Benefit Of Adjuvant Chemotherapy Research Articles

Cost-Effectiveness Analysis from a Societal Perspective of Recurrence Index for Distant Recurrence (RecurIndex) in Women with Hormone Receptor-Positive and HER2-Negative Early-Stage Breast Cancer

PurposeA clinical-genomic prognostic multigene panel (RI-DR assay, RecurIndex®), predicting the risk level of distant recurrence (DR) in early-stage breast cancer (EBC) patients with an Asian background, has been validated as a valuable tool for identifying high-risk patients to develop distant recurrence (metastasis). Although the clinical benefit of adjuvant chemotherapy from the assay’s prediction is already proved, its affordability remains uncertain. This study is the first time in which the long-term cost-effectiveness of the RI-DR assay is evaluated.Patients and MethodsA lifetime Markov decision-analytic model was developed from a societal perspective to estimate the life-years gained (LYGs), quality-adjusted life-years (QALYs), medical costs, and incremental cost-effectiveness ratios (ICERs), comparing EBC women with and without RI-DR genomic testing. A decision tree was used to classify patients in one of the fifteen end nodes (by order, each arm was stratified by a patient being tested or not with the RI-DR assay, being treated or not with adjuvant chemotherapy and had no, minor, major, or fatal toxicity after adjuvant chemotherapy). Health utilities, costs, transition probabilities, and survival data were extracted from the scientific literature. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed on variables to assess the robustness of the model. A willingness-to-pay (WTP) threshold of 790,000 NT$ per QALY gained was considered as a cost-effectiveness criterion.ResultsThe incremental cost per QALY gained under base-case assumptions of the model was 173,842 NT$. Findings on the variation in model input parameters were robust and confirmed that every key variable was cost-effective for the benefit of RI-DR testing.ConclusionThe clinical-genomic RI-DR assay is cost-effective in guiding adjuvant chemotherapy decisions compared to current clinical practice guidelines.

Benefit for single-agent adjuvant chemotherapy in elderly patients with locally advanced gastric adenocarcinoma

Current NCCN guidelines exclude the possibility of using single-agent adjuvant chemotherapy in locally advanced gastric adenocarcinoma, while allowing doublet chemotherapy. However, single-agent adjuvant chemotherapy is a valid treatment option in other gastrointestinal malignancies, preferred for elderly and/or frail patients. The current study used a nationwide oncology database to assess the benefit of single-agent adjuvant chemotherapy, specifically in the elderly population. Using the National Cancer Database (2004-2016) we identified 1953 individuals with non-metastatic gastric adenocarcinoma who underwent upfront D2 gastrectomy with pathologic stage ≥ T3 or Npos and free surgical margins, and had not received either preoperative chemotherapy or pre-/postoperative radiotherapy. We used IPTW analysis to compare overall survival between individuals receiving either single- or multi-agent adjuvant chemotherapy, or referred to observation alone. Individuals receiving single-agent chemotherapy had an overall survival benefit compared with observation alone, with an HR of 0.70 (95% CI 0.55-0.88, p < 0.001). Individuals over the age of 65 had an OS benefit with an HR of 0.61 (95% CI 0.46-0.82, p < 0.001). Comparing individuals over the age of 65 receiving single- vs. multi-agent chemotherapy, there was no overall survival difference with an HR of 0.87 (95% CI 0.64-1.18, p = 0.38). Single-agent adjuvant chemotherapy with a fluoropyrimidine in locally advanced gastric adenocarcinoma following D2 gastrectomy can improve overall survival in elderly patients. Clinicians may consider using either capecitabine or 5-FU as a treatment option in the adjuvant setting for this age group.

Multimodal Management of Grade 1 and 2 Pancreatic Neuroendocrine Tumors.

Simple SummaryAs we are facing an increasing incidence of pancreatic neuroendocrine tumors (pNETs), it appears necessary to better classify this disease—and in 2017 the WHO classification introduced a new category of well differentiated grade 3 tumors. pNETs treatment requires some specific background and recent reviews on the multimodal management of this disease are missing. Indeed, those modalities constantly evolve and this review, focusing on Grade 1 and Grade 2 pNETs, aims to clarify both oncological and surgical treatment options from localized tumors to multi metastatic disease. Every aspect of the strategy are discussed in this review from the oncologist and the surgeon’s point of view and with a special focus on a minimally invasive approach.Pancreatic neuroendocrine tumors (p-NETs) are rare tumors with a recent growing incidence. In the 2017 WHO classification, p-NETs are classified into well-differentiated (i.e., p-NETs grade 1 to 3) and poorly differentiated neuroendocrine carcinomas (i.e., p-NECs). P-NETs G1 and G2 are often non-functioning tumors, of which the prognosis depends on the metastatic status. In the localized setting, p-NETs should be surgically managed, as no benefit for adjuvant chemotherapy has been demonstrated. Parenchymal sparing resection, including both duodenum and pancreas, are safe procedures in selected patients with reduced endocrine and exocrine long-term dysfunction. When the p-NET is benign or borderline malignant, this surgical option is associated with low rates of severe postoperative morbidity and in-hospital mortality. This narrative review offers comments, tips, and tricks from reviewing the available literature on these different options in order to clarify their indications. We also sum up the overall current data on p-NETs G1 and G2 management.

Benefit of adjuvant chemotherapy in node-negative T1a versus T1b and T1c triple-negative breast cancer.

National comprehensive cancer network guidelines recommend delivery of adjuvant chemotherapy in node-negative triple-negative breast cancer (TNBC) if the tumor is > 1cm and consideration of adjuvant chemotherapy for T1b but not T1a disease. These recommendations are based upon sparse data on the role of adjuvant chemotherapy in T1a and T1b node-negative TNBC. Our objective was to clarify the benefits of chemotherapy for patients with T1N0 TNBC, stratified by tumor size. We performed a retrospective analysis of survival outcomes of TNBC patients at two academic institutions in the United States from 1999 to 2018. Primary tumor size, histology, and nodal status were based upon surgical pathology. The Kaplan-Meier plot and 5-year unadjusted survival probability were evaluated. Among 282 T1N0 TNBC cases, the status of adjuvant chemotherapy was known for 258. Mean follow-up was 5.3years. Adjuvant chemotherapy was delivered to 30.5% of T1a, 64.7% T1b, and 83.9% T1c (p < 0.0001). On multivariable analysis, factors associated with delivery of adjuvant chemotherapy were tumor size and grade 3 disease. Improved overall survival was associated with use of chemotherapy in patients with T1c disease (93.2% vs. 75.2% p = 0.008) but not T1a (100% vs. 100% p = 0.3778) or T1b (100% vs. 95.8% p = 0.2362) disease. Our data support current guidelines indicating benefit from adjuvant chemotherapy in node-negative TNBC associated with T1c tumors but excellent outcomes were observed in the cases of T1a and T1b disease, regardless of whether adjuvant chemotherapy was delivered.

Controversial benefit of 5-fluorouracil/leucovorin-based adjuvant chemotherapy for ampullary cancer: a propensity score-matched analysis.

Although surgery is the primary treatment for ampullary cancer (AC), the benefit of adjuvant chemotherapy (CTx) has not yet been confirmed. AC patients who were administered 5-fluorouracil(FU)/leucovorin(LV)-based CTx after curative intent surgery between 2011 and 2019 were included. Prognosis was compared between the observation (OB) and CTx groups after propensity score matching (PSM) using perioperative variables to control differences in patient characteristics. Before PSM, of 475 patients, those in the CTx group (n = 281) had worse 5-year overall survival (OS) (82.1% vs. 78.5%, p = 0.017) and worse 5-year recurrence-free survival (RFS) (54.9% vs. 75.7%, p < 0.001) than those in the OB group (n = 194). In addition, the CTx group had a higher rate of poor prognostic factors such as a high T stage (p < 0.001), node metastasis (p < 0.001), and poor differentiation (p < 0.001). After PSM, perioperative outcomes were comparable. In addition, there were no significant differences in OS (hazard ratio [HR], 1.085; 95% confidence interval [CI], 0.688-1.710; p = 0.726) or RFS (HR, 0.883; 95% CI, 0.613 1.272; p = 0.505) between the CTx (n = 123) and OB (n = 123) groups even after stratification by TNM stage. Intestinal subtype showed better 5-year OS (83.7% vs 33.2%, p = 0.015) and RFS (46.5% vs 24.9%, p = 0.035) rate compared with pancreatobiliary/mixed subtype. Patients who received adjuvant chemotherapy based on 5-FU/LV showed comparable oncologic outcomes to patients in the OB group even after stratification by tumor stage. The patients with intestinal subtype showed oncologic benefit for adjuvant 5-FU/LV CTx compared with pancreatobiliary or mixed subtypes.

A potential biomarker based on clinical-radiomics nomogram for predicting survival and adjuvant chemotherapy benefit in resected node-negative, early-stage lung adenocarcinoma.

BackgroundWe aimed to construct a clinical-radiomics nomogram to predict disease-free survival (DFS) and the added survival benefit of adjuvant chemotherapy (ACT) for node-negative, early-stage (I–II) lung adenocarcinoma (ADC).MethodsIn this retrospective study including 310 patients from two independent cohorts, the CT-derived radiomics features were selected by least absolute shrinkage and selection operator Cox regression to generate a radiomics signature associated with DFS. The radiomics signature was incorporated to construct a clinical-radiomics nomogram along with the independent clinical risk predictors. The model performance was evaluated with reference to discrimination quantified by Harrell concordance index (C-index), integrated discrimination improvement (IDI) and net reclassification index (NRI), calibration and clinical utility. The risk score (RS) for clinical-radiomics nomogram was calculated. The association between ACT and survival benefit was assessed in high and low RS subgroup.ResultsThe clinical-radiomics nomogram achieved the highest C-index of 0.822 [95% confidence interval (CI): 0.769, 0.876] in training cohort and 0.802 (95% CI: 0.716, 0.888) in validation cohort. The incorporation of radiomics signature into clinical-radiomics nomogram showed an incremental benefit over clinical nomogram according to the improved NRI and IDI. The calibration curves and decision curve analysis further verified the clinical utility of clinical-radiomics nomogram. Further, patients with high RS based on clinical-radiomics nomogram were more prone to benefit from ACT.ConclusionsThe clinical-radiomics nomogram approach can feasibly conduct risk prediction and have potential to identify the beneficiaries of ACT among patients with node-negative, early-stage ADC, which might serve as a helpful tool in informing therapeutic decision-making.

The Benefit of Adjuvant Chemotherapy Following Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoma Depends on Response to Neoadjuvant Therapy

Introduction: Neoadjuvant therapy (NT) is increasingly offered to patients with pancreatic ductal adenocarcinoma (PDAC). However, it’s unclear which patients benefit from additional adjuvant therapy (AT) after NT and resection.

Predicting prognosis and evaluating the benefits of adjuvant chemotherapy depending on the tumor location in intrahepatic cholangiocarcinoma: focusing on the involvement of below 2nd bile duct confluence.

PurposeIntrahepatic cholangiocarcinoma (ICC) has various characteristics according to anatomical, histologic classifications, and its prognoses are different. This study aimed to compare oncologic outcomes according to tumor location (second bile duct confluence) and evaluate the effect of adjuvant chemotherapy.MethodsClinical data of 318 patients who underwent curative resection for ICC was reviewed. Central type ICC (C-ICC) and peripheral type ICC (P-ICC) were defined when the tumor invades the intrahepatic secondary biliary confluence and when located more peripherally, respectively.ResultsA larger tumor size, higher rate of elevated CA 19-9 level, vascular invasion, R1 resection, advanced T stage, and lymph node metastasis were found in C-ICC. C-ICC had poorer overall survival (median, 33 months vs. 58 months; P = 0.001), and the difference was more prominent in the early stage. C-ICC had a higher recurrence rate (68.7% vs. 55.1%, P = 0.014); otherwise, there was no difference in the recurrence patterns. There were no survival benefits of adjuvant chemotherapy in the entire cohort, but there were benefits in advanced stages (T3–4, N1 stage), especially in C-ICC.ConclusionC-ICC has more aggressive tumor characteristics and poor survival compared to P-ICC. Adjuvant chemotherapy seems to have survival benefits in the advanced stages, especially in the central type.

Adjuvant treatment of colon cancer with microsatellite instability - the state of the art.

Adjuvant chemotherapy with fluoropyrimidine (FP) plus oxaliplatin in stage III resected colorecatal cancer (RCRC) resulted in a 30% relative reduction of disease recurrence risk and mortality. The presence of altered mismatch repair genes identify tumors with microsatellite instability (MSI) that have a better prognosis than stable tumors, but data about adjuvant chemotherapy benefit in this subgroup are compelling. We investigate the role of adjuvant therapy in resected MSI RCRC. The standard treatment is the association of FP plus oxaliplatin, while it can avoided in low risk stage II, thanks to its good prognosis. We propose a practice strategy to approach MSI RCRC in line with the current knowledge. In consideration of the dramatic results in chemorefractory MSI metastatic CRC, there are assumptions that immunotherapy can become a potential alternative to classical systemic therapies also in the adjuvant setting. We await the results of ongoing studies to draw further conclusions."

Clinicopathologic Features and Outcomes of Biliary Cystic Carcinoma

Introduction: Biliary cystadenocarcinomas are very rare cystic tumors arising in the liver that remains poorly understood. There is a paucity of data regarding biliary cystadenocarcinoma in the literature. The aim of this study is to characterize the clinicopathologic features and outcomes of these rare cancers. Methods: Patients with biliary cystadenocarcinoma were identified using a national database from 2004 to 2015. Patient demographics, tumor characteristics, treatment, and overall survival were analyzed. Results: Of the 132 patients identified with biliary cystadenocarcinoma , 53% were female and 71% were White. A total of 44.5% were treated at community hospitals while 55.4% were treated at high volume academic centers. The median age was 67 years, and 25% of patients have a history of multiple primary cancers. The median tumor size was 44mm(IQR 26-80mm) with nodal involvement in 48% and distant metastases in 18.3% of patients. Among patients with resectable disease, 28.6% underwent segmentectomy while 71.4% required major hepatectomy. No adjuvant chemotherapy in 71% of patients after surgery, while 26% were treated with multi-drug systemic chemotherapy and 10.1% were treated with single agent chemotherapy. While nonoperative management translated into a 3-year survival of 11% and 5-year survival of 4.3%, patients who underwent complete resection had a 3-year survival of 71% following segmentectomy and 61.8%.with major hepatectomy. Conclusions: While few patients have resectable disease, surgical resection of biliary cystadenocarcinoma remain the treatment of choice when feasible. Further investigation is needed to assess the benefit of adjuvant chemotherapy and/or radiation for this rare histologic subtype.

Effectiveness of oral fluoropyrimidine monotherapy as adjuvant chemotherapy for high-risk stage II colon cancer.

PurposeThe benefit of adjuvant chemotherapy for stage II colon cancer has not been clearly demonstrated even in cases with high-risk factors. This study aimed to compare the effectiveness of oral fluoropyrimidine monotherapy as adjuvant chemotherapy with that of intravenous fluoropyrimidine-based chemotherapy for high-risk stage II colon cancer.MethodsThis single-institution, retrospective study included patients who underwent curative resection for high-risk stage II colon cancer between 2003 and 2014. Patients were classified into 3 postoperative treatment groups: observation, oral fluoropyrimidine monotherapy group (OG), or intravenous fluoropyrimidine-based chemotherapy group (IVG).ResultsWe identified 356 patients, including 87 (24.4%) in the observation group, 172 (48.3%) in the OG, and 97 (27.2%) in the IVG. Patients in the OG were older (63.8 ± 10.7 vs. 56.5 ± 10.8, P < 0.001) and had a lower number of T4 lesions (12.8% vs. 35.1%, P < 0.001) than those in the IVG. Regarding survival outcomes, the 5-year overall and disease-free survival rates were not different between the OG and IVG (91.2% vs. 92.6% [P = 0.090] and 85.1% vs. 81.9% [P = 0.535], respectively). In multivariate analysis, age over 70 years and no adjuvant chemotherapy were associated with poor overall survival and disease-free survival. Fewer chemotherapy-related adverse events of grade ≥3 were observed in the OG than in the IVG (12.2% vs. 34.0%, P < 0.001).ConclusionIn high-risk stage II colon cancer, adjuvant oral fluoropyrimidine monotherapy can be an effective and convenient alternative to intravenous fluoropyrimidine-based chemotherapy as it has comparable oncological outcomes and reduced chemotherapy-related complications.

Emerging Evidence from Landmark Clinical Trials on Perioperative Immunotherapy in Resectable Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) remains one of the most prevalent cancers worldwide, with high rates of local and distant recurrence limiting survival even after curative-intent surgical resection. Traditional adjuvant chemotherapy benefits only 5% of patients, and as such additional treatment modalities are urgently needed to improve NSCLC patient outcomes. Systemic therapy with PD1 and PDL1 immune check-point inhibitors (ICIs) has emerged as a promising treatment option in many types of solid malignancies, including lung cancer. Encouraging results from immunotherapy trials in metastatic lung cancer populations, and now newer results from ongoing clinical trials in early stage locally advanced lung cancers, suggested an evolving role for perioperative immune checkpoint inhibition in resectable NSCLC. In this review we examine the latest advances in the landscape of clinical trials on immunotherapy in resectable NSCLC. We discuss the key findings and specific clinical challenges related to neoadjuvant administration of these immune therapies in the CheckMate816, Impower030, AEGEAN and KEYNOTE671 phase III clinical trials. The role of adjuvant ICI is also discussed examining the ANVIL, Impower010, and PEARLS trials. By understanding the remaining unanswered questions and clinical dilemmas that exist in this rapidly evolving field for ICIs in early stage NSCLC, clinicians may provide patients options which may markedly improve survival outcomes for this life-threatening disease.

Lymphovascular invasion in hormone-positive, human epidermal growth factor-negative, low-burden axillary disease in early breast cancer patients tested for oncotype DX recurrence score.

IntroductionThe oncotype DX recurrence score (ODX-RS) is a validated 21-gene assay that can quantify the recurrence risk and assess the likelihood of adjuvant chemotherapy benefit in breast cancer. The presence of lymphovascular invasion (LVI) in breast cancer patients is regarded as a predictor for worse prognosis. This study sought to explore the association of ODX-RS with LVI in oestrogen receptor-positive, human epidermal growth factor receptor–2-negative, low-burden nodal disease, early breast cancer.Material and methodsAfter clinical improvement unit approval, an institutional database was queried to identify the breast cancer cases diagnosed in the period between 2017–2021 that fulfilled the inclusion criteria. The total resected tumours comprised 107 in 102 patients (5 patients had bilateral disease). The data related to patients’ age and tumour grade, LVI detection, nodal status, and ODX-RS were analysed.ResultsLymphovascular invasion was identified in 32.6% of 107 tumours. In the age group > 50 years, 13 tumours had lymphovascular invasion (LVI +ve), 9 tumours had ODX-RS < 15 (69%), and only one tumour (8%) had ODX-RS ≤ 25, and this is associated with substantial chemotherapy benefit. In the age group ≤ 50 years, 21 tumours were LVI +ve, and 18 tumours had ODX-RS ≤ 25 (86%), which is associated with no chemotherapy benefit; only 3 tumours (14%) had ODX-RS > 25, and this indicated substantial chemotherapy benefit.ConclusionsThis study revealed that in the targeted patient population lympho-vascular invasion did not have a statistically significant impact on ODX-RS (p = 0.29).

Lymph Node Metastasis Location and Postoperative Adjuvant Chemotherapy in Patients With pN1 Stage IIB Non-small Cell Lung Cancer.

The benefit of adjuvant chemotherapy for patients with pN1 non-small cell lung cancer (NSCLC) according to the location of lymph node (LN) metastases remains unclear. In this study, we examined the location of LN metastasis and prognosis to identify the significance of adjuvant chemotherapy. Thirty-five patients with pathological T1a-2bN1M0 NSCLC who underwent curative resection between 2010 and 2016 were enrolled in the study. We defined patients with LN metastasis extending in stations 10-12 as the hilar group (n=22), and only in stations 13-14 as the intralobar group (n=13). There was a significant difference in the overall survival (OS) (p=0.042) and disease-free survival (DFS) rates (p=0.021) between the intralobar and hilar groups. In the intralobar group, there were no significant differences in the OS and DFS rates according to adjuvant chemotherapy. However, patients without adjuvant chemotherapy had a poorer OS (p<0.001) and DFS rates (p<0.001) in the hilar group. Prognosis significantly differed according to adjuvant chemotherapy in the hilar group.

The effect of complete surgical staging and adjuvant chemotherapy on survival in stage I, grade 1 and 2 endometrioid ovarian carcinoma

ObjectivesTo assess the effect of complete surgical staging and adjuvant chemotherapy on survival in stage I, low grade endometrioid ovarian cancer.MethodsThis retrospective study was conducted at two cancer centers from...

The clinician's perspective on the 21-gene assay in early breast cancer.

Most patients with early HR+ and HER2- breast cancer receive a hormone therapy; the clinical question still open is how to identify patients who can really benefit from adjuvant chemotherapy. The accurate identification of these patients is essential to avoid an over-treatment, increasing the risk of an unnecessary toxicity; on the contrary, the omission of chemotherapy can deprive high risk patients of a potential life-saving treatment (under-treatment). Several multigene assays (MGAs), assessing the risk of relapse according to the biological characteristics of the tumor, have been developed. To date, the 21-gene assay (Oncotype DX Breast Recurrence Score®) is the only test developed and validated to be actionable, i.e., able to predict the benefit of adjuvant chemotherapy. The different available tests can be classified according to their clinical utility based on their prognostic and predictive value. A prognostic test gives information about the outcome of the disease, regardless of the administered therapy. When the aim of the test is to drive the treatment decisions, the predictive component, and therefore the ability to accurately identify which patients could benefit from chemotherapy, is essential. This review summarizes the clinical evidences of the Oncotype DX® test supporting its clinical utility.

Debating Pros and Cons of Total Neoadjuvant Therapy in Rectal Cancer.

Simple SummaryRectal cancers represent one third of all colorectal tumours. Patients diagnosed with localised colon cancer undergo surgery upfront, likely followed by adjuvant chemotherapy. Those diagnosed with localised rectal cancer, however, frequently benefit from neoadjuvant treatments with either radiotherapy or chemoradiotherapy before undergoing surgery. On the other hand, the benefit of adjuvant chemotherapy in this setting is more controversial. The main challenges in treating patients affected by rectal cancer encompass: decreasing the risks of local relapse and distant metastases, preserving the sphincter and minimising treatment-associated functional sequelae, and improving overall survival. Some of these fuelled the concept of total neoadjuvant therapy, namely giving all available treatments including radiotherapy and systemic chemotherapy before surgery. Here, we critically review the pros and cons of such a treatment strategy, but also discuss the biological rational to support neoadjuvant treatment intensification.Recently, two large, randomised phase III clinical trials of total neoadjuvant therapy (TNT) in locally advanced rectal cancer were published (RAPIDO and PRODIGE 23). These two trials compared short-course radiotherapy (SCRT) followed by chemotherapy with standard chemoradiotherapy (CRT) and chemotherapy followed by CRT with standard CRT, respectively. They showed improvement in some of the outcomes such as distant recurrence and pathological complete response (pCR). No improvement, however, was observed in local disease control or the de-escalation of surgical procedures. Although it seems lawful to integrate TNT within the treatment algorithm of localised stage II and III rectal cancer, many questions remain unanswered, including which are the optimal criteria to identify patients who are most likely to benefit from this intensive treatment. Instead of providing a sterile summary of trial results, we put these in perspective in a pros and cons manner. Moreover, we discuss some biological aspects of rectal cancer, which may provide some insights into the current decision-making process, and represent the basis for the future development of alternative, more effective treatment strategies.

The Uncertain Benefit of Adjuvant Chemotherapy in Advanced Low-Grade Serous Ovarian Cancer and the Pivotal Role of Surgical Cytoreduction.

In our center, adjuvant chemotherapy is routinely offered in high-grade serous ovarian cancer (HGSOC) patients but less commonly as a standard treatment in low-grade serous ovarian cancer (LGSOC) patients. This study evaluates the efficacy of this paradigm by analysing survival outcomes and by comparing the influence of different clinical and surgical characteristics between women with advanced LGSOC (n = 37) and advanced HGSOC (n = 300). Multivariate analysis was used to identify independent prognostic features for survival in LGSOC and HGSOC. Adjuvant chemotherapy was given in 99.7% of HGSOC patients versus in 27% of LGSOC (p < 0.0001). The LGSOC patients had greater surgical complexity scores (p < 0.0001), more frequent postoperative ICU/HDU admissions (p = 0.0002), and higher peri-/post-operative morbidity (p < 0.0001) compared to the HGSOC patients. The 5-year OS and progression-free survival (PFS) was 30% and 13% for HGSOC versus 57% and 21.6% for LGSOC, p = 0.016 and p = 0.044, respectively. Surgical complexity (HR 5.3, 95%CI 1.2–22.8, p = 0.024) and complete cytoreduction (HR 62.4, 95% CI 6.8–567.9, p < 0.001) were independent prognostic features for OS in LGSOC. This study demonstrates no clear significant survival advantage of chemotherapy in LGSOC. It highlights the substantial survival benefit of dynamic multi-visceral surgery to achieve complete cytoreduction as the primary treatment for LGSOC patients.

21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer

BackgroundThe recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary lymph-node–negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear.MethodsIn a prospective trial, we randomly assigned women with hormone-receptor–positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease–free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse–free survival.ResultsA total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease–free survival differed according to menopausal status (P=0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. Among postmenopausal women, invasive disease–free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P=0.89). Among premenopausal women, invasive disease–free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P=0.002), with a similar increase in distant relapse–free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P=0.009). The relative chemotherapy benefit did not increase as the recurrence score increased.ConclusionsAmong premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease–free survival and distant relapse–free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.)

P-OGC35 Does Adjuvant Chemotherapy Provide Additional Survival Benefit AfterNeoadjuvant Chemotherapy or Chemoradiotherapy and Esophagectomy forEsophageal Adenocarcinoma?

Abstract Background The evidence assessing the additional benefits of adjuvant chemotherapy (AC) following neoadjuvant therapy (NAT; i.e. chemotherapy or chemoradiotherapy) and esophagectomy for esophageal adenocarcinoma (EAC) are limited. This study aimed to determine whether AC improves long-term survival in patients receiving NAT and esophagectomy. Methods Patients receiving esophagectomy for EAC following NAT from 2004 - 2016 were identified from the National Cancer Data Base (NCDB). Patients with survival &amp;lt; 6 months were excluded to account for immortality bias. Propensity score matching (PSM) and Cox regression was performed to account for selection bias and analyze impact of AC on overall survival. Results Overall 12,972 (91%) did not receive AC and 1,255 (9%) received AC. After PSM there were 2,485 who received AC and 1,254 who did not. After matching, AC was associated with improved survival (median: 38.5 vs 32.3 months, p &amp;lt; 0.001), which remained after multivariable adjustment (HR: 0.78, CI 95% : 0.71 - 0.87, p &amp;lt; 0.001). On multivariable interaction analyses, this benefit persisted in subgroup analysis for nodal status: N0 (HR: 0.85, CI 95% : 0.69 - 0.96, p = 0.039), N1 (HR: 0.66, CI 95% : 0.56 - 0.78, p &amp;lt; 0.001), N2/3 (HR: 0.80, CI 95% : 0.66 - 0.97, p = 0.024) and margin status: R0 (HR: 0.77, CI 95% : 0.69 - 0.86, p &amp;lt; 0.001), R1 (HR: 0.60, CI 95% : 0.43 - 0.85, p = 0.004). Further, patients with stable disease following NAT (HR: 0.60, CI 95% : 0.59 - 0.80, p &amp;lt; 0.001) or downstaged (HR: 0.80, CI 95% : 0.68 - 0.95, p = 0.009) disease had significant survival benefit after AC, but not patients with upstaged disease. Conclusions AC following NAT and esophagectomy is associated with improved survival, even in node-negative and margin-negative disease. NAT response appears crucial in identifying patients who will benefit maximally from AC, and thus future research must be focused on identifying tumors that respond to chemotherapy to maximize this prognostic benefit.