Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naive and anthracycline pretreated metastatic breast cancer patients
Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naive and anthracycline pretreated metastatic breast cancer patients
复制标题
DOI：
10.1007/s00280-005-0116-2
复制
发表时间：
2006-05-01
影响因子：
3
通讯作者：
Cognetti, F
中科院分区：
文献类型：
--
作者：
Fabi, A;Ferretti, G;Cognetti, F
背景：该研究的目的是评估毒性。例如，聚乙二醇化脂质体阿霉素（PLD）和吉西他滨组合在未接受过化疗和接受过治疗的转移性乳腺癌（MBC）女性中的反应率、进展时间、总体生存率和生活质量方面的活性。方法：如果患者在接受早期乳腺癌或 MBC 化疗（包括或不包括蒽环类药物）后疾病进展，则符合资格。患者在第 1 天静脉注射 PLD 25 mg/m(2)，并在每个 21 天周期的第 1 天和第 8 天静脉注射吉西他滨 800 mg/m2。结果：在入组的 50 名患者中，37 名患者接受过既往辅助化疗（24 名患者接受过蒽环类药物），23 名患者接受过既往转移性疾病化疗（6 名患者接受过蒽环类药物）。 46 名可评估患者取得了 2 名完全缓解和 20 名部分缓解（总缓解率：47.8%）。在 30 名既往接受过蒽环类药物治疗的患者中，有 14 名（46.6%）出现缓解。中位缓解持续时间为 7 个月，中位临床获益持续时间为 8 个月，进展时间为 7 个月。中位随访 10 个月后，79.4% 的患者在 1 岁时仍存活。未观察到中性粒细胞减少并发症。非血液学毒性轻微。一名先前接受过蒽环类药物治疗的患者左心室射血分数出现短暂下降（26%），但心功能在 6 个月内恢复。结论：由于 PLD 和吉西他滨的毒性特征不重叠，对于先前治疗（包括蒽环类药物）治疗 MBC 失败的患者来说，该组合可被视为可靠的治疗选择。
Background: The aim of the study was to assess the toxicity pro. le, activity in terms of response rate, time to progression, overall survival, and quality of life of pegylated liposomal doxorubicin (PLD) and gemcitabine combination in chemo-naive and pretreated metastatic breast cancer (MBC) women. Methods: Patients were eligible if they had disease progression to prior chemotherapy (anthracycline-including or not) for early breast cancer or MBC. Patients received PLD 25 mg/m(2) intravenously on day 1 plus gemcitabine 800 mg/m2 intravenously on days 1 and 8 of each 21-day cycle. Results: Of 50 patients enrolled, 37 had received prior adjuvant chemotherapy ( 24 with an anthracycline) and 23 prior chemotherapy for metastatic disease ( 6 with an anthracycline). Two complete responses and 20 partial responses were achieved in 46 assessable patients (overall response rate: 47.8%). Responses were observed in 14 (46.6%) of 30 patients with previous anthracycline exposure. Median response duration was 7 months, median duration of clinical benefit 8 months, time to progression 7 months. At a median follow-up of 10 months, 79.4% patients were alive at 1 year. No neutropenic complication was observed. Non-hematological toxicities were mild. One patient previously treated with an anthracycline developed a transient decrease (26%) in the left ventricular ejection fraction, with cardiac function recovering within 6 months. Conclusion: Because of the non-overlapping toxicity profiles of both PLD and gemcitabine, this combination can be regarded as a reliable therapeutic option for patients who have failed previous treatments, including anthracycline, for MBC.