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Abstract Background Women who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women’s informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis. Methods/design This multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy. Discussion This timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12611000744954

Objective: To better serve women with gynaecological cancers, we need a sound understanding of their health, wellbeing and needs. This study sought to explore these issues in a sample of Australian women before commencing curative radiotherapy., Methods: We undertook a secondary analysis of baseline data from a supportive care trial (n = 311). Descriptive statistics were used to summarise responses to measures of wellbeing, general psychological distress, symptom distress, sexual function and vaginal changes, and supportive care needs. Pre-specified regression models were used to examine sources of variation in wellbeing and sexual function., Results: Women reported lower emotional, functional and physical wellbeing than population norms (all p < 0.001). The prevalence of general psychological distress was 31% (95% CI 26-36%). Distress caused by physical symptoms was typically low. Health system and information needs comprised eight of the top ten moderate-to-high supportive care needs. Most women reported no change in interest for physical contact or sex compared to pre-diagnosis, but some sexually active women (16-24%) reported smaller vaginal size, increased dryness, and more pain on intercourse. General psychological distress was a robust marker of poorer wellbeing and sexual function., Conclusions: Before radiotherapy, a substantial minority of women with gynaecological cancers experience general psychological distress, reduced wellbeing and moderate-to-high health system and information needs. A model of comprehensive care incorporating assessment of unmet needs, general psychological distress, and sexual issues is recommended. Healthcare providers may require training to elicit and respond to a constellation of interrelated issues and access relevant services for women requiring additional support., Competing Interests: Declaration of Competing Interest All authors declare no potential sources of conflict of interest., (Crown Copyright © 2022. Published by Elsevier Inc. All rights reserved.)

Context: Cervix cancer is still a leading cause of death in developing countries. Concurrent chemoradiation (CCRT) over 5 weeks followed by brachytherapy is standard of care in locoregionally advanced cervix cancer. Such prolonged treatment may not be tolerated in medically compromised patients. High-dose interrupted hypofractionated Quad-Shot (QS) radiotherapy with brachytherapy treatment was well tolerated., Aims: This study aims to assess the locoregional tumor control in cervix cancer patients who were treated with QS regimen., Settings and Design: Retrospective., Subjects and Methods: Newly diagnosed histologically confirmed cervix cancer patients who were unfit for conventional CCRT and who were treated with QS protocol between 1999 and 2016 were analyzed. Tumor stage, treatment, and follow-up details were retrieved from an ethics-approved prospective departmental database., Statistical Analysis Used: Descriptive statistics and Kaplan-Meier method were used for estimating survival., Results: Thirty-six patients were available for analysis. The median age was 70.5 (32-92) years. Twenty-two of 36 (61.1%) patients had nodal disease while 33% of all patients had distant metastasis. Of 27 patients who died during follow-up, the local and pelvic control was 75% and 60%, respectively. The median overall survival and progression-free survival were 18.6 months. Grade 3-4 toxicity was observed (16%) in the bowel only., Conclusions: Hypofractionated QS radiotherapy with brachytherapy resulted in an overall 82.1% at least stable disease at the primary site. This treatment regimen was well tolerated and may be considered appropriate for patients who may not be suitable for conventional fully fractionated CCRT., Competing Interests: None

Purpose: The aim of this study was to report clinical outcomes in a series of patients who underwent serial ultrasound and a single MRI to plan and verify intracavitary brachytherapy., Methods and Materials: Data for patients who were referred for curative intent radiotherapy for International Federation of Gynecology and Obstetrics (FIGO) Stage 1-1V cervix cancer between January 2007 and March 2012 were analyzed. All patients received external beam radiotherapy with concurrent chemotherapy and sequential high-dose rate brachytherapy. Brachytherapy was planned and verified using serial ultrasound imaging and a single MRI., Results: Data from 191 patients were available for analyses. The median (range) followup time was 5.08 (0.25-8.25) years. Five-year local control, failure-free survival, cancer-specific survival, and overall survival were 86%, 57.3%, 70% and 63%, respectively. Mean (standard deviation) combined external beam radiotherapy and brachytherapy target doses, equivalent to doses in 2 Gy fractions were 80.4 Gy10 (3.89), median (range) 80 (49-96) Gy10. Grade 3 or greater gastrointestinal, genitourinary, or vaginal late toxicity occurred in 3%, 1.6%, and 2% of patients, respectively. Survival, patterns of failure, and late complication rates were similar to published series of MRI/CT-based brachytherapy practices., Conclusions: This large study demonstrates that favorable treatment outcomes can be obtained using a pragmatic and innovative combination of ultrasound and MR imaging., (Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this analysis was to examine the management of cervix cancer in elderly patients referred for radiotherapy and the results of treatment in terms of overall survival (OS), relapse-free survival (RFS), and treatment-related toxicities., Methods: Patients were eligible if they were aged ≥75 years, newly diagnosed with cervix cancer and referred for radiotherapy as part of their treatment. Patient details were retrieved from the gynaecology service database where clinical, histopathological treatment and follow-up data were prospectively collected., Results: From 1998 to 2010, 126 patients aged ≥75 years, met selection criteria. Median age was 81.5 years. Eighty-one patients had definitive radiotherapy, 10 received adjuvant radiotherapy and 35 had palliative radiotherapy. Seventy-one percent of patients had the International Federation of Gynecology and Obstetrics stage 1b-2b disease. Median follow-up was 37 months. OS and RFS at 3 years among those treated with curative intent were 66.6% and 75.9% respectively with majority of patients dying without any evidence of cervix cancer. Grade 2 or more late toxicities were: bladder 5%, bowel 11%, and vagina 27%. Eastern Cooperative Oncology Group (ECOG) status was a significant predictor of OS and RFS with each unit increment in ECOG score increased the risk of death by 1.69 times (p<0.001)., Conclusion: Following appropriate patient selection, elderly patients treated curatively with radiotherapy for cervix cancer have good disease control. Palliative hypofractionated regimens are well tolerated in patients unsuitable for radical treatment., Competing Interests: No potential conflict of interest relevant to this article was reported.

Introduction: The purpose of this study is to evaluate patterns of failure, overall survival (OS), disease-free survival (DFS), prognostic factors and late toxicities in node positive International Federation of Gynaecology and Obstetrics (FIGO) stage IB cervix cancer treated with curative intent., Methods: Patients with FIGO stage IB cervix cancer and positive nodes were identified from the Peter MacCallum Cancer Centre prospective gynaecology database. Patients were treated with primary surgery and adjuvant radiotherapy (S + RT) or primary radiotherapy (primary RT). Prognostic factors examined were tumour size, histology, grade, lymphovascular invasion or corpus uterine invasion, MRI tumour volume, number of nodes involved, highest site of nodal involvement, treatment modality, age and smoking., Results: Of the 103 eligible patients, 43 patients had S + RT and 60 patients had primary RT. Tumours were significantly smaller in the S + RT group (mean 3.0 cm vs. 4.5 cm, P < 0.001). Five-year OS (95% confidence interval) and DFS (95% confidence interval) for the whole cohort was 67.6% (56.5-76.4%) and 66.1% (55.7-74.6%), respectively. Tumour diameter and number of positive nodes were significant prognostic factors for OS and DFS and smoking was related to DFS. Treatment modality was not a significant prognostic factor in OS and DFS. Of 33 patients that relapsed, 32 patients relapsed outside the pelvis. One patient failed in the pelvis only., Conclusions: Early stage cervix cancer with nodal involvement is associated with excellent pelvic disease control following curative intent treatment. Almost all relapses occurred beyond the pelvis and therefore more aggressive local treatment is unlikely to improve survival in these patients., (© 2015 The Royal Australian and New Zealand College of Radiologists.)

Background: The physical and psychosocial impact of radiotherapy for gynecologic cancer requires complex interventions to address treatment-related, psychosocial, and psychosexual and survivorship needs. A multidisciplinary approach is required to address these needs, but standard practice is varied and lacks a sound evidence base., Objective: The aim of this study was to describe the process of development and pilot testing of a novel evidence-based, complex psychoeducational intervention aiming to improve psychosocial outcomes for gynecologic-oncology patients treated curatively with radiotherapy., Methods: The intervention combines tailored nursing consultations with telephone peer support pretreatment, midtreatment, end of treatment, and posttreatment. The UK Medical Research Council framework for developing complex interventions was used to produce an evidence-based, feasible, and acceptable intervention., Results: Intervention manuals and study materials were informed by literature reviews of best-available evidence, relevant theory, and iterative consumer and expert consultations. The nurse manual specified content for consultations providing self-care information, coaching tailored to individual needs, and multidisciplinary care coordination. The peer manual described phone consultations aimed at providing psychosocial support and encouraging adherence to self-care strategies. Three peers and 1 nurse underwent rigorous skills and knowledge-based intervention delivery training. The intervention was pilot tested with 6 patients. Qualitative feedback led to minor design and content changes., Conclusions: The intervention was found to be feasible, relevant, and acceptable to participants and clinicians and is currently being tested in a national randomized controlled trial (PeNTAGOn)., Implications for Practice: The Medical Research Council framework is useful in developing nursing interventions. The specific methods and strategies described are useful for designing future complex studies targeting patient supportive care.

Purpose: To validate interoperator reliability of brachytherapy radiation therapists (RTs) in obtaining an ultrasound image and measuring the cervix and uterine dimensions using transabdominal ultrasound., Methods and Materials: Patients who underwent MRI with applicators in situ after the first insertion were included in the study. Imaging was performed by three RTs (RT1, RT2, and RT3) with varying degrees of ultrasound experience. All RTs were required to obtain a longitudinal planning image depicting the applicator in the uterine canal and measure the cervix and uterus. The MRI scan, taken 1 hour after the ultrasound, was used as the reference standard against which all measurements were compared. Measurements were analyzed with intraclass correlation coefficient and Bland-Altman plots., Results: All RTs were able to obtain a suitable longitudinal image for each patient in the study. Mean differences (SD) between MRI and ultrasound measurements obtained by RTs ranged from 3.5 (3.6) to 4.4 (4.23) mm and 0 (3.0) to 0.9 (2.5) mm on the anterior and posterior surface of the cervix, respectively. Intraclass correlation coefficient for absolute agreement between MRI and RTs was >0.9 for all posterior measurement points in the cervix and ranged from 0.41 to 0.92 on the anterior surface. Measurements were not statistically different between RTs at any measurement point., Conclusions: RTs with variable training attained high levels of interoperator reliability when using transabdominal ultrasound to obtain images and measurements of the uterus and cervix with brachytherapy applicators in situ. Access to training and use of a well-defined protocol assist in achieving these high levels of reliability., (Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess changes to the brachytherapy target over the course of treatment and the impact of these changes on planning and resources., Methods and Materials: Patients undergoing curative treatment with radiotherapy between January 2007 and March 2012 were included in the study. Intrauterine applicators were positioned in the uterine canal while patients were under anesthesia. Images were obtained by MRI and ultrasound at Fraction 1 and ultrasound alone at Fractions 2, 3, and 4. Cervix and uterine dimensions were measured on MRI and ultrasound and compared using Bland-Altman plots and repeated measures one-way analysis of variance., Results: Of 192 patients who underwent three fractions of brachytherapy, 141 of them received four fractions. Mean differences and standard error of differences between MRI at Fraction 1 and ultrasound at Fraction 4 for anterior cervix measurements were 2.9 (0.31), 3.5 (0.25), and 4.2 (0.27) mm and for posterior cervix 0.8 (0.3), 0.3 (0.3), and 0.9 (0.3) mm. All differences were within clinically acceptable limits. The mean differences in the cervix over the course of brachytherapy were less than 1 mm at all measurement points on the posterior surface. Replanning occurred in 11 of 192 (5.7%) patients, although changes to the cervix dimensions were not outside clinical limits., Conclusions: There were small changes to the cervix and uterus over the course of brachytherapy that were not clinically significant. Use of intraoperative ultrasound as a verification aid accurately assesses the target at each insertion, reduces uncertainties in treatment delivery, and improves efficiency of the procedure benefiting both the patient and staff., (Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.)

Purpose: To report 5-year outcomes of a prospective registry study investigating posttherapy FDG PET/CT in women with locally advanced cervical cancer. A secondary analysis assessing the prognostic significance of HPV infection was performed., Methods: Patients underwent definitive chemoradiation followed by a single FDG PET/CT scan for response assessment. A complete metabolic response (CMR) was defined as no evidence of FDG-avid disease. Patients were dichotomized according to HPV infection status into a 'higher-risk' group and a 'lower-risk' group, with the higher-risk group comprising those with alpha-7 strain HPV (subtypes 18, 39 and 45) and those who were HPV-negative and the lower-risk group comprising those with alpha-9 strain HPV (subtypes 16, 31, 33, 52 and 58) and those with mixed strains. Survival outcomes, patterns of failure and salvage therapy outcomes were investigated for their association with metabolic response and HPV status., Results: In 105 patients the median prospective follow-up was 5.2 years. The 5-year cancer-specific, overall and progression-free survival rates in patients with a CMR were 97 %, 93 % and 86 %, respectively. In patients without a CMR, the corresponding 5-year survival rates were 36 %, 22 % and 0 % respectively (p < 0.01). PET response was associated with patterns of failure (p < 0.01), with the 5-year freedom from local, nodal and distant failure in patients with a CMR being 94 %, 90 % and 94 %, respectively. Of 16 patients who underwent salvage therapy, 12 had disease detected on the surveillance PET scan, and 8 achieved a post-salvage CMR of whom all were alive at a median of 4.9 years. DNA adequate for HPV analysis was extracted in 68 patients. The likelihood of a PET metabolic response was not influenced by HPV infection status, with 71 % and 75 % of higher-risk and lower-risk patients, respectively, achieving CMR (p = 0.83). Higher-risk patients had a poorer OS (HR 2.6, range 1.0 - 6.6, p = 0.05) in univariable analysis but not multivariable analysis (p = 0.11)., Conclusion: At 5 years CMR remains a powerful factor predicting survival after initial and salvage therapy. Metabolic response was not associated with HPV infection risk. Further studies are required to establish the association with HPV infection risk and survival after chemoradiation.

Objective: The optimal method of assessing disease distribution in endometrial cancer is widely debated. Knowledge of disease distribution assists in planning adjuvant radiotherapy; in this study we used positron emission tomography/computed tomography (PET/CT) to assess disease distribution before radiotherapy., Methods: Seventy-three consecutive patients referred to the Peter MacCallum Cancer Centre for adjuvant radiotherapy for endometrial cancer, with either high-risk disease after a hysterectomy or recurrent disease, had a PET/CT before treatment. The findings on PET/CT and clinical course were recorded., Results: PET/CT found additional disease in 35% of postoperative patients, changing planned treatment in 31%. In the group with known recurrence, additional disease was found in 72%, changing management in 36%., Conclusions: PET/CT is a valuable tool for planning radiotherapy in endometrial cancer.

There is wide disparity in the practice of brachytherapy for cervical cancer around the world. Although select well-resourced centers advocate use of MRI for all insertions, planar X-ray imaging remains the most commonly used imaging modality to assess intracavitary implants, particularly where the burden of cervical cancer is high. Incorporating soft tissue imaging into brachytherapy programs has been shown to improve the technical accuracy of implants, which in turn has led to improved local control and decreased toxicity. These improvements have a positive effect on the quality of life of patients undergoing brachytherapy for cervical cancer. Finding an accessible soft tissue imaging modality is essential to enable these improvements to be available to all patients. A modality that has good soft tissue imaging capabilities, is widely available, portable, and economical, is needed. Ultrasound fulfils these requirements and offers the potential of soft tissue image guidance to a much wider brachytherapy community. Although use of ultrasound is the standard of care in brachytherapy for prostate cancer, it only seems to have limited uptake in gynecologic brachytherapy. This article reviews the role of ultrasound in gynecologic brachytherapy and highlights the potential applications for use in brachytherapy for cervical cancer., (Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to evaluate the patterns of failure, overall survival (OS), disease-free survival (DFS) and factors influencing outcome in endometrial cancer patients who presented with metastatic lymph nodes and were treated with curative intent., Methods: One hundred and twenty-six patients treated between January 1996 to December 2008 with surgery and adjuvant radiotherapy were identified from our service's prospective database. Radiotherapy consisted of 45 Gy in 1.8 Gy fractions to the whole pelvis. The involved nodal sites were boosted to a total dose of 50.4 to 54 Gy., Results: The 5-year OS rate was 61% and the 5-year DFS rate was 59%. Grade 3 endometrioid, serous, and clear cell histologies and involvement of upper para-aortic nodes had lower OS and DFS. The number of positive nodes did not influence survival. Among the histological groups, serous histology had the worst survival. Among the 54 patients relapsed, only three (6%) failed exclusively in the pelvis and the rest of the 94% failed in extrapelvic nodal or distant sites. Patients with grade 3 endometrioid, serous and clear cell histologies did not influence pelvic failure but had significant extrapelvic failures (p<0.001)., Conclusion: Majority of node positive endometrial cancer patients fail at extrapelvic sites. The most important factors influencing survival and extrapelvic failure are grade 3 endometrioid, clear cell and serous histologies and involvement of upper para-aortic nodes.

Background: Smoking is a risk factor for cervix cancer and causes hypoxemia, which promotes tumor infiltration and potentially impacts on treatment outcome. We performed a retrospective study to determine if smokers had an increased risk of uterine corpus infiltration, which is associated with more advanced disease and/or treatment failure after primary chemoradiation., Methods: Results from a prospective database of patients treated with primary chemoradiation for locally advanced cervix cancer with a pretreatment MRI were analyzed. Smoking status was assessed by self-report at presentation., Results: Smoking status was recorded for 346 of the 362 patients with 98 current smokers (28%), 56 ex-smokers (16%), and 192 nonsmokers (55%). Median age was 58 years with ever-smokers having a younger age at diagnosis than nonsmokers. Histologic type, International Federation of Gynecology and Obstetrics stage, tumor volume, and nodal involvement were similar across groups, as were toxicities of treatment. Ever-smokers were more likely to have corpus uterine invasion than nonsmokers. Ever-smokers had more recurrences than nonsmokers, with nonsmokers having a longer median overall survival (50.1 vs 38.7 months, P = 0.004) and relapse-free survival (46.8 vs 28.5 months, P = 0.003). In multifactor analysis, ever-smoking status was a significant predictor of developing corpus invasive disease and of inferior relapse-free and overall survival after treatment., Conclusions: Smokers have a greater risk for developing corpus invasive cervix cancer. Although nonsmokers have an older age at diagnosis, they live longer and have fewer recurrences after a diagnosis of locally advanced carcinoma of the cervix.