Achievements (2009 - 2010)
In 2008 two trials were closed and have been analysed, two trials were opened for patient entry, and one trial was in protocol development. A total of 106 patients were entered in EORTC Lung Cancer Group trials in 2008.
Non-Small Cell Lung Cancer (NSCLC)
EORTC 08021 trial: A randomised phase II study of follow-up with or without adjuvant gefitinib
(Iressa) following chemotherapy in patients with advanced NSCLC. This trial closed in 2008 due to
slow accrual along with other negative studies using iressa, e.g. ISEL (Iressa Survival Evaluation in Lung
cancer). SATURN (Sequential Tarceva in Unresectable NSCLC), a similar study using tarceva, has been
positive for the primary endpoint of PFS. Iressa has recently received its license only in patients with
mutations of EGFR.
EORTC 08051 trial: A randomised phase II study of pemetrexed and cisplatin as either induction or
adjuvant chemotherapy in stage IB-II NSCLC. This study closed in 2008 because of poor recruitment
and reported no added benefit of neoadjuvant chemotherapy compared to adjuvant treatment.
EORTC 22055 - 08053 trial: Lung Adjuvant Radiotherapy Trial (ART) evaluating the role of postoperative
conformal radiotherapy after complete resection of NSCLC with N2 mediastinal involvement. This
trial was closed prior to recruiting its first patient. Despite the relevance of the question addressed
by this protocol, its feasibility was not guaranteed.
EORTC 75082 - 08086 trial: Randomized phase II trial of abraxane versus navelbine for patients aged
70 or older with NSCLC. This study is under development in collaboration with the EORTC Cancer
in the Elderly Task Force.
Small Cell Lung Cancer (SCLC)
EORTC 22003 - 08004 trial: International Prophylactic Cranial Irradiation (PCI) trial. This multicentre,
randomised trial was a joint study with the RTOG and the PCI 99-EULINT1 collaborative group.
It built on our previous positive trial of PCI for small cell lung cancer and examined the effect of
different doses of radiation in PCI to limited stage SCLC in complete responders. The study is closed,
and the data presented. In summary the higher dose of radiotherapy is no better than the current
standard dose.
EORTC 22074 - 08072 trial: CONVERT: a phase III study together with the EORTC Radiation Oncology
Group and Medical Research Council has started. The study is considered to be of great importance
for patients with limited stage SCLC and is designed to answer the question of dosing and timing of
radiation to the chest. Patients will be randomised to receive twice daily radiation with concurrent
chemotherapy versus four courses of chemotherapy followed by high dose radiation of 66 Gy.
EORTC 08061 trial: Phase II study of sunitinib in patients with SCLC who are either chemonaive (ED)
or have a sensitive relapse. In this phase II study 48 patients will be entered in the two different groups
and will be treated with the oral agent sunitinib for four weeks. The main end point of this study is
disease control at four weeks determined by CT and PET scan. Non-responding patients will be given
standard chemotherapy after evaluation. The study opened in 2008 and has specific FDG-PET scanning
and translational research questions.
EORTC 08062 trial: Randomised phase II study of amrubicin as single agent or in combination with
cisplatin versus etoposide/cisplatin as first-line treatment in patients with extensive stage SCLC. The
recently reported promising results from Japanese studies in SCLC are now tested in Caucasian
patients. Amrubicin single agent or amrubicin with cisplatin will be compared with the standard
treatment with cisplatin/etoposide. The study has completed recruitment and will be analysed in 2010.
The primary end-point is response rate, and secondary end-points focus on progression free survival,
toxicity and overall survival.
Mesothelioma
EORTC 08031 trial: A phase II feasibility trial of induction chemotherapy followed by extra pleural
pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma.
The study completed recruitment and has been analysed.
The study investigated the feasibility of combining induction chemotherapy, extra pleural
pneumonectomy and hemi-thoracic irradiation in patients with early stage mesothelioma. The
endpoint is the number of patients alive and without significant toxicity or disease at 90 days after the
last treatment, and the data suggest that this is only possible in <50% of patients.
EORTC 08052 trial: A phase II study of bortezomib (Velcade) with cisplatin as first-line treatment of
malignant mesothelioma. This trial is assessing the effect of bortezomib with cisplatin in patients with
inoperable malignant mesothelioma. The primary endpoint is progression free survival at 18 weeks,
and secondary endpoints are overall survival and toxicity. This study has completed the first cohort
and confirmed an acceptable progression free survival rate. A translational research component of
this study is linked to the EORTC 08031 trial. The study should finish in late 2009.