Trifluridine/Tipiracil Plus Bevacizumab for Vulnerable Patients With Pretreated Metastatic Colorectal Cancer: A Retrospective Study (WJOG14520G).

bevacizumab intensive therapy metastatic colorectal cancer trifluridine/tipiracil vulnerable patients

Journal

The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837

Informations de publication

Date de publication:
10 Nov 2023
Historique:
received: 15 07 2023
accepted: 19 10 2023
medline: 11 11 2023
pubmed: 11 11 2023
entrez: 11 11 2023
Statut: aheadofprint

Résumé

Trifluridine/tipiracil (FTD/TPI) plus bevacizumab has shown clinical benefit for metastatic colorectal cancer (mCRC) refractory to standard therapy. However, few data have been available for patients with pretreated mCRC who are intolerant of intensive therapy (vulnerable). We performed a multicenter retrospective study (WJOG14520G; TWILIGHT) of FTD/TPI plus bevacizumab for vulnerable patients with pretreated mCRC. Eligibility criteria included previous chemotherapy (although patients treated with all key cytotoxic agents, a fluoropyrimidine, oxaliplatin, and irinotecan, were excluded) and intolerance of full-dose combination therapy with oxaliplatin or irinotecan at the start of FTD/TPI plus bevacizumab. The median age of 93 evaluable patients was 79 years (range, 21-90). Intolerance of intensive therapy was attributable to an older age in 60 (65%) patients, serious concomitant disease in 24 (26%) patients, and a poor performance status in 19 (20%) patients. FTD/TPI plus bevacizumab was administered as second-line treatment in 74 (80%) patients and as third- or fourth-line treatment in 19 (20%) patients. The objective response rate was 4.9% (95% confidence interval [CI], 1.4%-12.2%), and the disease control rate was 67.9% (95% CI, 56.6%-77.8%). With a median follow-up time of 21.6 months, median overall survival and progression-free survival were 18.6 months (95% CI, 12.1-23.2) and 6.3 months (95% CI, 5.0-8.3), respectively. Neutropenia of grade ≥3 developed in 50 (54%) patients, whereas 2 (2%) patients experienced febrile neutropenia, and no treatment-related death was observed. Our data show the potential efficacy and acceptable safety profile of FTD/TPI plus bevacizumab for vulnerable patients with pretreated mCRC.

Sections du résumé

BACKGROUND BACKGROUND
Trifluridine/tipiracil (FTD/TPI) plus bevacizumab has shown clinical benefit for metastatic colorectal cancer (mCRC) refractory to standard therapy. However, few data have been available for patients with pretreated mCRC who are intolerant of intensive therapy (vulnerable).
METHODS METHODS
We performed a multicenter retrospective study (WJOG14520G; TWILIGHT) of FTD/TPI plus bevacizumab for vulnerable patients with pretreated mCRC. Eligibility criteria included previous chemotherapy (although patients treated with all key cytotoxic agents, a fluoropyrimidine, oxaliplatin, and irinotecan, were excluded) and intolerance of full-dose combination therapy with oxaliplatin or irinotecan at the start of FTD/TPI plus bevacizumab.
RESULTS RESULTS
The median age of 93 evaluable patients was 79 years (range, 21-90). Intolerance of intensive therapy was attributable to an older age in 60 (65%) patients, serious concomitant disease in 24 (26%) patients, and a poor performance status in 19 (20%) patients. FTD/TPI plus bevacizumab was administered as second-line treatment in 74 (80%) patients and as third- or fourth-line treatment in 19 (20%) patients. The objective response rate was 4.9% (95% confidence interval [CI], 1.4%-12.2%), and the disease control rate was 67.9% (95% CI, 56.6%-77.8%). With a median follow-up time of 21.6 months, median overall survival and progression-free survival were 18.6 months (95% CI, 12.1-23.2) and 6.3 months (95% CI, 5.0-8.3), respectively. Neutropenia of grade ≥3 developed in 50 (54%) patients, whereas 2 (2%) patients experienced febrile neutropenia, and no treatment-related death was observed.
CONCLUSION CONCLUSIONS
Our data show the potential efficacy and acceptable safety profile of FTD/TPI plus bevacizumab for vulnerable patients with pretreated mCRC.

Identifiants

pubmed: 37950903
pii: 7405405
doi: 10.1093/oncolo/oyad296
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Taiho Pharmaceutical Co., Ltd.

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press.

Auteurs

Yosuke Kito (Y)

Department of Medical Oncology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.

Hisato Kawakami (H)

Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.

Seiichiro Mitani (S)

Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.

Shinichi Nishina (S)

Department of Medical Oncology, Kurashiki Central Hospital, Okayama, Japan.

Toshihiko Matsumoto (T)

Department of Medical Oncology, Kobe City Medical Center General Hospital, Hyogo, Japan.

Takao Tsuzuki (T)

Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.

Yudai Shinohara (Y)

Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.

Hozumi Shimokawa (H)

Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.

Ryosuke Kumanishi (R)

Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.

Takashi Ohta (T)

Department of Clinical Oncology, Kansai Rosai Hospital, Hyogo, Japan.

Hiroo Katsuya (H)

Division of Hematology, Respiratory Medicine, and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Takeshi Kawakami (T)

Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Tomohiro Nishina (T)

Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.

Hiroko Hasegawa (H)

Department of Gastroenterology and Hepatology, National Hospital Organization Osaka National Hospital, Osaka, Japan.

Kohei Akiyoshi (K)

Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.

Yasutaka Chiba (Y)

Clinical Research Center, Kindai University Hospital, Osaka, Japan.

Kentaro Yamazaki (K)

Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Shuichi Hironaka (S)

Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.

Kei Muro (K)

Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.

Classifications MeSH