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Annals of Oncology Advance Access originally published online on May 20, 2009
Annals of Oncology 2009 20(8):1362-1368; 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

gynecologic tumors

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.

Key words: 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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