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Evaluation of a 30-gene paclitaxel, fluorouracil, doxorubicin and cyclophosphamide chemotherapy response predictor in a multicenter randomized trial in breast cancer

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Evaluation of a 30-gene paclitaxel, fluorouracil, doxorubicin and cyclophosphamide chemotherapy response predictor in a multicenter randomized trial in breast cancer

dc.contributor.author	Tabchy, Adel	es_ES
dc.contributor.author	Valero, Vicente	es_ES
dc.contributor.author	Vidaurre, Tatiana	es_ES
dc.contributor.author	Lluch Hernández, Ana	es_ES
dc.contributor.author	Gomez, Henry	es_ES
dc.contributor.author	Martín, Miguel	es_ES
dc.contributor.author	Qi, Yuan	es_ES
dc.contributor.author	Barajas-Figueroa, Luis Javier	es_ES
dc.contributor.author	Souchon, Eduardo	es_ES
dc.contributor.author	Coutant, Charles	es_ES
dc.contributor.author	Doimi, Franco D.	es_ES
dc.contributor.author	Ibrahim, Nuhad K	es_ES
dc.contributor.author	Gong, Yun	es_ES
dc.contributor.author	Hortobagyi, Gabriel N.	es_ES
dc.contributor.author	Hess, Kenneth R.	es_ES
dc.contributor.author	Symmans, W. Fraser	es_ES
dc.contributor.author	Pusztai, Lajos	es_ES
dc.date.accessioned	2015-06-29T10:32:28Z
dc.date.available	2015-06-29T10:32:28Z
dc.date.issued	2010	es_ES
dc.identifier.citation	Clinical cancer research : an official journal of the American Association for Cancer Research Vol. 16 Issue 21: pp. 5351-5361	es_ES
dc.identifier.uri	http://hdl.handle.net/10550/44799
dc.description.abstract	PurposeWe examined in a prospective, randomized, international clinical trial the performance of a previously defined 30-gene predictor (DLDA-30) of pathologic complete response (pCR) to preoperative weekly paclitaxel and fluorouracil, doxorubicin, cyclophosphamide (T/FAC) chemotherapy, and assessed if DLDA-30 also predicts increased sensitivity to FAC-only chemotherapy. We compared the pCR rates after T/FAC versus FAC×6 preoperative chemotherapy. We also performed an exploratory analysis to identify novel candidate genes that differentially predict response in the two treatment arms.Experimental Design273 patients were randomly assigned to receive either weekly paclitaxel × 12 followed by FAC × 4 (T/FAC, n=138), or FAC × 6 (n=135) neoadjuvant chemotherapy. All patients underwent a pretreatment FNA biopsy of the tumor for gene expression profiling and treatment response prediction.ResultsThe pCR rates were 19% and 9% in the T/FAC and FAC arms, respectively (p<0.05). In the T/FAC arm, the positive predictive value (PPV) of the genomic predictor was 38% (95%CI:21–56%), the negative predictive value (NPV) 88% (CI:77–95%) and the AUC 0.711. In the FAC arm, the PPV was 9% (CI:1–29%) and the AUC 0.584. This suggests that the genomic predictor may have regimen-specificity. Its performance was similar to a clinical variable-based predictor nomogram.ConclusionsGene expression profiling for prospective response prediction was feasible in this international trial. The 30-gene predictor can identify patients with greater than average sensitivity to T/FAC chemotherapy. However, it captured molecular equivalents of clinical phenotype. Next generation predictive markers will need to be developed separately for different molecular subsets of breast cancers.	es_ES
dc.title	Evaluation of a 30-gene paclitaxel, fluorouracil, doxorubicin and cyclophosphamide chemotherapy response predictor in a multicenter randomized trial in breast cancer	es_ES
dc.type	journal article	es_ES
dc.identifier.doi	10.1158/1078-0432.CCR-10-1265	es_ES
dc.identifier.idgrec	063428	es_ES