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Eur J Cancer. 2016 Feb;54:35-39. doi: 10.1016/j.ejca.2015.10.016. Epub 2015 Dec 21.

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).

Author information

1
Royal Marsden NHS Foundation Trust, London, United Kingdom; Clinical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
2
Dept. Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Dept. Pulmonary Diseases, Vrije Universiteit VU Medical Center, Amsterdam, The Netherlands.
3
EORTC Headquarters, Brussels, Belgium.
4
Royal Marsden NHS Foundation Trust, London, United Kingdom; Heart and Lung Institute, Imperial College London, United Kingdom.
5
Thoracic Oncology, University Hospital Antwerp, Belgium; Thoracic Oncology, University Hospital Ghent, Belgium.
6
Thoracic Oncology, University Hospital Ghent, Belgium.
7
Dept. Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
8
Royal Marsden NHS Foundation Trust, London, United Kingdom. Electronic address: mary.obrien@rmh.nhs.uk.

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.

KEYWORDS:

Phase II study; SCLC; Second-line treatment; Sunitinib; Targeted therapy; Tyrosine kinase inhibitor

PMID:
26716400
DOI:
10.1016/j.ejca.2015.10.016
[Indexed for MEDLINE]

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