Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

A Multicenter, NI, Retrospective, Observational Study Evaluating Real-World Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma (mRCC) Treated With Avelumab Plus Axitinib as First-line Therapy: J-DART2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05650164

Enrollment

171

Registered

2022-12-14

Start date

2023-01-25

Completion date

2023-10-13

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Retrospective, Multicenter, Non-interventional, Medical chart review, Japan, Metastatic renal cell cancer(mRCC), Avelumab, Axitinib, First-line therapy, Standard care in real-world clinical setting

Brief summary

This study is a multicenter, non-interventional, retrospective, medical chart review of participants with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.

Interventions

DRUGavelumab

as provided in real world practice

DRUGaxitinib

as provided in real world practice

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnoses of mRCC based on the General Rule for Clinical and Pathological Studies on RCC (Fifth Edition) before receiving avelumab plus axitinib as first-line therapy. Patients with mRCC who have unresectable disease, either unresectable locally advanced or metastatic disease. 2. Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline). 3. Index date from 20 December 2019 to 17 October 2022.

Exclusion criteria

1. Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period. 2. Patients (or a patient's legally representative) refusing to provide patient data during the consent process.

Design outcomes

Primary

Measure	Time frame	Description
Number of Risk Factors in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of risk factors in participants at baseline was reported
Number of Participants With Karnofsky Performance Status Less Than (<) 80 Percent (%) at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
Number of Participants With Hemoglobin Value Below the Lower Normal Limit at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of participants with Hemoglobin value below the lower normal limit at baseline was reported.
Number of Participants With Corrected Calcium Value Above the Upper Normal Limit in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of participants with Corrected calcium value above the upper normal limit at baseline was reported.
Number of Participants With Neutrophil Count Above the Upper Normal Limit in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of Participants with Neutrophil count above the upper normal limit at baseline was reported.
International Metastatic RCC Database Consortium (IMDC) Risk Group in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (\<) 80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium; neutrophils and platelets more than (\>) upper limit of normal (ULN); hemoglobin \<lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: Low risk (0 factor), Medium risk (1-2 factors), High risk (more than or equal to \[\>=\]3 factors).
Body Weight of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The body weight of participants at baseline was reported.
Age of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The age of participants at baseline was reported.
Height of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The height of participants at baseline was reported.
Body Mass Index of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The body mass index (BMI) of participants at baseline was reported.
C-Reactive Protein Levels of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The C-reactive protein levels of participants at baseline was reported.
Estimated Glomerular Filtration Rate of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The estimated Glomerular Filtration Rate (eGFR) is an index of kidney function. eGFR was calculated using factors such as serum creatinine level, age, sex, and in millimeter per minute per 1.73 square meter (ml/min/1.73 m\^2), and tabulated in three categories (\<60, ≥60, unknown). An eGFR \<60 indicates some degree of kidney impairment. And eGFR \> 60 is generally considered to be within the normal range.
Smoking History Status of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The smoking history status of participants at baseline was reported.
Eastern Cooperative Oncology Group (ECOG) Performance Scale Score Status of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair.
Number of Participants With Metastatic Organs at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The Number of participants with Metastatic Organs of participants at baseline was reported.
Invasion Depth (T Factor) of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	TX: Primary tumor cannot be assessed, T0: No evidence of primary tumor, T1: Tumor ≤7 cm in greatest dimension, limited to the kidney, T1a: Tumor≤4cm in greatest dimension, limited to the kidney, T1b: Tumor\>4 cm but ≤7 cm in greatest dimension, limited to the kidney, T2: Tumor \>7 cm in greatest dimension, limited to the kidney, T2a: Tumor \>7 cm but ≤10 cm in greatest dimension, limited to the kidney, T2b: Tumor \>10 cm, limited to the kidney, T3: Tumor extends into major veins or perinephric tissues, but not into the ipsilateral adrenal gland and not beyond Gerota's fascia,T3a: Tumor extends into the renal vein or its segmental branches, or invades the pelvicalyceal system, or invades perirenal and, T3b: Tumor extends into the vena cava below the diaphragm, T3c: Tumor extends into the vena cava above the diaphragm or invades the wall of the vena cava, T4: Tumor invades beyond Gerota's fascia (including contiguous extension into the ipsilateral adrenal gland)
Lymph Node Metastasis (N Factor) Status of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Lymph node metastasis (N factor) of participants at baseline was reported. NX: Regional lymph nodes cannot be assessed, N0: No regional lymph node metastasis, N1: Metastasis in regional lymph node(s).
Distant Metastasis (M Factor) Status of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Distant metastasis (M factor) of participants at baseline was reported. M0: No distant metastasis, M1: Distant metastasis.
Tumor Histological Type of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Tumor histological type of participants at baseline was reported.
Number of Participants With Presence or Absence of Sarcomatoid Component in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of Participants with Presence or Absence of Sarcomatoid Component at baseline was reported.
Fuhrman Grade Status of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against Unknown'.
Availability of Proteinuria in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative (-)= \<15 milligrams per deciliter (mg/dL) (Normal), positive (±) =15-29 mg/dL (increased risk for kidney disease), (1+) = 30 mg/dL(Early stages of kidney disease), (2+)= 100 mg/dL (Underlying kidney disease), (3+)= 300 mg/dL (kidney dysfunction).
Performance of Nephrectomy in Participants	At Baseline (prior to initial treatment with avelumab plus axitinib)	Performance of nephrectomy at baseline was reported.
Number of Participants With Presence or Absence of Clinically Important Comorbidities of Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of Participants with Presence or absence of clinically important comorbidities at baseline was reported.
Number of Participants With Presence or Absence of Clinically Important Concomitant Drugs in Participants at Baseline	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of participants with Presence or absence of clinically important concomitant drugs at baseline was reported.
Number of Participants With Initiation of Systemic Therapy Within One Year of Diagnosis	At Baseline (prior to initial treatment with avelumab plus axitinib)	Number of Participants with Initiation of Systemic Therapy within One Year of Diagnosis was reported.

Secondary

Measure	Time frame	Description
Time to Treatment Discontinuation (TTD)	From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)	TTD is defined as the time from the start of treatment with avelumab plus axitinib to the end of treatment due to any cause except the effectiveness of the treatment.
Overall Survival (OS)	From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)	OS is defined as the time from the start of treatment with avelumab plus axitinib to the date of death due to any cause. If there are no clinical records of death, the date when the patient was last documented to be alive will be confirmed based on medical records. The data will be censored at the date of last contact.
Percentage of Participants With Best Overall Response of CR or PR (Objective Response Rate)	From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)	The ORR is defined as the proportion of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR \> PR \> stable disease \[SD\] \> progressive disease \[PD\], not Evaluable \[NE\]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
Number of Participants With Best Overall Response (BOR) for Primary Lesions	From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)	BOR is the best tumor response recorded during observation period.Tumor response are defined as follows:Complete or PR as the best adjudication result (CR \> PR \> stable disease \[SD\] \> progressive disease \[PD\],not Evaluable\[NE\]) in a method complied with RECIST version. 1.1tumor assessment as closely as possible in clinical practice by investigator's judgment.CR:Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR:Atleast 30% decrease in sum of diameters of target lesions,taking as reference the baseline sum diameters.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters. PD:atleast a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Real-World Progression-Free Survival (Rw-PFS)	From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)	rwPFS is defined as: The time from start of avelumab plus axitinib therapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever occurred first.

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Participants With Metastatic Renal Cell Carcinoma Participants with metastatic renal cell carcinoma who were treated using avelumab plus axitinib as a first-line therapy.	170
Total	170

Baseline characteristics

Characteristic	Participants With Metastatic Renal Cell Carcinoma
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	58 Participants
Age, Categorical Between 18 and 65 years	112 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	170 Participants
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	125 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	19 / 150
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0