Ardizzoni A, Grossi F, Scolaro T, Giudici S, Foppiano F, Boni L, Tixi L, Cosso M, Mereu C, Ratto G B, Vitale V, Rosso R
Division of Medical Oncology I, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
Br J Cancer. 1999 Sep;81(2):310-5. doi: 10.1038/sj.bjc.6990693.
Both induction chemotherapy and concurrent low-dose cisplatin have been shown to improve results of thoracic irradiation in the treatment of locally advanced non-small-cell lung cancer (NSCLC). This phase II study was designed to investigate activity and feasibility of a novel chemoradiation regimen consisting of induction chemotherapy followed by standard radiotherapy and concurrent daily low-dose cisplatin. Previously untreated patients with histologically/cytologically proven unresectable stage IIIA/B NSCLC were eligible. Induction chemotherapy consisted of vinblastine 5 mg m(-2) intravenously (i.v.) on days 1, 8, 15, 22 and 29, and cisplatin 100 mg m(-2) i.v. on days 1 and 22 followed by continuous radiotherapy (60 Gy in 30 fractions) given concurrently with daily cisplatin at a dose of 5 mg m(-2) i.v. Thirty-two patients were enrolled. Major toxicity during induction chemotherapy was haematological: grade III-IV leukopenia was observed in 31% and grade II anaemia in 16% of the patients. The most common severe toxicity during concurrent chemoradiation consisted of grade III leukopenia (21% of the patients); grade III oesophagitis occurred in only two patients and pulmonary toxicity in one patient who died of this complication. Eighteen of 32 patients (56%, 95% CI 38-73%) had a major response (11 partial response, seven complete response). With a median follow-up of 38.4 months, the median survival was 12.5 months and the actuarial survival rates at 1, 2 and 3 years were 52%, 26% and 19% respectively. The median event-free survival was 8.3 months with a probability of 40%, 23% and 20% at 1, 2 and 3 years respectively. Induction chemotherapy followed by concurrent daily low-dose cisplatin and thoracic irradiation, in patients with locally advanced NSCLC, is active and feasible with minimal non-haematological toxicity. Long-term survival results are promising and appear to be similar to those of more toxic chemoradiation regimens, warranting further testing of this novel chemoradiation strategy.
诱导化疗和同步低剂量顺铂已被证明可改善局部晚期非小细胞肺癌（NSCLC）胸部放疗的疗效。本II期研究旨在探讨一种新型放化疗方案的活性和可行性，该方案包括诱导化疗，随后进行标准放疗以及同步每日低剂量顺铂治疗。符合条件的为先前未经治疗、经组织学/细胞学证实为不可切除的IIIA/B期NSCLC患者。诱导化疗包括在第1、8、15、22和29天静脉注射长春碱5mg/m²，在第1天和第22天静脉注射顺铂100mg/m²，随后进行连续放疗（60Gy，分30次），同时每日静脉注射顺铂5mg/m²。共纳入32例患者。诱导化疗期间的主要毒性为血液学毒性：31%的患者出现III-IV级白细胞减少，16%的患者出现II级贫血。同步放化疗期间最常见的严重毒性为III级白细胞减少（21%的患者）；仅2例患者出现III级食管炎，1例患者出现肺部毒性并死于该并发症。32例患者中有18例（56%，95%CI 38-73%）有主要反应（11例部分缓解，7例完全缓解）。中位随访38.4个月，中位生存期为12.5个月，1年、2年和3年的精算生存率分别为52%、26%和19%。中位无事件生存期为8.3个月，1年、2年和3年的概率分别为40%、23%和20%。对于局部晚期NSCLC患者，诱导化疗后同步每日低剂量顺铂和胸部放疗具有活性且可行，非血液学毒性最小。长期生存结果令人鼓舞，似乎与毒性更强的放化疗方案相似，有必要进一步测试这种新型放化疗策略。
