncology, NOVARTIS PHARMA, 92500 - RUEIL MALMAISON/FR
  • 13Medical Oncology, Bordeaux University Hospital Saint André, 33075 - Bordeaux/FR

Abstract

Aim

RECORD I results indicate that stomatitis and non-infectious lung disease were the most frequent AEs leading to dose reduction or treatment discontinuation with everolimus (eve). AFINITE study was designed to prospectively collect data related to these two AEs and their management in real life practice.

Methods

Between 09/10 and 08/12, 284 mRCC pts from 77 French centres, received eve as 2nd line were recorded. Primary endpoint was to describe the occurrence of stomatitis and non-infectious lung disease. Main secondary endpoints were: best tumoral response, self-reported tolerance of eve, extent of exposure to eve and the main reasons for dose reduction or discontinuation. Amongst 284 pts, 274 were analysed. Median age was 66 yrs, male 72%, clear cell histology 88%, sunitinib as first TKI 83%. Main comorbidities were: hypertension 51%, diabetes 16%, and hypercholesterolemia 2&%. At eve initiation, MSKCC classification was good 50%, intermediate 40% or poor 10%.

Results

43% pts had at least 1episode of stomatitis during eve treatment 17% Grade 1, 17% Grade 2 and 8% Grade 3. Main treatment was mouthwash 82%, analgesics 26% or anti-fungal agent 11%. 17% of pts had at least 1 episode of non-infectious lung disease during eve treatment, 4% were Grade 1, 11% Grade 2 and 2.5% Grade 3. Main treatment was corticosteroids 65%. The most others frequent all grades AEs were asthenia 24%, anaemia 16 %, diarrhoea 11%, hypertriglyceridemia 7%, decreased appetite 7%, hypercholesterolemia and hyperglycaemia 5% each. Eve discontinuation related to stomatitis and non-infectious lung disease was respectively 2% and 7%. Dose modification related to stomatitis and non-infectious lung disease was respectively 6% and 4 %. One pt showed a CR to eve, 13% a PR and 43% had stable disease. Overall, the median duration of treatment was 3.2 months and 66% of pts finished the study without interruption.

Conclusions

This study conducted in real life confirms that stomatitis and non-infectious lung disease occur commonly with EVE use. These AEs were rarely severe and were relatively easily and efficiently managed.

Disclosure

F. Joly Lobbedez: Ad board Novartis Pfizer et GSK; J. Eymard: Ad Board: Novartis Sanofi Janssen Astellas

L. Albiges Sauvin: Ad.Board/Honoraria: Novartis, Pfizer, Sanofi, Amgen Research Grant: novartis, Pfizer

T. Nguyen: Novartis advisory board; A. Guillot: Advisory board: Pfizer Novartis Janssen Astellas; F. Rolland: Novartis advisory board, Novartis personnal fees; D. Spaeth: Novartis Grant; P. Colin: Novartis ad borad

T. Lebret: Ad Board: Novartis GSK Roche Bayer; K. Slimane: Novartis full time employee; N. Kelkouli: full time employee; A. Ravaud: Ad board: Novartis Pfizer GSK BMS. All other authors have declared no conflicts of interest.