Editor’s Note: A previous version of this article’s title referred to doxorubicin; this was corrected to “docetaxel.”
A docetaxel based-combination may be an effective perioperative option for patients with gastric or gastro-esophageal cancer, according to the phase 2 results of a phase 2/3 study published in The Lancet Oncology.1
The 5-year survival for patients with advanced gastric tumors is about 20% in the Western world. Previous research shows that chemotherapy is an efficacious option for these patients, and for patients with gastro-esophageal cancer. For the present study (ClinicalTrials.gov Identifier: NCT01216644), researchers evaluated whether a combination of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) improves clinical outcomes over epirubicin, cisplatin, and fluorouracil (ECF) or epirubicin, cisplatin, and capecitabine (ECX).
Three hundred patients were randomized 1:1 to receive FLOT or ECF/ECX perioperative therapy; 137 from the ECF/ECX cohort and 128 from the FLOT cohort were assessable in the intention-to-treat analysis.
Twenty patients in the FLOT group achieved a complete response, versus only 9 in the ECF/ECX cohort. The same percentage (38%) of either group, however, had minimal or no response at all.
Of the 111 patients in the ECF/ECX cohort and 119 of the FLOT cohort included in the per-protocol analysis, 40% and 25% had at least 1 adverse event involving a “perioperative morbidity,” respectively.
Although there was not an even spread between the groups of patients with gastric and gastro-esophageal cancers, the authors conclude that FLOT should be an internationally standard option for patients with resectable cancer of either variety.
Phase 3 results of this study are forthcoming.
- Al-Batran SE, Hofheinz RD, Pauligk C, et al. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial. Lancet Oncol. 2016 Oct 21. doi: 10.1016/S1470-2045(16)30531-9 [Epub ahead of print]