Article

Safety and efficacy of lenalidomide (Revlimid®) in recurrent ovarian and primary peritoneal carcinoma

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Stanford University School of Medicine, 300 Pasteur Drive, Room HH333, Stanford, CA 94305-5317, USA
Gynecologic Oncology DOI:10.1016/j.ygyno.2006.11.026

ABSTRACT ObjectivesTo conduct a phase I trial to determine the safety and toxicity profile of a novel immunomodulatory drug, lenalidomide, in recurrent ovarian and primary peritoneal cancer. The secondary objective is to evaluate the efficacy profile and quality of life (QOL) parameters in patients receiving this treatment.MethodsPatients with recurrent ovarian or peritoneal cancer who received standard staging surgery and at least one prior platinum-based chemotherapy regimen were treated with single-agent oral lenalidomide 25 mg daily for 21 days of a 28-day cycle. Toxicities were monitored by patient report, physical exam, and laboratories. Response was assessed by imaging, physical exam, and CA-125. Therapy was discontinued with disease progression and/or unacceptable toxicity.Results20 patients with recurrent ovarian or peritoneal cancer were enrolled and received 70 completed 28-day cycles and 10 partial cycles of lenalidomide therapy. The majority of adverse events were grades 1–2, including fatigue (25/80 cycles), nausea/vomiting (23/80), constipation (13/80), abdominal pain (17/80), rash (12/80), neutropenia (12/80), and anemia (12/80). Grade 3 toxicities occurred in 12 of 80 cycles (14%) and no grade IV toxicities were observed. Eleven patients completed ≥ 2 cycles and were evaluable for response. Nine achieved stable disease (SD) of at least 3 months, with four patients maintaining SD for > 6 months. The mean time to progression was 5.8 months (range 2–12 months).ConclusionOverall, oral lenalidomide was well tolerated and may have some activity as a single agent in this heavily pre-treated population. Further studies combining lenalidomide with cytotoxic treatments may be warranted in this disease setting.

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    Article: Mechanism of action of lenalidomide in hematological malignancies.
    Venumadhav Kotla, Swati Goel, Sangeeta Nischal, Christoph Heuck, Kumar Vivek, Bhaskar Das, Amit Verma
    [show abstract] [hide abstract]
    ABSTRACT: Immunomodulatory drugs lenalidomide and pomalidomide are synthetic compounds derived by modifying the chemical structure of thalidomide to improve its potency and reduce its side effects. Lenalidomide is a 4-amino-glutamyl analogue of thalidomide that lacks the neurologic side effects of sedation and neuropathy and has emerged as a drug with activity against various hematological and solid malignancies. It is approved by FDA for clinical use in myelodysplastic syndromes with deletion of chromosome 5q and multiple myeloma. Lenalidomide has been shown to be an immunomodulator, affecting both cellular and humoral limbs of the immune system. It has also been shown to have anti-angiogenic properties. Newer studies demonstrate its effects on signal transduction that can partly explain its selective efficacy in subsets of MDS. Even though the exact molecular targets of lenalidomide are not well known, its activity across a spectrum of neoplastic conditions highlights the possibility of multiple target sites of action.
    Journal of Hematology & Oncology 09/2009; 2:36. · 3.99 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

10 partial cycles
 
28-day cycle
 
28-day cycles
 
disease progression
 
efficacy profile
 
Grade 3 toxicities
 
grade IV toxicities
 
lenalidomide therapy
 
novel immunomodulatory drug
 
one prior platinum-based chemotherapy regimen
 
patients
 
peritoneal cancer
 
primary peritoneal cancer
 
range 2–12 months).ConclusionOverall
 
recurrent ovarian
 
single agent
 
single-agent oral lenalidomide 25 mg
 
toxicity profile
 
unacceptable toxicity.Results20 patients
 
≥ 2 cycles