Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group.
Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group.
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DOI：
10.1093/jnci/91.1.66
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发表时间：
1999-01
期刊：
影响因子：
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通讯作者：
C. Gridelli;F. Perrone;C. Gallo;A. Rossi;F. Scognamiglio;C. Guida;S. Monfardini;G. Ianniello;V. Tinessa;M. G. Caprio;A. Santoro;L. Maiorino;M. Santoro;F. Piantedosi;L. Brancaccio;C. Crispino;S. Cigolari;M. Lanno;V. Angelini;L. Manzione;D. Bilancia;A. Dinota;G. Failla;R. Aiello;P. Tralongo;F. Figoli;L. Zuccarino;T. Pedicini;A. Febbraro;C. Zollo;L. Frontini;S. Zonato;G. Azzarello;O. Vinante;F. Castiglione;G. Porcile;A. Bearz;R. Sorio;M. Tonato;S. Darwish;E. Veltri;M. D'aprile;C. Curcio;M. Vasta;M. Clerici;G. Luporini;A. Farris;R. Iaffaioli;A. Favaretto;G. Gualtieri
中科院分区：
文献类型：
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作者：
C. Gridelli;F. Perrone;C. Gallo;A. Rossi;F. Scognamiglio;C. Guida;S. Monfardini;G. Ianniello;V. Tinessa;M. G. Caprio;A. Santoro;L. Maiorino;M. Santoro;F. Piantedosi;L. Brancaccio;C. Crispino;S. Cigolari;M. Lanno;V. Angelini;L. Manzione;D. Bilancia;A. Dinota;G. Failla;R. Aiello;P. Tralongo;F. Figoli;L. Zuccarino;T. Pedicini;A. Febbraro;C. Zollo;L. Frontini;S. Zonato;G. Azzarello;O. Vinante;F. Castiglione;G. Porcile;A. Bearz;R. Sorio;M. Tonato;S. Darwish;E. Veltri;M. D'aprile;C. Curcio;M. Vasta;M. Clerici;G. Luporini;A. Farris;R. Iaffaioli;A. Favaretto;G. Gualtieri
长春瑞滨是一种半合成的长春花生物碱，是治疗老年晚期非小细胞肺癌（NSCLC）的一种耐受性良好的药物。我们在一项多中心随机试验中探讨了这类患者的生活质量（QoL），该试验比较了长春瑞滨治疗与单独支持治疗。符合条件的患者年龄≥ 70岁，患有不适合放疗的IV期或IIIB期NSCLC，体能状态为0-2（完全活跃状态至能够完全自理但无法工作的状态）。长春瑞滨在21天治疗周期的第1天和第8天静脉给药，共6个周期。采用欧洲癌症研究和治疗组织问卷QLQ-C30和QLQ-LC 13评价生活质量，并通过拟合每个生活质量量表的线性混合模型分析生活质量数据。绘制生存曲线，并与Mantel-Haenszel检验进行比较。通过考克斯模型估计死亡的相对风险和95%置信区间（CI）。结果：研究者对结果不知情，由于入组率低而提前停止了试验。(From 1996年4月至1997年11月，350名目标患者中的191名被随机分配。分析了161例患者的数据。长春瑞滨治疗的患者在生活质量功能量表上的得分优于对照组患者，他们报告的肺癌相关症状较少，但报告的毒性相关症状更差。接受长春瑞滨治疗的患者具有统计学显著性（双侧P = .03）生存优势;长春瑞滨治疗组的中位生存期从21周增加到28周。长春瑞滨治疗患者死亡的相对风险为0.65（95% CI = 0.45-0.93）。结论长春瑞滨可提高老年晚期NSCLC患者的生存率，并可能改善患者的总体生活质量。
BACKGROUND Vinorelbine, a semisynthetic vinca alkaloid, represents a well-tolerated treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC). We explored the quality of life (QoL) of such patients in a multicenter randomized trial that compared vinorelbine treatment with supportive care alone. METHODS Eligible patients were 70 years of age or older, had stage IV or IIIB NSCLC that was ineligible for radiotherapy, and had a performance status of 0-2 (a status of fully active to a status of capable of all self-care but unable to work). Vinorelbine was given intravenously on days 1 and 8 of a 21-day treatment cycle, for a total of six cycles. QoL was evaluated with European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-LC13, and the QoL data were analyzed by fitting a linear mixed model for each QoL scale. Survival curves were plotted and were compared with the Mantel-Haenszel test. Relative hazards of death and 95% confidence intervals (CIs) were estimated by the Cox model. RESULTS Investigators, blinded to the results, stopped the trial early because of a low enrollment rate. (From April 1996 to November 1997, 191 of the 350 targeted patients were randomly assigned.) Data from 161 patients have been analyzed. Vinorelbine-treated patients scored better than control patients on QoL functioning scales, and they reported fewer lung cancer-related symptoms but reported worse toxicity-related symptoms. There was a statistically significant (two-sided P = .03) survival advantage for patients receiving vinorelbine; median survival increased from 21 to 28 weeks in the vinorelbine-treated group. The relative hazard of death for vinorelbine-treated patients was 0.65 (95% CI = 0.45-0.93). CONCLUSION Vinorelbine improves survival of elderly patients with advanced NSCLC and possibly improves overall QoL.