Summary of various concepts commonly found in oncology

Summary of common concepts in oncology 1. 5-year survival rate: Five-year survival rate refers to the proportion of a certain tumor that survives for more than five years after various comprehensive treatments. Meaning: The expression of five-year survival rate has its certain scientific nature. After a certain tumor is treated, some of them may have metastasis and recurrence, and some of them may die because the tumor enters the advanced stage. Most of the metastases and recurrences occur within three years after radical surgery, accounting for about 80%, and a small number of them occur within five years after radical surgery, accounting for about 10%. Therefore, if various tumors do not recur within five years after radical surgery, there is little chance of recurrence, so the five-year survival rate is often used to indicate the efficacy of various cancers. Within five years after surgery, it is necessary to consolidate treatment and have regular checkups to prevent recurrence, and even if there are metastasis and recurrence, it can be treated early. In addition, three-year survival rate and ten-year survival rate are also used to indicate the efficacy of treatment. 2.Complete remission (CR: Complete response) means that all tumor masses and clinical manifestations of the tumor have completely disappeared and lasted for at least 1 month; 3.Partial remission (PR: Partial Response) means that the vertical diameter of the tumor has shrunk by 50% compared with the baseline and lasted for at least 1 month; 4.Progression (Progression) means that the vertical diameter of the tumor has shrunk by 50% compared with the baseline and lasted for at least 1 month; 4.Progress (Progress) means that the vertical diameter of the tumor has shrunk by 50% compared with the baseline and lasted for at least 1 month. 4, Progression (Progress) is an increase of 25% in the sum of the vertical diameters of the tumor compared with the minimum value, or the emergence of new tumors or significant progression of the evaluable disease. 5, Disease-free survival (Disease-freesurvival, DFS) is defined as the time from the beginning of randomization to the recurrence of disease or death of the patient due to disease progression. This metric is also often used as the primary endpoint of phase III clinical trials of antitumor drugs. In some cases, DFS is more difficult to document as an endpoint compared to OS because it requires careful follow-up to detect disease recurrence in a timely manner and because the cause of death in oncology patients is difficult to determine (16). Tumor patients often have comorbidities (e.g., cardiovascular disease), and these comorbidities may interfere with the determination of DFS. Moreover, tumor patients often die outside the hospital and autopsies cannot be routinely performed. 6, Overallsurvival (OS) is defined as the time from the start of randomization to death from any cause. It is often considered the best efficacy endpoint in oncology clinical trials. A small improvement in survival can be considered evidence of meaningful clinical benefit. As an endpoint, survival should be evaluated on a daily basis, either through direct contact with the patient at the time of hospitalization or by talking to the patient over the phone, which is relatively easy to document. There is usually little difficulty in confirming the date of death and that the timing of death has its own independent causal relationship. When recording lost patients up to the time of death, usually up to the time of the last recorded contact with the patient. 7, Time toProgression (TTP) is defined as the time from the start of randomization to the onset of disease progression or death. Potential advantages of using TTP include that it requires a smaller sample size and a shorter follow-up period than using survival endpoints. In addition, if cross-over efficacy exists, the difference in TTP is not masked by the second treatment. It would be interesting to improve the evaluation of this endpoint by taking the changes observed on imaging and analyzing them in relation to delayed onset of new symptoms or delayed worsening of symptoms, among other things. The use of TTP as an endpoint in antitumor drug trials presents a number of additional difficulties. First, most trials are not blinded designs, which makes it possible to introduce bias into the decision-making process regarding TTP. Second, patients must be evaluated at regular intervals, all lesion sites must be fully identified at baseline and follow-up visits, and the same evaluation techniques and protocols must be used in all patients in order to justify TTP judgments. Third, the question of how large a difference is necessary to determine clinical significance is difficult to determine because most indicators are tested every 2-3 months, and the magnitude of TTP differences may be very similar. Secondly there are difficulties with the treatment of missing data and decisions about data cut-offs. Time to treatmentfailure (TTF) is defined as the time from randomization to disease progression, death, withdrawal due to an adverse event, patient refusal to continue in the study, or the use of a new treatment.The nature of the TTF is a composite metric, and as such can result in the potential for a reduction in toxicity in order to achieve a reduction in the expected efficacy. generation of the expected efficacy. Given this situation, TTF is not commonly used as a primary endpoint in phase III clinical trials in oncology. PFS (progression-freesurvival) is defined as the time from randomization to the first occurrence of disease progression or death from any cause.PFS differs from TTP in that PFS may include the time of death of the patient and thus has a better correlation with OS. TTP, however, is an acceptable endpoint when the majority of deaths are not tumor-related.PFS reflects tumor growth and can be evaluated before a survival benefit is derived and is not interfered with by subsequent therapy, but formal approval as a surrogate for survival in several different malignancies is difficult. Whether improvement in PFS represents a clinical benefit directly or indirectly depends on the magnitude of the effect and risk-benefit of the new treatment compared with existing effective treatments. Care needs to be taken in the design of PFS trials to specify in detail the methods of assessing, observing and analyzing PFS, and to carefully define good criteria for tumor progression; blinding is important throughout its execution, and ideally should be performed by an independent evaluation panel composed of imaging and clinical experts. Missing values can complicate PFS analyses, so protocols should identify sufficient evaluation visits per subject, and the statistical analysis plan should detail the primary analysis and one or more sensitivity analyses to evaluate the reliability of the results.The FDA recommends that if there are no prior missing evaluations and there is no tumor progression as determined by review of the final imaging evaluation, then the time to progression should be determined as the initial time at which any aspect of progression was observed to occur.