Felix Neis

Electrochemotherapy as a symptom-oriented palliative treatment option: an exploratory single-center study in 15 patients with locally advanced or locoregionally recurrent vulvar carcinoma

Abstract Background Vulvar carcinoma (VC), a rare cancer, recurs in over a third of women, usually within 2 years. Treatment options other than repeat surgery and radiotherapy are often required in the recurrence setting. Systemic chemotherapy is an option but is generally associated with stressful side effects. In the palliative setting, electrochemotherapy (ECT) is a better-tolerated alternative, which provides local tumor control while obviating systemic side effects. Objective To descriptively analyze a case series of patients with inoperable locally advanced or locoregionally recurrent VC receiving bleomycin-based ECT. Methods Descriptive analysis of prospectively collected data from a case series. Postmenopausal women with locally advanced or locoregionally recurrent VC were eligible for inclusion. Bleomycin was administered at 15 mg/m 2 body surface as a single 1-min intravenous injection; 8 min later, electrochemical treatment using sterile disposable electrodes was performed under anesthesia for ≤ 30 min. Postoperatively, patients received pain medication to mitigate muscle soreness. Results 15 patients were included in the study. Median patient age at ECT was 81 (range, 51–100) years. Recurrences (1–5) were present in 12 patients. Surgery and radiotherapy were not justifiable options in 3 patients. In our clinical observation, ECT was well tolerated by all patients for the management of pain, itching, odor, and secretion. This allowed for time to be gained until further treatment became necessary or disease progression occurred. Conclusions In our clinical experience, bleomycin-based ECT is an oncologically efficacious and better-tolerated alternative to systemic chemotherapy or immunotherapy in patients with recurrent VC in a palliative setting with limited capacity to undergo treatment.

Large Conization—Retrospective Monocentric Results for Fertility Preservation in Young Women with Early Stage Cervical Cancer

Abstract  The shorter cervical segment after classic radical trachelectomy (RT) imposes a number of pregnancy associated risk factors. In this aspect, large conization (LC) could be an oncologically safe alternative to RT in young women with early stage cervical cancer who want to spare their fertility. Our aim was to evaluate fertility-sparing surgical treatment of early stage cervical cancer after the introduction of LC. Our objectives were to assess surgical, oncological, fertility and obstetric outcomes. We retrospectively investigated oncological and fertility outcomes of patients who underwent LC in a large oncological single University centre between 2009 and 2014. Medical records were reviewed and analysed for surgical, oncological, fertility and obstetric outcomes. Postal questionnaires were collected to further evaluate and validate the fertility and obstetric outcomes. A total of 23 LCs were analysed. Seven patients had to undergo secondary radical hysterectomy after LC due to unclear resection margins. Nine of 16 women tried to conceive, of which all nine became pregnant. Seven patients underwent a prophylactic cerclage between 13 and 16 gestational weeks and seven women delivered 9 children; the majority of women conceived spontaneously. Follow-up time was a median of 3.9 years (2.6–8 years). There was no relapse of cervical cancer in the investigated timeframe. Early stage cervical cancers treated by LC are associated with excellent oncological outcomes. LC appears to be a safe option for eligible women who intend to maintain their fertility.

Proposal for a descriptive and differentiated presentation of the longitudinal impact of the new organized cancer screening guideline and HPV vaccination in Germany

Abstract Introduction Since 01/01/2020, the cervical cancer screening in Germany has been carried out due to the organized early cancer diagnosis guideline (oKFE-RL). In 2007, HPV vaccination was initiated in Germany. The main goal of both initiatives is to further reduce the incidence of invasive cervical cancer. To assess the effect of the new screening strategy in a timely manner, monitoring of short-term changes need to be considered. Ideally, the effects of both prevention methods would be presented together in one model. Materials and methods Because no change in the incidence of invasive cervical cancer is initially expected, the incidence of CIN 3 is used as a surrogate parameter to assess the effects of the prevention efforts. Based on expected additional effects of vaccination and co-testing, a model-based estimation of the expected CIN 3 incidence during the evaluation of the screening program is performed using the CIN 3 incidence in the Saarland population. Modeling results The oKFE-RL provides for two groups: Primary cytodiagnosis continues until 35 years of age. Here, in the next few years, CIN 3 incidence will be reduced not by the oKFE-RL but by the increasing proportion of vaccinated women. In the group over 35 years, co-testing was introduced with a stringent algorithm. Due to the higher sensitivity of the HPV test, significantly more CIN 3 are detected in the first round of 3 years and thus, the CIN 3 incidence initially increases. As these CIN 3 are absent in the second round, significantly fewer CIN 3 cases will be detected then. These effects suggest a global decrease in CIN 3 incidence of 25.8% after 6 years. Conclusion Observation of the age distribution curve of CIN 3 allows both effects of prevention to be assessed in a timely manner and separately. In the future, data from epidemiologic cancer registries should be incorporated into the model to replace modeling with real data.

Recovery After Transcervical Fibroid Ablation Versus Minimally Invasive Myomectomy for Symptomatic Uterine Fibroids: A Randomised Controlled Trial

ABSTRACT Objective To evaluate early recovery outcomes with transcervical fibroid ablation (TFA) compared to minimally invasive myomectomy (MIM) in women with symptomatic uterine fibroids. Design Randomised controlled trial. Setting Tübingen University Hospital (Tübingen, Germany). Sample Premenopausal women aged 18–50 years with symptomatic uterine fibroids. Methods Participants were randomised to undergo TFA or MIM. The MIM group underwent laparoscopic myomectomy with concurrent hysteroscopic myomectomy if submucosal fibroids were present. Main Outcome Measures The primary endpoint was the time to return to normal activities. Secondary outcomes included procedure time, postprocedural pain, hospital discharge readiness, time to return to 10 additional activities of daily living, and adverse events. Clinical outcomes through 7 weeks of follow‐up were reported. The primary endpoint was evaluated at p  < 0.028 due to a pre‐planned interim analysis; secondary outcomes were evaluated at p  < 0.05. Results Among 144 randomised patients, 119 provided follow‐up data (58 TFA; 61 MIM). The primary endpoint was met with the median time to return to normal activities favouring TFA (5.5 vs. 13 days; log‐rank p  < 0.001). Procedure time (51 ± 21 vs. 95 ± 37 min; p  < 0.001), postprocedural pain through discharge (all p  < 0.01), opioid utilisation (25.9% vs. 49.2%, p  = 0.009), and time to discharge readiness (22.9 ± 13.2 vs. 58.9 ± 33.1 h; p  < 0.001) favoured TFA. Nine of 10 treatment recovery metrics statistically favoured TFA with none favouring MIM. One serious adverse event occurred in a patient treated with MIM (diagnostic laparoscopy for postoperative bleeding). Conclusions TFA offers a faster recovery than MIM for the treatment of symptomatic uterine fibroids, with a comparable short‐term safety profile. Trial Registration This trial was prospectively registered on the German Clinical Trials Register; https://drks.de/search/de/trial/DRKS00028847