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 journalArticle

100 Citations (Scopus)

Abstract

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 (US)
Pages (from-to)522-526
Number of pages5
JournalJournal of Thoracic Oncology
Volume4
Issue number4
DOIs
StatePublished - Apr 2009

Fingerprint

Non-Small Cell Lung Carcinoma
vorinostat
Lymphopenia
Histone Deacetylase Inhibitors
Survival
Hypokalemia
Neutropenia
Embolism
Dehydration
Venous Thrombosis
Antineoplastic Agents
Fatigue
Alkaline Phosphatase
Survival Rate
Stroke
Safety
Lung

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Traynor, A. M., Dubey, S., Eickhoff, J. C., Kolesar, J. M., Schell, K., Huie, M. S., ... Schiller, J. H. (2009). Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study. Journal of Thoracic Oncology, 4(4), 522-526. https://doi.org/10.1097/JTO.0b013e3181952478

Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study. / Traynor, Anne M.; Dubey, Sarita; Eickhoff, Jens C.; Kolesar, Jill M.; Schell, Kathleen; Huie, Michael S.; Groteluschen, David L.; Marcotte, Sarah M.; Hallahan, Courtney M.; Weeks, Hilary R.; Wilding, George; Espinoza-Delgado, Igor; Schiller, Joan H.

In: Journal of Thoracic Oncology, Vol. 4, No. 4, 04.2009, p. 522-526.

Research output: Contribution to journalArticle

Traynor, AM, Dubey, S, Eickhoff, JC, Kolesar, JM, Schell, K, Huie, MS, Groteluschen, DL, Marcotte, SM, Hallahan, CM, Weeks, HR, Wilding, G, Espinoza-Delgado, I & Schiller, JH 2009, 'Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study', Journal of Thoracic Oncology, vol. 4, no. 4, pp. 522-526. https://doi.org/10.1097/JTO.0b013e3181952478
Traynor, Anne M. ; Dubey, Sarita ; Eickhoff, Jens C. ; Kolesar, Jill M. ; Schell, Kathleen ; Huie, Michael S. ; Groteluschen, David L. ; Marcotte, Sarah M. ; Hallahan, Courtney M. ; Weeks, Hilary R. ; Wilding, George ; Espinoza-Delgado, Igor ; Schiller, Joan H. / Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study. In: Journal of Thoracic Oncology. 2009 ; Vol. 4, No. 4. pp. 522-526.
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abstract = "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.",
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T1 - Vorinostat (NSC# 701852) in Patients with relapsed non-small cell lung cancer; A wisconsin oncology network phase II study

AU - Traynor, Anne M.

AU - Dubey, Sarita

AU - Eickhoff, Jens C.

AU - Kolesar, Jill M.

AU - Schell, Kathleen

AU - Huie, Michael S.

AU - Groteluschen, David L.

AU - Marcotte, Sarah M.

AU - Hallahan, Courtney M.

AU - Weeks, Hilary R.

AU - Wilding, George

AU - Espinoza-Delgado, Igor

AU - Schiller, Joan H.

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N2 - 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.

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