Unique ID issued by UMIN | UMIN000042333 |
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Receipt number | R000048326 |
Scientific Title | Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer |
Date of disclosure of the study information | 2021/03/01 |
Last modified on | 2023/07/02 22:47:27 |
Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer
Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer
Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer
Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer
Japan |
non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To verify the effects and prognosis of docetaxel/ramucirumab secondary therapy following combination therapy with programmed cell death 1 (PD-1) inhibitor and chemotherapy.
Efficacy
Best response
Last date of survival confirmation/date of death
Others,meta-analysis etc
20 | years-old | <= |
99 | years-old | > |
Male and Female
1. The patients had received anti-PD-1/L1 antibody + chemotherapy (+bevacizumab) as the primary therapy, followed by secondary therapy with docetaxel/ramucirumab starting by August 31, 2020.
2. Patients aged 20 years or older
Patients judged by the principal investigator of each institution to be inappropriate for registration
300
1st name | Ou |
Middle name | |
Last name | Yamaguchi |
Saitama Medical University International Medical Center
respiratory medicine
350-1298
1397-1 Yamane, Hitaka City, Saitama Prefecture
042-984-4111
ouyamagu@saitama-med.ac.jp
1st name | Ou |
Middle name | |
Last name | Yamaguchi |
Saitama Medical University International Medical Center
respiratory medicine
350-1298
1397-1 Yamane, Hitaka City, Saitama Prefecture
042-984-4111
ouyamagu@saitama-med.ac.jp
Saitama Medical University International Medical Center
Eli Lilly Japan
Profit organization
IRB, Saitama Medical University International Medical Center
1397-1 Yamane, Hitaka City, Saitama Prefecture
042-984-4523
chikens@saitama-med.ac.jp
NO
2021 | Year | 03 | Month | 01 | Day |
none
Unpublished
https://pubmed.ncbi.nlm.nih.gov/36905770/
288
The ORR and DCR of RD were 28.8% (95% CI, 23.7-34.4) and 69.8% (95% CI, 64.1-75.0), respectively. Median PFS was 4.1 months (95% CI, 3.5-4.6); median OS was 11.6 months (95% CI, 9.9-13.9). Univariate and multivariate Cox regression analysis of OS showed that bone metastases at diagnosis, poor PS (2-3), and non-adenocarcinoma were independent poor prognostic factors.
2023 | Year | 07 | Month | 02 | Day |
222 (77.1%) were male, 262 (91.0%) were under 75 years old, 199 (69.1%) had adenocarcinoma, 236 (81.9%) had stage III/IV, 52 (18.1%) had postoperative recurrence, 42 (14.6%) had pleural effusion, 40 (13.9%) had brain, 34 (11.8%) liver, 97 (33.7%) bone metastases, and 3 (1.0%) had interstitial lung disease. PD-L1 was measurable in 264 patients, of whom 123 (46.6%) were negative for PD-L1 expression. 56.3%, followed by pembrolizumab plus paclitaxel/nab-paclitaxel plus platinum (20.1%). Taxanes and bevacizumab were also used in combination in 32.6% and 12.8% of patients, respectively, for first-line therapy. 60 mg/m2 of docetaxel (DTX) was the highest dose in RD (93.8%). 19 patients (6.6%) had PS 2-3 included at the start of RD. In addition, 223 patients (77.4%) received prophylactic pegfilgrastim from the first cycle of RD.
288 patients who received anti-PD-1/L1 antibody + platinum-based chemotherapy as first-line treatment and RD as second-line treatment at 62 centers in Japan between January 2017 and August 31, 2020.
Hematologic toxicities included febrile neutropenia in 12.2%. Non-hematologic toxicities included pneumonitis of all grades in 10.8% and grade 3 or higher in 4.9%.
Anti-tumor effect (ORR, DCR), overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), adverse events, etc.
Completed
2020 | Year | 07 | Month | 01 | Day |
2021 | Year | 01 | Month | 13 | Day |
2021 | Year | 03 | Month | 01 | Day |
2021 | Year | 12 | Month | 31 | Day |
Multicenter Retrospective Study
2020 | Year | 11 | Month | 03 | Day |
2023 | Year | 07 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048326
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