Crinò L, Corgna E, Porrozzi S, Palladino M A, Darwish S, Minotti V, Mosconi A M, Tonato M
Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
Ann Oncol. 1997 Jul;8(7):709-11. doi: 10.1023/a:1008277604261.
In our previous experience with chemotherapy for non-small-cell lung cancer (NSCLC) the combination of mitomycin, ifosfamide and cisplatin (MIC) showed the highest activity in a three-arm randomized trial; the MIC regimen also yielded the most toxic effects, with 8% WHO grade 2-4 nephrotoxicity, 21% grade 3-4 leukopenia and 10% grade 3-4 thrombocytopenia. In that study cisplatin (120 mg/m2) was delivered on day 1 and ifosfamide and mitomycin on day 2. In an effort to reduce MIC toxicity a modified regimen was tested in a phase II trial: cisplatin 100 mg/m2 was given on day 2 and ifosfamide on day 1 with mitomycin.
From November 1993 to December 1995, 70 advanced NSCLC patients entered the trial.
Twenty-nine of 70 patients achieved major response (41%) with 6 complete (9%) and 23 partial remissions (33%). We recorded 4% of WHO grade 3-4 anemia, and 2% of leukopenia and thrombocytopenia.
We confirmed the activity of the MIC regimen in NSCLC, and the modified schedule seems to substantially improve the safety of the combination.
根据我们之前使用化疗治疗非小细胞肺癌（NSCLC）的经验，丝裂霉素、异环磷酰胺和顺铂（MIC）联合方案在一项三臂随机试验中显示出最高活性；MIC方案也产生了最大的毒性作用，世界卫生组织（WHO）2 - 4级肾毒性发生率为8%，3 - 4级白细胞减少症发生率为21%，3 - 4级血小板减少症发生率为10%。在该研究中，顺铂（120mg/m²）于第1天给药，异环磷酰胺和丝裂霉素于第2天给药。为了降低MIC的毒性，在一项II期试验中对一种改良方案进行了测试：顺铂100mg/m²于第2天给药，异环磷酰胺于第1天给药，丝裂霉素不变。
1993年11月至1995年12月，70例晚期NSCLC患者进入该试验。
70例患者中有29例（41%）获得主要缓解，其中6例（9%）完全缓解，23例（33%）部分缓解。我们记录到WHO 3 - 4级贫血发生率为4%，白细胞减少症和血小板减少症发生率均为2%。
我们证实了MIC方案对NSCLC的活性，改良方案似乎显著提高了该联合方案的安全性。
