Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial

Gridelli, Cesare; Perrone, Francesco; Palmeri, Sergio; D’Aprile, Modesto; Cognetti, F.; Rossi, Antonio; Gebbia, Vittorio; Pepe, Rosario; Veltri, Enzo; Airoma, Giuseppe; Russo, Antonio; Incoronato, Pasquale; Scinto, Angelo Fedele; Palazzolo, Giovanni; Natali, M.; Leonardi, V.; Gallo, Ciro; Placido, Sabino De; Bianco, A. R.

doi:10.1093/oxfordjournals.annonc.a010761

Cited by 32 publications

(11 citation statements)

References 13 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).…”

mentioning

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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“…17 Despite modern antiemetic and hydration regimens, cisplatin has substantial side effects that limit its use. 18,19 There are several ways to circumvent cisplatin-induced toxicities, including omitting cisplatin and replacing it with a cytotoxic drug with similar activity. One such regimen, paclitaxel plus gemcitabine, has been shown in a phase II study to produce a major response rate of 24% with acceptable toxicity.…”

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confidence: 99%

Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group—EORTC 08975

Smit

Meerbeeck

Lianes

et al. 2003

JCO

325

222

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“…However, combination chemotherapy containing CDDP has significant toxicities, including severe nausea, vomiting and renal toxicity requiring adequate hydration, which increases the difficulty in the treatment of the elderly or outpatients. In previous randomised studies, CDDP-containing combinations have proved more toxic than those without cisplatin (Luedke et al, 1990;Gridelli et al, 1996;Georgoulias et al, 2001). Carboplatin is a platinum without the toxic disadvantages of CDDP; however, this agent still causes nausea, vomiting and myelosuppression.…”

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confidence: 99%

Gemcitabine and vinorelbine followed by docetaxel in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial of nonplatinum sequential triplet combination chemotherapy (JMTO LC00-02)

et al. 2003

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To evaluate the efficacy and toxicity of the sequential nonplatinum combination chemotherapy consisting of gemcitabine (GEM) and vinorelbine (VNR) followed by docetaxel (DOC) in patients with advanced non-small-cell lung cancer (NSCLC), we conducted the multiinstitutional phase II study. A total of 44 chemotherapy-naive patients with advanced NSCLC were treated with GEM 1000 mg m À2 and VNR 25 mg m À2 intravenously on days 1 and 8 every 3 weeks for three cycles. DOC 60 mg m À2 was then administrated intravenously at 3-week intervals for three cycles. Patients were evaluated for response and toxicity with each cycle of the treatment. The major objective response rate was 47.7% (95% confidence interval (CI), 33.8 -62.1%). Median survival time (MST) was 15.7 months and 1-year survival rate was 59%. In the GEM/VNR cycle, grade 3/4 neutropenia occurred in 36.3%, grade 3/4 anaemia in two patients (4.5%) and grade 3 thrombocytopenia in one patient (2.3%). Grade 3 pneumonitis occurred in two patients (4.5%) in GEM/VNR cycles. In the DOC cycles, grade 3/4 neutropenia occurred in 39.4% but no patient experienced grade 3/4 anaemia or thrombocytopenia. Of the 44 eligible patients, 33 patients completed three cycles of GEM/VNR and 22 patients completed six cycles of planned chemotherapy (three cycles of GEM/VNR followed by three cycles of DOC). The sequential triplet nonplatinum chemotherapy consisted of GEM/VNR followed by DOC, and was very active and well tolerated. This study forms the basis for an ongoing phase III trial that compares this nonplatinum triplet and standard platinum doublet combination (carboplatin/ paclitaxel).

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Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial

Cited by 32 publications

References 13 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

Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group—EORTC 08975

Gemcitabine and vinorelbine followed by docetaxel in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial of nonplatinum sequential triplet combination chemotherapy (JMTO LC00-02)

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