Recent Achievements
In 2009, two trials were closed to patient entry: the EORTC 08062 trial was closed after attaining full accrual, the EORTC 08021 trial was closed due to poor accrual. Final analysis report was completed for the EORTC 08021 trial. A total of 65 patients were entered in EORTC Lung Cancer Group trials in 2009.
During first half of 2010 two trials, one in non small cell lung cancer (NSCLC) and the other in mesothelioma, were fully developed. Two trials were closed to patient entry: the EORTC 08052 trial was closed after attaining full accrual, and the EORTC 08061 trial was closed due to poor accrual. The final analysis report was completed for the EORTC 08062 trial.
A dedicated NSCLC Strategy meeting was held at EORTC Headquarters on 06 October 2010.This meeting was organized by EPOD who will be developing concepts based on discussions held at this meeting.
NSCLC
EORTC 08021 trial: A randomized phase III 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. The slow accrual was triggered by the negative results in SWOG 0023 and ISEL (IRESSA Survival Evaluation in Lung cancer) studies. Iressa has recently been licensed for use in patients with epidermal growth factor receptor (EGFR) mutations. Abstracts concerning this trial were presented at ASCO 2010 and at ESMO 2010 as poster discussions.
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 is being reevaluated.
EORTC 08092 (MAPPING) trial: Double blind randomized phase III study of maintenance Pazopanib versus placebo in NSCLC patients non progressive after first line chemotherapy. This study is in regulatory process.
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. Recent results presented at ASCO 2010 are leading to a redefinition of the patient population.
Small Cell Lung Cancer (SCLC)
EORTC 22074 - 08072 trial: CONVERT: 2-arm randomized controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status, a phase III trial being conducted together with the EORTC Radiation Oncology Group and Medical Research Council, has started. This is the only phase III trial in LS-SCLC in Europe.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 are randomized 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 either chemonaive (ED) or presenting a sensitive relapse. 48 patients are planned to be entered in two different groups and be treated with the oral agent sunitinib for four weeks. The primary end point is disease control at four weeks determined by CT and PET scan. Non-responding patients are planned to be given standard chemotherapy after evaluation. The study opened in 2008 and has specific FDG-PET scanning and translational research questions. The trial has been closed due to poor accrual in June 2010.
EORTC 08062 trial: Randomized 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. Promising results that were recently reported from Japanese studies in SCLC are now being tested in caucasian patients. The activity of amrubicin single agent or amrubicin with cisplatin versus the standard treatment cisplatin/etoposide was investigated. The study completed recruitment and was analyzed in 2010. The primary endpoint is response rate; secondary endpoints focus on progression free survival, toxicity, and overall survival. A poster was presented at ASCO 2010 and publication of the final results is expected by the end of 2010.
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 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. Publication will appear in ERJ at the end of 2010. Translational research related to this study is ongoing.
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; secondary endpoints are overall survival and toxicity. A translational research component of this study is linked to the EORTC 08031 trial. The study has completed recruitment and will be analyzed first quarter 2011.
EORTC 08091 trial Randomized phase II study of cisplatin plus pemetrexed with either TRAIL-Receptor-2 agonist (CS-1008) or placebo as first line therapy for malignant pleural mesothelioma. After full protocol development the project has been withdrawn by the company producing CS-1008.