Objective Response to Chemotherapy As a Potential Surrogate End Point of Survival in Metastatic Breast Cancer Patients

作者: Paolo Bruzzi , Lucia Del Mastro , Maria P. Sormani , Lars Bastholt , Marco Danova

DOI: 10.1200/JCO.2005.02.106

关键词:

摘要: Purpose To assess the validity of objective response to chemotherapy as a surrogate end point for survival in metastatic breast cancer. Patients and Methods We carried out meta-analysis on individual data from 2,126 cancer patients who were enrolled onto 10 randomized trials comparing standard versus intensified epirubicin-containing chemotherapy. Results The was associated with significantly higher tumor rate compared (pooled odds ratio nonresponse, 0.60; 95% CI, 0.51 0.72). regimens also led better (although not significant) ratio, 0.94; 0.86 1.04; P = .22). Tumor highly significant predictor (P < .0001). When introduced Cox model, hazard favor experimental treatment changed 0.94 1.005 (95% 0.91 1.11; .92), indicating that no residual effect sur...

参考文章(29)
Lucia Del Mastro, Marco Venturini, Rita Lionetto, Flavio Carnino, Domenico Guarneri, Luigi Gallo, Antonio Contu, Paolo Pronzato, Lorella Vesentini, Marina Bergaglio, Silvia Comis, Riccardo Rosso, Accelerated-intensified cyclophosphamide, epirubicin, and fluorouracil (CEF) compared with standard CEF in metastatic breast cancer patients: results of a multicenter, randomized phase III study of the Italian Gruppo Oncologico Nord-Ouest-Mammella Inter Gruppo Group. Journal of Clinical Oncology. ,vol. 19, pp. 2213- 2221 ,(2001) , 10.1200/JCO.2001.19.8.2213
T Habeshaw, J Paul, R Jones, S Stallard, M Stewart, S B Kaye, M Soukop, R P Symonds, N S Reed, E M Rankin, Epirubicin at two dose levels with prednisolone as treatment for advanced breast cancer: the results of a randomized trial. Journal of Clinical Oncology. ,vol. 9, pp. 295- 304 ,(1991) , 10.1200/JCO.1991.9.2.295
L Bastholt, M Dalmark, S B Gjedde, P Pfeiffer, D Pedersen, E Sandberg, M Kjaer, H T Mouridsen, C Rose, O S Nielsen, P Jakobsen, S M Bentzen, Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. Journal of Clinical Oncology. ,vol. 14, pp. 1146- 1155 ,(1996) , 10.1200/JCO.1996.14.4.1146
Michael D. Hughes, Evaluating surrogate endpoints Controlled Clinical Trials. ,vol. 23, pp. 703- 707 ,(2002) , 10.1016/S0197-2456(02)00264-7
L. Del Mastro, O. Garrone, M.R. Sertoli, G. Canavese, A. Catturich, M. Guenzi, R. Rosso, M. Venturini, A pilot study of accelerated cyclophosphamide, epirubicin and 5-fluorouracil plus granulocyte colony stimulating factor as adjuvant therapy in early breast cancer European Journal of Cancer. ,vol. 30, pp. 606- 610 ,(1994) , 10.1016/0959-8049(94)90529-0
A Ardizzoni, M Venturini, MR Sertoli, PG Giannessi, F Brema, M Danova, F Testore, GL Mariani, MC Pennucci, P Queirolo, S Silvestro, P Bruzzi, R Lionetto, F Latini, R Rosso, Granulocyte-macrophage colony-stimulating factor (GM-CSF) allows acceleration and dose intensity increase of CEF chemotherapy: a randomised study in patients with advanced breast cancer. British Journal of Cancer. ,vol. 69, pp. 385- 391 ,(1994) , 10.1038/BJC.1994.71
RP A'Hern, SR Ebbs, MB Baum, Does chemotherapy improve survival in advanced breast cancer? A statistical overview. British Journal of Cancer. ,vol. 57, pp. 615- 618 ,(1988) , 10.1038/BJC.1988.140
Marc Buyse, Geert Molenberghs, Criteria for the validation of surrogate endpoints in randomized experiments Biometrics. ,vol. 54, pp. 1014- 1029 ,(1998) , 10.2307/2533853
M. Venturini, L. Del Mastro, Franco Testore, Marco Danova, Ornella Garrone, Claudio Lanfranco, Fabio Latini, Mario R. Sertoli, Rita Lionetto, Paola Queirolo, Andrea Ardizzoni, Riccardo Rosso, Erythropoietin and granulocyte-macrophage colony-stimulating factor allow acceleration and dose escalation of cyclophosphamide/epidoxorubicin/5-fluorouracil chemotherapy: a dose-finding study in patients with advanced breast cancer. Cancer Chemotherapy and Pharmacology. ,vol. 38, pp. 487- 494 ,(1996) , 10.1007/S002800050516