Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)
- Registration Number
- NCT05650164
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- 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.
- Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
- Index date from 20 December 2019 to 17 October 2022.
- Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period.
- Patients (or a patient's legally representative) refusing to provide patient data during the consent process.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with metastatic renal cell carcinoma avelumab Participants with metastatic renal cell carcinoma Participants with metastatic renal cell carcinoma axitinib Participants with metastatic renal cell carcinoma
- Primary Outcome Measures
Name Time Method 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 Weight of Participants at Baseline At Baseline (prior to initial treatment with avelumab plus axitinib) The body weight 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.
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.
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).
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 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.
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.
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.
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)
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.
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.
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).
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
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (19)
Osaka University Hospital
🇯🇵Suita-city, Osaka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Yamagata University Hospital
🇯🇵Yamagata-Shi, Yamagata, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe-city, Hyogo, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kochi Medical School Hospital
🇯🇵Nankoku, Kōchi, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama City, Saitama, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyoto Medical Center
🇯🇵Kyoto-shi, Kyoto, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Wakayama, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan