Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study
Abstract
Background Platinum-containing two-drug combinations improve survival and cancer-related symptoms in patients with advanced non-small-cell lung cancer (NSCLC). However, survival benefit is modest and platinum-containing regimens cause substantial toxic effects. We did a prospective randomised open-label phase III study to compare an experimental platinum-free, triplet, sequential regimen of vinorelbine plus gemcitabine followed by docetaxel with the standard platinum-containing, doublet regimen paclitaxel plus carboplatin in patients with advanced NSCLC.Methods Between March, 2001, and April, 2005, patients with stage IIIB (positive pleural effusion) or IV NSCLC, performance status 0 to 1, and adequate organ function, were randomly assigned to experimental treatment or to standard treatment. Randomisation was done centrally by use of a dynamic balancing algorithm. Patients were stratified by weight loss, lactate dehydrogenase concentration, and disease stage. Patients in the experimental group were scheduled to receive intravenous vinorelbine (25 mg/m(2)) plus gemcitabine (1000 mg/m(2)) on days 1 and 8 every 21 days for three cycles, followed by intravenous docetaxel (60 mg/m(2)) on day 1 every 21 days for three cycles. Patients in the standard group were scheduled to receive intravenous paclitaxel (225 mg/m(2)) plus carboplatin (area under the curve=6) for 3 h on day 1, every 21 days for six cycles. The primary endpoint was overall survival, and secondary endpoints were progression-free survival, response, and toxic effects. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00079287.Findings Of the 401 patients enrolled and randomised in the trial, five patients in the experimental group and three in the standard group were ineligible for analysis; thus 196 patients in the experimental group and 197 in the standard group were included in analyses. Patient characteristics were well-balanced between the two groups with regard to major prognostic factors. Median overall survival was 13.6 months (range 12.0-16.4) in the experimental group versus 14.1 months (11.9-17.5) in the standard group (p=0.97). 49 of 196 patients (25%) in the experimental group had a partial response compared with 73 of 197 patients (37%) in the standard group (p=0.012). There were no complete responses. Median progression-free survival was 5.5 months (95% CI 4.9-6.3) in the experimental group compared with 5.8 months (5.3-6.1) in the standard group (p=0.74). The incidence of grade 3 and 4 neutropenia, neuropathy, arthralgia, and myalgia was lower in the experimental group than in the standard group, although the incidence of pulmonary toxic effects was higher.Interpretation Although platinum-containing regimens remain the standard treatment for advanced NSCLC, non-platinum regimens could provide equivalent efficacy with a different toxicity profile.
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In that trial, response rate was higher with carboplatin plus paclitaxel.
“although the response rate was higher with carboplatin plus paclitaxel”
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 [74]
In a trial comparing vinorelbine plus gemcitabine followed by docetaxel with carboplatin plus paclitaxel, OS and PFS were not statistically significantly different.
“Another trial, in which vinorelbine plus gemcitabine followed by docetaxel was compared with carboplatin plus paclitaxel, found that OS and PFS were not statistically significantly different for efficacy, although the response rate was higher with carboplatin plus paclitaxel; each regimen had different toxicity rates that were higher than the other.74”
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 [74]
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- Authors
- Kubota, K., Kawahara, M., Ogawara, M., Nishiwaki, Y., Komuta, K., Minato, K., Fujita, Y., Teramukai, S., Fukushima, M., & Furuse, K.
- Affiliations
- National Cancer Center Hospital East (JP)
- NHO Kinki Chuo Chest Medical Center (JP)
- Osaka Police Hospital (JP)
- Gunma Prefectural Cancer Center (JP)
- Kyoto University Hospital (JP)
- The Japan-Multinational Trial Organization (JP)
- Corresponding author
- Kawahara, Masaaki
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2008-12
- Volume
- 9
- Issue
- 12
- Pages
- 1135-1142
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W2109015989
- Cited by
- 75
- References
- 39
- Citations by year
- 2023: 2 · 2021: 2 · 2020: 1 · 2019: 3 · 2018: 5 · 2017: 6 · 2016: 3 · 2015: 6 · 2014: 5 · 2013: 6 · 2012: 9
- FWCI
- 8.29
- Type
- journal article
- Language
- en
- Update notices
- erratum (2009-01-01)
- Open access
- closed
- Locations
- The Lancet Oncology (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
- non-small cell lung cancer, vinorelbine, gemcitabine, docetaxel, paclitaxel, carboplatin, platinum-free chemotherapy, sequential chemotherapy, overall survival, progression-free survival, treatment toxicity, advanced non-small cell lung cancer, stage IIIB, stage IV, pleural effusion, prognostic factors
- MeSH terms
- Docetaxel, Vinorelbine, Gemcitabine, Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Antineoplastic Agents, Phytogenic, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Smoking, Vinblastine, Carboplatin, Paclitaxel, Disease-Free Survival, Taxoids, Kaplan-Meier Estimate
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