The optimum combination curative approach to locally advanced GEJ/EAC is unknown. A key question is whether neoadjuvant multimodal therapy, specifically the CROSS regimen (i.e. carboplatin/paclitaxel, 41.4 Gy radiation therapy), is superior to optimum perioperative chemotherapeutic regimens including modified MAGIC (i.e. epirubicin, cisplatin [oxaliplatin], 5-FU [capecitabine]) and more recently FLOT (i.e. docetaxel, 5-FU, leucovorin, oxaliplatin).
The Neo-AEGIS trial (NCT01726452) is the first randomised controlled trial designed to address this question. At 24 European sites, 377 patients with cT2-3N0-3M0 EAC or GEJ were randomly assigned to CROSS or perioperative chemotherapy. The primary outcome was overall survival. The initial power calculation was based on CROSS superiority of 10%. After the first futility analysis (70 events), this was modified to a non-inferiority margin of 5%. Secondary endpoints included toxicity, pathologic measures of response, and postoperative complications. Prof. John Reynolds (Trinity St James Cancer Institute, Ireland) presented the results of the second futility analysis [1].
A total of 362 patients were evaluated; 178 receiving CROSS, 184 receiving MAGIC/FLOT (157/27), 90% male, median age 64 years, 84% cT3, and 58% cN1. At a median follow-up of 24.5 months, 143 deaths occurred (70 in the CROSS and 73 in the MAGIC/FLOT arm). The second futility analysis (60% of planned events) showed a 3-year estimated survival probability of 56% in the CROSS arm and 57% in the MAGIC/FLOT arm (HR 1.02; 95% CI 0.74–1.42). Markers of response (pathologic complete response, major pathologic response, R0 rate, and nodal downstaging) were significantly better in the CROSS arm. Neutropenia, diarrhoea, and vomiting were significantly increased in the chemotherapy arm compared with CROSS. However, there were no differences in toxic deaths, neutropenic sepsis, or pulmonary embolism. Based on the absence of futility, evidenced recruitment was closed in December 2020.
- Reynolds JV, et al. Neo-AEGIS (Neoadjuvant trial in Adenocarcinoma of the Esophagus and Esophago-Gastric Junction International Study): Preliminary results of phase III RCT of CROSS versus perioperative chemotherapy (Modified MAGIC or FLOT protocol). Abstract 4004, ASCO 2021 Virtual Meeting, 4–8 June.
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Table of Contents: ASCO 2021
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Breast Cancer
Excellent prognosis for breast cancer patients with ultra-low-risk gene signature
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Platinum-based adjuvant chemotherapy in TNBC is not superior or non-inferior to capecitabine
Dalpiciclib benefits patients with HR-positive, HER2-negative advanced breast cancer
Trastuzumab-deruxtecan showed clinical activity in patients with brain metastases
Lung Cancer
Neoadjuvant nivolumab plus chemotherapy improves surgical outcomes in NSCLC
Immune-related adverse events are associated with efficacy of atezolizumab in patients with advanced NSCLC
Sustained efficacy of nivolumab/ipilimumab plus 2 cycles of chemotherapy in NSCLC
Patritumab deruxtecan (HER3-DXd) in EGFR TKI-resistant NSCLC
Melanoma
Long-term results from ground-breaking melanoma trials
Novel dual checkpoint blockade improves progression-free survival in melanoma
Neoadjuvant therapy with nivolumab plus relatlimab is safe and effective in patients with stage III melanoma
Genitourinary Cancers
VISION trial shows improved survival with 177Lu-PSMA-617 in mCRPC
Abiraterone added to ADT + docetaxel nearly doubles survival in de novo mCSPC
Post-nephrectomy pembrolizumab improves disease-free survival
Glutaminase inhibitor telaglenastat does not improve survival mRCC
Promising efficacy and safety of feladilimab in recurrent/metastatic urothelial carcinoma
Gastrointestinal Cancers
Pembrolizumab benefits survival in MSI-H/dMMR metastastic colorectal cancer
Panitumumab added to 5-FU/LV effective as maintenance therapy in patients with mCRC
Trastuzumab-deruxtecan showed promising activity in patients with HER2-expressing mCRC
Benefit of both I-O/chemo combo and I-O/I-O combo over chemotherapy alone in oesophageal squamous cell cancer
Benefit of I-O/chemo combo over chemotherapy alone in advanced GC/GEJC/EAC
Perioperative chemotherapy and neoadjuvant multimodality therapy appear equally effective
Haematological Cancers
Olutasidenib demonstrates efficacy in patients with relapsed/refractory IDH1 mutant AML
Acalabrutinib as effective but better tolerated than ibrutinib in CLL
Gynaecological Cancers
Adjuvant chemotherapy does not improve outcome in patients with locally advanced cervical cancer
Novel drug combination for recurrent ovarian cancer
Dual HER2-blockade shows anti-tumour activity in patients with uterine cancer
Paediatric Cancer
Molecular tumour profiling impacts the diagnosis and treatment of solid tumours
Circulating tumour DNA to evaluate response in children with neuroblastoma
Basic Science
PARP7 inhibitor shows promising results in first-in-human trial
IACS-6274 is well tolerated and biologically active in selected advanced tumours
CYT-0851 shows promising anti-tumour activity across different tumour types
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