Trial Outcomes & Findings for Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC) (NCT NCT01263769)

Last Updated: 2024-09-19

Results Overview

Objective response rate is defined as Complete Response (CR)+ Partial Response (PR) and evaluated when CT abdomen is done after 12 weeks of treatment. Per Response Evaluation Criteria in Solid Tumors Criteria ( RECIST v1.0) Complete Response (CR) is complete disappearance of renal mass; and, Partial Response (PR) is \>= 30% decrease in the largest diameter (LD) of the renal mass taking as reference the baseline largest diameter.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-09-19

Participant Flow

39 participants consented, but 14 not treated (11 not meeting criteria and 3 declined). Only 25 underwent treatment

Participant milestones

Participant milestones
Measure	Axitinib 5 mg by mouth twice each day for 12 weeks.
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib 5 mg by mouth twice each day for 12 weeks.
Overall Study Non-Compliant with treatment	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib n=24 Participants 5 mg by mouth twice each day for 12 weeks.
Age, Continuous	60 years n=24 Participants
Sex: Female, Male Female	5 Participants n=24 Participants
Sex: Female, Male Male	19 Participants n=24 Participants
Region of Enrollment United States	24 participants n=24 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Axitinib n=24 Participants 5 mg by mouth twice each day for 12 weeks.
Objective Response Rate	28.3 percentage of participants Interval 5.3 to 42.9

SECONDARY outcome

Timeframe: After completion of treatment, patients followed w/evaluations every 4 months for 1st year, then every 6 months for next 2 years, yearly until disease progression identified or start of new treatment & yearly survival thereafter until study completion

Population: Anyone who received study treatment

We will evaluate recurrence-free survival by plotting Kaplan-Meier curves and estimating median recurrence-free survival. RFS is the time from reatment start until death, recurrence or progressive disease, whichever comes first.

Outcome measures

Outcome measures
Measure	Axitinib n=24 Participants 5 mg by mouth twice each day for 12 weeks.
Recurrence Free Survival	103.1 Months Interval 49.5 to Not estimable for the upper found of the 95% Confidence Interval due to insufficient number of participants with events

SECONDARY outcome

Timeframe: From date of randomization until the date of death from any cause, or date of last follow-up, whichever came first, assessed up to 5 years

Population: Anyone who received study treatment.

We will evaluate overall survival by plotting Kaplan-Meier curves and estimating median overall survival. OS is the time from treatment start until death.

Outcome measures

Outcome measures
Measure	Axitinib n=24 Participants 5 mg by mouth twice each day for 12 weeks.
Overall Survival	NA months Not reached for meeting OS and not estimable for the 95% Confidence Interval due to insufficient number of participants with events

SECONDARY outcome

Timeframe: From surgery until 30 days after surgery

Population: Anyone who received study treatment and completed the 30-day post-op FU visit

We used Clavien-Dindo score to record postoperative complications of any grade (Grade 1 thru 5)

Outcome measures

Outcome measures
Measure	Axitinib n=23 Participants 5 mg by mouth twice each day for 12 weeks.
Postoperative Complications-Any Grade	9 Participants

SECONDARY outcome

Timeframe: From surgery until 30 days after surgery

Population: Anyone who received study treatment and completed the 30-day post-op FU visit

We used Clavien-Dindo score to record postoperative complications of high grade (Grade 3-5)

Outcome measures

Outcome measures
Measure	Axitinib n=23 Participants 5 mg by mouth twice each day for 12 weeks.
Surgery-related Complications - High Grade	2 Participants

Adverse Events

Axitinib

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Axitinib n=24 participants at risk 5 mg by mouth twice each day for 12 weeks.
Vascular disorders Hypertension	79.2% 19/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Respiratory, thoracic and mediastinal disorders Hoarseness	79.2% 19/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
General disorders Fatigue	75.0% 18/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Oral mucositis	70.8% 17/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Immune system disorders Hypothyroidism	62.5% 15/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Skin and subcutaneous tissue disorders Hand-foot syndrome	62.5% 15/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Nausea	37.5% 9/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Diarrhea	37.5% 9/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Investigations AST/ALT increase	33.3% 8/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 8/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Metabolism and nutrition disorders Anorexia	29.2% 7/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 6/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Nervous system disorders Dysgeusia	25.0% 6/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Nervous system disorders Headache	16.7% 4/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Immune system disorders Myalgias	16.7% 4/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Gastroesophageal reflux	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Skin and subcutaneous tissue disorders Pruritus	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Gastrointestinal disorders Vomiting	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Investigations Weight loss	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Musculoskeletal and connective tissue disorders Back pain	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Skin and subcutaneous tissue disorders Scrotal skin rash	12.5% 3/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Renal and urinary disorders Acute kidney injury	4.2% 1/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.
Blood and lymphatic system disorders Thrombocytopenia	4.2% 1/24 • Adverse Events monitored/assessed up to 12 weeks. All-Cause Mortality monitored/assessed up to 5 years No participant deaths reported throughout study.

Additional Information

Dr. Jose Karam, MD, Associate Professor, Urology

UT MD Anderson Cancer Center

Phone: (713) 745-0374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place