Cumulative Overall Survival Research Articles

Overall survival in treated ovarian cancer patients in Argentina: OCEANIA study.

e17595 Background: OCEANIA is a retrospective, real-world database study that evaluated treatment patterns and outcomes in a cohort of patients diagnosed with ovarian cancer (OC) in private healthcare settings in Latin America. The present analysis focused on evaluating up to five-year overall survival (OS) in a cohort of treated patients with OC in Argentina. Methods: Patients with an OC code diagnosed from 2010 to 2019 and with a cancer-related treatment claim (antineoplastics, surgery, and/or radiotherapy) were selected from a private healthcare provider’s database (Hospital Italiano de Buenos Aires) in Argentina. Patients were followed from diagnosis until the end of observation period or death. Frequency of OC patients by FIGO (International Federation of Gynecology and Obstetrics) stage was described. Cumulative treatment type was described through the whole follow-up period. One- to five-year survival Kaplan–Meier curves were built; patients who were lost to follow-up were censored. Results: 741 patients with OC were identified in the database with a mean (standard deviation) follow-up time of 31.7 (30.6) months; 539 (72.7%) were treated during this period. Among this population, 76.3% had information about FIGO staging: 73 (17.8%) were stage 1; 36 (8.8%) stage 2; 259 (63.0%) stage 3; and 43 (10.5%) stage 4. Cumulative distribution across treatment types revealed 355 (65.9%) patients received antineoplastics (321 [90.4%] received platinum-based treatment), 496 (92.0%) surgery and 18 (3.3%) radiotherapy. During a five-year observation window, 111 patients died (more than one half within two years of diagnosis). The adjusted cumulative OS for all treated patients in years 1–5 was 93.2%, 87.2%, 80.9%, 74.1%, and 69.0%, respectively (Table). Conclusions: OS is a key outcome in assessing the impact of current standards of care. Based on the results, although most (69.0%) of the patients survived after 5 years of follow-up, further improvement in OS presents a challenge. However, recent drug releases for OC management in Latin America may change this scenario. [Table: see text]

Preoperative Platelet-Lymphocyte Ratio (PLR) as a prognostic inflammation biomarker in Asian HIV-infected patients with gastric cancer: a single-center study

BackgroundThe serum systemic inflammation biomarkers have been established as predictors of prognosis in gastric cancer (GC) patients, but their prognostic value in human immunodeficiency virus (HIV)-infected patients with GC has not been well studied. This retrospective study aimed to evaluate the prognostic value of preoperative systemic inflammation biomarkers in Asian HIV-infected patients with GC.MethodsWe retrospectively analyzed 41 HIV-infected GC patients who underwent surgery between January 2015 and December 2021 at the Shanghai Public Health Clinical Center. Preoperative systemic inflammation biomarkers were measured and patients were divided into two groups based on the optimal cut-off value. Overall survival (OS) and progression-free survival (PFS) were measured using the Kaplan–Meier method and the log-rank test. Multivariate analysis of variables was performed using the Cox proportional regression model. As a comparison, 127 GC patients without HIV infection were also recruited.ResultsThe median age of the 41 patients included in the study was 59 years, with 39 males and two females. The follow-up period for OS and PFS ranged from 3 to 94 months. The cumulative three-year OS rate was 46.0%, and the cumulative three-year PFS rate was 44%. HIV-infected GC patients had worse clinical outcomes compared to the normal GC population. The optimal cut-off value for preoperative platelet to lymphocyte ratio (PLR) was 199 in HIV-infected GC patients. Multivariate Cox regression analysis revealed that a low PLR was an independent predictor of better OS and PFS (OS: HR = 0.038, 95% CI: 0.006–0.258, P < 0.001; PFS: HR = 0.027, 95% CI: 0.004–0.201, P < 0.001). Furthermore, higher preoperative PLR in HIV-infected GC was significantly associated with lower BMI, hemoglobin, albumin, CD4 + T, CD8 + T, and CD3 + T cell counts.ConclusionThe preoperative PLR is an easily measurable immune biomarker that may provide useful prognostic information in HIV-infected GC patients. Our findings suggest that PLR could be a valuable clinical tool for guiding treatment decisions in this population.

Efficacy and safety of HAIC alone vs. HAIC combined with lenvatinib for treatment of advanced hepatocellular carcinoma

To investigate efficacy and safety of hepatic arterial infusion chemotherapy combined with lenvatinib (HAIC-Len) and HAIC alone for the treatment of advanced hepatocellular carcinoma (Ad-HCC). Totally 349 patients with Ad-HCC participated in the research from February 2018 to October 2020. On the basis of propensity score matching (PSM), 132 and 110 cases were assigned to the HAIC group and the HAIC-Len group, respectively, with a ratio of 1:1. Progression-free survival (PFS), overall survival (OS), and complications were compared between two groups. The Kaplan-Meier method and log-rank test were utilized to estimate cumulative OS and PFS. Additionally, uni- and multi-variate Cox regression models were employed to identify significant independent factors. The median follow-up period in this study was set to be 20.8months. Following PSM, the one-, two- and three-year cumulative OS rates in the HAIC-Len and HAIC groups were 63.6%, 12.1%, and 3.0%, and 47.2%, 11.8%, and 2.7%, respectively, with a significant difference (P < 0.001). The first-three-year cumulative incidence rates PFS in the HAIC-Len and the HAIC groups were 15.2%, 1.5%, and ND, and 11.8%, 4.5%, and 3.6%, respectively, with no significant difference detected (P = 0.092). BMI (HR 0.709. 95% CI 0.549, 0.915. P = 0.008) and AST (HR 1.005. 95% CI 1.003, 1.007. P < 0.001) represented independent prognostic factors for OS. Additionally, the two groups exhibited no significant difference in the incidence rates of adverse events. HAIC-Len significantly improved survival outcomes of patients with Ad-HCC and demonstrated acceptable toxicity compared to HAIC alone.

Pathological nodal status as a main predictive factor of survival and treatment outcomes of submandibular salivary gland cancers: A 25-year single center experience

IntroductionAim of this study was to explore the survival predictive factors and treatment outcomes in a cohort of SGC patients treated at a single center over a period of 25 years. Materials and methodsPatients who had received primary treatment for SGC were enroled. Outcomes evaluated were: overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), locoregional recurrence free survival (LRFS) and distant metastasis free survival (DFS). ResultsA total of 40 patients with SGC were enroled in the study. The most common tumor was the adenoid cystic carcinoma (60% of cases). Cumulative OS for 5-and 10-year follow up period was 81% and 60%, respectively. Thirteen patients (32.5%) developed distant metastases during follow-up. Nodal status, high-grade histology, tumor stage and adjuvant radiation-therapy (RT) were significant variables on multivariate analysis for survival and treatment outcomes. ConclusionsSubmandibular gland carcinomas represent rare and heterogenous tumor group regarding histological appearance and locoregional and distant metastatic potential. Tumor histological grade, AJCC tumor stage and nodal status were the strongest predictive factors for survival and treatment outcomes. RT improved OS and locoregional treatment outcome, but not DFS. Elective neck dissection (END) could be beneficial for selected cases of SGC. Superselective neck dissection of levels I-IIa may be the level of dissection for END. Distant metastases were the main cause of death and treatment failure. Prognostic factors for poor DMFS were AJCC stage III and IV, high tumor grade and nodal status.

Higher Neutrophil-to-Lymphocyte Ratio (NLR) Is a Preoperative Inflammation Biomarker of Poor Prognosis in HIV-Infected Patients with Colorectal Cancer: A Retrospective Study.

The serum systemic inflammation biomarkers are known predictors of colorectal cancer (CRC) patient prognosis. However, their significance in human immunodeficiency virus (HIV)-infected patients with CRC has not been studied. To address this gap, we conducted a retrospective study to evaluate the prognostic value of preoperative systemic inflammation biomarkers in HIV-infected patients with CRC. The study enrolled 57 patients with colorectal cancer (CRC) and HIV who underwent surgery at the Shanghai Public Health Clinical Center between January 2015 and December 2021. Preoperative tests were conducted, and systemic inflammation biomarkers were measured. The patients were categorized into two groups using the optimal cut-off value. The Kaplan-Meier method and the log-rank test were used to determine overall survival (OS) and progression-free survival (PFS). Multivariate analysis was performed using the Cox proportional regression model. A time-dependent receiver operating characteristic (t-ROC) was used to compare the prognostic abilities of the biomarkers. The study included 57 HIV-infected CRC patients, with a median age of 60 and a follow-up time ranging from 3 to 86 months. Of the patients, 49 were male and 8 were female. The cumulative three-year OS and PFS rates were 55.0% and 45.0%, respectively. The optimal cut-off value for preoperative NLR was found to be 2.8, which was significantly correlated with lower CD8+ T and CD3+ T lymphocyte counts. Multivariate Cox regression analysis revealed that a low NLR was an independent predictor of better OS and PFS (OS: HR = 0.094, 95% CI: 0.02-0.45, P=0.003; PFS: HR = 0.265, 95% CI: 0.088-0.8, P=0.019). The time-dependent receiver operating characteristic (t-ROC) analysis showed that NLR was a superior systemic inflammation biomarker for predicting the prognosis of HIV-infected CRC patients throughout the observation period. The preoperative neutrophil-to-lymphocyte ratio (NLR), an easily measurable immune biomarker, may provide useful prognostic information in HIV-infected colorectal cancer (CRC) patients.

Network meta-analysis of the prognosis of curative treatment strategies for recurrent hepatocellular carcinoma after hepatectomy.

Recurrent hepatocellular carcinoma (rHCC) is a common outcome after curative treatment. Retreatment for rHCC is recommended, but no guidelines exist. To compare curative treatments such as repeated hepatectomy (RH), radiofrequency ablation (RFA), transarterial chemoembolization (TACE) and liver transplantation (LT) for patients with rHCC after primary hepatectomy by conducting a network meta-analysis (NMA). From 2011 to 2021, 30 articles involving patients with rHCC after primary liver resection were retrieved for this NMA. The Q test was used to assess heterogeneity among studies, and Egger's test was used to assess publication bias. The efficacy of rHCC treatment was assessed using disease-free survival (DFS) and overall survival (OS). From 30 articles, a total of 17, 11, 8, and 12 arms of RH, RFA, TACE, and LT subgroups were collected for analysis. Forest plot analysis revealed that the LT subgroup had a better cumulative DFS and 1-year OS than the RH subgroup, with an odds ratio (OR) of 0.96 (95%CI: 0.31-2.96). However, the RH subgroup had a better 3-year and 5-year OS compared to the LT, RFA, and TACE subgroups. Hierarchic step diagram of different subgroups measured by the Wald test yielded the same results as the forest plot analysis. LT had a better 1-year OS (OR: 1.04, 95%CI: 0.34-03.20), and LT was inferior to RH in 3-year OS (OR: 10.61, 95%CI: 0.21-1.73) and 5-year OS (OR: 0.95, 95%CI: 0.39-2.34). According to the predictive P score evaluation, the LT subgroup had a better DFS, and RH had the best OS. However, meta-regression analysis revealed that LT had a better DFS (P < 0.001) as well as 3-year OS (P = 0.881) and 5-year OS (P = 0.188). The differences in superiority between DFS and OS were due to the different testing methods used. According to this NMA, RH and LT had better DFS and OS for rHCC than RFA and TACE. However, treatment strategies should be determined by the recurrent tumor characteristics, the patient's general health status, and the care program at each institution.

Effect of RRx-001 on nephrotoxicity of cisplatin/etoposide in patients with solid tumors.

657 Background: RRx-001 is a small molecule anticancer agent that preclinically protects non-malignant tissues, but not tumors, against the cytotoxicities of chemotherapy and radiation. In a completed, multicenter Phase 2 trial, QUADRUPLE THREAT, patients with previously platinum-treated extrapulmonary small cell cancer (SCC), high-grade neuroendocrine carcinoma (HGNEC), non-small cell lung cancer (NSCLC), and genitourinary cancer (GUC) received 4 mg IV RRx-001 followed by etoposide plus cisplatin or carboplatin (EP). In addition to overall survival (OS), and progression-free survival (PFS), this study also evaluated the possible prevention of nephrotoxicity by RRx-001. Methods: 90 patients with SCC, HGNEC, NSCLC, and GUC that previously received ≥2 lines of therapy including a platinum doublet were treated with 4 mg RRx-001 IV once per week. At progression, RRx-001 was discontinued and 40 patients were re-challenged with IV etoposide 80-100 mg/m2 (Days 1, 2, and 3) and cisplatin 60-80 mg/m2 on Day 1 for 4-6 cycles. The co-primary endpoints were PFS and OS. For all patients, serum creatinine (Cr), blood urea nitrogen (BUN), and electrolytes were determined prior to, during and after each treatment cycle. Results: After 2 cycles of chemotherapy, no patients experienced BUN elevations above 20 mg/dL and creatinine beyond 1.5 mg/dL. After four cycles of chemotherapy, 36/40 (90%) patients experienced no elevations of BUN above 20 mg/dL and creatinine above 1.5 mg/dL and none of the patients experienced &gt; Grade 2 elevations of creatinine. 1/40 (2.5%) patients experienced Grade 3 hypomagnesemia (0 Grade 4). 3/40 (7.5%) patients were dose reduced or withdrawn from the trial due to platinum-related adverse events. No patients experienced renal-related serious adverse events (SAEs). One patient experienced a renal failure SAE, which was not drug related. The cumulative OS and PFS median of all the tumor types were 8.6 and 6.4 months, respectively. Conclusions: 20%-35% of patients develop acute kidney injury after cisplatin administration. Based on published clinical literature, approximately 33% of patients experience kidney injury just days following initial treatment (p = 0.0034, two-sided chi-square test comparing our study nephrotoxicity of 10% (4/40) in the first four cycles against 33% historical rate), and 20% of patients taking high-dose cisplatin experience severe renal dysfunction. The nephrotoxic effect of cisplatin is cumulative. In this heavily platinum-treated population, none of the patients were ineligible to receive cisplatin as scheduled because their serum creatinine levels had failed to return to &lt; or = 1.5 mg/dL. RRx-001 pretreatment did not affect the antitumor effects of EP as assessed by PFS and OS. This dose of RRx-001 warrants further evaluation as a nephroprotectant that reduces the cumulative renotoxic effects of cisplatin but not its antitumor efficacy. Clinical trial information: NCT02489903 .

Predictive factors for survival and treatment outcomes of patients with minor salivary gland malignancies: a retrospective study.

Aim of this study was to explore the incidence, pathology, clinical behaviour and evaluate factors predictive on survival and treatment outcomes in a cohort of patients with minor salivary gland (MiSG) malignancies treated at a single center over a period of 25years. Patients who had received primary treatment for MiSG malignancy during 25years observation period were identified. Outcomes that were evaluated were overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), locoregional recurrence free survival (LRFS) and distant metastasis free survival (DFS). A total of 88 patients with MSG malignancies were included in the study. The most common location for MiSG malignancies was the oral cavity (65 tumors; 77%). Cumulative OS for 5 and 10year follow up period was 82% and 62% respectively. Cumulative DSS for 5 and 10year follow up period was 85% and 73% respectively. Twenty one (23%) patients developed distant metastases during follow-up. High-grade pathology and tumor stage were significant variables on multivariate analysis for all survival and treatment outcomes. Minor salivary gland malignancies are minor only by name. Tumor histological grade, AJCC tumor stage and pT stage were the strongest predictive factors for survival and treatment outcomes. The elective neck dissection could be considered therapeutic approach for selected cases of high grade MiSG malignancies. Distant metastases were the main cause of death and treatment failure.

The survival of childhood leukemia: An 8-year single-center experience.

The survival of childhood leukemia has improved. We aimed to report the survival rate and the associated factors in children with acute leukemia during an 8-year follow-up. This study investigates the 8-year survival rates of children with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) in Shiraz, the largest oncology center in Southern Iran. We also aimed to assess the independent factors associated with higher mortality in childhood leukemia. Children 0-18 years with acute leukemia were followed from 2013 to 2021 in Shiraz, Iran. The 8-year overall survival (OS) and event-free survival (EFS) rates were estimated by the Kaplan-Meier method. Independent factors associated with survival were assessed by the Cox regression hazard modeling. We included 786 children, with 43.5% female, and a mean age of 6.32 ± 4.62 years. Patients with AML compared to ALL experienced more relapse (34.6% vs. 22.5%, p=.01) and death (31.7% vs. 11.3%, p < .001). The cumulative 8-year OS and EFS were 81% (95% confidence interval (CI), 74.3% to 86.1%) and 68.3% (95% CI, 63.5% to 72.7%) in ALL patients and 63.5% (95% CI, 52.1% to 72.9%) and 43% (95% CI, 33.1% to 52.6%) in AML patients. Multivariable analysis revealed that hepatomegaly (hazard ratio=4, 95% CI, 1.0 to 22.3, p=.05) was the main independent risk factor of death in ALL patients. No definite risk factor was defined for AML patients. The survival of childhood leukemia has recently increased dramatically in low-middle income countries. Hepatomegaly was introduced as a potential risk factor for lower survival in ALL patients. Further multicenter studies are needed to confirm the validity of this association.

Phase II Multicenter, Randomized Controlled Study on Infusion of MSCs at 45 Days after Haplo-Hematopoietic Stem Cell Transplantation in the Prophylaxis of Gvhd

Background: Haploidentical hematopoietic stem-cell transplantation (haplo-HSCT) has successfully solved the problem of donor shortness. However, the increased risk of GVHD and the increased incidence of relapse after the administration of immune depressors for GVHD treatment have significantly influenced the quality of life of patients. Therefore, to prevent GVHD in patients who received haplo-HSCT, we designed a clinical trial that evaluated repeated infusions of UC-MSCs from day 45 after haplo-HSCT to prevent GVHD. Methods: A total of 148 qualified subjects aged between 18 and 60 with haplo-HSCT in five transplant centers in the Midwest of China were enrolled and randomly assigned equally into the MSC group and the control group. The patients in the MSC group received 4 rounds of UC-MSC infusions (1×106 cells/kg every two weeks from 45 days after transplantation) and a regular GVHD prophylaxis regimen, while the patients in the control group received only a regular GVHD prophylaxis regimen. The incidence and severity of cGVHD was the primary endpoint, and the incidence and severity of aGVHD, GVHD-free and relapse-free survival (GRFS), cumulative relapse rate, overall survival (OS), progression-free survival (PFS) and transplantation complications were recorded to measure the efficacy of MSCs in GVHD prophylaxis. Results: The overall incidence of cGVHD was 27% after MSC infusion and 43.2% in the control group (P=0.0388). The incidences of severe cGVHD and III-IV aGVHD in the patients in the MSC group were significantly decreased to 5.4% and 2.7%, respectively, while that in the control group they were 17.5% and 13.5%, respectively (P=0.0096 and P=0.0094). There was no significant difference in the cumulative relapse rate, OS or PFS between the two groups (P=0.6481, P=0.1980 and P= 0.3346). Conclusion: In this trial, we indicated that early repeated infusions of UC-MSCs effectively decreased the incidence and severity of cGVHD, and the incidence and severity of aGVHD manifested as an improved GRFS rate for patients after haplo-HSCT. Therefore, MSC infusion is an effective GVHD prophylaxis method after haplo-HSCT. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Long-Term Outcome of Sustained Endocrine Monotherapy for Elderly Breast Cancer Patients.

Among elderly breast cancer patients, endocrine therapy may be chosen as definitive treatment by patients or physicians. This study investigated the efficacy of endocrine monotherapy (ET) in terms of avoidance of invasive local treatment. Elderly patients (≥70 years) with a diagnosis of estrogen receptor-positive breast cancer who underwent ET between 2008 and 2015 were identified through the Netherlands Cancer Registry. The primary outcome was the cumulative risk of undergoing invasive local treatment (radiotherapy or surgery) for the primary tumor. The secondary outcomes were development of uncontrolled local disease and overall survival (OS). Of the 105 patients (median age, 86 years) enrolled in this study, 91 (78 %) received ET as definitive treatment, whereas 14 received ET as a "bridge to surgery." For the 91 patients who used ET as intended definitive treatment, the 5-year cumulative risk of undergoing invasive local treatment and experiencing uncontrolled disease were respectively 28 % and 16 %. The 5-year cumulative OS was 42 %. Whereas 11 patients had metastatic or locally progressive breast cancer at the time of death, cardiovascular disease, infectious diseases, and old age or dementia were reported as contributing to the death of 39 patients. For a select group of elderly breast cancer patients who received sustained ET, the risk of undergoing invasive local treatment was surpassed by a twofold higher risk of dying. As an alternative to invasive local treatment, ET can be discussed as a safe and effective option for patients unwilling or unfit to undergo surgery.

Locoregionally Recurrent Colon Cancer: How Far Have We Come? A Population-Based, Retrospective Cohort Study

BackgroundThe reported outcomes of locoregionally recurrent colon cancer (LRCC) are poor, but the literature about LRCC is scarce and aged. Recent population-based studies to provide current insight into LRCC are warranted. This study aimed to provide an overview of the incidence, risk factors, treatment, and overall survival (OS) of patients with LRCC after curative resection of stage I–III primary colon cancer.MethodsData on disease recurrence were collected for all patients with a diagnosis of non-metastasized primary colon cancer in the Netherlands during the first 6 months of 2015. Patients who underwent surgical resection (N = 3544) were included in this study. The 3-year cumulative incidence, risk factors, treatment, and OS for patients with LRCC were determined.ResultsThe 3-year cumulative incidence of LRCC was 3.8%. Synchronous distant metastases (LRCC-M1) were diagnosed in 62.7% of the patients. The risk factors for LRCC were age of 70 years or older, pT4, pN1-2, and R1-2. Adjuvant chemotherapy was associated with a decreased risk of LRCC for high-risk stage II and stage III patients [hazard ratio (HR), 0.47; 95% confidence interval (CI) 0.31–0.93]. The median OS for the patients with LRCC was 13.1 months (95% CI 9.1–18.3 months). Curative-intent treatment was given to 22.4% of the LRCC patients, and the subsequent 3 years OS was 71% (95% CI 58–87%). The patients treated with palliative treatment and best supportive care showed 3-year OS rates of 15% (95% CI 7.0–31%) and 3.7% (95% CI 1.0–14%), respectively.ConclusionsThe cumulative incidence of LRCC was low, and adjuvant chemotherapy was associated with a decreased risk for LRCC among targeted patients. Curative-intent treatment was given to nearly 1 in 4 LRCC patients, and the OS for this group was high.

Percutaneous thermal ablation combined with transcatheter arterial chemoembolization for hepatitis C virus-related hepatocellular carcinoma: Efficacy and survival.

ObjectiveThe aim of this study was to investigate the efficacy and survival of Hepatitis C virus (HCV) -related hepatocellular carcinoma (HCC) undergoing percutaneous thermal ablation combined with transcatheter arterial chemoembolization (TACE).MethodsA total of 83 HCV-related HCC patients who were treated with percutaneous thermal ablation combined with TACE were retrospectively analyzed. The demographic and clinical data were collected. The overall survival (OS) and recurrence free survival (RFS) rates were assessed by the Kaplan-Meier method. Univariate and multivariate Cox regression analysis was used to assess independent risk factors of OS and RFS.Results92.8% patients (77/83) and 96.6% (170/176) tumor lesions achieved complete response (CR) 1 month after all treatment, and 10.8% (9/83) patients had minor complications. The median OS was 60 months (95% confidence interval (CI)= 48.0-72.0), and the 1-, 2-, 3-, 5- and 10-year cumulative OS rates were 94%, 78.3%, 72.3%, 43.4% and 27.5%, respectively. The cumulative RFS rates at 1-, 2-, 3- and 5-year were 74.7%, 49.3%, 30.7% and 25.3%, respectively. Sex (HR =0.529, P=0.048), ablation result (HR=5.824, P=0.000) and Albumin-bilirubin (ALBI) score (HR=2.725, P=0.011) were independent prognostic factors for OS. Alpha-fetoprotein (AFP) (HR =2.360, P = 0.005) and tumor number(HR=2.786, P=0.000) were independent prognostic factors for RFS.ConclusionsPercutaneous thermal ablation combined with TACE is a safe and effective treatment for HCV-related HCC. Sex, ablation result and ALBI are significant prognostic factors for OS. AFP and tumor number are significant prognostic factors for RFS.

Endoscopic debulking resection with additive chemoradiotherapy: Optimal management of advanced inoperable esophageal squamous cell carcinoma.

BACKGROUNDThere is no remedial strategy other than definitive chemoradiotherapy for patients with advanced esophageal squamous cell carcinoma (ESCC) who are not eligible to undergo surgical treatment.AIMTo introduce a novel therapy called endoscopic debulking resection (EdR) followed by additive chemoradiotherapy (CRT) and evaluate its efficacy and safety.METHODSAdvanced, inoperable ESCC patients between 1 January 2015 and 30 December 2019 were investigated retrospectively. Patients who received EdR followed by CRT were deemed the EdR + CRT group and those without CRT were deemed the EdR group. Overall survival (OS), progression-free survival (PFS), and adverse events were evaluated.RESULTSA total of 41 patients were enrolled. At a median follow-up of 36 mo (range: 1-83), the estimated 1-, 2-, and 3-year cumulative OS rates of patients who underwent EdR plus additive CRT were 92.6%, 85.2%, and 79.5%, respectively, which were higher than those of patients who underwent EdR alone (1-year OS, 83.3%; 2-year OS, 58.3%; 3-year OS, 50%; P = 0.05). The estimated 2-year cumulative PFS rate after EdR + CRT was 85.7%, while it was 61.5% after EdR (P = 0.043). According to the univariate and multivariate Cox regression analyses, early clinical stage (stage ≤ IIB) and additive CRT were potential protective factors for cumulative OS. No severe adverse events were observed during the EdR procedure, and only mild to moderate myelosuppression and radiation pneumonia were observed in patients who underwent additive CRT after EdR.CONCLUSIONEdR plus CRT is an alternative strategy for selective advanced inoperable ESCC patients.

Overall survival in colon cancer patients with different levels of circulating tumor cells and feasibility of enhancing its prognostic value

Development of personalized approaches to diagnosis, treatment and prognosis of colon cancer (CC) still remains challenging. Levels of circulating tumor (CTC) and cancer stem cells (CSC) are promising non-invasive prognostic factors. Our aim was to assess the overall survival (OS) of patients with stage II–IV CC with different levels of CTCs as well as to enhance their prognostic value by additionally determining the level of CD44+ CSCs. Material and methods. The study included 299 patients with stage II–IV CC. All patients underwent surgery followed by adjuvant chemotherapy (FOLFOX). patients with stage IV CC with resectable liver metastases underwent simultaneous resection of the primary tumor and liver metastases, followed by FOLFOX chemotherapy. the proportion of CTCs was evaluated before surgery using Veridex CellSearch™, and the level of CD44+ CSCs was determined in the tissue of the removed tumor by the IHC method. OS was studied in patients with different CTC levels, cumulative OS was calculated by Kaplan–Meier`s method. prognostic algorithm was designed by logistic regression analysis and cox proportional hazards model. Results. OS was found to be lower in patients with higher CTC levels divided into ranges: 0, 1–3, 4–9, ≥10 (χ2=11.59, p=0.009); thus enabling us to use it for prognosis. its prognostic value is enhanced by estimation of CD44+ CSC in tumor. Statistically significant conjugation between CTC and CD44+ ranges was found. an increase in CTC level by 1 range resulted in the increase in the risk of fatal outcome by 1.58 times (р=0.002); the additive increase in CD44+ expression ≥10 % resulted in the increase in the risk of fatal outcome by 7.2 times (p&lt;0.001). For individual risk assessment, a model for calculating the prognostic coefficient K with high diagnostic sensitivity and specificity was developed, and its mathematical expression was proposed. the value of K≥0.411 indicates a high risk of adverse outcome. Conclusion. The prognostic algorithm for the risk of unfavorable outcome of patients with CC, based on the assessment of CTC and CD44+ CSC levels, was developed.

Short- (30-90 days) and mid-term (1-3 years) outcomes and prognostic factors of patients with esophageal cancer undergoing surgical treatments.

BACKGROUNDThe factors influencing the prognosis of patients with esophageal cancer vary among studies and are still poorly known.AIMTo determine the factors associated with survival in patients with esophageal cancer.METHODSThis retrospective study included patients with esophageal cancer admitted between January 2017 and March 2020 at Heping Hospital Affiliated to Changzhi Medical College. All patients were treated according to the available guidelines. Follow-up was censored in October 2020. Univariable and multivariable Cox regression analyses were used to determine the independent risk factors for overall survival (OS).RESULTSIn total, 307 patients were included. Their median age was 64 (range, 44-79) years, 63.5% were male, and the median disease course was 2 (0.1-36) months. The median tumor size was 3 (0-10) cm. Most patients were T3 (29.6%), N0 (70.0%). Most tumors were grade 2 (48.2%), and 87.3% were squamous cell carcinoma. The in-hospital mortality was 16.9%, the 30-day mortality was 19.9%, and the 90-day mortality was 25.4%. The cumulative OS rates at the last follow-up were 82.1% (95%CI: 67.7%-96.5%) for stage 0/I/II and 47.4% (95%CI: 16.5-78.6%) for stage III/IVA (P < 0.001). The multivariable analysis showed that creatinine levels (HR = 1.02, 95%CI: 1.00-1.03, P = 0.050), pTNM III/IVA (HR = 4.19, 95%CI: 2.19-8.01, P < 0.001), adjuvant radiotherapy and/or chemotherapy (HR = 0.23, 95%CI: 0.11-0.49), and the Comprehensive Complication Index (CCI) (HR = 1.02, 95%CI: 1.004-1.03, P = 0.011) were independently associated with OS.CONCLUSIONThe survival of patients with esophageal cancer is poor, especially those with pTNM III/IVA. pTNM stage III/IVA, CCI, and adjuvant therapy (radiotherapy and/or chemotherapy) are independently associated with OS.

Combined stereotactic radiosurgery and tyrosine kinase inhibitor therapy versus tyrosine kinase inhibitor therapy alone for the treatment of non-small cell lung cancer patients with brain metastases.

Whether combined radiation and tyrosine kinase inhibitor (TKI) therapy in non-small cell lung cancer (NSCLC) patients with brain metastases (BMs) and epidermal growth factor receptor (EGFR) mutations confers additional benefits over TKI therapy alone remains a matter of debate. The goal of this study was to compare outcomes between combined TKI therapy with stereotactic radiosurgery (SRS) versus TKI therapy alone in NSCLC patients with BMs and EGFR mutations. Consecutive cases of NSCLC patients with EGFR mutations and BMs treated with TKIs were selected for inclusion in this study. Patients were categorized into two groups based on SRS: TKI therapy alone (group I) and combined SRS and TKI therapy (group II). Patients who had SRS or TKI as salvage therapy and those with prior radiation treatment for BMs were excluded. Tumor control (< 10% increase in tumor volume) and overall survival (OS) rates were compared using Kaplan-Meier analyses. Independent predictors of tumor control and OS were identified using multivariable Cox regression analyses. The study cohort comprised 280 patients (n = 90 in group I and n = 190 in group II). Cumulative tumor control rates were higher in group II than in group I (79.8% vs 31.2% at 36 months, p < 0.0001). Cumulative OS rates were comparable between groups I and II (43.8% vs 59.4% at 36 months, p = 0.3203). Independent predictors of tumor control were older age (p < 0.01, HR 1.03), fewer BMs (p < 0.01, HR 1.09), lack of extracranial metastasis (p < 0.02, HR 0.70), and combined SRS and TKI therapy (p < 0.01, HR 0.25). Independent predictors of OS were fewer BMs (p < 0.01, HR 1.04) and a higher Karnofsky Performance Status score (p < 0.01, HR 0.97). Although the OS rate did not differ between TKI therapy with and without SRS, the addition of SRS to TKI therapy resulted in improvement of intracranial tumor control. The lack of effect on survival rate with the addition of SRS may be attributable to extracranial disease progression. The addition of SRS to TKI therapy is recommended for intracranial disease control in NSCLC patients with BMs and EGFR mutations. Potential benefits may include prevention of neurological deficits and seizures. Future prospective studies may help clarify the clinical outcome benefits of SRS in these patients.

The association between minimal residual disease status and survival outcomes in transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) patients: Systematic review.

e20009 Background: Despite expanding therapeutic armamentarium of multiple myeloma (MM), it remains an incurable disease. Therefore, there is a need to assess the impact of deeper hematological responses to better gauge treatments in clinical trials and routine practice. The presence of minimal residual disease (MRD), is becoming crucial and a new standard in monitoring remission status. Clinical evidence shows that MRD status after treatment is an independent prognostic factor for MM. This review summarizes current data on MRD status and its role in predicting progression-free survival (PFS) and overall survival (OS) outcomes. Methods: We performed a literature search on four databases (PubMed, Embase, Cochrane, and Web of Science) following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. We screened 1307 studies using the Mesh terms “Multiple Myeloma and Minimal Residual disease.” After excluding review, duplicate, and non-relevant articles, 7 studies were included. Results: The association between MRD status and outcomes, including survival in TIE-NDMM patients was assessed in 7 studies, including 1083 patients. MRD status was determined using different techniques, such as flow cytometry and clonoSEQ. Different regimens were used in all studies. PFS was reported in all studies. Compared with MRD positive status, achieving MRD negativity improved PFS to 58 months versus 28.65 months as per cumulative analysis. The cumulative OS reported in 2 studies (n=196) was 95.85% in MRD-negative patients compared to 55.65% in MRD positive patients. Conclusions: Further clinical data focusing on post-treatment assessment of MRD will be useful in clinical decision-making and could be practice changing. MRD status may serve as surrogate end-points for PFS and OS in ongoing and future clinical trials. Achieving durable MRD negativity with PFS improvement might also increase the time between treatment relapses for MM and might help switch to a lesser aggressive regimen, chemotherapy-free period, avoiding drug toxicity. [Table: see text]

Myelodysplastic Syndromes with Isolated 20q Deletion: A New Clinical-Biological Entity?

Aims: To define the peculiar features of patients with the deletion of the chromosome 20 long arm (del20q), data from 69 patients with myelodysplastic syndromes (MDSs) and isolated del20q, followed by the Gruppo Romano-Laziale Sindromi Mielodisplastiche (GROM-L) and Ospedale Torrette of Ancona, were collected and compared with those of 502 MDS patients with normal karyotype (NK-MDS). Results: Compared to the NK-MDS group, patients with del20q at diagnosis were older (p = 0.020) and mainly male (p = 0.006). They also had a higher rate of bone marrow blast < 5% (p = 0.004), a higher proportion of low and int-1 risk according to IPSS score (p = 0.023), and lower median platelet (PLT) count (p < 0.001). To date, in the del20q cohort, 21 patients (30.4%) received no treatment, 42 (61.0%) were treated with erythropoiesis-stimulating agents (ESA), 3 (4.3%) with hypomethylating agents, and 3 (4.3%) with other treatments. Among 34 patients evaluable for response to ESA, 21 (61.7%) achieved stable erythroid response according to IWG 2006 criteria and 13 (38.2%) were resistant. Nine patients (13.0%) progressed to acute myeloid leukaemia (AML) after a median time from diagnosis of 28 months (IR 4.1–51.7). The median overall survival (OS) of the entire cohort was 60.6 months (95% CI 54.7–66.4). the 5-year cumulative OS was 55.9% (95% CI 40.6–71.2). Conclusion: According to our results, we hypothesize that MDSs with isolated del 20q may represent a distinct biological entity, with peculiar clinical and prognostic features. The physio-pathological mechanisms underlying the deletion of the chromosome 20 long arm are still unclear and warrant future molecular analysis.

Prognostic factors of recurrent intrahepatic cholangiocarcinoma after hepatectomy: A retrospective study.

BACKGROUNDIntrahepatic cholangiocarcinoma (ICC) is a highly malignant tumour. Hepatectomy is an effective treatment for early ICC, but postoperative recurrence greatly affects patient survival. Studies on recurrent ICC after hepatectomy are lacking.AIMTo investigate the clinical characteristics of patients with recurrent ICC after hepatectomy, analyse prognostic factors and explore diagnosis and treatment strategies.METHODSA retrospective analysis was performed on all ICC patients undergoing hepatectomy from January 2013 to August 2021. Patients with postoperative recurrence were selected according to the inclusion and exclusion criteria. Cumulative overall survival was plotted by the Kaplan-Meier method, and differences were assessed by univariate survival analysis using the log-rank test. Multivariate analysis of cumulative survival was performed using the Cox proportional risk model.RESULTSDuring the 8-year study period, 103 patients underwent ICC-related hepatectomy, and 54 exhibited postoperative recurrence. The median disease-free survival (DFS) was 6 mo, the median overall survival (OS) was 9 mo, and the cumulative OS rates at 1, 2 and 3 years after the operation were 40.7%, 14.8% and 7.4%, respectively. The median OS after recurrence was 4 mo, and the cumulative OS rates at 1, 2 and 3 years after recurrence were 16.1%, 6.7% and 3.4%, respectively. Multivariate analysis showed that alcohol consumption [hazard ratio (HR) = 4.64, 95% confidence interval (CI): 1.53-14.04, P = 0.007] and DFS < 6 mo (HR = 3.47, 95%CI: 1.59-7.60, P = 0.002) were independent risk factors for the cumulative survival of patients with recurrence, while treatment after recurrence (HR = 0.21, 95%CI: 0.08-0.55, P = 0.001) was an independent protective factor. The median OS time of patients receiving multimodality therapy after recurrence of ICC was 7 mo, which was significantly higher than that of patients receiving only local therapy (3 mo), patients receiving systematic therapy (4 mo) and patients receiving the best supportive therapy (1 mo). Patients with recurrent ICC who received multimodality therapy had a significantly better long-term survival after recurrence than those who did not (P = 0.026).CONCLUSIONThe prognosis of patients with recurrence after ICC-related hepatectomy is poor. Alcohol consumption and DFS < 6 mo are independent risk factors in terms of the cumulative survival of patients with recurrence, while treatment after recurrence is an independent protective factor. Multimodality therapy can effectively improve the prognosis of patients.