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Disease-free survival，Relapse-free survival和Recurrence-free survival的含義和一致性比較
一、定義
1. Disease-free survival（無疾病生存期）：隨機(jī)定義開始至腫瘤復(fù)發(fā)或（任何原因）死亡的時(shí)間間隔
Disease-free survival (DFS) is defined as the time from randomization to recurrence of tumor or death, and it is typically used in the adjuvant treatment setting. In some settings DFS may also be a surrogate for OS, because patients who remain disease free for an extended period of time may be cured.
Ref: https://www.sciencedirect.com/topics/medicine-and-dentistry/disease-free-survival
DFS常用于根治性手術(shù)或放療后輔助治療的研究，目前是作為乳腺癌輔助性激素治療、結(jié)腸癌輔助治療以及乳腺癌的輔助化療的主要審批基礎(chǔ)。疾病復(fù)發(fā)需要認(rèn)真的隨訪，而記錄同樣比較困難，且腫瘤患者常有并發(fā)癥容易干擾 DFS 的判斷。當(dāng)患者死于院外時(shí)，沒有預(yù)先記錄腫瘤進(jìn)展情況，此時(shí)又往往不能尸檢，無法確定復(fù)發(fā)情況。
關(guān)于DFS的優(yōu)缺點(diǎn)探討可以進(jìn)一步參考：
https://www.verywellhealth.com/disease-free-survival-dfs-2252148
2. Relapse-free survival（無復(fù)發(fā)生存期）：首次治療至腫瘤復(fù)發(fā)的時(shí)間間隔
In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the relapse-free survival is one way to see how well a new treatment works. Also called DFS, disease-free survival, and RFS.
Ref: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/relapse-free-survival
與上述National Cancer Institute給出的解釋略有不同，最近關(guān)于癌癥中時(shí)間-事件終點(diǎn)評估的定義指出，Relapse-free survival的endpoint 不包含 death。
Relapse-free survival is defined as any disease recurrence (local, regional, or distant), but death is censored (not included).
Ref: Definition for the Assessment of Time-to-event Endpoints in Cancer, January 2022，DOI:10.13140/RG.2.2.23392.20483
3. Recurrence-free survival
從字面上看Recurrence-free survival 和 Relapse-free survival 是一致的，但確實(shí)存在定義上的細(xì)微差別
National Cancer Institute 給出的Recurrence 含義：
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrent cancer. Recurrence Free Survival is defined as the time interval between the day of reference in the study (date of randomization, date of diagnosis, etc.) and the date of local relapse/recurrence or regional relapse/recurrence or death (all causes) whichever occurs first.
Ref： http://www.360doc6.net/wxarticlenew/979574406.html
The primary endpoint was recurrence-free survival (RFS), which was calculated from the date of surgery to the date of first detected disease recurrence or metastasis by dynamic CT or MRI studies, censoring recurrence-free patients at the date of last follow-up and those who died of other causes.
Ref: EBioMedicine. 2019 Dec;50, PMID: 31735556
二、關(guān)于其異同
1. 按照National Cancer Institute 的 詞典解釋，Disease-free survival 和 Relapse-free survival的含義一致
In a clinical trial, measuring the relapse-free survival is one way to see how well a new treatment works. Also called DFS, disease-free survival, and RFS.
In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Also called DFS, relapse-free survival, and RFS.
Ref: Definition of relapse-free survival - NCI Dictionary of Cancer Terms - National Cancer Institute
2. 研究者支持Disease-free survival 和 Recurrence-free survival的含義一致
Technically they are the same. Disease- free survival studies notes the time to first documentation of relapse/recurrences mostly for comparing efficacy in trials, and recurrence-free survival studies focuses on the onset of recurrence local/regional or distant after a standard treatment.
無病生存研究指出，首次記錄復(fù)發(fā)/復(fù)發(fā)的時(shí)間主要是為了在試驗(yàn)中比較療效。無復(fù)發(fā)生存研究集中于標(biāo)準(zhǔn)治療后局部/區(qū)域或遠(yuǎn)處復(fù)發(fā)的發(fā)生。
Ref: What does relapse free survival mean? – Moorejustinmusic
3. Relapse-free survival 與 Recurrence-free survival 的區(qū)別在于endpoint是否包含death
In contrast, recurrence-free survival (RFS) includes all-cause death which relapse free-survival does not. It is defined as the time interval between the date of treatment initiation until (a) local or regional disease recurrence or (b) death due to any cause.
Ref: Definition for the Assessment of Time-to-event Endpoints in Cancer, January 2022，DOI:10.13140/RG.2.2.23392.20483
小結(jié)：目前感覺這三者只具有極細(xì)微的差別，且更多體現(xiàn)在臨床意義上（2.2中研究者所述），在乳腺癌的研究中更多出現(xiàn)這些不同的定義。通常情況下，生信分析是是基于前期收集的endpoint直接分析，但需要注意，Relapse-free survival 與 Recurrence-free survival 關(guān)于 endpoint 是否包含 death 的區(qū)別。
