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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name