5-year On Overall Survival Rates Research Articles

Abstract PO2-16-12: Real world evidence of neoadjuvant chemotherapy for breast cancer treatment in a Brazilian multicenter cohort: correlation of pathological complete response and overall survival

Abstract Introduction: Breast cancer is the most common malignancy among women in Brazil and worldwide. Neoadjuvant chemotherapy (NAC) has been increasingly used for the treatment of breast cancer conditions ranging from locally advanced tumors to early-stage triple-negative and HER-2 positive tumors. Nowadays only 5% of breast cancer patients are enrolled in clinical trials. Real-world data is important to evaluate how clinical trial treatments behave in the real world with all the heterogeneous patient characteristics of those treated differently from the homogeneity of clinical trials. Objectives: To evaluate the rates of pathological complete response (pCR) in patients undergoing neoadjuvant chemotherapy (NAC) for the treatment of breast cancer (BC) To examine the differences in pathological complete response (pCR) rates between HER-2 positive breast cancer patients with and without trastuzumab treatment, and between triple-negative breast cancer (TNBC) patients with and without platinum-based treatment, Additionally, we aim to assess the impact of pCR on overall survival (OS) and disease-free survival (DFS) using real-world data (RWD). Methods: This was a retrospective, multicentric cohort study, that included female patients over 18 years of age, with a diagnosis of non-metastatic breast cancer undergoing NAC. As an exploratory real-world data study, no confirmatory hypothesis was established, so no corrections for multiple comparisons were necessary. Overall survival (OS) and disease-free survival (DFS) were estimated by the Kaplan-Meier method calculated at five years. Additionally, we conducted a multivariate analysis to identify significant associations with pathologic complete response (pCR) and overall survival (OS). We employed a forest plot to visually represent these associations Results: From 2011 to 2020, 1,891 patients were included in the study, and 421 (22,3%) achieved pCR (ypT0 ypN0) and considering the presence of residual in situ carcinoma (DCIS) the pCR was seen in 467 patients (23,5) without significant difference (p=0,567) . The pCR rate varied between the subtypes: luminal A 17,0%, luminal B 21,3%, luminal HER2 23,0%, TNBC 22,5% and HER2 28,5% (p = 0,057). The type of neoadjuvant chemotherapy (NAC) regimen was correlated with pathological complete response (pCR). Among HER2-positive patients, those who received Trastuzumab had a significantly higher rate of pCR compared to those who did not receive it (p < 0.0001). Similarly, in patients with TNBC, those who underwent treatment with platinum-based regimens also showed higher rates of pCR (p < 0.0001). There were 694 deaths, and the 5-year OS rate was 62.9%. OS was also grouped according to pCR status, and pCR OS rate was 88,3% and non-pCR 58.1% significant difference observed (p < 0.0001). Five-year DFS of pCR was 92.2% and non-pCR 64.3% (p < 0.0001). Conclusion: this real-world data study evaluated the rates of pathological complete response (pCR) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC). The results revealed varying pCR rates among different breast cancer subtypes, with HER2-positive and triple-negative subtypes showing higher rates. The use of Trastuzumab in HER2-positive patients and platinum-based regimens in triple-negative patients correlated with significantly higher pCR rates. Furthermore, achieving pCR was associated with improved overall survival (OS) and disease-free survival (DFS). These findings emphasize the importance of considering individual tumor characteristics and tailoring treatment strategies for breast cancer patients to optimize outcomes. Clinicopathological characteristics of patients AJCC, American Joint Committee on Cancer; IDC, invasive ductal carcinoma; ILC, invasive lobular carcinoma; TNBC triple negative breast cancer. NAC schemas and correlation with pCR. AC-T, doxorubicin + cyclophosphamide – taxane; AC-TPlatinum, doxorubicin + cyclophosphamide – taxane+carboplatin; AC-TH, doxorubicin + cyclophosphamide – taxane+herceptin. Citation Format: Marcelo Antonini, Andre Mattar, Fernanda Grace Bauk Richter, Gabriel Pannain, Andressa Amorim, Marina Diogenes, Odair Ferraro, Luiz Gebrim, Reginaldo Coelho Lopes, Juliana Real. Real world evidence of neoadjuvant chemotherapy for breast cancer treatment in a Brazilian multicenter cohort: correlation of pathological complete response and overall survival [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 PO2-16-12.

Macroscopic type is implicated in the prognostic impact of initial chemotherapy on peritoneal lavage cytology-positive gastric cancer with no other noncurative factors.

Initial chemotherapy (Initial-C) followed by surgery is a promising treatment strategy for peritoneal lavage cytology-positive gastric cancer (CY1 GC) with no other noncurative factors. The aim of this study was to investigate the survival advantage of Initial-C compared to initial surgery (Initial-S) for this disease according to the macroscopic type, which was associated with prognosis and the efficacy of chemotherapy in GC. One hundred eighty-nine patients who were diagnosed with CY1 GC with no other noncurative factors at four institutions from January 2007 to December 2018 were enrolled. The patients were divided into a macroscopic type 4 group (N = 48) and a non-type 4 group (N = 141). The influence of initial treatment on overall survival (OS) in each group was evaluated. In the type 4 group, the 5-year OS rates of Initial-C (N = 35) and Initial-S (N = 13) were 11.6% and 0%, respectively (P = 0.801). The multivariate analysis could not show the survival advantage of Initial-C. In the non-type 4 group, the 5-year OS rates of Initial-C (N = 41) and Initial-S (N = 100) were 48.4% and 29.0%, respectively (P = 0.020). The multivariate analysis revealed that Initial-C was independently associated with prolonged OS (hazard ratio, 0.591; 95% confidence interval, 0.375-0.933: P = 0.023). Initial-C improves the prognosis of non-type 4 CY1 GC with no other noncurative factors. On the other hand, further development of effective chemotherapeutic regimens and innovative treatment strategies are required for type 4 CY1 GC.

The influence of marital status at diagnosis on survival of adult patients with mantle cell lymphoma

PurposeMarital status has been reported to influence the survival outcomes of various cancers, but its impact on patients with mantle cell lymphoma (MCL) remains unclear. This study aimed to assess the influence of marital status at diagnosis on overall survival (OS) and cancer-specific survival (CSS) in patients with MCL.MethodsThe study utilized data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER)-18 databases, including 6437 eligible individuals diagnosed with MCL from 2000 to 2018. A 1:1 propensity matching method (PSM) minimized confounding factor. Univariate and multivariate analyses determined hazard ratios (HR). Stratified hazard models were developed for married and unmarried statuses across time intervals.ResultsMarried patients exhibited better 5-year OS and CSS rates compared to unmarried patients (54.2% vs. 39.7%, log-rank p < 0.001; 62.6% vs. 49.3%, log-rank p < 0.001). Multivariate analysis indicated that being unmarried was an independent risk factor for OS (adjusted HR 1.420, 95% CI 1.329–1.517) and CSS (adjusted HR 1.388, 95% CI 1.286–1.498). After PSM, being unmarried remained an independent risk factor for both OS and CSS. Among unmarried patients, widowed individuals exhibited the poorest survival outcomes compared to patients with other marital statuses, with 5-year OS and CSS rates of 28.5% and 41.0%, respectively. Furthermore, in the 10-year OS and CSS hazard model for widowed individuals had a significantly higher risk of mortality, with the probability of overall and cancer-specific mortality increased by 1.7-fold and 1.6-fold, respectively.ConclusionMarital status at diagnosis is an independent prognostic factor for MCL patients, with widowed individuals showing worse OS and CSS than those who are married, single, or divorced/separated. Adequate psychological and social support for widowed patients is crucial for improving outcomes in this patient population.

Impact of preoperative white blood cell count on outcomes in different stage colorectal cancer patients undergoing surgical resection: a single-institution retrospective cohort study

PurposeTo explore the association between preoperative WBC count and the long-term survival outcomes and clinical outcomes in different stage patients who underwent surgical resection for colorectal cancer (CRC).Patients and methodsA cohort of 8121 Chinese patients who underwent surgical resection for CRC from January 1, 2008 to December 31, 2014 were enrolled as part of the retrospective cohort were retrospectively analyzed. Based on that the preoperative WBC optimal cut-off value was 7*109/L (7,000/µL), the high preoperative WBC group and the low preoperative WBC group was defined. Inverse probability of treatment weighting (IPTW) using the propensity score was used to reduce confounding. The impact of preoperative WBC count on overall survival (OS) and disease-free survival (DFS) was investigated using the Kaplan-Meier method and Univariate Cox proportional hazards models in different stage subgroup respectively.ResultsAfter IPTW, the clinical characters in the high preoperative WBC count group and the low preoperative WBC count group were balanced. Kaplan-Meier analysis showed that the 5-year OS rate were significantly lower in the high preoperative WBC count group overall, in stage II and IV. The 5-year DFS rate was significantly lower overall, in stage II and III in the high preoperative WBC count group. High preoperative WBC count was associated with poorer OS overall in stage II and stage IV.ConclusionsThis study suggests that preoperative WBC count is an independent risk factor for survival in patients undergoing colorectal surgery and may need to consider the stage of cancer when applied to predict long-term adverse outcome prognosis.

Outcomes of Tcrαβ and CD19-Depleted Hematopoietic Stem Cell Transplantation from Matched, Mismatched Unrelated and Haploidentical Donors for Pediatric Patients with Hematological Malignancy: A Meta-Analysis

Introduction: TCR αβ+/CD19+ depletion in hematopoietic stem cell transplantation (HSCT) is an emerging graft manipulation technique to help overcome the HLA barrier in the mismatched or haploidentical transplant setting and reduce or prevent graft-versus-host disease. Limited research has explored the impact of various donor sources, and type of malignancy on the outcomes of TCR αβ+/CD19+ depleted HSCT for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). Therefore, we performed a comprehensive meta-analysis of published clinical studies using individual patient data (IPD) to address this scientific gap. Methods: This meta-analysis combined patient-level data from studies involving AML/MDS and ALL patients treated with TCR αβ+/CD19+ depleted HSCT. By utilizing the IPDfromKM technique, we reconstructed time-to-event data from aggregated Kaplan-Meier curves, specifically focusing on overall survival (OS), disease-free survival (DFS), and GVHD-free, relapse-free survival (GRFS). Additionally, we conducted parallel meta-analyses to calculate the pooled incidences of GVHD, graft failure, mortality, as well as CMV and EBV reactivation, and sinusoidal obstruction syndrome (SOS) using aggregate data. All analyses were performed using STATA software. Our comprehensive literature search included publications up to May 2023, excluding studies with significant sample overlap. Results: The meta-analysis incorporated 817 children with AML/MDS or ALL from 12 studies. Successful primary engraftment was observed in 95% of patients (95% CI: 92 - 98), with an average time to neutrophil and platelet engraftment of 12 days. The incidence of acute GVHD grades I-II was 24% (95% CI: 14 - 34), while grades III and IV were 11% (95% CI: 3.0 - 0.18). Chronic GVHD was observed in 19% of patients (95% CI: 11 - 28). The relapse and graft failure rates were 25% (95% CI: 19 - 32) and 6% (95% CI: 2.0 - 9.0), respectively. The all-cause mortality was 34% (95% CI: 29 - 38), with HSCT-related mortality at 11% (95% CI: 8.0 - 13), while relapse-related mortality accounted for 22% (95% CI: 17 - 28). At a median follow-up of 2.55 years, the 1-year and 5-year OS rates were 74.7% (95% CI: 60.6 - 78.3) and 64.4% (95% CI: 59.9 - 68.5), respectively. No significant differences in OS were found between ALL and AML/MDS patients (HR= 0.99, 95% CI: 0.48 - 2.02, P=0.98) or between different donor types (Figure 1A). The DFS rates at 1- and 5-year were 72.8% (95%CI: 67.6 - 77.3) and 61.8% (95%CI: 56.1 - 67.0), respectively. No significant differences in DFS were observed between ALL and AML/MDS patients (HR = 0.74 95%CI: 0.48 - 1.14, P=0.17) or between different donor types (Figure 1B). The overall 1- and 5-year GRFS rates were 71.1% (95% CI: 64.1 - 77.4) and 63.0% (95% CI: 55.3 - 69.8), respectively. The overall incidence of CMV and EBV reactivation was 33% (95% CI: 19 - 46) and 16% (95% CI: 0 - 38), respectively. Conclusions: Our meta-analysis confirms the effectiveness and safety of TCRαβ and CD19-depleted HSCT for hematological malignancies, demonstrating high engraftment success, low graft failure, and a manageable incidence of acute and chronic GVHD. The consistently favorable outcome data across different donor types and malignancies support the broad applicability of this form of graft manipulation.

Nodal pCR and overall survival following neoadjuvant chemotherapy for node positive ER+/Her2- breast cancer.

The role of neoadjuvant chemotherapy (NAC) in node-positive (N+) ER+/HER2- breast cancer (BC) is debated, given low total pathologic complete response (pCR) rates. However, the rate and impact of nodal pCR is unknown. We sought to evaluate nodal pCR rates and the impact on overall survival (OS). Further, we sought to validate the association between nodal pCR with age and Ki67. We queried the National Cancer Database for cN + ER+/HER2- BC patients treated with NAC and surgery. Data from 2010 to 2018 were used to evaluate nodal pCR and OS, with multivariable Cox proportional hazards modeling for OS, as well as Ki67 for the years 2018-2019. From 2010 to 2018, we identified 19,611 cN + ER+/HER2- BC patients treated with NAC. While total pCR occurred in only 7.4%, nodal pCR rates were nearly double (14.3%). Nodal pCR (+/- breast pCR) was seen in 21.7% and associated with 5-year OS rate of 86.1% (95% CI: 84.9-87.4%) versus 77.1% (95% CI: 76.3-77.9%) in patients without nodal pCR (p < 0.001). On multivariable analysis, nodal pCR had better OS (adjusted HR 0.57, 95%CI 0.52-0.63, p < 0.001) across all age groups. Of 2,444 patients with available Ki67, those with age < 50 and Ki67 ≥ 20% had the highest nodal pCR at 31.6%. In cN + ER+/HER2- BC treated with NAC, nodal pCR is common, associated with age and Ki67, and prognostic for OS. These data strongly suggest that for cN + patients, eradication of nodal disease is critical for OS, and total pCR may not be the optimal measure of NAC benefit.

Enhanced antitumour immunity following neoadjuvant chemoradiotherapy mediates a favourable prognosis in women with resected pancreatic cancer

BackgroundThis study investigates sex disparities in clinical outcomes and tumour immune profiles in patients with pancreatic ductal adenocarcinoma (PDAC) who underwent upfront resection or resection preceded by gemcitabine-based neoadjuvant chemoradiotherapy...

Impact of systemic immune-inflammation index in patients with limited-stage small cell lung cancer.

e20626 Background: The systemic immune-inflammation index (SII) has been suggested as a prognostic marker in several solid malignant neoplasms. However, there are few studies on the prognostic value of SII in patients with limited-stage SCLC. This study explored the impact of SII on overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer, and compared the predictive ability of SII and platelet/lymphocyte ratio (PLR) to find a better prognostic marker. Methods: In total, 572 patients with new diagnosis of limited-stage SCLC were included in this study. The optimal threshold of SII and PLR were determined using the outcome(OS)-based method by maximizing the log-rank test statistic and the survival differences.The predictive ability of SII and PLR were compared by drawing the continuous time-dependent receiver operating characteristic curves (time-dependent ROC). Logistic multivariable analysis was performed to identify factors associated with high SII. Propensity score matching (PSM) was used to balance confounders between groups and adjust observed selection bias. Kaplan-Meier methods and Cox proportional hazards models were used to assess the impact of pre-treatment SII on OS and PFS. Results: The median age of the whole group was 60.0 (25.0-81.0) years, and the median follow-up time was 56.5 (2.5-95.4) months. The optimal cutoff value of SII and PLR were 760.6 and 137.3, respectively. The area under the time-dependent ROC curves of SII and PLR in 1-, 2- and 3-year were 0.727, 0.708, 0.680 and 0.680, 0.669, 0.649, respectively. The high SII group was correlated with pleural effusion (P = 0.001), T stage (P = 0.009), N stage (P = 0.048), and pretreatment serum sodium (P = 0.003). The median OS and PFS of the whole group was 26.0 months (95%CI 23.8-28.2) and 13.0 months (95%CI 11.3 -14.7), and the 1-, 3-, 5-year OS rates and the 1-, 3-, 5-year PFS rates were 81.1%, 35.5%, 27.1% and 52.8%, 24.8%, 19.9%, respectively.There were 414 patients after PSM. In multivariable survival analysis, SII remained an independent prognostic factor for OS (HR1.792; 95%CI 1.416-2.268; P &lt; 0.001) and PFS (HR1.410; 95%CI 1.043-1.906; P = 0.025). Conclusions: Elevated SII is an independent adverse prognostic factor in patients with limited-stage SCLC and is superior to PLR in terms of prognostic ability.

Neoadjuvant Treatments for Pancreatic Ductal Adenocarcinoma: Where We Are and Where We Are Going.

Pancreatic ductal adenocarcinoma (PDAC) represents a challenging disease for the surgeon, oncologist, and radiation oncologist in both diagnostic and therapeutic settings. Surgery is currently the gold standard treatment, but the role of neoadjuvant treatment (NAD) is constantly evolving and gaining importance in resectable PDACs. The aim of this narrative review is to report the state of the art and future perspectives of neoadjuvant therapy in patients with PDAC. A PubMed database search of articles published up to September 2022 was carried out. Many studies showed that FOLFIRINOX or Gemcitabine-nab-paclitaxel in a neoadjuvant setting had a relevant impact on overall survival (OS) for patients with locally advanced and borderline resectable PDAC without increasing post-operative complications. To date, there have not been many published multicentre randomised trials comparing upfront surgery with NAD in resectable PDAC patients, but the results obtained are promising. NAD in resectable PDAC showed long-term effective benefits in terms of median OS (5-year OS rate 20.5% in NAD group vs. 6.5% in upfront surgery). NAD could play a role in the treatment of micro-metastatic disease and lymph nodal involvement. In this scenario, given the low sensitivity and specificity for lymph-node metastases of radiological investigations, CA 19-9 could be an additional tool in the decision-making process. The future challenge could be to identify only selected patients who will really benefit from upfront surgery despite a combination of NAD and surgery.

Abstract P6-01-22: Age, Ki-67, Nodal pCR and overall survival following Neoadjuvant Chemotherapy for Node Positive ER+/Her2- Breast Cancer

Abstract Background: The role of chemotherapy in node positive (N+) luminal breast cancer (BC) is often debated, given low total pathologic complete response (pCR) rates following neoadjuvant chemotherapy (NAC) and discrepancy in adjuvant chemotherapy benefit. A prior single institution study of cN+ luminal BC showed that pts age &amp;lt; 50 and tumor Ki-67 ≥ 20% had high nodal pCR (&amp;gt; 35%). This study’s goals were 1) to validate Ki-67 and age in relation to nodal pCR and 2) evaluate the prognostic impact of nodal pCR on overall survival (OS). Methods: We queried the National Cancer Database 2010-2019 for pts with cN+ ER+/HER2- BC treated with NAC and surgery. Breast pCR was defined as ypT0/ypTis and nodal pCR as ypN0/ypN0i+. Ki-67 was available in 2018 &amp; 2019 only and was used to evaluate Ki-67 and nodal pCR. 2010-2018 data were used to evaluate nodal pCR and OS. OS was analyzed using multivariable Cox proportional hazards regression. Results: In 2018-2019, 4,801 pts were identified and 2,473 (51.5%) had Ki-67 available. Nodal pCR was 23.7% and was higher in pts &amp;lt; 50 years old (28.1% vs 21.1%) and in those with Ki67 ≥ 20% (28.4% vs 12.7%), both p &amp;lt; 0.001. Pts &amp;lt; 50 with Ki67 ≥ 20% had the highest nodal pCR at 31.7%, followed by age ≥ 50 with Ki67 ≥ 20% at 26.3%. With Ki67 &amp;lt; 20%, nodal pCR was 15.4% (in age &amp;lt; 50) and 11.3% (in age ≥ 50). From 2010-2018, we identified 20,084 cN+ ER+/HER2- BC pts treated with NAC. Total pCR was 7.4%, 14.3% had nodal pCR only, 3.8% had breast pCR only, and 74.5% had residual disease in breast and nodes. OS at 5 years was 79.1% and varied by NAC response: 90.8% with total pCR, 83.8% with nodal pCR only, 80.7% with breast pCR only, and 76.9% with residual disease in breast and nodes. Specifically nodal pCR (with or without breast pCR) was seen in 22.0% and was associated with 5-year OS rate of 86.4% compared to 77.1% without nodal pCR, p &amp;lt; 0.001. On multivariable analysis adjusted for other clinical and treatment factors, nodal pCR was associated with better OS (adjusted HR 0.56, 95% CI: 0.50-0.61, p &amp;lt; 0.001) in all ages combined and within both the age &amp;lt; 50 and age ≥ 50 subgroups (see Table). In a subgroup of pts approximating RxPonder entry criteria (defined as cT1-3, N1, Grade I or II, ER+/PR+), results were consistent with the overall cohort: nodal pCR varied by both age (17.5% in age &amp;lt; 50 and 13.6% in age ≥ 50, p &amp;lt; 0.001) and by Ki67 ≥ 20% vs &amp;lt; 20% (16.8% vs 7.9%, p &amp;lt; 0.001) and nodal pCR remained prognostic for OS with adjusted HR 0.63 (95% CI: 0.50-0.81, p &amp;lt; 0.001). Conclusion: In cN+ ER+/HER2- BC treated with NAC, nodal pCR is more common in pts&amp;lt; 50 and those with high Ki-67 and is highly prognostic for OS. These data strongly suggest that NAC chemotherapy benefit should not be evaluated using total pCR rates in isolation, but for N+ pts to also consider nodal response. Given that nodal pCR is highly prognostic for OS, future neoadjuvant strategies should consider nodal pCR as a potential intermediate biomarker for long term survival. Multivariable analysis of factors associated with overall survival, including the adjusted effect of nodal pCR Citation Format: Dan Moldoveanu, Matthew P. Goetz, Tanya L. Hoskin, Courtney N. Day, Judy C. Boughey. Age, Ki-67, Nodal pCR and overall survival following Neoadjuvant Chemotherapy for Node Positive ER+/Her2- Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-01-22.

Prognostic Utility of Nutritional Risk Index in Patients with Head and Neck Soft Tissue Sarcoma.

The nutritional risk index (NRI) is an excellent indicator of nutritional status and a significant prognostic factor in several malignancies, but the relationship between NRI and the prognosis of head and neck soft tissue sarcoma (HNSTS) patients remains unclear. The aim of this study was to investigate the role of NRI in patients with HNSTS. We retrospectively reviewed patients with HNSTS between 1990 and 2021. In order to determine the optimal cut-off value of NRI, the Maximally selected log-rank statistic was performed. We evaluated the effect of NRI on overall survival (OS) and progression-free survival (PFS) by using the Kaplan-Meier method and Cox regression analysis. Then, OS and PFS nomograms based on NRI were constructed. In total, 436 HNSTS patients were included in this study. The optimal cut-off value of NRI was 99.34. Patients with low-NRI showed significantly worse OS and PFS than patients with high-NRI, respectively (5-year OS rate of 43.0 vs. 70.8%, 5-year PFS rate of 29.0 vs. 45.0%, all p < 0.05). In the multivariate analysis, distant metastasis, deep tumor depth, tumor grade, and NRI were prognostic factors for both PFS and OS, and treatment modality was associated with OS but not PFS. The concordance indexes (C-indexes) of OS and PFS nomograms were 0.794 (95% CI, 0.759-0.829) and 0.663 (95% CI, 0.626-0.700), respectively, which also performed well in the validation set. NRI is an independent predictor of OS and PFS in HNSTS patients. The validated nomograms based on NRI provide useful predictions of OS and PFS for patients with HNSTS.

Neoadjuvant Chemotherapy Compared with Surgery for Oesophageal Carcinoma: A Retrospective Study and Missing Evidence.

Background: Negative evidence for the use of neoadjuvant chemotherapy (NAC) to treat oesophageal squamous cell carcinoma (ESCC) has been reported in Western countries in the past century. However, in China, most ESCC patients underwent paclitaxel and platinum-based NAC without evidence from local RCTs. Empiricism or a lack of evidence does not necessarily mean that the evidence is negative. However, there was no way to compensate for the missing evidence. The only way to obtain evidence is by conducting a retrospective study using propensity score matching (PSM) to compare the effects of NAC and primary surgery on overall survival (OS) and disease-free survival (DFS) among ESCC patients in China, which is the country with the highest prevalence of ESCC patients. Methods: From January 1, 2015, to December 31, 2018, a total of 5443 patients with oesophageal cancer/oesophagogastric junction carcinoma who underwent oesophagectomy were retrospectively identified at Henan Cancer Hospital. After PSM, 826 patients were selected for the retrospective study and divided into the NAC and primary surgery groups. The median follow-up period was 54.08 months. Toxicity and tumour responses to NAC, intraoperative and postoperative outcomes, recurrence, DFS and OS were analysed. Results: The postoperative complication rates were not significantly different between the two groups. The 5-year DFS rates were 57.48% (95% CI, 52.05% to 62.53%) for the NAC group and 49.93% (95% CI, 44.56% to 55.05%) for the primary surgery group (P=0.0129). The 5-year OS rates were 62.95% (95% CI, 57.63% to 67.79%) for the NAC group and 56.29% (95% CI, 50.99% to 61.25%) for the primary surgery group (P=0.0397). Conclusion: Compared with primary surgery, NAC with paclitaxel and platinum-based chemotherapy and two-field extensive mediastinal lymphadenectomy might be associated with long-term survival benefits among ESCC patients.

Disease Characteristics, Patterns of Care and Survival Outcomes in Patients with Synovial Cell Sarcoma of the Head and Neck (HNSCS)

<h3>Purpose/Objective(s)</h3> HNSCS is a rare diagnosis with an overall poor prognosis. Due to its rarity, our understanding of HNSCS and its optimal management is mainly derived from retrospective and single-institution studies. We aimed to evaluate the disease characteristics, patterns of care, and survival outcomes in patients with HNSCS. <h3>Materials/Methods</h3> Using the National Cancer Database (NCDB), we identified patients with HNSCS diagnosed between 2004 and 2018. Kaplan-Meier analysis was used to evaluate the significance of treatment options and disease characteristics on overall survival (OS). Univariate (UVA) and multivariate Cox proportional hazard models (MVA) were used to identify prognostic factors associated with OS. <h3>Results</h3> Our study cohort consisted of 414 patients with a mean age of 38.1 years (range 1 to 82 years). 61.1% of patients were male and 38.9% were female. 40.1% of cases were coded as spindle cell histology, and 18.7% were coded as biphasic; in 40.9% of cases, the tumor was classified as synovial sarcoma, NOS. Regarding tumor size, 9.7% (n=40) were ≤2 cm, 27.8% (n=115) were >2 cm and ≤4 cm, and 49.3% (n=204) were >4 cm. 354 patients (85.5%) were treated with surgery (among whom n=126 had laser/excisional biopsy). Of the patients who underwent surgery, 203 patients achieved negative margins and 109 patients had positive margins. 56.3% of patients received radiation therapy (RT) to the head and neck while 37.9% did not. Of the patients who received head and neck RT, 188 received adjuvant RT, 23 received neoadjuvant RT, and 17 received RT alone. The 5-year OS rate for the entire cohort was 75.4%. The 5-year OS for no surgery, laser/excisional biopsy, and surgery were 55.5%, 84.3%, and 74.9%, respectively (p<0.001). On MVA, factors associated with worse OS included no surgery or positive margins, tumor size >4 cm, node-positive disease, CDCC score ≥1, male sex, and older age were significantly associated with worse OS. <h3>Conclusion</h3> HNSCS is a rare and aggressive oncological entity with limited information regarding the optimal management and disease characterization. In a national database analysis of patients with HNSCS, the largest cohort of patients with this rare condition reported to date, we report a 5-year OS of 75.4%. Proper management should include surgery with negative resection margins when possible.

The Impact of Postoperative Complications on Survival after Simultaneous Resection of Colorectal Cancer and Liver Metastases.

Background: The aim of this study was to investigate the impact of postoperative complications on the long-term outcomes of patients who had undergone simultaneous resection (SR) of colorectal cancer and synchronous liver metastases (SCLMs). Methods: We conducted a single-institution survival cohort study in patients with SR, collecting clinical, pathological, and postoperative complication data. The impact of these variables on overall survival (OS) and disease-free survival (DFS) was compared by log rank test. Multivariate Cox regression analysis identified independent prognostic factors. Results: Out of 243 patients, 122 (50.2%) developed postoperative complications: 54 (22.2%) major complications (Clavien–Dindo grade III–V), 86 (35.3%) septic complications, 59 (24.2%) hepatic complications. Median comprehensive complication index (CCI) was 8.70. Twelve (4.9%) patients died postoperatively. The 3- and 5-year OS and DFS rates were 60.7%, 39.5% and 28%, 21.5%, respectively. Neither overall postoperative complications nor major and septic complications or CCI had a significant impact on OS or DFS. Multivariate analysis identified the N2 stage as an independent prognostic of poor OS, while N2 stage and four or more SCLMs were independent predictors for poor DFS. Conclusion: N2 stage and four or more SCLMs impacted OS and/or DFS, while CCI, presence, type, or grade of postoperative complications had no significant impact on long-term outcomes.

A Nutrition-Related Factor-Based Risk Stratification for Exploring the Clinical Benefits in the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma Receiving Definitive Chemoradiotherapy: A Retrospective Cohort Study.

ObjectiveNo study has reported the risk stratification of BMI and PNI in patients with locally advanced esophageal squamous cell carcinoma (ESCC) undergoing definitive chemoradiotherapy (dCRT). This study aimed to construct a risk stratification to guide the treatment of ESCC following dCRT.MethodsA total of 1,068 patients with locally advanced ESCC who received dCRT were retrospectively analyzed. The impacts of clinicopathological factors on overall survival (OS) and progression-free survival (PFS) were analyzed. Besides, the novel prognostic indices of pre-therapeutic nutritional index (PTNI) and prognostic index (PI) were developed.ResultsThe median follow-up period of OS and PFS were 22.9 and 17.4 months, respectively. The high body mass index (BMI) group had better 5-year OS and PFS (36.4 and 34.0%) than the low BMI group (18.8 and 17.2%). The high prognostic nutritional index (PNI) group also had better 5-year OS and PFS (33.4 and 30.9%) than the low PNI group (17.5 and 17.2%). Multivariate Cox regression analysis showed that BMI and PNI were independent prognostic factors for OS and PFS. Based on nutritional indices, patients were categorized into the low-risk (PTNI = 1), medium-risk (PTNI = 2), and high-risk (PTNI = 3) groups with 5-year OS rates of 38.5, 18.9, 17.5%, respectively (p < 0.001) and 5-year PFS rates of 35.8, 17.6, 16.8%, respectively (p < 0.001). Besides, we also constructed a prognostic index (PI) for OS and PFS which was calculated based on statistically significant factors for predicting OS and PFS. The results revealed that the high-risk group had worse OS and PFS than the low-risk group (p < 0.001). Finally, RCS analysis demonstrated a non-linear relationship between the PNI, BMI, and survival for patients with ESCC. The death hazard of PNI and BMI sharply decreased to 41.8 and 19.7.ConclusionThe decreased pre-therapeutic BMI and PNI levels were associated with a worse survival outcome. BMI and PNI are readily available and can be used to stratify risk factors for locally advanced ESCC patients undergoing dCRT. The novel risk stratification may help to evaluate patients’ pre-therapeutic status and guide dCRT for locally advanced ESCC patients.

Survival Comparison Between Squamous Cell Carcinoma and Adenocarcinoma for Radiotherapy-Treated Patients with Stage IIB-IVA Cervical Cancer.

ObjectiveTo compare the prognostic significance of adenocarcinoma (AC) with squamous cell carcinoma (SCC) on overall survival (OS) in patients with stage IIB-IVA cervical cancer (CC) treated by external beam radiotherapy (EBRT) and brachytherapy (BRT) with/without chemotherapy registered in the Surveillance, Epidemiology, and End Results database.MethodsData of eligible patients were extracted between 2004 and 2016. A univariate analysis was conducted using the cumulative incidence function (CIF) by considering competing events and compared using Gray’s test. The significant variables in univariate analysis were further evaluated in a multivariate analysis performed with the Fine-Gray regression model. Propensity score matching (PSM) analysis was also employed to reconfirm the results found in the present study.ResultsA total of 2,243 patients with SCC and 176 patients with AC were extracted from the database. The 5-year OS rates were 57.8% in the SCC group and 52.8% in the AC group. 149 patients died of causes other than CC—considered as competing events. Compared with the SCC group, patients diagnosed with AC had statistically significant worse 5-year OS rate before and after PSM. In the multivariate Fine-Gray regression model, the histological subtype of AC was proven as an independent prognostic factor associated with poorer OS before [hazard ratio (HR) = 1.340; 95% confidence interval (CI): 1.081-1.660; P = 0.007] and after [HR = 1.376; 95% CI: 1.107-1.711; P = 0.004] PSM.ConclusionsThe histological subtype of AC is significantly correlated with impaired OS as an independent prognostic variable in patients with stage IIB-IVA CC who received EBRT and BRT compared to patients with SCC. Future studies should incorporate effective and individualized treatment strategies into clinical decision-making to improve the unsatisfactory survival outcomes for patients with AC.

Prognostic factors in colorectal liver metastases patients with various tumor numbers treated by liver resection: a single-center, retrospective study

BackgroundMultiple liver metastases is considered a risk factor for overall survival of colorectal liver metastases patients (CRLM) after curative resection. However, whether the prognostic factors were constant in patients with various liver metastases (LM) numbers has not been adequately investigated. This retrospective study aimed to evaluate the changing of prognostic factors on overall survival (OS) in CRLM patients with various LM after curative resection.MethodsPatients who underwent liver resection for CRLM between January 2000 and November 2020 were retrospectively studied. They were divided into three subgroups according to LM numbers by X-tile analysis. Multivariable analysis identified prognostic factors in each subgroup. Nomograms were built using different prognostic factors in three subgroups, respectively. Performance of the nomograms was assessed according to the concordance index (C-index) and calibration plots. The abilities of different scoring systems predicting OS were compared by calculating the area under the time-dependent receiver operating characteristic (ROC) curve (AUC).ResultsA total of 1095 patients were included. Multivariable analysis showed tumor number increasing was an independent risk factor. Patients were subsequently divided into 3 subgroups according to the number of LM by X-tile analysis, namely solitary (n = 375), 2–4 (n = 424), and ≥ 5 (n = 296). The 3-year and 5-year OS rates were 64.1% and 54.0% in solitary LM group, 58.1% and 41.7% in 2–4 LM group, and 50.9% and 32.0% in ≥ 5 LM group, respectively (p < 0.001). In multivariable analysis, RAS mutation was the only constant independent risk factor in all subgroups. The nomograms were built to predict survival based on independent factors in three subgroups. The C-index for OS prediction was 0.707 (95% CI 0.686–0.728) in the solitary LM group, 0.695 (95% CI 0.675–0.715) in the 2–4 LM group, and 0.687 (95% CI 0.664–0.710) in the ≥ 5 LM group. The time-dependent AUC values of nomograms developed using different risk factors after stratifying patients by tumor number were higher than the traditional scoring systems without patient stratification.ConclusionsThe prognostic factors varied among CRLM patients with different LM numbers. RAS mutation was the only constant risk factor. Building prediction models based on different prognostic factors improve patient stratification.

Positive impact of academic center care on overall survival in malignant pleural mesothelioma (MPM): A National Cancer Database (NCDB) socioeconomic factor analysis.

8558 Background: MPM is a rare cancer with a poor prognosis. Median survival for untreated patients is 4-13 months, and for treated patients is 6-18 months. Despite asbestos regulations in the United States, annual deaths from MPM rose from 2,479 in 1999 to 2,597 in 2015. Given recent treatment advances, including improvements in multimodality therapy and the introduction of immunotherapy as a treatment option in the frontline setting, the impact that patient demographics and treatment factors have on survival outcomes for MPM requires further evaluation. Methods: We identified all patients with MPM in the NCDB from 2004 to 2017. Differences in demographic, disease, and treatment characteristics were assessed by year of diagnosis using Chi-square test. The effect of age, race, insurance status, income, distance to treatment center, and education level on overall survival (OS) was assessed by log-rank test. Results: There were 15,287 MPM diagnoses in the NCDB between 2004-2010 and 17,059 diagnoses between 2011-2017. OS improved between the two time periods, with median OS of 9.46 months (95% CI: 9.23-9.63) and 5-year OS rate of 8.3% (95% CI: 7.9-8.7%) in patients from 2004-2011 and median OS of 11.33 months (95% CI: 11.01-11.7) and 5-year OS rate of 12.4% (95% CI: 11.8-13.1%) in patients after 2011, despite an increase in stage IV disease in the latter group. Older patients (≥65 years-old), males, patients with stage IV disease, patients with government primary payer insurance, and patients from urban areas all had significantly worse OS. Patients without comorbidities and those treated at an academic center had significantly better OS. OS was found to significantly increase as both income and education level increase. Patients diagnosed after 2011 were significantly older, were more frequently female, had more stage IV disease, were more frequently treated at academic centers, more commonly had government primary payer insurance, and lived significantly further away from their treatment center. Patients’ time to treatment was significantly increased after 2011 (from 28 to 31 days). Conclusions: Socioeconomic factors play an important role in survival outcomes for patients with MPM. Many of these are linked with access to healthcare resources, which may increase the likelihood of evaluation at academic centers. For a rare malignancy such as mesothelioma, subspecialty care consisting of a comprehensive thoracic surgical evaluation and appropriate multimodality treatment are of great importance. Time to treatment increased during the study period yet OS improved, which our findings suggest are a result of an increase in evaluation and treatment at academic centers by providers skilled in delivering care to MPM patients.

The impact of CA 19-9 on survival in patients with clinical stage I pancreatic cancer.

606 Background: Standard of care for early-stage resectable pancreatic cancer (PC) includes a combination of surgical resection and chemotherapy. Frequently, CA 19-9 is used as a biomarker to monitor treatment effect and has prognostic significance. We evaluated the impact of CA 19-9 on overall survival (OS) in patients with clinical stage I PC (cT1N0 and cT2N0) utilizing the National Cancer Database (NCDB). Methods: The NCDB was queried between 2010 and 2014 to identify patients with clinical stage I PC. Patients who had missing or undocumented CA 19-9 value at diagnosis were excluded. Demographic and clinical characteristics were analyzed. Patients were stratified into two cohorts based on the CA 19-9 value at diagnosis – CA 19-9 &lt; 98 U/mL and CA 19-9 &gt; 98 U/mL. Univariable and multivariable analyses were performed, and variables associated with OS were identified. Kaplan-Meier survival curves were computed to compare the OS between the two cohorts. Results: A total of 12,480 patients met our inclusion criteria. A majority of patients were female (51.9%), white (84.4%), with a median age of 70 years. Nearly, half the patients received care in an academic/research program (49.5%). A majority of patients had tumors located in the head of the pancreas (71.9%), and received single-agent (35.1%) or multiagent (22.9%) chemotherapy. Over half the patients (6505 patients, 52.1%) had a CA 19-9 value &gt; 98 U/mL. A CA 19-9 value &gt; 98 U/mL in patients predicted a significantly shorter median OS of 12.1 months compared to 19.4 months in patients with a CA 19-9 &lt; 98 U/mL, p&lt;0.0001 (Table). The 5-year OS rate was 9.9% in patients with a CA 19-9 value of &gt; 98 U/mL compared to a 5-year OS rate of 18.1% for patients with a CA 19-9 value &lt; 98 U/mL. On multivariable analysis, CA 19-9 &gt; 98 compared to CA 19-9 &lt; 98 (HR 1.53, p&lt;0.001) and black race compared to white race (HR 1.10, p&lt;0.001) was associated with worse survival, whereas tumor location in the body and tail compared to the head (HR 0.82, p&lt;0.001), single-agent (HR 0.55, p&lt;0.001) and multiagent (HR 0.55, p&lt;0.001) chemotherapy compared to no chemotherapy, independently predicted improved OS. Conclusions: This is the first National Cancer Database study to demonstrate the prognostic value of CA 19-9 in patients with clinical stage I pancreatic cancer, with a value &lt; 98 U/mL predicting improved survival. Clinical stage I pancreatic cancer patients appear to derive a significant benefit from chemotherapy, including single and multiagent chemotherapy, irrespective of the CA 19-9 value.[Table: see text]

Clinical Significance and Risk Factors of Local Recurrence in Synovial Sarcoma: A Retrospective Analysis of 171 Cases.

Objective: To investigate risk factors of local recurrence of synovial sarcoma and the impact of local recurrence on survival.Methods: We retrospectively reviewed clinical data of patients with II to IIIB (AJCC8) synovial sarcoma who underwent surgery at our center between March 2005 and December 2016. Data relating clinicopathological factors, treatment and prognosis were collected. The impact of local recurrence on overall survival (OS), local recurrence-free survival (LRFS), and distant relapse-free survival (DRFS) were analyzed. The prognostic factors associated with local recurrence were also analyzed using Kaplan-Meier Curves and Cox regression analysis.Results: A total of 171 patients were included in this analysis. After a median follow-up of 48 months, 66 patients (38.6%) experienced local recurrence. The 5-year OS, LRFS, and DRFS rates of patients with local recurrence were 37.6, 6.1, and 24.1%, respectively. Multivariate analysis showed that larger initial tumors, multiple recurrences, positive resection margins, marginal resection, and lack of adjuvant therapy were associated with higher local recurrence.Conclusion: Local recurrence of synovial sarcoma is associated with distant metastasis and poor survival. Chemoradiation improves the prognosis of patients with local recurrence, in particular those for which recurrence occurs shortly after initial treatment.