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Ifosfamide cisplatin and etoposide combination in locally advanced inoperable non-small-cell lung cancer: a phase II study

机译:异环磷酰胺顺铂和依托泊苷联合治疗局部晚期不能手术的非小细胞肺癌:II期研究

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摘要

From March 1993 to February 1997, 43 eligible patients with inoperable stage IIIA (ten patients) and stage IIIB (33 patients), histologically confirmed NSCLC received 3 courses of the ICE combination (ifosfamide 1.5 g m−2 and mesna 750 mg m−2 two times a day, cisplatin 25 mg m−2 and etoposide 100 mg m−2, all administered intravenously (i.v.) on days 1–3 every 3 weeks) with G-CSF support. After three cycles, patients were submitted to radical surgery or received two additional courses of the ICE regimen and/or curative radiotherapy. Grade 3–4 neutropenia occurred in 21% of 114 evaluable courses, but was of short duration, leading to neutropenic fever in 5% of the courses. Severe thrombocytopenia and anaemia were observed in 13% and 3% of the courses respectively. Non-haematological toxicity was generally mild with only two episodes of reversible renal impairment. The overall response rate after three chemotherapy courses was 69% (28 partial responses, one complete response). Ten patients (8/10 patients in stage IIIA, 2/33 patients in stage IIIB) underwent radical surgery. Median TTP for patients not undergoing surgery (n = 33) was 8 months (range 3–34+); median DFS for patients rendered NED by surgery (n = 10) was 26 months (range 1–54+). Median OS for the entire group was 12.5 months (range 2–57+). The ICE regimen is active in locally advanced NSCLC with acceptable toxicity and warrants further exploration as induction chemotherapy in larger series. © 1999 Cancer Research Campaign
机译:从1993年3月至1997年2月,经组织学证实NSCLC的43例IIIA期不能手术的患者(10例)和IIIB期(33例)的患者接受了3个疗程的ICE联合用药(异环磷酰胺1.5 gm −2 和每天两次两次,分别为mesna 750 mg m −2 ,顺铂25 mg m −2 和依托泊苷100 mg m −2 ,均通过静脉给药( iv)在每3周的1-3天)获得G-CSF支持。在三个周期之后,患者接受了根治性手术或接受了ICE方案和/或根治性放疗的另外两个疗程。 114个可评估疗程中有21%发生3–4级中性粒细胞减少,但持续时间较短,导致5%疗程中性白细胞减少。分别在13%和3%的疗程中观察到严重的血小板减少症和贫血。非血液学毒性一般是轻度的,只有两次可逆性肾功能不全。在三个化疗疗程后的总缓解率为69%(28个局部缓解,一个完全缓解)。 10例患者(IIIA期为8/10例,IIIB期为2/33例)接受了根治性手术。未接受手术的患者(n = 33)的中位TTP为8个月(范围3–34 +)。通过手术(N = 10)进行NED的患者的中位DFS为26个月(范围1–54 +)。整个小组的OS中位数为12.5个月(范围2–57 +)。 ICE方案在局部晚期NSCLC中有效,且毒性可接受,并且有必要在更大系列的诱导化疗中进一步探索。 ©1999癌症研究运动

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