Silly can't tell || ORR, DCR, PFS, OS, what are the objective indicators for evaluating tumor outcomes?

The four endpoint indicators for tumor therapy were objective mitigation rate (Objective Response Rate; ORR), disease control rate (DCR), progression-free survival( PFS), and total survival (overall survival; OS).
These four endpoint indicators are divided into near-term efficacy treatment and long-term efficacy indicators, the near-term efficacy indicators mainly assess the direct impact of drugs on tumors (including causing tumors to disappear or shrink, etc.), of which ORR is the most critical, and long-term efficacy indicators mainly assess the impact of drugs on patient survival time, OS is the most critical.
OrR In May 2012, the State Food and Drug Administration issued the Technical Guidelines for Clinical Trials of Anti-Tumor Drugs, which state that objective remission rate (ORR) refers to the proportion of patients with tumor volume reduction that meets predetermined values and maintains minimum time limits.
period usually refers to the period from the beginning of the emergence of efficacy until the confirmation of tumor progression.
generally defines the objective mitigation rate as the total mitigation plus the combined partial mitigation (CR-PR).
Objective mitigation rate is a direct measure of drug anti-tumor activity and can be evaluated in one-arm trials (but it is worth noting that single-arm trials do not adequately reflect time-event endpoints, such as PFS and OS, so randomized controlled studies are required when using time-event endpoint indicators).
disease stability should not be an integral part of objective mitigation rates.
disease stability reflects the natural course of the disease, and tumor shrinking is a direct effect, which is one reason why ORR is more important than DCR.
, standardized indicators should be used to determine efficacy, such as the RECIST standard.
mitigation criteria should be defined in advance in the scenario prior to the start of the trial.
objective mitigation rate includes the degree of remission, the duration of the remission, and the full rate of remission (no tumors to measure).
orR", the end point of clinical trials used to support drug approval should normally be an indicator of clinical benefits.
in the field of oncology, improved survival is considered a reasonable criterion for assessing the clinical benefits of a drug.
1970s, ORR, which is usually measured by tumor assessment methods such as imaging or physical examination, was approved for the market for anti-tumor drugs.
in the decades that followed, it became increasingly recognized that the approval of anti-tumor drugs should be based on more direct evidence of clinical benefits, such as improved survival, improved quality of life for patients, reduced physical condition or tumor-related symptoms.
these clinical benefits are often not predicted by objective mitigation rates or indicators associated with them.
OS Became Gold Standard Technical Guidelines for Clinical Trials of Anti-Tumor Drugs, published in May 2012, states that total lifetime (OS) is defined as the time between the start of randomization and the death of a patient for a variety of reasons, and is calculated by intentional treatment population (ITT).
this endpoint is accurate and provides the basis for the date of death.
will not be biased during the endpoint evaluation.
is by far the most reliable clinical trial endpoint for evaluating anti-tumor drugs, and it is usually the preferred endpoint when the study can fully evaluate survival.
Although an alternative endpoint (Surrogate End Point) may be used to support a drug's application for market under certain conditions when it is used to treat a serious or life-threatening disease, to significantly improve existing treatments, or to fill treatment gaps.
these alternative endpoints may not be like well-proven indicators such as blood pressure or serum cholesterol, but may reasonably predict clinical benefits and may be eligible for market approval.
this case, the applicant must commit to a post-market clinical trial to confirm the actual clinical benefits of the drug.
If a post-marketing study does not demonstrate the clinical benefits of the drug, or if the applicant does not conduct the promised post-market study as required, the FDA may withdraw the drug from the market.
examples include 10 patients with advanced tumors, all of which have been widely metastasis throughout the body.
used an anti-tumor drug at this time, and after 1 week regretfully found that all of these patients died, i.e. OS -0.25 months.
tracking the cause of death found that these patients were all due to the tumor subsidion caused by the rupture of blood vessels, and finally due to haemorrhage caused by death, if the tumor disappeared as an indicator of efficacy, ORR is 100%.
this example tells us that ORR does not necessarily directly reflect the patient's final OS benefit.
changes in the conclusion orR reflect the historical trajectory of evidence-based medicine, as well as the further understanding of tumor and tumor treatment, and continuous improvement, with a view to overcoming tumor determination and confidence.
orR status is no better than it was then, it is still an important indicator of the near-term efficacy of the drug.
in a word: today's cancer treatment, OS is the king.
References: Technical Guidelines for Clinical Trials of Anti-Tumor Drugs, State Food and Drug Administration, May 15, 2012, National Food and Drug Administration, No. 122 issued before Zhang Shi Source: Zhang Shi's previous copyright notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Original" are owned by Mets Medical and may not be reproduced by any media, website or individual without authorization, and shall be reproduced with the words "Source: Mets Medicine".
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