The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.
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
Abstract
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 2 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 2 added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 8% 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.
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Pancreatic Adenocarcinoma, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology
Tempero, M. A., Malafa, M. P., Al-Hawary, M., Asbun, H., Bain, A., Behrman, S. W., Benson, A. B., Binder, E., Cardin, D. B., Cha, C., et al. (2017) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2017.0131 · Cited by 1,020
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Weizman, N., Krelin, Y., Shabtay-Orbach, A., Amit, M., Binenbaum, Y., Wong, R. J., & Gil, Z. (2014) · Oncogene · doi:10.1038/onc.2013.357 · Cited by 281
Screening for Pancreatic Cancer: Why, How, and Who?
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Metadata
- Authors
- Colucci, G., Labianca, R., Di Costanzo, F., Gebbia, V., Cartenì, G., Massidda, B., Dapretto, E., Manzione, L., Piazza, E., Sannicolò, M., Ciaparrone, M., Cavanna, L., Giuliani, F., Maiello, E., Testa, A., Pederzoli, P., Falconi, M., Gallo, C., Di Maio, M., & Perrone, F.
- Venue
- Journal of Clinical Oncology
- Published
- 2010-04-01
- Volume
- 28
- Issue
- 10
- Pages
- 1645-1651
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2158397794
- Cited by
- 304
- References
- 32
- FWCI
- 12.39
- Type
- journal article
- Language
- en
- Open access
- closed
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- Colucci, G., Labianca, R., Di Costanzo, F., Gebbia, V., Cartenì, G., Massidda, B., Dapretto, E., Manzione, L., Piazza, E., Sannicolò, M., Ciaparrone, M., Cavanna, L., Giuliani, F., Maiello, E., Testa, A., Pederzoli, P., Falconi, M., Gallo, C., Di Maio, M., & Perrone, F. (2010). 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. https://doi.org/10.1200/jco.2009.25.4433
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
