Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial

Zatloukal, Petr; Petruželka, Luboš; Zemanová, Milada; Kolek, Vı́tězslav; Skřičková, Jana; Pešek, Miloš; Fojtů, Hana; Grygárková, Ivona; Sixtová, Dimka; Roubec, Jaromı́r; Hořenková, Eva; Havel, Libor; Průša, Petr; Novakova, L.; Skácel, Tomáš; Kůta, M

doi:10.1016/s0169-5002(03)00233-2

Cited by 151 publications

(145 citation statements)

References 24 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: 96%

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: 96%

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

et al. 2007

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“…Several trials in the past compared regimens containing cisplatin vs carboplatin with conflicting results [26][27][28][29][30][31][32][33]. In 2007, an individual patient data meta-analysis performed by Ardizzoni et al [34], including 9 of these trials and comparing cisplatin VS carboplatin-based chemotherapy in 2968 NSCLC patients, showed a significant improvement of ORR in favour of cisplatin arm (30% VS 24%; OR: 1.37, P < 0.001), while no significant differences between two arms were observed in survival rate.…”

Section: Citaɵonmentioning

confidence: 99%

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Bronte

Rolfo

Passiglia

et al. 2015

Critical Reviews in Oncology/Hematology

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“…The median number of chemotherapy cycles administered was 6 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]. No patients are still receiving the doublet, although at the time of this writing two patients are continuing on single-agent pemetrexed.…”

Section: Treatment Administration and Toxicitymentioning

confidence: 99%

Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer

Zinner

Fossella

Gladish

et al. 2005

Cancer

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BACKGROUNDThe primary objectives of this study were to determine the efficacy and tolerability of a pemetrexed‐carboplatin combination as first‐line therapy in patients with advanced nonsmall cell lung cancer.METHODSEligibility criteria included Zubrod performance status of 0 or 1, Stage IIIB (malignant effusion) or IV disease, and no prior chemotherapy. Treatment was pemetrexed 500 mg/m2 given intravenously and carboplatin area under the serum concentration–time curve = 6 given intravenously on Day 1 every 3 weeks for six cycles; patients could receive additional cycles at the discretion of the treating physician and patient. All patients received folic acid, vitamin B12, and dexamethasone prophylaxis.RESULTSFifty patients (31 men and 19 women) were treated. The median age was 62 years. Ninety‐six percent of patients had Stage IV disease, and 88% had a performance status of 1. The median number of cycles was 6; 15 patients received 8 or more cycles. There was Grade 3/4 neutropenia in 11 (22%) and 2 (4%) patients, respectively; Grade 3/4 thrombocytopenia in 1 (2%) and 0 patients, respectively. Three patients (6%) experienced Grade 3 nonhematologic side effects (diarrhea, neutropenic pneumonia, and fatigue). No patients had sensory neuropathy or alopecia >Grade 1. The partial response rate was 24%, median time to progression 5.4 months, 1‐year survival 56.0%, and median survival 13.5 months.CONCLUSIONSThis is an active, very well‐tolerated regimen. Trials focused on how to integrate this doublet with novel agents are warranted. Cancer 2005. © 2005 American Cancer Society.

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Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial

Cited by 151 publications

References 24 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

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Phase II study of pemetrexed in combination with carboplatin in the first‐line treatment of advanced nonsmall cell lung cancer

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