A three-arm phase III randomised trial comparing combinations of platinum derivatives, ifosfamide and/or gemcitabine in stage IV non-small-cell lung cancer

Sculier, Jean-Paul; Lafitte, Jean-Jacques; Lecomte, Jacques; Berghmans, Thierry; Thiriaux, J; Florin, M; Efremidis, Anna; Alexopoulos, Constantinos; Recloux, P; Ninane, Vincent; Mommen, Paul; Paesmans, Marianne; Klastersky, Jean

doi:10.1093/annonc/mdf154

Cited by 40 publications

(26 citation statements)

References 21 publications

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“…Other trials showed similar response rates and survival, and less toxicity in patients treated with nonplatinum-based schedules compared to platinum-containing combinations (Gatzemeier et al, 1991;Gridelli et al, 1996;Georgoulias et al, 2001;Sculier et al, 2002). A recently published study compared four platinum-based regimens for advanced NSCLC (cisplatin with either paclitaxel, gemcitabine, or docetaxel, and carboplatin with paclitaxel), and showed no difference in survival (the median survival was 7.9 months for all patients) and response rate (19% for all patients).…”

Section: Discussionmentioning

confidence: 95%

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First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial

Wachters¹,

Putten²,

Kramer³

et al. 2003

Br J Cancer

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The purpose of our study was to compare progression-free survival and quality of life (QOL) after cisplatin -gemcitabine (CG) or epirubicin -gemcitabine (EG) in chemotherapy-naive patients with unresectable non-small-cell lung cancer. Patients (n ¼ 240) were randomised to receive gemcitabine 1125 mg m À2 (days 1 and 8) plus either cisplatin 80 mg m À2 (day 2) or epirubicin 100 mg m À2 (day 1) every 3 weeks for a maximum of five cycles. Eligible patients had normal organ functions and Eastern Cooperative Oncology Group performance status p2. QOL was measured with European Organisation for Research and Treatment of Cancer QLQ-C30 and LC13 questionnaires. There were no significant differences in median progression-free survival (CG 26 weeks, EG 23 weeks), median overall survival (CG 43 weeks, EG 36 weeks), or tumour response rates (CG 46%, EG 36%). Toxicity was mainly haematologic. In the EG arm granulocytopenia occurred more frequently, leading to more febrile neutropenia. Also, elevation of serum transaminases, mucositis, fever, and decline in LVEF were more common in the EG arm. In the CG arm, more patients experienced elevated serum creatinine levels, sensory neuropathy, nausea, and vomiting. Global QOL was not different in both arms. Progression-free survival, overall survival, response rate, and QOL were not different between both arms; however, overall toxicity was more severe in the EG arm.

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Section: Discussionmentioning

confidence: 95%

“…Phase III studies have reported similar response rates and overall survival in cisplatin and noncisplatin-based regimens. However, in the majority of these trials the nonplatinum regimens had a more favourable toxicity profile (Gatzemeier et al, 1991;Gridelli et al, 1996;Georgoulias et al, 2001;Kosmidis et al, 2002;Sculier et al, 2002).…”

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confidence: 99%

First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial

Wachters¹,

Putten²,

Kramer³

et al. 2003

Br J Cancer

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“…Responses were assessed according to the usual criteria (Sculier et al, 2002b). Complete remission was defined as the disappearance of all signs of disease, for at least 4 weeks.…”

Section: Criteria Of Evaluationmentioning

confidence: 99%

Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

et al. 2007

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In the context of a phase III trial comparing in advanced non-small cell lung cancer (NSCLC) sequential to conventional administration of cisplatin-based chemotherapy and paclitaxel, we evaluated the activity of paclitaxel as second-line chemotherapy and investigated any relation of its efficacy with the type of failure after cisplatin. Patients received three courses of induction GIP (gemcitabine, ifosfamide, cisplatin). Non-progressing patients were randomised between three further courses of GIP or three courses of paclitaxel. Second-line paclitaxel was given to patients with primary failure (PF) to GIP and to those progressing after randomisation to further GIP (secondary failure or SF). One hundred sixty patients received second-line paclitaxel. Response rates were 7.7% for PF and 11.6% for SF (P ¼ 0.42). Median survival times (calculated from paclitaxel start) were 4.1 and 7.1 months for PF and SF (P ¼ 0.002). In multivariate analysis, three variables were independently associated with better survival: SF (hazard ratio (HR) ¼ 1.55, 95% confidence interval (CI) 1.08 -2.22; P ¼ 0.02), normal haemoglobin level (HR ¼ 1.56, 95% CI 1.08 -2.26; P ¼ 0.02) and minimal weight loss (HR ¼ 1.79, 95% CI 1.26 -2.55; P ¼ 0.001). Paclitaxel in NSCLC patients, whether given for primary or for SF after cisplatin-based chemotherapy, demonstrates activity similar to other drugs considered active as second-line therapy.

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“…Although poor PS was always considered a poor prognostic factor for survival, it was an independent poor prognostic factor for response in two trials [10,11], while it was not in others [12][13][14]. In the present study, the recently completed randomised trial in advanced NSCLC (European Lung Cancer Working Party (ELCWP) protocol 01995) [15,16] was retrospectively analysed in order to determine if cisplatin-based chemotherapy was associated with clinical improvement in patients with poor PS (Karnofsky 60-70).…”

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Chemotherapy improves low performance status lung cancer patients

Sculier

Lafitte²,

Paesmans³

et al. 2007

Eur Respir J

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The aim of the present study was to determine the potential benefit of conventional cisplatin-based chemotherapy on patients with advanced nonsmall cell lung cancer (NSCLC) and poor performance status (PS), defined as 60-70 on the Karnofsky scale.Retrospective analysis was carried out of a randomised trial performed in advanced NSCLC where 485 patients received three courses of gemcitabine+ifosfamide+cisplatin induction chemotherapy.Of the patients, 80% had good PS (Karnofsky 80-100) and 20% poor PS. Response rates were 38 and 28%, respectively. Clinical improvement, defined as achieving a good PS during chemotherapy, was observed overall in 25% of the poor PS patients, with rates of 38, 20 and 14%, respectively, in case of response, no change and progression. PS improved more quickly in the responders. Survival of patients with poor PS was significantly worse, but survival of responders was similar, irrespective of the initial poor or good PS. Although nonfatal toxicity was almost similar, there were more toxic deaths (including vascular and cardiac fatalities) in the poor PS patients (9.2 versus 2.1%).In conclusion, combination chemotherapy is associated with clinical improvement in a substantial number of patients with advanced nonsmall cell lung cancer of poor performance status.

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A three-arm phase III randomised trial comparing combinations of platinum derivatives, ifosfamide and/or gemcitabine in stage IV non-small-cell lung cancer

Cited by 40 publications

References 21 publications

First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial

First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial

Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

Chemotherapy improves low performance status lung cancer patients

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