If no relevant toxicity occurred, this was then done every other cycle.
The defined groups were as follows: Group 1a patients with TTL<50 ng ml−1 at day 15 and no relevant toxicity (n=5; 17%), Group 1b patients with TTL<50 ng ml−1 at day 15 with relevant toxicity (n=10; 34%), Group 2a patients with TTL>50 ng ml−1 at day 15 and no relevant toxicity (n=8; 28%), Group 2b patients with TTL>50 ng ml−1 at day 15 with relevant toxicity (n=6; 21%).
Toxicity was evaluated according to NCI-CTCAE (version 3.0), before every treatment of the first three cycles, and every other cycle thereafter if no relevant toxicity had appeared.
No relevant toxicity was reported, except an episode of febrile aplasia after the 6th cycle leading to red blood cells and platelets transfusion.
For example, Freyia and co-workers found no relevant toxicity in mouse alveolar macrophages and human epithelial cells due to hematite exposures in the nano, submicrometer, and micrometer scale, thus suggesting that hematite regardless of size has little toxic effect.
It is widely used in humans to detect hepatic lesions or liver metastases respectively and well tolerated following intravenous injection either of a diagnostic single or repeated doses, with no relevant toxicity to the liver in either humans or rodents [ 47– 47].
Similar to other combination trials involving anti-IGF-1R monoclonal antibodies, the observed adverse events in this study comprised known class-effect toxicities and no new relevant toxicities were described (Calvo et al, 2010; Di Cosimo et al, 2010; Naing et al, 2011; Quek et al, 2011).
In a retrospective analysis over a 10-year-period we found no indices for relevant toxicities.
Myelosuppression, febrile neutropenia (FN) and encephalopathy are the most relevant toxicities (Lorigan et al, 2007).
Recent studies suggest that larger irradiated volumes could be directly responsible for clinically relevant toxicities [7].
