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Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: The GIP-1 study

Journal of Clinical Oncology, ISSN: 0732-183X, Vol: 28, Issue: 10, Page: 1645-1651
2010
  • 307
    Citations
  • 0
    Usage
  • 145
    Captures
  • 1
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    307
    • Citation Indexes
      296
    • Policy Citations
      7
      • Policy Citation
        7
    • Clinical Citations
      4
      • PubMed Guidelines
        4
  • Captures
    145
  • Mentions
    1
    • References
      1
      • Wikipedia
        1

Article Description

Purpose: Single-agent gemcitabine became standard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil. The Gruppo Italiano Pancreas 1 randomized phase III trial aimed to compare gemcitabine plus cisplatin versus gemcitabine alone (ClinicalTrials.gov ID NCT00813696). Patients and Methods: Patients with locally advanced or metastatic pancreatic cancer, age 18 to 75 years, and Karnofsky performance status (KPS) ≥ 50, were randomly assigned to receive gemcitabine (arm A) or gemcitabine plus cisplatin (arm B). Arm A: gemcitabine 1,000 mg/m weekly for 7 weeks, and, after a 1-week rest, on days 1, 8, and 15 every 4 weeks. Arm B: cisplatin 25 mg/m added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 80% power of detecting a 0.74 hazard ratio (HR) of death, with bilateral α .05, 355 events were needed and 400 patients planned. Results: Four hundred patients were enrolled (arm A: 199; arm B: 201). Median age was 63, 59% were male, 84% had stage IV, and 83% had KPS ≥ 80. Median overall survival was 8.3 months versus 7.2 months in arm A and B, respectively (HR, 1.10; 95% CI, 0.89 to 1.35; P = .38). Median progression-free survival was 3.9 months versus 3.8 months in arm A and B, respectively (HR, 0.97; 95% CI, 0.80 to 1.19; P = .80). The objective response rate was 10.1% in A and 12.9% in B (P = .37). Clinical benefit was experienced by 23.0% in A and 15.1% in B (P = .057). Combination therapy produced more hematologic toxicity, without relevant differences in nonhematologic toxicity. Conclusion: The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer. © 2010 by American Society of Clinical Oncology.

Bibliographic Details

Colucci, Giuseppe; Labianca, Roberto; Di Costanzo, Francesco; Gebbia, Vittorio; Cartenì, Giacomo; Massidda, Bruno; Dapretto, Elisa; Manzione, Luigi; Piazza, Elena; Sannicolò, Mirella; Ciaparrone, Marco; Cavanna, Luigi; Giuliani, Francesco; Maiello, Evaristo; Testa, Antonio; Pederzoli, Paolo; Falconi, Massimo; Gallo, Ciro; Di Maio, Massimo; Perrone, Francesco; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

American Society of Clinical Oncology (ASCO)

Medicine; Biochemistry, Genetics and Molecular Biology

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