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【drug-news】Lapatinib对晚期乳癌有效

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http://www.medscape.com/viewarticle/549986
Lapatinib Effective in Advanced Breast Cancer
December 28, 2006 — The experimental drug lapatinib (Tykerb, GlaxoSmithKline) doubled the median time to progression when added to capecitabine (Xeloda, Roche) in women with advanced HER2-positive breast cancer that had progressed after chemotherapy and trastuzumab (Herceptin, Genentech/Roche).

The results, from a trial involving 324 patients, are published in the December 28 issue of the New England Journal of Medicine. Preliminary findings were presented at the 2006 American Society of Clinical Oncology meeting and reported at that time by Medscape. The company-sponsored trial was stopped early by an independent data monitoring committee because of the positive results.

The patient population in this study — with advanced or metastatic HER2-positive breast cancer that has progressed despite chemotherapy and trastuzumab — represents the indication for which lapatinib is awaiting approval in the United States, the European Union, Switzerland, Australia, Canada, and New Zealand.

These patients have limited options, commented lead investigator Charles Geyer, MD, director of breast medical oncology at Allegheny General Hospital, in Pittsburgh, Pennsylvania. "Lapatinib combined with capecitabine has demonstrated superior efficacy over capecitabine alone in this group of patients, and we look forward to it being made available to women suffering from this devastating disease," he said in a news release.

Another of the trialists, David Cameron, MD, from the Western General Hospital in Edinburgh, Scotland, told Medscape that once lapatinib is approved, the combination of lapatinib plus capecitabine should be considered "standard of care" for this patient population. Capecitabine is already one of the standard treatments offered to these patients, he explained, and this trial shows adding lapatinib gave superior results.

Lapatinib is also considered to have potential in the treatment of earlier breast cancer, because of its novel mechanism of action, its oral administration, and also its penetration of the central nervous system (CNS). A huge study, aiming to recruit more than 3000 patients with early-stage HER2-positive breast cancer, has just begun to evaluate lapatinib as an adjuvant therapy. Known as the Tykerb Evaluation After Chemotherapy (TEACH), this study is also sponsored by the manufacturer. Dr. Cameron explained that this study would explore whether lapatinib fits into a similar therapeutic niche to that already occupied by trastuzumab, which very quickly became the standard of care.

Separately, lapatinib has also shown efficacy in inflammatory breast cancer, as previously reported by Medscape.

Study Terminated Early as Lapatinib Treatment Was Superior

The advanced breast cancer trial was terminated after an interim analysis showed superiority of the lapatinib group; the analysis was triggered by prespecified events and conducted for 2 years after enrollment started. The median time to progression was 8.4 months in the group taking lapatinib with capecitabine, compared with 4.4 months in the group treated with capecitabine alone (hazard ratio, 0.49; P < .001).

However, there was no difference in survival between the 2 groups, an accompanying editorial points out. There were 36 deaths in the combination-therapy group and 35 in the monotherapy group (hazard ratio, 0.92; P = .72).

The combination-therapy group had a higher tumor response rate (22% vs 14%; P = .09), and fewer patients had CNS metastases, although this difference was not statistically significant (4 vs 10 patients; P = .10).

The editorial notes that lapatinib has also shown activity as a single agent in patients with HER2-positive breast cancer with CNS metastases that are refractory to trastuzumab, adding: "This finding is important because HER2-positive tumors frequently spread to the CNS, where the tumor is sheltered from trastuzumab and most chemotherapeutic agents."

Adverse effects were similar in the 2 groups, except for diarrhea, rash, and dyspepsia, which were more common in the combination group. Less than 15% patients in both groups discontinued because of adverse effects.

Cardiac toxicity was minimal in both groups, the editorial notes, adding that this is a major adverse effect of trastuzumab. However, the trialists point out that there was a bias, as they had selected women who had normal cardiac function after having received various other therapies (including anthracyclines and taxanes) as well as trastuzumab. Also, since the duration of observation was limited, the possibility of late events cannot be excluded. "Nevertheless, the low incidence of adverse cardiac events is reassuring," they comment.

Dr. Cameron presented additional data from the same trial recently at the San Antonio Breast Cancer Symposium. This trial shows that women with advanced HER2-positive breast cancer as a group respond to lapatinib, he explained, but numerically only about half of the patients respond. Pressing questions include defining which ones respond and whether there is a way to identify them. As lapatinib is active against both HER1 and HER2, his team tested tumor samples for the HER1 protein to see whether there was any correlation between levels of this protein and response to treatment. "We found that there wasn't any, and so this protein is not useful for predicting response to therapy," he told Medscape. Further work is now under way to look at activated proteins and also to identify tumors that are resistant to trastuzumab. Finding a way to identify which patients will respond to lapatinib is important, he commented, as it will further refine the patient population that benefits.

Bevacizumab Also Shows Promise

In addition to lapatinib, the editorial highlights bevacizumab (Avastin, Genentech) as another targeted therapy that also shows "great promise in the treatment of breast cancer." However, while the development of lapatinib is directed at breast cancer, bevacizumab was first explored in, and has been approved for, the treatment of colorectal cancer. The 2 drugs also have very different mechanisms of action: lapatinib is targeted at HER1 and HER2, while bevacizumab acts on vascular endothelial growth factor and was the first approved angiogenesis inhibitor.

The editorial cites 2 studies in metastatic breast cancer in which bevacizumab, added to either paclitaxel or capecitabine, produced better results than either chemotherapy alone, However, there was no effect on overall survival in 1 study, and survival data from the other are incomplete.

This may eventually cause problems with patient access to these new therapies, the editorial suggests. All of the targeted therapies available to date are added onto conventional treatment, thus adding costs to the healthcare system. "When the goal is to improve the chance for a cure, these new treatments seem to be well worth the expenditure," comments editorialist Hyman Muss, MD, from the Vermont Cancer Center, in Burlington. "However, when the goal is to improve the quality of life or delay the time to progression by several months, as it is with many treatments for metastatic breast cancer, it is less clear whether the health system can and should bear these expenses."

N Engl J Med. 2006;355:2733-2743, 2783-2785.

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2006-12-28 22:53 浏览 : 995 回复 : 3

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本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。

2006-12-29 08:31

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Lapatinib Effective in Advanced Breast Cancer
Lapatinib对晚期乳腺癌有效

December 28, 2006 — The experimental drug lapatinib (Tykerb, GlaxoSmithKline) doubled the median time to progression when added to capecitabine (Xeloda, Roche) in women with advanced HER2-positive breast cancer that had progressed after chemotherapy and trastuzumab (Herceptin, Genentech/Roche).
2006,12,28－针对化疗和曲妥珠单抗 (赫塞汀,美国基因技术公司/罗氏)用药后，肿瘤有发展的HER2过表达的晚期乳腺癌患者，联合使用试验药物lapatinib (Tykerb，葛兰素史克)和卡培他滨 (希罗达，罗氏)能使肿瘤发展的平均时间延长一倍。

The results, from a trial involving 324 patients, are published in the December 28 issue of the New England Journal of Medicine. Preliminary findings were presented at the 2006 American Society of Clinical Oncology meeting and reported at that time by Medscape. The company-sponsored trial was stopped early by an independent data monitoring committee because of the positive results.
这项来自324名患者的试验结果发表在新英格兰药学杂志12月28期刊上。初步的发现在2006年美国临床肿瘤学会的会议上被提出并在当时的Medscape网站上报道。这项由Tykerb公司提供赞助的试验由于得到的阳性结果经独立数据监督委员会（IDMC）同意很早结束。

The patient population in this study — with advanced or metastatic HER2-positive breast cancer that has progressed despite chemotherapy and trastuzumab — represents the indication for which lapatinib is awaiting approval in the United States, the European Union, Switzerland, Australia, Canada, and New Zealand.
这项研究中的患者人数－通过化疗和曲妥珠单抗治疗仍然有发展的HER2过表达的晚期或转移性的乳腺癌患者－表明lapatinib正在美国、欧洲、瑞士、澳大利亚、加拿大和新西兰等待批准。

These patients have llimited options, commented lead investigator Charles Geyer, MD, director of breast medical oncology at Allegheny General Hospital, in Pittsburgh, Pennsylvania. "Lapatinib combined with capecitabine has demonstrated superior efficacy over capecitabine alone in this group of patients, and we look forward to it being made available to women suffering from this devastating disease," he said in a news release.
研究负责人Charles Geyer博士是宾夕法尼亚州匹兹堡Allegheny综合医院乳腺癌治疗主任，他指出这些患者可选择的治疗很有限。在一个新闻发布会上他说“Lapatinib联合卡培他滨用药被证明比单独使用卡培他滨的那组有效，我们期待那些患有这种绝症的妇女们能够使用上Lapatinib。”

Another of the trialists, David Cameron, MD, from the Western General Hospital in Edinburgh, Scotland, told Medscape that once lapatinib is approved, the combination of lapatinib plus capecitabine should be considered "standard of care" for this patient population. Capecitabine is already one of the standard treatments offered to these patients, he explained, and this trial shows adding lapatinib gave superior results.
另一个实验人员，来自苏格兰爱丁堡西部综合医院的David Cameron博士告知Medscape网站，一旦lapatinib获得批准，lapatinib和卡培他滨联合用药将被视为这类患者的“标准治疗方法”。他解释说，卡培他滨已是这类患者标准治疗方法之一，而这个试验显示增加了lapatinib以后疗效更好。

Lapatinib is also considered to have potential in the treatment of earlier breast cancer, because of its novel mechanism of action, its oral administration, and also its penetration of the central nervous system (CNS). A huge study, aiming to recruit more than 3000 patients with early-stage HER2-positive breast cancer, has just begun to evaluate lapatinib as an adjuvant therapy. Known as the Tykerb Evaluation After Chemotherapy (TEACH), this study is also sponsored by the manufacturer. Dr. Cameron explained that this study would explore whether lapatinib fits into a similar therapeutic niche to that already occupied by trastuzumab, which very quickly became the standard of care.
由于Lapatinib有新的作用机制，是口服给药，同时能渗透到中枢神经系统，被认为在治疗早期乳腺癌方面也有潜力。一项针对超过3000名HER2过表达的早期乳腺癌患者的大型试验刚刚开始，用以评价lapatinib作为辅助治疗药物的疗效。这项被称为TEACH（Tykerb化疗后评估）的研究也是由生产商赞助的。Cameron解释说，研究将探究lapatinib在相同的治疗态下，是否与那些已被曲妥珠单抗占有的相符，后者由于护理标准而相当快。（此句有待商榷）

Separately, lapatinib has also shown efficacy in inflammatory breast cancer, as previously reported by Medscape.
另外，据Medscape以前报道，lapatinib对于炎性乳腺癌也由疗效。

Study Terminated Early as Lapatinib Treatment Was Superior
由于Lapatinib疗效显著，研究很早就结束了。

The advanced breast cancer trial was terminated after an interim analysis showed superiority of the lapatinib group; the analysis was triggered by prespecified events and conducted for 2 years after enrollment started. The median time to progression was 8.4 months in the group taking lapatinib with capecitabine, compared with 4.4 months in the group treated with capecitabine alone (hazard ratio, 0.49; P < .001).
晚期乳腺癌试验的中间分析在显示了lapatinib组的优势以后结束，分析按照事先设计好的计划开始进行，在注册开始后进行了两年。同时服用lapatinib 和卡培他滨组的肿瘤发展的平均时间未8.4个月，而单独服用卡培他滨组的为4.4个月。（风险率，0.49; P < .001)。

However, there was no difference in survival between the 2 groups, an accompanying editorial points out. There were 36 deaths in the combination-therapy group and 35 in the monotherapy group (hazard ratio, 0.92; P = .72).
但是，一项相关评价指出，两组之间存活率并无明显区别。其中联合用药组死亡人数36人，单独用药组35人(风险率，0.92; P = .72)。

The combination-therapy group had a higher tumor response rate (22% vs 14%; P = .09), and fewer patients had CNS metastases, although this difference was not statistically significant (4 vs 10 patients; P = .10).
联合用药组的肿瘤反应率较高（22%对14%；P = .09），中枢神经系统转移偏少，虽然这种差别并不明显（4对10名患者；P = .10)。

The editorial notes that lapatinib has also shown activity as a single agent in patients with HER2-positive breast cancer with CNS metastases that are refractory to trastuzumab, adding: "This finding is important because HER2-positive tumors frequently spread to the CNS, where the tumor is sheltered from trastuzumab and most chemotherapeutic agents."
该社论指出，针对有中枢神经系统转移，曲妥珠单抗无疗效的HER2过表达乳腺癌患者，单独使用lapatinib时有活性，并补充说：“这项发现非常重要，因为HER2过表达的肿瘤常向中枢神经系统扩散，而在中枢神经系统，曲妥珠单抗和大多数化疗药物均对肿瘤无疗效。”

Adverse effects were similar in the 2 groups, except for diarrhea, rash, and dyspepsia, which were more common in the combination group. Less than 15% patients in both groups discontinued because of adverse effects.
除了腹泻、皮疹、消化不良在联合用药组更常见外，两组试验的副作用基本相同，其中都有不到15%的患者因副作用停药。

Cardiac toxicity was minimal in both groups, the editorial notes, adding that this is a major adverse effect of trastuzumab. However, the trialists point out that there was a bias, as they had selected women who had normal cardiac function after having received various other therapies (including anthracyclines and taxanes) as well as trastuzumab. Also, since the duration of observation was limited, the possibility of late events cannot be excluded. "Nevertheless, the low incidence of adverse cardiac events is reassuring," they comment.
两组的心脏毒性都很小，评价指出，且指出对于曲妥珠单抗来说是主要的副作用。但是，试验人员指出，这里有一个偏见，由于他们挑选的是在接受了其它多种治疗（包括蒽环类抗生素和紫衫烷）和曲妥珠单抗以后心功能正常的患者，同时，观察期是有限的，一些可能的后遗作用不能排除。“尽管如此，心脏副作用发生率很低仍然是令人鼓舞的。”

Dr. Cameron presented additional data from the same trial recently at the San Antonio Breast Cancer Symposium. This trial shows that women with advanced HER2-positive breast cancer as a group respond to lapatinib, he explained, but numerically only about half of the patients respond. Pressing questions include defining which ones respond and whether there is a way to identify them. As lapatinib is active against both HER1 and HER2, his team tested tumor samples for the HER1 protein to see whether there was any correlation between levels of this protein and response to treatment. "We found that there wasn't any, and so this protein is not useful for predicting response to therapy," he told Medscape. Further work is now under way to look at activated proteins and also to identify tumors that are resistant to trastuzumab. Finding a way to identify which patients will respond to lapatinib is important, he commented, as it will further refine the patient population that benefits.
Cameron博士在San Antonio乳腺癌专题会上也提供了近来这个试验的补充数据。这次的试验显示了HER2过表达的晚期乳腺癌一组的患者对lapatinib有应答，他解释说，但从数据来说，只有一半的患者有应答。当务之急是找出哪些有应答，且是否能找到一种方法来鉴别它们。由于lapatinib是HER1 和HER2的抑制剂，他们小组检测了肿瘤样品的HER1 蛋白，看蛋白水平与治疗应答之间是否有联系。“我们发现没任何联系，因此这个蛋白对于预测治疗应答没什么作用，”他告知Medscape。现在已在着手进一步的工作，寻找活性蛋白和对曲妥珠单抗有耐药性的肿瘤。找到一种方法来辨别哪些病人对lapatinib有应答非常重要，因为由此能进一步从中找出将受益的患者。

Bevacizumab Also Shows Promise
贝伐单抗同样显示了预期疗效。

In addition to lapatinib, the editorial highlights bevacizumab (Avastin, Genentech) as another targeted therapy that also shows "great promise in the treatment of breast cancer." However, while the development of lapatinib is directed at breast cancer, bevacizumab was first explored in, and has been approved for, the treatment of colorectal cancer. The 2 drugs also have very different mechanisms of action: lapatinib is targeted at HER1 and HER2, while bevacizumab acts on vascular endothelial growth factor and was the first approved angiogenesis inhibitor.
除lapatinib外，社论也强调贝伐单抗（Avastin, 美国基因技术）是在乳腺癌治疗中同样显示了显著疗效的另一种靶向治疗药物。“但是，lapatinib的研究开发是直接针对乳腺癌的，而贝伐单抗则首先探索并证实用于治疗结肠直肠癌。这两种药物同样具有明显不同的作用机制：lapatinib是以HER1 和HER2为靶点，而贝伐单抗作用于血管内皮生长因子，是首个被批准的血管生成抑制剂。

The editorial cites 2 studies in metastatic breast cancer in which bevacizumab, added to either paclitaxel or capecitabine, produced better results than either chemotherapy alone, However, there was no effect on overall survival in 1 study, and survival data from the other are incomplete.
社论引证了两项转移性乳腺癌的研究，贝伐单抗与紫杉醇或卡培他滨联用，疗效比单药化疗要好。但是，对其中一项研究的总存活数无影响，另一项研究中的存活数据也不完全。

This may eventually cause problems with patient access to these new therapies, the editorial suggests. All of the targeted therapies available to date are added onto conventional treatment, thus adding costs to the healthcare system. "When the goal is to improve the chance for a cure, these new treatments seem to be well worth the expenditure," comments editorialist Hyman Muss, MD, from the Vermont Cancer Center, in Burlington. "However, when the goal is to improve the quality of life or delay the time to progression by several months, as it is with many treatments for metastatic breast cancer, it is less clear whether the health system can and should bear these expenses."
社论暗示说，这可能成为这些新的治疗药物无法被用于病人的最终原因。迄今为止，所有可采用的靶向疗法都被加入常规治疗中，无疑增加了医药系统的费用。“当我们以提高治愈机会作为最终目标时，这些新疗法的支出就是值得的，”社评人，来自伯林顿佛蒙特癌症中心的Hyman Muss博士解释说。“但是，当我们以提高生活质量或延长数个月的肿瘤发展时间为最终目标时，由于针对转移性乳腺癌伴随了很多治疗，那么医疗系统是否能且是否必须承担这些费用就不那么确定了。

2006-12-29 16:32

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Lapatinib对晚期乳腺癌有效

2006,12,28－针对化疗和曲妥珠单抗 (赫塞汀,美国基因技术公司/罗氏)用药后，肿瘤有发展的HER2过表达的晚期乳腺癌患者，联合使用试验药物lapatinib (Tykerb，葛兰素史克)和卡培他滨 (希罗达，罗氏)能使肿瘤发展的平均时间延长一倍。

这项来自324名患者的试验结果发表在新英格兰药学杂志12月28期刊上。初步的发现在2006年美国临床肿瘤学会的会议上被提出并在当时的Medscape网站上报道。这项由Tykerb公司提供赞助的试验由于得到的阳性结果经独立数据监督委员会（IDMC）同意很早结束。

这项研究中的患者人数－通过化疗和曲妥珠单抗治疗仍然有发展的HER2过表达的晚期或转移性的乳腺癌患者－表明lapatinib正在美国、欧洲、瑞士、澳大利亚、加拿大和新西兰等待批准。

研究负责人Charles Geyer博士是宾夕法尼亚州匹兹堡Allegheny综合医院乳腺癌治疗主任，他指出这些患者可选择的治疗很有限。在一个新闻发布会上他说“Lapatinib联合卡培他滨用药被证明比单独使用卡培他滨的那组有效，我们期待那些患有这种绝症的妇女们能够使用上Lapatinib。”

另一个实验人员，来自苏格兰爱丁堡西部综合医院的David Cameron博士告知Medscape网站，一旦lapatinib获得批准，lapatinib和卡培他滨联合用药将被视为这类患者的“标准治疗方法”。他解释说，卡培他滨已是这类患者标准治疗方法之一，而这个试验显示增加了lapatinib以后疗效更好。

由于Lapatinib有新的作用机制，是口服给药，同时能渗透到中枢神经系统，被认为在治疗早期乳腺癌方面也有潜力。一项针对超过3000名HER2过表达的早期乳腺癌患者的大型试验刚刚开始，用以评价lapatinib作为辅助治疗药物的疗效。这项被称为TEACH（Tykerb化疗后评估）的研究也是由生产商赞助的。Cameron解释说，研究将探究lapatinib在相同的治疗态下，是否与那些已被曲妥珠单抗占有的相符，后者由于护理标准而相当快。（此句有待商榷）

另外，据Medscape以前报道，lapatinib对于炎性乳腺癌也由疗效。

由于Lapatinib疗效显著，研究很早就结束了。

晚期乳腺癌试验的中间分析在显示了lapatinib组的优势以后结束，分析按照事先设计好的计划开始进行，在注册开始后进行了两年。同时服用lapatinib 和卡培他滨组的肿瘤发展的平均时间未8.4个月，而单独服用卡培他滨组的为4.4个月。（风险率，0.49; P < .001)。

但是，一项相关评价指出，两组之间存活率并无明显区别。其中联合用药组死亡人数36人，单独用药组35人(风险率，0.92; P = .72)。

联合用药组的肿瘤反应率较高（22%对14%；P = .09），中枢神经系统转移偏少，虽然这种差别并不明显（4对10名患者；P = .10)。

该社论指出，针对有中枢神经系统转移，曲妥珠单抗无疗效的HER2过表达乳腺癌患者，单独使用lapatinib时有活性，并补充说：“这项发现非常重要，因为HER2过表达的肿瘤常向中枢神经系统扩散，而在中枢神经系统，曲妥珠单抗和大多数化疗药物均对肿瘤无疗效。”

除了腹泻、皮疹、消化不良在联合用药组更常见外，两组试验的副作用基本相同，其中都有不到15%的患者因副作用停药。

两组的心脏毒性都很小，评价指出，且指出对于曲妥珠单抗来说是主要的副作用。但是，试验人员指出，这里有一个偏见，由于他们挑选的是在接受了其它多种治疗（包括蒽环类抗生素和紫衫烷）和曲妥珠单抗以后心功能正常的患者，同时，观察期是有限的，一些可能的后遗作用不能排除。“尽管如此，心脏副作用发生率很低仍然是令人鼓舞的。”

Cameron博士在San Antonio乳腺癌专题会上也提供了近来这个试验的补充数据。这次的试验显示了HER2过表达的晚期乳腺癌一组的患者对lapatinib有应答，他解释说，但从数据来说，只有一半的患者有应答。当务之急是找出哪些有应答，且是否能找到一种方法来鉴别它们。由于lapatinib是HER1 和HER2的抑制剂，他们小组检测了肿瘤样品的HER1 蛋白，看蛋白水平与治疗应答之间是否有联系。“我们发现没任何联系，因此这个蛋白对于预测治疗应答没什么作用，”他告知Medscape。现在已在着手进一步的工作，寻找活性蛋白和对曲妥珠单抗有耐药性的肿瘤。找到一种方法来辨别哪些病人对lapatinib有应答非常重要，因为由此能进一步从中找出将受益的患者。

贝伐单抗同样显示了预期疗效。

除lapatinib外，社论也强调贝伐单抗（Avastin, 美国基因技术）是在乳腺癌治疗中同样显示了显著疗效的另一种靶向治疗药物。“但是，lapatinib的研究开发是直接针对乳腺癌的，而贝伐单抗则首先探索并证实用于治疗结肠直肠癌。这两种药物同样具有明显不同的作用机制：lapatinib是以HER1 和HER2为靶点，而贝伐单抗作用于血管内皮生长因子，是首个被批准的血管生成抑制剂。

社论引证了两项转移性乳腺癌的研究，贝伐单抗与紫杉醇或卡培他滨联用，疗效比单药化疗要好。但是，对其中一项研究的总存活数无影响，另一项研究中的存活数据也不完全。

社论暗示说，这可能成为这些新的治疗药物无法被用于病人的最终原因。迄今为止，所有可采用的靶向疗法都被加入常规治疗中，无疑增加了医药系统的费用。“当我们以提高治愈机会作为最终目标时，这些新疗法的支出就是值得的，”社评人，来自伯林顿佛蒙特癌症中心的Hyman Muss博士解释说。“但是，当我们以提高生活质量或延长数个月的肿瘤发展时间为最终目标时，由于针对转移性乳腺癌伴随了很多治疗，那么医疗系统是否能且是否必须承担这些费用就不那么确定了。

2006-12-29 16:33

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