Abdelraouf, F., Smit, E., Hasan, B., Menis, J., Popat, S., van Meerbeeck, J. P., Surmont, V. F., Baas, P., O'Brien, M. (2016) Sunitinib (SU11248) in patients with chemo naive extensive small cell lung cancer or who have a 'chemosensitive' relapse: A single-arm phase II study (EORTC-08061). EUROPEAN JOURNAL OF CANCER, 54. pp. 35-39. ISSN 0959-8049

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Abstract

Background: Targeted therapies have to date not been successful in the treatment of small cell lung cancer (SCLC). This study aimed to assess the therapeutic activity of sunitinib (an oral, multi-targeted tyrosine kinase inhibitor) using positron emission tomography (PET)-computed tomography (CT) imaging as an early indicator of response. Methods: This was a single-arm phase II study of sunitinib in patients with SCLC who are either chemo naive (extensive disease) or have a 'sensitive' relapse. A loading dose of 150 mg sunitinib was given orally followed by 37.5 mg/d. The primary end-point was disease control rate (DCR) at 8 weeks after the start of treatment and secondary end-points included toxicity of treatment and overall response. PET-CT was carried out at 4 weeks into the treatment. The study was closed early because of low accrual with only 9 of required 48 patients (19%) accrued. Results: Nine patients were registered, seven females and two males with a median age of 65 years and a median duration of sunitinib treatment of 7.4 weeks. DCR at 8 weeks was achieved in two patients, both of whom went on to long periods of disease control, one patient achieved a partial response which lasted 10 months and a second patient had stable disease (minor shrinkage) which lasted 20 months. One of these patients proved to have an atypical carcinoid tumour at rebiopsy after 10 months. DCR and PET-CT imaging both predicted these responses. Grade III-IV toxicities were encountered during treatment, most commonly neutropenia (n = 3), thrombocytopenia (n = 3) and hypermagnesaemia (n = 2). One toxic death occurred due to bronchial haemorrhage. Conclusion: This study emphasises the need for alternate study design and end-points for new drug assessment in SCLC. EudraCT number: 2006-002485-19. (C) 2015 Elsevier Ltd. All rights reserved.

Item Type:	Article
All Authors:	Abdelraouf, F., Smit, E., Hasan, B., Menis, J., Popat, S., van Meerbeeck, J. P., Surmont, V. F., Baas, P., O'Brien, M.
Additional Information:	ISI Document Delivery No.: DC3WQ Times Cited: 0 Cited Reference Count: 6 Abdelraouf, Fatma Smit, Egbert Hasan, Baktiar Menis, Jessica Popat, Sanjay van Meerbeeck, Jan P. Surmont, Veerle F. Baas, Paul O'Brien, Mary 0 ELSEVIER SCI LTD OXFORD EUR J CANCER
Uncontrolled Keywords:	SCLC Sunitinib Tyrosine kinase inhibitor Targeted therapy Phase II study Second-line treatment MAINTENANCE SUNITINIB CHEMOTHERAPY
Research teams:	Clinical Units > Lung Unit
Depositing User:	Barry Jenkins
Date Deposited:	23 Feb 2016 11:02
Last Modified:	23 Feb 2016 11:02
URI:	http://publications.icr.ac.uk/id/eprint/14805

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