title: A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma.
abstract: BACKGROUND
  Lenalidomide has dual antiangiogenic and immunomodulatory properties and confirmed antitumor activity in hematologic malignancies. A phase II study investigating the safety and efficacy of continuous lenalidomide in recurrent ovarian cancer patients was initiated.
  
  
  METHODS
  Patients with histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma, with asymptomatic recurrence 6 months after prior therapy were treated with continuous oral lenalidomide (20 mg/day). The primary end point was to evaluate efficacy according to the rate of disease control at 4 months. Secondary objectives were progression-free survival (PFS) and safety.
  
  
  RESULTS
  Most of the 45 patients enrolled and treated had serous histology (78%) and a single line of prior chemotherapy (73%). Median platinum-free interval (PFI) was 11.3 months (range 6.9-56.8). Clinical benefit at 4 months was 38% [95% confidence interval (CI) 23% to 53%]. A 59% disease control rate was reported in patients with a PFI >12 months versus 24% with PFI of 6-12 months (P = 0.023). Four patients had RECIST partial responses and 21 had stable disease. CA125 responses were reported in eight patients, including one complete response. Median PFS was 3.4 months (95% CI 2.4-4.4). Most frequent toxicity was hematologic, notably grade 3-4 neutropenia in 29% of patients, along with fatigue (69%), gastrointestinal toxicity (constipation 53%, abdominal pain 49%, diarrhea 38%, nausea/vomiting 36%) and thrombosis (11%). Eight patients withdrew due to related toxicity.
  
  
  CONCLUSIONS
  Lenalidomide shows interesting efficacy in late recurrent ovarian cancer patients. Toxicity was mainly hematologic, gastrointestinal and venous thrombosis. Future studies will evaluate combination of lenalidomide with chemotherapy agents.
  
  
  BACKGROUND
  NCT01111903.
authors.affiliation: Department of Medical Oncology, Assistance Publique des Hôpitaux de Paris, Hôpital Tenon and APREC (Alliance Pour la Recherche En Cancérologie), Paris. Electronic address: frederic.selle@tnn.aphp.fr.
authors.forename: F
authors.initials: F
authors.lastname: Selle
authors.affiliation: Department of Medical Oncology, Centre François Baclesse, Caen.
authors.forename: E
authors.initials: E
authors.lastname: Sevin
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Lyon.
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.affiliation: Department of Medical Oncology, Centre Antoine Lacassagne, Nice.
authors.forename: V
authors.initials: V
authors.lastname: Mari
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie de L'Ouest-René Gauducheau, Saint-Herblain.
authors.forename: D
authors.initials: D
authors.lastname: Berton-Rigaud
authors.affiliation: Department of Medical Oncology, Centre Georges François Leclerc, Dijon.
authors.forename: L
authors.initials: L
authors.lastname: Favier
authors.affiliation: Department of Medical Oncology, Institut de Cancer de Montpellier, Montpellier.
authors.forename: M
authors.initials: M
authors.lastname: Fabbro
authors.affiliation: Department of Medical Oncology, Centre Oscar Lambret, Lille.
authors.forename: A
authors.initials: A
authors.lastname: Lesoin
authors.affiliation: Department of Medical Oncology, Centre Catherine de Sienne, Nantes.
authors.forename: A
authors.initials: A
authors.lastname: Lortholary
authors.affiliation: University Paris Descartes, Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Oncologie, Paris, France.
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018394:CA-125 Antigen / Q000097:blood; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005185:Fallopian Tube Neoplasms; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008565:Membrane Proteins / Q000097:blood; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D010984:Platinum / Q000009:adverse effects; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins; D010984:Platinum; D013792:Thalidomide; D000077269:Lenalidomide
keywords: CA125; CC-5013; lenalidomide; ovarian cancer; platinum-sensitive; recurrent