By ecancer reporter Jo Amstrong

First-line FOLFIRI (irinotecan, leucovorin, bolus 5-fluorouracil [5-FU]) shows milder toxicity and significantly longer time to treatment failure than epirubicin, cisplatin, and capecitabine (ECX) in patients with gastric cancer, according to a study presented here at the 35th European Society for Medical Oncology (ESMO) Congress.

With best supportive care, patients with metastatic and locally advanced gastric cancer still have a short medial survival. "Median survival is consistently in the region of 1 year in advanced gastric cancer," said Dr Christophe Louvet, Service d’Oncologie, Hôpital St. Antoine, Paris, France, on October 10.

Irinotecan has, however, shown promising antitumoural activity and a good safety profile for patients with gastric cancer. It is usually combined with 5-FU, with the FOLFIRI regimen having shown promise.

For the study, patients with metastatic, nonresectable, locally advanced disease were randomised to ECX (n = 209) or FOLFIRI (n = 207).

ECX was comprised of epirubicin 50 mg/m² on day 1, cisplatin 60 mg/m² on day 1, plus capecitabine 2,000 mg/m² on days 2 to 15 every 3 weeks. FOLFIRI comprised irinotecan 180 mg/m² on day 1, leucovorin 400 mg/m² on day 1, plus 5-FU 400 mg/m² on day 1, and 5-FU 2,400 mg/m² over 46 hours, every 2 weeks.

Following disease progression, there was crossover to the other treatment arm as second-line treatment. Dr. Louvet also noted that the median duration of treatment was significantly shorter for both first and second line ECX compared with FOLFIRI (2.8 vs 3.0 months; P =.002; 1.2 vs 2.3 months, P =.03; respectively).

The primary endpoint of time-to-treatment failure represented time from randomisation to disease progression, treatment discontinuation, or patient death, which was 4.24 months for ECX, compared with 5.09 months with FOLFIRI (P =.008).

However, no differences were seen for the secondary endpoints of progression-free survival and overall survival (5.29 vs 5.75 months and 9.49 vs 9.72 months, respectively).

ECX showed significantly greater grades 3/4 haematological (65.5% vs 37.0%; P <.0001) toxicities than FOLFIRI. These differences were not seen during second-line treatment.

While noting that the benefit seen here for FOLFIRI over ECX does not translate into a difference between the 2 treatments as second-line, Dr. Louvet said that “the sequence of FOLFIRI followed by ECX should be preferred to the opposite one in advanced gastric cancer.”

Funding for this study was provided by Roche and Pfizer.

 Abstract 801O: Final Results of the Intergroup FFCD-GERCOR-FNCLCC 03-07 Phase 3 Study Comparing Two Sequences of Chemotherapy in Advanced Gastric Cancer.