Abstract
BACKGROUND In a previous phase 2 trial, axitinib was active and well tolerated in patients with advanced thyroid cancer. In this second phase 2 trial, the efficacy and safety of axitinib were evaluated further in this population, and pharmacokinetic/pharmacodynamic relationships and patient-reported outcomes were assessed. METHODS Patients (N=52) with metastatic or unresectable, locally advanced medullary or differentiated thyroid cancer that was refractory or not amenable to iodine-131 received a starting dose of axitinib 5 mg twice daily. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, pharmacokinetic parameters, and patient-reported outcomes assessed with the MD Anderson Symptom Inventory questionnaire. RESULTS The overall ORR was 35% (18 partial responses), and 18 patients had stable disease for ≥16 weeks. The median PFS was 16.1 months, and the median OS was 27.2 months. All-causality, grade ≥3 adverse events (>5%) were fatigue, dyspnea, diarrhea, decreased weight, pain in extremity, hypertension, decreased appetite, palmar-plantar erythrodysesthesia, hypocalcemia, and myalgia. Patients who had greater axitinib exposure had a longer median PFS. Quality of life was maintained during treatment with axitinib, and no significant deterioration in symptoms or interference in daily life caused by symptoms, assessed on MD Anderson Symptom Inventory subscales, were observed. CONCLUSIONS Axitinib has activity and a manageable safety profile while maintaining quality of life, and it represents an additional treatment option for patients with advanced thyroid cancer. Cancer 2014;120:2694-2703.
| Original language | English |
|---|---|
| Pages (from-to) | 2694-2703 |
| Number of pages | 10 |
| Journal | Cancer |
| Volume | 120 |
| Issue number | 17 |
| DOIs | |
| Publication status | Published - Sep 1 2014 |
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Keywords
- axitinib
- MD Anderson Symptom Inventory
- metastatic disease
- pharmacodynamic
- pharmacokinetic
- quality of life
- radioactive iodine-refractory
- thyroid cancer
- tyrosine kinase inhibitor
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Treatment of advanced thyroid cancer with axitinib : Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. / Locati, Laura D.; Licitra, Lisa; Agate, Laura; Ou, Sai Hong I; Boucher, Andree; Jarzab, Barbara; Qin, Shukui; Kane, Madeleine A.; Wirth, Lori J.; Chen, Connie; Kim, Sinil; Ingrosso, Antonella; Pithavala, Yazdi K.; Bycott, Paul; Cohen, Ezra E W.
In: Cancer, Vol. 120, No. 17, 01.09.2014, p. 2694-2703.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Treatment of advanced thyroid cancer with axitinib
T2 - Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments
AU - Locati, Laura D.
AU - Licitra, Lisa
AU - Agate, Laura
AU - Ou, Sai Hong I
AU - Boucher, Andree
AU - Jarzab, Barbara
AU - Qin, Shukui
AU - Kane, Madeleine A.
AU - Wirth, Lori J.
AU - Chen, Connie
AU - Kim, Sinil
AU - Ingrosso, Antonella
AU - Pithavala, Yazdi K.
AU - Bycott, Paul
AU - Cohen, Ezra E W
PY - 2014/9/1
Y1 - 2014/9/1
N2 - BACKGROUND In a previous phase 2 trial, axitinib was active and well tolerated in patients with advanced thyroid cancer. In this second phase 2 trial, the efficacy and safety of axitinib were evaluated further in this population, and pharmacokinetic/pharmacodynamic relationships and patient-reported outcomes were assessed. METHODS Patients (N=52) with metastatic or unresectable, locally advanced medullary or differentiated thyroid cancer that was refractory or not amenable to iodine-131 received a starting dose of axitinib 5 mg twice daily. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, pharmacokinetic parameters, and patient-reported outcomes assessed with the MD Anderson Symptom Inventory questionnaire. RESULTS The overall ORR was 35% (18 partial responses), and 18 patients had stable disease for ≥16 weeks. The median PFS was 16.1 months, and the median OS was 27.2 months. All-causality, grade ≥3 adverse events (>5%) were fatigue, dyspnea, diarrhea, decreased weight, pain in extremity, hypertension, decreased appetite, palmar-plantar erythrodysesthesia, hypocalcemia, and myalgia. Patients who had greater axitinib exposure had a longer median PFS. Quality of life was maintained during treatment with axitinib, and no significant deterioration in symptoms or interference in daily life caused by symptoms, assessed on MD Anderson Symptom Inventory subscales, were observed. CONCLUSIONS Axitinib has activity and a manageable safety profile while maintaining quality of life, and it represents an additional treatment option for patients with advanced thyroid cancer. Cancer 2014;120:2694-2703.
AB - BACKGROUND In a previous phase 2 trial, axitinib was active and well tolerated in patients with advanced thyroid cancer. In this second phase 2 trial, the efficacy and safety of axitinib were evaluated further in this population, and pharmacokinetic/pharmacodynamic relationships and patient-reported outcomes were assessed. METHODS Patients (N=52) with metastatic or unresectable, locally advanced medullary or differentiated thyroid cancer that was refractory or not amenable to iodine-131 received a starting dose of axitinib 5 mg twice daily. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, pharmacokinetic parameters, and patient-reported outcomes assessed with the MD Anderson Symptom Inventory questionnaire. RESULTS The overall ORR was 35% (18 partial responses), and 18 patients had stable disease for ≥16 weeks. The median PFS was 16.1 months, and the median OS was 27.2 months. All-causality, grade ≥3 adverse events (>5%) were fatigue, dyspnea, diarrhea, decreased weight, pain in extremity, hypertension, decreased appetite, palmar-plantar erythrodysesthesia, hypocalcemia, and myalgia. Patients who had greater axitinib exposure had a longer median PFS. Quality of life was maintained during treatment with axitinib, and no significant deterioration in symptoms or interference in daily life caused by symptoms, assessed on MD Anderson Symptom Inventory subscales, were observed. CONCLUSIONS Axitinib has activity and a manageable safety profile while maintaining quality of life, and it represents an additional treatment option for patients with advanced thyroid cancer. Cancer 2014;120:2694-2703.
KW - axitinib
KW - MD Anderson Symptom Inventory
KW - metastatic disease
KW - pharmacodynamic
KW - pharmacokinetic
KW - quality of life
KW - radioactive iodine-refractory
KW - thyroid cancer
KW - tyrosine kinase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=84906789850&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84906789850&partnerID=8YFLogxK
U2 - 10.1002/cncr.28766
DO - 10.1002/cncr.28766
M3 - Article
C2 - 24844950
AN - SCOPUS:84906789850
VL - 120
SP - 2694
EP - 2703
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 17
ER -