Impact of tumor shrinkage pattern with biweekly triplet gemcitabine+cisplatin+S-1 regimen for biliary tract cancers : Implications for neoadjuvant therapy from the data of KHBO1401 (KHBO1401-1A study)
S. Karger AG, Basel..
BACKGROUND: The multicenter randomized phase III KHBO1401 study (gemcitabine+cisplatin+S-1 [GCS] versus GC in biliary tract cancers [BTC]) demonstrated that GCS not only prolonged patient survival but also achieved a high response rate and that it should be good for neoadjuvant therapy. Therefore, to explore the possibilities of neoadjuvant therapy, we investigated the tumor shrinkage pattern.
METHODS: Among the total of 246 patients enrolled in the KHBO1401, the tumor shrinkage pattern and survival were investigated in patients with measurable BTC (n=183, 74%; GCS, n=91; GC, n=92).
RESULTS: The tumor shrinkage pattern could be divided to 4 categories based on the response at 100 days after enrollment: category A (<-30% in size), B (-30% to 0%), C (0% to +20%), and D (>+20%). The GCS arm included more category A and B cases (61 [67%] vs. 33 [36%], P<0.0001). Each category predicted best response and overall survival (P<0.0001). Category A showed sustained tumor response compared with category B; in GCS, the time to maximum tumor response was 165 ± 76 days in category A and 139 ± 78 in category B. Categories C and D did not achieve tumor shrinkage. The maximum tumor shrinkage size in category A was -53% in the GCS arm and -65% in the GC arm (P=0.0892). Twenty percent of patients in the GCS showed tumor regrowth 154 ± 143 days later.
CONCLUSION: GCS provided faster and greater tumor shrinkage with better survival in comparison to GC, although 20% of patients showed re-growth after 6 cycles.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
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| Enthalten in: |
Oncology - (2023) vom: 04. Dez. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kobayashi, Shogo [VerfasserIn] |
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| Links: |
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Date Revised 04.12.2023 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1159/000533669 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365397091 |
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| 100 | 1 | |a Kobayashi, Shogo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Impact of tumor shrinkage pattern with biweekly triplet gemcitabine+cisplatin+S-1 regimen for biliary tract cancers |b Implications for neoadjuvant therapy from the data of KHBO1401 (KHBO1401-1A study) |
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| 500 | |a Date Revised 04.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a S. Karger AG, Basel. | ||
| 520 | |a BACKGROUND: The multicenter randomized phase III KHBO1401 study (gemcitabine+cisplatin+S-1 [GCS] versus GC in biliary tract cancers [BTC]) demonstrated that GCS not only prolonged patient survival but also achieved a high response rate and that it should be good for neoadjuvant therapy. Therefore, to explore the possibilities of neoadjuvant therapy, we investigated the tumor shrinkage pattern | ||
| 520 | |a METHODS: Among the total of 246 patients enrolled in the KHBO1401, the tumor shrinkage pattern and survival were investigated in patients with measurable BTC (n=183, 74%; GCS, n=91; GC, n=92) | ||
| 520 | |a RESULTS: The tumor shrinkage pattern could be divided to 4 categories based on the response at 100 days after enrollment: category A (<-30% in size), B (-30% to 0%), C (0% to +20%), and D (>+20%). The GCS arm included more category A and B cases (61 [67%] vs. 33 [36%], P<0.0001). Each category predicted best response and overall survival (P<0.0001). Category A showed sustained tumor response compared with category B; in GCS, the time to maximum tumor response was 165 ± 76 days in category A and 139 ± 78 in category B. Categories C and D did not achieve tumor shrinkage. The maximum tumor shrinkage size in category A was -53% in the GCS arm and -65% in the GC arm (P=0.0892). Twenty percent of patients in the GCS showed tumor regrowth 154 ± 143 days later | ||
| 520 | |a CONCLUSION: GCS provided faster and greater tumor shrinkage with better survival in comparison to GC, although 20% of patients showed re-growth after 6 cycles | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Wada, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Sakai, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Baba, Hideo |e verfasserin |4 aut | |
| 700 | 1 | |a Kanai, Masashi |e verfasserin |4 aut | |
| 700 | 1 | |a Kamachi, Hirofumi |e verfasserin |4 aut | |
| 700 | 1 | |a Takayama, Tadatoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ueno, Masaki |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Masahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Sho, Masayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshimura, Kenichi |e verfasserin |4 aut | |
| 700 | 1 | |a Hatano, Etsuro |e verfasserin |4 aut | |
| 700 | 1 | |a Nagano, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Ioka, Tatsuya |e verfasserin |4 aut | |
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