Randomized Phase III Study of Gemcitabine and Vinorelbine Versus Gemcitabine, Vinorelbine, and Cisplatin in the Treatment of Advanced Non-Small-Cell Lung Cancer: From the German and Swiss Lung Cancer Study Group

Laack, Eckart; Dickgreber, N.; Müller, Thomas; Knuth, Alexander; Benk, J.; Lorenz, Christian; Gieseler, Frank; Dürk, Heinz; Engel-Riedel, Walburga; Dalhoff, K; Kortsik, C.; Graeven, Ullrich; Burk, M.; Dierlamm, T.; Welte, Tobias; Burkholder, Iris; Edler, Lutz; Hossfeld, D. K.

doi:10.1200/jco.2004.10.576

Cited by 84 publications

(72 citation statements)

References 20 publications

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“…Overall, there was no significant difference in survival, but toxicity was less pronounced. 10,11,16 GC and GV have comparable efficacy and less toxicity than platinum doublets, as discussed above. However, we do not know which regimen, GC or GV, is more feasible or more effective.…”

Section: Discussionmentioning

confidence: 82%

“…9 Several randomized Phase III trials have shown that this regimen conferred a comparable survival advantage and was less toxic than standard cisplatin-based chemotherapy. 10,11 Thus, we can state reasonably that both GC and GV are attractive alternatives to cisplatin-based chemotherapy. However, we have neither survival data nor toxicity data for GC in Japanese patients with NSCLC.…”

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confidence: 98%

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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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Section: Discussionmentioning

confidence: 82%

mentioning

confidence: 98%

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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“…Although many studies have used FACT-L assessment during chemotherapy for advanced NSCLC, data on differences between treatment groups are limited [45,46]. Nonetheless, clinical trials have shown that chemotherapy provides QOL benefits over supportive care in patients whose lung cancer responds or stabilizes in response to chemotherapy, perhaps through symptom palliation and improvement in physical function [14].…”

Section: Qol In First-line Treatment Of Lung Cancermentioning

confidence: 99%

Quality-of-Life Considerations in Patients with Advanced Lung Cancer: Effect of Topotecan on Symptom Palliation and Quality of Life

Gralla¹

2004

The Oncologist

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Key goals in the treatment of lung cancer are to improve both survival and quality of life (QOL). While formal techniques are frequently used to evaluate survival and response, such rigor is used less often in assessing the impact of treatment on quality of life. Many patients with lung cancer are elderly and have complex medical histories and a myriad of comorbidities. In these patients, with limited survival expectations, symptom palliation, quality of life, and convenience of therapy are especially important end points. Indeed, clinical trials are now incorporating symptom scores and QOL outcomes in their designs (now combined as "patient reported outcomes" or PROs). Moreover, symptom palliation correlates well with QOL and survival duration, providing further rationale for therapy selection based on these parameters. The potential palliative and QOL benefits of chemotherapy have been investigated for several agents in lung cancer trials. The Oncologist 2004;9(suppl 6):14-24 www.TheOncologist.com Correspondence: Richard J. Gralla, M.D., New York Lung Cancer Alliance, 459 Columbus Avenue (PMB-187), New York, New York 10024-5129, USA. Telephone: 212-579-6084; Fax: 801-365-6442; e-mail: rgralla@att.net Received October 4, 2004; accepted for publication October 9, 2004. ©AlphaMed Press 1083-7159/2004 The Oncologist ® LEARNING OBJECTIVESAfter completing this course, the reader will be able to:1. Explain the rationale for evaluating quality of life as a treatment end point.2. Describe the multidisciplinary dimensions incorporated into validated quality-of-life questionnaires.

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“…All other societies recommend first-line platinum-based chemotherapy for advanced NSCLC patients. There are multiple randomised published trials on this topic [71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89][90]. In terms of survival, there is no statistically significant difference between the two types of treatment in all but one trial.…”

Section: Lung Cancer Chemotherapy J-p Sculier and D Moro-sibilotmentioning

confidence: 99%

First- and second-line therapy for advanced nonsmall cell lung cancer

Sculier¹,

Moro-Sibilot²

2009

Eur Respir J

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The objectives for the treatment of advanced nonsmall cell lung cancer are palliative and include improvement of survival, symptom control, quality of life and cost. The level of evidence of these benefits is based on multiple randomised trials and meta-analyses. Cisplatinbased chemotherapy with one of the regimens shown to be effective should be preferred. Carboplatin may be substituted for cisplatin if medical contraindications exist. Nonplatinumbased regimens are indicated as first-line treatment for advanced nonsmall cell lung cancer in patients for whom platinum-based chemotherapy is contraindicated. Single drug chemotherapy may be considered in patients with poor performance status. The choice of the active drugs depends on the patient's medical condition. There is no conclusive evidence that high doses of cisplatin (100-120 mg?m -2 ) provide better results than standard lower doses (50-60 mg?m -2 ) in terms of survival. The optimal duration of chemotherapy is poorly documented in advanced nonsmall cell lung cancer. A minimum of four to six cycles is advised in responding patients. Second-line chemotherapy is now accepted as a standard and should be offered to patients with good performance status and failing platinum-based first-line chemotherapy. Evidence is in favour of docetaxel and in the case of adenocarcinoma and adequate renal function, pemetrexed is recommended.

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Randomized Phase III Study of Gemcitabine and Vinorelbine Versus Gemcitabine, Vinorelbine, and Cisplatin in the Treatment of Advanced Non-Small-Cell Lung Cancer: From the German and Swiss Lung Cancer Study Group

Abstract: In this phase III study, the cisplatin-based GVP regimen showed no survival benefit as first-line chemotherapy in advanced NSCLC when compared with the cisplatin-free GV regimen, which was substantially better tolerated.

Cited by 84 publications

References 20 publications

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

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

Quality-of-Life Considerations in Patients with Advanced Lung Cancer: Effect of Topotecan on Symptom Palliation and Quality of Life

First- and second-line therapy for advanced nonsmall cell lung cancer

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