Objective. The aim of the study was to analyze the benefit/toxicity profile of a second-line treatment with carboplatin alone or carboplatin plus another non-cross-resistant drug (epidoxorubicin) in ...ovarian cancer patients sensitive to cisplatin-based chemotherapy at first-line treatment.
Methods. We conducted a randomized clinical trial. Women with epithelial ovarian cancer FIGO Stage II–IV who had a complete or partial response to first-line treatment with cisplatin or carboplatin-based regiments and subsequently progressed or relapsed more than 6 months after discontinuation of first-line treatment were eligible for the study. A total of 190 subjects entered the study. They were randomly allocated to either 300 mg/m2 of carboplatin every 28 days for five cycles (95 patients) or 120 mg/m2 of epidoxorubicin and 300 mg/m2 of carboplatin every 28 days for five cycles (95 patients).
Results. A complete response was reported, respectively, in 32 (36%) women allocated to carboplatin alone and in 28 (31.8%) of those allocated to carboplatin plus epidoxorubicin. The corresponding figures for partial response were 18 (20.2%) and 26 (29.9%). Comparing the frequency of complete response, partial response, no change, and progression, the differences between the two groups were not significant (χ23 5.10, P = 0.16). The median duration of response was 16 months in the carboplatin alone and 20 months in the carboplatin plus epidoxorubicin group (P = not significant). The 3-year percentage of survival was 29% in the carboplatin alone and 42% in the carboplatin plus epidoxorubicin group; this difference was not statistically significant. The frequency of leukopenia, anemia, and thrombocytopenia grade 3–4 was higher in the epidoxorubicin plus carboplatin than in the carboplatin alone group. Alopecia G3 was present in 88% of women treated with epidoxorubicin plus carboplatin.
Conclusions. The general results of this study do not show any marked differences in response to second-line treatment among women treated with single-agent (carboplatin) or multiagent (carboplatin plus epidoxorubicin) schedules. Toxicity, particularly hematological, was more relevant in women treated with the multiagent schedule.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objective. The objective of this open uncontrolled study was to evaluate the toxicity and efficacy of topotecan in ovarian cancer cases with microscopic small residual disease to a first-line ...treatment, given as sequential treatment, including carboplatinum and paclitaxel.
Methods. Inclusion criteria were laparotomically or laparoscopically documented microscopic or macroscopic (<2 cm) residual disease after first-line chemotherapy including carboplatinum plus paclitaxel in patients with histologically documented epithelial ovarian cancer FIGO stage III or IV at first diagnosis. All patients had a response >50% after first-line treatment. Eligible patients received 1.25 mg/m2/day of topotecan intravenously as a 30-min infusion for 5 consecutive days every 21 days for four cycles. A total of 38 women entered the study. Surgical “third-look” laparotomy or laparoscopy was performed in patients without clinical/instrumental evidence of progressive disease within 1 month from the last topotecan administration.
Results. A complete response was observed in 10 cases (28.6%, 95% confidence interval, based on the Poisson's approximation, 15.6–59.5), a partial response in 1 (2.5%), progressive disease in 11 (31.4%) and no change/stable disease in 13. The median duration of response was 8 months (range 5–20). The overall 1-year survival after treatment was 82.8% (SE 6.4).
Conclusion. This study indicates that sequential therapy with carboplatin plus paclitaxel followed by topotecan, all given at standard doses, is feasible and provides favorable response rates.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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