Recurrence-free Survival Rates Research Articles

Clear surgical margins as a prognostic indicator for disease recurrence, with no impact on survival rates in patients with myxofibrosarcoma

Myxofibrosarcoma presents an infiltrating growth pattern that results in a high tendency for local recurrence. Clear margin resection is challenging because of microscopic infiltration. The purpose of the present study was to analyze the overall and disease-free survival rates of patients with myxofibrosarcoma and the prognostic factors that determine both survival and disease recurrence. Among the 111 patients included in our study, the 5-year overall survival rate was 65.5%. An age of more than 65 years (hazard ratio [HR] 1.9 [95% confidence interval (CI) 1.4–5.6]; p < 0.001), a tumor size of more than 5 cm (HR 2.8 [95% CI 0.9–8.1]; p = 0.049) and the G3 tumor grade (HR 14.1 [95% CI 2.1–105.0]; p < 0.001) negatively affected overall survival. The 5-year recurrence-free survival rate was 49.4%. R1/R2-type resection (HR 2.4 [95% CI 1.0–5.6]; p = 0.048) had a detrimental effect on tumor recurrence. Clear margins had a positive impact on recurrence-free survival, but did not significantly affect overall patient survival, suggesting that other factors may play a more significant role in determining patient outcomes. A surgical margin of 2 mm was not sufficient to significantly influence the incidence of recurrence. Consequently, a wider surgical margin may be necessary to reduce the risk of myxofibrosarcoma recurrence.

Can adjuvant immune checkpoint inhibitors improve the long-term outcomes of hepatocellular carcinoma with high-risk recurrent factors after liver resection? A meta-analysis and systematic review

BackgroundAdministering adjuvant therapy following liver resection is crucial for patients with hepatocellular carcinoma (HCC) exhibiting high-risk recurrence factors. Immune checkpoint inhibitors (ICIs) are effective against unresectable HCC; however, their effectiveness and safety for this specific patient group remain uncertain.MethodsWe conducted an extensive literature search across four scholarly databases to identify relevant studies. Our primary endpoints were overall survival (OS), recurrence-free survival (RFS), and adverse events (AEs). OS and RFS were quantified using hazard ratios (HRs), whereas the 1-, 2-, and 3-year OS and RFS rates were expressed as risk ratios (RRs). Additionally, the incidence of AEs was calculated.ResultsOur meta-analysis included 11 studies (N = 3,219 patients), comprising two randomized controlled trials (RCTs) and nine retrospective studies. Among these, eight studies reported HRs for OS, showing a statistically significant improvement in OS among patients receiving adjuvant ICIs (HR, 0.60; 95% confidence interval [CI], 0.45–0.80; p &amp;lt; 0.0001). All included studies reported HRs for RFS, indicating a favorable impact of adjuvant ICIs (HR, 0.62; 95% CI, 0.52–0.73; p &amp;lt; 0.0001). Moreover, aggregated data demonstrated improved 1- and 2-year OS and RFS rates with adjuvant ICIs. The incidence rate of AEs of any grade was 0.70 (95% CI, 0.49–0.91), with grade 3 or above AEs occurring at a rate of 0.12 (95% CI, 0.05–0.20).ConclusionAdjuvant ICI therapy can enhance both OS and RFS rates in patients with HCC exhibiting high-risk recurrence factors, with manageable AEs.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/#recordDetails PROSPERO, identifier CRD42023488250.

Outcome after cryoballoon ablation of persistent atrial fibrillation in patients with heart failure with preserved ejection fraction versus tachycardiomyopathy: a propensity score-matched analysis

Abstract Introduction Atrial fibrillation (AF) often coexists with heart failure (HF). The aim of the study was to detect differences in outcome between patients with arrhythmia induced cardiomyopathy (AIC)/tachycardiomyopathy and HFpEF undergoing cryoballoon pulmonary vein isolation (cryo-PVI) using a propensity score-based model. Methods In this retrospective observational study, we analysed persistent AF patients with HFpEF and AIC undergoing cryoballoon ablation between 2014 and 2020. AIC was diagnosed ex juvantibus during the first year after ablation at the 3- and 12-month follow-up when LVEF recovered to &amp;gt; 50% and by more than 10% after ablation and a different aetiology for reduced LVEF was excluded. Propensity score matching was used to pair patients based on their age, sex, CHA2DS2-VASc score and left atrial (LA) area. The primary endpoint was the first documented &amp;gt; 30-s recurrence of atrial arrhythmia after a 3-month blanking period during the one-year follow-up. The secondary endpoints were improvements in NYHA class and reduction of LA area. For identification of independent predictors of atrial arrhythmia recurrence after ablation, univariate and multivariate Cox regression analyses were performed. Results Out of 1293 consecutive patients who underwent cryo-PVI, 148 persistent AF patients with HFpEF and 66 patients with AIC were identified. Propensity score matching yielded 46 patients in each group. HFpEF patients were more symptomatic than AIC patients (NYHA: 2.4 +/- 0.5 vs. 2.0 +/- 0,8; p = 0.002). Other baseline characteristics did not differ between the two groups, except LVEF (57 % [IQR: 52-62%] vs. 41% [QR: 35%-45%]; p= 0.002). Kaplan-Meier curves (Figure 1) demonstrated no difference in recurrence-free survival rate between the groups during the 12-month follow-up (71.7 % vs. 56.5%, log-rank P = 0.16). After the 12-month follow-up, the median LA area decreased significantly in the HFpEF group from 25.8 cm2 (IQR: 23.4-29.5 cm2) to 24.6cm2 (IQR: 22.0-29.6 cm2; p = 0.045) and in the AIC group from 26.6 cm2 (IQR: 22.9-31.1 cm2) to 23.0 cm2 (IQR: 18.3-25.2 cm2; p=0.024). At the 12-month follow-up the median LA-area was significantly higher in the HFpEF than in the AIC cohort (p= 0.007). NYHA class improved significantly in both groups from baseline. At the 1-year follow-up NYHA class was similar between both groups (1.6 +/- 0.8 vs. 1.4 +/- 0,6; p = 0.206). After univariate and multivariate analysis, the following predictors of atrial arrhythmia recurrence were identified: body-mass-index (BMI; HR = 1.082, p = 0.015) and LA area (HR = 1.079, p = 0.003). Conclusions Cryoballoon catheter ablation of persistent AF seems to have similar effectiveness on arrhythmia free survival in patients with HFpEF and AIC. NYHA class and LA enlargement improved after ablation in both groups although LA area in HFpEF was higher than in AIC patients at follow-up. BMI and LA area were identified as predictors of arrhythmia recurrence.

Arrhythmia-induced versus arrhythmia-superimposed cardiomyopathy: outcome in patients with atrial fibrillation and heart failure undergoing cryoballoon pulmonary vein isolation

Abstract Introduction The outcome in patients with arrhythmia-induced cardiomyopathy (AIC) compared with that in patients with arrhythmia-mediated/superimposed cardiomyopathy (AMC) undergoing cryoballoon pulmonary vein isolation (cryo-PVI) is also poorly defined. Methods In this retrospective observational study, we analysed patients with AF and reduced left ventricular ejection fraction (LVEF &amp;lt; 50%) who underwent cryoballoon ablation between 2014 and 2020. Patients with LVSD were divided into AIC and AMC. AIC was diagnosed ex juvantibus during first year after ablation at 3- and 12-month follow-up when LVEF recovered to &amp;gt; 50% and by more than 10% after ablation and a different aetiology for reduced LVEF was excluded. AMC was diagnosed when structural heart disease was responsible for LVSD and AF had likely exacerbated pre-existing LVSD. For identification of independent predictors of LVEF non-improvement after ablation, univariate and multivariate logistic regression analyses were performed. LVEF non-improvement was defined when LVEF neither increased by more than 10% nor increased over absolute 50% at 12-month follow-up. The first documented &amp;gt; 30-s atrial arrhythmia recurrence after a 3-month blanking period during the one-year follow-up was compared by Kaplan-Meier analysis. Results Out of 1293 consecutive patients who underwent cryoballoon ablation, 113 AF patients with reduced LVEF (&amp;lt;50%) were identified. After 1-year follow-up these patients were divided into AIC (N= 77) and AMC (N = 36) groups. The prevalence of persistent AF was comparable in both groups (85.7% vs. 77.8 %, p = 0.435). LVEF, left atrial (LA) enlargement, and left ventricular end diastolic diameter (LVEDD) were similar between the groups. After one year, the median LVEF improved significantly in the AIC group from 42% (IQR: 35-45%) to 60% (IQR: 58-63%; p &amp;lt; 0.0001) and in the AMC group from 42% (IQR: 33-45%) to 47.5% (IQR= 43-53%; p=0.015). At follow-up LVEF was significantly higher in the AIC than in the AMC cohort (p &amp;lt; 0,001). After univariate and multivariate analysis, the following parameters were associated with non-LVEF improvement: LVEDD (OR = 1.12, p = 0.012) and atrial arrhythmia recurrence (OR = 5.87, p = 0.031; Figure 1). In the AIC group LA area decreased from 25.6 cm2 (IQR: 22.4-29.5 cm2) to 21.8 cm2 (IQR: 18.3-25.2 cm2; p = 0.012). In AMC patients LA enlargement did not change with respect to baseline. Kaplan-Meier curves demonstrated no difference in recurrence-free survival rate between the groups during the 12-month follow-up (75.3% vs. 75%, log-rank P = 0.89; Figure 2). Conclusions LVEDD and arrhythmia recurrence were identified as predictors of non-LVEF improvement after cryo-PVI. The LVEF increased in both groups after ablation, but in AIC group more than in AMC group. In the AIC group LA atrial area decreased compared to the AMC group. Atrial arrhythmia recurrence rates were comparable between AIC and AMC groups after 12 months.Figure 1Figure 2

Adjuvant Therapy Using Dabrafenib plus Trametinib in Chinese Patients with Resected Stage III Melanoma: A Multicenter Retrospective Cohort Study

Background. In patients with stage III melanoma carrying BRAF mutations, the risk of melanoma recurrence is relatively high even after complete resection of the primary melanoma and regional lymph nodes. Methods. We collected data from patients with stage III cutaneous and acral melanoma who received adjuvant trametinib combined with dabrafenib from three cancer centres in China between August 2019 and December 2022. Results. A total of 55 patients were included in this study. The one-year recurrence-free survival (RFS) rate was 79.8% (95% CI 73.6–86.0%). The one-year RFS rate was 79.8% (95% CI 72.8–86.8%) in the cutaneous melanoma subgroup, while the one-year RFS rate was 74.1% (95% CI 58.0–90.2%) in the acral melanoma subgroup. Six (46.2%) patients experienced recurrence during adjuvant therapy; 7 (53.9%) patients recurred after completion of the regimen. At the time of the first recurrence, distant metastasis occurred in 10 patients, local recurrence occurred in 2 patients, and one patient experienced both distant metastasis and local recurrence. Conclusions. This study confirmed the good tolerability and short-term benefits of adjuvant therapy with dabrafenib and trametinib in Chinese patients with stage III melanoma with BRAF V600 mutation.

Real-world clinical outcome and safety of adjuvant human Interferon-alpha1b in resected stage IIIB or IIIC melanoma: results of a retrospective study

BackgroundHuman interferon-α1b (hIFN-α1b) is the first genetically engineered drug approved by the National Medical Product Administration for cancer therapy in China. hIFN-α1b is a relatively safe therapy and can improve survival in advanced melanoma and its long-term efficacy against resection of stage III melanoma is unknown.ObjectiveThe objective of this study is to assess the safety and efficacy of hIFN-α1b in patients with resected stage III melanoma.MethodsThe clinical data were collected from patients who underwent resection of stage IIIB or IIIC melanoma and received subcutaneous injection of hIFN-α1b every other day. The efficacy of hIFN-α1b was determined by rate of recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and overall survival (OS). Safety data were acquired by review of adverse events at follow-ups.ResultsThe study included a total of 61 patients. The median follow-up duration was 45 months. The RFS at 12, 24, and 36 months were observed to be 75.4%, 47.4%, and 37.2% respectively, while the DMFS rates were found to be 83.6%, 65.5%, and 62.2%. Furthermore, the OS rates at these time points were recorded as being 100%, 81.9%, and 71.5%. The overall tolerability of hIFN-α1b was satisfactory, with only 8.2% of the patients experiencing grade 3/4 toxicity and no treatment-related deaths observed.ConclusionOur findings suggest that adjuvant hIFN-α1b treatment is relatively safe and may potentially enhance the rate of RFS, DMFS and OS in patients who have undergone resection for stage IIIB or IIIC melanoma.

Prognostic significance of MRI features in patients with solitary large hepatocellular carcinoma following surgical resection.

To assess the prognostic impact of preoperative MRI features on outcomes for single large hepatocellular carcinoma (HCC) (≥ 8 cm) after surgical resection. This retrospective study included 151 patients (mean age: 59.2 years; 126 men) with a single large HCC who underwent gadoxetic acid-enhanced MRI and surgical resection between 2008 and 2020. Clinical variables, including tumor markers and MRI features (tumor size, tumor margin, and the proportion of hypovascular component on hepatic arterial phase (AP) (≥ 50% vs. < 50% tumor volume) were evaluated. Cox proportional hazards model analyzed overall survival (OS), recurrence-free survival (RFS), and associated factors. Among 151 HCCs, 37.8% and 62.2% HCCs were classified as ≥ 50% and < 50% AP hypovascular groups, respectively. The 5- and 10-year OS and RFS rates in all patients were 62.0%, 52.6% and 41.4%, 38.5%, respectively. Multivariable analysis revealed that ≥ 50% AP hypovascular group (hazard ratio [HR] 1.7, p = 0.048), tumor size (HR 1.1, p = 0.006), and alpha-fetoprotein ≥ 400 ng/mL (HR 2.6, p = 0.001) correlated with poorer OS. ≥ 50% AP hypovascular group (HR 1.9, p = 0.003), tumor size (HR 1.1, p = 0.023), and non-smooth tumor margin (HR 2.1, p = 0.009) were linked to poorer RFS. One-year RFS rates were lower in the ≥ 50% AP hypovascular group than in the < 50% AP hypovascular group (47.4% vs 66.9%, p = 0.019). MRI with ≥ 50% AP hypovascular component and larger tumor size were significant factors associated with poorer OS and RFS after resection of single large HCC (≥ 8 cm). These patients require careful multidisciplinary management to determine optimal treatment strategies. Preoperative MRI showing a ≥ 50% arterial phase hypovascular component and larger tumor size can predict worse outcomes after resection of single large hepatocellular carcinomas (≥ 8 cm), underscoring the need for tailored, multidisciplinary treatment strategies. MRI features offer insights into the postoperative prognosis for large hepatocellular carcinoma. Hypovascular component on arterial phase ≥ 50% and tumor size predicted poorer overall survival and recurrence-free survival. These findings can assist in prioritizing aggressive and multidisciplinary approaches for patients at risk for poor outcomes.

Prognostic significance of pan-immune-inflammation value in hepatocellular carcinoma treated by curative radiofrequency ablation: potential role for individualized adjuvant systemic treatment

Background This study aimed to explore the prognostic role of pan-immune-inflammation value (PIV) and develop a new risk model to guide individualized adjuvant systemic treatment following radiofrequency ablation (RFA) for early-stage hepatocellular carcinoma (HCC). Materials and methods Patients with early-stage HCC treated by RFA were randomly divided into training cohort A (n = 65) and testing cohort B (n = 68). Another 265 counterparts were enrolled into external validating cohort C. Various immune-inflammatory biomarkers (IIBs) were screened in cohort A. Prognostic role of PIV was evaluated and validated in cohort B and C, respectively. A nomogram risk model was built in cohort C and validated in pooled cohort D. Clinical benefits of adjuvant anti-angiogenesis therapy plus immune checkpoint inhibitor (AA-ICI) following RFA was assessed in low- and high-risk groups. Results The cutoff point of PIV was 120. High PIV was an independent predictor of unfavorable recurrence-free survival (RFS) and overall survival (OS). RFS and OS rates of patients with high PIV were significantly lower than those with low PIV both in cohort B (P RFS=0.016, P OS=0.011) and C (P RFS<0.001, P OS<0.001). The nomogram model based on PIV, tumor number and BCLC staging performed well in risk stratification in external validating cohort C. Adjuvant AA-ICI treatment showed an added benefit in OS (p = 0.011) for high-risk patients. Conclusions PIV is a feasible independent prognostic factor for RFS and OS in early-stage HCC patients who received curative RFA. The proposed PIV-based nomogram risk model could help clinicians identify high-risk patients and tailor adjuvant systemic treatment and disease follow-up scheme.

The Effect of Neoadjuvant Systemic Therapy on Surgical Outcomes After Lymph Node Dissections for Stage III Melanoma; An Australian Cohort.

Neoadjuvant systemic therapy (NAST) for patients with stage III melanoma achieves high major pathologic response rates and high recurrence-free survival rates. This study aimed to determine how NAST with targeted therapies (TTs) and immune checkpoint inhibitors (ICIs) influences surgical outcomes after lymph node dissection in terms of complications, morbidity, and textbook outcomes. Patients who underwent a lymph node dissection after either NAST in a clinical trial or upfront surgery for stage III melanoma between 2014 and 2022 were identified from an institutional research database. The study included 89 NAST-treated patients and 79 upfront surgery-treated patients. The rate of postoperative complications did not differ between the NAST- and upfront surgery-treated patients (55% vs. 51%; p = 0.643), and steroid treatment for drug toxicity did not influence the complication rate (odds ratio [OR], 1.1; 95% confidence interval [CI], 0.4-3; p = 0.826). No significant differences in postoperative morbidity were observed in terms of seroma (23% vs. 11%; p = 0.570) or lymphedema (36% vs. 51%; p = 0.550). The rate of achievinga textbook outcome was comparable for the two groups (61% vs. 57%; p = 0.641). The surgical outcomes after lymph node dissections were comparable between the patients who received NAST and those who had upfront surgery, indicating that surgery can be safely performed after NAST with TT or ICI for stage III melanoma.

The impact of purified protein derivative prior to intravesical bacillus Calmette-Guérin for the treatment of patients with non-muscle invasive bladder cancer.

The aim of this study is to investigate the impact of the intradermal injection of purified protein derivative (PPD) and PPD skin test reactions on the oncological outcomes of patients with non-muscle invasive bladder cancer (NMIBC) treated by trans-urethral resection of bladder tumor (TURBT) and adjuvant intravesical BCG. The study included 100 consecutive patients with NMIBC prospectively given intradermal PPD 1-2 weeks before starting BCG therapy. Another 100 patients with NMIBC not given intradermal PPD before starting BCG were chosen as a historical control. The control group was chosen to be matching with the study group regarding baseline characteristics. The study group was divided into 2 subgroups with positive and negative reaction to PPD skin test. Oncological outcomes, immunological markers (TNF-α and IL-6) changes and BCG side effects were evaluated. There were no significant differences between patients who received PPD or not regarding the 2-year recurrence free survival (RFS) rates and progression-free survival (PFS) rates and immunological markers changes. The 2-year RFS and PFS rates were significantly higher in patients with positive reactions. Post-induction values of immunological markers increased in all patients with a significant increase in patients with positive reactions. BCG side effects were significantly higher in patients with positive reactions. The intradermal injection of PPD before intravesical BCG has no impact on oncological outcomes of patients with NMIBC treated with TURBT and intravesical BCG. However, the PPD skin test reactions before BCG therapy can predict the oncological outcomes, BCG side effects and the immunological outcomes of patients.

Which Surgical Technique for Liver Resection is Favourable in Patients with Colorectal Liver Metastases?

Abstract Background The liver is the most common metastatic site after curative treatment for colorectal cancer (CRC). Around 50% of all patients with CRC will develop colorectal liver metastases (CRLM). Liver resection (LR) represents a curative treatment option. Benefits of anatomic (ALR) versus non-anatomic liver resection (NALR) show a lack of consistent evidence. While ALR seems to be associated with a higher postoperative complication rate, NALR could lead to more recurrences. Aims We investigated complication and survival rates of patients with CRLM after both resection types. Methods This is a multicentre cohort study using retrospectively and prospectively collected data. All patients undergoing LR for CRLM between 2009 and 2020 from 3 specialised centres in Switzerland and Germany were included. Complication and survival rates after ALR versus NALR were analysed using uni- and multivariate Cox regression models. Results 624 patients were included. Median follow-up time was 25.49 months. In 292/624 patients (47%) ALR was performed, while 53% underwent NALR. Complications according to the Clavien-Dindo classification have been observed significantly more often in the ALR group (p=0.001). Especially severe complications grade III and IV have been more present after ALR (36/292 vs. 26/332 and 13/292 vs. 11/332, respectively). Both, length of ICU and postoperative hospital stay have been significantly longer in the ALR group (p&amp;lt;0.001 each). The uni- and multivariate models have shown no significant differences in overall survival (OS) and recurrence free survival rates (RFS) between both groups (for OS adjusted HR of 0.84 (95% CI 0.59 - 1.21; p=0.35) and for RFS adjusted HR 0.92 (95% CI 0.69 - 1.22, p=0.56)). Conclusion This multicentre prospective study investigating ALR versus NALR for CRLM has shown no significant differences in OS and RFS. However, postoperative complications have been reported significantly more often after ALR. NALR seems to be the better choice for patients with CRLM undergoing LR.

Outcomes of Conversion Surgery for Patients With Low-Risk Papillary Thyroid Carcinoma

The outcomes of patients with low-risk thyroid cancer who undergo surgery following a period of active surveillance (AS) are not well-defined. To evaluate surgical, pathologic, and oncologic outcomes among patients undergoing conversion surgery (CS) following AS for low-risk papillary thyroid carcinoma. In this cohort study, patients who underwent CS for disease progression were compared with patients who underwent CS without disease progression and with a propensity score-matched cohort of patients who underwent initial surgery (IS). The median (IQR) postsurgical follow-up time was 40.3 (18.0-59.0) months. Patients were treated at a quaternary cancer referral center in the United States. Surgery. Surgical complications, pathologic characteristics, overall survival (OS), and recurrence-free survival (RFS). Of 550 patients who underwent AS, 55 (10.0%) had CS, of whom 39 (7.1%) had surgery due to suspected disease progression (median [IQR] age, 48 [39-56] years; 32 [82.1%] female). There were no clinically meaningful differences in rates of surgical sequalae between the progression CS group (12 of 39 [30.7%]) and the nonprogression CS group (7 of 16 [43.8%]) (Cramer V, 0.2; 95% CI, 0.01-0.5). The 5-year OS was 100% (95% CI, 100%-100%) in both the disease-progression CS cohort and the IS cohort. Although the cohort of patients undergoing CS after disease progression was by definition a subset with more aggressive tumor behavior, no clinically meaningful differences were observed in the rates of regional recurrence (2 of 39 [5.1%] vs 0 of 39 patients with IS), local recurrence (0 patients), distant metastasis (0 patients), or disease-specific mortality (0 patients) when compared with the matched IS group. Five-year RFS rates were similar: 100% in the IS group and 86% (95% CI, 70%-100%) in the CS group. In this cohort study, CS for suspected disease progression was associated with surgical and oncologic outcomes similar to IS, supporting the feasibility and safety of AS for patients with low-risk papillary thyroid carcinoma.

Short-term and long-term outcomes after robotic radical surgery for rectal gastrointestinal stromal tumor

BackgroundThe optimal approach for ensuring both complete resection and preservation of anal function in rectal gastrointestinal stromal tumor (GIST) remains unknown. The aim of this study was to clarify short-term and long-term outcomes after robotic radical surgery for rectal GIST.MethodsA total of 13 patients who underwent robotic radical surgery for rectal GIST between December 2011 and April 2022 were included. All robotic procedures were performed using a systematic approach. A supplemental video of robotic radical surgery for rectal GIST is attached. The short-term outcome was the incidence of postoperative complications during the first 30 days after surgery. Surgical outcomes were retrieved from a prospective database. Long-term outcomes, including overall survival and recurrence-free survival, were determined in all patients.ResultsMedian distance from the tumor to the anal verge was 4.0 cm. Surgical margins were negative in all patients. Two patients underwent neoadjuvant imatinib therapy. All patients underwent sphincter-preserving surgery. None underwent conversion to open or laparoscopic surgery. The incidence of postoperative Clavien-Dindo grade II and grade ≥ III complications was 7.7% and 0%, respectively. The median postoperative hospital stay was 7 days. Twelve patients (92.3%) underwent stoma closure within 5 months of the initial surgery. Median follow-up time was 76 months. The 5-year overall survival and recurrence-free survival rates were both 100%. None of the patients had recurrence.ConclusionShort-term and long-term outcomes after radical robotic surgery for rectal GIST were favorable. Robotic surgery might be a useful surgical approach for rectal GIST.

Endoscopic submucosal dissection versus surgery for T1b esophageal carcinoma: a single-center retrospective study

IntroductionEndoscopic submucosal dissection (ESD) is a preferred treatment option for superficial esophageal squamous cell carcinoma (SESCC). However, only few studies compared long-term survival outcomes of ESD with surgery, especially for T1b SESCC. This study compared the overall survival (OS), disease-free survival (DSS), recurrence-free survival (RFS), and complication rates of both, to evaluate the value of ESD in patients with T1b SESCC.MethodsWe reviewed patients who underwent ESD (n = 47) or surgery (n = 73) for T1b SESCC at Affiliated Hospital of Nanjing University of Chinese Medicine from 2009 to 2021. To increase the precision of our results interpretation, subgroups were analyzed according to the depth of tumor invasion and elderly people.ResultsIn the ESD and surgery groups, the overall mortality rates were 0/100 and 12.3/100 person years, incidence rates of recurrence were 2.13/100 and 11/100 person years, respectively. Kaplan–Meier survival analysis revealed no significant different in OS, DSS and RFS. Charlson comorbidity index (CCI) and depth of submucosal invasion were identified as risk factors for cancer recurrence in multivariate analysis. For elderly people, no significant differences were found in OS, DSS and RFS between different treatments.ConclusionESD are related to lower complication rates and shorter hospital stay than surgery in long-term outcomes for patients with pT1b SESCC. But in pT1b-SM2 patients, we still need long-term follow-up.

The CONUT score is associated with the pathologic grade in non-small cell lung cancer.

Nutritional scores have been reported to be useful prognostic factors for various cancers. This study evaluated the usefulness of the preoperative controlling nutritional status (CONUT) score as a predictor of recurrence of non-small cell lung cancer (NSCLC). The present study included 422 patients with stage I-IIIA NSCLC who underwent complete resection at Tohoku University Hospital between January 2010 and December 2016. The patients were divided into the low-CONUT and high-CONUT groups based on their CONUT scores. Overall survival (OS), recurrence-free survival (RFS), and cumulative recurrence rates in the low- and high-CONUT groups were evaluated retrospectively. One hundred forty-seven patients (34.8%) were assigned to the high-CONUT group. The high-CONUT group had a significantly worse performance status, pleural invasion, vascular invasion, and lung metastasis. In the whole cohort, the low-CONUT group showed better overall survival, recurrence-free survival, and a low cumulative recurrence rate in comparison to the high-CONUT group. There was no significant difference in prognosis or recurrence between the low- and high-CONUT groups after propensity score matching. Patients with a high CONUT score may be at high risk of recurrence because of the high frequency of pleural invasion, vascular invasion, and lung metastasis.

Conversion surgery intervention versus continued systemic therapy in patients with a response after PD-1/PD-L1 inhibitor-based combination therapy for initially unresectable biliary tract cancer: a retrospective cohort study.

The role of conversion surgery in patients with unresectable biliary tract cancer (BTC) who responded positively to PD-1/PD-L1 inhibitor-based therapy remains unclear. This study aimed to assess the outcomes in patients with or without conversion surgery. In this cohort study, patients with advanced BTC who received combination therapy with PD-1/PD-L1 inhibitors from July 2019 to January 2023 were retrospectively. Patients who exhibited positive responses and met the criteria for conversion surgery were enrolled, and their surgical and oncological outcomes were analyzed. Out of 475 patients, 34 who met the conversion resection criteria were enrolled. The median follow-up was 40.5 months post-initiation of systemic therapy. Ultimately, 13 patients underwent conversion surgery, while 21 received continuation of systemic treatment alone (non-surgical group). The median interval from the initial antitumor therapy to surgery was 6.7 (interquartile range [IQR] 4.9-9.2) months. Survival with conversion surgery was significantly longer than the non-surgical cohort, with a median progression-free survival (PFS) (unreached vs. 12.4mo; hazard ratio 0.17 [95% CI 0.06-0.48]; P=0.001) and overall survival (OS) (unreached vs. 22.4mo; hazard ratio 0.28 [95% CI 0.09-0.84]; P=0.02), respectively. After a median postoperative follow-up of 32.2 months in the surgical cohort, 8 patients survived without recurrence. The estimated 3-year OS, PFS and recurrence-free survival rate in the surgical cohort were 59.9%, 59.2% and 60.6%, respectively. The R0 resection rate reached 92.3%, with 2 achieving a pathological complete response. One patient experienced a Clavien-Dindo grade 3 complication without surgery-related mortality. No serious adverse events or surgical delays were observed. Multivariate analysis indicated that conversion surgery was independently associated with OS (P=0.03) and PFS survival (P=0.003). Conversion surgery appears safe and offers survival benefits to patients responding to immune checkpoint inhibitors (ICIs)-based combinations. However, further studies are required to validate this strategy in the era of immunotherapy.

Primary Retroperitoneal Lymph Node Dissection for Clinical Stage II A/B Seminomas: A Systematic Review and Meta-Analysis.

Chemotherapy and radiation therapy are considered standard treatments for stage II seminoma patients; however, these therapies are associated with long-term toxicities. Recently, retroperitoneal lymph node dissection has emerged as an alternative strategy, and the first three phase II trials were published in 2023 with promising results. The present study conducted a systematic review and meta-analysis to evaluate this surgery as an alternative treatment for stage IIA/B seminoma patients. Seminomas are the most common testicular tumors, often affecting young adult males. Standard treatments for stage II seminomas include chemotherapy and radiation therapy, but these therapies are associated with long-term toxicities. Thus, identifying alternative strategies is paramount. Herein, we conducted a systematic review and meta-analysis to appraise the efficacy and safety of retroperitoneal lymph node dissection (RPLND) for treating this condition. We systematically searched the PubMed, Embase, and Cochrane databases for studies evaluating RPLND as a primary treatment for stage II A/B seminomas. Using a random-effects model, single proportion and means and pooled 2-year recurrence-free survival rates with hazard rates and 95% CI were calculated. Seven studies were included, comprising 331 males with stage II seminomas. In the pooled analysis, the recurrence rate was 17.69% (95% CI 12.31-24.75), and the 2-year RFS rate was 81% (95% CI 0.77-0.86). The complication rate was 9.16% (95% CI 6.16-13.42), the Clavien-Dindo > 2 complication rate was 8.83% (95% CI 5.76-13.31), and the retrograde ejaculation rate was 7.01% (95% CI 3.54-13.40). The median operative time was 174.68 min (95% CI 122.17-249.76 min), median blood loss was 105.91 mL (95% CI 46.89-239.22 mL), and patients with no evidence of lymph node involvement ranged from 0-16%. Primary RPLNDs for treating stage IIA/B seminomas have favorable RFS rates, with low complication and recurrence rates. These findings provide evidence that this surgery is a viable alternative therapy for these patients.

Abstract PO5-20-04: A Phase II Study of Ribociclib and Endocrine Treatment of Physician’s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Abstract Background Hormone receptor positive (HR+) breast cancer (BC) is the most common subtype of BC (70-80%). This subset tends to have good prognosis, therefore most patients with localized disease have excellent long-term survival, approaching 100% 5-year relative survival. However, 10% of patients experience loco-regional recurrence (LRR) within 5 year of final surgical management of the primary disease-well within the typical treatment window of adjuvant endocrine therapy. Few studies exists to guide the systemic treatment of patients who have suffered LRR of HR+ HER2 - BC. The randomized controlled CALOR trial demonstrated no benefit to systemic cytotoxic chemotherapy for this subgroup of patients and persistent high rate of subsequent recurrences (50% within 10 years on LRR event). There is no standard of care for managing this patient population. The combination of ribociclib and endocrine therapy (ET) (fulvestrant and aromatase inhibitors) is FDA approved for management of unresectable recurrences and metastatic HR+HER- BC (MONALEESA trials). CDK4/6 inhibitors have been investigated in early BC setting too, several trials showing positive results (monarchE, NATALEE). Data is needed to investigate their use in patients with LRR. Trial design This is a multicenter, single arm phase II study to evaluate efficacy and safety of ribociclib and ET in patients with LRR of HR+HER2- BC. Treatment includes ribociclib for 36 months, 600 mg daily for 21 days, 28-day cycle plus physician’s choice ET for 60 months (fulvestrant or AIs). Ribociclib dose was chosen based on approved dose in metastatic BC. Eligibility Criteria Patients ≥ 18 of age, with LRR of BC (ipsilateral breast, axilla, regional lymph nodes, chest wall), histologically confirmed estrogen receptor positive and/or progesterone receptor positive, HER 2 negative. Patients must have adequate local treatment for LRR (surgery and/or radiation) with negative microscopic margins, no evidence of distant metastatic disease. Prior treatment with neo-adjuvant and adjuvant chemotherapy and ET is allowed, no prior CDK 4/6 inhibitor in the last 12 months. Pre and post-menopausal women are allowed. Patient must enroll within 6 months of the last local therapy. Specific aims Primary objective: to estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET in patients with HR + HER2- BC with adequately resected local recurrence. Secondary objectives: to estimate distant metastasis-free survival and overall survival, to evaluate safety and tolerability, to identify predictors of LRR. Correlative analysis will explore prognostic and predictive biomarkers of treatment with ribociclib and ET and potential molecular mechanisms of resistance to treatment. Statistical Methods From previous published data (J Clin Oncol. 2018 Apr 10;36(11):1073-1079), we assume that patients receiving standard of-care management following recurrence would have a recurrence free survival (RFS) rate of 80% at 3 years and that treatment with ribociclib + ET will increase it by 7%. We wish to have at least 80% power at that significance level of 0.0487 to correctly detect that improvement in RFS rate at 3 years from 80 to 87%. Because only an improvement in RFS rate is of clinical interest, we have a directional hypothesis, and have used a 1-sided alpha. Using a one-sample survival study design, with assumed accrual duration of 3-years and additional follow-up time of 3 years, the minimum sample size requirement is N=180 patients. Target accrual The minimum sample size requirement is N=180 patients. A bigger sample size of N=200 patients will achieve a power of at least 84%. Current accrual is 6/200. This study will be open at up to 35 sites. Contact information The study is being administered through the HCRN, it can be identified as BRE20-468, NCT05467891, ocdanciu@uic.edu Citation Format: Oana Danciu, Nancy Chan, Kari Wisinski, Trish Millard, Kathleen Kemmer, Sneha Phadke, Zhengjia Chen, Ana Cuesta Fernandez, Melanie Clark, Alison Conlin, Coral Omene, Sima Ehsani, Stephanie Dublis, Vijayakrishna K. Gadi. A Phase II Study of Ribociclib and Endocrine Treatment of Physician’s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-20-04.

Ethanol Ablation of Ranulas and Risk Factor Analysis for Recurrence

Ethanol ablation (EA) was shown to be safe and effective for treating ranula, but few studies have assessed long-term outcomes and recurrence of ranula after EA. To evaluate the long-term outcomes and the risk factors for recurrence and receipt of subsequent surgery in patients who underwent treatment with EA for ranula. This case-series study was conducted at a single tertiary hospital and assessed patients who were treated with EA between July 2009 and March 2021. Among 70 consecutive patients, those with follow-up loss or who were followed up for less than 24 months were excluded. EA for ranula. The primary outcome was recurrence at last follow-up after single or multiple EA sessions. Secondary outcomes included receipt of subsequent surgery and the recurrence-free survival (RFS) rate after initial EA. Factors possibly associated with outcomes included patient age and sex; ranula site, type, diameter, volume, and echogenicity; the presentation-to-EA interval; parapharyngeal space extension; and sublingual gland herniation. Risk factors were identified on logistic regression analyses. Two-year RFS rates were analyzed for the initial cohort using the Kaplan-Meier method and compared by log-rank tests. A total of 57 patients (mean [SD] age, 26.4 [12.1] years; 24 female individuals [42%]) who were followed up for a median of 57 months (range, 24-167 months) were included. The recurrence rate was 33% (n = 19), and 11 (19%) underwent subsequent surgery. Among patients with recurrence, 86% (31 of 36) experienced first recurrence within 12 months after initial EA. A presentation-to-EA interval of 12 months or longer was associated with an increased risk of recurrence (adjusted odds ratio [OR], 3.74; 95% CI, 1.01-13.82). No risk factors were significantly associated with subsequent surgery (highest OR in parapharyngeal space extension: adjusted OR, 4.96; 95% CI, 0.94-26.35). Among the initial cohort of 70 patients, 2-year RFS was lower in a maximum diameter of ranula of 5 cm or greater than less than 5 cm (24% [95% CI, 7%-41%] vs 50% [95% CI, 34%-66%]; difference, 26% [95% CI, -4% to 56%]; log-rank test, P = .02). This case-series study found that the recurrence rate of ranula after EA was 33%. A presentation-to-EA interval of 12 months or longer may be a risk factor for recurrence, suggesting that early intervention with EA might minimize recurrence. Most first recurrences occurred within 12 months after EA, with a maximum diameter of ranula of 5 cm or greater being a possible risk factor.

Abstract PO1-28-01: MammaPrint and BluePrint identify racial disparities among women with HR+HER2- early-stage breast cancer

Abstract INTRODUCTION: Black women are 41% more likely to die from breast cancer compared to White women yet remain underrepresented in clinical trials and population studies. We have previously shown a higher proportion of Black women with HR+HER2- tumors further classify as Basal-Type compared with White women, using BluePrint molecular subtyping. Other studies have demonstrated higher 3-year recurrence rates in patients with BluePrint Basal-Type tumors compared to Luminal-Type. To determine whether the increased frequency of HR+/Basal-Type tumors impacts long-term outcomes in this cohort, we compared 3-year outcomes with BluePrint and the risk of distant recurrence signature, MammaPrint (MP), between Black and White women with HR+HER2- breast cancer. We also evaluated the association of MP and BluePrint with 10-year outcomes in a subset of Black women. METHODS: This study included 635 women with stage I-III, HR+HER2- breast cancer, of whom, 135 Black women were enrolled in the BEST study between 2005-2015 (R01-CA204819), and 120 Black women and 380 White women are enrolled in the ongoing FLEX study (NCT03053193). Each patient had MP and BluePrint testing. MP classifies tumors as having a Low Risk or High Risk of distant recurrence. BluePrint categorizes tumors as Luminal-Type, HER2-Type, or Basal-Type. Together, MP and BluePrint further stratify Luminal tumors into Luminal A-Type (MP Low Risk) and Luminal B-Type (MP High Risk). Recurrence-free survival (RFS) was the primary endpoint. Overall survival (OS) at 10 years was the secondary endpoint for those with long-term follow up. RFS and OS are defined per STEEP criteria. Survival curves were estimated using Kaplan-Meier analyses, and significance between groups was determined using log-rank test. RESULTS: Among all patients, 14.5% of Black women had BluePrint Basal-Type tumors compared to 5.8% of White women (p &amp;lt; 0.001). Median follow up was 3.0 years for patients in FLEX, and 10.1 years for patients in BEST. The unstratified 3-year RFS was 93.6% (95% CI 90.7 – 96.7) for Black patients and 93.6% (95% CI 91.1 – 96.3) for White patients. When further stratified by MP and BluePrint, 3-year RFS for patients with HR+HER2- tumors significantly differed (p=0.002). Patients with HR+/Luminal A tumors exhibited the best 3-year RFS (96.9%; 95% CI 95.0 – 98.9), followed by HR+/Luminal B tumors (91.6%; 95% CI 88.2 – 95.1), and HR+/Basal tumors (85.8%; 95% CI 77.2 – 95.5). For a subset of patients with 10-year follow up, we evaluated the association of MP and BluePrint with RFS (n=135) and OS (n=134). The unstratified 10-year RFS and OS rates for Black women were 88.4% (95% CI 82.9 – 94.2) and 89.0% (95% CI 83.7 – 94.7), respectively. When stratified by MP and BluePrint, Black patients with HR+/Luminal A tumors had a 10-year RFS of 97.7% (95% CI 93.4 – 100), versus 83.5% (95% CI 74.8 – 93.1) for patients with HR+/Luminal B, and 85.0% (95% CI 70.7 – 100) for patients with HR+/Basal tumors (p=0.080). Similarly, Black patients with HR+/Luminal A tumors exhibited excellent 10-year OS (100%), whereas OS for patients with HR+/Luminal B (83.5%; 95% CI 74.8 – 93.1) and HR+/Basal tumors (85.0%; 95% CI 70.7 – 100) were significantly lower (p=0.026). CONCLUSION: Survival outcomes at 3 years were comparable between Black and White patients. MP and BluePrint more precisely stratified tumors resulting in distinct 3- and 10-year outcomes, independent of race, beyond clinical subtype alone. Additionally, the subset of Black patients with Low Risk, Luminal A-Type tumors had excellent 10-year survival outcomes. Patients with HR+ tumors that further classify as Basal-Type, which occur more frequently in Black patients, have worse outcomes compared to Luminal A-Type tumors, and may warrant more aggressive treatment. These data highlight the importance of genomic testing to help optimize treatments and reduce outcome disparities in Black women. Citation Format: Sonya Reid, Xiao-Ou Shu, Lindsay Venton, Josien Haan, Andrea Menicucci, Patricia Dauer, William Audeh, Tuya Pal. MammaPrint and BluePrint identify racial disparities among women with HR+HER2- early-stage breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-28-01.