A randomized trial of 5-fluorouracil, leucovorin, cisplatin and epirubicin (PELF) versus 5-fluorouracil, leucovorin and etoposide (ELF) given as adjuvant chemotherapy to patients with resected advanced gastric adenocarcinomas.

Journal of B.U.ON. : official journal of the Balkan Union of Oncology · 2004 · Benefit · High evidence

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BenefitHigh evidencePaper 3608

Study snapshot

PublicationJournal of B.U.ON. : official journal of the Balkan Union of Oncology · 2004

Study typerandomized_trial

Reported directionBenefit

Evidence ratingHigh

Abstract

PURPOSE: To compare the efficacy and toxicity between 2 regimens [5 fluorouracil (5-FU), leucovorin and etoposide (ELF) and 5-FU, leucovorin, cisplatin and epirubicin (PELF)] administered as postoperative adjuvant chemotherapy to patients with completely resected advanced gastric cancer. PATIENTS AND METHODS: Between 1998-2002, 78 patients with advanced gastric cancer were randomly assigned to receive 6 cycles of adjuvant ELF or PELF combination chemotherapy after complete surgical tumor resection. Endpoints were disease-free survival (DFS), overall survival and treatment toxicity. RESULTS: ELF was administered to 37 and PELF to 41 patients. Median overall survival was 12.3 months in the ELF group and 17.2 months in the PELF group (p=0.01), respectively. For the ELF group the median DFS was 17 weeks (range 7-160 weeks), while for the PELF group it was 35 weeks (range 12-172 weeks) (p=0.0004). Two-year overall survival was 8% (3 patients) in the ELF group and 24% (10 patients) in the PELF group (p=0.03). Grade 2 hematologic toxicity occurred in 21% (8 patients) in the ELF group and in 22% (9 patients) in the PELF group (p=0.5) and grade 3 in 29% (11 patients) in the ELF group and in 24% (10 patients) in the PELF group (p=0.2). Grade 2 non-hematologic toxicity was seen in 8% (3 patients) in the ELF group and in 17% (7 patients) in the PELF group (p=0.2). Grade 3 non-hematologic toxicity occurred in 29% (11 patients) in the ELF group and in 26.8% (11 patients in the PELF group) (p=0.2). CONCLUSION: PELF combination chemotherapy resulted in DFS and overall survival advantage compared with ELF. No significant differences in hematologic or non-hematologic toxicities between the two groups were registered. PELF is superior to ELF and represents a valid option for the treatment of gastric cancer.

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Study typerandomized_trial

Effect directionbenefit

PopulationPatients with completely resected advanced gastric adenocarcinoma receiving postoperative adjuvant chemotherapy

Sample size78

ExposureNot supplied

Evidence strengthHighConfidence: 74% · Peer reviewed: yes

Main findings

In 78 randomized patients (ELF n=37; PELF n=41), median overall survival was 12.3 months with ELF vs 17.2 months with PELF (p=0.01). Median DFS was 17 weeks with ELF vs 35 weeks with PELF (p=0.0004), and 2-year overall survival was 8% vs 24% (p=0.03). No statistically significant differences in reported grade 2/3 hematologic or non-hematologic toxicities were observed between groups.

Outcomes measured

Disease-free survival (DFS)
Overall survival
Treatment toxicity (hematologic and non-hematologic; grade 2 and grade 3)

View raw extracted JSON

{
  "study_type": "randomized_trial",
  "exposure": {
    "band": null,
    "source": null,
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": null
  },
  "population": "Patients with completely resected advanced gastric adenocarcinoma receiving postoperative adjuvant chemotherapy",
  "sample_size": 78,
  "outcomes": [
    "Disease-free survival (DFS)",
    "Overall survival",
    "Treatment toxicity (hematologic and non-hematologic; grade 2 and grade 3)"
  ],
  "main_findings": "In 78 randomized patients (ELF n=37; PELF n=41), median overall survival was 12.3 months with ELF vs 17.2 months with PELF (p=0.01). Median DFS was 17 weeks with ELF vs 35 weeks with PELF (p=0.0004), and 2-year overall survival was 8% vs 24% (p=0.03). No statistically significant differences in reported grade 2/3 hematologic or non-hematologic toxicities were observed between groups.",
  "effect_direction": "benefit",
  "limitations": [],
  "evidence_strength": "high",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "gastric adenocarcinoma",
    "adjuvant chemotherapy",
    "randomized trial",
    "5-fluorouracil",
    "leucovorin",
    "cisplatin",
    "epirubicin",
    "etoposide",
    "overall survival",
    "disease-free survival",
    "toxicity"
  ],
  "suggested_hubs": []
}

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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: Not supplied
PubMed: 17415824

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