Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Med Oncol. 2012 Mar;29(1):199-204. doi: 10.1007/s12032-010-9772-0. Epub 2010 Dec 8.
A phase II trial of irinotecan and cisplatin (IP) as induction chemotherapy followed by conventional thoracic irradiation concurrent with low-dose weekly cisplatin for limited-disease small-cell lung cancer (LDS-SCLC). Between February 2005 and December 2008, 34 chemotherapy-naïve patients with LD-SCLC were enrolled. Treatment consisted of two 21-day cycles of cisplatin 40 mg/m(2) and irinotecan 80 mg/m(2) intravenously (IV) on days 1 and 8 followed by conventional thoracic irradiation at a dose of 54 Gy concurrent with cisplatin at dose of 20 mg/m(2) weekly then prophylactic cranial irradiation at dose of 30 Gy in 10 fractions for those achieved complete or partial response. Only 33 patients received the treatment protocol, and they were assessed for response and toxicity. After induction chemotherapy, overall response rate was (72.73%). After median follow-up of 27 months, the median survival was 25 months (95% CI, 21.249-28.751) with 1 and 2-year overall survival rates of 83 and 55%, respectively. Median progression-free survival (PFS) was 15 months (95% CI, 10.311-19.689) with a 1- and 2-year PFS of 59 and 38%, respectively. The most common toxicities during induction chemotherapy were neutropenia (81%), thrombocytopenia (69%), and diarrhea (63%) while esophagitis (84%) and pneumonitis (30%) were the most common toxicities during concurrent chemo-radiation. Relapse rate was 61% with distant metastasis in 42% and local recurrence in 26%. This protocol of induction irinotecon-based regimen followed by delayed concurrent thoracic irradiation with low-dose weekly cisplatin is effective with acceptable toxicities. Based on the favorable outcome in this trial, this regimen should be evaluated in a large phase III trial.
一项关于伊立替康和顺铂（IP）作为诱导化疗，随后进行常规胸部放疗并同时给予低剂量每周顺铂治疗局限期小细胞肺癌（LDS-SCLC）的 II 期临床试验。在 2005 年 2 月至 2008 年 12 月期间，共招募了 34 例未经化疗的 LD-SCLC 患者。治疗包括两个 21 天周期的静脉注射顺铂 40 mg/m2 和伊立替康 80 mg/m2，分别在第 1 天和第 8 天，然后给予 54 Gy 的常规胸部放疗，同时给予每周 20 mg/m2 的顺铂，然后对获得完全或部分缓解的患者进行预防性颅脑照射，剂量为 30 Gy，分 10 次进行。仅有 33 例患者接受了治疗方案，并对其反应和毒性进行了评估。诱导化疗后，总缓解率为（72.73%）。中位随访 27 个月后，中位生存期为 25 个月（95%CI，21.249-28.751），1 年和 2 年总生存率分别为 83%和 55%。中位无进展生存期（PFS）为 15 个月（95%CI，10.311-19.689），1 年和 2 年 PFS 率分别为 59%和 38%。诱导化疗期间最常见的毒性反应是中性粒细胞减少（81%）、血小板减少（69%）和腹泻（63%），而食管炎（84%）和肺炎（30%）是同期放化疗期间最常见的毒性反应。复发率为 61%，远处转移率为 42%，局部复发率为 26%。这种诱导伊立替康为基础的方案后延迟进行常规胸部放疗并同时给予低剂量每周顺铂的方案是有效的，毒性可接受。基于该试验的良好结果，该方案应在大型 III 期临床试验中进行评估。
