The proposed pre-operative HART with co-administration of 5FU had acceptable toxicity profile and provided satisfactory rate of ypCR. This created rationale to initiate a Phase III randomized study that was registered under ClinicalTrials.gov Identifier: NCT01814969. Advances in knowledge: The results of this research show that responders to pre-operative radiochemotherapy have favourable outcome. Tumour regression grade as prognostic clinical feature holds the promise of better classifying patients at high risk of local and systemic recurrence and this issue may be an interesting objective for future research.
We performed the analysis of database on 409 patients with LD-SCLC to evaluate as to what extent the clinical outcome of large prospective trials was reproduced in routine practice. The analysis has shown that the hazard rate of death in the absence of prophylactic cranial irradiation (PCI) adjusted for the effects of confounding factors, appeared larger than that reported in the trials on PCI in LD-SCLC, and was comparable to that estimated for extensive disease. Less intense routine staging procedures, compared to the trial settings, contributed for such outcome. Hyperfractionated thoracic radiotherapy provided survival advantage similar to that reported in the literature.
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