Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma.
Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma.
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DOI：
10.1038/sj.bjc.6600118
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发表时间：
2002-02-01
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
恶性胸膜间皮瘤是一个臭名昭著的化疗耐药肿瘤。然而，最近的一项单机构研究显示，吉西他滨和顺铂的活性令人印象深刻。我们的目的是研究吉西他滨和顺铂联合治疗组织学证实的恶性胸膜间皮瘤的疗效和毒性。方法：吉西他滨1250 mg m−2在第1天和第8天给药，顺铂80 mg m−2在第1天给药，3周为1周期，最多6个周期。根据WHO和NCIC-CTC标准进行缓解和毒性评价。对病理学和放射学进行集中审查。结果显示，在25例可评价患者中，观察到4例PR（ORR 16%，95% CI 1-31%）。7名患者的反应无法评价。未发生非预期毒性。至进展时间为6个月（5-7个月），自登记起的中位生存期为9. 6个月（95% CI 8-12个月）。总之，本试验以90%的把握度排除了以拟定剂量和方案联合使用吉西他滨和顺铂的恶性胸膜间皮瘤患者的缓解率大于30%。英国癌症杂志（2002）86，342-345。DOI：10.1038/sj/bjc/6600118 www.bjcancer.com © 2002癌症研究运动
Malignant pleural mesothelioma is a notoriously chemoresistant tumour. However, a recent single institution study showed an impressive activity of gemcitabine and cisplatin. Our aim is to investigate the efficacy and toxicity of a gemcitabine and cisplatin combination in selected and chemo-naive patients with histologically proven malignant pleural mesothelioma. Method: Gemcitabine 1250 mg m−2 was administered on day 1 and day 8 and cisplatin 80 mg m−2 was administered on day 1 in a 3-week cycle with a maximum of six cycles. Response and toxicity evaluations were performed according to WHO and NCIC-CTC criteria. Pathology and radiology were centrally reviewed. Results show that in 25 evaluable patients, four PR were observed (ORR 16%, 95% CI 1–31%). Responses of seven patients were unevaluable. No unexpected toxicity occurred. Time to progression was 6 months (5–7 months) with a median survival from registration of 9.6 months (95% CI 8–12 months). In conclusion this trial excludes with 90% power a response rate of greater than 30% in patients with malignant pleural mesothelioma using a combination of gemcitabine and cisplatin at the proposed dose and schedule. British Journal of Cancer (2002) 86, 342–345. DOI: 10.1038/sj/bjc/6600118 www.bjcancer.com © 2002 The Cancer Research Campaign
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影响因子：
8.4
作者：
BERGMAN, B;AARONSON, NK;SULLIVAN, M
通讯作者：
SULLIVAN, M
影响因子：
45.3
作者：
Steele, JPC;Shamash, J;Rudd, RM
通讯作者：
Rudd, RM
影响因子：
3.7
作者：
KAPLAN, EL;MEIER, P
通讯作者：
MEIER, P
DOI：
10.1093/jnci/85.5.365
发表时间：
1993-03-03
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
AARONSON, NK;AHMEDZAI, S;TAKEDA, F
通讯作者：
TAKEDA, F
影响因子：
45.3
作者：
Curran, D;Sahmoud, T;Giaccone, G
通讯作者：
Giaccone, G