Correlation between overall survival and other endpoints in metastatic breast cancer with second- or third-line chemotherapy: Literature-based analysis of 24 randomized trials - 12/02/16

Corrélation entre taux de survie globale et autres critères dans le cancer du sein métastatique traité par 2^e et 3^e ligne de chimiothérapie : analyse de la littérature basée sur 24 essais randomisés

Doi : 10.1016/j.bulcan.2016.01.002

Liya Liu ^1,^⁎ , Feng Chen ², Jinshun Zhao ¹, Hao Yu ²
¹ Ningbo University, Medical School, Department of Preventive Medicine, Ningbo, Zhejiang, PR China
² Nanjing Medical University, School of Public Health, Department of Epidemiology and Biostatistics, Nanjing, Jiangsu, PR China

^⁎Liya Liu, Ningbo University, Medical School, Department of Preventive Medicine, Ningbo, Zhejiang, PR China.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 12 February 2016
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Summary

Background and objective

Correlations between overall survival (OS) and other endpoints have been evaluated in patients with metastatic breast cancer (MBC) who received first-line chemotherapy. However, no corresponding analysis has been accomplished for patients who have undergone second- or third-line chemotherapy.

Methods

We evaluated the potential of progression-free survival (PFS)/time to progression (TTP) and objective response rate (ORR) as surrogates of OS when OS data were not available. Correlations were evaluated by Spearman's rank correlation coefficient (r_s) and weighted linear regression model. Subgroup analyses were performed for previous chemotherapy, regimen, study endpoint, study period and HER2 status.

Results

Twenty-four randomized trials involving 8617 patients were included for analysis. The correlation between PFS/TTP and OS was 0.7824 (95% CI: 0.6034–0.8702), whereas ORR did not strongly correlate with OS (r_s=0.5398, 95%CI: 0.2942–0.7233). Further, the association between hazard ratios (HRs) of PFS/TTP and OS of the 22 randomized studies showed a moderate correlation (r_s=0.5725, 95%CI: 0.1735–0.8277); the slope of the regression model (β) was 0.5366 (95%CI: 0.3479–0.7253). In particular, the PFS/OS correlation for HER2-positive MBC patients was stronger (r_s=0.9515, 95%CI: 0.7009–1.0000; β=0.8728, 95%CI: 0.0795–1.6661).

Conclusions

These results suggest that PFS/TTP is a useful early endpoint for patients with MBC who have undergone second- or third-line chemotherapy, especially for those who are HER2-positive.

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Keywords : Breast cancer, Subsequent chemotherapy, Progression-free survival, Time to progression, Objective response rate

Mots clés : Cancer du sein, Chimiothérapie, Survie globale, Survie sans progression, Taux de réponse