Stage IB Research Articles

Trends in incidence and survival of early-stage pancreatic ductal adenocarcinoma in the United States.

633 Background: Pancreatic ductal adenocarcinoma (PDAC) is associated with poor survival with nearly 80% mortality within the first year after diagnosis. There have been modest incremental improvements in survival over the last decade, however the reason for this improvement is unclear. The aim of this study is to evaluate the trends of diagnosis and survival in the last two decades using large public national databases. Methods: Incidence rates of PDAC between 2001 and 2020 (age-adjusted to the 2000 US standard population) were evaluated in the United States Cancer Statistics (USCS) database, representing approximately 98% of the US population. The data was analyzed with SEER*Stat using Joinpoint regression. A survival analysis was subsequently conducted using the American College of Surgeons’ (ACS) National Cancer Database (NCDB), of PDAC cases diagnosed between 2004 and 2015.Survival outcomes were stratified by AJCC stage. Kaplan-Meier survival curves were generated, and log-rank tests were conducted to assess differences in survival between stages. Cox proportional hazards model was employed to estimate hazard ratios and adjust for potential confounders. The analysis was performed with IBM SPSS 24. Results: From 2001 to 2020, the age-adjusted incidence rate of early-stage PDAC increased from 1.1 to 2.8 (per 100,000 person-years), while locally advanced PDAC increased from 3.6 to 4.3, and from 6.4 to 7.7 for metastatic PDAC (all p<0.01). The Annual Percent Change (APC) was 5.7 for Early-Stage PDAC (95% CI 5.1-6.4), 1.4 for locally advanced (95% CI 0.8-1.9), and 0.8 for Metastatic PDAC (95% CI 0.6-1.1). The incidence rate ratio (IRR) almost doubled for early-stage PDAC, increasing from 0.10 to 0.19. Conversely, for metastatic and locally advanced stages, the IRR decreased from 0.58 to 0.52 and 0.32 to 0.29, respectively. Survival analysis revealed 5-year overall survival rates of 74%, 69%, 57%, and 33% for stages 0, IA, IB, and IIA, respectively, with an overall improvement from 2004 to 2015. This increase was consistent among all age groups, genders, and races. Stages IA and IB demonstrated larger increases 45.9% and 56.6%, respectively (IA: 47% in 2004 to 75% in 2015; IB: 38% in 2004 to 68% in 2015). Conclusions: This study highlights a marked increase in the incidence of early-stage PDAC, surpassing the overall incidence increase, suggesting improving diagnostic capabilities over the last two decades. Furthermore, the substantial improvement in 5-year survival rates for stages IA and IB indicates progress in the management of early-stage PDAC. These findings emphasize the importance of continued efforts in early detection and treatment strategies for PDAC.

The role of pre-operative ctDNA in resectable intrahepatic cholangiocarcinoma.

528 Background: Genomic profiling of circulating tumor DNA (ctDNA) is increasingly used in intrahepatic cholangiocarcinoma (iCCA) to inform precision oncology approaches and determine resistance mechanisms to targeted therapies. The application of pre-operative ctDNA testing in the management of iCCA for prognostication remains unclear. Methods: In this retrospective study, we analyzed pre-operative plasma samples from 14 patients who underwent curative resection for iCCA without neoadjuvant therapy. A personalized and tumor-informed assay (Signatera; Natera, Inc.) was used for the detection and quantification of ctDNA. We correlated ctDNA profiles with baseline tumour characteristics and clinical outcomes. Results: The mean interval between pre-operative blood collection and surgery was 43 days (range: 1 to 90 days). ctDNA was detected in all patients except for one with stage Ia (AJCC 8th) disease (Table). The mean pre-operative ctDNA concentration was lowest in the stage Ia group [4.2 mean tumor molecules (MTM)/mL] and highest in the stage II group (134.0 MTM/mL). The mean pre-operative ctDNA concentration did not exhibit a linear correlation with disease recurrence or mortality rates, however, it showed a moderate-to-good linear correlation with the largest pathologic tumor size (R2 = 0.55). Among the three patients who had IDH1/2 mutations tracked in the plasma by Signatera, two patients had positive IDH1/2 detection in ctDNA with mean ctDNA concentrations of 83.7 MTM/mL (range: 33.8 to 133.5 MTM/mL). The patient with the second-highest ctDNA concentration (133.5 MTM/mL and 1818 days follow-up) had stage Ib disease with an IDH1 mutation but has shown no evidence of recurrence. Conclusions: In the pre-operative setting for iCCA resections, ctDNA can be reliably detected across all disease stages using a tumor-informed approach, even when blood is collected up to 90 days before surgery. While single time-point pre-operative ctDNA concentration levels do not appear to correlate with outcomes, similar to previous reports in colon adenocarcinoma, they may correlate with tumor volume. Further studies are needed to evaluate the utility of tumor-informed ctDNA testing in the post-operative setting to detect molecular residual disease for improved prognostication. [Table: see text]

Diagnosis, treatment, and prognosis of stage IB non-small cell lung cancer with visceral pleural invasion.

With the increasing implementation of early lung cancer screening and the increasing emphasis on physical examinations, the early-stage lung cancer detection rate continues to rise. Visceral pleural invasion (VPI), which denotes the tumor's breach of the elastic layer or reaching the surface of the visceral pleura, stands as a pivotal factor that impacts the prognosis of patients with non-small cell lung cancer (NSCLC) and directly influences the pathological staging of early-stage cases. According to the latest 9th edition of the TNM staging system for NSCLC, even when the tumor diameter is less than 3 cm, the final T stage remains T2a if VPI is present. There is considerable controversy within the guidelines regarding treatment options for stage IB NSCLC, especially among patients exhibiting VPI. Moreover, the precise determination of VPI is important in guiding treatment selection and prognostic evaluation in individuals with NSCLC. This article aims to provide a comprehensive review of the current status and advancements in studies pertaining to stage IB NSCLC accompanied by VPI.

Real-World Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Early-Stage Non-Small-Cell Lung Cancer.

The prognosis of early non-small-cell lung cancer (eNSCLC) remains poor. An understanding of current therapies and outcomes can provide insights into how novel therapies can be integrated into clinics. We conducted a large, retrospective, population-based cohort study of patients with de novo eNSCLC (stages IB, IIA, IIB, and IIIA) diagnosed in Alberta, Canada, between 2010 and 2019. The primary objectives were to describe treatment patterns and survival outcomes among patients with eNSCLC. A total of 5126 patients with eNSCLC were included. A total of 45.3% of patients were referred to a medical oncologist, ranging from 23.7% in stage IB to 58.3% in IIIA. A total of 23.6% of patients initiated systemic therapy (ST), ranging from 3.5% in stage IB to 38.5% in IIIA. For stage IIB and IIIA individuals who received surgery, adjuvant ST was associated with a decreased likelihood of death (hazard ratios (HR) of 0.77 (95% CI: 0.56-1.07) and 0.69 (95% CI: 0.54-0.89), respectively). In a Canadian real-world setting, stage IIB and IIIA patients who received adjuvant ST tended to have better survival than patients who did not, but future studies that provide adjustment of additional confounders are warranted. Examining referral pathways that account for disparities based on age, sex, and comorbidities in the real world would also provide further insights.

SUCCOR morbidity: complications in minimally invasive versus open radical hysterectomy in early cervical cancer

ObjectiveThe aim of this study was to compare the incidence of intra-operative and post-operative complications in open and minimally invasive radical hysterectomy for patients with early-stage cervical cancer.MethodsData were collected...

The 31-Gene Expression Profile Test Outperforms AJCC in Stratifying Risk of Recurrence in Patients with Stage I Cutaneous Melanoma.

Patients with stage I cutaneous melanoma (CM) are considered at low risk for metastasis or melanoma specific death; however, because the majority of patients are diagnosed with stage I disease, they represent the largest number of melanoma deaths annually. The 31-gene expression profile (31-GEP) test has been prospectively validated to provide prognostic information independent of staging, classifying patients as low (Class 1A), intermediate (Class 1B/2A), or high (Class 2B) risk of poor outcomes. Patients enrolled in previous studies of the 31-GEP were combined and evaluated for recurrence-free (RFS) and melanoma-specific survival (MSS) (n = 1261, "combined"). A second large, unselected real-world cohort (n = 5651) comprising clinically tested patients diagnosed 2013-2018 who were linked to outcomes data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program registries was evaluated for MSS. Combined cohort Class 1A patients had significantly higher RFS than Class 1B/2A or Class 2B patients (97.3%, 88.6%, 77.3%, p < 0.001)-better risk stratification than AJCC8 stage IA (97.5%) versus IB (89.3%). The SEER cohort showed better MSS stratification by the 31-GEP (Class 1A = 98.0%, Class 1B/2A = 97.5%, Class 2B = 92.3%; p < 0.001) than by AJCC8 staging (stage IA = 97.6%, stage IB = 97.9%; p < 0.001). The 31-GEP test significantly improved patient risk stratification, independent of AJCC8 staging in patients with stage I CM. The 31-GEP provided greater separation between high- (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB. These data support integrating the 31-GEP into clinical decision making for more risk-aligned management plans.

Meta-analysis of the efficacy of postoperative adjuvant chemotherapy for stage IB non-small cell lung cancer.

Many clinical trials have shown that postoperative adjuvant chemotherapy can provide a survival benefit for patients with stage IB non-small cell lung cancer. However, whether adjuvant chemotherapy should be routinely given after surgery remains controversial. Therefore, we performed a meta-analysis to investigate the efficacy of adjuvant chemotherapy versus surgery alone for stage IB non-small cell lung cancer (NSCLC). Relevant retrospective studies or randomized controlled trial comparing the efficacy of postoperative adjuvant chemotherapy versus observation on the survival outcomes of NSCLC patients up to October 30, 2023 were searched in PubMed, Web of Science, EMBASE, Cochrane Library, VIP database, Wanfang database, and China National Knowledge Internet database. Patient survival data, population characteristics, and other relevant information were extracted, and data were analyzed using Review Manager 5.4. The primary endpoints included overall survival, disease-free survival, and recurrence-free survival. A total of 13 randomized controlled trials or cohort studies including 19,442 patients were included. The results of the meta-analysis showed that postoperative adjuvant chemotherapy in patients with stage IB NSCLC had better overall survival (odds ratio [OR] = 1.25, 95% confidence interval [CI] 1.19-1.31, P < .00001) and disease-free survival or recurrence-free survival (OR = 1.57, 95% CI 1.3-1.9, P < .00001) compared with observation; and the 4-year survival rate of patients who received postoperative adjuvant chemotherapy was better than the observation group (OR = 1.52, 95% CI 1.05-2.18, P = .03); and the 8-year survival rate of patients receiving postoperative adjuvant chemotherapy (OR = 1.5, 95% CI 0.94-2.4, P = .09) was comparable to the observation group. Receiving postoperative adjuvant chemotherapy improved people's survival and prolonged disease-free survival and recurrence-free survival in patients with stage IB non-small cell lung cancer compared with surgery alone.

Adjuvant chemotherapy on survival of patients with stage IB non‑small cell lung cancer: a comparison study with propensity score matching

BackgroundThis study aimed to investigate whether patients with stage IB NSCLC could benefit from adjuvant chemotherapy.MethodsIn the years 2010 to 2015, 1,829 NSCLC patients with stage IB disease were chosen from the SEER database. To equalize the baseline characteristics between the surgery plus adjuvant chemotherapy group (intervention) and the surgery alone group (control), propensity score matching (PSM) was used. The log-rank test plotted Kaplan–Meier survival curves to compare the overall survival (OS) and disease-specific survival (DSS). Cox proportional hazard regression was used to perform univariate and multivariate analysis on overall survival.ResultsOne hundred ninety-seven patients in each group with a mean follow-up period of 65.4 months were enrolled after PSM. A significant benefit in overall survival ([intervention vs. control] HR = 0.72; 95% CI: 0.54 to 0.94; P = 0.026) was detected in the intervention group before PSM. And there were significantly improved OS (HR = 0.63; 95% CI: 0.42 to 0.92; P = 0.036) and DSS (HR = 0.73; 95% CI: 0.52 to 0.95; P = 0.044) for the patients with visceral pleural invasion (VPI) in the intervention group compared with the control group. After PSM, the patients with VPI in the intervention group had better overall survival (HR = 0.69; 95% CI: 0.40 to 0.98; P = 0.048) than those in the control group. The Cox proportional hazard regression analysis showed that VPI (HR = 1.29; 95% CI: 1.11 to 1.54; P < 0.001) was also an independent prognostic factor.ConclusionStage IB NSCLC with VPI could benefit from adjuvant chemotherapy after R0 resection.

Influence of adjuvant chemotherapy on survival for patients with completely resected high-risk stage IB NSCLC

BackgroundThe use of adjuvant chemotherapy (ACT) in completely resected stage IB NSCLC is still controversial. This study aims to investigate the efficacy of ACT in pathological stage IB non-small cell lung cancer (NSCLC) with high risk factors.MethodsPatients with pT2aN0M0 stage IB NSCLC who underwent complete resection from 2013 to 2017 were retrospectively analyzed. Univariate and multivariable logistic regression analysis was used to assess potential independent risk factors associated with poor prognosis. To compare survival between patients who received ACT and those who did not.ResultsIn univariate and multivariate analyses, adenocarcinomas with predominantly micropapillary (MIP) and solid patterns (SOL), poorly differentiated squamous cell carcinoma (SCC), number of lymph nodes dissected less than 16 and tumor size larger than 36 mm were identified as high-risk factors for recurrence. In patients with high risk factors for recurrence, ACT resulted in significantly longer DFS (HR, 0.4689, 95%CI, 1.193–3.818; p = 0.0108) and OS (HR, 0.4696, 95%CI, 0.6578–6.895; p = 0.2073), although OS failed to reach statistically significance. After propensity score matching (PSM), 67 pairs of patients were 1:1 matched in the two groups and all baseline characteristics were well balanced. The results also demonstrated that ACT was associated with improved DFS (HR, 0.4776, 95%CI, 0.9779–4.484; p = 0.0440) while OS was not significantly different (92.5% vs. 91.0%; HR, 0.6167, 95%CI, 0.1688–2.038; p = 0.7458). In patients with low-risk factors for recurrence, DFS (HR, 0.4831, 95%CI, 0.03025-7.715; p = 0.6068) and OS (HR, 0.969, 95%CI, 0.08364-11.21; p = 0.9794) was not significantly different between those who received ACT and those who did not.ConclusionIn patients with completely resected stage IB NSCLC, ACT can improve survival in patients with high risk for recurrence. Further large multicenter studies are needed to confirm these findings.

Lymphoepithelioma-like carcinoma of the cervix: Diagnostics, treatment, monitoring

Lymphoepithelioma-like carcinoma of the cervix (LELC) is a rare subtype of squamous cell carcinoma. This is a case report of a 40-year-old female patient diagnosed with LELC. The tumor is clinically presented as an exophytic mass on the front lip of the cervix. Magnetic resonance imaging (MRI) of the pelvis revealed a cervical tumor mass with a diameter of 21 mm. The findings of the preoperative pathohistological analysis of the biopsy tissue indicated LELC. The disease was clinically and radiologically staged as IB1 stage according to the 2009 FIGO classification, and the patient underwent surgical treatment. A total radical hysterectomy with pelvic lymphadenectomy was performed, followed by external beam radiotherapy. The patient was regularly monitored with the last check-up on February 2024 (36 months) and MRI control of the pelvis and abdomen without signs of recurrence of the underlying disease. The patient is in good general condition, without subjective complaints and side effects of the applied therapy.

Immunohistochemical markers Ki67 and P16 help predict prognosis in locally advanced cervical cancer

ObjectiveTo investigate the relationship between Ki-67 and P16 expression levels after neoadjuvant chemotherapy, and the clinicopathological characteristics and prognosis of patients with locally advanced cervical cancer. MethodsPatients with FIGO 2009 stage IB2 or IIA2 cervical cancer, who underwent neoadjuvant chemotherapy combined with radical hysterectomy at the First Affiliated Hospital of Chongqing Medical University between January 2015 and December 2019, were identified retrospectively to correlate postoperative Ki-67 and P16 expression levels with clinicopathological factors. The optimal threshold for predicting recurrence was analysed using receiver operating characteristic (ROC) curves for the Ki-67 index, and univariate and multi-factorial Cox regression analysis were used to investigate the association between clinicpathological features including Ki-67 and P16 and recurrence-free survival. ResultsIn total, 334 patients were included after screening. The cut-off value of Ki-67 for determining recurrence was 67.5 % according to the ROC curve. On multi-factorial Cox analysis, lymphatic vascular space (p = 0.003) and Ki-67 index (p = 0.005) were shown to increase the risk of recurrence, and were independent prognostic factors for recurrence, while the expression of P16 was not significantly associated with the risk of recurrence (p = 0.097, odds ratio = 0.319). Patients with cervical cancer in the high Ki-67 expression group (Ki-67 ≥ 67.5 %) had lower recurrence-free survival and overall survival than patients in the low Ki-67 expression group (Ki-67 < 67.5 %) (p = 0.001 and 0.036, respectively). ConclusionThe expression levels of Ki-67 and P16 after neoadjuvant chemotherapy for locally advanced cervical cancer correlated with tumour differentiation. High expression of Ki-67 (Ki-67 ≥ 67.5 %) may indicate poorer recurrence-free survival and overall survival.

Efficacy and safety of pembrolizumab in cervical cancer: Protocol for systematic review and meta-analysis of randomized clinical trials.

This paper reports a systematic review and meta-analysis protocol that will be used to evaluate the efficacy and safety of pembrolizumab, alone or combined with bevacizumab and other therapies, in adult women with cervical carcinoma from stage IB2 onwards. The protocol follows PRISMA-P recommendations and was registered on PROSPERO (CRD42024531233). The search will be conducted without restrictions on language and year of publication in the following databases: Pubmed, Embase, Scopus, Web of Science, Cancerlit, The World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) and Clinical Trials Registry Platform. Grey literature will be searched using the following sources: Clinicaltrials.gov, Google Scholar and Opengrey. Manual search will be carried out for the reference lists of eligible studies. The studies will be selected independently by two reviewers and all completed or ongoing randomized clinical trials that evaluated the efficacy and safety of pembrolizumab, used alone or combined with chemotherapy, radiotherapy, bevacizumab or surgery, in adult women diagnosed with cervical cancer, will be included. The data extraction will include population characteristics, type of treatment and main outcomes of studies. The methodological quality of the studies will be assessed using the Cochrane Risk of Bias 2.0. The certainty of the evidence will be rated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). The findings will be presented in narrative summary tables and a quantitative synthesis will be conducted using the 'meta' package of R software, version 4.3.1. This future systematic review may contribute with quality evidence for clinical decision-making on the use of pembrolizumab in women with cervical cancer.

Unveiling the lymph node drainage route in stage IB1 to IIA2 cervical cancer: insights from a retrospective cohort study

Unveiling the lymph node drainage route in stage IB1 to IIA2 cervical cancer: insights from a retrospective cohort study

Comparison of the efficacy of Cf-252 neutron intracavitary brachytherapy monotherapy with neutron intracavitary brachytherapy plus external beam radiotherapy in stage IB1 cervical cancer

ObjectiveWe aimed to compare the efficacy of californium (Cf)-252 neutron intracavitary brachytherapy (NIBT) monotherapy with NIBT plus external beam radiotherapy (ERBT) in the treatment of stage IB1 cervical cancer. MethodsFrom May 2006 to March 2014, 38 patients with stage IB1 cervical cancer with negative pelvic lymph node metastasis (NPLNM) who were treated at our hospital were enrolled in this retrospective study. A matched-pair design based on age, hemoglobin level, and tumor histology was used for the analysis. The status of all patients was assessed by the positron emission tomography - computer tomography (PET-CT) scan or the contrast enhancement pelvic CT scan. Cf-252 NIBT was administered for four times, and the total dose at point A was 42–44 Gy. ResultsThe local tumor control rate, overall survival rate, tumor-free survival rate, and late complication incidence rate in the NIBT group were 94.7%, 100%, 94.7% and 0%, respectively, which in the EBRT + NIBT group were 94.7%, 89.5%, 89.5% and 5.26%, respectively. The return of menstruation incidence rate was 36.8% in the NIBT group and 0% in the EBRT + NIBT group. ConclusionThe treatment outcomes in the NIBT group were similar to those in the EBRT + NIBT group for patients with stage IB1 cervical cancer with NPLNM, regular menstruation and at least 3 years of follow-up data. The additional advantage of NIBT monotherapy is the potential preservation of ovarian and endometrial function and hence fertility.

Post-Lobectomy Tracheal Metastasis of Stage Ib Lung Cancer

Post-Lobectomy Tracheal Metastasis of Stage Ib Lung Cancer

Therapeutic pathomorphosis of stage IB–IIA cervical cancer cells after various regimens of preoperative HDR brachytherapy

Background. Despite of the constant improvement of existing treatment methods, involving the latest technologies into the treatment programs, the results of the treatment remain unsatisfactory. It is impossible to prevent the dissemination of tumor cells during surgery, which cause the tumor recurrence. Even in case of early stage cervical cancer, after only adequate conducted surgery, the relapse-rate is 20–30%, and the five-year survival rate is 40–60%. The aim of the work is to evaluate the effectiveness of different doses of preoperative HDR-brachytherapy in cervical cancer patients stage IB–IIA, based on the data of therapeutic pathomorphosis of the tumor. Materials and methods. There was investigated the structural and functional status of cells of squamous cell cervical cancer stage IB–IIA in two treatment schemes. According to the first scheme, there was conducted two sessions of brachytherapy with a single dose of 5 Gy with an interval of 7 days, up to the common dose of 10 Gy (5+5 Gy). According to another scheme, the single dose at the first session was 7 Gy, at the second session – 5 Gy, total dose was 12 Gy. The comparison group included primary patients with squamous cell cervical cancer and patients, who received fractional EBRT and EBRT + LDR-brachytherapy, total dose of 20 Gy and 40 Gy respectively. The morphofunctional status of cancer cells was investigated using standard electron microscopy methods. In all studied groups, there was detected the frequency of tumors samples, which contain large cells, the frequency of tumors with the presence of mitoses, and frequency of cases with significant therapeutic pathomorphosis. The obtained data was processed by the application of non-parametric statistical methods, using the «Biostat» software, and non-parametric criterion of the most plausible reliability assessment for small selections. Results. It is established that 26.9% of primary patients with cervical cancer had tumors with large cancer cells. After fractional irradiation with total doses of 20 and 40 Gy, an increase in the frequency of cases of tumors with such cells to 37.5 and 50.0%, respectively, was observed although these changes were unreliable in comparison with the control group of primary patients. However, after the first session of HDR-brachytherapy in a single dose of 5 or 7 Gy, in contrast to the indicators in the group of primary patients, there was a sharp and reliable increase in the frequency of tumors cases with large cancer cells up to 83.3% and 90%, respectively. At the same time, pronounced therapeutic pathomorphosis did not exceed 10.0–16.7% of cases. The second session of HDR brachytherapy at a dose of 5 Gy (total doses of 10 and 12 Gy) led both to a decrease in the frequency of tumors with large cancer cells to the level of control values (20 and 27.3%), and to a dose-dependent increase in the indicators of pronounced therapeutic pathomorphosis ( 40 and 70% respectively). Conclusions. There has been established that HDR-brachytherapy with the initial single dose of 5 or 7 Gy initiate a significant reaction, when the primary population of cancer cells is replaced by others, where prevail their large forms, which may be giant polyploid cancer cells. After the second session of brachytherapy of 5 Gy, the proportion of tumors, which are composed of large cells, significantly decreases simultaneously with the increase of significant therapeutic pathomorphosis in the cellpopulation of cervical cancer. The application of HDR-brachytherapy of 7 Gy at the first session will lead to the higher efficacy of the proposed scheme of the preoperative irradiation in cervical cancer patients stages IB–IIA, when the therapeutic pathomorphosis reaches 70%, when at the same time with a total dose of brachytherapy of 10 Gy, therapeutic pathomorphosis is only 40%.

EGFR-mutation testing, treatment patterns and clinical outcomes in patients with stage IB–IIIA non-small cell lung cancer in Norway–a nationwide cohort study

IntroductionTesting for mutations of epidermal growth factor receptor (EGFR) is crucial to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with EGFR tyrosine kinase inhibitors (EGFR-TKIs); This study aims to describe EGFR-mutation testing, treatment patterns, and overall survival (OS) in localized NSCLC patients. Materials and MethodsPatients with localized (Stage IB–IIIA) NSCLC registered in the Norwegian Cancer Registry during 2010–2017 were followed from diagnosis until emigration, death, or end of study in 2018. The cohort was linked to data from the Norwegian Patient Registry, the Prescription Database, and the Cause of Death Registry. ResultsOf 2367 patients identified with localized NSCLC, 52 % were females and median age at diagnosis was 69 years. Most (66 %) were treated with surgery, while 16 % received curatively-intended radiotherapy (RT). EGFR-mutation testing increased significantly from 58 to 84 % during the study period. Testing frequencies varied across regions and comorbidity levels. Nine-percent of tested patients were EGFR-mutation positive (EGFRm+), of whom 27 % were treated with EGFR-TKIs. There was no correlation between initial treatment with either surgery or RT and EGFR-TKI use. The 3-year OS did not vary considerably by EGFR-mutation testing, but EGFRm+ patients had a higher 3-year OS (78.8 %) than wild-type EGFR (EGFRwt) patients (65.9 %). DiscussionAlthough EGFR-mutation testing is increasingly being implemented in the early-stage setting in line with national recommendations, some patients are still not being tested for molecular markers as part of their diagnostic workup–a prerequisite for providing equal access to effective targeted treatments, such as EGFR-TKIs, to eligible patients.

High-risk endometrial carcinoma in early stages: Hospital Italiano de Buenos Aires, oncological results

Endometrial cancer is the second most frequent gynecological tumor in Argentina, representing 6% of all cancers in women. The objective of this study is to evaluate the oncological and perioperative results in patients with high-risk endometrial cancer (HREC) limited to the uterus, treated at the Hospital Italiano de Buenos Aires, between January 2010-2018. Retrospective cohort study that evaluated perioperative results, disease-free survival at 2, 4 years in patients with HREC. Of a total of 123 patients, 74 met the inclusion criteria. Serous tumors were the most frequent histological type, n=38 (51%), while dedifferentiated tumors were the least frequent, n=2 (3%). Of all the patients included, 56 (76%) received at least one adjuvant treatment. Taxol platinum-based chemotherapy was implemented in 28 patients (38%), while 24 (33%) received a combination of chemotherapy and radiotherapy. The median follow-up time was 2.9 years. Disease-free survival in patients with stage IA at 2 and 4 years was 71% (95% CI 55-82) and 63% (CI 46-76), respectively, while those with stage IB were 53 (95% CI 33-70) and 38 (95% CI 19-58). Regarding the surgical approach, no significant differences were found in disease-free or overall survival when comparing the laparoscopic with the laparotomy approach (p=0.06). Only the FIGO stage showed an increased probability of death or relapse regardless of the type of adjuvant treatment and the type of surgery approach. Perioperative complications were similar in both approaches.

The nomogram for the prediction of overall survival after surgery in patients in early-stage NSCLC based on SEER database and external validation cohort.

Currently, there is a lack of effective tools for predicting the prognostic outcome of early-stage lung cancer after surgery. We aim to create a nomogram model to help clinicians assess the risk of postoperative recurrence or metastasis. This work obtained 16,459 NSCLC patients based on SEER database from 2010 to 2015. In addition, we also enrolled 385 NSCLC patients (2017/01-2019/06) into external validation cohort at Tianjin Medical University General Hospital. Univariable as well as multivariable Cox regression was carried out for identifying factors independently predicting OS. In addition, we built a nomogram by incorporating the above prognostic factors for the prediction of OS. Tumor size was positively correlated with the risk of poor differentiation. Advanced age, male and adenocarcinoma patients were factors independently predicting poor prognosis. The risk of white race is higher, followed by Black race, Asians and Indians, which is consistent with previous study. Chemotherapy is negatively related to prognostic outcome in patients of Stage IA NSCLC and positively related to that in those of Stage IB NSCLC. Lymph node dissection can reduce the postoperative mortality of patients. AUCs of the nomograms for 1, 2, and 3-year OS was 0.705, 0.712, and 0.714 for training cohort, while those were 0.684, 0.688, and 0.688 for validation cohort. The nomogram could be used as a tool to predict the postoperative prognosis of patients with Stage I non-small cell lung cancer.

Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis

IntroductionIn Chinese patients with NSCLC, prevalence of EGFR-mutated (EGFRm) disease is high. In the global phase 3 ADAURA study (NCT02511106), adjuvant osimertinib was found to have a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus placebo in resected stage IB to IIIA EGFRm NSCLC. We present efficacy and safety data from a subgroup analysis of 159 Chinese patients enrolled in the People’s Republic of China from ADAURA. MethodsIn ADAURA, patients with completely resected stage IB to IIIA EGFRm (exon 19 deletion/exon 21 L858R) NSCLC were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo for 3 years or until disease recurrence/discontinuation. Adjuvant chemotherapy was permitted before randomization, per physician/patient choice. Primary end point was investigator-assessed DFS in stage II to IIIA disease; secondary end points included DFS in stage IB to IIIA (overall population), overall survival, health-related quality of life (HRQoL), and safety. ResultsOf 682 patients enrolled globally, 159 patients in the People’s Republic of China were included in this subgroup analysis (osimertinib n = 77; placebo n = 82). Baseline characteristics were balanced across the treatment arms. At data cutoff, stage II to IIIA DFS hazard ratio (HR) was 0.23 (95% confidence interval [CI]: 0.13–0.42; maturity 59%); stage IB to IIIA DFS HR was 0.29 (95% CI: 0.17–0.48; maturity 42%). At 13% maturity (21 deaths), HR for overall survival in the stage IB to IIIA population was 0.51 (95% CI: 0.21–1.20). HRQoL was maintained from baseline, and safety was consistent with the global population. ConclusionsIn this population of Chinese patients from ADAURA, adjuvant osimertinib was found to have a clinically meaningful improvement in DFS versus placebo, with maintained HRQoL and a safety profile consistent with the global study population.