Docetaxel plus cisplatin and fluorouracil (DCF) chemotherapy is promising in the pre-operative setting for the treatment of patients with locally advanced resectable gastric cancer, a study published in the journal Annals of Oncology has shown.1
Although previous research has demonstrated improved survival with perioperative chemotherapy in locally advanced resectable gastric cancer, the role of neoadjuvant chemotherapy and optimal regimen remains unknown. Therefore, researchers sought to compare a neoadjuvant docetaxel-based regimen with an adjuvant one.
For the prospective, phase 3 trial, researchers enrolled 69 patients with cT3-4 any N M0 or anyT cN1-3 M0 gastric carcinoma and randomly assigned them to receive docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 300 mg/m2/day over days 1-14, either prior to gastrectomy or afterwards.
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After a median follow-up of 10 years, results showed that event-free survival was 2.5 years in both arm, and overall survival was 4.3 years in neoadjuvant arm vs 3.7 years in the adjuvant arm. There was no statistically significant difference in terms of event-free or overall survival between the 2 arms of the study. There was also a 12% complete response rate in the neoadjuvant group.
Researchers observed a higher dose-intensity of chemotherapy in the neoadjuvant arm and more frequent chemotherapy-associated serious adverse events in the adjuvant group.
Of note, the trial was closed early due to insufficient accrual after 6 years, which the investigators say could mask the real effectiveness of neoadjuvant treatment. They warn that the adjuvant chemotherapy arm could do the same.
“However, the complete pathological tumor responses, feasibility and safe surgery, warrant further investigation of a taxane-based regimen in the preoperative setting,” the investigators concluded.
Reference
- Fazio N, Biffi R, Maibach R, et al. Pre-operative versus post-operative docetaxel-cisplatin-fluorouracil (TCF) chemotherapy in locally advanced resectable gastric carcinoma: 10-year follow-up of the SAKK 43/99 phase III trial [published online ahead of print December 27, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv620.
