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Annals of Oncology Advance Access published online on May 20, 2009
Annals of Oncology, doi:10.1093/annonc/mdn797
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Randomized multicenter phase II trial of cisplatin and ifosfamide with or without paclitaxel in recurrent or metastatic carcinoma of the uterine cervix: a Hellenic Cooperative Oncology Group (HeCOG) study

G. Mountzios1, M. A. Dimopoulos1, A. Bamias1, G. Vourli2, H. Kalofonos3, G. Aravantinos4, G. Fountzilas5 and C. A. Papadimitriou1,*

1 Department of Clinical Therapeutics, "Alexandra" Hospital, University of Athens School of Medicine, Athens
2 Hellenic Cooperative Oncology Group Data Office, Athens
3 Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School, Rion
4 Third Department of Medical Oncology, "Agii Anargiri" Cancer Hospital, Athens
5 Department of Medical Oncology, "Papageorgiou" Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece

* Correspondence to: Assist. Prof. C. A. Papadimitriou, Tatoiou 146, GR-14671 Nea Erythrea, Athens, Greece. Tel: +30-694-462-8688; Fax: +30-210-338-1511; E-mail: chr_papadim{at}yahoo.gr

Background: We undertook a randomized phase II trial to test whether the addition of paclitaxel (Taxol) to the cisplatin and ifosfamide (IP) combination could improve objective response (OR) rate, progression-free survival (PFS) and overall survival (OS) in patients with recurrent or metastatic cancer of the uterine cervix.

Patients and methods: One hundred and fifty-three patients were randomly allocated to receive either the IP regimen (ifosfamide 1.5 g/m2, daily, on days 1–3 and cisplatin 70 mg/m2 on day 2) or the same combination with the addition of paclitaxel 175 mg/m2 on day 1 [ifosfamide, paclitaxel and cisplatinum (ITP) regimen]. Cycles were administered every 4 weeks on an outpatient basis.

Results: A modest increase in neurotoxicity was observed with the triplet combination. OR rate was significantly higher in the ITP group (59% versus 33%, P = 0.002). Median PFS was 7.9 and 6.3 months for patients in the ITP and IP arms, respectively (P = 0.023). Median OS was 15.4 months and 13.2 months in the ITP and IP arms, respectively (P = 0.048). In multivariate analysis, the triplet yielded a hazard ratio of 0.70 for relapse or progression (P = 0.046) and 0.75 for death (P = 0.124) compared with the doublet.

Conclusion: The ITP combination merits further investigation in randomized phase III studies.

advanced cervical cancer, cisplatinum, ifosfamide, neurotoxicity, paclitaxel, triplet combination

Received for publication November 15, 2008. Revision received December 21, 2008. Accepted for publication December 22, 2008.


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