Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group
Articolo
Data di Pubblicazione:
2003
Citazione:
Doxorubicin versus doxorubicin and cisplatin in endometrial
carcinoma: definitive results of a randomised study (55872) by the
EORTC Gynaecological Cancer Group / M.S. Aapro1, F.H. van Wijk, G. Bolis, B. Chevallier, M.E.L. van der Burg, A. Poveda, C. F. de Oliveira, S. Tumolo, V. Scotto di Palumbo, M. Piccart, M. Franchi, F. Zanaboni, A. J. Lacave, R. Fontanelli, G. Favalli, P. Zola, J. P. Guastalla, R. Rosso, C. Marth, M. Nooij, M. Presti, C. Scarabelli, T.A.W. Splinter, E. Ploch, L.V.A. Beex, W. ten Bokkel Huinink, M. Forni, M. Melpignano, P. Blake, P. Kerbrat, C. Mendiola, A. Cervantes, A. Goupil, P.G. Harper, C. Madronal, M. Namer, G. Scarfone, J.E.G.M. Stoot, I. Teodorovic, C. Coens, I. Vergote, J.B. Vermorken. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 14:3(2003 Mar), pp. 441-448. [10.1093/annonc/mdg112]
Abstract:
Background: Combination chemotherapy yields better response rates which do not always lead to a
survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy
and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in
endometrial adenocarcinoma lead to significant advantage in favour of the combination.
Patients and methods: Eligible patients had histologically-proven advanced and/or recurrent endometrial
adenocarcinoma and were chemo-naïve. Treatment consisted of either DOX 60 mg/m2 alone or CDDP 50 mg/m2
added to DOX 60 mg/m2, every 4 weeks.
Results: A total of 177 patients were entered and median follow-up is 7.1 years. The combination
DOX–CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell
toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4
alopecia (72% versus 65%) and nausea/vomiting (36 % versus 12%). The combination DOX–CDDP provided
a significantly higher response rate than single agent DOX (P <0.001). Thirty-nine patients (43%) responded
on DOX–CDDP [13 complete responses (CRs) and 26 partial responses (PRs)], versus 15 patients (17%) on
DOX alone (8 CR and 7 PR). The median overall survival (OS) was 9 months in the DOX–CDDP arm versus
7 months in the DOX alone arm (Wilcoxon P = 0.0654). Regression analysis showed that WHO performance
status was statistically significant as a prognostic factor for survival, and stratifying for this factor, treatment
effect reaches significance (hazard ratio = 1.46, 95% confidence interval 1.05–2.03, P = 0.024).
Conclusions: In comparison to single agent DOX, the combination of DOX–CDDP results in higher but
acceptable toxicity. The response rate produced is significantly higher, and a modest survival benefit is
achieved with this combination regimen, especially in patients with a good performance status.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
chemotherapy ; cisplatin ; doxorubicin ; endometrial carcinoma ; randomised clinical trial ; phase III
Elenco autori:
M.S. Aapro1, F.H. van Wijk, G. Bolis, B. Chevallier, M.E.L. van der Burg, A. Poveda, C. F. de Oliveira, S. Tumolo, V. Scotto di Palumbo, M. Piccart, M. Franchi, F. Zanaboni, A. J. Lacave, R. Fontanelli, G. Favalli, P. Zola, J. P. Guastalla, R. Rosso, C. Marth, M. Nooij, M. Presti, C. Scarabelli, T.A.W. Splinter, E. Ploch, L.V.A. Beex, W. ten Bokkel Huinink, M. Forni, M. Melpignano, P. Blake, P. Kerbrat, C. Mendiola, A. Cervantes, A. Goupil, P.G. Harper, C. Madronal, M. Namer, G. Scarfone, J.E.G.M. Stoot, I. Teodorovic, C. Coens, I. Vergote, J.B. Vermorken
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