Bisogno Gianni, Riccardi Riccardo, Ruggiero Antonio, Arcamone Giampaolo, Prete Arcangelo, Surico Gianmarco, Provenzi Massimo, Bertolini Patrizia, Paolucci Paolo, Carli Modesto
Division of Hematology/Oncology, Department of Pediatrics, University-Hospital of Padova, Italy.
Cancer. 2006 Feb 1;106(3):703-7. doi: 10.1002/cncr.21629.
Irinotecan (CPT-11) is a novel antineoplastic agent that takes effect by inhibiting topoisomerase I. The Italian Soft Tissue Sarcoma (STS) Committee performed a multiinstitutional Phase II study to evaluate its effect on STS.
Over a 2-year period between 2002 and 2004, 32 heavily pretreated patients were administered 60-minute infusions of irinotecan at 20 mg/m2/day, for 5 days a week, for 2 consecutive weeks. The courses were repeated every 4 weeks for at least 2 courses, unless there were signs of toxicity or disease progression. Thirty patients, 13 with peripheral primitive neuroectodermal tumor (PNET), 12 with rhabdomyosarcoma (RMS), 3 with desmoplastic small round cell tumor (DSRCT), and 2 with other STS were evaluable for response.
A total of 79 cycles were delivered. The main regimen-related toxicity was diarrhea, occurring in 58% of cycles with 9 episodes graded as 3 or 4. Grade 3-4 neutropenia was recorded in 10% of cycles. The overall response rate was 23% (2 complete remissions +5 partial remissions of 30 patients), 38% for PNET and 16% for RMS. In addition, 4 minor responses were noted.
As a single agent in the treatment of recurrent and refractory STS, irinotecan administered on a daily x5 x2 schedule revealed a noteworthy response rate in a population of heavily pretreated patients, especially in the subset of patients with PNET. Its hematologic toxicity profile warrants further investigation in association with other myelotoxic agents.
伊立替康（CPT-11）是一种新型抗肿瘤药物，通过抑制拓扑异构酶I发挥作用。意大利软组织肉瘤（STS）委员会进行了一项多机构II期研究，以评估其对STS的疗效。
在2002年至2004年的2年期间，32例经过大量预处理的患者接受伊立替康静脉输注60分钟，剂量为20mg/m²/天，每周5天，连续2周。除非出现毒性迹象或疾病进展，每4周重复疗程，至少进行2个疗程。30例患者可评估疗效，其中13例为外周原始神经外胚层肿瘤（PNET），12例为横纹肌肉瘤（RMS），3例为促纤维增生性小圆细胞肿瘤（DSRCT），2例为其他STS。
共进行了79个周期的治疗。主要的治疗相关毒性是腹泻，58%的周期出现腹泻，其中9次发作分级为3级或4级。10%的周期记录到3-4级中性粒细胞减少。总缓解率为23%（30例患者中2例完全缓解+5例部分缓解），PNET为38%，RMS为16%。此外，还观察到4例轻微缓解。
作为复发和难治性STS的单一治疗药物，按每日×5×2方案给药的伊立替康在经过大量预处理的患者群体中显示出值得注意的缓解率，尤其是在PNET患者亚组中。其血液学毒性特征值得与其他骨髓毒性药物联合进一步研究。
