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癌症与白血病B组8935方案结果。一项针对IIIA期(N2)非小细胞肺癌的多机构II期三联疗法试验。癌症与白血病B组胸外科组

Results of cancer and leukemia group B protocol 8935. A multiinstitutional phase II trimodality trial for stage IIIA (N2) non-small-cell lung cancer. Cancer and Leukemia Group B Thoracic Surgery Group.

作者信息

Sugarbaker D J, Herndon J, Kohman L J, Krasna M J, Green M R

机构信息

Division of Thoracic Surgery, Brigham & Women's Hospital, Harvard Medical School, Boston, MA 02115.

出版信息

J Thorac Cardiovasc Surg. 1995 Mar;109(3):473-83; discussion 483-5. doi: 10.1016/s0022-5223(95)70278-4.

DOI:10.1016/s0022-5223(95)70278-4
PMID:7877308
Abstract

From October 1989 to February 1992, 74 patients with mediastinoscopically staged IIIA (N2) non-small-cell lung cancer from 30 CALGB-affiliated hospitals received two cycles of preresectional cisplatin and vinblastine chemotherapy. Patients with responsive or stable disease underwent standardized surgical resection and radical lymphadenectomy. Patients who underwent resection received sequential adjuvant therapy with two cycles of cisplatin and vinblastine, followed by thoracic irradiation (54 Gy after complete resection and 59.4 Gy after incomplete resection or no resection at 1.8 Gy per fraction). There were no radiographic complete responses to the neoadjuvant chemotherapy, although 65 (88%) patients had either a response or no disease progression. During induction chemotherapy, disease progressed in seven patients (9%). Sixty-three patients (86%) had exploratory thoracotomy, and 46 of those (75%) had resectable lesions. A complete surgical resection was accomplished in 23 patients, and 23 patients had an incomplete resection with either a diseased margin or diseased highest node resected. Operative mortality was 3.2% (2/63). In 10 patients (22% of the 46 having resection) the disease was pathologically downstaged. There was no correlation between radiographic response to the induction chemotherapy and downstaging at surgical resection. The full protocol was completed by 33 patients (45% of original cohort). Overall survival at 3 years was 23%. Patients undergoing resection had significantly improved survival at 3 years compared with patients not having resection: 46% for complete resection (median 20.9 months), 25% for incomplete resection (median 17.8 months), and 0% for no resection (median 8.5 months). Five deaths occurred during the treatment period. A total of 18 of the 46 (39%) patients who underwent resection are either alive and disease-free or have died without recurrence.

摘要

1989年10月至1992年2月,来自30家CALGB附属医院的74例经纵隔镜分期为IIIA期(N2)的非小细胞肺癌患者接受了两个周期的术前顺铂和长春碱化疗。疾病缓解或稳定的患者接受了标准化手术切除和根治性淋巴结清扫术。接受手术切除的患者接受了两个周期的顺铂和长春碱序贯辅助治疗,随后进行胸部放疗(完全切除后54 Gy,不完全切除或未切除后59.4 Gy,每次分割剂量1.8 Gy)。新辅助化疗未出现影像学完全缓解,尽管65例(88%)患者有缓解或疾病无进展。诱导化疗期间,7例患者(9%)疾病进展。63例患者(86%)接受了开胸探查,其中46例(75%)有可切除病灶。23例患者完成了完整的手术切除,23例患者进行了不完全切除,切除边缘或最高病变淋巴结有病变。手术死亡率为3.2%(2/63)。10例患者(46例接受切除患者中的22%)疾病在病理上降期。诱导化疗的影像学反应与手术切除时的降期之间无相关性。33例患者(原队列的45%)完成了整个方案。3年总生存率为23%。与未接受切除的患者相比,接受切除的患者3年生存率显著提高:完全切除患者为46%(中位生存期20.9个月),不完全切除患者为25%(中位生存期17.8个月),未切除患者为0%(中位生存期8.5个月)。治疗期间有5例死亡。46例接受切除的患者中,共有18例(39%)存活且无疾病或死于无复发。

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