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Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: results from a phase II study.

AbstractPURPOSE:
This phase II study evaluated efficacy and safety of single-agent axitinib, an oral, potent, selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, in patients with advanced non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS:
This was an open-label, single-arm, multicenter, phase II study with a Simon two-stage minimax design. Patients received a starting dose of axitinib 5 mg orally BID. The primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) -defined objective response rate. Secondary end points included safety and tolerability, overall survival (OS), and progression-free survival (PFS).
RESULTS:
Thirty-two patients were enrolled, with a median age of 66.5 years. The majority of patients (75%) had adenocarcinoma. Nine patients (28%) had received no prior chemotherapy for metastatic disease, and 23 (72%) had received > or = one regimen. Three patients (9%) had a RECIST investigator-assessed, confirmed partial response (PR); disease control rate (PR + stable disease) was 41%. Median PFS was 4.9 months overall (95% CI, 3.6 to 7.0 months). Median OS was 14.8 months (95% CI, 10.7 months to not estimable) overall and 14.8 months (95% CI, 12.5 months to not estimable) in patients receiving first-line axitinib. One-year survival rates for patients with or without prior therapy for metastatic disease were 57% and 78%, respectively. Grade 3 treatment-related adverse events in > or = 5% of patients comprised fatigue (22%), hypertension (9%), and hyponatremia (9%).
CONCLUSION:
Axitinib demonstrated single-agent activity in patients with advanced NSCLC. Therapy was well tolerated with manageable toxicities. Further investigation of this VEGFR inhibitor in NSCLC is of interest.
AuthorsJoan H Schiller, Timothy Larson, S-H Ignatius Ou, Steven Limentani, Alan Sandler, Everett Vokes, Sinil Kim, Katherine Liau, Paul Bycott, Anthony J Olszanski, Joachim von Pawel
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 27 Issue 23 Pg. 3836-41 (Aug 10 2009) ISSN: 1527-7755 [Electronic] United States
PMID19597027 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Imidazoles
  • Indazoles
  • Axitinib
  • Receptors, Vascular Endothelial Growth Factor
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
  • Axitinib
  • Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Imidazoles (administration & dosage, adverse effects, therapeutic use)
  • Indazoles (administration & dosage, adverse effects, therapeutic use)
  • Kaplan-Meier Estimate
  • Lung Neoplasms (drug therapy, pathology)
  • Male
  • Middle Aged
  • Receptors, Vascular Endothelial Growth Factor (antagonists & inhibitors)
  • Treatment Outcome

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