Age <70 yrs |
WHO performance status 0–1 |
Fit enough to receive chemotherapy, to undergo a pneumonectomy and receive post-operative radiotherapy. The responsible physician, surgeon and radiation therapist judged the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary and cardiac) examinations. Proposed exclusion criteria were: predicted post-operative FEV1 <40% and/or V′O2,max <20 mL·min−1·kg−1, significant pulmonary hypertension, significant decrease in cardiac ejection fraction (<40%) and myocardium at risk of ischaemic injury. |
Pathologically proven MPM (all subtypes accepted) |
cT3N1M0 or less severe according to UICC TNM classification |
No N2 or N3 lymph node involvement (pathologically confirmed), cervical mediastinoscopy required |
No clinical invasion of mediastinal structures (heart, aorta, spine, oesophagus, etc.) |
No widespread chest wall invasion, only focal chest wall lesions are acceptable |
No clinical or radiological evidence of “shrinking hemithorax” |
No prior chemotherapy for mesothelioma |
No prior radiotherapy of the lower neck, thorax or upper abdomen |
No secondary or primary malignancy except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin or prior malignancy treated >5 yrs previously without recurrence |
Adequate haematological, hepatic and renal function |
Acceptable, predicted post-radiotherapy renal function, as indicated by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥40% |
No pre-existing sensory neurotoxicity greater than grade 1 according to CTCAE version 3.0 12 |
No clinically significant third-space fluid (e.g. pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis (according to institutional practice) |
No uncontrolled infection |
Patients of reproductive potential were required to agree to use a reliable method of birth control during protocol treatment and for 3 months following the end of protocol treatment. Females of child-bearing potential were required to test negative for pregnancy at the time of enrolment, based on a serum pregnancy test |
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions were discussed with the patient before registration |
Before patient registration, written informed consent was to be obtained and documented according to national and local regulatory requirements, and the local rules followed in the institution. |
WHO: World Health Organization; FEV1: forced expiratory volume in 1 s; V′O2,max: maximal oxygen uptake; MPM: malignant pleural mesthelioma; UICC: International Union Against Cancer; TNM: tumour, nodes, metastasis; CTCAE: Common Terminology Criteria for Adverse Events.