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Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patents’ data from large randomized controlled trials








Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patents’ data from large randomized controlled trials


Akira Tsuburaya, MD PhD


Chief of Surgery, JCHO Nihonmatsu Hospital
Research Professor, Fukushima Medical University


None, planned to be provided by Japanese Gastric Cancer Association, JGCA


None


14 September 2017


We aim to analyze clinical markers to choose the most effective additional treatment for patients who underwent curative surgery for stomach cancer.
Stomach cancer is the fourth most common cancer worldwide and the second leading cause of cancer-related deaths due to its poor prognosis overall. Guidelines recommend additional drug therapy for advanced and curatively resected tumors, mostly stage II and III, by the robust evidence from each clinical trial. Since surgical procedures and additional drugs were different among the trials, the recommendations are also different with no global standard. Recently, the West and East have collaborated to standardize cancer staging and surgical procedures to dissect lymph nodes (D2). D2 is systematic removal of lymph nodes around stomach and pancreas to prevent local and regional tumor regrowth.
The profiles (trial name: countries, published year, % D2; and treatment) of the robust clinical trials are as follows.
a) INT 0116: USA, 2001, 10%; FU and radiation   
b) MAGIC: Europe, 2006, 38%; Epirubicin, Cisplatin and FU
c) ACTS-GC: Japan, 2007, 100%; S-1
d) CLASSIC: Korea and China, 2012, 100%; Capecitabine and Oxaliplatin
e) SAMIT: Japan, 2014, 100%; UFT, S-1 and Paclitaxel
Among the three trials recruited D2 received patients; proportion of advanced disease was different. % stage III was 55% in ACTC-GC, 50% in CLASSIC, and 60% in SAMIT, respectively. The subgroup analysis in ACTS-GC suggested that treatment might have less effect in patients with stage III than in those with stage II disease, while the effects between the stages were similar in CLASSIC. In SAMIT, combined therapy was more effective than monotherapy for stage III. Since preventive drug therapy after stomach resection is highly stressful for patients, physicians have to predict the most efficient treatment for each patient. Several treatments after surgery have been accepted by health insurance in the world, but there is no guideline for treatment selection.
Since comparing treatments by a new clinical trial takes long time, it is important to identify clinical markers from finished good trials now. Considering surgical procedures, we plan to analyze the three Asian trials altogether. By using each patient background, treatment and progress; we could identify useful clinical markers for treatment selection to support patients with stomach cancer.



[{ "PostingID": 4263, "Title": "*SANOFI-MO17527/L_9570", "Description": "A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin versus Surgery Alone in Patients with Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0), and IIIb (T3N2) Gastric Adenocarcinoma

Medicine: Oxaliplatin /Capecitabine, Condition: Gastric cancer/Stomach neoplasms, Phase: 3, Clinical Study ID: MO17527/L_9570, Sponsor: Sanofi" }]

Statistical Analysis Plan


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