UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044101 |
|---|---|
| Receipt number | R000050361 |
| Scientific Title | A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002) |
| Date of disclosure of the study information | 2021/05/04 |
| Last modified on | 2023/12/10 08:35:08 |
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Basic information
Public title
A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002)
Acronym
HOT2002
Scientific Title
A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002)
Scientific Title:Acronym
HOT2002
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical course, efficacy and safety of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of patients who were progression-free survival at 1 year (1-year PFS)
Key secondary outcomes
safety profile, objective response rate (ORR), disease control rate (DCR), PFS, and overall survival (OS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Advanced/Relapsed non-small cell lung cancer
2.Patients who received first-line osimertinib between August 2018 and December 20119
Key exclusion criteria
Patients who had received other EGFR-TKIs before receiving osimertinib were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Asahina |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
011-706-5911
asahinah@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Gaku |
| Middle name | |
| Last name | Yamamoto |
Organization
Hokkaido University Graduate school of Medicine
Division name
Department Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
Kita 14, North 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-5911
Homepage URL
gaku.yamamoto0306@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group(HOT)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
Kita 14, North 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-021-02561-z
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-021-02561-z
Number of participants that the trial has enrolled
132
Results
This study investigated the effects of osimertinib in 132 elderly non-small cell lung cancer patients aged 75 or older. The 1-year progression-free survival rate was 65.8%, with a median duration of 19.4 months. 17.4% of patients experienced severe pneumonitis, mostly within three months of treatment initiation. While osimertinib is effective, there's a notable risk of pneumonitis.
Results date posted
| 2023 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, 132 patients (94 females, 38 males; median age 80, range 75-90) were analyzed. A majority (70.5%) had stage IV NSCLC, while 25.8% had postoperative or post-radiotherapy recurrence. Most patients (74.2%) had a low CCI (0 or 1), and 92 were non-smokers. PS was 0-1 in 85.6% of patients, with fewer having higher PS. All had adenocarcinoma, with 34.9% having EGFR exon 19 deletions and 60.6% having exon 21 L858R mutations.
Participant flow
The Hokkaido Lung Cancer Clinical Study Group Trial 2002 (HOT2002) was a retrospective, multicenter study across 19 Japanese institutions. It aimed to evaluate the clinical characteristics and outcomes of elderly patients (aged 75 or older) with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations, who were treated with first-line osimertinib in a real-world setting. This study included patients with histologically or cytologically confirmed NSCLC and EGFR-TKI-sensitizing mutations, who began osimertinib between August 2018 and December 2019. Exclusion criteria were previous treatment with other EGFR-TKIs. Data on demographics, clinical characteristics, treatment exposure, and outcomes were collected retrospectively, with a data cut-off date of December 31, 2020.
Adverse events
During first-line osimertinib therapy, 41.7% of patients reported Grade 3 or higher AEs. Common AEs were paronychia (43.9%, 1.5% grade 3 or more), rash/acne (39.4%, grade 3 or more), dry skin (38.6%, grade 3 or more), and anemia (38.6%, 3.0% grade 3 or more). Pneumonitis occurred in 17.4% of patients, 9.1% being grade 3 or higher, with a 13.0% pneumonitis mortality rate. Median time to osimertinib discontinuation due to pneumonitis was 2.2 months. No major differences in baseline characteristics were noted between patients with or without pneumonitis. Additionally, 40.9% needed at least one dose reduction due to AEs, mainly from anorexia, rash, and diarrhea. Osimertinib was discontinued by 26.5% of patients, mostly due to pneumonitis. There were four treatment-related deaths, three from pneumonitis and one from heart failure.
Outcome measures
At a median 20.5 months follow up, 1-year PFS for osimertinib-treated patients was 65.8%. Median PFS and TTF were 19.4 and 17.7 months, respectively. Median OS was not reached. In patients with measurable lesions (85.6%), ORR was 75.2% and DCR was 92.9%. There were 3 complete responses, 82 partial responses, 20 stable diseases, and 2 progressive diseases. No significant efficacy difference was found between patients aged less or older than 80 years, or between CCI scores of 0-1 and 2 or more. PS of 2 or worse was a poor prognostic factor. Patients with EGFR exon 19 deletions had better PFS compared to L858R mutations. Univariate analysis showed PS of 2 or worse significantly correlated with shorter PFS, with no other significant factors in univariate or multivariate analyses.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 05 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050361
