Physicians in England and Wales may not prescribe four drugs as first- or second-line treatment for advanced or metastatic renal cell carcinomas, under guidance published Aug. 26.
The National Institute for Health and Clinical Excellence stated that bevacizumab, sorafenib and temsirolimus cannot be used as first-line treatment, and sorafenib and sunitinib cannot be used as second-line treatment.
NICE stated that although the evidence shows bevacizumab plus interferon alfa-2a, temsirolimus, and sorafenib all were superior to existing treatment in certain subgroups, none has demonstrated cost-effectiveness, with cost estimates reaching well over U.K. £100,000 per quality-adjusted life-year. The usual limit is £30,000 per quality-adjusted-life year. The agency has more flexibility with life-extending end-of-life treatments such as the ones considered for renal cell carcinomas, however.
While temsirolimus as a first-line treatment and sorafenib as a second-line treatment for people with advanced disease in whom immunotherapy has failed qualified for more flexible cost-effectiveness standards, NICE’s assessment committee said it could not justify increases in quality of life assumptions necessary to meet the cost-effectiveness thresholds.
As with all of its guidelines, NICE stated that patients currently being treated for renal cell carcinoma with the drugs can continue to do so “until they and their clinicians consider it appropriate to stop.”
The agency also issued a final guideline authorizing the use of cetuximab in combination with 5-fluorouracil, folinic acid, and oxaliplatin as a first-line treatment of metastatic colorectal cancer.
The medication is allowed only when the primary tumor has been resected or is potentially operable and the metastatic disease is confined to the liver and is unresectable. The patient must also be fit enough to undergo surgery to resect the primary tumor and to undergo liver surgery if the metastases become resectable after treatment with cetuximab. Further, the manufacturer must rebate 16% of the amount of cetuximab used on a per patient basis.
The same guidance authorized cetuximab in combination with 5-fluorouracil, folinic acid, and irinotecan.
The irinotecan combination is allowed in patients unable to tolerate oxaliplatin or for whom oxaliplatin is contraindicated. The irinotecan combination is allowed under similar conditions as the oxaliplatin combination, except that rebate is not required.
Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
8月26日公布的一份指南指出：在英格兰和威尔士，医生不得将4种药物作为晚期或转移性肾细胞癌的一线或二线治疗药物。
英国国家卫生与临床优化研究所(NICE)声明称，贝伐单抗(bevacizumab)、索拉非尼(sorafenib)、驮瑞塞尔(temsirolimus/Torisel®)不能用作一线方案，索拉非尼和舒尼替尼(sunitinib)则不可作为二线方案使用。
NICE指出，尽管有证据表明贝伐单抗、α干扰素-2a、驮瑞塞尔和索拉非尼治疗某些亚型的肾细胞癌均优于现有方案，但都不具备成本疗效优势，其估算费用均大大超过每质量调整生命年10万英镑，而通常的上限则为每质量调整生命年3万英镑。该机构在肾细胞癌等的终末期延长生命疗法的药物选择上可以有较大的自由。
尽管驮瑞塞尔和索拉非尼分别作为免疫治疗失败后晚期肾癌患者的一线方案和二线方案，满足更为灵活的成本疗效标准，但NICE评审委员会说，这与符合成本疗效阈值所必须的预期生活质量的提升并不相称。
正如在所有的指南中所声明的，NICE指出目前正在接受治疗的肾细胞癌患者可继续现有方案，“直到患者和医生认为应停止治疗。”
该机构还发布一份最终指南，批准西妥昔单抗联合5-氟尿嘧啶、亚叶酸钙、奥沙利铂作为转移性结直肠癌的一线治疗方案。
该方案仅允许用于原发肿瘤已被切除或将被切除、转移灶限于肝脏且不可切除的结直肠癌患者。而且如果经西妥昔单抗治疗后转移灶可以切除时，患者必须能够经受原发肿瘤灶及肝转移灶的切除手术。此外，制药商必须向每个使用西妥昔单抗的患者退16%的费用。
该指南还批准了西妥昔单抗联合5-氟尿嘧啶、亚叶酸钙、伊立替康的方案。
联合伊立替康允许用于不能耐受或禁忌使用奥沙利铂的患者。其适应证与上述联合奥沙利铂的方案类似，但不需要退费。
爱思唯尔 版权所有
