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Neoadjuvant chemoradiation therapy for resectable esophago-gastric adenocarcinoma: a meta-analysis of randomized clinical trials.

ABSTRACT: The efficacy and safety of preoperative chemoradiation therapy (CRT) for advanced esophago-gastric adenocarcinoma are still in question, and the prognosis of these patients is poor.We systematically searched electronic databases from January 1990 to July 2014. The primary outcome was overall survival. The secondary outcomes were a R0 resection rate, positive rate of lymph node metastasis, postoperative recurrence rate, pathological complete response (pCR) rate and perioperative mortality. Overall survival was measured with a hazard ratio (HR), while other secondary outcomes were measured with an odds ratio (OR).Seven randomized controlled trials (RCTs) including 1085 patients were searched and, of these, 869 had adenocarcinoma. Patients receiving preoperative CRT had a longer overall survival (HR 0.74; 95% confidence interval (CI) 0.63-0.88), higher likelihood of R0 resection and greater chance of pCR, while they had a lower likelihood of lymph node metastasis and postoperative recurrence. The difference of perioperative mortality was non-significant. In addition, the result of the comparison between preoperative CRT and preoperative chemotherapy (CT) in two RCTs was non-significant.Patients with resectable esophago-gastric adenocarcinoma can gain a survival advantage from preoperative CRT. However, limited to the number of RCTs, the effect of adding radiotherapy to preoperative CT separately is still uncertain and more high-quality prospective trials are needed.

SUBMITTER: Fu T

PROVIDER: S-EPMC4415228 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Neoadjuvant Chemoradiation Treatment for Resectable Esophago-Gastric Cancer: A Systematic Review and Meta-Analysis.

Project description:Background: Neoadjuvant chemoradiation (CRT) remains controversial in the treatment of the oesophagus or gastro-oesophageal junction (GOJ) carcinomas. Methods: We conducted a meta-analysis to assess the efficacy and safety of Neoadjuvant CRT plus surgery comparing with neoadjuvant CT plus surgery or surgery alone. Feasible studies were searched from electronic databases. The outcomes of survival, R0 resection rate and adverse effects were analyzed. The outcomes were measured with relative risk (RR) and odds ratio(OR). Results: Seventeen records including 4095 patients were included. Neoadjuvant CRT improved 1-,2-,3-and 5-year survival. The relative risk (RR) [95% confidence interval (CI),P value] was respectively 1.08(1.03-1.14,0.002), 1.21(1.12-1.32,<0.00001),1.31(1.09-1.58,0.004),1.38(1.17-1.62, <0.001).In subgroup analysis, patients with squamous cell carcinoma benefited more survival advantage from neoadjuvant CRT than those with adenocarcinoma[1.23(1.15-1.33)vs1.11 (1.03-1.19)]. A significant advantage was observed in analysis of neoadjuvant CRT for PFS [1.32 (1.22-1.44),<0.00001]. Tests for DFS between neoadjuvant CRT and neoadjuvant CT or surgery alone were not statistically significant[1.06 (0.97-1.17,0.19)]. Neoadjuvant CRT was associated with higher R0 resection [2.58(1.75-3.82),<0.00001] and pCR rate [4.37(2.68-7.13),<0.00001]. Neoadjuvant CRT lowered the local recurrence rate [0.52(0.39-0.69),<0.00001] and didn't control distant metastasis rate[0.85(0.67-1.08),0.19].There was no evidence that neoadjuvant CRT increased the treatment-related mortality[1.27(0.95-1.71),0.11]. Neoadjuvant CRT plus surgery did not increase the risk of adverse events morbidity[1.14(0.99-1.32),0.08]. Conclusion: Patients with oesophagus or GOJ carcinomas can obtain a survival advantage from neoadjuvant CRT. The addition of radiation was efficacy and safe in range. However, these results need further high-quality prospective RCTs confirmation.

| S-EPMC6329872 | biostudies-other

Neoadjuvant Therapy for Resectable and Borderline Resectable Pancreatic Cancer: A Meta-Analysis of Randomized Controlled Trials.

Project description:The efficacy of neoadjuvant therapy (NT) versus surgery first (SF) for pancreatic ductal adenocarcinoma (PDAC) remains controversial. A random-effects meta-analysis of only prospective randomized controlled trials (RCTs) comparing NT versus SF for potentially resectable (PR) or borderline resectable (BR) PDAC was performed. Among six RCTs including 850 patients, 411 (48.3%) received NT and 439 (51.6%) SF. In all included trials, NT was gemcitabine-based: four using chemoradiation and two chemotherapy alone. Based on an intention-to-treat analysis, NT resulted in improved overall survival (OS) compared to SF (HR 0.73, 95% CI 0.61-0.86). This effect was independent of anatomic classification (PR: hazard ratio (HR) 0.73, 95% CI 0.59-0.91; BR: HR 0.51 95% CI 0.28-0.93) or NT type (chemoradiation: HR 0.77, 95% CI 0.61-0.98; chemotherapy alone: HR 0.68, 95% CI 0.54-0.87). Overall resection rate was similar (risk ratio (RR) 0.93, 95% CI 0.82-1.04, I2 = 39.0%) but NT increased the likelihood of a margin-negative (R0) resection (RR 1.51, 95% CI 1.18-1.93, I2 = 0%) and having negative lymph nodes (RR 2.07, 95% CI 1.47-2.91, I2 = 12.3%). In this meta-analysis of prospective RCTs, NT significantly improved OS in an intention-to-treat fashion, compared with SF for localized PDAC. Randomized controlled trials using contemporary multi-agent chemotherapy will be needed to confirm these findings and to define the optimal NT regimen.

| S-EPMC7231310 | biostudies-literature

Prognostic value of neoadjuvant therapy for resectable and borderline resectable pancreatic cancer: A meta-analysis of randomized controlled trials.

Project description:ObjectiveTo investigate the prognostic value of preoperative neoadjuvant therapy (NT) compared to upfront surgery (US) in patients with resectable and borderline resectable pancreatic cancer.MethodsPubMed, Embase, Web of Science were searched to collect randomized controlled trials on preoperative neoadjuvant therapy versus upfront surgery for resectable and borderline resectable pancreatic cancer before April 7, 2023, and data were extracted after screening according to inclusion and exclusion criteria, and HRs were obtained indirectly using enguage software; Stata 12.0 software was used for data analysis.ResultsA total of 8 randomized controlled trials (RCTs) were included in this study, comprising a total of 1058 cases, including 503 cases in the NT group and 555 cases in the US group. Using an intention-to-treat population (ITT) analysis, the results showed that neoadjuvant treatment improved the R0 resection rate (RR 2.71, 95% CI 1.59-4.62; P = 0.000; I2 = 46.20%) and overall survival (HR 0.66, 95% CI 0.54-0.82; P = 0.000; I2 = 0.00%). In the subgroup of patients with resectable pancreatic cancer, the R0 resection rate in the NT group versus the US group (RR 1.14, 95% CI 0.93-1.39; P = 0.196; I2 = 0.00%) and overall survival (HR 0.89, 95% CI 0.64-1.24; P = 0.489; I2 = 0.00%) were not statistically significant.ConclusionsPreoperative neoadjuvant treatment is of prognostic value in patients with borderline resectable pancreatic cancer, as it increases the R0 resection rate and improves overall survival compared to upfront surgery.

| S-EPMC10482298 | biostudies-literature

Neoadjuvant strategies in resectable carcinoma esophagus: a meta-analysis of randomized trials.

Project description:BackgroundThe survival benefit of neoadjuvant therapy in resectable carcinoma esophagus has been elucidated. We performed a meta-analysis in light of new studies and long-term results of past trials. The search strategy was refined to include only "neoadjuvant" so that any bias by adjuvant treatment is eliminated.MethodsA detailed search of MEDLINE, Embase, and Cochrane Library was done. Only published randomized English language trials were included. Data were categorized as neoadjuvant concurrent chemoradiation (NACRT), neoadjuvant chemotherapy (NACT), neoadjuvant radiotherapy (NART), and neoadjuvant sequential chemoradiotherapy (SCRT). Meta-analysis was done using odds ratio (OR) and 95% CI using fixed/random effects model. Heterogeneity was tested by chi-square and I2 test. Z probability calculated significant difference across subgroups. Outcomes assessed were overall survival (OS) and disease-free survival (DFS) at 3 and 5 years, respectively, mortality (30/90 day) and failures (local/systemic).ResultsTwenty-five randomized trials involving 5272 patients were included for quantitative analysis. NACRT was evaluated in 12 studies (2676 patients). Superior 3-year OS (OR = 0.68 CI 0.52-0.90, p = 0.007), 3-year DFS (OR = 0.55 CI 0.45-0.68, p = 0.00001), and 5-year DFS (OR = 0.59 CI 0.47-0.74, p = 0.00001), with lower failures (OR = 0.52 CI 0.37-0.73, p = 0.0001), were seen in favor of NACRT at the cost of increased perioperative mortality (OR = 1.79 CI 1.15-2.80, p = .01). However, 5-year OS (OR = 0.78 CI 0.60-0.1.01, p = 0.06) was not found to be significantly superior. NACT, NART, and SCRT were not found to have any benefit over surgery alone.ConclusionThis meta-analysis presents strong evidence favoring NACRT over upfront surgery. It also shows no survival advantage of neoadjuvant chemotherapy.

| S-EPMC7085863 | biostudies-literature

Neoadjuvant chemotherapy with or without radiotherapy versus upfront surgery for resectable pancreatic adenocarcinoma: a meta-analysis of randomized clinical trials.

Project description:BackgroundThe role of neoadjuvant chemotherapy (NC) in resectable pancreatic cancer (RPC) has yet to be defined. This review aims to analyze the benefit of NC in RPC compared with upfront surgery (US) in terms of overall survival (OS) and disease-free survival (DFS).Patients and methodsPubMed, CENTRAL (The Cochrane Library), and Embase were systematically reviewed until 3 November 2021. Abstract proceedings and virtual meeting presentations from the American Society of Clinical Oncology and the European Society of Medical Oncology conferences, reference articles of published clinical trials, and review articles were considered. Only randomized clinical trials (RCTs) comparing NC administration with or without radiotherapy previous with surgery (experimental arm) versus US followed by adjuvant chemotherapy with or without radiotherapy (control arm) for RPC were included.ResultsA total of 1135 studies were screened. Of these, 1117 studies were primarily excluded. Of the remaining 18 studies, 5 were excluded because of no adequate trial design for this work and 7 others had no available results. Finally, 6 trials with 469 patients with pancreatic cancer randomized to NC (n = 212) or US (n = 257) were selected. Compared with US, NC significantly improved OS [hazard ratio (HR) 0.75; 95% confidence interval (CI) 0.58-0.98; P = 0.033] and DFS (HR 0.73; 95% CI 0.59-0.89; P = 0.002). While the NC approach was not significantly associated with lower resection rate [relative risk (RR) 0.92; 95% CI 0.84-1.01; P = 0.069], the R0 resection rate was significantly higher for NC than for US (RR 1.31; 95% CI 1.13-1.52; P = 0.0004).ConclusionThis is the first meta-analysis of RCTs showing that NC improves OS for RPC compared with US followed by adjuvant therapy. Ongoing RCTs should confirm these findings with FOLFIRINOX to generalize the indication of NC.

| S-EPMC9117867 | biostudies-literature

Harnessing biomarkers of response to improve therapy selection in esophago-gastric adenocarcinoma.

Project description:Advanced esophago-gastric (OG) adenocarcinomas have a high mortality rate and new therapeutic options are urgently required. Despite recent advances in understanding the molecular characteristics of OG cancers, tumor heterogeneity poses a challenge in developing new therapeutics capable of improving patient outcomes. Consequently, chemotherapy remains the mainstay of systemic treatment, with the HER2 being the only predictive biomarker routinely targeted in clinical practice. Recent data indicate that immunotherapy will be incorporated into first-line chemotherapy, but further research is required to refine patient selection. This review will summarize the clinical strategies being evaluated to utilize our knowledge of predictive biomarkers with reference to novel therapeutics, and discuss the barriers to implementing precision oncology in OG adenocarcinoma.

| S-EPMC8265282 | biostudies-literature

A hypofractionated radiation regimen avoids the lymphopenia associated with neoadjuvant chemoradiation therapy of borderline resectable and locally advanced pancreatic adenocarcinoma.

Project description:BackgroundPreclinical studies have shown synergy between radiation therapy and immunotherapy. However, in almost all preclinical models, radiation is delivered in single doses or short courses of high doses (hypofractionated radiation). By contrast in most clinical settings, radiation is delivered as standard small daily fractions of 1.8-2 Gy to achieve total doses of 50-54 Gy (fractionated radiation). We do not yet know the optimal dose and scheduling of radiation for combination with chemotherapy and immunotherapy.MethodsTo address this, we analyzed the effect of neoadjuvant standard fractionated and hypofractionated chemoradiation on immune cells in patients with locally advanced and borderline resectable pancreatic adenocarcinoma.ResultsWe found that standard fractionated chemoradiation resulted in a significant and extended loss of lymphocytes that was not explained by a lack of homeostatic cytokines or response to cytokines. By contrast, treatment with hypofractionated radiation therapy avoided the loss of lymphocytes associated with conventional fractionation.ConclusionHypofractionated neoadjuvant chemoradiation is associated with reduced systemic loss of T cells.Trial registrationClinicalTrials.gov NCT01342224, April 21, 2011; NCT01903083, July 2, 2013.

| S-EPMC4986363 | biostudies-literature

Neoadjuvant chemoradiation with IMRT in resectable and borderline resectable pancreatic cancer.

Project description:PurposeNeoadjuvant chemoradiation is an alternative to the surgery-first approach for resectable pancreatic cancer (PDA) and represents the standard of care for borderline resectable (BLR).Materials and methodsAll patients with resectable and BLR PDA treated with neoadjuvant chemoradiation using IMRT between 1/2009 and 11/2011 were reviewed. Patients were treated to a customized CTV which included the primary mass and regional vessels.ResultsNeoadjuvant chemoradiation was completed in 69 patients (39 BLR and 30 resectable). Induction chemotherapy was used in 32 (82%) of the 39 patients with BLR disease prior to chemoXRT. All resectable patients were treated with chemoXRT alone. Following neoadjuvant treatment, 48 (70%) of the 69 patients underwent successful pancreatic resection with 47 (98%) being margin negative (RO). In 30 of the BLR patients who had arterial abutment or SMV occlusion, 19 (63%) were surgically resected and all had RO resections. The cumulative incidence of local failure at 1 and 2 years was 2% (95% CI 0-6%) and 9% (95% CI 0.6-17%) respectively. The median overall survival for all patients, patients undergoing resection, and patients without resection were 20, 26 and 11 months respectively. Sixteen (23%) of the 69 patients are alive without disease with a median follow-up of 47 months (36-60).ConclusionNeoadjuvant chemoXRT can facilitate a margin negative resection in patients with localized PCa.

| S-EPMC4530020 | biostudies-literature

Neoadjuvant chemoradiotherapy for resectable gastric cancer: A meta-analysis.

Project description:ObjectivesTo evaluate the clinical curative effects and toxicity of neoadjuvant chemoradiotherapy for resectable gastric cancer compared to those of neoadjuvant chemotherapy.MethodsA systematic review and meta-analysis of the randomized controlled trials (RCTs) of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy were performed in patients with resectable gastric cancer.ResultsSeven RCTs were included (601 patients; 302 in the neoadjuvant chemoradiotherapy group and 299 in the neoadjuvant chemotherapy group). The neoadjuvant chemoradiotherapy group had an increased number of patients with a complete response [odds ratio (OR) = 3.79, 95% confidence interval (CI): 1.68-8.54, p = 0.001] and improved objective response rate (OR = 2.78, 95% CI: 1.69-4.57, p < 0.0001), 1-year (OR = 3.51, 95% CI: 1.40-8.81, p = 0.007) and 3-year (OR = 2.14, 95% CI: 1.30-3.50, p = 0.003) survival rates, R0 resection rate (OR = 2.21, 95% CI: 1.39-3.50, p = 0.0008), and complete pathologic response (OR = 4.39, 95% CI: 1.59-12.14, p = 0.004). Regarding the incidence of adverse effects after neoadjuvant therapy, only the occurrence rate of gastrointestinal reaction in the neoadjuvant chemoradiotherapy group was higher than that in the neoadjuvant chemotherapy group (OR = 1.76, 95% CI: 1.09-2.85, p = 0.02), and there was no significant difference in other adverse effects. There was no difference in the incidence of postoperative complications between the two groups.ConclusionNeoadjuvant chemoradiotherapy for resectable gastric cancer has several advantages in terms of efficacy and safety compared to neoadjuvant chemotherapy. Therefore, neoadjuvant chemoradiotherapy has great potential as an effective therapy for resectable gastric cancers.Systematic review registrationhttps://inplasy.com/inplasy-2022-3-0164, registration number INPLASY202230164.

| S-EPMC9388908 | biostudies-literature

Neoadjuvant therapy in pancreatic adenocarcinoma: a meta-analysis of phase II trials.

Project description:BackgroundNeoadjuvant treatment has proven beneficial for many gastrointestinal (GI) malignancies, but no phase III trials have been completed examining this approach in pancreatic cancer. This meta-analysis examines the best available phase II trials using neoadjuvant treatment for resectable and borderline/unresectable pancreatic adenocarcinoma.MethodsPhase II trials were identified using a MEDLINE search, and the Cochrane Central Register of Controlled Trials from 1960 to July 2010. Patients were divided into 2 groups: Patients with initially resectable tumors (group A), and patients with borderline/unresectable tumors (group B). Primary outcome measures were rate of resection and survival. Pooled proportions and 95% confidence intervals (CIs) were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies.ResultsA total of 14 phase II clinical trials including 536 patients were analyzed. After treatment, resectability was 65.8% (95% CI, 55.4-75.6%) compared with 31.6% in group B (95% CI, 14.0-52.5%). A partial response was observed in patients with borderline/unresectable tumors; 31.8 (95% CI, 24.2-39.8%) in group B and 9.5% (95% CI, 2.9-19.4%) in group A (P = .003). Progressive disease was seen in 17.0% (95% CI, 11.9-22.7) of patients in group A versus 21.8% (95% CI, 10.1-36.5%) in group B (P = .006). Median survival in resected patients was 23 months for group A and 22 months for group B.ConclusionNeoadjuvant treatment seems to have some activity in patients with borderline/unresectable pancreatic adenocarcinoma. Nearly one third of tumors initially deemed marginal for operative intervention were able to be ultimately resected after treatment. Until more effective targeted chemotherapeutics are developed, the only group of patients with pancreatic cancer that may benefit from neoadjuvant treatment are those with locally advanced disease.

| S-EPMC3164966 | biostudies-literature

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