Gefitinib (ZD1839) combined with gemcitabine or vinorelbine as single-agent in elderly patients with advanced non-small cell lung cancer (NSCLC)

Scagliotti, Giorgio V.; Rossi, Alessandra; Novello, S.; Marinis, Filippo de; Dogliotti, Luigi; Crinò, Lucio; Lorusso, V.; Martoni, A.; Paccagnella, Agostino; Gridelli, C.

doi:10.1200/jco.2004.22.90140.7081

Cited by 9 publications

(14 citation statements)

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“…Although there has been documentation of ineffectiveness of single-agent vinorelbine as salvage chemotherapy, 22 it was 1 of the few chemotherapeutic agents that had not been administered previously to our selected patient group; in addition, although severe myelosuppression leading to an unacceptable rate of febrile neutropenia had been reported in patients on concurrent gefitinib/vinorelbine/cisplatin or gefitinib/vinorelbine, very high response rates have been reported, 12,23 so that lowdose vinorelbine was selected for this clinical trial. The safety profiles in the current study of gefitinib plus low-dose vinorelbine were highly tolerable in our patients.…”

Section: Discussionmentioning

confidence: 99%

“…Large-scale, randomized Phase III studies of first-line combination use of doublet chemotherapy with gefitinib have taken place but have produced negative results. 10,11 Scagliotti et al 12 performed a prospective study combining gefitinib with single-agent gemcitabine (1200 mg/m 2 on Days 1 and 8 every 3 weeks) or vinorelbine (30 mg/m 2 on Days 1 and 8 every 3 weeks) in elderly patients with NSCLC. Those authors reported that vinorelbine plus gefitinib was too toxic to be tolerated by their patients.…”

mentioning

confidence: 99%

“…However, the response rate and median survival were higher for those patients who received vinorelbine plus gefitinib treatment. 12 In addition, a subset analysis of nonsmokers who received carboplatin/paclitaxel with or without erlotinib (another TKI) in the Tarceva Responses in Conjunction with Paclitaxel and Carboplatin (TRIBUTE) study revealed a markedly greater survival benefit for nonsmokers who received chemotherapy plus erlotinib compared with nonsmokers who received chemotherapy alone (median 22.5 months vs 10 months; P ¼ .01). 13,14 When developing a new anticancer drug, an important Phase II objective is to identify the most appropriate target population for a subsequent Phase III trial.…”

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confidence: 99%

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Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Chen

Liu

Chou

et al. 2007

Cancer

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BACKGROUND.The objective of this study was to assess the efficacy of adding chronic, intermittent, low‐dose vinorelbine to gefitinib treatment for patients who had adenocarcinoma of the lung who failed ≥2 regimens of chemotherapy.METHODS.Patients were randomized into 2 arms: Oral gefitinib 250 mg daily (the G arm) or vinorelbine 15 mg/m2 as an intravenous infusion on Day 1 and oral gefitinib 250 mg daily on Days 2 through 14 every 2 weeks (the GV arm). From August 2004 to October 2005, 48 patients were enrolled. Epidermal growth factor receptor (EGFR) exon 18 through 21 nucleotide sequence analysis and fluorescence in situ hybridization were performed in patients who had tumor tissue specimens available for analysis.RESULTS.After randomization, each arm had 24 patients. However, 3 patients refused vinorelbine treatment and were given gefitinib treatment only. Thus, 27 patients received G treatment, and 21 patients received GV treatment. Objective response rates were 55.6% in the G arm and 52.4% in the GV arm. All toxicities in both arms were mild. The 1‐year progression‐free survival rate was 57.1% in the GV arm and 21.2% in the G arm (P = .008). The median survival was 13.3 months in the G arm and 23.4 months in the GV arm (P = .1231). Three of 6 patients (50%) had an exon 19 in‐frame deletion, and 2 of 10 patients had EGFR gene high polysomy or amplification (20%).CONCLUSIONS.Gefitinib was highly effective in ethnic Chinese patients with adenocarcinoma of the lung who failed previous platinum and taxane treatment. The addition of low‐dose vinorelbine every 2 weeks produced a significantly better 1‐year progression‐free survival rate. Cancer 2007. © 2007 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Chen

Liu

Chou

et al. 2007

Cancer

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“…NSCLC remains the major cause of cancer-related Copin et al [58] Yes [60] Yes (94.5%) ≥ 70 18 0 (0) 2 (11) 4.4 None No (5.5%) Cappuzzo et al [61] Yes (100%) ≥ 70 40 2 (5) 18 (45) 5.0 G4 diarrhoea 2.5% Hotta et al [62] Yes (57%) ≥ [64] TXT 75 mg/m², day 1, Q3W Ⅱ 21 8 (38) 5 (24) 12.4 G3-4 toxicity 28.5% Scagliotti et al [65] GEM 1200 mg/m², days Jackman et al [67] No ( Buffoni L et al . NSCLC in elderly patients deaths.…”

Section: Resultsmentioning

confidence: 99%

“…A phase Ⅱ trial evaluated gefitinib with vinorelbine or gemcitabine. Vinorelbine plus gefitinib produced 72% of grade 3-4 neutropenia and 3 treatment-related deaths while the association with gemcitabine reported a lower activity (RR 5.7%, SD 14%, MST 9.1 mo) but a better safety profile (grade 3-4 neutropenia 11.4%; thrombocytopenia 8.6%, asthenia and diarrhoea 5.7%) [65,66] (Table 6). …”

Section: Egfr Tyrosine Kinase Inhibitorsmentioning

confidence: 99%

Advanced non-small cell lung cancer in elderly patients: A review

Buffoni¹

2015

WJR

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Over 50% of patients diagnosed with non-smallcell lung cancer (NSCLC) are 65 years old while 30% exceed 70 years old. Comparing elderly patients to their younger counterpart they poorly tolerate chemotherapy due to progressive reduction of organ function and age-related co-existing pathologies. Due to this reason elderly are usually excluded from platinum-based chemotherapy, which still represent the standard of care for advanced NSCLC. In every-day practice, single-agent schedule with a third-generation drug is the recommended option for elderly patients with advanced NSCLC. A modest increase in toxicity for elderly patients has been demonstrated by subgroup analyses concluding for platinum-based combination chemotherapy being similar in young patients and fit elderly. Even though the cited evidence, feasibility of chemotherapy based on platinum remains an open question. Prospective randomised trials are warranted in order to change guide lines and give the clinicians a new therapeutic option. Recent emerging role of molecular target in selecting patients for new targeted therapies suggest dedicated trials for elderly patients. The same is for more accurate evaluation of elderly patients with increasing evidence for a comprehensive geriatric assessment as a valid tool for customized treatment in NSCLC elderly patients. Suitable evidences for the treatment of elderly patients affected by advanced NSCLC together with more appropriate and validated tools for patients selection are reviewed along the manuscript.

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Histopathology of aspirated thrombus and its association with ST‐segment recovery in patients undergoing primary percutaneous coronary intervention with routine thrombus aspiration

Verouden¹,

Kramer²,

Li³

et al. 2010

Cathet Cardio Intervent

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Gefitinib (ZD1839) combined with gemcitabine or vinorelbine as single-agent in elderly patients with advanced non-small cell lung cancer (NSCLC)

Cited by 9 publications

References 0 publications

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Phase II randomized study of daily gefitinib treatment alone or with vinorelbine every 2 weeks in patients with adenocarcinoma of the lung who failed at least 2 regimens of chemotherapy

Advanced non-small cell lung cancer in elderly patients: A review

Histopathology of aspirated thrombus and its association with ST‐segment recovery in patients undergoing primary percutaneous coronary intervention with routine thrombus aspiration

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