ESOPEC: prospective randomized controlled multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (NCT02509286)

Hoeppner, Jens; Lordick, Florian; Brunner, Thomas; Glatz, Torben; Bronsert, Peter; Röthling, N.; Schmoor, Claudia; Lorenz, D.; Ell, Christian; Hopt, Ulrich T.; Siewert, J. R.

doi:10.1186/s12885-016-2564-y

Cited by 252 publications

(219 citation statements)

References 20 publications

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“…Therefore, further studies are certainly needed to assess the potential clinical relevance of the different CTC detection technologies in EC. With this goal, the immunomagnetic CellSearch method and the epithelial marker-independent ISET method are currently being compared in a multicenter clinical trial of multimodal treatment of non-metastasized EAC in more than 400 patients [40].…”

Section: Ctc In Ecmentioning

confidence: 99%

Circulating Tumor Cells in Esophageal Cancer

Hoeppner¹,

Kulemann

2017

Oncol Res Treat

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Esophageal cancer (EC) is mostly diagnosed due to clinical symptoms such as dysphagia or anemia. Depending on the staging and the histological subtype, squamous cell carcinoma or adenocarcinoma, patients with non-metastasized disease mostly undergo neoadjuvant chemoradiation or perioperative chemotherapy followed by esophageal resection. Nearly 50% of the curatively treated patients develop distant metastasis within 5 years, although no metastases were clinically evident at time of treatment. More recently, the concept of circulating tumor cells (CTC) has also been introduced for EC. CTC are thought to be the means of systemic tumor spread, with the ability to set up metastases in distant organs. Much effort has been made to capture, enrich and detect these very rare cells from the blood stream of EC patients. CTC have been found to be independent risk factors for worse prognosis in patients with EC. Pre- and intra-therapeutic CTC enrichment and detection has the potential to improve preoperative staging, and provide a differential indication for neoadjuvant therapeutic modality and an indication for adjuvant therapy.

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Section: Ctc In Ecmentioning

confidence: 99%

Circulating Tumor Cells in Esophageal Cancer

Hoeppner¹,

Kulemann

2017

Oncol Res Treat

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“…Again, similar to neo-AEGIS, it includes all junctional tumors including AEG type III. The trial, activated in March 2016,aims to recruit 438 participants with adenocarcinoma of the lower esophagus or junction (stage Ib -IIIc) with the primary end point being overall survival at 36 months (22). In contrast to neo-AEGIS, the power calculation is based on the FLOT arm being superior, with 3-year survival of 68% based on published and unpublished experience, compared with 55% for the published CROSS trial (23).…”

Section: Key Current Questions and Active Trialsmentioning

confidence: 99%

Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials

Donohoe¹,

Reynolds²

2017

J. Thorac. Dis.

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Recent trials, including CROSS, MAGIC, ACCORD, and OEO2, have established neoadjuvant therapy as standard of care for locally advanced (cT 2-3 N any M 0 ) esophageal and junctional cancer compared with surgery alone. The CROSS trial in particular defines a new benchmark for outcomes from multimodal therapy, with a 5 year survival rate of 47% , a median survival of 47 months, a pathologic complete response rate (pCR) of 29% and an R0 resection rate of 92%. Several key questions remain, in particular whether CROSS-regimen chemoradiotherapy is superior to neoadjuvant chemotherapy alone for esophageal cancer, in particular adenocarcinoma. Second, with respect to neoadjuvant chemoradiation, whether an apparent complete clinical response can justify a "watch and wait" surveillance policy, with salvage surgery reserved for where relapse occurs. Third, whether with modern staging, predicted node negative cT2 tumors merit neoadjuvant therapy as standard. Finally, with the enormous interest in the application of targeted and immune-based therapies, and positive leads from other cancers, whether such approaches can improve outcomes in patients undergoing treatment with curative intent. We review herein a brief overview of the existing evidence-base and current active trials addressing these key questions.

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“…The Neo-AEGIS trial (23) will randomize 366 patients with adenocarcinoma of the GEJ and esophagus to the MAGIC regimen followed by surgery or the CROSS protocol. The ESOPEC trial (24) will randomize 438 patients with adenocarcinoma of the esophagus to either the previously mentioned FLOT regimen followed by surgery or the CROSS protocol. Finally the NExT trial (JCOG 1109), a 3-arm phase II trial (25), will randomize over 500 patients with squamous cell cancer to either of two chemotherapy regimens (Cis/ FU or DCF) followed by surgery or chemoradiation followed by surgery.…”

Section: Future Directionsmentioning

confidence: 99%

What is the role of neoadjuvant chemotherapy, radiation, and adjuvant treatment in resectable esophageal cancer?

Altorki

Harrison

2017

Ann. Cardiothorac. Surg.

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The majority of patients with operable esophageal cancers present with locally advanced disease, for which surgical resection as a sole treatment modality has been historically associated with poor survival. Even following radical resection, most of these patients will eventually succumb to their disease due to distant metastasis. For this reason, there has been intense interest in the role of neoadjuvant therapy. Neoadjuvant therapy primarily consists of either chemotherapy, radiation therapy, or a combination of the two. Multiple studies of variable scope, design, and patient characteristics have been conducted to determine whether neoadjuvant therapy is warranted, and-if so-what is the best modality of treatment. Despite nearly three decades of study, decisions regarding neoadjuvant therapy for esophageal cancer remain controversial.Regardless, the available evidence provided by large, prospective studies supports preoperative chemotherapy as opposed to surgery alone. Therefore, in our opinion, there is no longer any question as to whether induction therapy is appropriate for locally advanced esophageal cancer. Less clear, however, is the evidence that the addition of radiation to chemotherapy in the preoperative setting is superior to neoadjuvant chemotherapy alone. Our group generally advocates for neoadjuvant chemotherapy alone followed by radical esophageal resection. The data for adjuvant therapy are soft, and particularly troubling is the high rate of treatment drop out in trials studying adjuvant therapy. Therefore, we strongly prefer neoadjuvant chemotherapy and reserve adjuvant chemotherapy for those rare, highly selected patients-patients with T1tumors, for example-who do not receive neoadjuvant treatment and are found to have occult nodal disease at the time of surgery.

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ESOPEC: prospective randomized controlled multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (NCT02509286)

Cited by 252 publications

References 20 publications

Circulating Tumor Cells in Esophageal Cancer

Circulating Tumor Cells in Esophageal Cancer

Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials

What is the role of neoadjuvant chemotherapy, radiation, and adjuvant treatment in resectable esophageal cancer?

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