Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: a multicentre phase II study.
Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: a multicentre phase II study.
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聚乙二醇化脂质体阿霉素和吉西他滨用于复发/转移性乳腺癌的一线治疗：一项多中心 II 期研究。
DOI：
10.1038/sj.bjc.6604409
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发表时间：
2008-06-17
影响因子：
8.8
通讯作者：
Ferrandina, G.
中科院分区：
文献类型：
--
作者：
Adamo, V.;Lorusso, V.;Rossello, R.;Adamo, B.;Ferraro, G.;Lorusso, D.;Condemi, G.;Priolo, D.;Di Lullo, L.;Paglia, A.;Pisconti, S.;Scambia, G.;Ferrandina, G.
这项多中心II期研究旨在研究聚乙二醇脂质体多柔比星（PLD）和吉西他滨（GEM）作为一线治疗在大量未经化疗的复发性/转移性乳腺癌患者中的活性和安全性。从2003年6月至2006年12月，共有71例复发/转移性乳腺癌患者入组。中位年龄为63岁（范围=37-79岁），31例患者（43.7%）年龄> 65岁。患者接受PLD，25 mg m−2，第1天，然后GEM，800 mg m−2，第1天和第8天，q21。64例病例的缓解可评价。8例完全缓解（12.5%）和17例部分缓解（26.6%），总缓解率为39.1%。30例患者（46.9%）病情稳定，总体临床获益为85.9%。中位疾病进展时间（TTP）为11个月，而中位总生存期（OS）未达到。1年和2年OS率分别为79%和61%。共有443个疗程可评价毒性：3级和4级恶心呕吐分别影响14例患者（20.3%）和3例患者（4.3%）。在5例（7.2%）和1例（1.4%）病例中记录了3级和4级掌跖红肿综合征，而分别在6例（8.7%）和2例（2.9%）病例中发生了3级和4级粘膜炎。仅在1例病例中观察到2级心脏毒性。有趣的是，根据患者的年龄（<65岁vs> 65岁），血液学或非血液学毒性的百分比和严重程度没有差异。我们在未经化疗的复发性/转移性乳腺癌患者的大型、非常同质的研究样本中证实了PLD/GEM联合治疗的疗效和安全性，其缓解率、中位TTP和OS值与毒性更大的联合治疗相当。
This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37–79), and 31 patients (43.7%) were ⩾65 years old. Patients received PLD, 25 mg m−2, day 1, followed by GEM, 800 mg m−2, days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (<65 vs ⩾65 years). We confirmed in a large, very homogenous study sample of chemotherapy-naïve recurrent/metastatic breast cancer patients the efficacy and safety of PLD/GEM combination, providing response rates, median TTP and OS values comparable with those achieved with more toxic combinations.
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影响因子：
45.3
作者：
CARMICHAEL, J;POSSINGER, K;HARRIS, AL
通讯作者：
HARRIS, AL
影响因子：
3
作者：
Fabi, A;Ferretti, G;Cognetti, F
通讯作者：
Cognetti, F
影响因子：
4.7
作者：
Ferrandina, G;Paris, I;Scambia, G
通讯作者：
Scambia, G
影响因子：
45.3
作者：
Moliterni, A;Ménard, S;Bonadonna, G
通讯作者：
Bonadonna, G
影响因子：
50.5
作者：
O'Brien, MER;Wigler, N;Tendler, C
通讯作者：
Tendler, C