NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors

Schulz C, Kullmann F, Kunzmann V, Fuchs M, Geissler M, Vehling-Kaiser U, Stauder H, Wein A, Al-Batran SE, Kubin T, Schaefer C, Stintzing S, Giessen C, Modest DP, Ridwelski K, Heinemann V (2015)

Publication Type: Journal article

Publication year: 2015

Journal

International Journal of Cancer Wiley-Blackwell

Book Volume: 137

Pages Range: 678-85

Journal Issue: 3

DOI: 10.1002/ijc.29403

Abstract

Perioperative treatment is a standard of care in locally advanced gastroesophageal cancer (GEC) (gastric adenocarcinoma and gastroesophageal junction (GEJ) adenocarcinoma). While preoperative treatment can be applied to the majority of patients, postoperative chemotherapy can be given only to a fraction. The NeoFLOT-study therefore investigates the application of prolonged neoadjuvant chemotherapy (NACT). Patients with T3, T4, and/or node-positive adenocarcinoma (GEC) were eligible for this multicenter phase II trial. NACT consisted of 6 cycles of oxaliplatin 85 mg/m(2) , leucovorin 200 mg/m(2) , 5-fluorouracil 2600 mg/m(2) and docetaxel 50 mg/m(2) (FLOT) applied q 2 wks. Application of adjuvant chemotherapy was explicitly not part of the protocol. R0-resection rate was evaluated as a primary endpoint. Of 59 enrolled patients, 50 patients underwent surgery and were assessable for the primary endpoint. R0-resection rate was 86.0% (43/50). Pathologic complete response (pCR) was 20.0% (10/50) and a further 20% (10/50) of patients achieved near complete histological remission (<10% residual tumor). Among these very good responders, 85% (17/20) had intestinal type tumors, 10% (2/20) had diffuse and 5% (1/20) had mixed type tumors. After 3 cycles of NACT, 6.9% (4/58) of patients developed progressive disease. Median disease-free survival was 32.9 months. The 1-year survival-rate was 79.3%. Grade 3-4 toxicities included neutropenia 29.3%, febrile neutropenia 1.7%, diarrhea 12.1% and mucositis 6.9%. This study indicates that intensified NACT with 6 cycles of FLOT is highly effective and tolerable in resectable GEC. Very good response (pCR and <10% residual tumor) was predominantly observed in patients with intestinal type tumors.

Authors with CRIS profile

Axel Wein Medizinische Fakultät

Involved external institutions

Krankenhaus Nordwest DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) Universitätsklinikum Magdeburg A.ö.R. DE Germany (DE) Kliniken des Landkreises Neumarkt i.d.OPf. DE Germany (DE) Kliniken Südostbayern AG DE Germany (DE) Krankenhaus Barmherzige Brüder DE Germany (DE) Onkozentrum Landshut DE Germany (DE) Städtische Kliniken Esslingen DE Germany (DE) Städtisches Klinikum München DE Germany (DE) Julius-Maximilians-Universität Würzburg DE Germany (DE) Kliniken Nordoberpfalz DE Germany (DE)

How to cite

APA:

Schulz, C., Kullmann, F., Kunzmann, V., Fuchs, M., Geissler, M., Vehling-Kaiser, U.,... Heinemann, V. (2015). NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors. International Journal of Cancer, 137(3), 678-85. https://dx.doi.org/10.1002/ijc.29403

MLA:

Schulz, Christoph, et al. "NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors." International Journal of Cancer 137.3 (2015): 678-85.

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