The emerging emetogenicity of trifluridine/tipiracil (TAS‑102) from patient self-reporting : a multicenter, prospective, observational study
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature..
BACKGROUND: Trifluridine/tipiracil (TAS-102) is an oral anticancer drug with adequate efficacy in unresectable colorectal cancer, but frequently also induces chemotherapy-induced nausea and vomiting (CINV). To investigate the occurrence of CINV and antiemetic therapy in patients with colorectal cancer treated with TAS-102 (JASCC-CINV 2001).
METHODS: We conducted a multicenter, prospective, observational study in patients with colorectal cancer who received TAS-102 without dose reduction for the first time. Primary endpoint was the incidence of vomiting during the overall period. Secondary endpoints were the incidence of nausea, significant nausea, anorexia, other adverse events (constipation, diarrhea, insomnia, fatigue, dysgeusia) and patient satisfaction. Patient diaries were used for primary and secondary endpoints. All adverse events were subjectively assessed using PRO-CTCAE ver 1.0. and CTCAE ver 5.0.
RESULTS: Data from 100 of the 119 enrolled patients were analyzed. The incidence of vomiting, nausea, and significant nausea was 13%, 67%, and 36%, respectively. The incidence of vomiting in patients with and without prophylactic antiemetic therapy were 20.8% and 10.5%, respectively. Prophylactic antiemetics were given to 24% of patients, of whom 70% received D2 antagonists. Multivariate Cox proportional hazards analysis showed that experience of CINV in previous treatment tended to be associated with vomiting (hazard ratio [HR]: 7.13, 95% confidence interval [CI]: 0.87-58.5, P = 0.07), whereas prophylactic antiemetic administration was not (HR: 1.61, 95 CI: 0.50-5.21, P = 0.43). With regard to patient satisfaction, the proportion of patients who were "very satisfied," "satisfied," "slightly satisfied" or "somewhat satisfied" was 81.8%.
CONCLUSIONS: The low incidence of vomiting and high patient satisfaction suggest that TAS-102 does not require the use of uniform prophylactic antiemetic treatments. However, patients with the experience of CINV in previous treatment might require prophylactic antiemetic treatment.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:32 |
|---|---|
| Enthalten in: |
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer - 32(2024), 5 vom: 17. Apr., Seite 291 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Fujii, Hironori [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 18.04.2024 Date Revised 18.04.2024 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s00520-024-08498-z |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM371192951 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM371192951 | ||
| 003 | DE-627 | ||
| 005 | 20240418233604.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240417s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s00520-024-08498-z |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1379.xml |
| 035 | |a (DE-627)NLM371192951 | ||
| 035 | |a (NLM)38630197 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Fujii, Hironori |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The emerging emetogenicity of trifluridine/tipiracil (TAS‑102) from patient self-reporting |b a multicenter, prospective, observational study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.04.2024 | ||
| 500 | |a Date Revised 18.04.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. | ||
| 520 | |a BACKGROUND: Trifluridine/tipiracil (TAS-102) is an oral anticancer drug with adequate efficacy in unresectable colorectal cancer, but frequently also induces chemotherapy-induced nausea and vomiting (CINV). To investigate the occurrence of CINV and antiemetic therapy in patients with colorectal cancer treated with TAS-102 (JASCC-CINV 2001) | ||
| 520 | |a METHODS: We conducted a multicenter, prospective, observational study in patients with colorectal cancer who received TAS-102 without dose reduction for the first time. Primary endpoint was the incidence of vomiting during the overall period. Secondary endpoints were the incidence of nausea, significant nausea, anorexia, other adverse events (constipation, diarrhea, insomnia, fatigue, dysgeusia) and patient satisfaction. Patient diaries were used for primary and secondary endpoints. All adverse events were subjectively assessed using PRO-CTCAE ver 1.0. and CTCAE ver 5.0 | ||
| 520 | |a RESULTS: Data from 100 of the 119 enrolled patients were analyzed. The incidence of vomiting, nausea, and significant nausea was 13%, 67%, and 36%, respectively. The incidence of vomiting in patients with and without prophylactic antiemetic therapy were 20.8% and 10.5%, respectively. Prophylactic antiemetics were given to 24% of patients, of whom 70% received D2 antagonists. Multivariate Cox proportional hazards analysis showed that experience of CINV in previous treatment tended to be associated with vomiting (hazard ratio [HR]: 7.13, 95% confidence interval [CI]: 0.87-58.5, P = 0.07), whereas prophylactic antiemetic administration was not (HR: 1.61, 95 CI: 0.50-5.21, P = 0.43). With regard to patient satisfaction, the proportion of patients who were "very satisfied," "satisfied," "slightly satisfied" or "somewhat satisfied" was 81.8% | ||
| 520 | |a CONCLUSIONS: The low incidence of vomiting and high patient satisfaction suggest that TAS-102 does not require the use of uniform prophylactic antiemetic treatments. However, patients with the experience of CINV in previous treatment might require prophylactic antiemetic treatment | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bevacizumab | |
| 650 | 4 | |a Chemotherapy-induced nausea and vomiting | |
| 650 | 4 | |a Trifluridine/tipiracil | |
| 650 | 4 | |a Unresectable colorectal cancer | |
| 650 | 7 | |a tipiracil |2 NLM | |
| 650 | 7 | |a NGO10K751P |2 NLM | |
| 650 | 7 | |a trifluridine tipiracil drug combination |2 NLM | |
| 650 | 7 | |a Trifluridine |2 NLM | |
| 650 | 7 | |a RMW9V5RW38 |2 NLM | |
| 650 | 7 | |a Antiemetics |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Pyrrolidines |2 NLM | |
| 650 | 7 | |a Thymine |2 NLM | |
| 650 | 7 | |a QR26YLT7LT |2 NLM | |
| 700 | 1 | |a Tsuchiya, Masami |e verfasserin |4 aut | |
| 700 | 1 | |a Watanabe, Daichi |e verfasserin |4 aut | |
| 700 | 1 | |a Otsuka, Ryo |e verfasserin |4 aut | |
| 700 | 1 | |a Hirate, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Katsuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Go, Makiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kudo, Toshihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Shimomura, Kazuhiro |e verfasserin |4 aut | |
| 700 | 1 | |a Ando, Yosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Tani, Shinya |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Takao |e verfasserin |4 aut | |
| 700 | 1 | |a Hayashi, Katsuhisa |e verfasserin |4 aut | |
| 700 | 1 | |a Chin, Miki |e verfasserin |4 aut | |
| 700 | 1 | |a Matsunami, Naomi |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Masaya |e verfasserin |4 aut | |
| 700 | 1 | |a Hasegawa, Akiko |e verfasserin |4 aut | |
| 700 | 1 | |a Uchida, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Hashimoto, Hironobu |e verfasserin |4 aut | |
| 700 | 1 | |a Kubo, Akiko |e verfasserin |4 aut | |
| 700 | 1 | |a Matsuhashi, Nobuhisa |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Akio |e verfasserin |4 aut | |
| 700 | 1 | |a Nishimura, Junichi |e verfasserin |4 aut | |
| 700 | 1 | |a Inui, Naoki |e verfasserin |4 aut | |
| 700 | 1 | |a Iihara, Hirotoshi |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer |d 1994 |g 32(2024), 5 vom: 17. Apr., Seite 291 |w (DE-627)NLM07487618X |x 1433-7339 |7 nnns |
| 773 | 1 | 8 | |g volume:32 |g year:2024 |g number:5 |g day:17 |g month:04 |g pages:291 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00520-024-08498-z |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 32 |j 2024 |e 5 |b 17 |c 04 |h 291 | ||