Quality of life after extended pelvic exenterations.

BACKGROUND: The aim of the study was to compare health-related quality of life (QoL) and oncological outcome between gynaecological cancer patients undergoing pelvic exenteration (PE) and extended pelvic exenteration (EPE). EPEs were defined as extensive procedures including, in addition to standard PE extent, the resection of internal, external, or common iliac vessels; pelvic side-wall muscles; large pelvic nerves (sciatic or femoral); and/or pelvic bones. METHODS: Data from 74 patients who underwent PE (42) or EPE (32) between 2004 and 2019 at a single tertiary gynae-oncology centre in Prague were analysed. QoL assessment was performed using EORTC QLQ-C30, EORTC CX-24, and QOLPEX questionnaires specifically developed for patients after (E)PE. RESULTS: No significant differences in survival were observed between the groups (P > 0.999), with median overall and disease-specific survival in the whole cohort of 45 and 49 months, respectively. Thirty-one survivors participated in the QoL surveys (20 PE, 11 EPE). No significant differences were observed in global health status (P = 0.951) or in any of the functional scales. The groups were not differing in therapy satisfaction (P = 0.502), and both expressed similar, high willingness to undergo treatment again if they were to decide again (P = 0.317). CONCLUSIONS: EPEs had post-treatment QoL and oncological outcome comparable to traditional PE. These procedures offer a potentially curative treatment option for patients with persistent or recurrent pelvic tumour invading into pelvic wall structures without further compromise of patients´ QoL.

Preoperative staging of ovarian cancer: comparison between ultrasound, CT and whole-body diffusion-weighted MRI (ISAAC study).

OBJECTIVES: To compare the performance of transvaginal and transabdominal ultrasound with that of the first-line staging method (contrast-enhanced computed tomography (CT)) and a novel technique, whole-body magnetic resonance imaging with diffusion-weighted sequence (WB-DWI/MRI), in the assessment of peritoneal involvement (carcinomatosis), lymph-node staging and prediction of non-resectability in patients with suspected ovarian cancer. METHODS: Between March 2016 and October 2017, all consecutive patients with suspicion of ovarian cancer and surgery planned at a gynecological oncology center underwent preoperative staging and prediction of non-resectability with ultrasound, CT and WB-DWI/MRI. The evaluation followed a single, predefined protocol, assessing peritoneal spread at 19 sites and lymph-node metastasis at eight sites. The prediction of non-resectability was based on abdominal markers. Findings were compared to the reference standard (surgical findings and outcome and histopathological evaluation). RESULTS: Sixty-seven patients with confirmed ovarian cancer were analyzed. Among them, 51 (76%) had advanced-stage and 16 (24%) had early-stage ovarian cancer. Diagnostic laparoscopy only was performed in 16% (11/67) of the cases and laparotomy in 84% (56/67), with no residual disease at the end of surgery in 68% (38/56), residual disease ≤ 1 cm in 16% (9/56) and residual disease > 1 cm in 16% (9/56). Ultrasound and WB-DWI/MRI performed better than did CT in the assessment of overall peritoneal carcinomatosis (area under the receiver-operating-characteristics curve (AUC), 0.87, 0.86 and 0.77, respectively). Ultrasound was not inferior to CT (P = 0.002). For assessment of retroperitoneal lymph-node staging (AUC, 0.72-0.76) and prediction of non-resectability in the abdomen (AUC, 0.74-0.80), all three methods performed similarly. In general, ultrasound had higher or identical specificity to WB-DWI/MRI and CT at each of the 19 peritoneal sites evaluated, but lower or equal sensitivity in the abdomen. Compared with WB-DWI/MRI and CT, transvaginal ultrasound had higher accuracy (94% vs 91% and 85%, respectively) and sensitivity (94% vs 91% and 89%, respectively) in the detection of carcinomatosis in the pelvis. Better accuracy and sensitivity of ultrasound (93% and 100%) than WB-DWI/MRI (83% and 75%) and CT (84% and 88%) in the evaluation of deep rectosigmoid wall infiltration, in particular, supports the potential role of ultrasound in planning rectosigmoid resection. In contrast, for the bowel serosal and mesenterial assessment, abdominal ultrasound had the lowest accuracy (70%, 78% and 79%, respectively) and sensitivity (42%, 65% and 65%, respectively). CONCLUSIONS: This is the first prospective study to document that, in experienced hands, ultrasound may be an alternative to WB-DWI/MRI and CT in ovarian cancer staging, including peritoneal and lymph-node evaluation and prediction of non-resectability based on abdominal markers of non-resectability. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX).

OBJECTIVE: Sentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy. MATERIALS AND METHODS: SENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up. CONCLUSIONS: The first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063).

SLN biopsy in cervical cancer patients with tumors larger than 2cm and 4cm.

OBJECTIVES: The aim of this study was to assess the detection rate, false-negative rate and sensitivity of SLN in LN staging in tumors over 2cm on a large cohort of patients. METHODS: Data from patients with stages pT1a - pT2 cervical cancer who underwent surgical treatment, including SLN biopsy followed by systematic pelvic lymphadenectomy, were retrospectively analyzed. A combined technique with blue dye and radiocolloid was modified in larger tumors to inject the tracer into the residual cervical stroma. RESULTS: The study included 350 patients with stages pT1a - pT2. Macrometastases, micrometastases, and isolated tumor cells were found in 10%, 8%, and 4% of cases. Bilateral detection rate was similar in subgroups with tumors<2cm, 2-3.9cm, and ≥4cm (79%, 83%, 76%) (P=0.460). There were only two cases with false-negative SLN ultrastaging for pelvic LN status among those with bilateral SLN detection. The false negative rate was very low in all three subgroups of different tumor sizes (0.9%, 0.9%, and 0.0%; P=0.999). Sensitivity reached 96% in the whole group and was high in all three groups (93%, 93%, 100%; P=0.510). CONCLUSIONS: If the tracer application technique is adjusted in larger tumors, SLN biopsy can be equally reliable in pelvic LN staging in tumors smaller and larger than 2cm. The bilateral detection rate and false negative rate did not differ in subgroups of patients with tumors<2cm, 2-3.9cm, and ≥4cm.

Pelvic floor reconstruction by modified rectus abdominis myoperitoneal (MRAM) flap after pelvic exenterations.

OBJECTIVE: To describe the technique and report experiences with pelvic floor reconstruction by modified rectus abdominis myoperitoneal (MRAM) flap after extensive pelvic procedures. METHODS: Surgical technique of MRAM harvest and transposition is carefully described. The patients in whom pelvic floor reconstruction with MRAM after either infralevator pelvic exenteration and/or extended lateral pelvic sidewall excision was carried out were enrolled into the study (MRAM group, n=16). Surgical data, post-operative morbidity, and disease status were retrospectively assessed. The results were compared with a historical cohort of patients, in whom an exenterative procedure without pelvic floor reconstruction was performed at the same institution (control group, n=24). RESULTS: Both groups were balanced in age, BMI, tumor types, and previous treatment. Substantially less patients from the MRAM group required reoperation within 60days of the surgery (25% vs. 50%) which was due to much lower rate of complications potentially related to empty pelvis syndrome (1 vs. 7 reoperations) (p=0.114). Late post-operative complication rate was substantially lower in the MRAM group (any grade: 79% vs. 44%; grade≥3: 37% vs. 6%) (p=0.041). The performance status 6months after the surgery was ≤1 in the majority of patients in MRAM (81%) while in only 38% of patients from the control group (p=0.027). There was one incisional hernia in MRAM group while three cases were reported in the controls. CONCLUSIONS: Pelvic floor reconstruction by MRAM in patients after pelvic exenterative procedures is associated with a substantial decrease in postoperative complications that are potentially related to empty pelvis syndrome.

Ultrasound in preoperative assessment of pelvic and abdominal spread in patients with ovarian cancer: a prospective study.

OBJECTIVE: To analyze the accuracy of ultrasound in assessing pelvic and intra-abdominal spread in patients with ovarian cancer. METHODS: This prospective study enrolled all consecutive patients referred to a single gynecological oncology center for suspected ovarian cancer. We analyzed only data from patients with histologically confirmed primary ovarian cancer who were evaluated following predefined preoperative ultrasound, intraoperative and pathology protocols. We evaluated the agreement of depth of infiltration of the rectosigmoid wall, tumor spread in different peritoneal compartments and presence of metastatic retroperitoneal and inguinal lymph nodes, as determined at ultrasound, with intraoperative and histopathological findings. RESULTS: In total, 578 patients were enrolled between March 2008 and January 2013, of whom 394 met the study inclusion criteria and were analyzed; 74% of these suffered from advanced-stage cancer. Our results showed excellent agreement between ultrasound and histology in assessment of rectosigmoid wall infiltration (kappa value, 0.812; area under the receiver-operating characteristics curve, 0.898). The overall accuracy in evaluating different peritoneal compartments, retroperitoneal and inguinal lymph nodes and depth of rectosigmoid wall infiltration was 85.3%, 84.8%, 99.7% and 91.1%, respectively. Ultrasound showed high sensitivity only in the assessment of rectosigmoid wall infiltration (83.1%), peritoneal spread into the pelvis (81.4%) and omentum (67.3%), and inguinal metastatic lymph nodes (100%). The specificity of ultrasound in detection of all evaluated parameters was > 90%. CONCLUSION: This is the largest imaging study to date on ovarian cancer staging. Ultrasound can be used as the method of choice to plan rectosigmoid wall resection and dissection of infiltrated inguinal lymph nodes. In assessing different peritoneal and retroperitoneal compartments, ultrasound was accurate and highly specific. However, similar to other modern imaging techniques, it had relatively low sensitivity, further supporting the role of comprehensive surgical staging. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Risk of micrometastases in non-sentinel pelvic lymph nodes in cervical cancer.

OBJECTIVE: A high sensitivity of sentinel lymph nodes (SLN) for pelvic lymph node (LN) staging has been repeatedly shown in patients with cervical cancer. However, since only SLN are evaluated by pathologic ultrastaging, the risk of small metastases, including small macrometastases (MAC) and micrometastases (MIC), in non-SLN is unknown. This can be a critical limitation for the oncological safety of abandoning a pelvic lymphadenectomy. METHODS: The patients selected for the study had cervical cancer and were at high risk for LN positivity (stage IB-IIA, biggest diameter≥3cm). The patients had no enlarged or suspicious LN on pre-operative imaging; SLNs were detected bilaterally and were negative on intra-operative pathologic evaluation. All SLNs and all other pelvic LNs were examined using an ultrastaging protocol and processed completely in intervals of 150µm. RESULTS: In all, 17 patients were enrolled into the study. The mean number of removed pelvic LNs was 30. A total of 573 pelvic LNs were examined through ultrastaging protocol (5762 slides). Metastatic involvement was detected in SLNs of 8 patients (1× MAC; 4× MIC; 3× ITC) and in non-SLNs in 2 patients (2× MIC). In both cases with positive pelvic non-SLNs, there were found MIC in ipsilateral SLNs. No metastasis in pelvic non-SLNs was found by pathologic ultrastaging in any of the patients with negative SLN Side-specific sensitivity was 100% for MAC and MIC. There was one case of ITC detected in non-SLN, negative ipsilateral SLN, but MIC in SLN on the other pelvic side. CONCLUSIONS: After processing all pelvic LNs by pathologic ultrastaging, there were found no false-negative cases of positive non-SLN (MAC or MIC) and negative SLN. SLN ultrastaging reached 100% sensitivity for the presence of both MAC and MIC in pelvic LNs.

[Technique of pelvic and paraaortic lymphadenectomy]. / Technika pánevní a paraaortální lymfadenektomie.

OBJECTIVE: Overview of classification, anatomical conditions, methods and complications of pelvic and paraaortic lymph-node dissection. DESIGN: Review article. SETTING: Department of Obstetrics and Gynecology, General Faculty Hospital and 1st Medical Faculty, Charles University, Prague. MATERIALS AND METHODS: Lymphadenectomy is classified according to its extent into sentinel lymph-node biopsy, debulking, sampling and systematic procedure and according to approach into extraperitoneal or transperitoneal procedure. The most complex variant is systematic pelvic and paraaortic lymph-node dissection, which requires removal of fatty-lymphatic tissue from anatomically strictly defined areas. Procedure can be performed from laparotomy, laparoscopically or robotically. RESULTS: The main objective criterium of systematic procedure is the number of harvested nodes. The most common complications comprise bleeding and lymphocele formation. CONCLUSIONS: Pelvic and paraaortic lymphadenectomy represent basic component of surgical management in majority of gynecological cancers. The knowledge of extent, different techniques and ability to solve complications represents essential skill in gynecological oncology.

[Contribution of sentinel lymph-node biopsy to treatment of locally advanced stages of cervical cancers]. / Prínos biopsie sentinelových uzlin pro lécbu lokálne pokrocilých stadií karcinomu delozního hrdla.

OBJECTIVE: Usage of sentinel lymph-node (SLN) concept in locally advanced cervical cancers might help to individualise management. According to SLN status could be patients refered to neoadjuvant chemotherapy (NAC) with subsequent surgery or to primary chemoradiation. The aim of our study was to evaluate sensitivity of SLN detection in locally advanced cervical cancers and to assess the impact of NAC on frequency of their metastatic involvement. DESIGN: Retrospective clinical study. SETTING: Department of Obstetrics and Gynecology, General Faculty Hospital and 1st Medical Faculty, Charles University, Prague. MATERIALS AND METHODS: Included were patients with cervical cancer stages FIGO IB1 (> 3 cm), IB2, IIA2 and selected cases of stages IIB with incipient parametrial involvement. Patients were distributed into two different protocols - patients in group NAC-SLN were refered to radical hysterectomy with SLN biopsy after 3 cycles of NAC, other patients (group SLN) underwent SLN biopsy and NAC was administered only in SLN-negative cases. RESULTS: Altogether 101 patients were included (group SLN = 62, group NAC-SLN = 39). Detection of SLN in whole cohort reached 90.1% per patient and 68.3% bilaterally. No differences were found between SLN group and NAC-SLN group in frequency of per patient SLN detection (90.3% vs 89.7%) and bilateral detection (69.4% vs 66.7%). Prevalence of macrometastases, micrometastases and ITC in the SLN group was 37.1% (23/62), 11.3% (7/62) and 8.1% (5/62), respectively. In the NAC-SLN group macrometastases in SLN were detected in 17.9% (7/39) patients, in 1 patient was detected micrometastis in SLN and no patient had ITC. Difference in frequency of metastases in SLN was significant (p = 0,013). No patient had progressed during NAC, complete response was seen in 15.1% (11/73) patients and reduction of tumour volume > 30% in 84.9% (62/73) patients. CONCLUSIONS: Detection of SLN in locally advanced cervical cancers reached comparable results to early stages. NAC did not influence frequency of SLN detection, but it significantly decreased prevalence of metastatic SLN involvement.

Factors affecting sonographic preoperative local staging of endometrial cancer.

OBJECTIVES: To identify major factors in the under- and overestimation of cervical and myometrial invasion by endometrial cancer at preoperative staging by ultrasound. METHODS: This prospective study involved all patients with histologically confirmed endometrial cancer referred consecutively for surgical staging between January 2009 and December 2011. All patients underwent transvaginal ultrasound examination, obtaining metric and perfusion data, and the results were compared with final histology: myometrial invasion was defined at histology in the final pathology report as being either < or ≥ 50%, while cervical stromal invasion was reported as being either present or absent, and sonographic over-/underestimation was determined relative to these. RESULTS: Enrolled prospectively into the study were 210 patients. The proportion of cases with sonographic underestimation, relative to final histology, of myometrial invasion (i.e. false-negative estimation of no or superficial invasion < 50%) and of cervical invasion (i.e. false-negative finding of absence of stromal invasion) was comparable: 8.6% (n = 18) and 10.5% (n = 22), respectively. Myometrial invasion was overestimated by ultrasound (i.e. false-positive estimation of deep invasion ≥ 50%) in 15.7% (n = 33) of cases, and cervical invasion was overestimated (i.e. false-positive finding of presence of stromal invasion) in 4.8% (n = 10) of cases. These outcomes correspond to positive and negative predictive values of 67.6% (95% CI, 57.7-76.6) and 83.3% (95% CI, 74.9-89.8), respectively, for the subjective assessment of myometrial invasion, and 60.0% (95% CI, 38.2-79.2) and 88.1% (95% CI, 82.5-92.4), respectively, for that of cervical stromal invasion. The staging error in subjective assessment was not related to body mass index (BMI), to the position of the uterus in the pelvis or to image quality. Cervical and myometrial invasion were more often underestimated in well-differentiated endometrial cancers that were smaller in size, with thick minimum tumor-free myometrium and lower perfusion, and more often overestimated in moderately and poorly differentiated cancers that were larger in size, with thin minimum tumor-free myometrium and richer perfusion. CONCLUSION: The accuracy of subjective assessment of myometrial and cervical invasion by ultrasound was significantly influenced by tumor size, density of tumor vascularization, tumor vessel architecture and histological grading, while it was not significantly affected by BMI, uterine position and image quality.

Tropisetron for the prevention of postoperative nausea and vomiting in women undergoing gynecologic surgery.

The aim of this study was to evaluate the efficacy of tropisetron, a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, versus placebo in the prevention of postoperative nausea and vomiting in patients undergoing general anesthesia for gynecologic surgery. Ten minutes before induction of general anesthesia, 80 patients received in a double-blind manner a single intravenous (IV) injection of either 5 mg tropisetron or a matching placebo. Anesthesia was induced with thiopental and maintained with nitrous oxide and enflurane in oxygen. In the first 24 h postoperatively 7 of 40 patients (17.5%) given tropisetron and 16 of 40 patients (40%) receiving placebo vomited (P < 0.05). The incidence of nausea was 30% (12/40) in the tropisetron group and 52% (21/40) in the placebo group (P < 0.05). A total effective antiemetic response showed 26 patients (65%) in the tropisetron group and 16 patients (40%) in the placebo group (P < 0.05). We conclude that tropisetron given IV prior to gynecologic procedures in general anesthesia significantly reduces postoperative nausea and vomiting when compared to placebo without causing any adverse effect.