Annals of Oncology Advance Access published online on July 15, 2009
Annals of Oncology, doi:10.1093/annonc/mdp266
Evaluation of pemetrexed (Alimta, LY231514) as second-line chemotherapy in persistent or recurrent carcinoma of the cervix: the CERVIX 1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) Group
1 Department of Gynaecologic Oncology, Catholic University of the Sacred Heart, Rome
2 Gynecologic Oncology Unit, Department of Oncology, Catholic University of Campobasso, Campobasso
3 Medical Oncology, Uro-Gynaecological Department, National Cancer Institute, Naples
4 Department of Obstetrics and Gynecology, San Raffaele Hospital, Milan
5 Division of Medical Oncology C, National Cancer Institute, Aviano, Pordenone
6 Obstetrics and Gynecology Unit, Cannizzaro Hospital, Catania
7 Medical Oncology, Fatebenefratelli Hospital, Rome, Italy
* Correspondence to: Dr D. Lorusso, Department of Gynecologic Oncology, Catholic University of the Sacred Heart, Largo Agostino Gemelli 8, IT-00168 Rome, Italy. Tel/Fax: +39-06-3550-8736; E-mail: kettalorusso{at}libero.it
Background: The objective of the study was to estimate the antitumor activity of pemetrexed in patients with advanced/recurrent carcinoma of the cervix and to determine the nature and degree of toxicity.
Methods: A multicenter phase II trial was conducted by the Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group. Patients with advanced/recurrent measurable carcinoma of the cervix that had failed one prior chemotherapy regimen in association or not with radiotherapy were treated with pemetrexed at a dose of 500 mg/m2 every 21 days. All the patients had a measurable lesion according to RECIST criteria in a not previously irradiated field.
Results: From November 2006 to September 2008, 43 patients were entered by seven member institutions of the MITO-Group. A total of 164 cycles (median 2, range 1–9) were administered. The treatment was well tolerated. More serious toxic effects (grades 3 and 4) included leukopenia in 27.9% and neutropenia in 30.2% of patients. No treatment-related deaths were reported. Six patients (13.9%) had partial responses (at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) with a median response of 7 weeks (range 3–27). Twenty-three patients (53.4%) had stable disease (less than a 50% reduction and less than a 25% increase in the sum of the products of two perpendicular diameters of all measured lesions and the appearance of no new lesions) and fourteen (32.5%) patients had progressive disease. Median progression-free survival was 10 weeks and overall survival was 35 weeks.
Conclusion: Pemetrexed showed moderate activity against advanced/recurrent cervical cancer that had failed prior chemotherapy.
chemotherapy, pemetrexed, recurrent cervical cancer
Received for publication January 26, 2009. Revision received April 1, 2009. Accepted for publication April 6, 2009.