Phase III study of gemcitabine (GEM) plus vinorelbine (NAV) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC)

Lorusso, Vito; Mancarella, S.; Carpagnano, Francesco; Rienzo, Gaetano Di; Oisternino, L; Napoli, Gaetano; Orlando, Silvio; Lena, M. De

doi:10.1016/s0169-5002(98)90121-0

Cited by 5 publications

(5 citation statements)

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“…This is lower than recommended, but it allows the administration of full doses of GEM and reduces the rate of neurotoxicity. Two ongoing trials use higher doses of GEM and VNB given on Days 1 and 8 every 21 days, 38,39 which may increase dose intensity and improve patient compliance. Although preliminary results show a 36% response rate in 1 of these studies, with a 37% rate of Grade 3-4 neutropenia, 38 elderly patients were not included in these trials.…”

Section: Discussionmentioning

confidence: 99%

Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin

Feliú

Gómez

Madroñal³

et al. 1999

Cancer

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Section: Discussionmentioning

confidence: 99%

Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin

Feliú

Gómez

Madroñal³

et al. 1999

Cancer

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“…Five phase I or II studies have recently evaluated the combination of gemcitabine plus vinorelbine [44][45][46][47][48]. Three studies utilized a three-week cycle with gemcitabine and vinorelbine administered on days 1 and 8 [44][45][46]. Recommended phase II doses for vinorelbine ranged from 25 to 30 mg/m 2 and for gemcitabine 1,000 to 1,250 mg/m 2 .…”

Section: Gemcitabine Plus Vinorelbine (Table 7)mentioning

confidence: 99%

Gemcitabine: Single-Agent and Combination Therapy in Non-Small Cell Lung Cancer

Sandler

Ettinger²

1999

The Oncologist

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With the advent of several newer agents with singleagent response rates greater than 20% and approximately 30%-40% in combination therapy, non-small cell lung cancer (NSCLC) may now be considered a malignancy that is moderately sensitive to chemotherapy. Examples of these agents include the taxanes, paclitaxel and docetaxel; vinorelbine, a new vinca alkaloid, and the camptothecins, of which CPT-11 is the most actively studied agent. Another new and exciting agent is gemcitabine, a nucleoside analogue structurally related to cytosine arabinoside. Gemcitabine's mechanism of action is activated by deoxycytidine kinase to dFdCMP, dFdCDP and dFdCTP. The latter two compounds, when incorporated into DNA, result in chain termination. Phase I studies using a short infusion schedule given weekly for three weeks followed by one week off established 1,000-1,250 mg/m 2 /week as the maximum tolerated dose. Single-agent gemcitabine has been extensively studied in patients with chemotherapynaïve advanced NSCLC with response rates of approximately 20%. Response rates for the combination of gemcitabine plus cisplatin are approximately 28%-54% in phase II trials. Recently, this combination has been studied in randomized phase II and III trials revealing improvements in response rates, time to progression and, in the phase III trial, survival. Current and future studies are evaluating gemcitabine in non-cisplatin combinations (i.e., taxanes).

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“…Recent trials of new anticancer drugs have indicated that some non-platinum-based combinations are almost as active as CDDP-based chemotherapy regimens, but are less toxic. In particular, the GEM/VNR combination has been shown to be well tolerated by patients, and to be very active (Non-small Cell Lung Cancer Collaborative Group 1995;Lorusso et al 1998;Feliu et al 1999;Isokangas et al 1999;Beretta et al 2000;Chen et al 2000;Frasci et al 2000;Lorusso et al 2000;Krajnik et al 2000;Herbst et al 2002;Gridelli et al 2003), and thus might be a good alternative to CDDP-based chemotherapy regimens. A new nonplatinum sequential triplet combination, GEM and VNR, followed by DOC, was recently evaluated in a JMTO phase II study, and was found to be well tolerated, with one of the highest response rates yet reported for treatment of advanced NSCLC (JMTO LC00-02; Hosoe et al 2003).…”

Section: Discussionmentioning

confidence: 99%

“…Recently, new chemotherapeutic agents, such as the taxanes, vinorelbine (VNR), gemcitabine (GEM), and several non-platinum combinations have been developed for the treatment of NSCLC. The new non-platinum combination of GEM plus VNR has been shown to be active for the treatment of NSCLC, and seems to be less toxic than platinum-based combinations, including those involving CDDP (Non-small Cell Lung Cancer Collaborative Group 1995; Lorusso et al 1998;Feliu et al 1999;Isokangas et al 1999;Beretta et al 2000;Chen et al 2000;Frasci et al 2000;Lorusso et al 2000;Krajnik et al 2000;Herbst et al 2002;Gridelli et al 2003). Treatment with docetaxel (DOC) alone has also been shown to confer a survival benefit, especially as a second-line treatment (Roszkowski et al 2000).…”

Section: Introductionmentioning

confidence: 99%

Efficacy, toxicity and cost analysis for non-platinum triplet (gemcitabine and vinorelbine, followed by docetaxel) vs. platinum-based chemotherapy in IIIB/IV non-small-cell lung cancer: single-institution experience

et al. 2008

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A new non‐platinum sequential triplet combination chemotherapy regimen, comprising gemcitabine (1000 mg/m2) and vinorelbine (25 mg/m2), followed by docetaxel (60 mg/m2), was compared in terms of efficacy, toxicity and cost with platinum‐based chemotherapy regimens (comprising cisplatin plus one or more other anti‐tumour drugs) for the treatment of advanced non‐small‐cell lung cancer in a matched, small‐sample size, case–control study. Patients were selected from a single institution. Patients in the platinum and non‐platinum groups were matched for clinical stage (IIIB/IV), performance status (0/1), age and sex. For the non‐platinum and platinum groups, the overall response rates were 40% and 47%, and the median survival times were 14 and 14.5 months respectively. The most common grade 3–4 toxicity was neutropenia (27%) in the non‐platinum group and nausea/vomiting (67%) in the platinum group. The total treatment cost did not differ significantly between the two groups. The non‐platinum sequential triplet combination chemotherapy regimen studied was shown to be as effective as the traditional cisplatin‐based combination chemotherapy regimen, and was associated with less toxicity.

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Phase III study of gemcitabine (GEM) plus vinorelbine (NAV) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC)

Cited by 5 publications

References 0 publications

Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin

Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin

Gemcitabine: Single-Agent and Combination Therapy in Non-Small Cell Lung Cancer

Efficacy, toxicity and cost analysis for non-platinum triplet (gemcitabine and vinorelbine, followed by docetaxel) vs. platinum-based chemotherapy in IIIB/IV non-small-cell lung cancer: single-institution experience

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