This randomized, open label, phase III clinical trial (1988-1992) compared the efficacy and safety of a dose-dense regimen of single-agent cisplatin with a standard 3-weekly schedule in first-line chemotherapy for advanced epithelial ovarian cancer. Two hundred eighty-five patients were randomly assigned to the experimental dose-dense arm (cisplatin 50 mg/m2 weekly × nine cycles) or to the control (standard treatment) arm (cisplatin 75 mg/m 2, administered on day 1 every 21 days × six cycles). The primary outcome was progression-free survival (PFS). Secondary outcomes were overall survival (OS), overall response to chemotherapy, and toxicity. Toxicity and response to treatment were compared with the χ2 test using trend or exact correction. PFS and OS were estimated by Kaplan-Meier analyses and treatment hazard ratios (HRs) with the Cox proportional hazards model. All statistical tests were two-sided. After a median follow-up of 16.8 years, no differences were observed between the two treatments in PFS (experimental arm: 17.2 months; control arm: 18.1 months; HR = 1.08, 95% confidence interval [CI] = 0.83 to 1.40; P =. 57) and in OS (experimental arm: 35 months; control arm: 32 months; HR = 0.97, 95% CI = 0.75 to 1.26; P =. 97). Thus, increasing dose intensity of cisplatin does not improve PFS or OS compared with standard chemotherapy. © The Author 2011. Published by Oxford University Press.

Fruscio, R., Garbi, A., Parma, G., Lissoni, A., Garavaglia, D., Bonazzi, C., et al. (2011). Randomized phase III clinical trial evaluating weekly cisplatin for advanced epithelial ovarian cancer. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 103(4), 347-351 [10.1093/jnci/djq530].

Randomized phase III clinical trial evaluating weekly cisplatin for advanced epithelial ovarian cancer

FRUSCIO, ROBERT;GARBI, ANNALISA;LISSONI, ANDREA ALBERTO;DELL' ANNA, TIZIANA;MILANI, RODOLFO;COLOMBO, NICOLETTA
2011

Abstract

This randomized, open label, phase III clinical trial (1988-1992) compared the efficacy and safety of a dose-dense regimen of single-agent cisplatin with a standard 3-weekly schedule in first-line chemotherapy for advanced epithelial ovarian cancer. Two hundred eighty-five patients were randomly assigned to the experimental dose-dense arm (cisplatin 50 mg/m2 weekly × nine cycles) or to the control (standard treatment) arm (cisplatin 75 mg/m 2, administered on day 1 every 21 days × six cycles). The primary outcome was progression-free survival (PFS). Secondary outcomes were overall survival (OS), overall response to chemotherapy, and toxicity. Toxicity and response to treatment were compared with the χ2 test using trend or exact correction. PFS and OS were estimated by Kaplan-Meier analyses and treatment hazard ratios (HRs) with the Cox proportional hazards model. All statistical tests were two-sided. After a median follow-up of 16.8 years, no differences were observed between the two treatments in PFS (experimental arm: 17.2 months; control arm: 18.1 months; HR = 1.08, 95% confidence interval [CI] = 0.83 to 1.40; P =. 57) and in OS (experimental arm: 35 months; control arm: 32 months; HR = 0.97, 95% CI = 0.75 to 1.26; P =. 97). Thus, increasing dose intensity of cisplatin does not improve PFS or OS compared with standard chemotherapy. © The Author 2011. Published by Oxford University Press.
Articolo in rivista - Articolo scientifico
Treatment Outcome; Aged, 80 and over; Kaplan-Meier Estimate; Middle Aged; Female; Research Design; Neoplasm Staging; Disease-Free Survival; Humans; Carcinoma; Antineoplastic Agents; Follow-Up Studies; Odds Ratio; Ovarian Neoplasms; Neoplasms, Glandular and Epithelial; Aged; Proportional Hazards Models; Adult; Drug Administration Schedule; Cisplatin
English
347
351
Fruscio, R., Garbi, A., Parma, G., Lissoni, A., Garavaglia, D., Bonazzi, C., et al. (2011). Randomized phase III clinical trial evaluating weekly cisplatin for advanced epithelial ovarian cancer. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 103(4), 347-351 [10.1093/jnci/djq530].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/28697
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