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
- 307Citations
- 145Captures
- 1Mentions
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations307
- Citation Indexes296
- 296
- CrossRef205
- Policy Citations7
- Policy Citation7
- Clinical Citations4
- PubMed Guidelines4
- Captures145
- Readers145
- 145
- Mentions1
- References1
- Wikipedia1
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
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=77950498286&origin=inward; http://dx.doi.org/10.1200/jco.2009.25.4433; http://www.ncbi.nlm.nih.gov/pubmed/20194854; https://clinicaltrials.gov/ct2/show/NCT00813696; http://ascopubs.org/doi/10.1200/JCO.2009.25.4433; http://ascopubs.org/doi/pdf/10.1200/JCO.2009.25.4433; https://ascopubs.org/doi/10.1200/JCO.2009.25.4433; https://dx.doi.org/10.1200/jco.2009.25.4433
American Society of Clinical Oncology (ASCO)
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