Transfers and anesthesia-related postoperative outcomes after 3361 same-day cancer surgeries at a freestanding surgery center: An observational retrospective study.

BACKGROUND AND OBJECTIVES: Expanding outpatient surgery to the increasing number of procedures and patient populations warrants continuous evaluation of postoperative outcomes to ensure the best care and safety. We describe adverse postoperative outcomes and transfer rates related to anesthesia in a large sample of patients who underwent same-day cancer surgery at a freestanding ambulatory surgery center. METHODS: Between January 2017 and June 2021, 3361 cancer surgeries, including breast and plastic, head and neck, gynecology, and urology, were performed. The surgeries were indicated for diagnosis, staging, and/or treatment. We report the incidence of transfers and adverse postoperative outcomes related to anesthesia. RESULTS: Breast and plastic surgeries were the most common (1771, 53%), followed by urology (1052, 31%), gynecology (410, 12%), and head and neck surgeries (128, 4%). Based on patients' first procedure, comorbidity levels were highest for urology (75% American Society of Anesthesiologists physical status score 3, 1.7% score 4) and lowest for breast surgeries (31% score 3, 0.2% score 4). Most gynecology surgeries used general anesthesia (97.6%), whereas breast surgeries used the least (38%). A total of seven patients (0.2%; 95% CI: 0.08%-0.4%) were immediately transferred to an outside hospital; four due to anesthesia-related reasons. Only 7 (0.2%) patients needed additional postoperative care related to anesthesia-related adverse events, specifically cardiac events (4), difficult intubations (2), desaturation (1), and agitation, nausea, and headache (1). CONCLUSIONS: The incidence of anesthesia-related adverse postoperative outcomes is low in cancer patients undergoing outpatient surgeries at our freestanding ambulatory surgery center. This suggests that carefully selected cancer patients, including patients with metastatic cancer, can undergo anesthesia for same-day surgery, making cancer care accessible locally and reducing stress associated with travel for treatment. More research investigating complication rates related to surgery and to cancer disease trajectory are needed to establish a complete evaluation of safety for outpatient cancer surgery.

Electronic Patient-Reported Symptoms After Ambulatory Cancer Surgery.

Importance: Complex cancer procedures are now performed in the ambulatory surgery setting. Remote symptom monitoring (RSM) with electronic patient-reported outcomes (ePROs) can identify patients at risk for acute hospital encounters. Defining normal recovery is needed to set patient expectations and optimize clinical team responses to manage evolving problems in real time. Objective: To describe the patterns of postoperative recovery among patients undergoing ambulatory cancer surgery with RSM using an ePRO platform-the Recovery Tracker. Design, Setting, and Participants: In this retrospective cohort study, patients who underwent 1 of 5 of the most common procedures (prostatectomy, nephrectomy, mastectomy, hysterectomy, or thyroidectomy) at the Josie Robertson Surgery Center at Memorial Sloan Kettering Cancer Center from September 2016 to June 2022. Patients completed the Recovery Tracker, a brief ePRO platform assessing symptoms for 10 days after surgery. Data were analyzed from September 2022 to May 2023. Main Outcomes and Measures: Symptom severity and interference were estimated by postoperative day and procedure. Results: A total of 12 433 patients were assigned 110 936 surveys. Of these patients, 7874 (63%) were female, and the median (IQR) age at surgery was 57 (47-65) years. The survey response rate was 87% (10 814 patients responding to at least 1 of 10 daily surveys). Among patients who submitted at least 1 survey, the median (IQR) number of surveys submitted was 7 (4-8), and each assessment took a median (IQR) of 1.7 (1.2-2.5) minutes to complete. Symptom burden was modest in this population, with the highest severity on postoperative days 1 to 3. Pain was moderate initially and steadily improved. Fatigue was reported by 6120 patients (57%) but was rarely severe. Maximum pain and fatigue responses (very severe) were reported by 324 of 10 814 patients (3%) and 106 of 10 814 patients (1%), respectively. The maximum pain severity (severe or very severe) was highest after nephrectomy (92 of 332 [28%]), followed by mastectomy with reconstruction (817 of 3322 [25%]) and prostatectomy (744 of 3543 [21%]). Nausea (occasionally, frequently, or almost constantly) was common and experienced on multiple days by 1485 of 9300 patients (16%), but vomiting was less common (139 of 10 812 [1%]). Temperature higher than 38 °C was reported by 740 of 10 812 (7%). Severe or very severe shortness of breath was reported by 125 of 10 813 (1%). Conclusions and Relevance: Defining detailed postoperative symptom burden through this analysis provides valuable data to inform further implementation and maintenance of RSM programs in surgical oncology patients. These data can enhance patient education, set expectations, and support research to allow iterative improvement of clinical care based on the patient-reported experience after discharge.

Remote Symptom Monitoring with Clinical Alerts Following Mastectomy: Do Early Symptoms Predict 30-Day Surgical Complications.

BACKGROUND: Electronic patient-reported outcome measures (ePROMs) for real-time remote symptom monitoring facilitate early recognition of postoperative complications. We sought to determine whether remote, electronic, patient-reported symptom-monitoring with Recovery Tracker predicts 30-day readmission or reoperation in outpatient mastectomy patients. METHODS: We conducted a retrospective review of breast cancer patients who underwent outpatient (< 24-h stay) mastectomy with or without reconstruction from April 2017 to January 2022 and who received the Recovery Tracker on Days 1-10 postoperatively. Of 5,130 patients, 3,888 met the inclusion criteria (2,880 mastectomy with immediate reconstruction and 1,008 mastectomy only). We focused on symptoms concerning for surgical complications and assessed if symptoms reaching prespecified alert levels-prompting a nursing call-predicted risk of 30-day readmission or reoperation. RESULTS: Daily Recovery Tracker response rates ranged from 45% to 70%. Overall, 1,461 of 3,888 patients (38%) triggered at least one alert. Most red (urgent) alerts were triggered by pain and fever; most yellow (less urgent) alerts were triggered by wound redness and pain severity. The 30-day readmission and reoperation rates were low at 3.8% and 2.4%, respectively. There was no statistically significant association between symptom alerts and 30-day reoperation or readmission, and a clinically relevant increase in risk can be excluded (odds ratio 1.08; 95% confidence interval 0.8-1.46; p = 0.6). CONCLUSIONS: Breast cancer patients undergoing mastectomy with or without reconstruction in the ambulatory setting have a low burden of concerning symptoms, even in the first few days after surgery. Patients can be reassured that symptoms that do present resolve quickly thereafter.

Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

BACKGROUND AND OBJECTIVE: The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis. METHODS: We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy. KEY FINDINGS AND LIMITATIONS: A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d. CONCLUSIONS AND CLINICAL IMPLICATIONS: Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making. PATIENT SUMMARY: In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

Amount of Gleason Pattern 3 Is Not Predictive of Risk in Grade Group 2-4 Prostate Cancer.

We investigated whether total Gleason pattern 3 or the proportion of Gleason pattern 4 on biopsy is a significant predictor of adverse pathology. Our findings suggest that quantifying the amount rather than the proportion of Gleason pattern 4 would improve grade group assignment for decision-making in localized prostate cancer.

Do Phosphodiesterase Type 5 Inhibitors Increase the Risk of Biochemical Recurrence After Radical Prostatectomy?

PURPOSE: There have been conflicting studies on the association between phosphodiesterase type 5 inhibitor (PDE5i) use and biochemical recurrence (BCR) following radical prostatectomy (RP). Our aim was to determine whether PDE5i drug exposure after RP increases the risk of BCR in patients undergoing RP. MATERIALS AND METHODS: An institutional database of prostate cancer patients treated between January 2009 and December 2020 was reviewed. BCR was defined as 2 PSA measurements greater than 0.1 ng/mL. PDE5i exposure was defined using a 0 to 3 scale, with 0 representing never use, 1 sometimes use, 2 regularly use, and 3 routinely use. The risk of BCR with any PDE5i exposure, the quantity of exposure, and the duration of PDE5i exposure were assessed by multivariable Cox proportional hazards models. RESULTS: The sample size included 4630 patients to be analyzed, with 776 patients having BCR. The median follow-up for patients without BCR was 27 (IQR 12, 49) months. Eighty-nine percent reported taking a PDE5i at any time during the first 12 months after RP, and 60% reported doing so for 6 or more months during the year after RP. There was no evidence of an increase in the risk of BCR associated with any PDE5i use (HR 1.05, 95% CI 0.84, 1.31, P = .7) or duration of PDE5i use in the first year (HR 0.98 per 1 month duration, 95% CI 0.96, 1.00, P = .055). Baseline oncologic risk was lower in patients using PDE5i, but differences between groups were small, suggesting that residual confounding is unlikely to obscure any causal association with BCR. CONCLUSIONS: Prescription of PDE5i to men after RP can be based exclusively on quality of life considerations. Patients receiving PDE5is can be reassured that their use does not increase the risk of BCR.

Evaluating a Physician Audit and Feedback Intervention to Increase Clinical Trial Enrollment in Radiation Oncology in a Multisite Tertiary Cancer Center: A Randomized Study.

PURPOSE: Clinical trial participation continues to be low, slowing new cancer therapy development. Few strategies have been prospectively tested to address barriers to enrollment. We investigated the effectiveness of a physician audit and feedback report to improve clinical trial enrollment. METHODS AND MATERIALS: We conducted a randomized quality improvement study among radiation oncologists at a multisite tertiary cancer network. Physicians in the intervention group received quarterly audit and feedback reports comparing the physician's trial enrollments with those of their peers. The primary outcome was trial enrollments. RESULTS: Among physicians randomized to receive the feedback report (n = 30), the median proportion of patients enrolled during the study period increased to 6.1% (IQR, 2.6%-9.3%) from 3.2% (IQR, 1.1%-10%) at baseline. Among those not receiving the feedback report (n = 29), the median proportion of patients enrolled increased to 4.1% (IQR, 1.3%-7.6%) from 1.6% (IQR, 0%-4.1%) at baseline. There was a nonsignificant change in the proportion of enrollments associated with receiving the feedback report (-0.6%; 95% CI, -3.0% to 1.8%; P = .6). Notably, there was an interaction between baseline trial accrual and receipt of feedback reports (P = .005), with enrollment declining among high accruers. There was an increase in enrollment throughout the study, regardless of study group (P = .001). CONCLUSIONS: In this study, a positive effect of physician audit and feedback on clinical trial enrollment was not observed. Future efforts should avoid disincentivizing high accruers and might consider pairing feedback with other patient- or physician-level strategies. The increase in trial enrollment in both groups over time highlights the importance of including a comparison group in quality improvement studies to reduce confounding from secular trends.

Cognitive function and ability to complete a web-based geriatric assessment among older adults with cancer.

BACKGROUND: The purpose of this study was determined whether cognitive impairment is associated with time taken to complete the electronic rapid fitness assessment (eRFA). We hypothesized that taking more time to complete the eRFA will indicate worsened cognitive function. METHODS: We retrospectively identified patients who presented to the Memorial Sloan Kettering Cancer Center Geriatrics Service for preoperative evaluation and completed the eRFA as a part of their preoperative assessment from February 2015 to December 2020. Cognitive function was assessed using the Mini-Cog©, which is a screening test for cognitive function status. Patients in this study underwent elective surgery and had a hospital length of stay ≥1 day. Time to complete the eRFA was automatically recorded by a web-based tool; assistance with eRFA completion was self-reported by the patient. In total, 2599 patients were included, of which 2387 had available Mini-Cog© scores. RESULTS: Overall, 50% of surveys were completed without assistance, 37% were completed with assistance, and 13% were completed by somebody else; Mini-Cog© scores were lower, corresponding to worsened cognitive function status, in patients requiring assistance (median score respectively, 5 vs. 4 vs. 3; p-value <0.0001; rates of cognitive impairment 7.5%, 22%, and 38%). Among patients who completed the questionnaire independently, greater cognitive impairment was associated with longer time to complete the eRFA (change in score per 5 min = -0.09; 95% CI -0.14, -0.03; p = 0.002). CONCLUSIONS: We found evidence that requirement for assistance in completing web-based questionnaires, and time taken to complete a questionnaire, predict which patients benefit from more comprehensive cognitive function assessments. Future studies should further validate this finding in a more diverse population and establish optimal clinical pathways.

Comparison of salvage radical prostatectomy vs. salvage ablation therapy for biopsy-proven radio-recurrent localized prostate cancer.

INTRODUCTION: Radiation therapy for prostate cancer is associated with a 15-20% five-year recurrence rate. Patients with recurrence in the prostate only are candidates for salvage local therapies; however, there is no consensus on modality. This study uses registries at Memorial Sloan Kettering Cancer Center (MSKCC) and University of Western Ontario (UWO) to compare the oncologic outcomes of salvage radical prostatectomy (SRP) and salvage ablation (SA). METHODS: A total of 444 patients were available for analysis. Due to intergroup differences, propensity score methodology was used and identified 378 patients with more comparable pre-salvage prostate-specific antigen (PSA), Gleason score, and primary radiation treatment. Patients underwent SRP at MSKCC and SA at UWO. RESULTS: Of the 378 patients, 48 died of disease, with a 6.0-year median (interquartile range [IQR] 3.0, 9.7) followup among survivors; 88 developed metastases, with a median 4.6-year (IQR 2.3, 7.9) followup among metastasis-free survivors. There was a non-significantly higher rate of cancer-specific (hazard ratio [HR ] 1.02, 95% confidence interval [CI] 0.51, 2.06, p=0.9) and improved metastasis-free survival (HR 0.71, 95% CI 0.44, 1.13, p=0.15) among patients undergoing SA compared to patients undergoing SRP. There were 143 patients who received hormonal therapy, with higher rates of androgen deprivation therapy (ADT) in SA (HR 1.42, 95% CI 0.97, 2.08, p=0.068), although this did not meet conventional levels of significance. CONCLUSIONS: This propensity score analysis of salvage therapy for radio-recurrent prostate cancer identified no statistically significant differences in oncologic outcome between SRP and SA; however, there was evidence of a lower risk of ADT in the cohort undergoing SRP. Given they are both potentially curative therapies, these treatments are viable options for men with clinically localized, radio-recurrent prostate cancer rather than ADT alone. Future research may further elucidate subpopulations that may be more amenable to either SRP or SA.

Preoperative frailty predicts postoperative falls in older patients with cancer.

INTRODUCTION: Patient falls in the hospital lead to adverse outcomes and impaired quality of life. Older adults with cancer who are frail may be at heightened risk of falls in the postoperative period. We sought to evaluate the association between degree of preoperative frailty and risk of inpatient postoperative falls and other outcomes among older adults with cancer. MATERIALS AND METHODS: We identified 7,661 patients aged 65 years or older who underwent elective cancer surgery from 2014 to 2020, had a hospital stay of ≥1 day, and had Memorial Sloan Kettering-Frailty Index (MSK-FI) data to allow assessment of frailty. Univariable logistic regression analysis was performed to evaluate the association between frailty and falls. Multivariable logistic regression analysis was performed to evaluate the composite outcome of 30-day readmission or 90-day death, with frailty, falls, and the interaction between frailty and falls as predictors; the analysis was adjusted for age, sex, race, and preoperative albumin level. RESULTS: In total, 7,661 patients were included in the analysis. Seventy-one (0.9%) had a fall, of whom eight (11%) were readmitted to the hospital within 30 days and seven (10%) died within 90 days. Higher MSK-FI score was associated with higher risk of falls (odds ratio [OR], 1.40 [95% confidence interval [CI], 1.21-1.59]). The risk of falls for a patient with an MSK-FI score of 1 was 0.6%, compared with 1.7% for a patient with an MSK-FI score of 4. Poor outcome was associated with frailty (OR, 1.07 [95% CI, 1.02-1.13]) but not with falls (OR, 1.17 [95% CI, 0.57-2.22]). DISCUSSION: Preoperative frailty is associated with risk of inpatient postoperative falls and with other adverse outcomes after surgery among older adults with cancer. Screening for frailty in the preoperative setting would enable healthcare institutions to implement interventions aimed at reducing the incidence of inpatient postoperative falls to reduce fall-related adverse events.

Adding a Coefficient for Race to the 4Kscore Improves Calibration for Black Men.

PURPOSE: Black men face a higher incidence of high-risk prostate cancer (PCa) compared with non-Black men. While the 4Kscore is a widely utilized commercial test for PCa risk assessment, it does not currently account for racial differences. The aim of this study is to describe and validate a prespecified race coefficient for the 4Kscore with the goal of improving the accuracy of this test for Black men. MATERIALS AND METHODS: Using data from 85 Black men from the initial US prospective validation study, a race coefficient of 0.6 on the log-odds scale was prespecified. We calculated discrimination, calibration, and clinical utility of the 4Kscore with and without this coefficient for Black race in our primary analysis cohort of 205 Black men undergoing biopsy for PCa in a Veterans Affairs (VA) institution. We performed a sensitivity analysis using a combined cohort from the US prospective validation and the VA studies. RESULTS: The mean probability of high-grade PCa from the 4Kscore in the primary cohort increased from 25% to 37% with race coefficient addition. Incorporating the race coefficient improved 4Kscore's calibration in Black men, with consequent improvements in clinical utility based on decision curve analysis. Model discrimination was maintained (AUC 0.825 vs 0.828, P = .14) in the combined cohort of Black and non-Black men from the US prospective and VA studies and the calibration remained largely unchanged. CONCLUSIONS: Incorporating a prespecified coefficient for Black race improved calibration and clinical utility of the 4Kscore among Black men and should be added to the 4Kscore.

A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: a clinically integrated randomized controlled trial with 2-staged consent.

OBJECTIVES: Many patients experience pain, anxiety, and discomfort with prostate biopsy, which may discourage enrollment in active surveillance programs or follow-up biopsy. Guided meditation can significantly reduce pain and anxiety during percutaneous biopsy. We sought to evaluate the effectiveness of a brief mind-body intervention on patient-reported outcomes after prostate biopsy. METHODS AND MATERIALS: We performed a clinically-integrated randomized controlled trial of a brief mind-body intervention during biopsy compared to usual care at a single tertiary care center from 2018 to 2022. All patients offered transrectal ultrasound-guided prostate biopsy in the clinic with local anesthesia were eligible for enrollment. This clinically integrated trial was conducted simultaneously with a randomized controlled trial of 1-stage and 2-stage consent. The primary outcome was patient-reported pain, anxiety, discomfort, and tolerability on a visual-analog scale (0-10). A 15% improvement was prespecified as clinically relevant. We compared the proportion of men in each arm reporting a severe score (7-10) on any of the 4 scales using Fisher's exact test and then compared means for each scale separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. RESULTS: Of 263 eligible patients, 238 enrolled (119 per arm). One hundred seventy-two (72%) enrolled with 2-stage consent. A total of 37/94 (39%) and 38/102 (37%) patients randomized to usual care and intervention, respectively, reported severe scores in any of the 4 domains, a difference of 2.1% (95% confidence interval [CI] -13, 17%, P = 0.8). There was no evidence of a difference in mean postbiopsy anxiety (P = 0.3), discomfort (P = 0.09), pain (P = 0.4) or tolerability scores (P = 0.2). CONCLUSIONS: A clinically meaningful benefit for this brief mind-body intervention during prostate biopsy is unlikely. Robust patient enrollment is feasible using 2-stage consent.

The Highest Grade Group Does Not Drive the Risk of Recurrence when Systematic and Multiparametric Magnetic Resonance Imaging (MRI)-targeted Biopsies are Discordant: Preliminary Findings Using Radical Prostatectomy Pathology as a Surrogate for MRI-targeted Biopsy Grade.

Pathology grading of prostate biopsy follows the rule that the highest International Society of Urological Pathology grade group (GG) is the GG assigned. This rule was developed in the systematic biopsy (SBx) era and makes sense when samples are from very different areas of the prostate. This rule has been kept for multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy (MRI-TBx), for which multiple samples-targeted and systematic-are taken from small areas. In particular, if the results for SBx and MRI-TBx are discordant, the patient is assigned the higher GG. However, the most appropriate grading when MRI-TBx and SBx grades are discordant has never been investigated empirically. A cohort of patients who have undergone SBx and MRI-TBx with long oncological follow-up does not yet exist. To estimate the risk of recurrence for every combination of biopsy and pathological grades, we used the GG on radical prostatectomy (RP) as a surrogate for GG on MRI-TBx GG surrogate. We analyzed data for 12 468 men who underwent SBx and RP at a tertiary referral center and assessed 5-yr biochemical recurrence-free survival (bRFS) for each pairwise combination of biopsy and surgical GG results. We found that for cases with discordant SBx and RP grades, the risk of recurrence was intermediate, irrespective of whether the highest grade was at RP or SBx. For instance, the 5-yr bRFS rate was 57% for men with GG 3 on RP and 60% for men with GG 3 on SBx, but 63% for men with RP GG 3 and SBx GG 2, and 79% for men with RP GG 2 and SBx GG 3. Translating these findings to MRI-TBx casts doubt on current grading practice: when GGs are discordant between SBx and MRI-TBx, the risk of biochemical recurrence risk is not driven by the highest grade but by an intermediate between the two grades. Our findings should motivate studies assessing long-term outcomes for patients undergoing both MRI-TBx and SBx with a view to empirically evaluating current grading practices. PATIENT SUMMARY: Patients with prostate cancer may undergo two biopsy types: (1) systematic biopsy, for which sampling follows a systematic template; and (2) targeted biopsy, for which samples are taken from lesions detected on scans. There may be a difference in prostate cancer grade identified by the two approaches. In such cases, the risk of cancer recurrence seems to be predicted by an intermediate grade between the lower and higher grades.