First-line treatment with sunitinib monotherapy in patients with advanced urothelial cancer ineligible for cisplatin-based chemotherapy: Pretreatment levels of IL8 and Hounsfield units as predictors of clinical benefit.
Authors: J. Bellmunt, J. L. Gonzalez-Larriba, J. P. Maroto, J. Carles, D. E. Castellano, B. Mellado, E. Gallardo, J. L. Perez-Gracia, X. Villanueva, J. Albanell
Journal: Journal of Clinical Oncology (2010)

Article Tools Genitourinary Cancer Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/jco.2010.28.15_suppl.4540 Journal of Clinical Oncology - published online before print May 20, 2010 First-line treatment with sunitinib monotherapy in patients with advanced urothelial cancer ineligible for cisplatin-based chemotherapy: Pretreatment levels of IL8 and Hounsfield units as predictors of clinical benefit. J. BellmuntxJ. BellmuntSearch for articles by this author , J. L. Gonzalez-LarribaxJ. L. Gonzalez-LarribaSearch for articles by this author , J. P. MarotoxJ. P. MarotoSearch for articles by this author , J. CarlesxJ. CarlesSearch for articles by this author , D. E. CastellanoxD. E. CastellanoSearch for articles by this author , B. MelladoxB. MelladoSearch for articles by this author , E. GallardoxE. GallardoSearch for articles by this author , J. L. Perez-GraciaxJ. L. Perez-GraciaSearch for articles by this author , X. Villanueva Sr.xX. Villanueva Sr.Search for articles by this author , J. AlbanellxJ. AlbanellSearch for articles by this author Show More Hospital del Mar, IMIM, Barcelona, Spain; Hospital Universitario Clínico San Carlos, Madrid, Spain; Hospital Santa Creu, Barcelona, Spain; Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain; Hospital Clinic, Barcelona, Spain; Corporacio Parc Tauli, Sabadell, Spain; Clinica Universidad de Navarra, Pamplona, Spain; Hospital del Mar, Barcelona, Spain https://doi.org/10.1200/jco.2010.28.15_suppl.4540 Abstract Abstract 4540 Background: There is a need for improving therapy in "unfit" patients (pts) who are not able to receive standard cisplatinum-based chemotherapy and to look for response predictors. VEGF is expressed in transitional cell carcinoma and its overexpression is associated with an aggressive behavior; targeting angiogenesis maybe a rational approach. Methods: This is a multicenter, open-label, phase II clinical trial assessing oral sunitinib at 50 mg daily in a 4/2-week schedule as first-line in "unfit" urothelial cancer pts. Eligibility criteria to define "unfit" included creatinine clearance under 60 ml/min but over 30 ml/min and performance status ≥ 1 (ECOG). Pretreatment sequential serum samples and measurements of Hounsfield units were collected in pts undergoing treatment. 14 potential serum markers (cytoquines, soluble receptors, growth factors and methaloproteases) were studied (xMAP Technology of Luminex Corp). Results: 37 pts with median age of 75 years were enrolled between July 2006 and September 2009. Bladder was the most frequent primary tumor site. Visceral disease included lung (33.3 %), liver (12%) and bone metastases (12%). Median number of cycles was 2.4 (1-6). Twenty-seven pts are evaluable for efficacy; 3 PRs (8.1%) were obtained, one not confirmed due to brain mets progression; 14 pts (53.8%) had SD lasting > 3m; clinical benefit rate of 62% and median PFS being 5.9 m. Three pts are still on therapy. Most frequent toxicities were fatigue, neutropenia and thrombopenia, hypertension, hand-foot syndrome, stomatitis, haematuria, and epistaxis. IL8 baseline levels were significantly increased in nonresponders and significantly associated with PFS. Final correlative analysis with Hounsfield units is ongoing. Conclusions: Sunitinib first line in “unfit” bladder pts shows significant benefit in 62 % of pts with a median PFS of 5.9 m. leading to a delay on time to start chemotherapy. Baseline levels of IL8 were able to predict benefit and warrant further study as predictive marker of sunitinib activity. Supported by FISS PI061239 and Cellex Foundation. No significant financial relationships to disclose. © 2010 by American Society of Clinical Oncology