Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study

New treatments, particularly second‐line options, are needed to improve outcomes for patients with recurrent/metastatic cervical cancer (r/mCC). Tisotumab vedotin (TV) is an antibody–drug conjugate directed to tissue factor, a transmembrane protein commonly expressed in cancer cells, to deliver cytotoxic monomethyl auristatin E. This single‐arm, open‐label phase 1/2 trial evaluated the consistency of safety and efficacy outcomes of TV in Japanese patients with r/mCC to bridge the current findings with those reported in previous trials in non‐Japanese patients in the United States and Europe. In part 1 (dose escalation; N = 6), patients with advanced solid tumors received TV 1.5 or 2.0 mg/kg once every 3 weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 (dose expansion; N = 17) evaluated the RP2D in r/mCC patients with 1–2 prior lines of therapy. In part 1, no dose‐limiting toxicities were observed, the MTD was not reached, and TV 2.0 mg/kg was established as the RP2D. In part 2, the most common treatment‐emergent adverse events were anemia (58.8%), nausea (58.8%), alopecia (47.1%), epistaxis (47.1%), and diarrhea (35.3%); adverse events of special interest were bleeding (76.5%), ocular events (35.3%), and peripheral neuropathy (17.6%), and were mostly grade 1/2. In part 2, confirmed objective response rate was 29.4%, median duration of response was 7.1 months, and median time to response was 1.2 months. In Japanese patients with r/mCC, TV demonstrated a manageable and tolerable safety, pharmacokinetics, and efficacy profile consistent with that observed in non‐Japanese patients.     

静止中立位状态及加载模拟头部重量后对髓核内压力影响的研究

目的:通过测试颈椎标本在静止中立位及模拟头部重量后的髓核内压力,从而探讨颈椎髓核内压力的变化规律。方法:利用生物力学材料实验机及微型压力传感器测试新鲜人体颈椎标本在静止中立位及加载100N压力时的髓核内压力。结果:静止中立位及加载100N压力时,C3～4和C4～5节段髓核内压力比较无显著性差异(P0.05),C5～6和C6～7节段髓核内压力比较无显著性差异(P0.05);C5～6,C6～7高于C3～4,C4～5髓核内压力(P0.05);加载100N后所有节段髓核内压力均升高具有显著性差异(P0.05)。结论:正常人体下颈段髓核内压力高于上颈段髓核内压力,并且随外在负荷的增加而压力增加。     

颈椎“骨错缝筋出槽”临床评价方法

结合临床研究结果 ,从关节功能评估和关节结构评估两个方面阐述＂骨错缝筋出槽＂临床特征的评价方法。关节功能评估包括动态触诊评估和颈椎自主活动度检测,关节结构评估包括静态触诊评估和影像学评估。     

Attitudes towards HPV testing: a qualitative study of beliefs among Indian,Pakistani, African-Caribbean and white British women in the UK

This study examined attitudes to human papillomavirus (HPV) testing among a purposively selected sample of women from four ethnic groups: white British, African Caribbean, Pakistani and Indian. The design was qualitative, using focus group discussion to elicit women's attitudes towards HPV testing in the context of cervical cancer prevention. The findings indicate that although some women welcomed the possible introduction of HPV testing, they were not fully aware of the sexually transmitted nature of cervical cancer and expressed anxiety, confusion and stigma about HPV as a sexually transmitted infection. The term 'wart virus', often used by medical professionals to describe high-risk HPV to women, appeared to exacerbate stigma and confusion. Testing positive for HPV raised concerns about women's sexual relationships in terms of trust, fidelity, blame and protection, particularly for women in long-term monogamous relationships. Participation in HPV testing also had the potential to communicate messages of distrust, infidelity and promiscuity to women's partners, family and community. Concern about the current lack of available information about HPV was clearly expressed and public education about HPV was seen as necessary for the whole community, not only women. The management of HPV within cervical screening raises important questions about informed participation. Our findings suggest that HPV testing has the potential to cause psychosocial harm to women and their partners and families.     

Effectiveness and safety of loop electrosurgical excision procedure in a low-resource setting

Objective

To evaluate the effectiveness and safety of the loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in a low-resource setting.

Methods

Women participating in a cervical screening study in India with histologically confirmed CIN unsuitable for cryotherapy were advised to undergo LEEP. One year after treatment the cervix was visually inspected with acetic acid, followed by colposcopy and biopsy taken from abnormal areas. Cure was defined as no clinical or histologic evidence of CIN. Factors influencing cure rates were evaluated by ^χ2 tests.

Results

Of the 311 women who underwent LEEP, 283 reported for 1-year follow-up and 248 (87.6%) were disease free. Cure rates were 93.0% for CIN 1, 85.5% for CIN 2, and 72.7% for CIN 3. Minor adverse effects were observed in 34 women and complications were seen in 5 women.

Conclusion

LEEP was associated with minimal complications and acceptable cure rates in a low-resource setting, although women with larger lesions had lower cure rates.     

Vaginal reconstructive surgery for severe pelvic organ prolapses: a 'uterine-sparing' technique using polypropylene prostheses

OBJECTIVE: The Ulmsten's "Integral Theory" for pelvic floor dysfunctions is based on the need to reinforce fascias and ligaments with prostheses to obtain a reconstitution of the pelvic floor's anatomy. In September 2004 we developed a "uterine-sparing" surgical technique to correct such pathologies and in this paper we present results obtained. Primary outcome was to evaluate the technique's efficacy, secondary outcomes the resolution of stress urinary incontinence, postoperative pain (VAS scale), safety and complications. STUDY DESIGN: This prospective study included patients affected by stage 3 and 4 uterine-vaginal prolapse who wished to conserve their uterus. Those with (1) minor degrees of severity, (2) unfit for surgery, (3) with a clear indication to hysterectomy (i.e. endometrial cancer), (4) with an elevated operative risk (American Society of Anaesthesiologists-ASA score III and IV), (5) previous vaginal surgeries and (6) with moderate/severe defecation problems were excluded. The technique consisted in a sacrospinous colposuspension with polypropylene mesh. The pelvic status was classified according to the international Pelvic Organ Prolapse staging system (POP-Q). Postoperative pain was scored with the VAS Scale. All patients were given the King's Health questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and the Wexner questionnaire. RESULTS: From September 2004 to November 2006 we treated 80 patients. Polypropylene prostheses (Gynemesh-Soft PS, 10cmx15cm - GyneMesh, Gynecare Ethicon - Somerville, NJ, USA) were used to reconstruct the pubo-cervix or the recto-vaginal fascia. We performed an anterior-central vaginal reconstruction in 35 (43.8%) patients, central-posterior in 25 (31%) and total reconstruction in 20 (25%). The median follow-up was 21 months (range 18-26). The severe pelvic prolapse, evaluated with the POP-Q System, was completely treated in all the patients and no recurrences were observed. The urodynamic examination showed a complete resolution of the stress urinary incontinence in 10 patients (83%). Sexual activities improved in all patients. We recorded three vaginal erosions and one patient complained of a postoperative dyspareunia. CONCLUSIONS: This pilot study suggests that our technique is safe and effective and can efficiently repair the pelvic organs prolapse, without undergoing hysterectomy and with a low rate of vaginal erosions.     

Hysterectomy for hematometra in a 15-year-old mentally handicapped girl with congenital cervicovaginal agenesis and concomitant ovarian adenoma

We report a case of hematometra and bilateral hematosalphinx in a 15-year-old mentally handicapped adolescent girl, complicated by vaginal agenesis over cervical atresia in the presence of an ovarian adenoma. The case was managed by abdominal hysterectomy and bilateral salphingectomy of the hematosalphinx, which had formed a tubo-ovarian mass. One ovary was preserved. This case also considers the management of the mentally handicapped patient unable to comprehend pain arising from cryptomenorrhea.     

Stage IIB carcinoma of the cervix that is associated with pelvic kidney: A therapeutic dilemma

Locally advanced cervical cancer with congenital pelvic kidney is reported uncommonly. A 50-year-old patient with stage IIB cervical cancer and pelvic kidney was treated with irradiation and concurrent chemotherapy. Follow-up evaluation for 2 years revealed normal renal function and no evidence of recurrent disease.