Phase II trial of single-agent oral vinorelbine in elderly (> or =70 years) patients with advanced non-small-cell lung cancer and poor performance status.
Phase II trial of single-agent oral vinorelbine in elderly (> or =70 years) patients with advanced non-small-cell lung cancer and poor performance status.
复制标题
单药口服长春瑞滨治疗老年(≥70 岁)晚期非小细胞肺癌且体力状态不佳的 II 期试验。
作者:
A. Camerini;C. Valsuani;F. Mazzoni;O. Siclari;C. Puccetti;S. Donati;M. Rondini;G. Tartarelli;P. Puccinelli;F. D. Costanzo;D. Amoroso
BACKGROUND
Elderly patients with advanced non-small-cell lung cancer (NSCLC) with poor performance status (PS) are a special population requiring particular attention. Single-agent oral vinorelbine could be an attractive option.
PATIENTS AND METHODS
A total of 43 patients with stage IIIB-IV NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of two or more with good functional status were prospectively recruited. Oral vinorelbine was administered at the dose of 60 mg/m(2) on days 1-8 every 3 weeks. Primary end points were response rate and safety.
RESULTS
Overall response rate was 18.6% with 8 partial responses; 18 of 43 (41.8%) experienced stable disease lasting >12 weeks and 17 of 43 (39.6%) disease progression for an overall clinical benefit of 60.4%. Median time to progression was 4.0 (range 2-22) months and median overall survival 8.0 (range 3-35) months. Treatment was well tolerated. Of 187 cycles, we did not observe any grade 3/4 toxicity with the exception of a single not-febrile G3 neutropenia. Regardless of severity, main toxic effects observed were nausea in 48.1% and vomiting in 22.9% of patients, anemia in 43.2%, fatigue in 32.6% and leukopenia in 23.2%.
CONCLUSION
Single-agent oral vinorelbine is extremely safe in elderly patients with advanced NSCLC and ECOG PS of two or more and may represent a valid option in this very special population.
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影响因子:
45.3
作者:
ALBAIN, KS;CROWLEY, JJ;LIVINGSTON, RB
通讯作者:
LIVINGSTON, RB
影响因子:
5.3
作者:
Kanard, A;Jatoi, A;Kugler, JW
通讯作者:
Kugler, JW
影响因子:
45.3
作者:
Lilenbaum, RC;Herndon, JE;Green, MR
通讯作者:
Green, MR
影响因子:
45.3
作者:
Bunn, PA
通讯作者:
Bunn, PA
影响因子:
158.5
作者:
Schiller, JH;Harrington, D;Johnson, DH
通讯作者:
Johnson, DH