D'Agostino G, Ferrandina G, Ludovisi M, Testa A, Lorusso D, Gbaguidi N, Breda E, Mancuso S, Scambia G
Department of Gynecology Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 8, Rome 00168, Italy.
Br J Cancer. 2003 Oct 6;89(7):1180-4. doi: 10.1038/sj.bjc.6601284.
In total, 70 patients were enrolled into this phase II study, to evaluate the activity of the pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) combination in recurrent ovarian cancer patients. PLD, 30 mg m(-2), was administered on day 1 by 60' i.v. infusion, followed by GEM, 1000 mg m(-2), given by 30' i.v. on days 1 and 8; cycles were repeated every 21 days. In all, 67 patients are so far evaluable for response. Seven complete responses (10.4%, 95% CI: 3.1-17.7), 16 partial responses (23.9%, 95% CI: 13.7-34.1), 26 disease stabilisations (38.8%, 95% CI: 27.1-50.5) and 18 progressions (26.9%, 95% CI: 16.3-37.5) have been registered. Within the resistant population (n=36), the response rate was 25% (95% CI: 10.9-39.1). Within the group of platinum-sensitive patients (n=31), the response rate was 45.2% (95% CI: 27.7-62.7). A total of 443 courses are evaluable for toxicity. Grade 3-4 hematological toxicity was registered in 30 patients (42.8%), mainly represented by neutropenia (35.6%); palmar-plantar erythrodysesthesia affected 24 patients (34.2%), but it was of grade 3 in only seven of them (10%).
总共70例患者被纳入这项II期研究，以评估聚乙二醇化脂质体阿霉素（PLD）与吉西他滨（GEM）联合用药对复发性卵巢癌患者的疗效。第1天静脉输注60分钟给予PLD 30 mg/m²，随后第1天和第8天静脉输注30分钟给予GEM 1000 mg/m²；每21天重复1个周期。截至目前，共有67例患者可评估疗效。记录到7例完全缓解（10.4%，95%CI：3.1 - 17.7），16例部分缓解（23.9%，95%CI：13.7 - 34.1），26例病情稳定（38.8%，95%CI：27.1 - 50.5）和18例病情进展（26.9%，95%CI：16.3 - 37.5）。在耐药人群（n = 36）中，缓解率为25%（95%CI：10.9 - 39.1）。在铂敏感患者组（n = 31）中，缓解率为45.2%（95%CI：27.7 - 62.7）。共有443个疗程可评估毒性。30例患者（42.8%）出现3 - 4级血液学毒性，主要表现为中性粒细胞减少（3
