Results presented at the 22nd Annual Meeting of the Society of Urologic Oncology indicate that the rates of upgrading and adverse pathology at radical prostatectomy cancer are similar in Hispanic and non-Hispanic men with prostate cancer.

“Hispanics are the largest ethnic minority and one of the most rapidly growing populations in the United States and prostate cancer is the highest incident non-cutaneous malignancy in this population,” said Helen Y. Hougen, MD, SUO fellow at the University of Miami, during a presentation of the findings. However, compared with other well studied populations, such as White non-Hispanic or Black men, the Hispanic or Latino population as a whole has been studied to a lesser extent, either it's combined with disparate groups or excluded altogether.”

Researchers sought to examine a rate and pattern of upgrading (any increase in Gleason grade [GG] from biopsy to prostatectomy) and adverse pathology (extraprostatic extension, seminal vesicle invasion, lymph node-positive) in Hispanic patients using an institutional prostatectomy database, specifically in the south Florida region.

Previously, the SEER database has demonstrated there are similar survival outcomes between Hispanic and White patients with prostate cancer; however, this database does not include South Florida—which has a high population of Hispanic men.

Patients included in the study were non-Hispanic White (NHW; n = 688), Hispanic White (HW; n = 736), and Black (n = 426) men who underwent a radical prostatectomy between 2014 and present. There was no significant difference in age, body mass index (BMI), prostate-specific antigen (PSA), prostate size, or biopsy GG between groups.

Results demonstrated that 651 patients had upgrading, and it was not different between groups.

On the univariable analysis, patients who were Black had a lower rate of adverse pathology compared with patients who were White. Hougen explained this may be because the Black population in south Florida has a greater number of men who are of Caribbean decent, not of African origin.

In the multivariable analysis, significant predictors for upgrading included older age, higher PSA, and lower prostate weight. And there were no differences observed between the three groups and the rate of upgrading.

Adverse pathology odds increased with older age, higher PSA, higher BMI, lower prostate weight, increased number of biopsy cores, and higher GG.

“Hispanic (patients) are more negatively impacted by socioeconomic factors, such as neighborhood effects, compared (with White patients). However, despite this, they have similar survival compared with white (patients) suggesting an at least equal, if not more favorable, cancer characteristic,” Hougen concluded.

Hourgen H, Iakymenko O, Punnen S, et al. Race is not associate with prostate cancer upgrading in Hispanic men undergoing radical prostatectomy. Presented at: Society of Urologic Oncology 22nd Annual Meeting; November 30-December 3, 2021; Orlando, FL. Abstract 148

Articles

Hispanics are the largest ethnic minority and one of the most rapidly growing populations in the United States. Prostate cancer represents the highest incident non-cutaneous malignancy in this population.

Rates of Upgrading, Adverse Pathology Similar in Hispanic and White Non-Hispanic Men With Prostate Cancer

Lindsay Fischer is the Associate Editor at ONN. She joined MJH life sciences in 2021 after graduating from Rutgers University with majors in both English and Spanish and a minor in creative writing. When she is not writing, or researching the latest oncology nursing news, Lindsay is an amateur backpacker and rollerblader. Email Lindsay at lfischer@mjhlifesciences.com

The majority of patients with prostate cancer adjusted their androgen deprivation therapy (ADT) post-scan management plan after receiving a 18F-fluciclovine PET/CT scan, according to findings presented at the 22nd Society of Urologic Oncology Annual Meeting.

Moreover, after the scans identified lesions, plans were commonly amended to target salvage therapy and spare patients the morbidity associated with ADT, said investigators.

Specifically, a total of 93 out of 146 patients (64%) had a change in management plan following their scans. The scan results also caused 55 patients (59%) to no longer have ADT included in their care plan. Furthermore, only 25% of patients who initially had a plan to receive ADT as a monotherapy still had a plan for ADT monotherapy post 18F-fluciclovine PET/CT.

“The advent of highly sensitive molecular imaging has allowed the identification of men with oligometastatic disease to may be more optimally treated with metastasis directed therapy than with systemic treatments, such as androgen deprivation therapy,” explained Gerald L. Andriole, Jr., MD, Division of Urologic Surgery, Department of Surgery, and the Alvin J. Siteman Cancer Center, Washington University School of Medicine, in a presentation of the findings. “So, the goal of this particular study was to evaluate the impact of 18F-fluciclovine PET scans on plans to use androgen deprivation therapy in patients with biochemical recurrence.”

Investigators performed a secondary analysis of 2 treatment alteration studies: LOCATE (NCT02680041) and FALCON (NCT02680041). Out of the 317 patients with biochemical recurrence (BCR) enrolled in these studies, 146 had ADT, either as a monotherapy or in combination with another treatment modality, included in their post-scan plan.

PET/CT detection rates for prostate/prostate bed region; pelvic and extra-pelvic lymph nodes (LN); and soft tissues and bones, were determined at a per-patient level. The post hoc analysis compared post-scan treatment plans with pre-scan treatment plans and used imagining findings to stratify the data.

Sixty patients in the study were initially planned to receive ADT as a monotherapy, while 86 were initially going to receive ADT with another modality. Overall, lesions were detected in 85 patients (58%) who were planning to receive ADT. Lesions were detected in prostate/bed, pelvic LN, extra-pelvic LN, and soft tissue and bones, at rates of 30%, 25%, 13%, 2.1% and 13%, respectively.

Findings revealed that 25 patients (17%) had positivity that was limited to the prostate/prostate bed, 21 patients (14%) had 18F fluciclovine–positive pelvic nodes, and 39 patients (27%) had positive detection beyond the prostate/bed and pelvic nodes.

Notably, patients with the most disseminated disease (extra-pelvic involvement,12/30; 40%) were the patients who were likely to have a post-scan plan for ADT monotherapy. In contrast, patients with a negative scan were most likely to have a modified post-scan plan which aborted ADT (14/54; 26%). Among those whose post-scan plan aborted ADT, local disease was common.

“So, in summary, data from two prospective trials indicate that 18F-fluciclovine significantly influences the management plans for a majority of patients who had a pre-scan plan that included androgen deprivation therapy,” concluded Andriole. “Androgen deprivation therapy was aborted in about 40% of the patients originally intended to receive that and management plans were commonly amended to target salvage metastasis directed treatment to 18F-fluciclovine PET/CT abnormalities, and this spared the patients the morbidity associated with androgen deprivation therapy.”

1. Andriole GL, Scarsbrook AF, Davis P, Chaglassian A, et al. Impact of 18f-fluciclovine PET/CT on plans for ADT in patients with biochemical recurrence of prostate cancer; data analysis from 2 prospective clinical trials. Presented at: Society of Urologic Oncology 22nd Annual Meeting; November 30-December 3, 2021; Orlando, FL. Abstract 144.

A secondary analysis of 2 treatment alterations studies demonstrated that 18F-fluciclovine PET/CT scans play a pivotal role in determining if androgen deprivation therapy is appropriate for patients with prostate cancer. 

18F-fluciclovine PET/CT Significantly Influences ADT Plans for Patients with Prostate Cancer

Pembrolizumab (Keytruda) has been granted an FDA approval on the indication of adults and pediatric patients (aged 12 and older) with stage IIB or IIIC melanoma following complete resection.

The regulatory agency also expanded the indication for the immunotherapy for adjuvant use in patients with stage III melanoma following CR to include pediatric patients aged 12 years and older.

The indication for the agent's use in patients with stage IIB and IIC melanoma is based on findings from the first interim analysis of the phase 3 KEYNOTE-716 trial (NCT03553836), in which pembrolizumab resulted in a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% (HR, 0.65; 95% CI, 0.46-0.92; 

= .0132) vs placebo. Specifically, the median RFS was not reached in either treatment arm.

After a median follow-up of 14.4 months, 11% (n = 54/487) of patients who received the immunotherapy experienced a recurrence or died vs 17% (n = 82/489) of those who were given placebo.

Efficacy in pediatric patients, aged 12 years and older, who had stage IIB, IIC and III melanoma is supported by extrapolation of efficacy findings from adults, given similar biology, pharmacology of drug effect, as well as similar exposure-response for efficacy and safety.

“The standard of care for patients with resected stage IIB and IIC melanoma has been observation, despite the fact that for these patients, the risk of recurrence is nearly the same as for patients with later-stage disease for whom treatment is recommended,” Jason Luke, MD, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, stated in a press release. “Today’s approval of pembrolizumab for the adjuvant treatment of patients 12 years and older with stage IIB and IIC melanoma following complete resection is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning.”

The multicenter, double-blind, placebo-controlled phase 3 trial enrolled a total of 976 patients with completely resected stage IIB or IIC melanoma. Study participants were randomized to receive 200 mg of pembrolizumab or the pediatric dose of 2 mg/kg every 3 weeks or placebo for up to 1 year until either recurrence or intolerable toxicity. Patients were stratified based on AJCC eighth edition T Stage (> 2.0-4.0 mm with ulceration vs > 4.0 mm without ulceration vs > 4.0 mm with ulceration).

The main efficacy outcome measure for the trial was investigator-assessed RFS.

Regarding safety, adverse effects that were reported in those with stage IIB or IIC melanoma were comparable to those reported in 1011 patients with stage III melanoma from the phase 3 KEYNOTE-054 trial (NCT02362594) or the 2799 patients with melanoma or non–small cell lung cancer treated with the immunotherapy as a monotherapy.

FDA approves Merck's KEYTRUDA (pembrolizumab) as adjuvant treatment for adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection. News release. Merck; December 3, 2021. Accessed December 3, 2021. https://bit.ly/3DrqYal

This article was originally published on OncLive as “FDA Approves Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma Following CR”

Pembrolizumab has been approved for the adjuvant treatment of adults and pediatric patients with stage IIB or IIC melanoma who have underwent complete resection.

FDA Oks Adjuvant Pembrolizumab for Adult and Pediatric Melanoma Following Complete Resection

Robotic-assisted radical cystectomy (RARC) was not found to negatively impact health-related quality of life (HRQOL) compared with patients with nonmetastatic bladder cancer who received open radical cystectomy (ORC), according to results of a study presented at the 22nd Annual Meeting of the Society of Urologic Oncology.

“This study is limited by a small sample size and the fact that it only includes a subset of the overall randomized control trial patients, therefore potentially introducing selection bias,” Matthew B. Clements, MD, a urologic oncology fellow at Memorial Sloan Kettering Cancer Center, said in a presentation of the data. “However, we feel that this study could reasonably exclude a large signal for differences based on operative approach and included a broad variety of quality-of-life domains.”

The study aimed to compare the 2 cystectomy types—RARC and ORC—over a broader range in a 2-year period, due to the fact that previous studies had short postoperative follow-ups of 3 to 6 months and looked at limited quality-of-life (QOL) domains.

To examine this broader range, the researchers analyzed patients with nonmetastatic bladder cancer at Memorial Sloan Kettering Cancer Center who received a cystectomy. They focused on a randomized controlled trial comparing RARC with ORC along with an open urinary diversion performed in both arms, as well as a prospective study of HRQOL that collected 14 patient-reported outcome measures. These measures were reported at baseline as well as 3-, 6-, 12-, 18-, and 24-months post-RC.

Additionally, longitudinal QOL was compared in linear mixed-effect models adjusting for baseline scores as well as interaction for study arm by time over 24-months postoperatively.

Among 118 patients in the randomized controlled trial, 88 participated in the prospective HRQOL study. After excluding for ineligibility, researchers analyzed 72 patients (n = 32 for RARC and n = 40 for ORC).

They found that clinical characteristics between the 2 arms were generally balanced, but those who received RARC were more likely to be married or partnered and less likely to have received prior pelvic surgery.

There were no major differences in effect based on time of follow-up (aside from social functioning, among which scores were higher in ORC at 12 and 18 months but lower at 24 months [

 = .057]); pain, fatigue, appetite, abdominal symptoms (

 = .2), or bowel and psychosocial domains. There was higher sexual functioning with patients receiving ORC not meeting traditional significance (

 = .055). Body image was similar between groups (

 = .6), as well as urinary symptoms and incontinence (

 >.5), although some patients with ORC had evidence of lower early symptoms (

“These results are hypothesis-generating for larger studies that are needed comparing the approaches, which should also evaluate intracorporeal urinary diversion,” Clements concluded.

1. Clements M, Atkinson T, Dalbagni G, et al. Health-related quality of life after robotic-assisted vs open radical cystectomy: analysis of a randomized trial. Presented at: Society of Urologic Oncology 22nd Annual Meeting; November 30-December 3, 2021; virtual. Abstract 174.

A study presented at the 22nd SUO Annual Meeting did not identify any significant or clinically meaningfully differences in HRQOL in patients with nonmetastatic bladder cancer who receive robotic-assisted vs open radical cystectomy. 

Health-Related QOL Similar in Patients With Nonmetastatic Bladder Cancer Who Receive Robotic-Assisted Vs Open Radical Cystectomy 

Next-generation sequencing (NGS) via urine cytology specimens may represent a valid, minimally invasive profiling tool for assessing genomic alterations in upper tract urothelial carcinoma (UTUC), according to a poster presented during the 22nd Society of Urologic Oncology Annual Meeting.

Specifically, researchers concluded that the overall success rate of NGS of urine cytology specimens from UTUC was 86% and that the derived genomic profiles were similar to those obtained via ureteroscopic biopsies and radical nephroureterectomies.

“Many times, genomic profiling is from tissue from FFPE cell blocks–obtaining tissue requires invasive surgical procedures, and DNA is often moderately degraded,” explained Wesley Yip, MD, urologic oncology fellow at Memorial Sloan Kettering, in a presentation of the findings. “Our group has previously shown that urine cytology specimens, at least in the context of [patients with] non-muscle invasive bladder cancer treated with BCG, present a potential source for genomic analysis. So, we asked the question: ‘Can genomic profiling upper tract tumors be performed through cytology specimens.’”

Researchers compared a total of 14 urine cytology specimens from UTUC tumors with paired tissue specimens including ureteroscopic biopsies and radical nephroureterectomies. The 20 most frequently altered genes in the urine cytology samples were consistent with the gene alterations present in the tissue samples. In both specimen groups, TERT (in cytology vs tumor specimen, 50% vs 67%, respectively), KMT2D (50% vs 67%), and FGFR3 (42% vs 58%) represented the most prevalent genomic mutations.

The tumor specimen findings yielded a total of 124 gene alterations, with TERT (67%), FGFR3 (58%), KMT2D (67%), and STAG2 (50%) as the most prominent mutations. The average tumor mutation burden was 12.3 (range, 2.6-61.4) in this collection of samples. Other prevalent mutations included CREBBP (33%), CCND1, FLT4, and KMT2C (all 25%), and ELF3, PRKD1, MAPKAP1 (all 20%).

Urine cytology specimen findings identified a total of 66 genomic alterations and the TMB average was 8 (range, 2.6–16.7). The most common alterations identified in this collection included FGFR3 (42%), KMT2D (50%), and TERT (50%). Other prevalent alterations included STAG2 (33%) and PIk3CA (25%).

“We demonstrate an 86% success rate of next generation sequencing of urine cytology specimens from upper track tumors. There are similar genetic profiles between the urine cytology, specimens and tissue specimens are there from biopsy or radical nephroureterectomy,” concluded Kip. “This demonstrates that urine cytology is actually a useful minimally invasive tool but has some room for improvement. Sequencing these specimens has the potential for risk stratification and treatment response monitoring.”

Yip W, Reisz P, Tracey A, et al. Feasibility and validation of genomic profiling of upper tract urothelial carcinoma from urine cytology specimens. Presented at: SUO 22nd Annual Meeting; December 1-3, 2021; Orlando, Florida. Poster 120.

Urine cytology specimen NGS was found to be a feasible and valid method of assessing genomic alterations in patients with upper tract urothelial carcinoma.

Urine Cytology NGS Comparable to Tumor Biopsy in Identifying UTUC Mutations 

A presentation at the SUO Annual Meeting underscored best surveillance strategies for patients with low-grade upper tract urothelial carcinoma who have undergone radical nephroureterectomy.

Smoking and Large Tumor Size Linked With Risk of Early Recurrence Post-Radical Nephroureterectomy in Low-Grade UTUC 

The FDA has approved the combination of rituximab plus chemotherapy to treat children aged between 6 months and 18 years who have advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). 

FDA Approves Rituximab Plus Chemotherapy for Children With Select Previously Untreated Lymphoma, Leukemia

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Adding Bevacizumab to Pembrolizumab Enhances Response Rates in Epithelial Ovarian Cancer

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NBTXR3 Plus Radiotherapy Does Not Negatively Affect Quality of Life in Soft Tissue Sarcoma

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In this episode of “The Vitals,” 2 health care professionals discuss how to safely celebrate the holidays in oncology units. 

Merry and Bright: Bringing a Festive Air into the Oncology Space for the Holidays

Although White women and Black women carry similar rates of pathogenic variants, a study found that White women were almost 5 times more likely to undergo genetic counseling and testing.

Oncologist Attitudes May Factor into Underutilization of Genetic Counseling, Testing in Black Women with Breast Cancer

In a phase 1 dose-escalation trial, treatment with the investigative agent was well tolerated with no dose-limiting toxicities.

SL-17154 Appears Promising, Tolerable in Treatment of Platinum-Resistant Ovarian Cancer

Among patients who had participated in telemedicine, 45% preferred it to in-office visits, highlighting the need to make telemedicine a priority in cancer care.

Patients with Cancer Report Satisfaction with Telemedicine both Before and During Pandemic 

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Patients with neuroendocrine tumors across various origins experienced favorable responses after receiving tidutamab.

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Top Medical News

Rates of Upgrading, Adverse Pathology Similar in Hispanic and White Non-Hispanic Men With Prostate Cancer

18F-fluciclovine PET/CT Significantly Influences ADT Plans for Patients with Prostate Cancer

FDA Oks Adjuvant Pembrolizumab for Adult and Pediatric Melanoma Following Complete Resection

Health-Related QOL Similar in Patients With Nonmetastatic Bladder Cancer Who Receive Robotic-Assisted Vs Open Radical Cystectomy

Urine Cytology NGS Comparable to Tumor Biopsy in Identifying UTUC Mutations

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