A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic Non-Small Cell Lung Cancer
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Background: To compare the activity and toxicity of docetaxel/carboplatin (DC) doublet vs single agent docetaxel (D) as second-line treatment in patients with advanced non-small cell lung cancer (NSCLC). Methods: Patients pre-treated with front-line platinum-free regimens, were randomized to receive either docetaxel/carboplatin (DC), (docetaxel 50 mg/m 2; carboplatin AUC4; both drugs administered on days 1 and 15) or docetaxel single-agent (D), (docetaxel 50 mg/m 2 on days 1 and 15). Results: Response rate was similar between the two arms (DC vs D: 10.4% vs 7.7%; p = 0.764). After a median follow-up time of 28.0 months for DC arm and 34.5 months for D arm, progression free survival (PFS) was significantly higher in the DC arm (DC vs D:3.33 months vs 2.60 months; p-value = 0.012), while no significant difference was observed in terms of overall survival (OS) (DC vs D: 10.3 months vs 7.70 months; p-value = 0.550). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed. Conclusions: This study has not achieved its primary objective of significant OS prolongation with docetaxel/carboplatin combination over single-agent docetaxel in patients who had not received front-line docetaxel; however, the docetaxel/carboplatin combination was associated with a significant clinical benefit in terms of PFS.
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In that trial, adverse events were not uniformly less common in one arm versus the other.
“Adverse events were not uniformly less common in one arm versus the other.67”
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 [67]
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- Authors
- Pallis, A. G., Agelaki, S., Agelidou, A., Varthalitis, I., Syrigos, K., Kentepozidis, N., Pavlakou, G., Kotsakis, A., Kontopodis, E., & Georgoulias, V.
- Affiliations
- Hellenic Oncology Research Group (GR)
- Corresponding author
- Georgoulias, Vassilis
- Venue
- BMC Cancer
- Published
- 2010-11-19
- Volume
- 10
- Issue
- 1
- Pages
- 633-633
- ISSN
- 1471-2407 (ISSN-L)
- PMC
- PMC2994826
- OpenAlex
- W2089202229
- Cited by
- 36
- References
- 35
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2018: 3 · 2017: 2 · 2016: 3 · 2015: 2 · 2014: 3 · 2013: 3 · 2012: 11
- FWCI
- 4.52
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Cancer (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- 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, carboplatin, non-small cell lung cancer, second-line chemotherapy, combination chemotherapy, single-agent chemotherapy, progression-free survival, overall survival, chemotherapy toxicity
- MeSH terms
- Docetaxel, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Drug Administration Schedule, Female, Humans, Lung Neoplasms, Male, Middle Aged, Carboplatin, Treatment Outcome, Disease-Free Survival, Taxoids
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