Pelvic organ-preserving robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion allowed most female patients to return to sexual activity following surgery without risking compromised oncological outcomes, according to retrospective findings presented at the 22nd Annual Meeting of the Society of Urologic Oncology.

In a virtual presentation shared during the meeting, study author Etienne Lavallee, MD, a urology fellow at the Icahn School of Medicine at Mount Sinai, said that the multicenter analysis included sexually active females undergoing pelvic organ–preserving RARC. Women had ≤pT2, N0, M0 urothelial cancer as determined by examination, imaging, and pathological staging. All patients had unifocal tumors away from the bladder base. Patients were excluded from the analysis if they had multifocal, trigonal, or locally advanced disease (>cT2) with potential internal genital organ involvement.

Sexual and urinary function after surgery was the primary study end point. To evaluate this end point, patients completed a sexual function questionnaire and the investigators used patient records from follow-up visits to assess urinary function. Secondary end points included perioperative and oncological outcomes.

Overall, the study included 23 female patients who underwent pelvic organ–preserving RARC. The surgeries were performed at 2 academic institutions between 2008 and 2020. Twenty (87%) patients underwent intracorporeal neobladder reconstruction and 3 (13%) patients received Ileal conduit urinary diversion.

The median patient age was 54 years (range, 34-79) and the median body mass index (BMI) was 23.6 kg/m (range, 18.2-33.1). Twelve patients were current smokers, 7 were former smokers, and 4 were never-smokers. The clinical stages were Tis/Ta/T1 (n = 10) and T2 (n = 13); the pT stages were T0 (n = 11), Tis/Ta/T1 (n = 2), T2 (n = 7), and T3 (n = 3); and the pN stages were pN0 (n = 19) and pN1(n = 3).

Seven patients had prior Bacillus Calmette-Guérin and 13 had neoadjuvant chemotherapy. The average operating time was 300 minutes (range, 250-390 minutes) and the average hospital stay was 6 days (range, 3-16). Eight patients had grade 1/2 surgical complications. There were no grade 3 to 5 surgical complications.

At a median follow-up of 20 months (range, 7-151), about two-thirds (65%; n= 15) of the patients completed the postoperative sexual function questionnaire. Of these patients, 87% (n = 13) resumed sexual activity within a median time of 6 months following surgery. Of these 13 patients, 8% (n = 1), 54% (n = 7), and 38% (n = 5) reported having low, moderate, and high levels of sexual activity, respectively. Orgasm during sexual activity was able to be achieved by all of the sexually active patients.

“Of the 10 patients who participated in penetrative intercourse, only 1 had occasional pain,” noted Lavallee.

Among patients who received neobladder reconstruction, 70% (n = 14) achieved daytime continence and 80% (n= 16) achieved nighttime continence.

“Half of the patients who underwent neobladder needed occasional clean intermittent catheterization,” added Lavallee.

Four (17%) patients had disease recurrence. The median time to recurrence was 13 months (range, 11-28). The recurrence-free survival rate was 83%. The cancer-specific survival and overall survival rates were both 91%. Two patients died of bladder cancer at 20 and 36 months, respectively.

“Of note, only 1 patient had a positive surgical margin, located at the left ureter. This was not considered to be due to the selection of an organ-preserving approach,” said Lavallee.

In his concluding remarks, Lavallee said, “Pelvic organ–preserving robot-assisted radical cystectomy with intracorporeal urinary diversion should be considered in selected sexually active women who wish to preserve sexual function after surgery.

1. Etienne Lavallee E, Dovey Z, Pathak P, et al. Female pelvic organ preserving robot-assisted radical cystectomy; functional outcomes of a modern robotic technique. Presented at: 2021 Society of Urologic Oncology Annual Meeting; November 30-December 3, 2021; Orlando, FL. Abstract 52.

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A retrospective study presented at the 22nd SUO Annual Meeting revealed that pelvic organ–preserving robot-assisted radical cystectomy allowed women to return to sexual activity post-surgery. 

Women Who Receive Organ-Sparing Robotic Cystectomy Experience Preserved Sexual, Urinary Function

There is an association between increased prostate-specific antigen (PSA) screening and improved outcomes in younger African American patients, according to findings presented in a presscast in advance of the 2021 ASCO Annual Meeting.

In this population, an increase in the frequency of PSA screening was linked to a nearly 25% reduction in prostate cancer–specific mortality and an approximately 40% lower risk of having metastatic disease at the time of a prostate cancer diagnosis.

“We found that PSA screening was associated with a decreased risk of Gleason score ≥8, PSA >20, and metastatic disease at diagnosis, as well as prostate cancer–specific mortality. Taken together, these results would suggest that [increased] PSA screening may improve cancer outcomes for young African American men. Although the results of this study are just one step in addressing all of the other racial disparities that still exist in prostate cancer,” said lead author Edmund M. Qiao, BS, of the University of California San Diego.

Overall, the study included 4726 African American men diagnosed with prostate cancer. The mean patient age was 51.8 years. The mean number of previous PSA screening tests was 1.9. The “high PSA screening” group had received an average of 3 prior screening tests and the “low PSA screening” group had received an average of 0.5 prior screening tests.

Regarding disease severity at diagnosis, all key metrics showed that the high PSA screening group had lower severity. Specifically, the rate of patients with Gleason score ≥8 and PSA >20 at diagnosis was 15.3% versus 10.7% and 16.3% versus 7.2% in the lower versus higher screening groups, respectively. Further, the rate of metastatic disease at diagnosis was 4.2% versus 1.4%, respectively, translating to a 39% risk reduction (odd ratio, 0.61; 95% CI, 0.47-0.81; 

Qiao added, “In our statistical model, controlling for the confounders, we found that PSA screening was associated with about a 25% reduction in prostate cancer–specific mortality [hazard ratio, 0.75; 95% CI, 0.59-0.95; 

 = .02].” The confounding factors controlled for in the statistical model included primary care visit rate, age at diagnosis, year of diagnosis, Charlson comorbidity score, employment, marital status, college education, and income.

Regarding the importance of the research, Qiao said, “African American men have the highest mortality rate for prostate cancer; however, the data for PSA screening includes very few African American men and no young African American men between the ages of 40 and 55. This has led to discordant PSA screening recommendations for these patients and as a result, young African American men are an at-risk group that needs additional research to help guide their clinicians and themselves when deciding when to start PSA screening.”

In 2012, the US Preventive Services Task Force (USPSTF) issued a grade D recommendation against the use of PSA screening in the general US population, regardless of age. The current USPSTF PSA screening policy is slightly changed, with a grade C recommendation for men aged 55 to 69 years, meaning in this population, an individual decision on screening should be made based on a physician-clinician discussion of the potential benefits and risks.

While the USPSTF acknowledges that family history and African American race are two of the most significant risk factors for developing prostate cancer, the panel maintains that there is insufficient evidence to issue individualized screening recommendations in any age group based on those factors.

Commenting on the study during the presscast, ASCO President Lori J. Pierce, MD, FASTRO, FASCO, said, “We know African American men are nearly one-and-a-half times more likely to develop prostate cancer and more than twice as likely to die from prostate cancer as White patients. And despite this, young African American men are poorly represented in PSA studies from which evidence-based guidelines are developed. So, this really limits proper PSA guidance screening guidance for African American patients, especially for those who are younger than 55. And so, because we don't have adequate screening data, there are differences in opinion as to what the guidelines should be. And so, this abstract makes a very strong statement to discuss screening at a younger age in African American men.”

1. Qiao E, Kotha N, Nalawade V, et al. Association of increased intensity of prostate-specific antigen screening in younger African American men with improved prostate cancer outcomes. Presented at: 2021 ASCO Annual Meeting Virtual Embargoed Presscast; May 14, 2021. Abstract 5004.

There is an association between increased prostate-specific antigen (PSA) screening and improved outcomes in younger African American patients.

PSA Screening Leads to Better Outcomes in Young African Americans

Two studies conducted at NYU Grossman School of Medicine and NYU Langone’s Perlmutter Cancer Center found that misinformatoin and bias is prevalent in YouTube videos about prostate and bladder cancer. 

A massive amount of misinformation and bias is being spread in YouTube videos on bladder and prostate cancer, according to 2 studies conducted at NYU Grossman School of Medicine and NYU Langone’s Perlmutter Cancer Center.1

Investigators on the bladder cancer study,2 led by Stacy Loeb, MD, MSc, ranked the overall quality of over two-thirds of the YouTube videos they assessed as poor to moderate. A moderate to high amount of misinformation was noted in 21% of the videos and a commercial bias was found in 17% of the videos.

In the prostate cancer study,3 also led by Loeb, it was discovered that over three-fourths of the videos included content that was potentially misinformative in the video itself or in the comments section. Further, while treatment benefits were highlighted in 75% of the videos, the risks of the treatments were only adequately described in 50%.

For the bladder cancer study, the investigators used these 2 validated instruments to score the quality of the videos: the Patient Education Materials Assessment Tool (PEMAT) and the DISCERN quality criteria for consumer health information.

The researchers found that there were 242,000 bladder cancer videos on YouTube and then used the 2 instruments to evaluate the first 150 of these. Overall, 67% of the 150 videos ranked as poor to moderate using DISCERN. Of concern, over 1 million (1,289,314) viewers watched the 21% of videos that were noted to have a moderate to high amount of misinformation, and 324,287 viewers watched the 17% of videos found by Loeb et al to contain commercial bias.

“Bladder cancer is the second most common urologic cancer worldwide, but evidence is lacking on the accuracy of information available on YouTube, the most popular social network,” Loeb, professor of Urology and Population Health at NYU Grossman School of Medicine and NYU Langone’s Perlmutter Cancer Center, stated in a press release.

“Our findings highlight an urgent need for more accurate, patient-friendly social media content,” added Loeb, who is also the incoming chair of the American Urological Association Public Media Committee.

Loeb et al used the same instruments—DISCERN and PEMAT—for the prostate cancer study that were used in the bladder cancer assessment. The investigators found that there were more than 600,000 videos about prostate cancer on YouTube and assessed the first 150 of these for their study.

Overall, 77% (n = 115) of the videos contained content that was potentially misinformative in the video itself or in the comments section. According to Loeb et al, these 115 videos reached more than 6 million viewers.

The potential benefits of treatments were highlighted in 75% of the 150 videos, while only 53% explained potential side effects and other risks. Further, only half of the videos advocated shared decision-making despite it being a key recommendation in current guidelines. Loeb et al’s analysis also determined that there was a significant negative correlation between the scientific quality of the videos and viewer engagement.

Summarizing her advice to providers on these findings, Loeb said, “Having lots of ‘likes’ and views does not mean that a video is medically accurate. As health-care providers, we can help counter this trend by better communicating with patients and guiding them to trustworthy sources for additional information.”

In the press release highlighting the findings of the studies, Loeb provider several tips for providers:

“Engage in shared decision-making, clearly outlining the benefits and risks of treatment and offering actionable steps for patients.

Encourage patients to learn how to spot medical misinformation.

Arm patients with trustworthy sources of information, such as the Bladder Cancer Advocacy Network, Prostate Cancer Foundation, the Urology Care Foundation, and the National Cancer Institute.

Actively participate in social media to disseminate accurate, evidence-based content.”

1. Many Popular YouTube Videos Spread Misinformation on Bladder & Prostate Cancer, Studies Find. Published online April 27, 2021. Accessed May 5, 2021. https://bit.ly/3xNYXID.

2. Loeb S, Reines K, Abu-Salha Y, et al. Quality of bladder cancer information on YouTube. 

. 2021;79(1):56-59. doi: 10.1016/j.eururo.2020.09.014

3. Loeb S, Sengupta S, Butaney M, et al. Dissemination of misinformative and biased information about prostate cancer on YouTube. 

. 2019;75(4):564-567. doi: 10.1016/j.eururo.2018.10.056

This article was originally published on Urology Times as, "

Studies spotlight misinformation in YouTube bladder and prostate cancer videos

Studies found that misinformation and bias is prevalent in YouTube videos about prostate and bladder cancer. 

YouTube Videos Spread Cancer Misinformation

The FDA has approved single-agent atezolizumab (Tecentriq) as a first-line treatment for adult patients with metastatic non—small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression, as determined by an FDA-approved test, with no 

High PD-L1 expression is defined as PD-L1 stained ≥ 50% of tumor cells (TC ≥ 50%) or PD-L1 stained tumor-infiltrating (IC) covering ≥10% of the tumor area (IC ≥ 10%). The approval is based on findings from the phase III IMpower110 trial, which showed that atezolizumab monotherapy demonstrated a 7.1-month improvement in overall survival (OS) versus chemotherapy, with a median OS of 20.2 months and 13.1 months, respectively (HR, 0.59; 95% CI, 0.40-0.89; 

 = .0106) in patients with NSCLC and high PD-L1 expression.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, stated in a press release. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”

In the open-label, randomized, phase III IMpower110 study, investigators randomized 572 PD-L1—selected, chemotherapy-naïve patients with advanced nonsquamous or squamous NSCLC without ALK or EGFR mutations 1:1 to receive single-agent atezolizumab (arm A) or cisplatin or carboplatin plus pemetrexed or gemcitabine (arm B). Atezolizumab was administered until loss of clinical benefit, unacceptable toxicity or death, or per investigator discretion.

For nonsquamous disease, chemotherapy regimens consisted of cisplatin at 75&thinsp;mg/m2 or carboplatin area under the curve (AUC) 6, plus pemetrexed at 500&thinsp;mg/m2 intravenously every 3 weeks. Patients with squamous histology who were on the chemotherapy arm received cisplatin at 75&thinsp;mg/m2 plus gemcitabine at 1250&thinsp;mg/m2, or carboplatin AUC 5 plus gemcitabine at 1000&thinsp;mg/m2 intravenously every 3 weeks.

Maintenance therapy consisted of atezolizumab in arm A and pemetrexed (nonsquamous) or best supportive care (squamous) in arm B. No crossover was permitted.

The primary endpoint was OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1/2/ 3/IC1/2/3-WT), as determined by the SP142 assay. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR).

The primary endpoint of OS was tested hierarchically in WT patients (TC3 or IC3, then TC2/3 or IC2/3, then TC1/2/3 or IC1/2/3); a total of 205 patients were TC3 or IC3 WT. The secondary endpoint of PFS would only be formally tested if the primary endpoint was positive among all 3 TC/IC cohorts.

The OS testing boundary was not crossed in the TC2/3 or IC2/3 WT population, so OS was not formally tested in this population as well as in the TC1/2/3 and IC1/2/3 populations.

Baseline characteristics were well balanced between the arms, including in the TC3 or IC3 subset. About half of the patients overall were <65 years old, about 70% were male, >80% were white, and 13% never used tobacco. Approximately 70% in both arms had nonsquamous histology.

In arm A, 38.6% of patients were TC3 or IC3 WT, compared with 35.4% of patients in arm B. Some 59.9% in arm A and 58.5% in arm B were TC2/3 or IC2/3 (≥5% expression on tumor cells or immune cells) wild type.

In the TC3/IC3 wild-type population, 76.3% in arm A and 70.1% in arm B were alive at 6 months, and the 12-month OS rates were 64.9% and 50.6%, respectively. Subset analysis showed a consistent benefit on OS favoring atezolizumab in all subgroups with TC3 or IC3 wild type, except for in those who had never used tobacco.

In the TC 2/3 or IC 2/3 wild-type subgroup, median OS was 18.2 months (95% CI, 13.3-not evaluable) in the atezolizumab arm versus 14.9 months (95% CI, 10.8-16.6) in the chemotherapy arm (HR, 0.72; 95% CI, 0.52-0.99; P = .0416). OS also favored atezolizumab in the TC 1/2/3 or IC 1/2/3 wild-type population but was not found to be significant (HR, 0.83; 95% CI, 0.65-1.07; P = .1481).

Additionally, 29.6% of patients in the atezolizumab arm and 49.5% in the chemotherapy had ≥1 subsequent cancer therapy, and 28.9% in the chemotherapy arm ultimately received a form of immunotherapy.

In the TC3 or IC3 WT population, the 6-month PFS rate was 59.8% in arm A and 38.3% in arm B, and at 12 months, 36.9% in arm A were without disease progression compared with 21.6% in arm B. PFS was numerically superior in the atezolizumab arm in the TC2/3 or IC2/3 and TC1/2/3 or IC1/2/3 subgroups, although the statistical significance could not be tested.

Regarding safety, TRAEs occurred in 60.5% (arm A) and 85.2% (arm B) of patients.

FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer. Published May 18, 2020. https//bit.ly/2AGRNNh. Accessed May 18, 2020.

A version of this article originally appeared on OncLive

FDA Approves Frontline Atezolizumab for PD-L1-High NSCLC

The FDA has approved the single-agent atezolizumab as a first-line treatment for patients with metastatic non-small cell lung cancer who have a high PD-L1 expression and no EGFR or ALK genomic tumor aberrations.
 

FDA Approves Atezolizumab for PD-L1 High NSCLC

Dasatinib (Sprycel) has been approved by the FDA to treat pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

The approval is based on results with dasatinib demonstrated in 97 pediatric patients with CP-CML enrolled across 2 studies, an open-label, nonrandomized, single-arm phase II trial (CA180-226; NCT00777036) and an open-label, nonrandomized, dose-ranging phase I trial (CA180-018; NCT00306202). Fifty-one patients (all from the single-arm trial) were newly diagnosed, and the remaining 46 (29 from the single-arm study and 17 from the dose-ranging trial) were intolerant or resistant to prior imatinib (Gleevec).

At a median follow-up of 4.5 years, more than half of the responding patients in the treatment-naïve cohort had not progressed at the time of the data cutoff, and thus, the median duration of complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR) could not be estimated. The same was true at the median follow-up time of 5.2 years for the previously treated cohort.

The range of duration of response (DOR) for the newly diagnosed patients was 2.5+ to 66.5+ months for CCyR, 1.4 to 66.5+ months for MCyR, 5.4+ to 72.5+ months for patients who achieved MMR by month 24, and 0.03+ to 72.5+ months for patients who achieved MMR at any time. The ‘+’ denotes a censored observation. Among the imatinib-intolerant cohort, the DOR ranges were 2.4 to 86.9+ months for CCyR, 2.4 to 86.9+ months for MCyR, and 2.6+ to 73.6+ months for MMR.

“Options for pediatric patients with chronic myeloid leukemia are limited, and it is challenging to conduct clinical trials investigating potential new treatments in this small patient population,” Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital Colorado, said in a statement. “Dasatinib is an important new option to help address the unmet needs of children with Philadelphia chromosome-positive CML in chronic phase.”

The 3-, 6-, 12-, and 24-month CCyR rates among newly diagnosed patients were 43.1% (95% CI, 29.3-57.8), 66.7% (95% CI, 52.1-79.2), 96.1% (95% CI, 86.5-99.5), and 96.1% (95% CI, 86.5-99.5), respectively. In the previously treated group, the corresponding rates were 45.7% (95% CI, 30.9-61.0), 71.7% (95% CI, 56.5-84.0), 78.3% (95% CI, 63.6-89.1), and 82.6% (95% CI, 68.6-92.2), respectively.

The 3-, 6-, 12-, and 24-month MCyR rates among treatment-naive patients were 60.8% (95% CI, 46.1-74.2), 90.2% (95% CI, 78.6-96.7), 98.0% (95% CI, 89.6-100), and 98.0% (95% CI, 89.6-100), respectively. The corresponding rates in the imatinib-intolerant group were 60.9% (95% CI, 45.4-74.9), 82.6% (95% CI, 68.6-92.2), 89.1% (95% CI, 76.4-96.4), and 89.1% (95% CI, 76.4-96.4), respectively.

The 3-, 6-, 12-, and 24-month MMR rates among newly diagnosed patients were 7.8% (95% CI, 2.2-18.9), 31.4% (95% CI, 19.1-45.9), 56.9% (95% CI, 42.2-70.7), and 74.5% (95% CI, 60.4-85.7), respectively. The corresponding rates in the previously treated group were 15.2% (95% CI, 6.2-28.9), 26.1% (95% CI, 14.3-41.1), 39.1% (95% CI, 25.1-54.6), and 52.2% (95% CI, 36.9-67.1), respectively.

Across both patient groups, 14.4% experienced treatment-related serious adverse events. Adverse events occurring in 15% or more of patients included myelosuppression, headache, nausea, diarrhea, skin rash, pain in extremity, and abdominal pain.

“While chronic myeloid leukemia is rare in children, accounting for less than three percent of all pediatric leukemias, it is often more aggressive in younger patients than in adults and until recently, there have been few available treatment options,” Vickie Buenger, President, Coalition Against Childhood Cancer, said in a statement. “The FDA’s decision to approve the expanded use of Sprycel in children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase may bring new hope to these patients and their families.”

Jason Broderick

Articles

Women Who Receive Organ-Sparing Robotic Cystectomy Experience Preserved Sexual, Urinary Function

PSA Screening Leads to Better Outcomes in Young African Americans

YouTube Videos Spread Cancer Misinformation

FDA Approves Atezolizumab for PD-L1 High NSCLC

Dasatinib Approved for Pediatric Ph+ Chronic Phase CML