Radiosensitization with carboplatin for patients with unresectable stage III non-small-cell lung cancer: A phase III trial of the Cancer and Leukemia Group B and the Eastern Cooperative Oncology Group

Radiosensitization with carboplatin for patients with unresectable stage III non-small-cell lung cancer: A phase III trial of the Cancer and Leukemia Group B and the Eastern Cooperative Oncology Group
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DOI:
10.1200/jco.1999.17.1.4
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发表时间:
1999-01-01
影响因子:
45.3
通讯作者:
Green, MR
Green, MR
中科院分区:
医学1区
文献类型:
--
作者:
Clamon, G;Herndon, J;Green, MR

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目的:确定卡铂与放射治疗同时应用是否能提高不可手术的Ⅲ期非小细胞肺癌患者的生存率。 患者与方法:283例不可手术的Ⅲ期非小细胞肺癌患者由癌症与白血病B组和东部肿瘤协作组纳入一项随机试验。在任何治疗开始前进行随机分组。所有患者接受长春碱和顺铂诱导化疗方案5周,随后在6周内接受6000 cGy的放射治疗。137例患者被随机分配仅接受此治疗方案;146例患者被随机分配在接受放射治疗的同时接受100 mg/m²/周的卡铂。 结果:同时应用卡铂的完全缓解率为18%,而单独放疗为10%(P = 0.101)。在4年时,无失败生存率(卡铂组为10%,单独放疗组为9%)或总生存率(卡铂组为13%,单独放疗组为10%)方面没有差异。在未接受卡铂的患者中,放射野内复发率为69%,加量照射区域为53%。在接受卡铂的患者中,放射野内复发率为59%,加量照射区域为43%。肿瘤大小超过70 cm²的患者生存率明显更差(P = 0.01)。 结论:所使用的剂量和疗程的卡铂对疾病控制或生存率没有显著影响。胸部内的复发率仍超过50%。需要更有效的方案来影响局部疾病控制和生存率。 《临床肿瘤学杂志》17:4 - 11。(C)1999年美国临床肿瘤学会。
Purpose: to determine whether the administration of carboplatin concurrently with radiation treatment improves survival in patients with inoperable stage III non-small-cell lung cancer.Patients and Methods: Two hundred eighty-three patients with inoperable stage ill non-small-cell lung cancer were entered onto a randomized trial by the Cancer and Leukemia Group B and the Eastern Cooperative Oncology Group. Randomization was performed before initiation of any therapy. All patients received an induction chemotherapy program with vinblastine and cisplatin for 5 weeks, followed by 6,000 cGy of radiation therapy over 6 weeks. One hundred thirty-seven patients were randomized to this therapy regimen alone; 146 patients were randomized to receive carboplatin at 100 mg/m(2)/wk concurrent with the radiation therapy.Results: The complete response was 18% with concurrent carboplatin versus 10% with radiotherapy alone (P = .101). There was no difference with respect to failure-free survival (10% with carboplatin and 9% with radiotherapy alone) or overall survival (13% with carboplatin and 10% with radiotherapy alone) at 4 years. In patients not receiving carboplatin, the relapse rate was 69% within the field of radiation and 53% in the boost volume. In patients receiving carboplatin, the relapse rare was 59% within the field of radiation and 43% in the boost volume. patients with cancers more than 70 cm(2) in size had significantly poorer survival (P = .01).Conclusion: Carboplatin at the dose and schedule used did not significantly impact on disease central or survival. The relapse rate within the chest remained more than 50%. More effective regimens will be required to impact on local disease central and survival.J Clin Oncol 17:4- 11. (C) 1999 by American Society of Clinical Oncology.