부산대학교 도서관

Cer vical cancer represents a global public health issue, particularly burdening many low-incomeand middle-income countries. Effective inter ventions, such as vaccination against thehuman papillomavirus and screening, render cer vical cancer a preventable disease [1]. By implementing these inter ventions, the incidence of cer vical cancer can be reduced,simultaneously enhancing the quality of life for cancer sur vivors, particularly those in theearly stages. Currently, the standard treatment for cer vical cancer is surger y with radicalhysterectomy (RH), which can lead to complications such as urinar y incontinence. The SHAPE trial results have been published in the New England Journal of Medicine [2], generatingenthusiasm among patients with early-stage cer vical cancer and gynecologic oncologists. The trial demonstrated that less invasive surger y is non-inferior to standard surger y for low-riskpatients. The trial results demonstrate that a lot of patients with early-stage cer vical cancer cansur vive with a good quality of life in clinical practice. However, I am composing this articledue to certain concerns regarding this trial. First, there are concerns related to the quality assurance of the surgical procedures. This trial excels in terms of external validity, specifically in terms of study generalization. However, doubts arise when considering whether the trial was conducted with adequateinternal validity. A crucial issue related to this trial is the quality assurance of the trial inter vention, i.e.,surgical therapy. To what extent was quality assurance implemented for RH or surgicaltherapy? Upon reviewing the trial results, in the RH group, there were 9 cases (2.7%) withpositive vaginal margins, which is higher than the expected occurrence rate. The studyincluded low-risk patients alone based on preoperative assessment. Considering thefrequency of positive vaginal margins when performing RH on the eligible trial participants,questions arise regarding the quality assurance of surgical therapy. For quality assurance,an audit of surgical therapy is crucial, and central review through photographs (or videos)should be considered mandator y. In particular, did the trial manager ensure that thecomponents deemed essential for RH, as outlined in the trial protocol, were appropriatelyperformed in the standard treatment group? According to the protocol, the followingprocedures are specified for RH: the en block removal of the uterus, cer vix, medial one-thirdof parametria, 2 cm of the uterosacral ligaments, and upper 1–2 cm of the vagina, the ligationof uterine arteries lateral to the ureters, and the unroofing of ureters from the ureterovesical junction. If these techniques were not adequately conducted, the trial could not evaluate itsoriginal research question, which means the trial may inadvertently compare 'hysterectomy-mimicked RH' to simple hysterectomy. In the SHAPE trial, only photographic images of thesurgical specimen were requested for quality assurance [2], which may not be sufficient. Considering these factors, although the external validity is somewhat lacking, it might havebeen prudent to conduct the trial by limiting participating facilities and surgeons to enhancethe internal validity. Secondly, there are concerns about the primar y endpoint and non-inferiority margin. The primar y endpoint was changed from pelvic relapse-free sur vival to pelvic recurrence rateat 3 years (PRR3) due to the ver y low event rate. However, the choice of the primar y endpointas PRR3 raises concerns. Can we assert the establishment of surrogacy for the essentialultimate goal of cancer treatment, i.e., overall sur vival, based on PRR3? It is questionablewhether sufficient obser vation has been conducted for cases with an obser vation period<3 years. Furthermore, the outcomes may var y depending on the number of patients lostwithin the 3-year period and how they were labeled in the process of analysis. Additionall...
Cer vical cancer represents a global public health issue, particularly burdening many low-incomeand middle-income countries. Effective inter ventions, such as vaccination against thehuman papillomavirus and screening, render cer vical cancer a preventable disease [1]. By implementing these inter ventions, the incidence of cer vical cancer can be reduced,simultaneously enhancing the quality of life for cancer sur vivors, particularly those in theearly stages. Currently, the standard treatment for cer vical cancer is surger y with radicalhysterectomy (RH), which can lead to complications such as urinar y incontinence. The SHAPE trial results have been published in the New England Journal of Medicine [2], generatingenthusiasm among patients with early-stage cer vical cancer and gynecologic oncologists. The trial demonstrated that less invasive surger y is non-inferior to standard surger y for low-riskpatients. The trial results demonstrate that a lot of patients with early-stage cer vical cancer cansur vive with a good quality of life in clinical practice. However, I am composing this articledue to certain concerns regarding this trial. First, there are concerns related to the quality assurance of the surgical procedures. This trial excels in terms of external validity, specifically in terms of study generalization. However, doubts arise when considering whether the trial was conducted with adequateinternal validity. A crucial issue related to this trial is the quality assurance of the trial inter vention, i.e.,surgical therapy. To what extent was quality assurance implemented for RH or surgicaltherapy? Upon reviewing the trial results, in the RH group, there were 9 cases (2.7%) withpositive vaginal margins, which is higher than the expected occurrence rate. The studyincluded low-risk patients alone based on preoperative assessment. Considering thefrequency of positive vaginal margins when performing RH on the eligible trial participants,questions arise regarding the quality assurance of surgical therapy. For quality assurance,an audit of surgical therapy is crucial, and central review through photographs (or videos)should be considered mandator y. In particular, did the trial manager ensure that thecomponents deemed essential for RH, as outlined in the trial protocol, were appropriatelyperformed in the standard treatment group? According to the protocol, the followingprocedures are specified for RH: the en block removal of the uterus, cer vix, medial one-thirdof parametria, 2 cm of the uterosacral ligaments, and upper 1–2 cm of the vagina, the ligationof uterine arteries lateral to the ureters, and the unroofing of ureters from the ureterovesical junction. If these techniques were not adequately conducted, the trial could not evaluate itsoriginal research question, which means the trial may inadvertently compare 'hysterectomy-mimicked RH' to simple hysterectomy. In the SHAPE trial, only photographic images of thesurgical specimen were requested for quality assurance [2], which may not be sufficient. Considering these factors, although the external validity is somewhat lacking, it might havebeen prudent to conduct the trial by limiting participating facilities and surgeons to enhancethe internal validity. Secondly, there are concerns about the primar y endpoint and non-inferiority margin. The primar y endpoint was changed from pelvic relapse-free sur vival to pelvic recurrence rateat 3 years (PRR3) due to the ver y low event rate. However, the choice of the primar y endpointas PRR3 raises concerns. Can we assert the establishment of surrogacy for the essentialultimate goal of cancer treatment, i.e., overall sur vival, based on PRR3? It is questionablewhether sufficient obser vation has been conducted for cases with an obser vation period<3 years. Furthermore, the outcomes may var y depending on the number of patients lostwithin the 3-year period and how they were labeled in the process of analysis. Additionall...