Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial - PubMed (original) (raw)
Clinical Trial
. 2003 Jun 21;361(9375):2099-106.
doi: 10.1016/s0140-6736(03)13718-x.
J A Ledermann, N Colombo, A du Bois, J-F Delaloye, G B Kristensen, S Wheeler, A M Swart, W Qian, V Torri, I Floriani, G Jayson, A Lamont, C Tropé; ICON and AGO Collaborators
- PMID: 12826431
- DOI: 10.1016/s0140-6736(03)13718-x
Clinical Trial
Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial
M K B Parmar et al. Lancet. 2003.
Abstract
Background: 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.
Methods: 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.
Findings: 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]).
Interpretation: 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.
Comment in
- Chemotherapy for recurrent ovarian cancer.
Kaye SB. Kaye SB. Lancet. 2003 Jun 21;361(9375):2094-5. doi: 10.1016/s0140-6736(03)13726-9. Lancet. 2003. PMID: 12826426 No abstract available. - ICON4/AGO-OVAR-2.2: questions about trial design, cost-effectiveness, and clinical benefit.
Newman G. Newman G. Lancet. 2003 Oct 18;362(9392):1333; author reply 1334. doi: 10.1016/S0140-6736(03)14602-8. Lancet. 2003. PMID: 14575996 No abstract available. - ICON4/AGO-OVAR-2.2: questions about trial design, cost-effectiveness, and clinical benefit.
Wheatley K, Gray R. Wheatley K, et al. Lancet. 2003 Oct 18;362(9392):1333; author reply 1334. doi: 10.1016/S0140-6736(03)14601-6. Lancet. 2003. PMID: 14575997 No abstract available. - ICON4/AGO-OVAR-2.2: questions about trial design, cost-effectiveness, and clinical benefit.
Green JA. Green JA. Lancet. 2003 Oct 18;362(9392):1334; author reply 1334. doi: 10.1016/S0140-6736(03)14603-X. Lancet. 2003. PMID: 14575998 No abstract available. - Which second-line treatment regimen should be used following relapse of platinum-sensitive ovarian cancer?
Pecorelli S, Odicino F. Pecorelli S, et al. Nat Clin Pract Oncol. 2007 Jun;4(6):340-1. doi: 10.1038/ncponc0795. Epub 2007 Apr 3. Nat Clin Pract Oncol. 2007. PMID: 17406383 No abstract available.
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