To date, there is no consensus regarding first-line chemotherapy for patients with HER2-negative, locally advanced/metastatic gastric cancer (a/m GC). In the present study we reported a retrospective case-series of patients treated with a weekly regimen containing timed-flat infusion of 5-fluorouracil (TFI/5-FU), docetaxel and oxaliplatin. From June 2007 to July 2017, 32 consecutive a/m GC patients were treated with first-line standard (st) or modulated (mod) ‘FD/FOx’ regimen: Weekly 12 h (from 10.00 p.m. to 10.00 a.m.) TFI/5-FU for two consecutive nights at 900 mg/m2/day, associated to weekly alternating docetaxel, 50 mg/m2 and oxaliplatin, 80 mg/m2. The median age of the patients was 60 years and their Eastern Cooperative Oncology Group-performance status (ECOG-PS) was as follows: i) ECOG-PS 0/1, (n=28, 87.5%); and ii) ECOG-PS 2 (n=4, 12.5%). Patient activity, efficacy and safety data were collected and subgroup analyses were conducted among patients treated with st and mod FD/FOx. In the intention-to-treat (ITT) analysis, the objective response rate (ORR) was 75% (95% CI, 53-90) and the disease control rate (DCR) was 87.5% (95% CI, 67.6-97.3). After a median follow-up of 16 months, median progression-free survival (PFS) and median overall survival (OS) were 14.0 and 19.0 months, respectively. The received dose-intensities were ~80% of the standard doses for each agent. The most relevant treatment-related grade 3 adverse events were: Neutropenia (40.6%), asthenia (18.7%) and diarrhea (18.7%). The only treatment-related grade 4 adverse event was neutropenia (9.3%). No febrile neutropenia was observed and none of the patients died as a result of adverse events. FD/FOx regimen appeared to be a feasible option as a first-line treatment of a/m GC patients, especially in case of high-tumor burden, with the need of rapid tumor shrinkage and disease-related symptoms palliation.
Timed-flat infusion of 5-fluorouracil with docetaxel and oxaliplatin as first-line treatment of gastroesophageal adenocarcinoma: A single institution experience with the FD/FOx regimen / Cortellini, A.; Cannita, K.; Parisi, A.; Venditti, O.; Baldi, P. L.; De Berardis, B.; Vicentini, R.; Vicentini, V.; Verna, L.; Porzio, G.; Ficorella, C.. - In: ONCOLOGY REPORTS. - ISSN 1021-335X. - 40:2(2018), pp. 803-812. [10.3892/or.2018.6475]
Timed-flat infusion of 5-fluorouracil with docetaxel and oxaliplatin as first-line treatment of gastroesophageal adenocarcinoma: A single institution experience with the FD/FOx regimen
Parisi A.;
2018-01-01
Abstract
To date, there is no consensus regarding first-line chemotherapy for patients with HER2-negative, locally advanced/metastatic gastric cancer (a/m GC). In the present study we reported a retrospective case-series of patients treated with a weekly regimen containing timed-flat infusion of 5-fluorouracil (TFI/5-FU), docetaxel and oxaliplatin. From June 2007 to July 2017, 32 consecutive a/m GC patients were treated with first-line standard (st) or modulated (mod) ‘FD/FOx’ regimen: Weekly 12 h (from 10.00 p.m. to 10.00 a.m.) TFI/5-FU for two consecutive nights at 900 mg/m2/day, associated to weekly alternating docetaxel, 50 mg/m2 and oxaliplatin, 80 mg/m2. The median age of the patients was 60 years and their Eastern Cooperative Oncology Group-performance status (ECOG-PS) was as follows: i) ECOG-PS 0/1, (n=28, 87.5%); and ii) ECOG-PS 2 (n=4, 12.5%). Patient activity, efficacy and safety data were collected and subgroup analyses were conducted among patients treated with st and mod FD/FOx. In the intention-to-treat (ITT) analysis, the objective response rate (ORR) was 75% (95% CI, 53-90) and the disease control rate (DCR) was 87.5% (95% CI, 67.6-97.3). After a median follow-up of 16 months, median progression-free survival (PFS) and median overall survival (OS) were 14.0 and 19.0 months, respectively. The received dose-intensities were ~80% of the standard doses for each agent. The most relevant treatment-related grade 3 adverse events were: Neutropenia (40.6%), asthenia (18.7%) and diarrhea (18.7%). The only treatment-related grade 4 adverse event was neutropenia (9.3%). No febrile neutropenia was observed and none of the patients died as a result of adverse events. FD/FOx regimen appeared to be a feasible option as a first-line treatment of a/m GC patients, especially in case of high-tumor burden, with the need of rapid tumor shrinkage and disease-related symptoms palliation.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
