Trends in guideline-adherent chemoradiation therapy for locally advanced cervical cancer before and after the affordable care act.

OBJECTIVE: To assess trends in guideline-adherent chemoradiation therapy (GA-CRT) for locally advanced cervical cancer relative to Patient Protection and Affordable Care Act (ACA) implementation. METHODS: National Cancer Database patients treated with chemoradiation for locally advanced cervical cancer (FIGO 2018 Stage IB3-IVA) from 2004 to 2016 were included. GA-CRT was defined according to NCCN guidelines and included: 1) delivery of external beam radiation, 2) brachytherapy, and 3) chemotherapy, 4) no radical hysterectomy. Logistic regression was used to determine trends in GA-CRT relative to the ACA. Survival was also estimated using Kaplan-Meier analysis. RESULTS: 37,772 patients met inclusion criteria (Pre-ACA:16,169; Post-ACA:21,673). A total of 33,116 patients had squamous cell carcinoma and 4626 patients had other histologies. Forty-five percent of patients had lymph node-positive disease. A total of 14.6% of patients had Stage I disease, 41.8% had Stage II disease, 36.4% had Stage III disease, and 7.9% had Stage IVA disease. On multivariable analysis, medicare insurance (OR 0.91; 95%CI: 0.84-0.99 compared to commercial insurance), non-squamous histology (OR 0.83; 95%CI: 0.77-0.89 for adenocarcinoma) and increasing Charlson-Deyo score were associated with decreased odds of receiving GA care. Increasing T-stage was associated with greater receipt of GA-CRT. The percentage of the population that received guideline adherent care increased post-ACA (Pre-ACA 28%; Post-ACA 34%; p < 0.001). Adherence to treatment guidelines increased 2-year survival by 15% (GA 76%; Not GA 61%; p < 0.001). Increased 2-year survival was seen in the post-ACA cohort (Pre-ACA 62%; Post-ACA 69%; p < 0.001). CONCLUSIONS: Implementation of the ACA was associated with improved GA-CRT and survival in patients with locally advanced cervical cancer.

Congress of Neurological Surgeons systematic review and evidence-based guidelines update on the role of radiation therapy in the management of progressive and recurrent glioblastoma in adults.

TARGET POPULATION: These recommendations apply to adult patients (18 years of age and above) with progressive/recurrent glioblastoma multiforme (pGBM) after first line combined multimodality treatment. QUESTION: Can re-irradiation (by using conventional radiotherapy, fractionated radiosurgery, or single fraction radiosurgery) be used in patients with pGBM after the first adjuvant combined multimodality treatment with radiation and chemotherapy? RECOMMENDATION: Level III: When the target tumor is amenable for additional radiation, re-irradiation is recommended as it provides improved local tumor control, as measured by best imaging response. Such re-irradiation can take the form of conventional fractionation radiotherapy, fractionated radiosurgery, or single fraction radiosurgery. LEVEL III: Re-Irradiation is recommended in order to maintain or improve a patient's neurological status and quality of life prior to any further tumor progression.

Trends in inpatient palliative care use for primary brain malignancies.

INTRODUCTION: Primary brain malignancies (PBMs) pose significant morbidity and poor prognosis. Despite NCCN recommendations that palliative care should be integrated into general oncologic care plans, it has been historically underused in patients with PBM. We sought to examine trends and factors associated with inpatient palliative care use in patients with PBM. METHODS: Data from the 2007-2016 National (Nationwide) Inpatient Sample was analyzed for descriptive statistics and trends. Multivariable logistic regression was used to identify factors associated with inpatient palliative care in patients with PBMs. RESULTS: Of the 510,238 observed hospitalizations of adults with PBM in a 10-year period, 37,365 (7.3%) had an associated inpatient palliative care consult. Rates of inpatient palliative care have increased significantly over the 10-year period, from 2.3 in 2007 to 11.9% in 2011. Patients receiving inpatient palliative care were less likely to receive inpatient oncologic treatment such as brain surgery, chemotherapy, or radiation compared to those without palliative care (14.6% with palliative care vs. 42.4% without, p < 0.001). They were more likely to receive life-sustaining treatments such as intubation, mechanical ventilation, tracheostomy, nutritional support, hemodialysis, or CPR (21.0% with palliative care vs. 10.4% without, p < 0.001). Palliative care was associated with decreased cost of admission ($18,602 with palliative care vs. $20,077 without). In a multiple variable logistic regression, age, non-elective admission, comorbidities, history of chemotherapy and radiation, and mechanical ventilation were associated with significantly increased odds of receiving palliative care. CONCLUSIONS: Inpatient palliative care utilization for patients hospitalized with PBM significantly increased between 2007 and 2016, though the service is still underutilized in the context of the severe symptoms and poor prognosis associated with PBM.

Impact of pathologic lymph node-positive renal cell carcinoma on survival in patients without metastasis: Evidence in support of expanding the definition of stage IV kidney cancer.

BACKGROUND: Stage III renal cell carcinoma (RCC) encompasses both lymph node-positive (pT1-3N1M0) and lymph node-negative (pT3N0M0) disease. However, prior institutional studies have indicated that among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease. The objective of the current study was to validate these findings using a large, nationally representative sample of patients with kidney cancer. METHODS: Patients with AJCC stage III or stage IV RCC were identified using the National Cancer Data Base (NCDB). Patients were categorized as having lymph node-positive stage III (pT1-3N1M0), lymph node-negative stage III (pT3N0M0), or stage IV metastatic (pT1-3 N0M1) disease. Cox proportional hazards models compared outcomes while adjusting for comorbidities. Kaplan-Meier estimates illustrated relative survival when comparing staging groups. RESULTS: A total of 8988 patients met the inclusion criteria, with 6587 patients classified as having lymph node-negative stage III disease, 2218 as having lymph node-positive stage III disease, and 183 as having stage IV disease. Superior survival was noted among patients with lymph node-negative stage III disease, but similar survival was noted between patients with lymph node-positive stage III and stage IV RCC, with 5-year survival rates of 61.9% (95% confidence interval [95% CI], 60.3%-63.4%), 22.7% (95% CI, 20.6%-24.9%), and 15.6% (95% CI, 11.1%-23.8%), respectively. CONCLUSIONS: Current RCC staging systems group pT1-3N1M0 and pT3N0M0 disease as stage III disease. However, the results of the current validation study suggest the need for further stratification and even placement of patients with pT1-3N1M0 disease into the stage IV category. Staging that accurately reflects oncologic prognosis may help clinicians better counsel and select patients who might derive the most benefit from lymphadenectomy, adjuvant systemic therapy, more rigorous imaging surveillance, and clinical trial participation.

A retrospective analysis on safety and effectiveness of hypofractioned post-mastectomy radiotherapy.

The data supporting hypofractionated post-mastectomy radiotherapy is limited. The purpose of this study is to present the experience from Tarnów of hypofractionated PMRT over 20 fractions with respect to toxicity and effectiveness. We delivered post-mastectomy radiotherapy at the dose of 45 Gy in 20 fractions to the chest wall and the draining regional lymph nodes. The primary outcome of interest was to ensure that the rate of grade 3 or greater toxicity from the hypofractionation, at any time point, was non-inferior to standard post-mastectomy radiotherapy. We conducted a retrospective analysis of 211 women with stages I-IV breast cancer. After a median follow-up of 30 months, there were four reported grade 3 toxicities, with grade 3 lymphedema being the most frequent (1.5%). There were 134 reported grade 2 toxicities, with grade 2 fatigue being the most frequent (18%). There were six instances of isolated locoregional (6 of 211; 2.8%). Three-year estimated local recurrence-free survival was 96.4% (95% CI 0.921-0.984). The 3-year estimated distant recurrence-free survival was 77.8% (95% CI 0.699-0.838). To our knowledge, the results presented here are the largest single institution experience of hypofractionated post-mastectomy radiotherapy published in the literature to date. Our fractionation scheme, 45 Gy in 20 fractions, seems to be safe and effective with low toxicity.

Risk of leptomeningeal carcinomatosis in patients with brain metastases treated with stereotactic radiosurgery.

There is limited available literature examining factors that predispose patients to the development of LMC after stereotactic radiosurgery (SRS) for brain metastases. We sought to evaluate risk factors that may predispose patients to LMC after SRS treatment in this case-control study of patients with brain metastases who underwent single-fraction SRS between 2011 and 2016. Demographic and clinical information were collected retrospectively for 19 LMC cases and 30 controls out of 413 screened patients with brain metastases. Risk factors of interest were evaluated by univariate and multivariate logistic regression analyses and overall survival rates were evaluated by Kaplan-Meier survival analysis. About 5% of patients with brain metastases treated with SRS developed LMC. Patients with LMC (median 154 days, 95% CI 33-203 days) demonstrated a poorer overall survival than matched controls (median 417 days, 95% CI 121-512 days, p = 0.002). The most common primary tumor histologies  that lead to the development of LMC were non-small cell lung cancer (36.8%), breast cancer (26.3%), and melanoma (21.1%). No association was found between the risk of LMC and the location of the brain lesion or total volume of brain metastases. Prior surgical resection of brain metastases before SRS was associated with a 6.5 times higher odds (95% CI 1.45-29.35, p = 0.01) of developing LMC post-radiosurgery compared to those with no prior resections of brain metastases. Additionally, adjuvant WBRT may help to reduce the risk of LMC and can be considered in decision-making for patients who have had brain metastasectomy.

Local Therapy Improves Overall Survival in Patients With Newly Diagnosed Metastatic Prostate Cancer.

BACKGROUND: The role of local therapy, in the form of radiation therapy (RT) or radical prostatectomy(RP), and its association on outcomes is not well established in patients with metastatic prostate cancer. METHODS: Using the National Cancer Database (NCDB), we evaluated patterns of care and outcomes among patients diagnosed with metastatic prostate cancer from 2004 to 2013 treated with local therapy (RP, intensity-modulated radiation therapy [IMRT], or 2D/3D-conformal radiation therapy [CRT]). The association between local therapy, co-variates, and outcomes was assessed in a multivariable Cox proportional hazards model and Propensity score (PS) matching was performed to balance confounding factors. Survival was estimated using the Kaplan-Meier method. RESULTS: Among the 1,208,180 patients in the NCDB with prostate cancer, 6,051 patients met the inclusion criteria. No local therapy was used in 5,224 patients, while 622 (10.3%), 52 (0.9%), 153 (2.5%) patients received RP, IMRT, and 2D/3D-CRT, respectively. Use of local therapy was associated with younger age (≤70), lower co-morbidity score, lower T-stage, Gleason score <8, node-negative status, private, and Medicare insurance, higher income quartile, and treatment at comprehensive or academic/research programs (P < 0.05). Five-year overall survival for patients receiving local therapy was 45.7% versus 17.1% for those not receiving local therapy (P < 0.01). In multivariate analysis, RP (HR = 0.51; 95%CI, 0.45-0.59, P < 0.01) and IMRT (HR = 0.47; 95%CI, 0.31-0.72, P < 0.01) were independently associated with superior overall survival. After PS-matching, the use of local therapy (RP or IMRT) remained significantly associated with overall survival (HR = 0.35; 95%CI, 0.30-0.41, P < 0.01). CONCLUSIONS: The use of RP and IMRT, to treat the primary disease, was associated with improvements in overall survival for patients with metastatic prostate cancer. We have identified patient-specific variations in the use of local therapy that may be tested in subsequent prospective clinical trials to improve patient outcomes in this setting. Prostate 77: 559-572, 2017. © 2017 Wiley Periodicals, Inc.

Effect of travel distance and time to radiotherapy on likelihood of receiving mastectomy.

BACKGROUND: Breast-conserving surgery (BCS) followed by adjuvant radiation therapy (RT) is the standard of care for women with early-stage breast cancer as an alternative to mastectomy. The purpose of this study was to examine the relationship between receipt of mastectomy and travel distance and time to RT facility in New Jersey (NJ). METHODS: Data were collected from a cohort of 634 NJ women diagnosed with early-stage breast cancer. In patients receiving RT, the precise RT facility was used, whereas in patients not receiving RT, surgeons were contacted to determine the location of RT referral. Travel distance and time to RT facility from the patients' residential address were modeled separately using multiple binomial regression to examine their association with choice of surgery while adjusting for clinical and sociodemographic factors. RESULTS: Overall, 58.5 % patients underwent BCS with median travel distance to the radiation facility of 4.8 miles (vs. 6.6 miles for mastectomy) and median travel time of 12.0 min (vs. 15.0 min for mastectomy). Patients residing > 9.2 miles compared with ≤ 9.2 miles from radiation facility were 44 % more likely to receive mastectomy. Additionally, patients requiring > 19 min compared with ≤ 19 min of travel time were 36 % more likely to receive mastectomy. CONCLUSIONS: These data found that travel distance and time from RT facility act as barriers to undergoing BCS in women with early-stage breast cancer. Despite being in an urban region, a significant number of women in NJ with early-stage breast cancer did not receive BCS.

ACR Appropriateness Criteria® Ductal Carcinoma in Situ.

Ductal carcinoma in situ (DCIS) is a breast neoplasm with potential for progression to invasive cancer. Management commonly involves excision, radiotherapy, and hormonal therapy. Surgical assessment of regional lymph nodes is rarely indicated except in cases of microinvasion or mastectomy. Radiotherapy is employed for local control in breast conservation, although it may be omitted for select low-risk situations. Several radiotherapy techniques exist beyond standard whole-breast irradiation (ie, partial-breast irradiation [PBI], hypofractionated whole-breast radiation); evidence for these is evolving. We present an update of the American College of Radiology (ACR) Appropriateness Criteria® for the management of DCIS. The ACR Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions, which are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review includes an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi technique) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Racial Disparities in Hypofractionated Radiotherapy Breast Cancer Clinical Trials.

There is a paucity of data regarding factors affecting enrollment onto radiation oncology clinical trials. The purpose of this study was to determine patients and tumor characteristics that influenced enrollment of breast cancer patients onto hypofractionated breast radiotherapy trials (HBRTs) at a single institution. In this retrospective cohort study, patients enrolled on HBRTs at the Rutgers Cancer Institute of New Jersey (n = 132) were compared with a cohort of breast cancer patients eligible for, but not enrolled onto HBRTs treated during the same time period (n = 132). Charts were retrospectively reviewed to determine patients' demographics, clinico-pathologic factors, and treatment characteristics. Statistical analysis was performed to analyze variables affecting enrollment onto HBRTs between the two groups. Over a 42-month time period, 132 patients treated on HBRTs received 2,475-4,995 cGy over 3 to 15 fractions. When compared with patients treated off trial, there was no statistically significant effect of age, family history, lymph node positivity, tumor grade, estrogen or Her-2 receptor status, use of chemotherapy or hormones, use of brachytherapy, or the site of initial consultation on HBRT enrollment. Non-White women were less likely to enroll in HBRT's when compared with White women (25.7% versus 40.1%, p = 0.0129), though this was found to be a nonsignificant trend when taking stage into consideration on multivariate analysis (OR for lower T-stage: 0.281, p = 0.003, OR 1.839 for white race, p = 0.076). Consistent with previous studies, non-White women were less likely to enroll in HBRTs than White women. However, disease stage accounted for these racial disparities. Further studies must be performed to determine if race is an independent factor determining radiation oncology clinical trial enrollment.

ACR Appropriateness Criteria local-regional recurrence (LRR) and salvage surgery-breast cancer.

Although both breast-conserving surgery and mastectomy generally provide excellent local-regional control of breast cancer, local-regional recurrence (LRR) does occur. Predictors for LRR include patient, tumor, and treatment-related factors. Salvage after LRR includes coordination of available modalities, including surgery, radiation, chemotherapy, and hormonal therapy, depending on the clinical scenario. Management recommendations for breast cancer LRR, including patient scenarios, are reviewed, and represent evidence-based data and expert opinion of the American College of Radiology Appropriateness Criteria Expert Panel on LRR.The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel.The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Fixed and random effect selections in generalized linear mixed models.

Generalized linear mixed models are commonly used to describe relationships between correlated responses and covariates in medical research. In this paper, we propose a simple and easily implementable regularized estimation approach to select both fixed and random effects in generalized linear mixed model. Specifically, we propose to construct and optimize the objective functions using the confidence distributions of model parameters, as opposed to using the observed data likelihood functions, to perform effect selections. Two estimation methods are developed. The first one is to use the joint confidence distribution of model parameters to perform simultaneous fixed and random effect selections. The second method is to use the marginal confidence distributions of model parameters to perform the selections of fixed and random effects separately. With a proper choice of regularization parameters in the adaptive LASSO framework, we show the consistency and oracle properties of the proposed regularized estimators. Simulation studies have been conducted to assess the performance of the proposed estimators and demonstrate computational efficiency. Our method has also been applied to two longitudinal cancer studies to identify demographic and clinical factors associated with patient health outcomes after cancer therapies.

Long-Term Clinical and Cosmetic Outcomes of Once-Daily Accelerated Partial Breast Irradiation in Early Breast Cancer.

Purpose: Accelerated partial breast irradiation (APBI) is one of the standard treatment options in early-stage node negative breast cancer in selected patients. However, the optimal dose fractionation schedule still represents a challenge. We present the 12-year follow up results of clinical and cosmetic outcomes of once daily APBI with external beam radiation therapy which provides an APBI radiation dose equivalent to the whole breast radiation with a boost. Methods and Materials: From July 2008 to August 2010, we enrolled 34 patients with T1, T2 (< 3cm) N0 to receive once daily APBI with three dimensional conformal radiation therapy (3D-CRT) to a total dose of 49.95 Gy over 15 single daily fractions over 3 weeks at 3.33 Gy per fraction. Ipsilateral breast tumor recurrence (IBTR), acute toxicity, late toxicity and cosmesis was analyzed. The median follow-up for all patients is 144 months (12 years). Results: The median age of the patients was 61 years (range 46-83). Nine patients had ductal carcinoma in situ (DCIS) and 25 patients had invasive cancer. The median size of the tumor with DCIS pathology was 0.5 cm, while median size of the tumor with invasive cancer pathology was 1.0 cm. All of the patients had negative margins and negative nodes. Two IBTR was observed (5.8%). One patient had DCIS at recurrence and other had invasive recurrence. Two patients died due to non-cancer cause. The 12-year actuarial ipsilateral breast recurrence free survival was 93.5% and the 12-year actuarial overall survival was 93.2%. Late Grade 2 toxicity was observed in 6 patients and late grade 3 toxicity was seen in 1 patient. 91% of the patients had excellent to good cosmesis. Conclusions: This novel APBI dosing schema is based on an equivalent dose compared to whole breast radiation plus a tumor bed boost. This once daily APBI scheme is well-tolerated and demonstrates good to excellent cosmetic outcome and low rates of late complications on long term follow-up.

Lumpectomy closure technique does not affect dosimetry in patients undergoing external-beam-based accelerated partial breast irradiation.

BACKGROUND: During the breast lumpectomy procedure, surgeons traditionally elect to use either a superficial or full-thickness closure when sealing the wound depending on surgeon preference as well as desired outcomes. The purpose of this study was to examine dosimetric endpoints in patients with superficial versus full-thickness closures with accelerated partial breast irradiation (APBI). METHODS: Patients who underwent breast conservation surgery followed by 3D conformal external-beam APBI were identified (n = 45) and were separated according to the type of cavity closure performed: superficial and full thickness. Data gathered from the retrospective review of patient charts was analyzed according to criteria in the NSABP B-39 protocol in order to quantify the amount of radiation delivered to organs at risk. The patient seroma cavity was further given a cavity visualization score to assess the impact of wound closure on treatment planning. RESULTS: There was no significant difference in the mean CVS score for the 2 groups. There were no statistical differences in all dosimetric endpoints compared for the 2 types of closure, and both groups met NSABP B-39 guidelines for the ipsilateral breast, heart, and ipsilateral lung dosimetry. CONCLUSIONS: We found no significant difference in dosimetric outcomes in either the superficial or deep closure treatment groups. Breast surgeons should not alter their preferred closure strategy in anticipation of 3D-CRT APBI.

Interferon-induced protein with tetratricopeptide repeats 1 (IFIT1) as a prognostic marker for local control in T1-2 N0 breast cancer treated with breast-conserving surgery and radiation therapy (BCS + RT).

Interferon-induced protein with tetratricopeptide repeats 1 (IFIT1) expression, involved in the regulation of translation, has been implicated to mediate resistance to chemotherapy and radiation in cancer cells in vitro. The purpose of this study was to evaluate the prognostic significance of IFIT1 protein expression in patients with breast cancer treated with Breast-Conserving Surgery and Radiation Therapy (BCS + RT). A tissue microarray was constructed with specimens from 282 women with node-negative, early-stage (I/II) breast cancer who were treated with BCS + RT. Immunohistochemistry was used to stain for the IFIT1 protein. Cytoplasmic IFIT1 protein expression levels were correlated with clinicopathologic factors, local relapse-free survival (LRFS), disease-free survival (DFS), and overall survival (OS). IFIT1 positivity was found in 123 (49%) of cases. The median follow-up time was 7.3 years. Eighty percent of the patients had T1 disease, 88% were human epidermal growth factor receptor 2 (HER2) negative, and 20% had triple-negative breast cancer (TNBC). IFIT1 positivity was associated with estrogen receptor negative status (p = 0.002), progesterone receptor negative status (p = 0.02), TNBC (p = 0.01), and HER2-positive status (p = 0.006). In univariate and multivariate analysis, IFIT1 positivity was associated with improved LRFS (p = 0.055 and p = 0.04, respectively). Using a log-rank test, IFIT1 positivity was found to be associated with improved LRFS (94% versus 85%, p = 0.046) but not DFS or OS at 10 years. On subset analysis of the TNBC patients, IFIT1 positivity was found to correlate with improved LRFS (100% versus 53%, p = 0.004) and DFS in (87% versus 49%, p = 0.048) at 10 years. Elevated IFIT1 protein expression is associated with improved LRFS. In addition, our data suggest that IFIT1 expression may help risk stratify patients with TNBC who may benefit from more aggressive therapy. As there is limited data on IFIT1 in breast cancer, additional work is needed to ascertain its significance.

The relative benefits of tamoxifen in older women with T1 early-stage breast cancer treated with breast-conserving surgery and radiation therapy.

Small, hormone receptor-positive breast carcinomas in older women are associated with low local recurrence rates. The relative benefits of adjuvant hormonal therapy remain unclear in elderly women with small, node-negative breast cancer after breast-conserving surgery and adjuvant radiation therapy. From our institutional data base, 224 patients ≥65 years of age with T1N0M0 breast cancer treated with BCS+RT were identified. Of these, 102 patients (45.5%) received tamoxifen (TAM) and 122 patients (54.5%) did not (no-TAM). The median follow-up time was 62.6 months. The 10-year local relapse-free survival (LRFS) was 98% in both the TAM and no-TAM cohorts (p = 0.58); the 10-year DMFS was 83% TAM vs. 89% no-TAM (p = 0.91). There was no difference in 10-year contralateral breast relapse or overall survival (OS) between the two cohorts. In univariate and multivariate analysis, use of TAM was not associated with LRFS, distant metastases-free survival (DMFS), OS, or a reduction in contralateral breast cancers when compared with the no-TAM cohort. In this large cohort of T1N0 elderly breast cancer patients treated with CS+RT, the use of TAM did not appear to decrease ipsilateral breast relapse, contralateral breast relapse, distant metastasis, or OS.

Prostate Cancer Outcomes in Patients Living With HIV/AIDS Treated With Radiation Therapy: A Systematic Review.

Purpose: A consensus has not been reached regarding the treatment and outcomes of prostate cancer (PCa) in people living with HIV/AIDS (PLWHA). This systematic review aims to summarize the evidence on the management of PCa with radiation therapy (RT) in PLWHA diagnosed with PCa. Methods and Materials: Searches were conducted in the PubMed, Cochrane Library, and Scopus databases during September 2021 using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Articles reporting on outcomes of PLWHA treated for PCa with definitive RT were sought for inclusion. Results: A total of 9 studies with 187 patients with HIV who received diagnoses of PCa met inclusion criteria. The duration of HIV infection to PCa diagnosis ranged from 8.5 to 18.6 years with 69% to 100% of patients on highly active antiretroviral therapy at the time of diagnosis. Patients' prostate-specific antigen levels ranged from 8 to 82 ng/mL. The majority of patients (59%) were treated with external beam RT, followed by brachytherapy (20.5%). The 4- or 5-year biochemical failure-free rate was reported to be between 87% and 97% in 3 studies, and 2 studies reported an 84% to 97% 5-year cancer-specific survival. Using Common Terminology Criteria for Adverse Events criteria, 3 studies reported toxicities and grade 3 toxicity was observed in only 2 patients. Conclusions: RT is efficacious and well tolerated in PLWHA as supported by the comparable biochemical control, clinical outcome, and mortality to the general population as well as by the mild reports of radiotoxicity. There is mixed evidence regarding the effect of RT on CD4 count and viral load, and further studies are needed to better understand this relationship. These findings support the use of definitive RT in PLWHA with PCa.

Management of Localized Prostate Cancer in Men With Human Immunodeficiency Virus: Analysis of a Large Retrospective Cohort.

INTRODUCTION: We aimed to characterize the clinicopathological characteristics and outcomes of HIV-positive patients with clinically localized, prostate cancer (PCa). METHODS: A retrospective study was conducted of HIV-positive patients from a single institution with elevated PSA and diagnosis of PCa by biopsy. PCa features, HIV characteristics, treatment type, toxicities, and outcomes were analyzed by descriptive statistics. Kaplan-Meier analysis was used to determine progression-free survival (PFS). RESULTS: Seventy-nine HIV-positive patients were included with a median age at PCa diagnosis of 61 years-old and median duration from HIV infection to PCa diagnosis of 21 years. The median PSA level at diagnosis and Gleason Score was 6.85 ng/mL and 7, respectively. The 5-year PFS was 82.5% with the lowest survival observed in patients treated with radical prostatectomy (RP) + radiation therapy (RT), followed by cryosurgery (CS). There were no reports of PCa-specific deaths, and the 5-year overall survival was 97.5%. CD4 count declined post-treatment in pooled treatment groups that included RT (P = .02). CONCLUSION: We present the characteristics and outcomes of the largest cohort of HIV-positive men with prostate cancer in published literature. RP and RT ± ADT is well-tolerated in HIV-positive patients with PCa as seen by the adequate biochemical control and mild toxicity. CS resulted in worse PFS compared to alternative treatments for patients within the same PCa risk group. A decline in CD4 counts was observed in patients treated RT, and further studies are needed to investigate this relationship. Our findings support the use of standard-of-care treatment for localized PCa in HIV-positive patients.

Efficacy and safety of regorafenib as second-line treatment for patients with hepatocellular carcinoma and macrovascular invasion and(or) extrahepatic metastasis.

Background: Macrovascular invasion and(or) extrahepatic metastasis are the main clinical characteristics of Chinese patients with hepatocellular carcinoma (HCC) after entering the second-line treatment. The aim of this study was to explore the efficacy and safety of regorafenib as a second-line treatment for these patients with HCC. Methods: We selected 253 patients with primary liver cancer who were treated in Henan Cancer Hospital from June 2017 to September 2020. According to the inclusion and exclusion criteria, 63 patients with HCC with macrovascular invasion and/or extrahepatic metastasis were finally included. The clinical data of patients were obtained by consulting the electronic medical record system and through telephone follow-up. The median overall survival (mOS), duration of drug use, and disease control rate (DCR) of patients were evaluated, and the Cox regression model was used to analyze the risk factors of prognosis. Results: The mOS of 63 patients with HCC administered regorafenib as second-line treatment was 9.6 months, the duration of drug use was 3.8 months, and the DCR was 59% (37/63). Cox multivariate analysis showed that overall survival (OS) was closely related to the level of alpha-fetoprotein (AFP) and treatment method but not to the type of first-line drug. The mOS of patients with AFP ≥400 ng/mL was 7.4 months, which was significantly lower than that of those with AFP <400 ng/mL (12.5 months) (P=0.0052). The mOS of patients treated with regorafenib alone was 6.8 months, which was significantly lower than that of those treated with regorafenib combined with immunotherapy (24.3 months) and intervention therapy (17.5 months) (P<0.0001). The mOS of patients using regorafenib as second-line treatment in the first-line sorafenib group and first-line nonsorafenib group were 9.5 and 9.6 months, respectively (P=0.9766). The grade ≥3 adverse events (AEs) with an incidence of more than 10% included hand-foot syndrome, increased bilirubin, decreased albumin, and elevated transaminase, with incidences of 22%, 14%, 11%, and 10%, respectively. Conclusions: As second-line treatment for patients with HCC with macrovascular invasion and(or) extrahepatic metastasis, regorafenib has definite efficacy and tolerable adverse reactions. It is the preferred drug for the second-line treatment of patients with advanced HCC.

Radiology and radiation oncology considerations for transgender and intersex patients: A qualitative study.

INTRODUCTION: In this qualitative study, we explored experiences of radiologists and radiation oncologists in providing clinical care to transgender, gender diverse (TGD), and intersex patients by asking about comfort level, relevant past training and training gaps, and clinical recommendations for TGD and intersex patient care. METHODS: A purposive sample of radiology and radiation oncology professionals (n = 16) from diverse practice settings were interviewed on a videoconferencing platform. Transcripts were auto-populated and checked manually for accuracy. Two coders used a mix of deductive and inductive coding to identify key themes. Member checking was conducted with interviewees. RESULTS: Participants reported major gaps in training, knowledge, and confidence related to all aspects of TGD and intersex patient care. Recommendations for improvements included training that encompassed key terminology, how to conduct a physical exam on TGD and intersex patients, radiology and radiation oncology adaptations for TGD and intersex patients, and care coordination among multi-disciplinary oncology team members and gender affirming care providers. Exposure to diverse TGD and intersex persons in personal and professional life contributed to higher levels of comfort among providers in caring for TGD and intersex patients. CONCLUSION: Gaps in knowledge and limited confidence characterized the sample. Training at all levels is needed to improve radiology and radiation oncology care for TGD and intersex patients.