Another trial for pancreatic cancer bites the dust. This one is for gemcitabine in combination with Lenalidomide (Revlimid by Celgene).
Lenalidomide in combination with gemcitabine as first-line treatment for patients with metastatic carcinoma of the pancreas: A Sarah Cannon Research Institute phase II trial
Cancer Biology & Therapy
Volume 14, Issue 4 March 2013
Authors: Jeffrey R. Infante, Hendrik-Tobias Arkenau, Johanna C. Bendell, Mark S. Rubin, David Waterhouse, George Tripp Jones, David R. Spigel, Cassie M. Lane, John D. Hainsworth and Howard A. Burris, III
Abstract:
Objectives: To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer. Methods: Eligibility included: previously untreated metastatic adenocarcinoma of the pancreas with metastases incurable by surgery/radiation therapy; ECOG PS 0-2; adequate organ function; prophylactic anticoagulation for venous thromboembolic events (VTEs). Patients received lenalidomide 25mg PO (days 1-21) and gemcitabine 1000mg/m2 IV (days 1, 8 and 15) each 28-day cycle, with response evaluations every 8 weeks. Results: Between 5/2009-4/2010, 72 patients (median age 64 years; 68% male; 42% ECOG PS 0) were enrolled in this multicenter, community-based study. Six-month OS was 37% (95% CI 26-48%). Median PFS and OS were 2.3 (95% CI 1.9-3.5) and 4.7 (95% CI 3.4-5.7) months, respectively. Eight partial responses (11%) were documented. Thirty-nine patients (54%) experienced thrombocytopenia (2 patients, 3% grade 4). Hematologic toxicities resulted in dose modifications for the majority of patients. Twenty patients (28%) developed VTEs during treatment. Conclusions: The observed 6-month OS (37%) of lenalidomide with gemcitabine does not suggest improvement compared to historical results with gemcitabine alone. Toxicities and dose modifications likely limited dose intensity. Further development of this regimen in pancreas cancer is not recommended.
