Axitinib in the treatment of renal cell carcinoma: patient selection and perspectives

Figures & data

Table 1 Axitinib clinical efficacy by prior therapy and prognostic group

Clinical subgroup	Number of patients	PFSa hazard ratio (95% CI)
Prior sunitinib therapy	389	0.741 (0.574–0.958)
Prior cytokine therapy	251	0.462 (0.318–0.673)
MSKCC favorable risk	201	0.497 (0.326–0.758)
MSKCC intermediate risk	264	0.795 (0.578–1.094)
MSKCC poor risk	238	0.680 (0.491–0.941)
Heng favorable risk	145	0.701 (0.441–1.114)
Heng intermediate risk	461	0.644 (0.502–0.826)
Heng poor risk	71	0.860 (0.495–1.494)

Note:

a Hazard ratio for survival time comparison as against with sorafenib. Data from Rini et al.⁶

Abbreviations: PFS, progression-free survival; CI, confidence interval; MSKCC, Memorial Sloan-Kettering Cancer Center.

Table 2 Common grade ≥3 toxicities (≥3% incidence) reported in prospective axitinib trials

Grade ≥3 toxicity	Incidence (%)
	Rini et al^Citation6	Rini et al^Citation49	Rini et al^Citation29	Rixe et al^Citation22	Tomita et al^Citation45
	N=359	N=213a	N=59	N=52	N=64
Diarrhea	11	8	15	10	5
Hypertension	16	30	16	15	70
Fatigue	11	6	16	8	5
Decreased appetite	5	3			5
Stomatitis			5
Nausea	3		7
Vomiting	3		5
Hand–foot syndrome	5	4	16		22
Decreased weight		6	5		3
Dyspnea			13
Asthenia	5				6
Back pain		4
Arthralgia			3		3
Limb pain			3	4
Abdominal pain			11
Proteinuria					9
Lymphopenia	3		16
Lipase elevation	5
ALT elevation					3

Note:

a Includes patients treated in both dose-titration and nondose-titration groups.

Abbreviation: ALT, alanine aminotransferase.

Table 3 Selected ongoing axitinib clinical trials

Trial identifier	Phase	Description
NCT01599754	III	Adjuvant axitinib therapy of renal cancer in high-risk patients
NCT02493751	I	Avelumab in combination with axitinib in advanced RCC
NCT02489695	II	Axitinib in first line for advanced or metastatic papillary RCC
NCT01727336	II	Dalantercept and axitinib in advanced RCC
NCT02133742	I	Axitinib in combination with MK-3475 in previously untreated advanced RCC

Abbreviation: RCC, renal cell carcinoma.

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RiniBIMelicharBUedaTAxitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trialLancet Oncol201314121233124224140184

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RiniBIWildingGHudesGPhase II study of axitinib in sorafenib-refractory metastatic renal cell carcinomaJ Clin Oncol200927274462446819652060

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RixeOBukowskiRMMichaelsonMDAxitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II studyLancet Oncol200781197598417959415

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TomitaYUemuraHFujimotoHKey predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell carcinomaEur J Cancer201147172592260221889330

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