Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer : A Randomized Phase II Trial
© Copyright: Yonsei University College of Medicine 2021..
PURPOSE: Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer.
MATERIALS AND METHODS: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m² and oxaliplatin 50 mg/m² on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m² on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR).
RESULTS: Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82-27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34-12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%).
CONCLUSION: The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:62 |
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| Enthalten in: |
Yonsei medical journal - 62(2021), 8 vom: 02. Aug., Seite 671-678 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lim, Sung Hee [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.07.2021 Date Revised 07.12.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.3349/ymj.2021.62.8.671 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM328414662 |
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| 100 | 1 | |a Lim, Sung Hee |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer |b A Randomized Phase II Trial |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 26.07.2021 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Copyright: Yonsei University College of Medicine 2021. | ||
| 520 | |a PURPOSE: Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer | ||
| 520 | |a MATERIALS AND METHODS: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m² and oxaliplatin 50 mg/m² on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m² on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR) | ||
| 520 | |a RESULTS: Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82-27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34-12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%) | ||
| 520 | |a CONCLUSION: The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Pancreatic adenocarcinoma | |
| 650 | 4 | |a gemcitabine and erlotinib | |
| 650 | 4 | |a oxaliplatin | |
| 650 | 4 | |a palliative chemotherapy | |
| 650 | 7 | |a Oxaliplatin |2 NLM | |
| 650 | 7 | |a 04ZR38536J |2 NLM | |
| 650 | 7 | |a Deoxycytidine |2 NLM | |
| 650 | 7 | |a 0W860991D6 |2 NLM | |
| 650 | 7 | |a Erlotinib Hydrochloride |2 NLM | |
| 650 | 7 | |a DA87705X9K |2 NLM | |
| 650 | 7 | |a Gemcitabine |2 NLM | |
| 700 | 1 | |a Yun, Jina |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Min Young |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Han Jo |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kyoung Ha |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Se Hyung |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sang Chul |e verfasserin |4 aut | |
| 700 | 1 | |a Bae, Sang Byung |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Chan Kyu |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Namsu |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Kyu Taek |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Seong Kyu |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Yun Nah |e verfasserin |4 aut | |
| 700 | 1 | |a Moon, Jong Ho |e verfasserin |4 aut | |
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