Efficacy and safety of dose-dense taxotere cisplatin fluorouracil regimen (mTCF-dd) in a large cohort of patients (pts) with metastatic or locally advanced non-squamous gastroesophageal cancer (GEC)

Background

TCF is one of the most effective first-line options in metastatic GEC. We previously reported the significant activity of mTCF-dd (Tomasello G et al: Gastric Cancer 2014 Oct;17(4):711-7). Aim of this study is to describe clinical outcomes, safety and studying potential clinical prognostic factors of this intensified regimen in a very large consecutive cohort of pts coming from a single center

Methods

201 consecutive pts with measurable or evaluable GEC treated in the same

institution were longitudinally followed. 136 were enrolled in 3 different Clinical Trials and 65 treated according to clinical practice. We considered pts with PS ECOG 0-2 and adequate organ function who received from 2004 to 2015 mTCF-dd: Docetaxel (50-85 mg/m2 d 1), Cisplatin (50-75 mg/m2 d 1),l-Folinic Acid (100 mg/m2 d 1-2), 5-FU (400 mg/m2 bolus d 1-2, and 600 mg/m2 as a 44 h c.i. d 1), plus Pegfilgrastim 6 mg d 3, q2w. Analysis was done according to ITT principle.

Results

Median age was 63 (range 25-81), M:F 140:51. Metastatic sites were: liver 38%, peritoneum 33.5%, bone 14%, lung 12%. A median of 4 cycles (range 1-8) per patient were administered: 15% required a dose reduction, 48% were treated without any delay. At a median follow up of 60 months, 192 pts were evaluable. We observed 6% CR, 52% PR, 14% SD, 13% PD and 13% NE, for an ORR of 59% (95% CI 52-66); DCR was 76%. Median OS was 11.1 months (95% CI 9.5-13.5). Most frequent grade 3/4 toxicities: neutropenia (26%), asthenia (31%), thrombocytopenia (17%), hypokalemia (16%), diarrhea (13%), febrile neutropenia (11%). 18 pts (9%) became resectable after mTCF-dd and underwent surgery. Finally, we identified 18 pts (9%) [12 metastatic, 6 locally advanced] with OS > 3 years and 7 (4%) still maintaining a response at the time of the current analysis.Moreover, we identifued a specific cohort of 21 pts with bone metastases at diagnosis bearing a very poor prognosis (OS: 7.8 m 95% CI 3.8-10 ). A multivariate Cox model will be presented at the meeting.

Conclusions

mTCF-dd in GEC is an effective and feasible option. A careful monitoring of adverse events is recommended. A biomolecular analysis of long-term survivors is underway.

Clinical trial identification

The clinical trials were promoted as GOIRC (GRUPPO ONCOLOGICO DI RICERCA ITALIANO- GOIRC 01/2009)

Legal entity responsible for the study

Azienda Socio Sanitaria di Cremona

Funding

MEDEA ONLUS

Disclosure

R. Passalacqua: Member of Scientific Boards: Amgen, Lilly, Pfizer, Novartis. All other authors have declared no conflicts of interest.