Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer
AIM: To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC).
METHODS: This study was a prospective, multicenter, one-arm, open-label, phase II trial. Patients with unresectable PC, who showed disease progression during GEM-based chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin (RIO; irinotecan 120 mg/m2 and oxaliplatin 60 mg/m2), which was set according to the phase I study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events were evaluated. Additionally, changes in quality of life (QoL) were assessed using a questionnaire on QoL.
RESULTS: Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval (CI): 3.7-7.9] and median OS was 9.0 mo (95%CI: 6.4-11.6). Neutropenia (64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia (16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment (45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548).
CONCLUSION: FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
World journal of gastrointestinal oncology - 10(2018), 12 vom: 15. Dez., Seite 505-515 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chung, Moon Jae [VerfasserIn] |
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| Links: |
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| Themen: |
Chemotherapy |
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| Anmerkungen: |
Date Revised 01.10.2020 published: Print Citation Status PubMed-not-MEDLINE |
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| doi: |
10.4251/wjgo.v10.i12.505 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM292248989 |
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| 100 | 1 | |a Chung, Moon Jae |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer |
| 264 | 1 | |c 2018 | |
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| 500 | |a Date Revised 01.10.2020 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a AIM: To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC) | ||
| 520 | |a METHODS: This study was a prospective, multicenter, one-arm, open-label, phase II trial. Patients with unresectable PC, who showed disease progression during GEM-based chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin (RIO; irinotecan 120 mg/m2 and oxaliplatin 60 mg/m2), which was set according to the phase I study of FOLFIRINOX. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), adverse events were evaluated. Additionally, changes in quality of life (QoL) were assessed using a questionnaire on QoL | ||
| 520 | |a RESULTS: Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval (CI): 3.7-7.9] and median OS was 9.0 mo (95%CI: 6.4-11.6). Neutropenia (64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia (16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment (45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548) | ||
| 520 | |a CONCLUSION: FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a FOLFIRINOX | |
| 650 | 4 | |a Gemcitabine refractory | |
| 650 | 4 | |a Pancreatic cancer | |
| 700 | 1 | |a Kang, Huapyong |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Ho Gak |e verfasserin |4 aut | |
| 700 | 1 | |a Hyun, Jong Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Jun Kyu |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Kwang Hyuck |e verfasserin |4 aut | |
| 700 | 1 | |a Noh, Myung Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Dae Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sang Hyub |e verfasserin |4 aut | |
| 700 | 1 | |a Bang, Seungmin |e verfasserin |4 aut | |
| 700 | 0 | |a Pancreatobiliary Cancer Study Group of Korean Society of Gastrointestinal Cancer |e verfasserin |4 aut | |
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