Campos S M, Penson R T, Mays A R, Berkowitz R S, Fuller A F, Goodman A, Matulonis U A, Muzikansky A, Seiden M V
Dana Farber Cancer Institute and the Brigham and Women's Hospital, Boston, MA 02115, USA.
Gynecol Oncol. 2001 May;81(2):206-12. doi: 10.1006/gyno.2000.5980.
The aim of this study was to determine the efficacy and toxicity of single agent off-protocol, liposomal doxorubicin (Doxil Alza), in consecutive patients with recurrent ovarian cancer and to investigate the influence of HER-2/neu expression on response to liposomal doxorubicin.
Retrospective analysis of 72 consecutive patients treated, typically with liposomal doxorubicin 40 mg/m(2) q28 days between January 1997 and December 1998. Results. Twenty-nine patients (40%) had platinum- and taxane-resistant tumors. Nineteen patients (27%) responded with clinical or radiological evidence of response with reduction in CA-125 of >50%. One complete response (CR) and 7 partial responses (PRs) occurred in platinum- and taxane-resistant patients (radiological response (RR) 29%) and 8 PRs occurred in patients with visceral metastases (RR 28%). Time to progression was 5.3 (2.1-12.1) months. Only 7 dose delays (3%) and 20 dose reductions (8%) were necessary in 265 cycles of treatment. Hematological toxicity was generally mild with grade (Gr) > or =III neutropenia in 1 (2%), Gr > or =III thrombocytopenia in 1 (1%), and Gr > or =III anemia in 8 patients (11%). One patient (1%) was admitted with fever and neutropenia. Other toxicity was minimal with Gr > or =III mucositis occurring in 3 patients (4%). Gr > or =III cutaneous toxicity was seen in 6 patients (8%). Three patients (4%) had a >10% fall in ejection fraction but there was no unequivocal clinical heart failure.
The data suggest that liposomal doxorubicin is an active drug in both taxane- and platinum-sensitive and resistant recurrent ovarian cancer. Liposomal doxorubicin is associated with tolerable toxicity and is particularly well tolerated in patients with multiple prior lines of treatment.
本研究旨在确定非标准方案单药脂质体阿霉素（多美素，阿尔扎制药公司生产）对复发性卵巢癌连续患者的疗效和毒性，并研究HER-2/neu表达对脂质体阿霉素反应的影响。
对1997年1月至1998年12月期间连续接受治疗的72例患者进行回顾性分析，通常采用脂质体阿霉素40mg/m²，每28天一次。结果。29例患者（40%）患有铂类和紫杉烷耐药肿瘤。19例患者（27%）有临床或影像学反应证据，CA-125降低>50%。铂类和紫杉烷耐药患者中出现1例完全缓解（CR）和7例部分缓解（PR）（影像学缓解率（RR）29%），内脏转移患者中出现8例PR（RR 28%）。疾病进展时间为5.3（2.1 - 12.1）个月。在265个治疗周期中，仅需7次剂量延迟（3%）和20次剂量减少（8%）。血液学毒性一般较轻，1例（2%）出现≥III级中性粒细胞减少，1例（1%）出现≥III级血小板减少，8例患者（11%）出现≥III级贫血。1例患者（1%）因发热和中性粒细胞减少入院。其他毒性极小，3例患者（4%）出现≥III级黏膜炎。6例患者（8%）出现≥III级皮肤毒性。3例患者（4%）射血分数下降>10%，但无明确的临床心力衰竭。
数据表明脂质体阿霉素在紫杉烷和铂类敏感及耐药的复发性卵巢癌中均为活性药物。脂质体阿霉素毒性可耐受，在接受过多次前期治疗的患者中耐受性尤其良好。
