Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study.

PURPOSE

This phase II trial aimed to evaluate the efficacy and safety of docetaxel, cisplatin, and fluorouracil (DCF) combination in neoadjuvant setting in patients with locally advanced gastric adenocarcinoma.

METHODS

Fifty-nine patients with resectable or unresectable locally advanced gastric and gastroesophageal cancer were recruited in this multicenter, single-arm, open-label, local clinical phase II study conducted at three centers from Turkey between June 2006 and March 2012. Patients had T3-4 or lymph node-positive disease. After staging with imaging and laparotomy or laparoscopy, they received three cycles of DCF with lenograstim. Imaging studies were repeated after the last two cycles. Patients who underwent surgery were followed up for at least 1 year after the surgery. Toxicity and response were evaluated in accordance with NCI-CTC version3.0 and RECIST 1.0.

RESULTS

At baseline, 66.1 % of patients were considered resectable. In 47 patients evaluable, partial response in 16 (34.0 %), stable disease in 27 (57.5 %), and progressive disease in four (8.5 %) were observed. Forty-six patients underwent surgery. In 38 (64.4 %; 95 % confidence interval (CI) 52.2-76.6 %) out of 59 patients, complete resection (R0) was achieved. Median overall and disease-free survival were 19.1 months (95 % CI 13.5-24.7) and 11.6 months (95 % CI 5.9-17.4), respectively. The most frequent grade 3-4 adverse events were neutropenia (52.5 %), febrile neutropenia (11.9 %), leukopenia (39.0 %), and diarrhea (10.5 %). One patient died from an unknown cause.

CONCLUSIONS

Classical DCF triplet with lenograstim showed a good clinical response with acceptable safety profile in the treatment of locally advanced gastric and gastroesophageal cancer with a significant R0 rate and manageable toxicity.