Gemcitabine Plus Carboplatin Versus Mitomycin, Ifosfamide, and Cisplatin in Patients With Stage IIIB or IV Non-Small-Cell Lung Cancer: A Phase III Randomized Study of the London Lung Cancer Group

Rudd, RM; Gower, Nicole H.; Spiro, Stephen; Eisen, Tim; Harper, Peter; Littler, J.A.H.; Hatton, M.; Johnson, Peter; Martin, William McChesney; Rankin, Elaine M.; James, Lisa M.; Gregory, WM; Qian, Wendi; Lee, Siow Ming

doi:10.1200/jco.2005.03.037

Cited by 144 publications

(104 citation statements)

References 22 publications

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“…The overall compliance rate regarding completion of the HRQOL forms during the study period was 88%, which is equal or better than previous lung cancer studies using the EORTC questionnaire (Cardenal et al, 1999;Scagliotti et al, 2002;Gridelli et al, 2003a, b;Smit et al, 2003;Rudd et al, 2005;Sederholm et al, 2005;Plessen et al, 2006). However, the higher frequency of toxicity and interventions after GC therapy were not reflected in any HRQOL difference between the treatment arms.…”

Section: Discussionmentioning

confidence: 53%

“…For vinorelbine/platinum combinations, recent phase III studies have yielded median survival data ranging from 6.5 to 11 months (Wozniak et al, 1998;Kelly et al, 2001;Scagliotti et al, 2002;Fossella et al, 2003;Gebbia et al, 2003;Georgoulias et al, 2005;Martoni et al, 2005;Tan et al, 2005;Plessen et al, 2006). In the gemcitabine/platinum metaanalysis (Le Chevalier et al, 2005), median survival in the gemcitabine group was 9 months, reflecting the mean value for a number of studies (Le Chevalier et al, 1994;Cardenal et al, 1999;Sandler et al, 2000;Scagliotti et al, 2002;Schiller et al, 2002;Alberola et al, 2003;Gebbia et al, 2003;Smit et al, 2003;Zatloukal et al, 2003;Martoni et al, 2005;Rudd et al, 2005;Sederholm et al, 2005). Our shorter median survival is possibly explained by the high proportion of patients with PS 2 (28%), which is the most powerful predictor of survival in NSCLC patients (Stanley, 1980).…”

Section: Discussionmentioning

confidence: 96%

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Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

et al. 2007

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This randomised phase III study in advanced non-small cell lung cancer (NSCLC) patients was conducted to compare vinorelbine/ carboplatin (VC) and gemcitabine/carboplatin (GC) regarding efficacy, health-related quality of life (HRQOL) and toxicity. Chemonaive patients with NSCLC stage IIIB/IV and WHO performance status 0 -2 were eligible. No upper age limit was defined. Patients received vinorelbine 25 mg m À2 or gemcitabine 1000 mg m À2 on days 1 and 8 and carboplatin AUC4 on day 1 and three courses with 3-week cycles. HRQOL questionnaires were completed at baseline, before chemotherapy and every 8 weeks until 49 weeks. During 14 months, 432 patients were included (VC, n ¼ 218; GC, n ¼ 214). Median survival was 7.3 vs 6.4 months, 1-year survival 28 vs 30% and 2-year survival 7 vs 7% in the VC and GC arm, respectively (P ¼ 0.89). HRQOL, represented by global QOL, nausea/vomiting, dyspnoea and pain, showed no significant differences. More grade 3 -4 anaemia (Po0.01), thrombocytopenia (Po0.01) and transfusions of blood (Po0.01) or platelets (Po0.01) were observed in the GC arm. There was more grade 3 -4 leucopoenia (Po0.01) in the VC arm, but the rate of neutropenic infections was the same (P ¼ 0.87). In conclusion, overall survival and HRQOL are similar, while grade 3 -4 toxicity requiring interventions are less frequent when VC is compared to GC in advanced NSCLC.

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Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 96%

Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

et al. 2007

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“…Seventy eight (71%) were treated with first-line carboplatin and gemcitabine. This regimen was the most commonly used platinum doublet regimen locally and within the UK prior to published data favouring pemetrexed for nonsquamous histology [Scagliotti et al 2008;Rudd et al 2005]. For reasons of PS, clinician preference or comorbidity, a different regimen was substituted in 32 (29%) cases.…”

Section: Resultsmentioning

confidence: 99%

Experience of first- and subsequent-line systemic therapy in the treatment of non-small cell lung cancer

et al. 2011

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Abstract:Introduction: The treatment of advanced non-small cell cancer (NSCLC) has changed with multiple new treatment algorithms proposed based on histological and molecular subtyping but low mutation rates will ensure the dominance of cytotoxic chemotherapy. Accordingly, we undertook a detailed review of our practice delivering multiple lines of systemic therapy. Method: We undertook a retrospective review of consecutive patients presenting with advanced (stage IIIb/IV) NSCLC treated with systemic therapy at two UK hospitals during a 2-year period, January 2007 to December 2008. Results: A total of 130 patients were identified, treated with predominantly carboplatin/ gemcitabine (20 initially radically). Fifty of 110 patients (45%) treated with first-line systemic therapy subsequently received second-line therapy, of which 10 patients received third-line and two patients fourth-line therapy. Sixty three of 110 first-line patients (58%) achieved clinical benefit, 19 out of 50 (38%) in the second-line, 6 out of 10 (60%) in third-line but both patients progressed at fourth-line. Median overall survival for 110 patients was 10 months (95% confidence interval [CI] 8.611.4); but 16 months (95% CI 14-17.9) in those receiving multiple lines. Median survival from the first cycle of last-line treatment to death in the multiple therapy lines was 5 months (95% CI 2.6-7.3) and the majority of patients spent more time off treatment. Conclusion: Overall our outcomes are consistent with published data and show good survival times can be achieved. The future of advanced NSCLC is in selecting the best treatment approach on a histological and genotypic basis.

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“…Sederholm et al of the Swedish Lung Cancer Group demonstrated that GC conferred a significant survival advantage compared with gemcitabine alone. 8 Other Phase III trials demonstrated that the GC regimen was tolerated better; conferred a survival advantage over the combination of mitomycin, ifosfamide, and cisplatin; 15 and resulted in a comparable survival advantage and less nausea and emesis compared with GC. 7 Based on a large body of Phase II data, including those from our study, 9 and Phase III data, the GV regimen apparently produces less hematologic and nonhematologic toxicity, when it is compared indirectly with more standard combinations.…”

Section: Discussionmentioning

confidence: 99%

Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer

Yamamoto¹,

Nakagawa²,

Uejima³

et al. 2006

Cancer

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BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty‐eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a 1‐year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1‐year survival rate was 53.3% in the GV arm. The median progression‐free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study. Cancer 2006. © 2006 American Cancer Society.

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Gemcitabine Plus Carboplatin Versus Mitomycin, Ifosfamide, and Cisplatin in Patients With Stage IIIB or IV Non-Small-Cell Lung Cancer: A Phase III Randomized Study of the London Lung Cancer Group

Cited by 144 publications

References 22 publications

Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

Experience of first- and subsequent-line systemic therapy in the treatment of non-small cell lung cancer

Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer

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