Background There is no one regimen considered standard for advanced gastric cancer. Platinum and fluoropyrimidine are the most consolidated for use as firstline palliative chemotherapy.
Purpose To compare the effectiveness (response rate (RR), progression free survival (PFS), overall survival (OS)) and tolerability of platinum and fluoropyrimidine based regimens for untreated advanced gastric cancer.
Material and methods AGAMENON is a multicentre, non-interventional, observational study. Eligibility criteria included the use of chemotherapy with platinum plus fluoropyrimidine for untreated advanced HER2 negative gastric adenocarcinoma between 2008 and 2015. The Kaplan-Meier and log-rank methods were used to estimate PFS and OS. The Concordance Index was applied to evaluate discriminatory capacity.
Results This analysis comprised 254 eligible patients from 946 registered. Baseline characteristics were: ECOG performance status 0–1, 78.7%; male, 67,3%; median age, 65,7 years; two or more chronic comorbidities, 19.3%.
The most common tumour location was the body of the stomach (30.7%). 48.4% of patients had an intestinal Lauren type and 16.1% had three or more sites of metastatic disease.
106 patients received cisplatin containing chemotherapy (5-fluorouracil/cisplatin in 16.0%, cisplatin/capecitabine in 90.0%). 148 patients received oxaliplatin alternatives (5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) in 54.7%, oxaliplatin/capecitabine (CapeOX) in 45.27%).
The median months of treatment was 4 for all regimens and drugs. Toxicity was reposted as the reason for discontinuation in 7.7%, 6,8%, 11.1% and 26.7% for fluorouracil, capecitabine, cisplatin and oxaliplatin, respectively.
The average dose intensities of 5-fluorouracil, capecitabine, cisplatin and oxaliplatin were 0.96, 0.85, 0.93 and 0.98, respectively.
The response rate was 40.2%, median PFS was 5.8 months (95% CI 5.3 to 6,4) and median OS was 10.9 months (95% CI 9.7 to 12.5).
Grade 3–4 toxicities included: neutropenia (15.4%), emesis (3.9%), diarrhoea (3.9%), neuropathy (2.8%), anaemia (2.0%), hand-foot syndrome (1.6%) and thrombocytopenia (0.4%).
The most frequent grade 1–2 toxicities were: anaemia (50.4%), neuropathy (46.1%), hand-foot syndrome (28.4%), emesis (28.0%), neutropenia (26.8%), diarrhoea (24.4%) and thrombocytopenia (20,5%). There were 40 toxicity treatment or tumour related inpatients.
Conclusion These outcomes are consistent with the efficacy and toxicity data from phase III and II clinical trials (ML17032 study, Ann Oncol 2009; Al-Batran S, et al. J Clin Oncol 2006). In the AGAMENON study, different combinations of platinum and fluoropyrimidine showed similar benefit in clinical practice.
References and/or Acknowledgements The investigators of the AGAMENON study.
No conflict of interest.
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