Perry M C, Eaton W L, Propert K J, Ware J H, Zimmer B, Chahinian A P, Skarin A, Carey R W, Kreisman H, Faulkner C
N Engl J Med. 1987 Apr 9;316(15):912-8. doi: 10.1056/NEJM198704093161504.
We conducted a prospective, randomized study to clarify the role of radiotherapy of the primary tumor in limited small-cell cancer of the lung. After stratification for sex and for performance score based on the ability to ambulate, patients were randomly assigned to receive initial radiotherapy plus chemotherapy, delayed radiotherapy plus chemotherapy, or chemotherapy alone. The chemotherapy consisted of cyclophosphamide, etoposide (VP-16-213), and vincristine, with doxorubicin subsequently replacing etoposide in alternate cycles 7 through 18. Chemotherapy was given every three weeks for 18 months. The radiotherapy comprised 4000 rad in four weeks, followed by a 1000-rad "boost" directed against residual disease. All patients received prophylactic whole-brain radiation. The patients enrolled totaled 426, and 399 were evaluable. There was a statistically significant difference in the frequency of complete responses in favor of the two radiotherapy regimens (P = 0.0013). Failure-free survival was also longer with these two regimens (P less than 0.001), as was the interval before treatment failure in the chest (P less than 0.001) and overall survival (P = 0.0099). As expected, toxic effects--chiefly neutropenia--were also increased. The addition of radiotherapy of the primary tumor to combination chemotherapy improved both complete-response rates and survival, with increased but acceptable toxicity.
我们进行了一项前瞻性随机研究，以阐明原发性肿瘤放疗在局限性小细胞肺癌中的作用。根据行走能力对性别和体能状态评分进行分层后，将患者随机分配接受初始放疗加化疗、延迟放疗加化疗或单纯化疗。化疗方案包括环磷酰胺、依托泊苷（VP - 16 - 213）和长春新碱，在第7至18个交替周期中阿霉素随后替代依托泊苷。每三周进行一次化疗，共18个月。放疗包括在四周内给予4000拉德，随后针对残留病灶给予1000拉德的“强化”放疗。所有患者均接受预防性全脑放疗。共纳入426例患者，其中399例可进行评估。两种放疗方案的完全缓解频率存在统计学显著差异（P = 0.0013），支持这两种放疗方案。这两种方案的无失败生存期也更长（P < 0.001），胸部治疗失败前的间隔时间（P < 0.001）和总生存期（P = 0.0099）也是如此。正如预期的那样，毒性作用——主要是中性粒细胞减少——也有所增加。在联合化疗中加入原发性肿瘤放疗可提高完全缓解率和生存率，同时毒性增加但仍可接受。
