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A phase II evaluation of lapatinib in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a gynecologic oncology group study.

AbstractOBJECTIVE:
Activation and dimerization of the ERBB family play a role in the pathogenesis and progression of ovarian cancer. We conducted a phase II trial to evaluate the activity and tolerability of lapatinib in patients with recurrent or persistent epithelial ovarian cancer (EOC) and to explore the clinical value of expression levels of epidermal growth factor receptors (EGFR), phosphorylated EGFR, HER-2/neu, and Ki-67, and the presence of EGFR mutations.
METHODS:
Eligible patients had recurrent or persistent EOC or primary peritoneal carcinoma, measurable disease, and up to 2 prior chemotherapy regimens for recurrent disease. Patients were treated with lapatinib 1500 mg/day. The primary endpoint of efficacy was 6-month progression free survival (PFS).
RESULTS:
Twenty-five of 28 patients were eligible and evaluable for analysis of efficacy and toxicity. Two (8.0%) were alive and progression-free at 6 months. No objective responses were observed. There were 1 grade 4 toxicity (fatigue) and few grade 3 toxicities. Associations between Ki-67 with prior platinum-free interval, PFS, and a polymorphism in EGFR were suggested.
CONCLUSIONS:
Lapatinib has minimal activity in recurrent ovarian cancer. Ki-67 expression may be associated with prior PFS and a polymorphism in EGFR exon 20 (2361G>A, Q787Q).
AuthorsAgustin A Garcia, Michael W Sill, Heather A Lankes, Andrew K Godwin, Robert S Mannel, Deborah K Armstrong, Robert L Carolla, Marcia K Liepman, Nick M Spirtos, Edgar G Fischer, Kimberly K Leslie
JournalGynecologic oncology (Gynecol Oncol) Vol. 124 Issue 3 Pg. 569-74 (Mar 2012) ISSN: 1095-6859 [Electronic] United States
PMID22037316 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
CopyrightCopyright © 2011. Published by Elsevier Inc.
Chemical References
  • Antineoplastic Agents
  • Ki-67 Antigen
  • Quinazolines
  • lapatinib
  • Receptor, Epidermal Growth Factor
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents (adverse effects, therapeutic use)
  • Disease-Free Survival
  • Female
  • Humans
  • Ki-67 Antigen (biosynthesis)
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy, genetics, metabolism)
  • Neoplasms, Glandular and Epithelial (drug therapy, genetics, metabolism)
  • Ovarian Neoplasms (drug therapy, genetics, metabolism)
  • Peritoneal Neoplasms (drug therapy, genetics, metabolism)
  • Polymorphism, Genetic
  • Quinazolines (adverse effects, therapeutic use)
  • Receptor, Epidermal Growth Factor (genetics, metabolism)

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