Dataset Information

Post-Neoadjuvant Surveillance and Surgery as Needed Compared with Post-Neoadjuvant Surgery on Principle in Multimodal Treatment for Esophageal Cancer: A Scoping Review.

ABSTRACT:

Background

A substantial fraction of patients with esophageal cancer show post-neoadjuvant pathological complete response (pCR). Principal esophagectomy after neoadjuvant treatment is the standard of care for all patients, although surveillance and surgery as needed in case of local recurrence may be a treatment alternative for patients with complete response (CR).

Methods

We performed a scoping review to describe key characteristics of relevant clinical studies including adults with non-metastatic esophageal cancer receiving multimodal treatment. Until September 2020, relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library, Science Direct, ClinicalTrials, the German study register, and the WHO registry platform.

Results

In total, three completed randomized controlled trials (RCTs, with 468 participants), three planned/ongoing RCTs (with a planned sample size of 752 participants), one non-randomized controlled study (NRS, with 53 participants), ten retrospective cohort studies (with 2228 participants), and one survey on patients' preferences (with 100 participants) were identified. All studies applied neoadjuvant chemoradiation protocols. None of the studies examined neoadjuvant chemotherapeutic protocols. Studies investigated patient populations with esophageal squamous cell carcinoma, adenocarcinoma, and mixed cohorts. Important outcomes reported were overall, disease-free and local recurrence-free survival. Limitations of the currently available study pool include heterogeneous chemoradiation protocols, a lack of modern neoadjuvant treatment protocols in RCTs, short follow-up times, the use of heterogeneous diagnostic methods, and different definitions of clinical CR.

Conclusion

Although post-neoadjuvant surveillance and surgery as needed compared with post-neoadjuvant surgery on principle has been investigated within different study designs, the currently available results are based on a wide variation of diagnostic tools to identify patients with pCR, short follow-up times, small sample sizes, and variations in therapeutic procedures. A thoroughly planned RCT considering the limitations in the currently available literature will be of great importance to provide patients with CR with the best and less harmful treatment.

SUBMITTER: Hipp J

PROVIDER: S-EPMC7865772 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Post-Neoadjuvant Surveillance and Surgery as Needed Compared with Post-Neoadjuvant Surgery on Principle in Multimodal Treatment for Esophageal Cancer: A Scoping Review.

Hipp Julian J Nagavci Blin B Schmoor Claudia C Meerpohl Joerg J Hoeppner Jens J Schmucker Christine C

Cancers 20210123 3

<h4>Background</h4>A substantial fraction of patients with esophageal cancer show post-neoadjuvant pathological complete response (pCR). Principal esophagectomy after neoadjuvant treatment is the standard of care for all patients, although surveillance and surgery as needed in case of local recurrence may be a treatment alternative for patients with complete response (CR).<h4>Methods</h4>We performed a scoping review to describe key characteristics of relevant clinical studies including adults w ...[more]

PMID: 33561090

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Project description:IntroductionIn current medical practice of curative treatment for non-metastatic oesophageal cancer, surgery on principle is carried out by oesophagectomy after neoadjuvant treatment. However, oesophagectomy is often associated with postoperative morbidity and mortality. Taking into account that modern neoadjuvant therapy is effective and many of patients show no vital tumour cells in the operative specimens, we aim to perform a scoping review as part of the development phase for a prospectively planned multicentre randomised controlled trial investigating 'surgery as needed vs surgery on principle in patients with postneoadjuvant complete response of oesophageal cancer' (Prospective trial registration number DRKS00022801). This scoping approach will allow us to finally define and/or adapt the research question including the design and methodology of the randomised controlled trial taking into account the findings for example, research gaps and/or pitfalls in the currently available study pool addressing this or very similar questions.Methods and analysisTo identify relevant research, we will conduct searches in the electronic databases Medline, Web of Science Core Collection, Cochrane Library and Science Direct. We will also check references of relevant studies and perform a cited reference research (forward citation tracking). Titles and abstracts of the records identified by the searches will be screened and full texts of all potentially relevant articles will be obtained. We will consider randomised trials and non-randomised controlled studies. Data extraction tables will be set up, including study and patients' characteristics, aim of study and reported outcomes. We will summarise the data using tables and figures (eg, bubble plots) to present the research landscape and to describe potential clusters and/or gaps to support the planning of a randomised trial in this patient population.Ethics and disseminationEthical approval is not required for this scoping review. Study findings will be shared by publication in a peer-reviewed journal and by presentation to key stakeholders on scientific meetings.

Project description:BackgroundNeoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy is a standard treatment for potentially curable esophageal cancer. Active surveillance in patients with a clinically complete response (cCR) 12 weeks after nCRT is regarded as possible alternative to standard surgery. The aim of this study is to monitor the safety, adherence and effectiveness of active surveillance in patients outside a randomized trial.MethodsThis nationwide prospective cohort study aims to accrue operable patients with non-metastatic histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or esophagogastric junction. Patients receive nCRT and response evaluation consists of upper endoscopy with bite-on-bite biopsies, endoscopic ultrasonography plus fine-needle aspiration of suspicious lymph nodes and 18F-fluorodeoxyglucose positron emission tomography/computed tomography scan. When residue or regrowth of tumor in the absence of distant metastases is detected, surgical resection is advised. Patients with cCR after nCRT are suitable to undergo active surveillance. Patients can consult an independent physician or psychologist to support decision-making. Primary endpoint is the number and severity of adverse events in patients with cCR undergoing active surveillance, defined as complications from response evaluations, delayed surgery and the development of distant metastases. Secondary endpoints include timing and quality of diagnostic modalities, overall survival, progression-free survival, fear of cancer recurrence and decisional regret.DiscussionActive surveillance after nCRT may be an alternative to standard surgery in patients with esophageal cancer. Similar to organ-sparing approaches applied in other cancer types, the safety and efficacy of active surveillance needs monitoring before data from randomized trials are available.Trial registrationThe SANO-2 study has been registered at ClinicalTrials.gov as NCT04886635 (May 14, 2021) - Retrospectively registered.

Project description:ObjectiveThe optimal treatment for resectable esophageal squamous cell carcinoma (ESCC) remains controversial. Surgery is the primary treatment but with poor results. Attempts to improve patient survival have been made by introducing chemotherapy, radiotherapy, or both. However, randomized comparisons for all these strategies are not always available. This network meta-analysis compared the overall survival of neoadjuvant and adjuvant therapy with surgery alone to identify the most effective approach.MethodsWe systematically searched electronic databases (PubMed, Embase, and Cochrane Library) for relevant studies published before April 2021. Only phase II and III randomized controlled trials comparing the following treatments were included: surgery alone, neoadjuvant chemotherapy (NCT), radiotherapy (NRT) or chemoradiotherapy (NCRT), adjuvant chemotherapy (ACT), radiotherapy (ART), or chemoradiotherapy (ACRT). The hazard ratios (HR) and 95% confidence intervals (CIs) of overall survival (OS) was identified as the measurement of effectiveness. A network meta-analysis was conducted to synthesize the evidence under the Bayesian framework, and the relative effects of all possible comparisons were made. The ranking analysis was performed to support the decision in clinical practice.ResultsA total of 19 relevant trials with 3,749 patients were identified. Compared with surgery alone, NCRT (HR 0.76, 95% CI 0.65-0.89) and NCT (HR 0.81, 95% CI 0.70-0.94) significantly improved OS, while other treatments, including NRT (HR 0.86, 95% CI 0.66-1.08), ACRT (HR 0.73, 95% CI 0.49-1.08), ACT (HR 0.96, 95% CI 0.75-1.21), and ART (HR 0.86, 95% CI 0.66-1.14), provided no significant survival advantage. None of the neoadjuvant and adjuvant treatments showed a statistically significant difference in OS to each other when compared in pairs.ConclusionFor resectable esophageal squamous cell carcinoma, this network meta-analysis showed that NCRT may be the optimal strategy, NCT may be the second choice, while other multimodality treatments could not improve OS compared with surgery alone. It remains unclear whether ESCC will benefit from adding radiotherapy into the neoadjuvant treatment.Systematic review registrationWe registered this meta-analysis protocol at the prospective register of systematic reviews, PROSPERO https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=172745 (Identification code: CRD42020172745).

Dataset Information

Post-Neoadjuvant Surveillance and Surgery as Needed Compared with Post-Neoadjuvant Surgery on Principle in Multimodal Treatment for Esophageal Cancer: A Scoping Review.

Background

Methods

Results

Conclusion

Publications

Post-Neoadjuvant Surveillance and Surgery as Needed Compared with Post-Neoadjuvant Surgery on Principle in Multimodal Treatment for Esophageal Cancer: A Scoping Review.

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