Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial

Despite improvements in the treatment of ovarian cancer, most patients develop recurrent disease within 3 years of diagnosis. There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment. In parallel international, multicentre, randomised t...

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Veröffentlicht in:The Lancet (British edition) 2003-06, Vol.361 (9375), p.2099-2106
Hauptverfasser: Parmar, M K B, Ledermann, J A, Colombo, N, du Bois, A, Delaloye, J-F, Kristensen, G B, Wheeler, S, Swart, A M, Qian, W, Torri, V, Floriani, I, Jayson, G, Lamont, A, Tropé, C
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container_end_page 2106
container_issue 9375
container_start_page 2099
container_title The Lancet (British edition)
container_volume 361
creator Parmar, M K B
Ledermann, J A
Colombo, N
du Bois, A
Delaloye, J-F
Kristensen, G B
Wheeler, S
Swart, A M
Qian, W
Torri, V
Floriani, I
Jayson, G
Lamont, A
Tropé, C
description Despite improvements in the treatment of ovarian cancer, most patients develop recurrent disease within 3 years of diagnosis. There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment. In parallel international, multicentre, randomised trials, between January, 1996, and March, 2002, 802 patients with platinum-sensitive ovarian cancer relapsing after 6 months of being treatment-free were enrolled from 119 hospitals in five countries. Patients were randomly assigned paclitaxel plus platinum chemotherapy or conventional platinum-based chemotherapy. Analysis was by intention to treat, except for toxic effects. With a median follow-up of 42 months, 530 patients have died. Survival curves showed a difference in favour of paclitaxel plus platinum (hazard ratio 0·82 [95% CI 0·69–0·97], p=0·02), corresponding to an absolute difference in 2-year survival of 7% between the paclitaxel and conventional treatment groups (57 vs 50% [95% CI for difference 1–12]), and median survival of 5 months (29 vs 24 months [1–11). 717 patients developed progressive disease or died. The progression-free survival curves show a difference in favour of paclitaxel plus platinum (hazard ratio 0·76 [0·66–0·89], p=0·0004), corresponding to an absolute difference in 1-year progression-free survival of 10% (50 vs 40% [4–15]) and in median progression-free survival of 3 months (13 vs 10 months [1–5]). Paclitaxel plus platinum chemotherapy seems to improve survival and progression-free survival among patients with relapsed platinum-sensitive ovarian cancer compared with conventional platinum-based chemotherapy.
doi_str_mv 10.1016/S0140-6736(03)13718-X
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There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment. In parallel international, multicentre, randomised trials, between January, 1996, and March, 2002, 802 patients with platinum-sensitive ovarian cancer relapsing after 6 months of being treatment-free were enrolled from 119 hospitals in five countries. Patients were randomly assigned paclitaxel plus platinum chemotherapy or conventional platinum-based chemotherapy. Analysis was by intention to treat, except for toxic effects. With a median follow-up of 42 months, 530 patients have died. 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There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment. In parallel international, multicentre, randomised trials, between January, 1996, and March, 2002, 802 patients with platinum-sensitive ovarian cancer relapsing after 6 months of being treatment-free were enrolled from 119 hospitals in five countries. Patients were randomly assigned paclitaxel plus platinum chemotherapy or conventional platinum-based chemotherapy. Analysis was by intention to treat, except for toxic effects. With a median follow-up of 42 months, 530 patients have died. Survival curves showed a difference in favour of paclitaxel plus platinum (hazard ratio 0·82 [95% CI 0·69–0·97], p=0·02), corresponding to an absolute difference in 2-year survival of 7% between the paclitaxel and conventional treatment groups (57 vs 50% [95% CI for difference 1–12]), and median survival of 5 months (29 vs 24 months [1–11). 717 patients developed progressive disease or died. The progression-free survival curves show a difference in favour of paclitaxel plus platinum (hazard ratio 0·76 [0·66–0·89], p=0·0004), corresponding to an absolute difference in 1-year progression-free survival of 10% (50 vs 40% [4–15]) and in median progression-free survival of 3 months (13 vs 10 months [1–5]). Paclitaxel plus platinum chemotherapy seems to improve survival and progression-free survival among patients with relapsed platinum-sensitive ovarian cancer compared with conventional platinum-based chemotherapy.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>12826431</pmid><doi>10.1016/S0140-6736(03)13718-X</doi><tpages>8</tpages></addata></record>
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subjects Aged
Antineoplastic Agents - administration & dosage
Antineoplastic Agents, Phytogenic - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Baldness
Cancer
Cancer therapies
Carboplatin - administration & dosage
Chemotherapy
Cisplatin - administration & dosage
Clinical trials
Disease-Free Survival
Drug Administration Schedule
Drug dosages
Fatalities
Female
Humans
Medical treatment
Middle Aged
Motivation
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - mortality
Ovarian cancer
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - mortality
Paclitaxel
Paclitaxel - administration & dosage
Patients
Platinum
Quality of Life
Survival
Toxicity
Womens health
title Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial
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