In patients with limited metastatic cancer of the stomach or oesophago gastric junction, neoadjuvant chemo therapy followed by surgery yields a significant survival benefit, according to new research. In a phase 2 trial, Salah-Eddin AlBatran (Institute of Clinical Cancer Research, Frankfurt, Germany) and colleagues assessed the effectiveness and feasibility of neoadjuvant fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy followed by surgery in 252 patients with metastatic or resectable gastric or gastro-oesophageal junction adeno carcinoma. After preoperative staging, the patients were divided into three groups: arm A (patients with resectable cancer [n=51], assigned to receive four preoperative FLOT cycles followed by surgery and four postoperative FLOT cycles); arm B (limited metastatic disease [n=60], prescribed at least four
neoadjuvant FLOT cycles, followed by surgery if restaging on CT or MRI suggested a chance of R0 tumour resection and at least complete resection of metastatic lesions); and arm C (extensive metastatic disease [n=127], prescribed FLOT, followed by surgery, only if needed for palliative care). 238 (94%) of 252 patients were eligible for the efficacy analysis. Median overall survival (the primary endpoint) was higher in arm B (22·9 months [95% CI 16·5–not reached]) than in arm C (10·7 months [9·1–12·8]; hazard ratio 0·37 [95% CI 0·25–0·55]; p<0·001). Surgery after FLOT was done in 36 (60%) of 60 patients in arm B; median overall survival in patients who had surgery was 31·3 months (95% CI 18·9–not reached) compared with 15·9 months (7·1–22·9) for those who did not undergo surgery. Al-Batran said, “We started a randomised phase 3 trial for defin
itive proof of the concept. I strongly recommend to apply such an approach in clinical trials only at this stage.” Oliver Waidmann (University Hospital Frankfurt, Frankfurt Germany) commented, “This is an important proof of principle trial showing that surgery following inten sified chemotherapy with FLOT in patients with limited metastatic adenocarcinoma of the stomach or esophagogastric junction might improve prognosis, especially in patients responding to chemotherapy.” Georg-Martin Haag (University Hospital Heidelberg, Heidelberg, Germany) commented, “An ongoing randomised phase 3 trial (FLOT 5) will define the role of surgery after systemic chemotherapy in oligometastatic (limited number of metastatic lesions) gastric cancer”.
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Neoadjuvant chemotherapy: survival benefit in gastric cancer
Lancet Oncol 2017 Published Online May 5, 2017 http://dx.doi.org/10.1016/ S1470-2045(17)30321-2 For the study by Al-Batran and colleagues see JAMA Oncol 2017; published online April 27. DOI:10.1001/ jamaoncol.2017.0515
www.thelancet.com/oncology Published online May 5, 2017 http://dx.doi.org/10.1016/S1470-2045(17)30321-2