Surrogate endpoints for overall survival in combined chemotherapy and radiotherapy trials in nasopharyngeal carcinoma: Meta-analysis of randomised controlled trials

Chen, Yu-Pei; Sun, Ying; Chen, Lei; Mao, Yan Ping; TANG, Ling; Li, Wen Fei; Liu, Xu; Zhang, Wen Na; Zhou, Guan Qun; Guo, Rui; Lin, Ai Hua

doi:10.1016/j.radonc.2015.07.030

Cited by 26 publications

(35 citation statements)

References 50 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)26,32,33,35,36,38,(40)(41)(42)47,49,50) The literature suggests that the relationship between PFS and OS can be different within the same cancer trial depending on the treatment applied or the therapy selected.…”

Section: Challenges For Analysing Pfs As a Surrogate Of Osmentioning

confidence: 99%

“…2) Treatment line (14,21,22,25,26,28,33,34,36,40,41,49,52) In some cases the analysis cannot validate the surrogacy for first line therapy, as distinct 3) Year of the trial (11,13,15,16,18,19,22,28,(31)(32)(33)(34)40) The importance of the year in which the clinical trial was conducted or published was explained by the number of drugs available having increased (11 and because the criteria applied to measure progression have changed (e.g. RECIST published in 2000 was modified in 2010 to mRECIST (54)).…”

Section: ) Type Of Treatment And/or Therapymentioning

confidence: 99%

“…RECIST published in 2000 was modified in 2010 to mRECIST (54)). (10,11,16,18,21,26,32,34,39,52) As in Davis, Tappenden (1), the results from the validation of PFS as a surrogate point for OS vary substantially between cancer types. Six out of 16 articles for lung cancer conclude that PFS is not an appropriate surrogate for OS, and consistency does not improve when we consider the line of therapy and the phase of the clinical trial.…”

Section: ) Type Of Treatment And/or Therapymentioning

confidence: 99%

See 2 more Smart Citations

Challenges and Methodologies in Using Progression Free Survival as a Surrogate for Overall Survival in Oncology

Hernández-Villafuerte¹,

Fischer

Latimer

2018

Int J Technol Assess Health Care

View full text Add to dashboard Cite

Objectives: A primary outcome in oncology trials is overall survival (OS). However, to estimate OS accurately requires a sufficient number of patients to have died, which may take a long time. If an alternative endpoint is sufficiently highly correlated with OS, it can be used as a surrogate. Progression-free survival (PFS) is the surrogate most often used in oncology, but does not always satisfy the correlation conditions for surrogacy.We analyse the methodologies used when extrapolating from PFS to OS. Methods: A wide range of methods has been used to determine the appropriateness of surrogates.While usually adhering to reporting standards, the standard of scholarship appears sometimes to be questionable and the reporting of results often haphazard. Conclusion:Standards of analysis and reporting PFS to OS surrogate studies should be improved by increasing the rigour of statistical reporting and by agreeing to a minimum set of reporting guidelines. Moreover, the use of IPD to assess surrogacy should increase.

show abstract

Section: Challenges For Analysing Pfs As a Surrogate Of Osmentioning

confidence: 99%

Section: ) Type Of Treatment And/or Therapymentioning

confidence: 99%

Section: ) Type Of Treatment And/or Therapymentioning

confidence: 99%

See 1 more Smart Citation

Challenges and Methodologies in Using Progression Free Survival as a Surrogate for Overall Survival in Oncology

Hernández-Villafuerte¹,

Fischer

Latimer

2018

Int J Technol Assess Health Care

View full text Add to dashboard Cite

show abstract

“…The gold standard endpoint for clinical trials of nasopharyngeal carcinoma was OS [11]. However, with augmented applications of secondary and tertiary treatments for nasopharyngeal carcinoma, PFS can be considered as a better primary endpoint than OS [12].…”

Section: Introductionmentioning

confidence: 99%

“…However, with augmented applications of secondary and tertiary treatments for nasopharyngeal carcinoma, PFS can be considered as a better primary endpoint than OS [12]. Moreover, PFS appears concordant with OS in trials of combined chemotherapy and radiotherapy for nasopharyngeal carcinoma [11]. In addition to the trials included in the previous meta-analyses, additional randomized studies on the benefit of NACT plus CCRT compared versus CCRT with or without AC in nasopharyngeal carcinoma have been available [13–17].…”

Section: Introductionmentioning

confidence: 99%

Significant benefits of adding neoadjuvant chemotherapy before concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma: a meta-analysis of randomized controlled trials

Wang

Tian

Li³

et al. 2016

Oncotarget

View full text Add to dashboard Cite

PurposeWe did a meta-analysis to compare the efficacy and safety of neoadjuvant chemotherapy (NACT) followed by concurrent chemoradiotherapy (CCRT) versus CCRT with or without adjuvant chemotherapy (AC) for patients with locoregionally advanced nasopharyngeal carcinoma based on randomized controlled trials.MethodsWe searched PubMed, Embase, Web of Science, ClinicalTrials.gov, Chinese National Knowledge Infrastructure, and meeting proceedings of major relevant conferences to identify published and unpublished randomized controlled trials. Progression-free survival (PFS) was the primary endpoint.ResultsThis meta-analysis included 9 randomized clinical trials with 2215 patients. NACT followed by CCRT significantly improved PFS (HR=0.68, 95% CI 0.56 – 0.81, P < 0.001) compared versus CCRT with or without AC, and no heterogeneity was observed (I2 = 0.0%, P = 0.975). NACT was associated with a significant improvement in overall survival (HR = 0.64, 95% CI 0.49 – 0.84, P = 0.001; I2 = 0.0%, P = 0.467) and distant failure-free survival (HR = 0.72, 95% CI 0.53 – 0.97, P = 0.031; I2 = 0.0%, P = 0.744). No significant benefit was shown by NACT for locoregional control. NACT with CCRT increased risks of grade 3 – 4 anemia, thrombocytopenia, leukopenia, and fatigue, compared versus CCRT with or without AC.ConclusionsOur meta-analysis confirmed that the addition of NACT to CCRT significantly improved PFS and OS versus CCRT with or without AC for locoregionally advanced nasopharyngeal carcinoma. These results may alter the standard of care - CCRT with or without AC, for locoregionally advanced nasopharyngeal carcinoma.

show abstract

The development and external validation of simplified T category classification for nasopharyngeal carcinoma to improve the prognostic value in the intensity‐modulated radiotherapy era

et al. 2019

Self Cite

View full text Add to dashboard Cite

Background Intensity‐modulated radiotherapy (IMRT) provides excellent local control in nasopharyngeal carcinoma (NPC). We investigated whether simplifying 8th American Joint Committee on Cancer staging system T categories improves prognostic value. Methods We used 2191 NPC patients as a training set and 414 patients separately as an independent, external validation cohort. Results In the training set, local relapse‐free survival (LRFS), disease‐free survival (DFS), and overall survival (OS) were not significantly different between the 8th edition T2/T3 ( P = 0.610, 0.380 and 0.353, respectively). Merging T2 and T3 to proposed T2 (proT2) provided significant differences in LRFS, DFS, and OS between proposed T categories. Proposed T categories had similar c‐indices for LRFS, DFS, and OS (vs the 8th edition), which was validated in the external cohorts. Moreover, for DFS, the adjusted HRs of the proT2N0 (3.8), proT1N1 (3.8), and proT2N1 (6.0) subsets were similar; the adjusted HRs of the proT3N0 (7.0), proT3N1 (11.4), proT1N2 (11.0), proT2N2 (11.6), and proT3N2 (13.3) subsets were similar; the adjusted HRs of the proT1N3 (17.8), proT2N3 (15.3), and proT3N3 (26.4) subsets were similar; the results of the adjusted HRs for OS had the same rule. Defining proT1N0 as stage I; proT1N1/proT2N0‐1 as stage II; proT3N0‐2/proT1‐2N2 as stage III; and proT1‐3N3 as stage IVa generated orderly, significant differences in DFS and OS between stages in the training set and external validation cohort. Conclusions In the IMRT era, three T categories are more reasonable (merging T2/T3 into T2) and proT3N0‐2 (the 8th edition T4N0‐2) should be down‐staged to stage III.

show abstract

Surrogate endpoints for overall survival in combined chemotherapy and radiotherapy trials in nasopharyngeal carcinoma: Meta-analysis of randomised controlled trials

Cited by 26 publications

References 50 publications

Challenges and Methodologies in Using Progression Free Survival as a Surrogate for Overall Survival in Oncology

Challenges and Methodologies in Using Progression Free Survival as a Surrogate for Overall Survival in Oncology

Significant benefits of adding neoadjuvant chemotherapy before concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma: a meta-analysis of randomized controlled trials

The development and external validation of simplified T category classification for nasopharyngeal carcinoma to improve the prognostic value in the intensity‐modulated radiotherapy era

Contact Info

Product

Resources

About