A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer
Open accessAbstract
Background Paclitaxel-carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen.Patients and methods A total of 1135 chemonaive patients with stage IIIB or IV NSCLC were randomly allocated to receive gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m(2) on days 1 and 8 plus paclitaxel 200 mg/m(2) on day 1 (GP), or paclitaxel 225 mg/m(2) plus carboplatin AUC 6.0 on day 1 (PC). Stratification was based on disease stage, baseline weight loss, and presence or absence of brain metastases. Cycles were repeated every 21 days for up to six cycles or disease progression.Results Median survival (months) with GC was 7.9 compared with 8.5 for GP and 8.7 for PC. Response rates (RRs) were as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%. The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC.Conclusions Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. However, the treatment arms had distinct toxicity profiles.
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In the three-arm study by Treat et al, there were fewer adverse effects without the platinum agent.
“there were fewer adverse effects (eg, neuropathy) without the platinum agent.”
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 [73]
In the updated systematic review, in the three-arm study by Treat et al, efficacy did not differ between the two platinum-containing arms and the paclitaxel plus gemcitabine arm.
“In the updated systematic review, in the three-arm study by Treat et al,73 although efficacy did not differ between the two platinum-containing arms and the paclitaxel plus gemcitabine arm, there were fewer adverse effects (eg, neuropathy) without the platinum agent.”
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 [73]
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- Authors
- Treat, J. A., Gonin, R., Socinski, M. A., Edelman, M. J., Catalano, R. B., Marinucci, D. M., Ansari, R., Gillenwater, H. H., Rowland, K. M., Comis, R. L., Obasaju, C. K., & Belani, C. P.
- Affiliations
- Eli Lilly (United States) (US)
- Westat (United States) (US)
- University of North Carolina at Chapel Hill (US)
- University of Maryland, Baltimore (US)
- Drexel University (US)
- Northern Indiana Cancer Research Consortium (US)
- University of Virginia Medical Center (US)
- Penn State Cancer Institute (US)
- Corresponding author
- Treat, J.A.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2010-03
- Volume
- 21
- Issue
- 3
- Pages
- 540-547
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2125357549
- Cited by
- 70
- References
- 65
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2022: 4 · 2021: 3 · 2020: 4 · 2019: 1 · 2018: 4 · 2017: 9 · 2016: 3 · 2015: 4 · 2014: 2 · 2013: 10 · 2012: 9
- FWCI
- 6.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (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
- gemcitabine, carboplatin, paclitaxel, non-small cell lung cancer, metastatic lung cancer, combination chemotherapy, gemcitabine/carboplatin, carboplatin-paclitaxel, overall survival, response rate, hematologic toxicity, neurotoxicity, hair loss
- MeSH terms
- Gemcitabine, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Prospective Studies, Survival Rate, Carboplatin, Treatment Outcome, Paclitaxel
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