Clinical T1b Research Articles

VE57 First HugoTM RAS robot-assisted partial nephrectomy for clinical T2b complex renal mass: How far can we go?

VE57 First HugoTM RAS robot-assisted partial nephrectomy for clinical T2b complex renal mass: How far can we go?

Surgical and endoscopic management of clinical T1b esophageal cancer

ObjectiveEsophageal cancers that invade the submucosa (T1b) have increased risk for occult lymph node metastases. To avoid the morbidity and recovery from esophagectomy, patients with cT1bN0 tumors have been increasingly managed endoscopically. We hypothesized that tumor attributes could predict upstaging and outcome associated with surgical and endoscopic treatment. Our objective was to evaluate the comparative effectiveness of esophagectomy across different cT1bN0 tumor attributes. MethodsTreatment-naïve patients who underwent endoscopic management or esophagectomy for a clinical stage cT1bN0 esophageal cancer diagnosed between 2010 and 2018 in the National Cancer Database were identified. Factors associated with upstaging were assessed by logistic regression. Adjusted survival was assessed by Kaplan-Meier analysis of 528 propensity-matched pairs and accelerated time failure models, stratified across tumor attributes. ResultsOverall, 1469 patients classified as cT1bN0 were identified; 926 underwent esophagectomy and 543 were managed endoscopically. In general, patients who were managed endoscopically were older (median, 71; interquartile range, 63-78; vs 66; interquartile range, 60-72; P < .0001) with smaller tumors compared with the patients who were managed with esophagectomy. Nodal upstaging was associated with lymphovascular invasion (odds ratio [OR], 6.88; confidence interval [CI], 4.39-10.77; P < .0001), poor tumor differentiation (OR, 2.77; CI, 1.30-5.88; P = .0081), and tumor size >1 cm (OR, 3.19; CI, 1.49-6.83, P = .0028). Overall survival was better among propensity-matched patients who underwent esophagectomy (5-year 68.4% vs 59.7% endoscopic, P < .001). However, accelerated time failure models suggested similar outcomes among patients with well-differentiated tumors managed surgically or endoscopically. ConclusionsEsophagectomy was associated with improved survival for cT1bN0 esophageal cancer; however, endoscopic treatment may achieve similar survival in patients with favorable tumor attributes. Further study is warranted.

Preoperative Tyrosine Kinase Inhibitors Before Percutaneous Cryoablation for Clinical T1b Renal Tumors.

Purpose To treat renal cell carcinoma, local ablative therapy is a viable alternative treatment option. Traditionally, cryoablation has been used for the treatment of T1a renal tumors. However, recent technological developments have expanded its application to encompass select T1b renal tumors. Here, we present a retrospective study of the utilization of preoperative tyrosine kinase inhibitors(TKIs) to induce tumor shrinkage and achieve favorable outcomes in percutaneous cryoablation (PCA). Methods We retrospectively evaluated the data from nine patients with clinical T1b renal tumors who underwent PCA. Six patients with TKI pretreatment at our institution between 2016 and 2018 were included in the study. We evaluated the safety and efficacy of preoperative TKIs prior to PCA. Results All patients received axitinib with a median treatment duration of 80.5 days (IQR: 49-85). All patients experienced tumor shrinkage (median: 13.5 mm; IQR: 7-16); five experienced downstaging to T1a following tumor shrinkage. There were no severe adverse events (common terminology criteria for adverse events (CTCAE) grade ≥ 3) in TKIs. After the discontinuation of TKIs for two weeks, all PCA procedures were performed successfully without any severe complications. During a median follow-up of 46 months, no local recurrence was observed in any of these cases. Conclusion In cases with large renal tumors, TKI pretreatment prior to PCA had potential benefits in terms of tumor shrinkage and long-term local control rate. Further well-designed studies in larger populations are needed to validate our findings.

Outcomes and predictors of clinical T1 renal mass (cT1) upstaged to pathological T3a (pT3a) after partial nephrectomy: A single-center experience.

Clinical T1 (cT1) renal mass treated surgically has a good prognosis, but there is an upstaging risk that potentially threatens oncological outcomes after partial nephrectomy (PN). We aim to analyze and study the incidence, predictors, perioperative morbidity, and oncological outcomes of pT3a upstaging. A retrospective study of 313 patients who underwent PN for cT1 renal mass at a single center from a single tertiary referral center between 2000 and 2021 was done. Demographic, perioperative, pathological, and outcome variables were reviewed. We compared these parameters between upstaged and non-upstaged groups. Multivariate logistic regression analysis was used to study preoperative variables associated with upstaging. Nineteen patients were upstaged to pT3a. Making an incidence of 6.1%. Upstaged tumors were bigger (5.02 cm vs. 4.08 cm, p = 0.004), had higher clinical stage T1b (84.2 vs. 40.5%, p < 0.001), had more tumors which were central location (21 vs. 3.4%, p < 0.001), had more endophytic and mesophytic tumors (15.8 vs. 5.8% and 52.6 vs. 9.5%, p < 0.001), and had higher R.E.N.A.L Nephrometry score (8.05 vs. 6, p < 0.001). Upstaged tumors had more operative times (227 vs. 203 min, p = 0.01), more postoperative complications (68.4 vs. 13.1%, p < 0.001), more major complications of Clavien Dindo Grade 3 and above (15.8 vs. 4.4%, p < 0.001). Age (OR 1.035, p = 0.034), Radiological tumor dimension (OR 1.578, p = 0.003), Radiological or Clinical stage (T1b) (9.19, p = 0.008), Higher Nephrometry score (Intermediate and High) (OR 6.184, p = 0.004) were preoperative predictors of upstaging. Oncological outcomes were comparable. Tumor upstaging was uncommon with more perioperative morbidity. Higher age, larger tumor size, higher tumor stage, and higher nephrometry scores were preoperative predictors of upstaging.

Predictive factors and oncological outcomes of pathological T3a upstaging in patients with clinical T1 renal cell carcinoma undergoing partial nephrectomy.

To investigate predictive factors and oncological outcomes of pathological T3a upstaging in renal cell carcinoma patients who were initially diagnosed as clinical T1 and treated with partial nephrectomy. The clinical records and survival data of 1617 patients, who had undergone partial nephrectomy for clinical T1 renal cell carcinoma at Tokyo Women's Medical University, Tokyo, Japan between January 2011 and December 2020, were analyzed retrospectively. Of 1617 clinical T1 renal cell carcinoma patients who underwent partial nephrectomy, 28 (1.73%) had pathological T3a upstaging. In the multivariable analysis for pathological T3a upstaging using logistic regression models, male sex and clinical T1b were significant factors associated with pathological T3a upstaging (male sex: odds ratio=5.07, 95% confidence interval: 1.18-21.8, clinical T1b: odds ratio=8.36, 95% confidence interval: 3.56-19.6). The Kaplan-Meier method of the recurrence-free survival showed shorter recurrence-free survival in patients with pathological T3a upstaging than in those with pathological T1 (P<0.0001). In the multivariable analysis using Cox proportional hazards regression models, pathological T3a upstaging was no longer significantly associated with recurrence-free survival after adjustment for other pathological factors (hazard ratio=1.59, 95% confidence interval: 0.58-4.36). In a sensitivity analysis that analyzed its components individually instead of whole pathological T3a, neither perinephric fat invasion, sinus fat invasion, nor renal vein invasion was associated with recurrence-free survival. Male sex and clinical T1b were significant predictors for pathological T3a upstaging after partial nephrectomy in clinical T1 renal cell carcinoma patients. Although patients with pathological T3a upstaging had worse recurrence-free survival compared with those without upstaging, multivariable analyses revealed that pathological T3a upstaging was not an independent predictor for poor recurrence-free survival.

Association of Prostate Specific Antigen Kinetics after Testosterone Recovery with Subsequent Recurrence: Secondary Analysis of a Phase III Randomized Controlled Trial.

The combination of short-term androgen deprivation therapy (ST-ADT) with prostate radiotherapy (RT) is a standard of care for patients with localized prostate cancer (LPCa). After cessation of ST-ADT, it takes about 8 to 10 months for the testosterone (T) to recover to supracastrate levels, which could drive changes in PSA kinetics. It largely remains unknown whether early changes in PSA kinetics after T recovery could predict for subsequent biochemical relapse. We performed a secondary analysis of a phase III randomized controlled trial in which patients with newly diagnosed LPCa with Gleason score £7, clinical stage T1b to T3a, and PSA <30 ng/mL were randomly allocated to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate RT (76 Gy in 38 fractions over 7.5 weeks) or concurrent and adjuvant ADT for 6 months starting simultaneously with prostate RT. Clinical assessment and laboratory investigations were repeated 1 month after completion of ADT, every 4 months for the first 2 years, every 6 months for the next 3 years, and annually thereafter. We calculated the PSA doubling time (PSADT) based on PSA values up to 18 months after recovery of T to a supracastrate level (>50 ng/dL). Patients with ³3 PSA measurements after T recovery to supracastrate level were included in this analysis. Fine and Gray cumulative incidence of biochemical recurrence (BCR) was calculated in patients with PSADT at or above median versus below median. Deaths were considered as competing events. All endpoints were calculated from the time of T recovery to supracastrate level. Subdistribution hazard ratios (sHR) with 95% confidence intervals (CI) were estimated for association of PSADT with relative incidence of recurrence using competing risk regression after adjusting for tumor stage, pre-treatment PSA, Gleason score, treatment regimen, and age at randomization. Overall, 311 patients were eligible for this analysis. Median PSADT was 8 months. Cumulative incidence of BCR at 10 years was 31.0% and 20.7% in patients with PSADT <8 months and ³8 months, respectively. Longer PSADT was associated with a significantly lower risk of cumulative incidence of BCR (sHR for PSADT as a continuous variable 0.43, 95% CI: 0.28-0.66; sHR for PSADT ³8 months 0.54, 95% CI: 0.30-0.99). After adjustment for time to recovery of T to supracastrate level in addition to the aforementioned variables, longer PSADT (³8 months) was associated with lower risk of cumulative incidence of BCR (sHR: 0.53, 95% CI: 0.27-1.01). These findings suggest that early PSA kinetics within 18 months of recovery of T to a supracastrate level predict for subsequent biochemical failure. Taking account of early changes in PSA after testosterone recovery may allow for recognition of potential failures earlier in the disease course and thereby permit greater personalization of management decisions.

An increase in tumor size increases the risk of the development of postoperative cardiopulmonary events in patients undergoing partial nephrectomy.

The aim of this study was to examine the effect of kidney tumor size on the risk of CPE developing in the first postoperative month. Evaluation was made of 127 patients who underwent PN between January 2010 and November 2022. The patients were separated into two groups as Group 1 (n: 13) including patients who developed CPE within the first postoperative month and Group 2 (n: 114) of patients who did not develop CPE. The factors that could affect CPE and overall survival were analyzed with multivariate logistic and Cox regression analysis, respectively. The groups were determined to be similar in respect of age, gender and Charlson Comorbidity Index (p = 0.35, p = 0.68, p = 0.42, respectively). The values of mean tumor size (48.6 ± 12.9 vs. 29.2 ± 8.7mm, p < 0.001), clinical T1b stage (61.5% vs. 9.6%, p < 0.001), median R.E.N.A.L. Nephrometry Score (9[3] vs.6 [1], p = 0.001) and mean warm ischaemia time (21.2 ± 3.5 vs. 15.9 ± 2.63min, p < 0.001) were determined to be statistically significantly higher in Group 1 than in Group 2. In the ROC curve analysis performed to predict the development of CPE within the first postoperative month, 35.5mm was determined to be the best cut-off point for tumor diameter (AUC = 0.88, p < 0.001). In the multivariate analysis, the presence of CPE for overall survival, and increased tumor size for the development of CPE were each determined to be independent risk factors (OR: 3.25, p = 0.03; OR: 1.4, p = 0.001, respectively). Tumor size serves as a significant marker for the development of CPE within the initial month following PN.

Analysis of trifecta outcomes in a single center with robot-assisted partial nephrectomy for T1b renal tumors.

This study was performed to investigate the preoperative factors associated with difficulty achieving trifecta in robot-assisted partial nephrectomy for clinical T1b renal cell carcinoma. Among 187 patients who underwent robot-assisted partial nephrectomy at our hospital from March 2012 to February 2022, we retrospectively examined 30 patients with unilateral single clinical T1b renal cell carcinoma with at least 6months of postoperative follow-up, excluding patients with hereditary disease. The following factors were examined in detail: patient-related factors, perioperative factors, surgical techniques, tumor factors, and R.E.N.A.L. nephrometry scores. We examined the preoperative factors associated with difficulty achieving trifecta. A positive surgical margin was pathologically defined as the presence of tumor cells at the margin of the resected specimen or visually defined as intraoperative tumor incision or pseudocapsular damage. Of the 30 patients in this study, 12 achieved trifecta and 18 did not. The reasons for not achieving trifecta were a warm ischemia time of >25 min (66.7%), positive surgical margin (23.3%), and Clavien-Dindo grade ≥3 complications (13.3%) (with overlapping factors). No patients had a pathologically positive surgical margin. Visually positive surgical margins were confirmed by the surgical records and surgical videos. Achieving trifecta was challenging in the multivariate analysis when the "L" component of the R.E.N.A.L. nephrometry score was ≥2 points. A preoperative "L" component of ≥2 points in the R.E.N.A.L. nephrometry score was associated with difficulty achieving trifecta.

Histopathological upstage, recurrence, and survival in a population-based cohort of surgically treated patients with clinical T1b renal cell carcinoma.

731 Background: T1 renal cell carcinoma (RCC) is considered to have a low malignant potential. Partial nephrectomy (PN) is recommended for nephron sparing whenever technically feasible also for T1b RCC. Despite a favorable prognosis there remains a risk for upstaging and recurrence, and the place for PN in clinical T1b tumors is questionable. Therefore, we have characterized these variables and overall survival (OS) in a real-world population-based cohort of patients with clinical T1b RCC. Methods: Patients without metastases registered in the National Swedish Kidney Cancer Register (99% of RCCs diagnosed in Sweden) 2005-2014 with clinical T1b (&gt; 4-7 cm), surgically treated and with a follow-up of ≥ 5 years were included. Results: There were 2137 patients (1300 males, 837 females) with a mean age of 66 years; 82% had clear cell (ccRCC), 11% papillary (pRCC) and 6% chromophobe (chRCC) RCC. Radical nephrectomy (RN) was performed in 1836 patients and PN in 301 patients. After histopathological examination 435 (20%) were upstaged to pathological (p) T3: 21% of ccRCCs, 13% of pRCC and 20% of chRCCs. Recurrent disease after ≥ 5-years follow-up was diagnosed in 127 (29%) pT3 patients and in 238 (14%) with pT1b, 322 (18%) in ccRCC, 127 (11%) in pRCC and 6(5%) in chRCC. Lung metastases occurred in 52% of patients with recurrencies and 144 (39%) of these had two or more metastatic sites. Patients with pT3RCC had a 67% five-year OS compared to 83% in pT1b patients (Log-rank test, p&lt;0.001). Regardless of other factors, patients treated with PN had a higher 5-year OS of 86% compared to 79% in patients treated with RN (Log-rank test, p=0.006). In multivariable analyses, lower age, female sex, smaller tumors, N0, pRCC and chRCC, and pT1b stage were significantly associated with longer survival. A hazard ratio of 0.93 [95% CI 0.65-1.32] for PN indicated that PN was non-inferior to the treatment with RN in patients with clinical T1bRCC. Conclusions: Clinical T1bRCC is a malignant disease with risk for upstaging and tumor recurrence. Nonetheless, the results indicate that PN is non-inferior to the treatment with RN in clinical T1bRCC and support the recommendation to offer PN also in these patients.

A Case of Endoscopic Submucosal Dissection for Clinical T1b Rectal Cancer after Chemoradiotherapy

症例は70歳男性．下部消化管内視鏡検査で直腸Rbに30mmの0-Is+IIa病変を認め，cT1bN0M0の直腸癌の診断となった．患者が手術を拒否したため，化学放射線療法（CRT）を施行して臨床的完全奏効の結果が得られればWatch and Waitを選択する方針とした．CRT終了後4週間で既知の腫瘍は25mmのLST-Gに変化していた．患者に再度根治切除を勧めるも希望されなかったため，CRT終了後8週間で内視鏡的粘膜下層剥離術（ESD）を施行する方針とした．3分割切除となったものの肉眼的には完全切除となった．病理結果はtub1，pTis（M），ly0，v0，HMX，VM0であった．2年1ヵ月経過した現在までに明らかな再発は認めていない．

Crisis Averted: Clinical T1b Renal Mass with Concurrent Arteriovenous Malformation and Renal Vein Thrombus

Arteriovenous malformations (AVMs) secondary to renal-cell carcinoma (RCC) are well-described in the literature. Independently, renal vein and inferior vena cava tumor thrombi can be detected in locally-advanced RCC. A 67-year-old gentleman presented with a cT1b renal mass detected on workup for elevated creatinine. Multiphase CT imaging obtained for partial nephrectomy surgical-planning revealed an initially-missed renal cortical AVM. This drastically changed the plan for intervention, including use of an open approach with AVM embolization by interventional radiology prior and avoidance of a nephron-sparing approach. Final pathology confirmed the AVM and a subclinical renal vein thrombus masked by arterial flow on CT imaging, making this the first concurrent case described in the literature. Herein, we describe avoidance of catastrophic intraoperative hemorrhage by careful review of preoperative imaging and provide a literature review of imaging modalities for both renal surgical-planning and detection of tumor thrombi in RCC.

Final Analysis of Diagnostic Endoscopic Resection Followed by Selective Chemoradiotherapy for Stage I Esophageal Cancer: JCOG0508

Final Analysis of Diagnostic Endoscopic Resection Followed by Selective Chemoradiotherapy for Stage I Esophageal Cancer: JCOG0508

The Different Evaluative Significance of Enlarged Lymph Nodes on Preoperative CT in the N Stage for Patients with Suspected Subsolid and Solid Lung Cancers

To investigate the clinical value of enlarged mediastinal and/or hilar lymph nodes on CT for patients with lung subsolid and solid nodules. The study was performed on patients who underwent surgical treatment for suspected lung cancer. One hundred seventeen subsolid nodules and 101 solid nodules with enlarged lymph nodes (LNs) were included in the study group. The same number of cases with normal LNs with a balanced distribution of the clinical T stage were randomly selected as the control group for each study group. The pathological statuses of the lymph nodes of these patients proven by histopathology after surgery were collected. Lung solid lesions with enlarged LNs were more prone to lymph node metastasis (37.6% vs. 13.9%, p <0.001). However, there were only two and one metastatic lesions in the subsolid group with and without enlarged LNs, respectively. (2/117 vs. 1/117, p=1.000). No pathological lymph node metastasis was observed in subsolid lesions under clinical stage T1b (cT1b), even though some of them (117/234) with enlarged LNs. The evaluative significance of enlarged LNs on CT is different for subsolid and solid lesions. CT is useful for lymph node evaluation and N staging of solid lesions but may has little value for subsolid lesions. There is a very low possibility of lymph node metastasis occurring in patients with subsolid lesions under cT1b. Enlarged LNs on CT may not be critical in subsequent management and treatment for subsolid nodules.

Propensity-matched pair analysis of safety and efficacy between laparoscopic and open radical nephrectomy for the treatment of large renal masses (>10 cm): a retrospective cohort study.

BackgroundOpen radical nephrectomy (ORN) is a practical procedure for treating patients with large renal carcinomas >10 cm in size, and few studies have focused on feasibility and safety of laparoscopic radical nephrectomy (LRN). The current study was to assess the safety and effectiveness of LRN and ORN in large renal carcinoma patients by propensity matched pair analysis.MethodsIn this cohort study, a retrospective review of radical nephrectomy data from October 2010 to October 2018 at Changhai Hospital was conducted. Patients with renal carcinomas >10 cm in size by pre-operative images were included. Patients’ demographics including age, gender, body mass index (BMI), tumor size, operation time, hospitalization days, etc. were collected. Renal tumor patients undergoing LRN or ORN were match-paired by gender, BMI, age, and tumor size. Peri-operative outcomes including estimated blood loss and complications were compared. The follow-up contents included survival time, disease progression, and cause of death, and cancer-specific and progression-free survival were estimated via Kaplan-Meier curve analysis.ResultsAmong 92 patients with clinical T2b renal masses, 37 pairs were matched. The average tumor sizes of the LRN and ORN groups were 11.37±0.30 and 11.67±0.33 cm (P=0.375), respectively. The average operating time for LRN was slightly longer (204.32±11.17 vs. 192.78±8.50 min, P=0.414). Estimated blood loss (EBL) (336.49±63.58 mL for LRN vs. 545.95±74.52 mL for ORN, P=0.036), the length of postoperative stay [6.0 (5.0–9.0) for LRN vs. 9.0 (6.0–11.5) days for ORN, P=0.015], and removal time of the drainage tube [4.0 (3.0–5.0) days for LRN vs. 5.0 (4.0–6.0) for ORN, P<0.001] were less than in the LRN group. The pathological subtype and Fuhrman grade were comparable. Both groups were followed up for a similar period, and no difference was observed in 5-year survival rates.ConclusionsConsidering the conversion rates and overall complication rates, it seems that LRN for large renal carcinomas demonstrated equivalent peri-operative safety and effectiveness compared with ORN, with no adverse effects on midterm oncological outcomes.

Differential efficacy of ablation therapy versus partial nephrectomy between clinical T1a and T1b renal tumors: A systematic review and meta-analysis.

To assess the differential clinical outcomes of patients treated with partial nephrectomy (PN) vs. those treated with ablation therapy (AT) such as radiofrequency ablation, cryoablation and microwave ablation for cT1b compared to cT1a renal tumors. Multiple databases were searched for articles published before August 2021. Studies were deemed eligible if they compared clinical outcomes in patients who underwent PN with those who underwent AT for cT1a and/or cT1b renal tumors. Overall, 27 studies comprising 13,996 patients were eligible for this meta-analysis. In both cT1a and cT1b renal tumors, there was no significant difference in the percent decline of estimated glomerular filtration rates or in the overall/severe complication rates between PN and AT. Compared to AT, PN was associated with a lower risk of local recurrence in both patients with cT1a and cT1b tumors (cT1a: pooled risk ratio [RR]; 0.43, 95% confidence intervals [CI]; 0.28-0.66, cT1b: pooled RR; 0.41, 95%CI; 0.23-0.75). Subgroup analyses regarding the technical approach revealed no statistical difference in local recurrence rates between percutaneous AT and PN in patients with cT1a tumors (pooled RR; 0.61, 95%CI; 0.32-1.15). In cT1b, however, PN was associated with a lower risk of local recurrence (pooled RR; 0.45, 95%CI; 0.23-0.88). There was no difference in distant metastasis or cancer mortality rates between PN and AT in patients with cT1a, or cT1b tumors. AT has a substantially relevant disadvantage with regards to local recurrence compared to PN, particularly in cT1b renal tumors. Despite the limitations inherent to the nature of retrospective and unmatched primary cohorts, percutaneous AT could be used as a reasonable alternative treatment for well-selected patients with cT1a renal tumors.

Analysis of Risk Factors Associated With Central Lymph Node Metastasis in Papillary Thyroid Carcinoma With cT1N0 Stage.

AimAnnual T1 stage papillary thyroid carcinoma (PTC) incidence rates continue to rise, yet the optimal treatment for this cancer type remains controversial. Central lymph node metastasis (CLNM) is a critical determinant in the context of treatment decision-making. While several prior studies have evaluated patients with clinica l T1a(cT1a) stage PTC, there have been fewer analyses of clinical T1b(cT1b) disease to date. The present study was thus formulated to explore predictors of CLNM in patients with cT1a and cT1b stage PTC.MethodsA retrospective analysis of data including clinicopathological characteristics and BRAFV600E mutation status was conducted for 452 PTC patients undergoing surgical treatment. Logistic univariate and multivariate analyses were performed to identify risk factors associated with CLNM in particular patients’ characteristics and the accuracy of the established logistic regression models was evaluated using the R software platform.ResultsRespective CLNM incidence rates in cT1a and cT1b disease were 39.39% and 67.21%. Factors associated with a higher risk of CLNM among PTC(cT1a) patients included male sex, young age, tumor size, contact with capsule, and multifocality as determined through comparisons of the area under the curve for logistic regression models. Whereas male sex and age were associated with CLNM risk in PTC(cT1b) patients in univariate and multivariate analyses, age was the only risk factor associated with CLNM incidence among women with PTC(cT1b).ConclusionPredictors of CLNM differ between PTC patients with cT1a and cT1b stage disease, and a comprehensive assessment of these risk factors should thus be conducted when designing individualized treatment regimens for PTC patients.

Abstract P3-01-15: Significant discordance between clinical and pathological staging in early stage HER2+ and triple negative breast cancers treated with upfront surgery

Abstract Introduction: Treatment of early-stage human epidermal receptor -2 (HER2) positive and triple negative breast cancer (TNBC) remains a challenge as disease recurrences and subsequent morbidity and mortality continues to be high for these tumors. Current guidelines suggest a neoadjuvant approach with chemotherapy alone (in TNBC’s), or in combination with single or dual HER2 directed therapy (in HER2 + tumors), for all ≥cT2 disease. Standard diagnostic modalities have oftentimes failed to confirm the correct size of these aggressive tumors. With recent data showing further survival improvement utilizing regimens for residual disease after neoadjuvant therapy, misrepresentation of the true size of these tumors may lead to patients being treated with upfront surgery and potentially missing the added benefits of residual treatment if they were later found to have ≥T2 disease. We aimed to determine whether there is significant discordance between the clinical and pathological staging of these tumors. Methods: We conducted a retrospective analysis via electronic medical record review of a large institutional database from 2008 to 2020. We reviewed all patients with a diagnosis of early-stage breast cancer (Stage I - III) with triple negative or HER2 positive tumors. Patients who received neoadjuvant chemotherapy were excluded. Data on demographics, comorbidities, receptor status, clinical staging, pathological staging, and mortality were collected. Results: Electronic charts from 448 patients were reviewed. 153 patients had ≤cT1 disease. 33 (21.6%) of the 153 patients were upstaged from cT1 to ≥pT2 tumors. Combined imaging modality with mammogram + ultrasound (US) yielded a statistically significant accuracy in clinical staging compared to US alone (82.6 vs. 44.4%; p=0.02). Comparisons between other imaging methods were not statistically significant (mammogram + US vs. mammogram only, 74.1 vs. 82.6%, p=0.41 and mammogram only vs. US only, 74.1 vs. 44.4%, p= 0.13). Conclusion: Significant discordance (&amp;gt;20%) exists between clinical and pathological staging of T1 TNBC and HER2 positive breast cancers. The possibility that these tumors could indeed be ≥T2 lesions is thus a significant concern. This discordance has considerable therapeutic implications. Landmark studies such as the CREATE-X and KATHERINE trials have provided better survival data with the use of drugs such as capecitabine and trastuzumab emtansine (T-DM1), respectively, in patients with residual disease who have undergone neoadjuvant chemotherapy followed by surgery. Combined imaging with mammography and US may yield the most accurate staging. Based on the data from our retrospective study, a strong consideration may be given to offer neoadjuvant therapy to all clinical T1b and T1c TNBC’s and HER2 positive breast cancers. Meaningful survival analysis was not done due to small sample size. Further studies are needed to validate our findings. Citation Format: Adarsh Sidda, Layana Biglow, Mahmoud Abdallah, Gurusidda Manu, Todd Gress, Maria Tirona. Significant discordance between clinical and pathological staging in early stage HER2+ and triple negative breast cancers treated with upfront surgery [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-01-15.

A0213 - Can ablation therapy be an alternative treatment to partial nephrectomy for clinical T1b renal tumors?: A systematic review and meta-analysis

A0213 - Can ablation therapy be an alternative treatment to partial nephrectomy for clinical T1b renal tumors?: A systematic review and meta-analysis

Association of Short-Term Patient-Reported Outcomes With Long-Term Oncologic Outcomes in Localized Prostate Cancer Patients Treated With Radiation Therapy and Androgen Deprivation Therapy in a Randomized Controlled Trial

PurposeBoth oncologic outcomes and patient-reported outcomes are pivotal in prostate cancer (PCa). However, it remains unknown if there is any association between these 2 outcomes. In this secondary analysis of a randomized controlled trial, we investigated the association of short-term changes in patient-reported outcome with long-term event-free survival (EFS) and metastasis-free survival (MFS) in localized PCa. Methods and MaterialsLocalized PCa patients with a Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen (PSA) <30 ng/mL were randomized to neoadjuvant and concurrent androgen deprivation therapy (ADT) for 6 months starting 4 months before prostate radiation therapy or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy. Patient-reported symptom burden was evaluated using the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ)-PR.25. Clinically meaningful deterioration (CMD) was defined as a ≥10-point worsening at any time within 10 months postrandomization regardless of subsequent improvement. Landmark analyses were performed to determine the association of CMD of urinary and bowel symptoms separately with EFS and MFS in patients who responded to the baseline questionnaire, were alive, and were event free at 10 months. ResultsOverall, 393 patients had responded to the baseline QLQ. One patient died, and 1 patient had failure within 10 months. Therefore, 391 patients were eligible for the landmark analyses. After adjusting for age, Gleason score, PSA, performance status, and treatment group, CMD of urinary symptoms was associated with worse EFS (hazard ratio [HR], 1.79; 95% confidence interval [CI], 1.21-2.65) and MFS (HR, 1.69; 95% CI, 1.11-2.57). Considering deaths as competing events, CMD of urinary symptoms was associated with a significant increase in the relative incidence of progression (subdistribution HR, 2.42; 95% CI, 1.12-5.20). However, no association was found between CMD of bowel symptoms and EFS or MFS. ConclusionsIn this study, short-term CMD of urinary symptoms was associated with significantly inferior EFS and MFS and an increase in the relative incidence of progression. Further investigations are needed to explore the biological rationale of such association in the context of ADT and radiation therapy.

Association of Baseline Patient-reported Health-related Quality of Life Metrics with Outcome in Localised Prostate Cancer

AimsAlthough health-related quality of life (HR-QoL) outcomes are pivotal in oncology, the prognostic significance of patient-reported HR-QoL metrics is largely undefined in localised prostate cancer. We report the association of baseline HR-QoL metrics with overall survival and toxicity in localised prostate cancer. Materials and methodsThis was a secondary analysis of a phase III randomised controlled study conducted in a single-payer health system. Patients with Gleason score ≤7, clinical stage T1b–T3a and prostate-specific antigen <30 ng/ml were randomised to neoadjuvant and concurrent androgen deprivation therapy (ADT) for 6 months starting 4 months before prostate radiotherapy or concurrent and adjuvant ADT for 6 months starting simultaneously with prostate radiotherapy. HR-QoL scores were estimated using the European Organisation for Research and Treatment of Cancer QoL questionnaire. A multistate Markov model was used to determine the association of baseline HR-QoL metrics with overall survival and a multilevel multivariable Cox regression was used to determine the association with the incidence of delayed-onset grade ≥3 radiotherapy-related toxicities. To adjust for multiple analyses, P < 0.025 was considered as statistically significant. ResultsOverall, 393 patients with baseline HR-QoL data were included in this analysis: 194 in the neoadjuvant arm and 199 in the adjuvant arm. Baseline financial difficulty (hazard ratio 1.020, 95% confidence interval 1.010–1.030, P = 0.02) and dyspnoea (hazard ratio 1.020, 95% confidence interval 1.003–1.030, P = 0.01) were associated with inferior overall survival. Baseline dyspnoea was associated with a higher incidence of grade ≥3 toxicity (hazard ratio 1.020, 95% confidence interval 1.010–1.030, P = 0.023). ConclusionIn a cohort of localised prostate cancer patients treated with radiotherapy and short-term ADT, a 10-point higher baseline financial difficulty or dyspnoea was associated with a 20% increased risk of death. With each 10-point increase in baseline dyspnoea, we noted a 20% increase in the associated risk of grade ≥3 delayed-onset radiotherapy-related toxicity.