Phase III Trial of Gemcitabine Plus Carboplatin Versus Single-Agent Gemcitabine in the Treatment of Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: The Swedish Lung Cancer Study Group

Sederholm, Christer; Hillerdal, Gunnar; Lamberg, Kristina; Kölbeck, Karl‐Gustav; Dufmats, Monika; Westberg, Ronny; Gawande, S.

doi:10.1200/jco.2005.01.2781

Cited by 160 publications

(94 citation statements)

References 22 publications

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“…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: 99%

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: 99%

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

et al. 2007

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“…To improve therapeutic efficacy, retrospective subgroup analyses of several phase III trials have investigated platinum-based treatment for elderly patients with advanced NSCLC (Kelly et al, 2001;Langer et al, 2002;Hensing et al, 2003;Belani et al, 2005;Sederholm et al, 2005;Ansari et al, 2007). In these studies were indicated that PFS OS, and response rate were not significantly superior between age groups.…”

Section: Discussionmentioning

confidence: 99%

“…In these studies were indicated that PFS OS, and response rate were not significantly superior between age groups. Grade 3-4 toxicities for elderly patients, some studies were higher (Langer et al, 2002;Belani et al, 2005;Sederholm et al, 2005;Ansari et al, 2007), whereas others were not observed (Kelly K et al, 2001;Hensing et al, 2003). We performed a retrospective analysis of the efficacy and side effects of cisplatin-based therapy for the treatment of elderly patients with NSCLC.…”

Section: Discussionmentioning

confidence: 99%

Cisplatin-Based Therapy for the Treatment of Elderly Patients with Non-Small-Cell Lung Cancer: a Retrospective Analysis of a Single Institution

İnal

Kaplan²,

Küçüköner³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Background: In spite of the fact that platinum-based doublets are considered the standard therapy for patients with advanced non-small-cell lung cancer (NSCLC), no elderly-specific platinum based prospective phase III regimen has been explored. The aim of this retrospective singlecenter study was to evaluate the efficacy and side effects of cisplatin-based therapy specifically for the elderly. Methods: Patients receiving platinum-based treatment were divided into three groups. In the first group (GC), Gemcitabine was administrated at 1000 mg/m 2 on days 1, 8 and cisplatin was added at 75 mg/m 2 on day 1. In the second group (DC), 75 mg/m 2 docetaxel and cisplatin were administered on day 1. The third group (PC) received 175 mg of paclitaxel and 75 mg of cisplatin on day 1. These treatments were repeated every three weeks. Result: GC arm had 36, the DC arm 42 and the PC arm 29 patients. Grade III-IV thrombocytopenia was higher in the GC arm (21.2% received GC, 2.8% received DC, and 3.8% received PC), while sensory neuropathy was lower in patients with GC arm (3.0%, 22.2%, and 23.1% received GC, DC and PC, respectively). There were no statistically significant difference in the response rates among the three groups (p>0.05). The median Progression-free survival (PFS) was 5.0 months and the median Overall survival (OS) in each group was 7.1, 7.4 and 7.1 months, respectively (p>0.05). Conclusion: The response rate, median PFS and OS were similar among the three treatment arms. Grade III-IV thrombocytopenia was higher in the GC arm, while the GC regimen was more favorable than the other cisplatin-based treatmetns with regard to sensory neuropathy.

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“…This approach has subsequently been discarded. A comparison of platinum-based two-drug combinations with novel single-agent therapy demonstrated higher survival and response rates with the combination [34,35]. Thus, two-drug combinations form the foundation of systemic therapy for NSCLC.…”

Section: Strategies To Improve the Efficacy Of Systemic Chemotherapymentioning

confidence: 99%

Systemic Chemotherapy for Advanced Non-Small Cell Lung Cancer: Recent Advances and Future Directions

2008

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Systemic therapy improves the survival and quality of life of patients with advanced stage non-small cell lung cancer (NSCLC). Several new therapeutic options have emerged for advanced NSCLC, incorporating novel cytotoxic agents (taxanes, gemcitabine, pemetrexed) and molecular-targeted agents (erlotinib, bevacizumab). Efforts to improve the outcome of firstline therapy for advanced and metastatic NSCLC have primarily focused on the addition of targeted agents to platinum-based two-drug regimens. Bevacizumab, an antibody against vascular endothelial growth factor, is the first drug to demonstrate superior outcomes when added to systemic chemotherapy in advanced disease. Evaluation of the role of maintenance therapy following four to six cycles of first-line combination chemotherapy is ongoing. Both cytotoxic agents and targeted agents are suitable for evaluation in the maintenance setting. Promising results have been noted with single-agent paclitaxel as maintenance therapy following four cycles of combination therapy with carboplatin and paclitaxel. Phase III studies are now under way to evaluate the roles of gemcitabine, pemetrexed, and erlotinib as maintenance therapies for patients who experience a response or disease stabilization after four cycles of combination chemotherapy. Whether this approach will be successful in extending the survival of a select group of patients remains to be seen. The Oncologist 2008;13(suppl 1):5-13

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Phase III Trial of Gemcitabine Plus Carboplatin Versus Single-Agent Gemcitabine in the Treatment of Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: The Swedish Lung Cancer Study Group

Abstract: In advanced NSCLC, gemcitabine/carboplatin therapy resulted in significant survival benefit compared with single-agent gemcitabine without undue increase in toxicity.

Cited by 160 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

Cisplatin-Based Therapy for the Treatment of Elderly Patients with Non-Small-Cell Lung Cancer: a Retrospective Analysis of a Single Institution

Systemic Chemotherapy for Advanced Non-Small Cell Lung Cancer: Recent Advances and Future Directions

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