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Peri-urethral cancer (PUC) in females is a rare malignancy. Brachytherapy (BT), either alone or combined with radiation therapy, is a preferred treatment option to spare the morbidity of surgery and achieve organ preservation. We report, to our best knowledge, the largest experience of brachytherapy as part of the treatment of female vaginal PUC. Medical records of all consecutive female patients receiving BT between 1990 and 2018 as part of their treatment for a PUC were examined. Patients were treated with low-dose rate (LDR) or pulse-dose rate (PDR) BT, with or without external beam radiotherapy. Patients were treated with interstitial needles (freehand implantation) +/—a personalized vaginal mold applicator. Patterns of relapse as well as morbidity were examined. A total of 44 patients with PUC (22 primary and 22 recurrent) were identified. Most frequent histologies were adenocarcinoma (n = 20), squamous cell carcinoma (n = 14) and urothelial carcinoma (n = 5). A total of 24 patients were treated with BT alone and 20 patients were treated in combination with EBRT. The median prescribed dose was 20 Gy (IQ range: 15–56.25 Gy) when BT was used as single modality and 60 Gy (IQ range: 60 - 60 Gy) when combined with EBRT. With a median follow-up of 21.5 months (range 7.5–60.75), a total of six patients experienced local relapse (17.5%). Overall survival probability was 63% at 2 years in the whole cohort (95%CI : 49.2 – 81.4 %) Most common toxicities were patients acute genito-urinary grade 1–2 toxicities. At last follow-up, severe morbidities were as follows: four patients experienced focal necrosis. In this cohort of LDR/PDR BT for PUC, we observed a high probability of local control with acceptable morbidity. Survival was however poor, with high metastatic relapse probability.; Les tumeurs péri-urétrales chez la femme sont une pathologie cancéreuse rare. La curiethérapie, seule ou associée à une radiothérapie externe, est un traitement privilégié pour éviter la morbidité chirurgicale et permettre une préservation d’organe maximale. Nous rapportons, à notre connaissance, la plus grande expérience de curiethérapie dans le traitement des tumeurs péri urétrales de la femme. Toutes les patientes traitées par curiethérapie pour une tumeur péri-urétrale entre 1990 et 2018 ont été examinées. La curiethérapie était délivrée en bas débit (LDR) ou débit pulsé (PDR) avec ou sans radiothérapie externe associée. Les patientes ont bénéficié d’une implantation interstitielle à main levée associé ou non à un applicateur moulé vaginal personnalisé. Au total, 44 patientes atteintes de tumeurs péri-urétrales (22 primaires et 22 récidivants) ont été identifiées. Les histologies les plus fréquentes étaient l’adénocarcinome (n = 20), le carcinome épidermoïde (n = 14) et le carcinome urothélial (n = 5). Au total, 24 patientes ont été traitées par curiethérapie seule. La dose médiane prescrite était de 20 Gy (IQR: 15 – 56.25 Gy) lorsque la curiethérapie était utilisée comme modalité unique et de 60 Gy (IQR : 60 - 60 Gy) lorsqu’elle était associée à une irradiation externe. Avec un suivi médian de 21.5 mois (7.5-60.75), six patientes au total ont présenté une rechute locale (17.5 %). La probabilité de survie globale était de 63 % à 2 ans dans l’ensemble de la cohorte (95%CI : 49.2 – 81.4 %). Les toxicités les plus courantes étaient aiguës génito-urinaires de grade 1-2. Au dernier suivi, les séquelles graves étaient marquées par la survenue de quatre nécroses focales. Dans cette cohorte de curiethérapie bas débit et débit pulsé pour des tumeurs péri-urétrales, nous avons observé une probabilité élevée de contrôle local avec une morbidité acceptable. La survie était cependant faible, avec une probabilité élevée de rechute métastatique.

Objective To evaluate financial toxicity and assess its risk factors among patients with gynecologic cancers. Methods This is a cross sectional study that included 2 survey tools, as well as patient demographics, disease characteristics, and treatment regimen. Financial toxicity is measured by validated Comprehensive Score for Financial Toxicity (COST) tool. Participants were also asked to complete a 55-question-survey on attitudes and perspectives surrounding cost of care. Descriptive statistics was used to report patient demographics. Spearman's rank correlation was calculated to assess the relation between financial toxicity and patient/disease related variables. Graphpad Prism Software Version 8.0 was used for analyses. Results A total of 50 patients with various gynecologic malignancies were enrolled. Median COST score was 20.5 (range, 1–33). Sixty-five percent of the patients reported being in debt due to their cancer care and 4% filed bankruptcy. Correlation analysis showed that COST score was correlated with age (r=−0.3, p=0.028), malignancy type (r=0.3, p=0.039) and income (r=0.3, p=0.047). Ovarian cancer patients had significantly less financial toxicity (median COST score=23) when compared to patients with other gynecologic malignancies (median COST score=17, p=0.043). When scores were dichotomized into low (score ≥22) and high toxicity (score, Synopsis Financial toxicity is a growing problem, however, data is very limited. This is a cross sectional study that included two survey tools, as well as patient demographics, disease characteristics, and treatment regimen. Sixty-five percent of the patients reported being in debt due to their cancer care and 4% filed bankruptcy. Correlation analysis showed that COST score was correlated with age, malignancy type and income.

Background: Many economic evaluations of human papillomavirus vaccination should ideally consider multiple disease outcomes, including anogenital warts, respiratory papillomatosis and non-cervical cancers (eg, anal, oropharyngeal, penile, vulvar and vaginal cancers). However, published economic evaluations largely relied on estimates from single studies or informal rapid literature reviews. Methods: We conducted a systematic review of articles up to June 2016 to identify costs and utility estimates admissible for an economic evaluation from a single-payer healthcare provider's perspective. Meta-analyses were performed for studies that used same utility elicitation tools for similar diseases. Costs were adjusted to 2016/2017 US$. Results: Sixty-one papers (35 costs; 24 utilities; 2 costs and utilities) were selected from 10 742 initial records. Cost per case ranges were US$124-US$883 (anogenital warts), US$6912-US$52 579 (head and neck cancers), US$12 936-US$51 571 (anal cancer), US$17 524-34 258 (vaginal cancer), US$14 686-US$28 502 (vulvar cancer) and US$9975-US$27 629 (penile cancer). The total cost for 14 adult patients with recurrent respiratory papillomatosis was US$137 601 (one paper). Utility per warts episode ranged from 0.651 to 1 (12 papers, various utility elicitation methods), with pooled mean EQ-5D and EQ-VAS of 0.86 (95% CI 0.85 to 0.87) and 0.74 (95% CI 0.74 to 0.75), respectively. Fifteen papers reported utilities in head and neck cancers with range 0.29 (95% CI 0.0 to 0.76) to 0.94 (95% CI 0.3 to 1.0). Mean utility reported ranged from 0.5 (95% CI 0.4 to 0.61) to 0.65 (95% CI 0.45 to 0.75) (anal cancer), 0.59 (95% CI 0.54 to 0.64) (vaginal cancer), 0.65 (95% CI 0.60 to 0.70) (vulvar cancer) and 0.79 (95% CI 0.74 to 0.84) (penile cancer). Conclusions: Differences in values reported from each paper reflect variations in cancer site, disease stages, study population, treatment modality/setting and utility elicitation methods used. As patient management changes over time, corresponding effects on both costs and utility need to be considered to ensure health economic assumptions are up-to-date and closely reflect the case mix of patients.

BackgroundMany economic evaluations of human papillomavirus vaccination should ideally consider multiple disease outcomes, including anogenital warts, respiratory papillomatosis and non-cervical cancers (eg, anal, oropharyngeal, penile, vulvar and vaginal cancers). However, published economic evaluations largely relied on estimates from single studies or informal rapid literature reviews.MethodsWe conducted a systematic review of articles up to June 2016 to identify costs and utility estimates admissible for an economic evaluation from a single-payer healthcare provider’s perspective. Meta-analyses were performed for studies that used same utility elicitation tools for similar diseases. Costs were adjusted to 2016/2017 US$.ResultsSixty-one papers (35 costs; 24 utilities; 2 costs and utilities) were selected from 10 742 initial records. Cost per case ranges were US$124–US$883 (anogenital warts), US$6912–US$52 579 (head and neck cancers), US$12 936–US$51 571 (anal cancer), US$17 524–34 258 (vaginal cancer), US$14 686–US$28 502 (vulvar cancer) and US$9975–US$27 629 (penile cancer). The total cost for 14 adult patients with recurrent respiratory papillomatosis was US$137 601 (one paper).Utility per warts episode ranged from 0.651 to 1 (12 papers, various utility elicitation methods), with pooled mean EQ-5D and EQ-VAS of 0.86 (95% CI 0.85 to 0.87) and 0.74 (95% CI 0.74 to 0.75), respectively. Fifteen papers reported utilities in head and neck cancers with range 0.29 (95% CI 0.0 to 0.76) to 0.94 (95% CI 0.3 to 1.0). Mean utility reported ranged from 0.5 (95% CI 0.4 to 0.61) to 0.65 (95% CI 0.45 to 0.75) (anal cancer), 0.59 (95% CI 0.54 to 0.64) (vaginal cancer), 0.65 (95% CI 0.60 to 0.70) (vulvar cancer) and 0.79 (95% CI 0.74 to 0.84) (penile cancer).ConclusionsDifferences in values reported from each paper reflect variations in cancer site, disease stages, study population, treatment modality/setting and utility elicitation methods used. As patient management changes over time, corresponding effects on both costs and utility need to be considered to ensure health economic assumptions are up-to-date and closely reflect the case mix of patients.

Primary non-Hodgkin's lymphoma (NHL) of the vagina is uncommon. The present case study reports the case of a 54-year-old female with a palpable mass between the rectum and vagina. The patient presented with symptoms consistent with vaginal cancer but lacked any of the 'B' symptoms often associated with systemic lymphoma, including fever, weight loss, night sweats and fatigue. The mass was resected under anesthesia. Immunohistochemistry and biopsy confirmed diffuse large B-cell NHL (DLBCL). Following surgery, six cycles of chemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone were administered. Subsequently, a vertebral body metastasis was observed using a computed tomography scan and whole-body bone imaging. The patient received palliative radiation for the vertebral body metastasis. Additionally, the available literature was reviewed in order to further characterize this rare disease.

Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. Methods: Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus). Results: We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates. Conclusions: These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination. Copyright © 2015 Wolters Kluwer Health, Inc.

As we contemplate the astonishing successes of human papillomavirus (HPV) vaccines, it is worthwhile to consider whether randomized controlled trials of the sort recently published in the Journal can ever show reductions in cervical cancer rates (1). In their excellent article, Munoz et al. (1) reported nearly complete efficacy of quadrivalent HPV vaccine against vulvar and cervical intraepithelial neoplasia, adenocarcinoma in situ, and genital warts that contained viral types in the vaccine. Of course, this study did not show differences in cervical cancer because that was never its intent. However, the hope that one day randomized controlled trials like these will finally show that HPV vaccines prevent cervical cancer is nicely summarized by the conclusion of a recent systematic review (2) of HPV vaccine trials, “To evaluate cervical cancer incidence and mortality, a longer follow-up is necessary.” But is this really true? Assessing clinical trial outcomes related to cervical disease typically requires regular Papanicolaou test screenings, and ethics require that women with abnormal screening results receive follow-up and treatment, as appropriate. This combination of screening and treatment should prevent all but the most aggressive interval cervical cancers (3). Indeed, one of the most interesting findings reported by Munoz et al. was that none of the women in the trial developed cervical cancer during the approximately 63 000 women-years reported. Because their study participants had at least annual screening for cervical abnormalities to assess the main outcomes, clinicians treated abnormalities identified during the tests with procedures known to be effective in preventing cervical cancer and thus vastly reduced the chances the women would get cervical cancer. We can think of this risk reduction as reflecting a “cervical cancer Heisenberg principle,” according to which studying intermediate outcomes obliterates more severe ones. One way that researchers have devised to get around this Heisenbergian challenge is to design studies that continue past the duration of most efficacy trials (ie, beyond 4–6 years) (3). Women remain randomly assigned to condition, but they no longer receive regular testing as part of the trial. Instead, the researchers follow the women over the next decades by linking their identities to national cancer registries. The ethical justification is that routine screening and medical treatment outside the trial are the standard of care. In contrast, HPV vaccine provision to older women is not the standard of care, and the majority of HPV infections will have already occurred during the ages in which women were enrolled in the trial. The other alternative to get around this Heisenbergian challenge is to evaluate HPV vaccine impact at the population level by use of one of the many alternatives that we have previously reviewed elsewhere (4). These evaluations have to rely on prospective cohort studies and other nonexperimental study designs that yield weaker evidence than randomized controlled trials. One such study (5) recently reported decreases in the incidence of genital warts after implementation of a national HPV vaccination program in Australia. It is highly likely that additional studies, many of which are under way, will provide similar correlational evidence for the population-level impact of HPV vaccine on cervical cancer. While we wait for further evidence to accumulate, it is important to remember that most randomized controlled trials cannot and will not tell us whether HPV vaccines prevent cervical cancer.

Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18–related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18–related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.