Surrogacy of progression free survival for overall survival in metastatic breast cancer studies: Meta-analyses of published studies

Kundu, Madan G.; Acharyya, Suddhasatta

doi:10.1016/j.cct.2016.12.004

Cited by 6 publications

(6 citation statements)

References 74 publications

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“…Overall, our results are highly consistent with the results of the two pivotal randomized studies of EM in MBC, 5,6 reporting a significant and meaningful impact on OS and marginal impact on PFS, and no significant difference in the early therapeutic lines. These results are surprising, as it is generally assumed that PFS could be used as a surrogate endpoint for OS, [18][19][20][21] but that a significant increase in PFS is required to increase OS. Nevertheless, our results, that is, a modest effect on PFS and a greater impact on OS, are extremely consistent with all previously reported comparative data of EM use in MBC.…”

Section: Discussionmentioning

confidence: 98%

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

Jacot

Heudel

Fraisse

et al. 2019

Intl Journal of Cancer

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Eribulin mesylate (EM) was recently approved for metastatic breast cancer (MBC) chemotherapy (CT) in late lines by the FDA, with debated results in second line. We evaluated outcomes in breast cancer patients receiving EM as second, third and fourth line in a national real‐life cohort of 16,703 consecutive MBC patients initiating their first metastatic therapeutic line between 2008 and 2014. Primary and secondary objectives were overall survival (OS) and progression‐free survival (PFS). An imbalance was seen for HER2+ tumors and concomitant anti‐HER2 targeted therapies use, we thus performed a subanalysis in HER2− patients. PFS and OS were significantly better in EM patients in third and fourth lines, compared to “Other chemotherapies” patients (PFS: 4.14 vs. 3.02 months, p = 0.0010; 3.61 vs. 2.53 months, p = 0.0102, third and fourth‐line; OS: 11.27 vs. 7.65 months, p = 0.0001; 10.91 vs. 5.95 months, p < 0.0001, third and fourth‐line). No significant difference was reported in second‐line (PFS: 5.06 vs. 4.14 months, p = 0.1171; OS: 13.99 vs. 11.66 months, p = 0.151). Among HER2− patients, a significant difference was seen for all lines, including 2nd‐line (PFS: 4.57 vs. 3.91 months, p = 0.0379; OS: 14.98 vs. 10.51 months, p = 0.0113). In this large real‐world database, HER2‐negative MBC patients receiving EM in second or later CT line presented significantly better PFS and OS. This difference disappeared in second line in the overall population, probably because of the imbalance in HER2‐targeted treatments use. Our results mirror those of the published randomized trials. The effect of anti‐HER2 therapies addition in this setting still needs to be defined.

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Section: Discussionmentioning

confidence: 98%

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

Jacot

Heudel

Fraisse

et al. 2019

Intl Journal of Cancer

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“…Even with the penalties currently applied for scores derived from PFS in ASCO-NHB v2, this approach tends to generate high scores on the basis of PFS, especially when the control PFS is very short (Table 3). PFS often is an unreliable surrogate for improved OS, [65][66][67][68][69] and this limitation of PFS surrogacy is not well reflected in these high scores.…”

Section: Different Approaches To Evaluation Of Hr and Absolute Gainmentioning

confidence: 99%

Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score

Cherny

Vries

Dafni

et al. 2019

JCO

105

128

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PURPOSE To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) and the ASCO Value Framework Net Health Benefit score version 2 (ASCO-NHB v2), ESMO and ASCO collaborated to evaluate the concordance between the frameworks when used to assess clinical benefit attributable to new therapies. METHODS The 102 randomized controlled trials in the noncurative setting already evaluated in the field testing of ESMO-MCBS v1.1 were scored using ASCO-NHB v2 by its developers. Measures of agreement between the frameworks were calculated and receiver operating characteristic curves used to define thresholds for the ASCO-NHB v2 corresponding to ESMO-MCBS v1.1 categories. Studies with discordant scoring were identified and evaluated to understand the reasons for discordance. RESULTS The correlation of the 102 pairs of scores for studies in the noncurative setting is estimated to be 0.68 (Spearman’s rank correlation coefficient; overall survival, 0.71; progression-free survival, 0.67). Receiver operating characteristic curves identified thresholds for ASCO-NHB v2 for facilitating comparisons with ESMO-MCBS v1.1 categories. After applying pragmatic threshold scores of 40 or less (ASCO-NHB v2) and 2 or less (ESMO-MCBS v1.1) for low benefit and 45 or greater (ASCO-NHB v2) and 4 to 5 (ESMO-MCBS v1.1) for substantial benefit, 37 discordant studies were identified. Major factors that contributed to discordance were different approaches to evaluation of relative and absolute gain for overall survival and progression-free survival, crediting tail of the curve gains, and assessing toxicity. CONCLUSION The agreement between the frameworks was higher than observed in other studies that sought to compare them. The factors that contributed to discordant scores suggest potential approaches to improve convergence between the scales.

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“…Several reviews and meta-analyses of anticancer therapies for mBC have found improved progression-free survival (PFS) hazard ratio (HR) to be only moderately associated with improved OS HR. [1][2][3] The surrogacy of PFS HR for OS HR improvement depends on the tumor type, survival post-progression, and crossover design. 4 Nevertheless, several investigators have tried to delineate the relationship between PFS and OS in mBC; closer correlations have been reported with percentage increases in median PFS, 1 PFS in later-line disease (≥ 2 lines) 5 , and in trials of targeted therapies.…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3] The surrogacy of PFS HR for OS HR improvement depends on the tumor type, survival post-progression, and crossover design. 4 Nevertheless, several investigators have tried to delineate the relationship between PFS and OS in mBC; closer correlations have been reported with percentage increases in median PFS, 1 PFS in later-line disease (≥ 2 lines) 5 , and in trials of targeted therapies. 2 However, the correlation between PFS and OS benefit in mBC subtype analyses remain equivocal.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Anti-HER2 antibody prolongs overall survival disproportionally more than progression-free survival in HER2-Positive metastatic breast cancer patients

Chen

Lin

et al. 2021

The Breast

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Surrogacy of progression free survival for overall survival in metastatic breast cancer studies: Meta-analyses of published studies

Cited by 6 publications

References 74 publications

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score

Anti-HER2 antibody prolongs overall survival disproportionally more than progression-free survival in HER2-Positive metastatic breast cancer patients

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