Lee J S, Komaki R, Fossella F V, Glisson B S, Hong W K, Cox J D
Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
Int J Radiat Oncol Biol Phys. 1998 Oct 1;42(3):479-86. doi: 10.1016/s0360-3016(98)00247-8.
To improve the outcome of patients with locally advanced inoperable non-small cell lung cancer (NSCLC), we conducted a pilot trial of concurrent chemoradiation therapy using a cisplatin and oral etoposide regimen given concurrently with hyperfractionated radiation therapy.
In this single-institution pilot trial, we enrolled 23 patients with inoperable Stage IIIa (4) and IIIb (19) NSCLC. Treatment consisted of two cycles of chemotherapy with oral etoposide 50 mg one day alternating with 50 mg b.i.d. (50 mg/day if BSA is < 1.70 m2) on days 1-21 and intravenous cisplatin (40 mg/m2) on days 1 and 8 of a 28-day cycle. Radiation therapy was given twice a day (1.2 Gy per fraction), 5 days a week, to a total dose of 69.6 Gy in 58 fractions over 6 weeks.
Overall, 18 (78%) of the 23 patients completed the chemotherapy as planned and 21 (91%) received thoracic irradiation per protocol. One patient died of radiation pneumonitis. Fourteen (78%) of 18 evaluable patients achieved objective responses. The median survival duration was 9.3 months for all patients and 20.2 months for 15 patients who had no more than 5% weight loss. After a minimum follow-up of 5 years, five patients (1 IIIa, 4 IIIb) are still alive and disease-free, which gives an actual 5-year survival rate of 22%. Four of the five 5-year survivors were among those who completed the treatment as planned.
This long-term survival outcome compares favorably with that of other chemoradiation therapy trials and even with those reported in multimodality trials including surgery. These results suggest that intensive concurrent chemoradiation therapy is feasible, and some patients with locally advanced inoperable NSCLC may enjoy long-term survivorship following nonsurgical therapy.
为改善局部晚期不可手术切除的非小细胞肺癌（NSCLC）患者的治疗效果，我们开展了一项同步放化疗的试点试验，采用顺铂和口服依托泊苷方案并与超分割放疗同时进行。
在这项单机构试点试验中，我们纳入了23例不可手术切除的Ⅲa期（4例）和Ⅲb期（19例）NSCLC患者。治疗包括两个周期的化疗，口服依托泊苷50mg，第1天服用，之后第2天起每日两次，每次50mg（如果体表面积<1.70m²，则每日50mg），在第1 - 21天给药，静脉注射顺铂（40mg/m²）在28天周期的第1天和第8天给药。放疗每天进行两次（每次1.2Gy），每周5天，在6周内分58次给予总剂量69.6Gy。
总体而言，23例患者中有18例（78%）按计划完成了化疗，21例（91%）按方案接受了胸部照射。1例患者死于放射性肺炎。18例可评估患者中有14例（78%）获得了客观缓解。所有患者的中位生存时间为9.3个月，15例体重减轻不超过5%的患者中位生存时间为20.2个月。经过至少5年的随访，5例患者（1例Ⅲa期，4例Ⅲb期）仍存活且无疾病，实际5年生存率为22%。5例5年生存者中有4例是按计划完成治疗的患者。
这一长期生存结果与其他放化疗试验相比，甚至与包括手术在内的多模式试验报告的结果相比都更有利。这些结果表明，强化同步放化疗是可行的，一些局部晚期不可手术切除的NSCLC患者在非手术治疗后可能获得长期生存。
