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논문 기본 정보

자료유형
학술저널
저자정보
Munetaka Takekuma (Division of Gynecology, Shizuoka Cancer)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.35 No.2
발행연도
2024.3
수록면
1 - 4 (4page)
DOI
https://doi.org/10.3802/jgo.2024.35.e48

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초록· 키워드

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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. Additionally,extra-pelvic recurrence was reported in only 2 cases (0.6%) in the RH group compared to7 cases (2.0%) in the simple hysterectomy group. It is unclear whether it is clinicallyacceptable for extra-pelvic recurrence to be occur in only 0.6% of patients with standardtreatment (RH), but 7 cases undergoing the less invasive approach of simple hysterectomy. This warrants discussion even though the primar y point (PRR3) was reached. Moreover, there are concerns regarding the non-interiority margin in this trial. The non-inferiority margin in this non-inferiority trial is set at 4%. On the other hand, the PRR3 ineach group is 2.52% for the simple hysterectomy group and 2.17% for the RH group. Withonly approximately 2% event occurrence in the population, a non-inferiority margin of 4%seems excessively large. Is it possible that both the setting of the primar y end point and thenon-inferiority margin were too favorable for the researchers?Third, there are concerns regarding the application of the minimally invasive surger y (MIS:laparoscopic and robotic surger y) in this trial. In the LACC trial, non-inferiority of MIS compared to open surger y for stage IA2–IB1 cer vicalcancer (according to International Federation of Gynecology and Obstetrics [FIGO] 2008)could not be demonstrated [3]. Therefore, globally, when performing surger y for early-stagecer vical cancer, open surger y is considered the gold standard [4,5]. However, in the SHAPEtrial, a majority of cases under went surger y using MIS (79.9% in the simple hysterectomygroup and 69.5% in the RH group), leading to confusion in interpreting the results. In conclusion, the patient population eligible for simple hysterectomy may be even morelimited than the subjects of the SHAPE trial. At the 2023 American Society of Clinical Oncology meeting, another confirmator y trialaimed at evaluating the effectiveness of less invasive surger y for stage IB1 cer vical cancerwas reported—the Japan Clinical Oncology Group (JCOG) 1101 trial [6]. The JCOG1101 trial,conducted in Japan from 2012 to 2017, focused on cases with a preoperative diagnosis ofcer vical cancer with a size of <2 cm and examined the non-inferiority of modified RH (mRH)compared to RH. The results demonstrated the non-inferiority of mRH with a 5-year overall sur vival rate of 98.2% (90% confidence inter val [CI]=96.0–99.2) as the primar y endpoint anda 5-year relapse-free sur vival rate of 94.7% (95% CI=90.8–96.9) as the secondar y endpoint. Additionally, the occurrence rate of postoperative late complications, such as urinar yincontinence and urinar y retention, were reported as 1.3% and 8.9%, respectively, whichwere lower than those reported for traditional RH. A comparison table between the SHAPE and JCOG1101 trials is presented. The maindifference between the 2 trials lies in the eligibility criteria and surgical procedures (Table 1). Significant differences in eligibility criteria between the 2 trials include the disease stageand depth of stromal infiltration. With regard to the disease stage, the SHAPE trial allowedthe inclusion of stage IA2, whereas the JCOG1101 trial did not. With regard to the depth ofstromal infiltration, the SHAPE trial considers stromal infiltration as <50%, whereas theJCOG1101 trial allows inclusion even if infiltration >50%. In other words, the JCOG1101 trialinvolved a patient population with a higher risk of recurrence. For such patient populations,the JCOG1101 trial adopted mRH as the surgical approach for less invasive surger y. Indeed, inthe postoperative pathological findings of excised organs, the SHAPE trial reported 25 cases(3.7%) with lymph node metastases (11 cases in the simple hysterectomy group and 14 casesin the RH group), whereas the JCOG1101 trial reported 16 cases (7.1%). MRH is considered equivalent to class II (Piver classification) [7] or type B (Querleuclassification) RH [8] and is identical to the original Westheim operation method [9,10]. The mRH is a hysterectomy method considered as intermediate between simplehysterectomy and RH, allowing for almost complete preser vation of the pelvic splanchnicner ves and hypogastric plexus. This surgical procedure involves cutting the anterior leaf,rather than the posterior one, of the vesico-uterine ligament of the uterus. The ureteris mobilized laterally, a portion of the parametrial tissue is transected at the level of theureteral tunnel, and at least 10–15 mm of the vaginal wall from uterine cer vix is removed. The favorable efficacy of mRH for FIGO IB1 patients in the low-risk group mentioned abovehas also been reported retrospectively [11-14], and the surgical procedure was considered themost appropriate for a clinical trial in Japan that tested non-inferiority by comparing it withRH (JCOG11101 trial). Less invasive surger y for stage IB1 cer vical cancer (according to FIGO 2018) is non-inferiorto RH, as reported by multiple confirmator y trials. This should be offered to patients as anew treatment option in routine clinical practice. However, the selection of the ideal patientpopulation for less invasive surger y and the choice of the appropriate surgical approachwarrant further investigations.

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