High dose rate (HDR) cervical ring applicator to control bleeding from cervical carcinoma

Abstract. Grigsby PW, Portelance L, Williamson JF. High dose rate (HDR) cervical ring applicator to control bleeding from cervical carcinoma.
The objective of this study was to evaluate the use of the high dose rate (HDR) cervical ring applicator to control acute cervical bleeding from carcinoma of the uterine cervix. This study consists of 15 patients presenting with invasive carcinoma of the uterine cervix with acute vaginal bleeding requiring transfusion. Initial irradiation, delivered emergently because of vaginal bleeding, consisted of two fractions (5 Gy each fraction to the surface of the cervix) utilizing the HDR intracavitary vaginal ring applicator. Two fractions were administered at one week intervals for a total of 10 Gy to the surface of the cervix. Irradiation doses from the HDR ring applications were not considered into the composite total dose to point A. Diagnostic imaging evaluation and initiation of external irradiation were commenced during this initial weekly interval between fractions. Vaginal bleeding requiring no additional transfusions was achieved in 93% (14/15) of patients. No acute or long-term Grades 3, 4, or 5 bowel or bladder sequelae were noted. In conclusion, HDR cervical ring brachytherapy is effective in controlling acute vaginal bleeding and can be delivered without undue acute or long-term toxicity.     

A novel technique with a flexible applicator for MRI-based brachytherapy of cervical cancer

PURPOSE: To introduce a novel technique for magnetic resonance (MR)-based 3-dimensional planned high-dose rate intracervical brachytherapy (BT). MATERIALS AND METHODS: During 2002, 16 patients received external beam radiotherapy and BT as part of radiochemotherapy for cervical cancer. A special adjustable applicator device was designed and used for BT. The isodose distribution was calculated from MR images with the applicator in place. RESULTS: The planning target volume coverage was adequate and the radiation burden on the organs at risk was within acceptable limits. Complete regression was achieved in two patients (12.5%), and partial regression in ten (62.5%) patients. The overall response rate for the complex treatment was 93.75%. In three cases the disease was considered to be stable. CONCLUSION: The MR-compatible, flexible applicator allows safe and reproducible cervical radiotherapy with no added discomfort or hazard for the patient.     

Dosimetric factors predicting severe radiation-induced bowel complications in patients with cervical cancer: combined effect of external parametrial dose and cumulative rectal dose

OBJECTIVE: The purpose of this study was to analyze dosimetric factors of radiation-induced severe bowel complications among patients with cervical cancer. METHODS: We reviewed 297 patients of stage IB-IVA cervical cancer managed by curative-intent radiotherapy from May 1993 through December 1997. Whole-pelvic irradiation of external beam radiation therapy (EBRT) (34.2-48.6 Gy/19-27 fractions) was delivered to all patients. Two hundred and three patients received additional bilateral parametrial boost (3.6-18 Gy/2-10 fractions). High dose-rate (HDR) intracavitary brachytherapy (ICBT), 16-24 Gy/5 fractions to Point A, was given after external irradiation. Cumulative rectal biologically effective dose (CRBED) at rectal reference point was determined by summation of EBRT and ICBT component. RESULTS: The 5-year incidences of Grade 3-4 enterocolitis and proctitis were 10% and 7%, respectively. Both complications were associated with external parametrial dose (PMD) and CRBED. Interaction of CRBED and PMD was noted in multivariate analysis of enterocolitis (P < 0.001) and proctitis (P < 0.001). In CRBED > or = 100 Gy(3) group, PMD was an independent factor in enterocolitis (P = 0.010) and proctitis (P = 0.039). In PMD > or = 54 Gy group, CRBED was an independent factor in enterocolitis (P = 0.003) and proctitis (P = 0.036). Patients with both PMD > or = 54 Gy and CRBED > or = 100 Gy(3) had higher incidence of 5-year enterocolitis (26%) (P < 0.001) and proctitis (17%) (P < 0.001) than other dose groups. CONCLUSION: Radiation-induced severe bowel complications are association on both high PMD and high CRBED. We do not suggest both external PMD > or = 54 Gy and CRBED > or = 100 Gy(3) for treatment of cervical cancer due to unacceptably high incidence of severe bowel complications.     

Assessment of uterus position as a surrogate for high-risk clinical target volume with respect to the applicator position for multiple fractions of brachytherapy in cervical cancer

Aim

Hybrid magnetic resonance imaging/computerized tomography (MRI/CT) planning for high-dose-rate (HDR) brachytherapy in cervical cancer with MR/CT fusion for the first fraction followed by CT for fraction 2 and 3 is used at our center. The aim of this study is to evaluate the position of applicator intrauterine tube (IU) in relation to uterine serosa with each fraction of intracavitary high-dose-rate brachytherapy.

Methods

Position of the applicator relative to uterus was measured from tip of the applicator (IU) to the top of uterus in the plane of IU and perpendicular to IU in anterior, posterior, left and right directions at the tip of IU, mid-point of the IU and 1 cm from the surface of vaginal ring. The mean absolute difference (±95 % confidence interval) between these positions at fraction 2 and 3 was calculated with fraction one as reference.

Results

The mean absolute difference (±95 %) of the applicator relative to uterus was 2.7 ± 0.5 mm at the tip, 1.5 ± 4 mm at mid-point and 1.1 ± 0.3 mm at 1 cm from the surface of the ring.

Conclusion

This study shows that there is consistency in inter-fraction applicator position relative to uterus apart from at the tip and, therefore, in situations where high-risk clinical target volume (HRCTV) extends towards uterine fundus, MRI should be used for each fraction of brachytherapy planning to accurately define HRCTV.     

252Cf中子腔内照射加全盆腔外照射治疗子宫内膜癌的临床观察

目的观察^252Cf中子腔内照射加全盆腔外照射治疗子宫内膜癌的3年局部控制率、生存率、远期并发症以及预后影响因素。方法选择40例未接受过任何治疗,按照国际妇产科联盟（FIGO）1971年临床分期标准诊断为临床Ⅰb-Ⅳa期的子宫内膜癌患者作为研究对象。其中,Ⅰb期15例,Ⅱ期15例,Ⅲ期8例,Ⅳa期2例;腺癌30例,腺鳞癌6例,乳头状腺癌4例;G1 25例,G2-G3 15例。治疗方案：^252Cf中子腔内照射,A点总剂量为35—45Gy（i）,F点总剂量为38—50Gy（i）。治疗间歇穿插全盆腔外照射,前后对穿野,外照射剂量达20—30Gy后,盆腔野中央屏蔽挡铅4cm,四野外照射治疗,使总剂量达到45—50Gy,总疗程5—6周。患者均随访36个月以上。结果患者的3年局部控制率为88％（35／40）,总生存率为75％（30／40）。其中,Ib期3年局部控制率为93％（14／15）,总生存率为87％（13／15）,虽高于Ⅱ期患者的80％（12／15）和87％（13／15）,但差异无统计学意义（P〉0．05）;明显高于Ⅲ-Ⅳ期的60％（6／10）和50％（5／10）,差异有统计学意义（P〈0．01）。G1患者的3年局部控制率为92％（23／25）,总生存率为88％（22／25）,明显高于G2-G3患者的80％（12／15）和53％（8／15）,差异有统计学意义（P〈0．01）。腺癌患者的3年局部控制率为93％（28／30）,总生存率为87％（26／30）,明显高于腺鳞癌及乳头状腺癌的70％（7／10）和30％（3／10）,差异有统计学意义（P〈0．01）。所有患者Ⅱ级以上远期放射性膀胱炎的发生率为2％（1／40）,Ⅱ级以上远期放射性直肠炎和乙状结肠炎的发生率为10％（4／40）。结论^252Cf中子腔内照射加全盆腔外照射治疗子宫内膜癌具有较好的临床应用前景。子宫内膜癌的临床分期、病理类型和病理分级是重要的预后影响因素。     

The effect on intrauterine device position and performance of a modified TCu380A insertion technique.

OBJECTIVE: To assess the validity of modifying the technique of intrauterine device (IUD) placement to decrease the incidence of incorrect positioning within the uterine cavity. METHODS: We used the current applicator in 78 women and an applicator shortened by 1.5 cm in 91 women, and examined the uterus by vaginal ultrasonography before and after application in both groups. RESULTS: Six of the 78 unmodified insertions were found to be incorrectly placed, while none of the IUDs inserted with the new technique was placed incorrectly. CONCLUSIONS: We suggest shortening the applicator or lengthening the push rod to increase the likelihood of proper IUD insertion and thereby enhance performance.     

Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder,With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study

BackgroundHypersexual disorder (HD) is a condition in which the individual experiences loss of control over engagement in sexual behaviors, leading to negative effects on various areas of life. Paraphilias often present concomitantly with HD, and although cognitive behavioral therapy (CBT) has been proven to reduce engagement in hypersexual behavior, no studies have investigated the effects of Internet-administered CBT (ICBT) on HD, with or without paraphilia(s) or paraphilic disorder(s).AimTo investigate the effects of Internet-administered CBT on HD, with or without paraphilia(s) or paraphilic disorder(s).MethodsMale participants (n = 36) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12 weeks of ICBT. Measures were administered weekly over the treatment period, with an additional follow-up measurement 3 months after completion of treatment. An assessment interview was performed 2 weeks after treatment.OutcomesThe primary outcome was the Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder: Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8).ResultsLarge, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms. These effects remained stable 3 months after treatment.Clinical ImplicationsICBT can ameliorate HD symptoms, psychiatric distress, and paraphilic symptoms, which suggests that the ICBT for HD, with or without paraphilia(s) or paraphilic disorder(s), may constitute a valuable addition of treatment options in clinical settings.Strengths and LimitationsThis is the first study evaluating the efficacy of ICBT on a sample of men suffering from HD. In addition, a proportion of the sample reported concomitant paraphilic interests and disorders, thus mirroring an everyday clinical practice in the field of sexual medicine. No control group was assigned, and some of the outcome measures are still to be validated. The long-term effects of ICBT and its efficacy in hypersexual women are unknown.ConclusionsThis study gives support for ICBT as an effective treatment option for HD. Future evaluations of the treatment program should include women and larger samples in randomized controlled procedures and investigate the long-term effects.Hallberg J, Kaldo V, Arver S, et al. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med 2020;17:2039–2054.     

Microwave endometrial ablation for an enlarged uterus

INTRODUCTION. An enlarged uterus of more than 12 cm in cavum length with a distorted cavity is a contra-indication for conventional ablative techniques. It is difficult to perform satisfactory endometrial ablation in a large uterus with submucosal myomas using straight instruments. A new curved microwave applicator 4 mm in diameter was developed for microwave endometrial ablation (MEA) for uteri with an enlarged distorted uterine cavity. METHOD. For three patients of menorrhagia due to submucosal myomas with cavum lengths 13 to 15 cm, MEA was performed using the curved applicator. RESULTS. Menorrhagia was improved in each case. No complications were encountered. CONCLUSION. A large number of hysterectomies could be avoided using the new curved microwave applicator.     

Studies on a cell sampling method in mass screening for uterine cervical cancer--comparison of data obtained with a cotton tipped applicator, wooden spatula and cotton tipped applicator plus colposcopy

In mass screening tests for uterine cancer carried out Shimane Prefecture, we used three different scraping methods. This summary is a report of a comparison of the findings with each method. Results are as follows: From 1973-1982, 214, 798 Japanese women were examined in mass screening tests. Among the 42, 443 examined using a cotton tipped applicator, there were 15 (0.035%) with mild dysplasia, 8 (0.019%) with severe dysplasia, 6 (0.014%) with carcinoma in situ and 8 (0.019%) with invasive carcinoma. In 38,106 women examined using the spatula, 25 (0.066%) had a mild dysplasia, 10 (0.026%) a severe dysplasia, 18 (0.047%) a carcinoma in situ and 26 (0.068%) an invasive carcinoma. In 134,249 examined using a cotton tipped applicator plus colposcopy, 283 (0.211%) had a mild dysplasia 108 (0.080%) a severe dysplasia, 57 (0.042%) a carcinoma in situ and 78 (0.058%) an invasive carcinoma. Thus, the use of a cotton tipped applicator plus colposcopy leads to higher rates of detection of mild and severe dysplasia. In the group with a negative Papanicolaou smear and for whom the cotton tipped applicator plus colposcopy was used, there were 214 with a mild dysplasia, 65 with a severe dysplasia, 11 with a carcinoma in situ and 7 with an invasive carcinoma. The combination of cotton tipped applicator and colposcopy proved to be the most effective for mass screenings for uterine cancer, as the detection rates for severe dysplasia and carcinoma in situ were higher and there were fewer incidences of false negative results.     

Treatment of stage I and II ovarian cancer (interim report of intraperitoneal chemotherapeutic perfusion and postoperative prophylactic intracavitary irradiation)

74 cases of primary ovarian cancer treated here previously were classified into three groups, no residual (corresponding to Stage Ia, Ib), cell residual (Ic-IIc) and mass residual (III, IV), and prognoses were compared. The 5 year survival rates were 83.3%, 29.4% and 12.6% respectively. In Stage I and II cases, almost all of the tumor mass would be removed by operation. Therefore the target of postoperative treatment should be the residual cancer as cell units spread widely throughout the abdominal cavity. For this purpose, IPCP has been performed on 35 cases of Stage I and II since 1977. The 3 year survival rate for this series is as good as 88.6%, and the sites of recurrence were localized in the small pelvic cavity adjacent to the Douglas pouch in 5 out of 6 relapsed cases. This fact suggests that IPCP is capable of controlling the cancer cells in the upper abdominal cavity, but still insufficient to control them in the pelvic cavity where deeper invasion is suspected. In order to improve the local control ability, utilization of the uterus as the applicator for prophylactic intracavitary irradiation came to be considered. The spread of cancer to the uterus was found in 5 out of 38 cases in Stage I and II(13.2%), but silent invasion was found in only one case. These results suggests that the utilization of the uterus as the applicator for prophylactic intracavitary irradiation would be feasible if no macroscopical cancer extention to the uterus exists and the uterus is suitable for application. Several combinations with Tandem and Ovoid have been tested and an adequate method has been proposed.     

Laparoscopic clips. Evaluation of absorbable and titanium with regard to hemostasis and tissue reactivity.

Advanced laparoscopic techniques require laparoscopic means of providing hemostasis. We tested the hemostatic ability of laparoscopic surgical clips and their tissue reactivity as assessed by adhesion formation in an animal model. Twenty-six New Zealand white rabbits were randomized at laparotomy to one of three treatment groups: titanium surgical clips, absorbable surgical clips (both applied with a laparoscopic clip applicator) and chromic sutures of equal mass. Either the right fallopian tube was transected, with clips or sutures applied proximally and distally to control bleeding, or the clips or sutures were applied 5 mm apart and the tube transected. A clip or suture of the same material was placed on the midportion of the left fallopian tube. Necropsy was performed at 42 days, and each clip/suture site was scored for adhesions. All the materials were easily applied and effective in achieving hemostasis. The adhesion scores tended to be lower with the absorbable clips; however, there were no statistically significant differences between the groups. Laparoscopic clips are effective in providing hemostasis, are easily applied and cause no more adhesion formation than do conventional suture materials.     

A randomized controlled trial of guided Internet-delivered cognitive behavioral therapy for erectile dysfunction

IntroductionMen with erectile dysfunction are often worried about their condition, have interpersonal difficulties, and have a reduced quality of life. Internet‐delivered cognitive behavior therapy (ICBT) has been shown effective for a number of health problems but evidence is limited concerning the treatment of erectile dysfunction.AimThe study investigated the effects of ICBT for erectile dysfunction.MethodsSeventy‐eight men were included in the study and randomized to either ICBT or to a control group, which was an online discussion group. Treatment consisted of a 7‐week Web‐based program with e‐mail‐based therapist support. Each therapist spent an average of 55 minutes per participant.Main Outcome MeasureThe International Index of Erectile Functioning five‐item version was administered via the telephone at pretreatment, post‐treatment, and 6 months after receiving ICBT.ResultsAt post‐treatment, the treatment group had significantly greater improvements with regard to erectile performance compared with the control group. Between‐group differences at post‐treatment were small (d = 0.1), but increased at the 6‐month follow‐up (d = 0.88).ConclusionsThis study provides support for the use of ICBT as a possible treatment format for erectile dysfunction. Andersson E, Walén C, Hallberg J, Paxling B, Dahlin M, Almlöv J, Källström R, Wijma K, Carlbring P, and Andersson G. A randomized controlled trial of guided Internet‐delivered cognitive behavioral therapy for erectile dysfunction. J Sex Med 2011;8:2800–2809.     

Early clinical outcomes of 3D-conformal radiotherapy using accelerated hyperfractionation without intracavitary brachytherapy for cervical cancer

PURPOSE/OBJECTIVE: To evaluate the outcome of cervical cancer patients unable to undergo conventional intracavitary brachytherapy (ICBT) treated with 3D-conformal radiotherapy (3DCRT) alone using accelerated hyperfractionation (AHF). METHODS AND MATERIALS: We reviewed the records of 7 patients who had received definitive radiotherapy with 3DCRT alone using AHF for cervical cancer between 2002 and 2005. FIGO stage was IB (1), IIB (2), IIIA (1), IIIB (2), and IVA (1). The reason we did not perform ICBT was due to patient refusal. In 1 patient with stage IB, a total dose of 65.4 Gy was delivered by local irradiation (LI) only. In 1 patient with stage IIIA, a total dose of 60 Gy was delivered by LI only. In 5 patients with Stage IIB-IV, a median total dose of 70.8 Gy was delivered by combination of whole pelvic irradiation (median dose of 45 Gy) with LI. Median overall treatment time was 42 days. RESULTS: Median follow-up for survival patients was 17 months. Out of 7 patients, 6 patients had CR and 1 patient had PR. The response rate was 100%. The 2-year local control rate was 85.7%. Of these patients, 5 are alive without disease and 1 is alive with lung metastasis. CONCLUSIONS: Our outcomes suggest that 3DCRT using AHF may be a promising as a definitive treatment for cervical cancer when ICBT is not able to be performed.     

Treatment of nulliparous women with severe fear of childbirth via the Internet: a feasibility study

Objective: The aim of the present study was to test the feasibility of Internet interventions among nulliparous women suffering from severe fear of childbirth (FOC) by means of an Internet-delivered therapist-supported self-help program based on cognitive behavioral therapy (ICBT).

Design: Prospective, longitudinal cohort study.

Setting: A feasibility study of an ICBT program for the treatment of severe FOC in pregnant women.

Sample: Twenty-eight Swedish-speaking nulliparous women with severe FOC recruited via a project home page from January 2012 to December 2013.Methods: The main components of the ICBT program for the treatment of severe FOC comprised psycho-education, breathing retraining, cognitive restructuring, imaginary exposure, in vivo exposure and relapse prevention. The study participants were anonymously self-recruited over the Internet, interviewed by telephone and then enrolled. All participants were offered 8 weeks of treatment via the Internet. Participants reported their homework weekly, submitted measurements of their fear and received feedback from a therapist via a secure online contact management system.

Main outcome measures: Level of FOC measured with the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A) during screening at enrollment and weekly during the treatment (W-DEQ version A), and after the delivery (W-DEQ version B).

Results: A statistically significant (p?<?0.0005) decrease of FOC [W-DEQ sum score decreased pre to post-therapy, with a large effect size (Cohen’s d?=?0.95)].

Conclusions: The results of this feasibility study suggest that ICBT has potential in the treatment of severe FOC during pregnancy in motivated nulliparous women. The results need to be confirmed by randomized controlled studies.     

In vivo feasibility of image-guided transvaginal focused ultrasound therapy for the treatment of intracavitary fibroids

OBJECTIVE: To determine the feasibility of uterine tissue ablation in vivo using a transvaginal focused ultrasound applicator guided by ultrasound imaging. DESIGN: Randomized in vivo animal study. SETTING: Academic research environment. ANIMAL(S): Healthy anesthetized sheep. INTERVENTION(S): Uterine treatment location was determined using a computerized targeting system. Five sonications 10 seconds in duration and averaging 2,000 W/cm(2) of focal ultrasound intensity were applied in each animal's uterus. Animals were euthanized either immediately or 2, 7, or 30 days post-treatment. MAIN OUTCOME MEASURE(S): Gross and microscopic analysis of the dissected uterus was used to quantitatively and qualitatively determine the ablated region and treatment side effects. RESULT(S): Treatments resulted in coagulative necrosis. Histopathological analysis showed that over 7 days, inflammatory cells appeared and smooth muscle bundles regenerated. By day 30, treated tissues healed and scar tissue formed. None of the animals showed abnormal behavior or medical problems. Complications in three animals were damage to the vaginal wall and colon, possibly due to inadequate applicator cooling and an empty bladder during treatment. CONCLUSION(S): Transvaginal image-guided high-intensity focused ultrasound has potential for treating uterine fibroids. Further safety testing of this treatment will prepare it for human use.     

The American brachytherapy society survey of brachytherapy practice for carcinoma of the cervix in the United States

PURPOSE: The purpose of this study was to survey the brachytherapy practice for cervical cancer in the United States. METHODS: The Clinical Research Committee of the American Brachytherapy Society (ABS) performed a retrospective survey of individual physicians of the ABS and American Society of Therapeutic Radiologists and Oncologists regarding the details of the brachytherapy techniques they personally used in the treatment of cervical cancer patients for the year 1995. The replies (some of which may have been an estimate only) were tabulated. The scope of this survey did not allow us to verify the data by chart audits. RESULTS: A total of about 3500 questionnaires were mailed out; 521 responses were received. Of these responders, 206 (40%) did not perform any brachytherapy for carcinoma of the cervix in 1995. Of the other 315 responders reporting a total of 4892 patients treated in 1995, 88% used low dose rate (LDR) while 24% used high dose rate (HDR). There was a wide variation in the doses used. For LDR treatments, the median total external beam radiation therapy (EBRT) dose was 45 and 50 Gy and the LDR dose was 42 and 45 Gy for early and advanced cancers, respectively. For HDR treatments, the median EBRT dose was 48 and 50 Gy and the median HDR dose was 29 and 30 Gy for early and advanced cancers, respectively. The median dose per fraction was 6 Gy for a median of five fractions. Interstitial brachytherapy was used as a component of the treatment in 6% of the patients by 21% of responders. Very few responders treated with pulsed or medium dose rates. CONCLUSION: This retrospective survey showed the current brachytherapy practice pattern in the treatment of cervical cancer in the United States and can serve as a basis for future prospective national brachytherapy data registry. There was wide variation in the practice pattern, emphasizing the urgent need for consensus on these issues.     

Analysis of fetal breathing movements at 30-38 weeks of gestation

AIMS: This study reports the changes in patterns of fetal breathing movements recorded with a photogrammetric method in three successive periods of gestation. METHODS: Respiratory movements were studied in fetuses of 28 healthy women with uncomplicated pregnancies of 30-38 weeks of gestation. Women were divided into three groups according to gestational age of the fetus: 30-32 weeks, 7 fetuses; 33-36 weeks, 9 fetuses; and 37-38 weeks, 12 fetuses. Sonographic images of the fetuses were recorded on videotape, digitized (1 image per 0.12 s) and analyzed with specially developed software. RESULTS: The proportion of fetuses in each age group for which movements were detectable was similar in all three groups, as was the frequency of movements. Duration of a complete respiratory cycle, the inspiratory phase and the expiratory phase tended to be shorter at 33-36 weeks of gestation than in younger and older fetuses. Fetuses in the 30-32-week group had slower breathing rates than fetuses in the two older groups. CONCLUSIONS: The photogrammetric technique revealed differences in some patterns of fetal breathing movements between weeks 30-32, 33-36 and 37-38 of gestation. The data provide a sound basis for relating changes in fetal breathing movements with physiological and anatomical changes that occur as the respiratory system matures.     

Outpatient vaginal cuff brachytherapy for endometrial cancer

Abstract. Petereit DG, Tannehill SP, Grosen EA, Hartenbach EM, Schink JC. Outpatient vaginal cuff brachytherapy for endometrial cancer.
The objective of this study was to determine the efficacy and complications of postoperative high-dose-rate (HDR) vaginal-cuff brachytherapy (VCB) in patients with endometrial carcinoma. Between August 1989 to September 1997, 191 patients were treated postoperatively after a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH/BSO) with outpatient adjuvant HDR VCB for low-risk endometrial cancer (IB–84%, grade 1 or 2–96%). Patients were treated with 2 HDR fractions, delivered one week apart while under conscious sedation (16.2 Gy X 2 to the vaginal surface). All clinical endpoints were calculated using the Kaplan Meier method. The median time in the brachytherapy suite was 60 min in which no acute complications were observed. The 30-day morbidity and mortality rates were both 0%. With a median follow-up of 38 months (12–82 months), the 4-year survival, relapse-free survival, and vaginal-control rates were 95%, 98%, and 100%, respectively. One patient developed a colo-vaginal fistula at 5 years.
Adjuvant HDR VCB in 2 outpatient insertions produced 100% vaginal control rates with minimal morbidity. The advantages of high dose-rate compared to low dose-rate vaginal brachytherapy include patient convenience, markedly shorter treatment times (1 h per insertion), and reduction in the cost and potential morbidity of hospitalization. HDR brachytherapy approach is a cost-effective alternative to either low-dose-rate brachytherapy or whole pelvic radiotherapy in carefully selected patients.     

Efficacy and toxicity of concomitant cisplatin with external beam pelvic radiotherapy and two high-dose-rate brachytherapy insertions for the treatment of locally advanced cervical cancer

OBJECTIVE: There is no standard high-dose-rate (HDR) brachytherapy dose for locally advanced cervical cancer. The objective of this study was to determine the efficacy, toxicity and clinicopathologic predictive markers affecting survival using cisplatin (CDDP) concomitant with external beam pelvic radiotherapy (EBRT) and two 9-Gy HDR insertions for the treatment of locally advanced cervical cancer. METHODS: 77 consecutive patients with Stage IB2-IV cervical cancer treated with CDDP, EBRT and two 9-Gy HDR insertions were included. Kaplan-Meier methods and Cox proportional hazards models were applied for survival statistics. RESULTS: Median age was 53. 90% had squamous cell carcinoma. Median follow-up time was 3.5 years (range 0.5-12 years). Overall 5-year progression-free survival (PFS) was 75%. Local control rate and 5-year PFS were 88% and 83%, respectively, for Stages IB2/II, and 68% and 61%, respectively, for Stages III/IV. Grade 3/4 GI symptoms were the most common acute side effects (47%). Grade 3/4 late toxicities occurred in five (6%) patients. CONCLUSIONS: HDR brachytherapy regimens consisting of two 9-Gy HDR insertions have similar efficacy and side effect profiles as other brachytherapy regimens for the treatment of cervical cancer with improved safety and patient convenience.     

Clinical safety-in-use study of a new tampon design

OBJECTIVE: To confirm the safety of a new experimental Tampax tampon and applicator compared with that of a currently marketed Tampax tampon and applicator using comprehensive gynecological and microbiological assessments. METHODS: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli, Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups. RESULTS: In total, 110 women completed the study. There were no significant differences between the groups that used either the experimental or control tampon with regard to prevalence or mean cell density for the selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion or ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments. There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal, and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon. There was a more favorable overall product rating for the experimental tampon (p = 0.003). CONCLUSIONS: This approach provides a combination of gynecological, microbiological and self-reported (diary recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed tampon.