Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study

Anne M. Traynor, Sarita Dubey, Jens C. Eickhoff, Jill M. Kolesar, Kathleen Schell, Michael S. Huie, David L. Groteluschen, Sarah M. Marcotte, Courtney M. Hallahan, Hilary R. Weeks, George Wilding, Igor Espinoza-Delgado, Joan H. Schiller

Research output: Contribution to journalArticlepeer-review

128 Scopus citations


Introduction: Vorinostat is a small molecule inhibitor of histone deacetylase, and has shown preclinical activity in non-small cell lung cancer (NSCLC). Methods: Patients with relapsed NSCLC were eligible. Patients received oral vorinostat, 400 mg daily. The primary objective was response rate, with the goal of at least one responder in the first 14 evaluable patients, according to the two-stage minimax esign. Secondary objectives included time to progression (TTP), overall survival (OS), and safety. Results: Sixteen patients enrolled from January 2006 to April 2007. The median age was 59.5 years. Thirteen patients were female. Two patients were not evaluable for response due to progressive disease within Cycle 1. No objective antitumor responses were seen in the 14 evaluable patients. Eight patients experienced stable disease (median 3.7 months, range 1.4 -19.4). Median TTP was 2.3 months (range 0.9-19.4 months), median OS was 7.1 months (range 1.4-30.0+ months), and estimated 1 year OS rate was 19% (SE 10%). One patient died on study from an acute ischemic stroke; this event was deemed possibly related to treatment. Grade 3/4 adverse events possibly related to vorinostat included neutropenia, lymphopenia, fatigue, pulmonary embolus/deep vein thrombosis, dehydration, elevated alkaline phosphatase, and hypokalemia. Conclusions: No objective antitumor activity was detected with single agent vorinostat in this setting; however, it yields TTP in relapsed NSCLC similar to that of other targeted agents. Further studies in NSCLC should focus on combining vorinostat with other antitumor agents.

Original languageEnglish
Pages (from-to)522-526
Number of pages5
JournalJournal of Thoracic Oncology
Issue number4
StatePublished - Apr 2009

Bibliographical note

Funding Information:
Supported by the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center K12 CA087716, the NCI Early Clinical Trials of Anti-Cancer Agents with Phase I Emphasis U01 CA062491, the UWCCC 2 P30 CA014520-34, and by the NCI/CTEP, with CTEP Translational Research Initiative Funding, Contract 24XS097.


  • Histone deacetylase inhibitors
  • Non-small cell lung cancer
  • Phase II
  • Relapsed disease

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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