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Hyperfractionated Radiotherapy Following Induction Chemotherapy for Stage III Non-Small Cell Lung Cancer: Random iced for Adjuvant Chemotherapy vs. Observation

机译:III期非小细胞肺癌诱导化疗后的超分割放疗:随机冰辅助化疗与观察

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Since Jan. 1991 a prospective randomized study for Stage III unresectable non small cell lung cancer(NSCLC) has been conducted to evaluate the response rate and tolerance of induction chemotherapy with MVP followed by hyperfractionated radiotherapy and evaluate the efficacy of maintenance chemotherapy in Asan Medical Center. All patients in this study were treated with hypefractionated radiotherapy (120 cGy/fx BID, 0480 cGy/54 fx) following 3 cycles of induction chemotherapy, MVP (Mitomycin C 6 mg/m2, Vinblastin B mg/ m2, Cisplatin 60 Mg/ m2) and then the partial and complete responders from induction chemotherapy were randomized to 3 cycles of adjuvant MVP chemotherapy group and observation group. 48 patients were registered to this study until December 1992; among 48 patients 3 refused further treatment after induction chemotherapy and 6 received incomplete radiation therapy because of patient's refusal, 39 completed planned therapy. Twenty-three(58%) patients including 2 complete responders showed response from induction chemotherapy. Among the 21 patients who achieved a partial response after induction chemotherapy, 1 patient rendered complete clearance of disease and 10 patients showed further regression of tumor following hypefractionated radiotherapy. Remaining 10 patients showed stable disease or progression after radiotherapy. Of the sixteen patients judged to have stable disease or progression after induction chemotherapy, seven showed more than partial remission after radiotherapy but nine showed no response in spite of radiotherapy. Of the 35 patients who completed induction chemotherapy and radiotherapy, 25 patients(64%) including 3 complete responders showed more than partial remission. Nineteen patients were randomized after radiotherapy. Nine patients were allocated to adjuvant chemotherapy group and 4/9 shewed further regression of tumor after adjuvant chemotherapy. For the time being, there is no suggestion of a difference between the adjuvant chemotherapy group and observation group in distant metastasis rate and survival. Median survival time was 13 months. Actuarial survival rates at 6, 12 and 18 months of 39 patients who completed this study were 84.6%, 53.7% and 40.3%, respectively. The partial and complete responders from induction chemotherapy showed significantly bettor survival than non-responders(p=0.028). Incidence of radiation pneumonitis in this stuffy group was less than that in historical control group inspite of induction chemotherapy. All patients tolerated hyperfractionated radiotherapy without definite increase of acute complications compared with conventional radiotherapy group. The longer fellow up is needed to evaluate the efficacies of induction and maintenance chemotherapy and survival advantage by hypefractionated radiotherapy but authors are encouraged with an excellent tolerance, higher response rate and improvement of one year survival rate in patients of this study.
机译:自1991年1月以来,已进行了一项针对III期不可切除的非小细胞肺癌(NSCLC)的前瞻性随机研究,以评估MVP诱导化疗后超分割放疗的反应率和耐受性,并评估在Asan Medical Center维持化疗的疗效。该研究中的所有患者在诱导化疗的3个周期后均接受超分割放疗(120 cGy / fx BID,0480 cGy / 54 fx),MVP(丝裂霉素C 6 mg / m2,长春花碱B mg / m2,顺铂60 Mg / m2 ),然后将诱导化疗的部分和完全应答者随机分为辅助MVP化疗组和观察组的3个周期。直到1992年12月,已有48例患者登记到该研究中。在48例患者中,有3例在诱导化疗后拒绝进一步治疗,有6例由于患者拒绝接受了不完全放疗,其中39例已完成计划治疗。 23名患者(58%)包括2名完全缓解者显示了诱导化疗的缓解。在21例诱导化疗后部分缓解的患者中,有1例患者完全清除了疾病,另有10例患者在超分割放疗后显示出肿瘤的进一步消退。其余10例患者放疗后显示稳定的疾病或进展。在16例经诱导化疗后疾病或进展稳定的患者中,有7例在放疗后表现出部分缓解,但有9例尽管进行了放疗也无反应。在完成诱导化疗和放疗的35例患者中,包括3名完全缓解者在内的25例患者(64%)表现出部分缓解。放疗后将19例患者随机分组。 9例患者被分配到辅助化疗组,辅助化疗后4/9显示肿瘤进一步消退。目前,尚无辅助化疗组和观察组在远处转移率和生存率方面的差异的建议。中位生存时间为13个月。完成这项研究的39名患者在6、12和18个月时的精算生存率分别为84.6%,53.7%和40.3%。诱导化疗的部分和完全反应者的投注者存活率显着高于无反应者(p = 0.028)。尽管诱导化疗,该闷组的放射性肺炎发生率低于历史对照组。与常规放疗组相比,所有患者均耐受超分割放疗,而没有明显增加急性并发症。需要更长的时间来评估超分割放疗的诱导和维持化学疗法的疗效以及生存优势,但是对于这项研究的患者,作者具有出色的耐受性,更高的缓解率和一年生存率的提高,受到鼓舞。

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