Carboplatin alone vs carboplatin plus epidoxorubicin as second-line therapy for cisplatin- or carboplatin-sensitive ovarian cancer

G. Bolis et al., Carboplatin alone vs carboplatin plus epidoxorubicin as second-line therapy for cisplatin- or carboplatin-sensitive ovarian cancer, GYNECOL ONC, 81(1), 2001, pp. 3-9
Citations number
Categorie Soggetti
Reproductive Medicine
Journal title
ISSN journal
0090-8258 → ACNP
Year of publication
3 - 9
SICI code
Objective. The aim of the study was to analyze the benefit/ toxicity profil e of a second-line treatment with carboplatin alone or carboplatin plus ano ther non-cross-resistant drug (epidoxorubicin) in ovarian cancer patients s ensitive to cisplatin-based chemotherapy at first-line treatment. Methods. We conducted a randomized clinical trial. Women with epithelial ov arian cancer FIGO Stage II-IV who had a complete or partial response to fir st-line treatment with cisplatin or carboplatin-based regiments and subsequ ently progressed or relapsed more than 6 months after discontinuation of fi rst-line treatment were eligible for the study. A total of 190 subjects ent ered the study. They were randomly allocated to either 300 mg/m(2) of carbo platin every 28 days for five cycles (95 patients) or 120 mg/m(2) of epidox orubicin and 300 mg/m(2) of carboplatin every 28 days for five cycles (95 p atients). Results. A complete response was reported, respectively, in 32 (36%) women allocated to carboplatin alone and in 28 (31.8%) of those allocated to carb oplatin plus epidoxorubicin, The corresponding figures for partial response were 18 (20.2%) and 26 (29.9%). Comparing the frequency of complete respon se, partial response, no change, and progression, the differences between t he two groups were not significant (chi (2)(3) 5.10, P = 0,16). The median duration of response was 16 months in the carboplatin alone and 20 months i n the carboplatin plus epidoxorubicin group (P = not significant). The 3-ye ar percentage of survival was 29% in the carboplatin alone and 42% in the c arboplatin plus epidoxorubicin group; this difference was not statistically significant, The frequency of leukopenia, anemia, and thrombocytopenia gra de 3-4 was higher in the epidoxorubicin plus carboplatin than in the carbop latin alone group. Alopecia G3 was present in 88% of women treated with epi doxorubicin plus carboplatin. Conclusions. The general results of this study do not show any marked diffe rences in response to second-line treatment among women treated with single -agent (carboplatin) or multiagent (carboplatin plus epidoxorubicin) schedu les. Toxicity, particularly hematological, was more relevant in women treat ed with the multiagent schedule. (C) 2001 Academic Press.