Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015) : an open-label, randomised, Phase 3 trial
© 2023. The Author(s)..
BACKGROUND: The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC.
METHODS: Patients recruited from 16 hospitals received gemcitabine (1000 mg/m2, D 1, 8, and 15)/capecitabine (830 mg/m2 BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety.
RESULTS: Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively.
CONCLUSIONS: GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC.
CLINICAL TRIAL REGISTRATION: NCT02854072.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:130 |
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| Enthalten in: |
British journal of cancer - 130(2024), 1 vom: 04. Jan., Seite 43-52 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jo, Jung Hyun [VerfasserIn] |
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| Links: |
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| Themen: |
0W860991D6 |
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| Anmerkungen: |
Date Completed 12.01.2024 Date Revised 05.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT02854072 ErratumIn: Br J Cancer. 2023 Dec 4;:. - PMID 38049557 Citation Status MEDLINE |
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| doi: |
10.1038/s41416-023-02474-w |
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| PPN (Katalog-ID): |
NLM363958886 |
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| 100 | 1 | |a Jo, Jung Hyun |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015) |b an open-label, randomised, Phase 3 trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 12.01.2024 | ||
| 500 | |a Date Revised 05.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02854072 | ||
| 500 | |a ErratumIn: Br J Cancer. 2023 Dec 4;:. - PMID 38049557 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC | ||
| 520 | |a METHODS: Patients recruited from 16 hospitals received gemcitabine (1000 mg/m2, D 1, 8, and 15)/capecitabine (830 mg/m2 BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety | ||
| 520 | |a RESULTS: Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively | ||
| 520 | |a CONCLUSIONS: GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: NCT02854072 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
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| 700 | 1 | |a Kim, Ho Gak |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Hong Sik |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Young Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Dong Uk |e verfasserin |4 aut | |
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| 700 | 1 | |a Park, Chang-Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Eun Kwang |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Jae Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Woo Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Moon, Hyungsik Roger |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Mi-Suk |e verfasserin |4 aut | |
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| 700 | 1 | |a Song, Si Young |e verfasserin |4 aut | |
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