Second-line chemotherapy with pegylated liposomal doxorubicin and carboplatin is highly effective in patients with advanced ovarian cancer in late relapse: a GINECO phase II trial

被引:81
作者
Ferrero, J. -M.
Weber, B.
Geay, J. -F.
Lepille, D.
Orfeuvre, H.
Combe, M.
Mayer, F.
Leduc, B.
Bourgeois, H.
Paraiso, D.
Pujade-Lauraine, E.
机构
[1] Hop Hotel Dieu, Dept Hematol & Oncol Med, F-75004 Paris, France
[2] Ctr Antoine Lacassagne, F-06054 Nice, France
[3] Ctr Alexis Vautrin, Vandoeuvre Les Nancy, France
[4] Clin Pasteur, Evreux, France
[5] Hop Fleyriat, Bourg En Bresse, France
[6] Ctr Hosp, Le Mans, France
[7] Ctr Georges Francois Leclerc, Dijon, France
[8] Ctr Hosp, Brive La Gaillarde, France
[9] CHU Bretonneau, F-37044 Tours, France
[10] Univ Paris 05, Paris, France
关键词
liposomal doxorubicin; ovarian cancer;
D O I
10.1093/annonc/mdl376
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Platinum-based chemotherapy is standard second-line treatment of patients with advanced ovarian cancer (AOC) in late relapse. Pegylated liposomal doxorubicin (PLD) has significant single-agent activity in this setting. Therefore, we evaluated the use of PLD plus carboplatin in this patient population. Patients and methods: PLD 30 mg/m(2) followed by carboplatin at area under the curve (AUC) 5 mg.min/ml, repeated every 28 days for a maximum of nine cycles, was administered to 104 women with AOC relapsing >= 6 months after completion of first- or second-line therapy with platinum-taxane-based regimens. Results: Overall response was 63%, with a 38% complete response, median progression-free survival of 9.4 months, and median overall survival (OS) of 32 months. Grade 3 or 4 neutropenia occurred in 51% of patients, but febrile neutropenia in only 3%. Nonhematologic toxic effects were primarily grades 1 and 2, with low rates of alopecia and neurotoxicity. Conclusions: PLD plus carboplatin is highly effective, prolongs OS, and is well tolerated in women with AOC in late relapse previously treated with both platinum and taxanes. Evaluation of this regimen in phase III trials is warranted.
引用
收藏
页码:263 / 268
页数:6
相关论文
共 26 条
[1]   Relapsed ovarian cancer: Challenges and management strategies for a chronic disease [J].
Armstrong, DK .
ONCOLOGIST, 2002, 7 :20-28
[2]   Advanced epithelial ovarian cancer:: 1998 consensus statements [J].
Berek, JS ;
Bertelsen, K ;
du Bois, A ;
Brady, MF ;
Carmichael, J ;
Eisenhauer, EA ;
Gore, M ;
Grenman, S ;
Hamilton, TC ;
Hansen, SW ;
Harper, PG ;
Horvath, G ;
Kaye, SB ;
Lück, HJ ;
Lund, B ;
McGuire, WP ;
Neijt, JP ;
Ozols, RF ;
Parmar, MKB ;
Piccart-Gebhart, MJ ;
van Rijswijk, R ;
Rosenberg, P ;
Rustin, GJS ;
Sessa, C ;
Thigpen, JT ;
Tropé, C ;
Tuxen, MK ;
Vergote, I ;
Vermorken, JB ;
Willemse, PHB .
ANNALS OF ONCOLOGY, 1999, 10 :87-92
[3]   The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin [J].
Berry, G ;
Billingham, M ;
Alderman, E ;
Richardson, P ;
Torti, F ;
Lum, B ;
Patek, A ;
Martin, FJ .
ANNALS OF ONCOLOGY, 1998, 9 (07) :711-716
[4]   Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG158) and an update on GOG0 182-ICON5 [J].
Bookman, MA ;
Greer, BE ;
Ozols, RF .
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2003, 13 (06) :735-740
[5]   CARBOPLATIN DOSAGE - PROSPECTIVE EVALUATION OF A SIMPLE FORMULA BASED ON RENAL-FUNCTION [J].
CALVERT, AH ;
NEWELL, DR ;
GUMBRELL, LA ;
OREILLY, S ;
BURNELL, M ;
BOXALL, FE ;
SIDDIK, ZH ;
JUDSON, IR ;
GORE, ME ;
WILTSHAW, E .
JOURNAL OF CLINICAL ONCOLOGY, 1989, 7 (11) :1748-1756
[6]   Pegylated liposomal doxorubicin and carboplatin in advanced gynecologic tumors: a prospective phase I/II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) [J].
du Bois, A ;
Burges, A ;
Meier, W ;
Pfisterer, J ;
Schmalfeldt, B ;
Richter, B ;
Jackisch, C ;
Staehle, A ;
Kimmig, R ;
Elser, G .
ANNALS OF ONCOLOGY, 2006, 17 (01) :93-96
[7]  
GABIZON A, 1994, CANCER RES, V54, P987
[8]  
Gonçalves A, 2003, ANTICANCER RES, V23, P3543
[9]   Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer [J].
Gordon, AN ;
Tonda, M ;
Sun, S ;
Rackoff, W .
GYNECOLOGIC ONCOLOGY, 2004, 95 (01) :1-8
[10]   Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan [J].
Gordon, AN ;
Fleagle, JT ;
Guthrie, D ;
Parkin, DE ;
Gore, ME ;
Lacave, AJ .
JOURNAL OF CLINICAL ONCOLOGY, 2001, 19 (14) :3312-3322