Validation of the JCOG prognostic index in advanced gastric cancer using individual patient data from the SPIRITS and G-SOX trials
BACKGROUND: In a phase III study for advanced gastric cancer (AGC), the Japan Clinical Oncology Group (JCOG) 9912 trial, we previously identified the following four prognostic factors-performance status ≥1, number of metastatic sites ≥2, no prior gastrectomy, and abnormal serum alkaline phosphatase levels-and proposed a prognostic index (good risk with 0 or 1 factor, moderate risk with 2 or 3 factors, and poor risk with all 4 factors). To assess the generalizability of this index, we attempted an external validation study using an independent data set.
METHODS: Individual patient data from the SPIRITS and G-SOX trials were applied to the JCOG prognostic index. The accuracy of the index for predicting survival was assessed by the Cox proportional hazards model.
RESULTS: The available data were obtained from 936 (94.5%) of the 990 patients in these trials. The three risk groups categorized by the JCOG prognostic index demonstrated highly significant survival differences; the hazard ratios (95% confidence interval) were 1.71 (1.46-2.01) between the good (n = 338) and moderate (n = 537) risk groups and 3.32 (2.47-4.46) between good and poor (n = 61) risk groups. The median overall survival times of the good, moderate, and poor risk groups were 17.2, 12.0, and 7.8 months, respectively.
CONCLUSIONS: The JCOG prognostic index was externally validated and can be widely utilized for clinical trials. Further studies are needed to apply this index to the Western population.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association - 20(2017), 5 vom: 01. Sept., Seite 757-763 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Takahari, Daisuke [VerfasserIn] |
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| Links: |
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| Themen: |
Advanced gastric cancer |
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| Anmerkungen: |
Date Completed 12.07.2018 Date Revised 10.12.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s10120-017-0702-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM269007628 |
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| 041 | |a eng | ||
| 100 | 1 | |a Takahari, Daisuke |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Validation of the JCOG prognostic index in advanced gastric cancer using individual patient data from the SPIRITS and G-SOX trials |
| 264 | 1 | |c 2017 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
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| 500 | |a Date Completed 12.07.2018 | ||
| 500 | |a Date Revised 10.12.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: In a phase III study for advanced gastric cancer (AGC), the Japan Clinical Oncology Group (JCOG) 9912 trial, we previously identified the following four prognostic factors-performance status ≥1, number of metastatic sites ≥2, no prior gastrectomy, and abnormal serum alkaline phosphatase levels-and proposed a prognostic index (good risk with 0 or 1 factor, moderate risk with 2 or 3 factors, and poor risk with all 4 factors). To assess the generalizability of this index, we attempted an external validation study using an independent data set | ||
| 520 | |a METHODS: Individual patient data from the SPIRITS and G-SOX trials were applied to the JCOG prognostic index. The accuracy of the index for predicting survival was assessed by the Cox proportional hazards model | ||
| 520 | |a RESULTS: The available data were obtained from 936 (94.5%) of the 990 patients in these trials. The three risk groups categorized by the JCOG prognostic index demonstrated highly significant survival differences; the hazard ratios (95% confidence interval) were 1.71 (1.46-2.01) between the good (n = 338) and moderate (n = 537) risk groups and 3.32 (2.47-4.46) between good and poor (n = 61) risk groups. The median overall survival times of the good, moderate, and poor risk groups were 17.2, 12.0, and 7.8 months, respectively | ||
| 520 | |a CONCLUSIONS: The JCOG prognostic index was externally validated and can be widely utilized for clinical trials. Further studies are needed to apply this index to the Western population | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Validation Study | |
| 650 | 4 | |a Advanced gastric cancer | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a Prognostic factor | |
| 650 | 4 | |a Prognostic index | |
| 700 | 1 | |a Mizusawa, Junki |e verfasserin |4 aut | |
| 700 | 1 | |a Koizumi, Wasaburo |e verfasserin |4 aut | |
| 700 | 1 | |a Hyodo, Ichinosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Boku, Narikazu |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:20 |g year:2017 |g number:5 |g day:01 |g month:09 |g pages:757-763 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s10120-017-0702-0 |3 Volltext |
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