TFI standard definition still applies to the classification in SCLC relapse -
By Laura Cowen, medwireNews Reporter
Italian researchers have confirmed that the use of an unpaid interval (IFT) failure 60 days to file a relapse of lung cancer small cell (SCLC) sensitive or resistant can be regarded as standard definition.
Marcello Tiseo (University Hospital of Parma) and colleagues explain that relapsed SCLC has historically been classified as sensitive or resistant in a TFI roughly 60 or 0 days.
"However, this definition was developed it several years ago based solely on retrospective small series at the standard first-line [treatment] was not based on platinum, and its validity has been under discussion by some recent studies, "they write in the European Journal of Cancer .
researchers used retrospective data on 631 patients with SCLC enrolled in phase II or III studies of treatment with second-line topotecan to validate these criteria. They also investigated whether the addition of other clinical parameters may improve discrimination between susceptible and resistant types of the disease.
Tiseo and team report that the sensitivity (97.1 vs 92.2%), specificity (22.7 vs 31.8%), positive predictive value (19.8 vs 21 0%) and negative predictive value (97.5 vs 95.4%) to correctly classify the response to treatment were similar in the TFI using thresholds 60 or 0 days.
increasing the interval TFI or adding information regarding the objective response to first-line treatment has not improved the accuracy significantly.
When the researchers considered other factors associated with objective response, they found that the presence of liver metastases, with a TFI cut 60 days off, were the only variables significantly and independently associated with it outcome on multivariate analysis. However, the combination of these two variables did not improve the ability to distinguish between sensitive and resistant disease.
independent prognostic factors for overall survival were 60 days cut TFI, age, liver metastases, the status of the performance, and serum albumin, hemoglobin and sodium .
These variables were combined in a prognostic model that enabled the team to separate patients into the categories low and high risk. In a set of bypass data including 419 patients included in the study, patients in the high risk group had a 2.56 times increased risk of death compared to those in the low risk group (median overall survival 20 , 0 vs. 41.4 weeks).
Similar results were observed in a validation data set comprising the remaining 212 patients with high-risk patients with a 2.53 times greater risk of death than those in the low risk category .
Tiseo and co-authors conclude that, in addition to TFI, other clinical parameters have a strong influence on the results and "should be considered in planning treatment and used as a stratification parameters future clinical studies. "
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