Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: A randomized, multicenter phase III trial
Abstract
To compare the overall survival (OS) of patients with advanced non-small cell lung (NSCLC) treated with either docetaxel plus gemcitabine or single-agent docetaxel. Chemotherapy-naive patients with advanced/metastatic NSCLC were randomly assigned to receive either DG [n=157; gemcitabine 1100mg/m(2) on days 1 and 8], docetaxel 75mg/m(2) on day 8 or D [n=155; docetaxel 100mg/m(2) on day 1] every 3 weeks. A total of 312 patients were evaluable for toxicity and response. A predefined interim intention-to-treat analysis showed significantly longer median OS (p=0.037) in favor of the DG regimen (9.4 months versus 8.3 months for DG and D regimens, respectively), resulting in the premature termination of the study. The DG regimen was also associated with a significantly higher response rate compared to D (26.8% versus 11.6%, p<0.001). TTP were 3.5 and 2.3 months for the DG and D regimen, respectively (p=0.054). Although there were two treatment-related deaths in the DG arm, the toxicity profiles of the two regimens were comparable. The DG regimen was associated with a significantly better quality of life. The efficacy of the docetaxel plus gemcitabine combination is superior to single-agent docetaxel in chemonaive patients with advanced NSCLC.
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In a trial comparing docetaxel plus gemcitabine with docetaxel alone, OS showed a statistically significant difference of 1.1 months in favor of the doublet.
“In a trial comparing docetaxel plus gemcitabine with docetaxel alone, the OS results showed a statistically significant difference of 1.1 months in favor of the doublet; the study was closed prematurely.52”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [52]
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- Authors
- Georgoulias, V., Androulakis, N., Kotsakis, A., Hatzidaki, D., Syrigos, K., Polyzos, A., Agelidou, A., Varthalitis, I., Ziras, N., Agelidou, M., Chandrinos, V., Boukovinas, I., Geroyianni, A., Vamvakas, L., & Mavroudis, D.
- Affiliations
- Hellenic Oncology Research Group (GR)
- Corresponding author
- Georgoulias, Vassilis
- Venue
- Lung Cancer
- Publisher
- Elsevier BV
- Published
- 2008-01
- Volume
- 59
- Issue
- 1
- Pages
- 57-63
- ISSN
- 0169-5002 (ISSN-L)
- OpenAlex
- W2102621753
- Cited by
- 44
- References
- 36
- Citations by year
- 2024: 1 · 2023: 2 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 3 · 2014: 1 · 2013: 2 · 2012: 4
- FWCI
- 4.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Lung Cancer (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- docetaxel, gemcitabine, non-small cell lung cancer, combination chemotherapy, single-agent chemotherapy, first-line therapy, overall survival, response rate, time to progression, quality of life, chemotherapy toxicity
- MeSH terms
- Docetaxel, Gemcitabine, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Female, Humans, Lung Neoplasms, Male, Middle Aged, Quality of Life, Taxoids
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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