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Efficacy of nelfinavir as monotherapy in refractory adenoid cystic carcinoma: Results of a phase II clinical trial
Author(s) -
Hoover Andrew C.,
Milhem Mohammed M.,
Anderson Carryn M.,
Sun Wenqing,
Smith Brian J.,
Hoffman Henry T.,
Buatti John M.
Publication year - 2015
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.23664
Subject(s) - nelfinavir , medicine , adenoid cystic carcinoma , oncology , refractory (planetary science) , response evaluation criteria in solid tumors , clinical trial , progressive disease , surgery , gastroenterology , chemotherapy , phases of clinical research , carcinoma , human immunodeficiency virus (hiv) , immunology , antiretroviral therapy , viral load , physics , astrobiology
Background Adenoid cystic carcinomas (ACCs) are malignant salivary gland tumors noteworthy for high rates of late failure with limited salvage therapy options. We have previously shown increased Akt signaling is common in ACC and the human immunodeficiency virus (HIV) protease inhibitor nelfinavir (NFV) inhibits in vitro tumor growth by suppressing Akt signaling. This phase II trial was conducted to determine progression‐free survival in response to NFV in patients with recurrent/endstage ACC who have failed standard therapies. Methods Eligible patients had recurrent or end‐stage ACC and measureable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. NFV was provided at 1250 mg twice daily. Results Among 15 trial participants, median progression‐free survival was 5.5 months (lower 95% bound 4.4 months). No patient achieved a RECIST partial or complete response to therapy. Conclusion NFV monotherapy does not result in a meaningful improvement in clinical outcomes among patients with recurrent ACC. © 2014 Wiley Periodicals, Inc. Head Neck 37: 722–726, 2015