Phase I clinical trial of bendamustine and bevacizumab for patients with advanced cancer. J Natl Compr Canc Netw 2014 Feb;12(2):194-203
Date
03/04/2014Pubmed ID
24586081DOI
10.6004/jnccn.2014.0020Scopus ID
2-s2.0-84895809305 (requires institutional sign-in at Scopus site) 3 CitationsAbstract
Bendamustine, a cytotoxic alkylating agent, has shown promising results in solid tumors. An investigator-initiated phase I clinical trial of the anti-vascular endothelial growth factor agent bevacizumab and bendamustine was conducted in patients with advanced cancer, because the 2 drugs have different mechanisms of antitumor activity and nonoverlapping toxicity. Patients were treated with escalating doses of intravenous bendamustine (70, 80, 90, and 100 mg/m(2); days 1 and 2) and intravenous bevacizumab (10 mg/kg; days 1 and 15). A conventional "3 + 3" study design was used. Forty-two patients were treated: 23 women and 19 men. The median age was 60 years. Patients had received a median of 4 prior therapies (range, 1-10). The most common cancer types were colorectal (n=9), head and neck (n= 8), non-small cell lung (n=6), and breast (n=5). Overall, 117 cycles were administered (median per patient, 2; range, 1-8). No dose-limiting toxicities were noted during the escalation phase. Therefore, the highest dose (level 4) of bendamustine (100 mg/m(2)) was used in the expansion phase. The most common toxicities were fatigue (n=22), nausea (n=14), anorexia (n=9), and thrombocytopenia (n=7). Of 38 patients who were evaluable for response, 23 (61%) had stable disease, including 2 (5.2%) who had stable disease for 6 months or more (1 with adenoid cystic carcinoma and 1 with non-small cell lung cancer). This regimen of bendamustine (100 mg/m(2)) and bevacizumab (10 mg/kg) was well tolerated and yielded disease stabilization in selected heavily pretreated patients with advanced cancer.
Author List
Tsimberidou AM, Adamopoulos AM, Ye Y, Piha-Paul S, Janku F, Fu S, Hong D, Falchook GS, Naing A, Wheler J, Fortier A, Kurzrock R, Hess KRAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Bendamustine Hydrochloride
Bevacizumab
Disease Progression
Female
Humans
Male
Middle Aged
Neoplasms
Nitrogen Mustard Compounds
Treatment Outcome
Young Adult
