Combined oral topotecan plus carboplatin in relapsed or advanced cervical cancer: a GINECO phase I-II trial.

Abstract:

AIM:Combined cisplatin-topotecan therapy is standard care for advanced cervical cancer, however it is associated with haematotoxicity and nephrotoxicity. This trial was designed to assess the combination of carboplatin which is less nephrotoxic, and oral topotecan. PATIENTS AND METHODS:Patients with advanced/recurrent squamous cervical cancer received carboplatin (AUC5) on day 1, with escalating oral topotecan (3.0 mg/m(2) starting dose) on days 1, 8 and 15, every 4 weeks. Endpoints were the maximal tolerated dose for the phase I part and safety profiles and response rates for the phase II part of the study. RESULTS:Two dose levels were evaluated. A total of 18 patients (6 phase I, 12 phase II) were treated. The maximal tolerated dose was 3.0 mg/m(2) topotecan with carboplatin AUC5. Phase II accrual was interrupted following unacceptable toxicity, with 10 therapy-related related serious events in 9 out of 12 patients: grade 3-4 pancytopenia (7), febrile neutropenia (1), grade 3 haemorrhage (1) and grade 3 vomiting (1). CONCLUSION:Weekly oral topotecan combined with carboplatin is associated with unmanageable toxicity and is not recommended. Future studies are warranted to better understand the toxicity of such a combination and explore alternative combinations for advanced cervical cancer.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

Kurtz JE,Freyer G,Joly F,Gladieff L,Kaminski MC,Fabbro M,Floquet A,Hardy-Bessard AC,Raban N,Ray-Coquard I,Pujade-Lauraine E,GINECO Group, France.

subject

Has Abstract

pub_date

2012-03-01 00:00:00

pages

1045-9

issue

3

eissn

0250-7005

issn

1791-7530

pii

32/3/1045

journal_volume

32

pub_type

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