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BACKGROUND: In this paper the clinical value of PET for early prediction of tumor response to erlotinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen is evaluated. The aim was to compare the early metabolic treatment response using European Organization for Research and Treatment of Cancer (EORTC) 1999 recommendations and PET Response Criteria in Solid Tumors (PERCIST), and the standard treatment response using Response Evaluation Criteria in Solid Tumors (RECIST). METHODS: Twenty patients with stage IV NSCLCwere enrolled prospectively. PET/CT studies were performed before, then 48 hours, and 45 days after the initiation of erlotinib treatment. The lesion with the highest uptake in each patient was evaluated according to EORTC1999 recommendations, PERCIST and RECIST to assess metabolic and anatomic response. Response classifications were compared statistically using Wilcoxon signed-rank test. Disease-free survival (DFS) and overall survival (OS) were calculated by the Kaplan-Meier Test. RESULTS: At 48 hours, the Kaplan-Meier analysis showed that EORTC proved to be a significant prognostic factor for predicting DFS and OS. At 45 days, there was a significant difference in response evaluation between RECIST and metabolic classifications. RECIST and PERCIST were significant prognostic factors for predicting DFS and OS. EORTC was not able to discriminate responder from non-responder patients. CONCLUSIONS: This study shows that, according to the EORTC protocol, the PET exam is able to provide early identification of patients who benefit from Erlotinib treatment. Used at the end of therapy, PERCIST could be considered an appropriate metabolic evaluation method to discriminate responders from non-responders.

AIM: In this paper the clinical value of PET for early prediction of tumor response to Erlotinib in patients with advanced or metastatic nonsmall cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen is evaluated. The aim was to compare the early metabolic treatment response using European Organization for Research and Treatment of Cancer (EORTC) 1999 recommendations and PET Response Criteria in Solid Tumors (PERCIST), and the standard treatment response using Response Evaluation Criteria in Solid Tumors (RECIST). METHODS: Twenty patients with stage IV NSCLC were enrolled prospectively. PET/CT studies were performed before, then 48 h, and 45 days after the initiation of Erlotinib treatment. The lesion with the highest uptake in each patient was evaluated according to EORTC 1999 recommendations, PERCIST and RECIST to assess metabolic and anatomic response. Response classifications were compared statistically using Wilcoxon signedrank test. Disease-Free Survival (DFS) and Overall Survival (OS) were calculated by the KaplanMeier test. RESULTS: At 48 h, the KaplanMeier analysis showed that EORTC proved to be a significant prognostic factor for predicting DFS and OS. At 45 days, there was a significant difference in response evaluation between RECIST and metabolic classifications. RECIST and PERCIST were significant prognostic factors for predicting DFS and OS. EORTC was not able to discriminate responder from non-responder patients. CONCLUSION: This study shows that, according to the EORTC protocol, the PET exam is able to provide early identification of patients who benefit from Erlotinib treatment. Used at the end of therapy, PERCIST could be considered an appropriate metabolic evaluation method to discriminate responders from nonresponders.

Medical ethics is the science of survival. It studies the working out of judgments on right or wrong referred to the human being as a biological entity interacting with the whole ecosystem. Medical ethics in clinical research raises numerous moral and technical issues. Methodological aspects are essential for carrying out the aim of clinical research. Medical ethics documents are inspired by the Nuremberg Code and culminate in the recently updated Helsinki Declaration of 1964. In Italy 2 ministerial decrees in 1997 and 1998 laid the basis for the work of a medical ethics committee. They acknowledge the European Good Clinical Practice Guidelines and set professional needs within ethical committees. In clinical research the use of ionising radiation merits special consideration. In the recent past, serious human rights abuses in radiation experiments of the 1950s and 1960s have been found. As regards research in this field we can refer to the publication of the International Commission on Radiological Protection (ICRP) and to the report of the World Health Organi-sation (WHO). Legislative decree no. 187 of May 26, 2000, which transposed the 97/43/ EURATOM Directive represents the most comprehensive and recent normative reference to clinical research using ionising radiation. However, law no. 39 of March 1, 2002 is important for the partial modifications of previous decrees (art. 108 of L.D. no. 230 of March 17, 1995 and, art. 4 and attachment III of L.D. no. 187 of May 26). In this paper medical ethics, research, methodological issues and aspects of ionizing radiation are discussed.

Distinguishing neoplastic from nonneoplastic intracerebral hematoma has great clinical relevance for the appropriate management of patients. Imaging is not always able to clearly identify a tumor-related intraparenchymal cerebral hemorrhage (ICH), especially in the acute phase, the diagnosis being frequently based on evolution patterns. The aim of this study was to test the value of (99m)Tc-methoxyisobutylisonitrile ((99m)Tc-MIBI) SPECT as a noninvasive diagnostic tool in early diagnosis of hemorrhagic brain neoplasm.We prospectively studied 29 patients harboring a nontraumatic acute onset of clinical deterioration caused by ICH with atypical clinical or neuroradiologic features. All patients underwent (99m)Tc-MIBI SPECT within 48 h from the clinical onset. Early and delayed images were obtained. Both visual and semiquantitative analyses were performed. The (99m)Tc-MIBI index was obtained from both early and delayed images and the retention index was calculated.In 19 patients (65.5%), a nonneoplastic hemorrhage (15 vascular degenerative diseases, 2 cavernous angiomas, 1 thrombosed middle cerebral artery giant aneurysm, and 1 sinus rectus thrombosis) was diagnosed by clinical and neuroradiologic follow-up or open surgery. In 10 patients (34.5%), a neoplastic hemorrhage (6 metastases, 2 glioblastomas multiforme, 1 ependymoma, and 1 intracranial angioblastic meningioma) was diagnosed by direct histologic typing (open surgery or stereotactic biopsy). In all neoplasm-related hemorrhages, a focal increased tracer uptake was observed in the area of the lesion, whereas no focal increased tracer uptake was noted in all nonneoplastic hematomas. A wide cutoff in the early ratio between neoplastic and nonneoplastic hemorrhages was found. Moreover, a statistically significant difference was found in the delayed ratio (P0.01) and the retention index (P0.05) between the 2 groups.Our data suggest that (99m)Tc-MIBI SPECT could play a role in the early noninvasive diagnostic work-up of hemorrhagic brain lesions, allowing a clear differentiation between neoplastic and nonneoplastic ICHs. The high availability and low cost of this nuclear medicine technique can be considered additional advantages.