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Phase II trial of imatinib mesylate in patients with recurrent platinum- and taxane-resistant low-grade serous carcinoma of the ovary, peritoneum, or fallopian tube
- Source :
- Gynecologic Oncology. 125:640-645
- Publication Year :
- 2012
- Publisher :
- Elsevier BV, 2012.
-
Abstract
- Objective To evaluate the efficacy and tolerability of imatinib mesylate in patients with recurrent low-grade serous carcinoma (LGSC) of the ovary, peritoneum, or fallopian tube. Methods This open-label, single-institution phase II trial enrolled patients with platinum-resistant LGSC who had measurable disease, had received up to 4 platinum- and/or taxane-containing chemotherapy regimens, and had been previously screened for at least one imatinib targeted biomarker (c-kit, platelet-derived growth factor receptor [PDGFR]-β, or bcr–abl). Imatinib (600mg) was administered daily for one 6-week course and continued in the absence of toxicity and disease progression. Results Thirteen patients were enrolled; 12 were evaluable for toxicity, and 11 were evaluable for response. A total of 17 courses were administered (median, 1 course; range, 1–5 courses). Complete or partial responses were not observed. One patient had stable disease for 7.3months. c-Kit, bcr–abl, or PDGFR-β were present in 48%, 77%, and 100% of patients, respectively. No correlation between best response (stable disease) and the presence of imatinib-targeted biomarkers was observed. Adverse events included grade 3 skin rash in one patient leading to discontinuation of the drug, and grade 3 febrile neutropenia and grade 2 weight gain in two patients leading to dose reductions. The most common grade 1 or 2 toxicities were fatigue (66%), nausea/vomiting (66%), and diarrhea (41%); grade 3 toxicities included skin rash and granulocytopenia events. No grade 4 or 5 toxicities were observed. The median progression-free survival time was 1.3months (95% CI, 1.27, 1.40months), and the median overall survival time was 14.9months (95% CI, 11.0, 18.9months). Conclusion Imatinib is well-tolerated but has no activity in patients with platinum- and taxane-resistant LGSC or the ovary, peritoneum, or fallopian tube.
- Subjects :
- Adult
medicine.medical_specialty
Organoplatinum Compounds
Serous carcinoma
medicine.medical_treatment
Antineoplastic Agents
Gastroenterology
Piperazines
Internal medicine
medicine
Fallopian Tube Neoplasms
Humans
Protein Kinase Inhibitors
Peritoneal Neoplasms
Aged
Ovarian Neoplasms
Chemotherapy
business.industry
Obstetrics and Gynecology
Imatinib
Middle Aged
medicine.disease
Rash
Cystadenocarcinoma, Serous
Surgery
Pyrimidines
Imatinib mesylate
Oncology
Tolerability
Drug Resistance, Neoplasm
Benzamides
Imatinib Mesylate
Female
Taxoids
Neoplasm Recurrence, Local
medicine.symptom
Ovarian cancer
business
Febrile neutropenia
medicine.drug
Subjects
Details
- ISSN :
- 00908258
- Volume :
- 125
- Database :
- OpenAIRE
- Journal :
- Gynecologic Oncology
- Accession number :
- edsair.doi.dedup.....bc644b155492c2f6df6cfa0debd54ee1