Phase 2 study of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type metastatic colorectal cancer: JACCRO CC-08

Background Regorafenib or trifluridine/tipiracil as third-line treatment have limited efficacy in metastatic colorectal cancer (mCRC). Methods This Phase 2 trial evaluated the efficacy and safety of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type mCRC patients who ach...

Celý popis

Uloženo v:
Podrobná bibliografie
Vydáno v:British journal of cancer Ročník 123; číslo 10; s. 1490 - 1495
Hlavní autoři: Masuishi, Toshiki, Tsuji, Akihito, Kotaka, Masahito, Nakamura, Masato, Kochi, Mitsugu, Takagane, Akinori, Shimada, Ken, Denda, Tadamichi, Segawa, Yoshihiko, Tanioka, Hiroaki, Hara, Hiroki, Sagawa, Tamotsu, Watanabe, Takanori, Takahashi, Takao, Negoro, Yuji, Manaka, Dai, Fujita, Hideto, Suto, Takeshi, Takeuchi, Masahiro, Ichikawa, Wataru, Fujii, Masashi
Médium: Journal Article
Jazyk:angličtina
Vydáno: London Nature Publishing Group UK 10.11.2020
Nature Publishing Group
Témata:
631/67/1059/602
631/67/1504/1885
Adenocarcinoma - drug therapy
Adenocarcinoma - genetics
Adenocarcinoma - mortality
Adenocarcinoma - pathology
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biomedical and Life Sciences
Biomedicine
Cancer Research
Cetuximab - administration & dosage
Cetuximab - adverse effects
Chemotherapy, Adjuvant
Colorectal cancer
Colorectal carcinoma
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - genetics
Colorectal Neoplasms - mortality
Colorectal Neoplasms - pathology
Disease control
Drug Resistance
Epidemiology
Female
Humans
Immunotherapy
Inhibitor drugs
Irinotecan
Irinotecan - administration & dosage
Irinotecan - adverse effects
K-Ras protein
Male
Metastases
Metastasis
Middle Aged
Molecular Medicine
Monoclonal antibodies
Neoplasm Metastasis
Oncology
Patients
Proto-Oncogene Proteins p21(ras) - genetics
Salvage Therapy
Survival
Survival Analysis
Targeted cancer therapy
Treatment Outcome
ISSN:0007-0920, 1532-1827, 1532-1827
On-line přístup:Získat plný text
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
Popis
Shrnutí:Background Regorafenib or trifluridine/tipiracil as third-line treatment have limited efficacy in metastatic colorectal cancer (mCRC). Methods This Phase 2 trial evaluated the efficacy and safety of irinotecan plus cetuximab rechallenge as third-line treatment in KRAS wild-type mCRC patients who achieved clinical benefit with first-line cetuximab-containing therapy. The primary endpoint was 3-month progression-free survival (PFS) rate. A sample size was calculated; 30 patients with a 3-month PFS rate of 45% deemed promising and 15% unacceptable. Patients with greater and less than the cut-off value of cetuximab-free intervals (CFIs) were classified into the long and short CFI groups, respectively, in subgroup analyses. Results Among 34 eligible patients who received treatment at least once, 3-month PFS rate was 44.1% (95% confidence interval, 27.4–60.8%). The median PFS and overall survival (OS) were 2.4 and 8.2 months, respectively. The response and disease control rates were 2.9 and 55.9%, respectively. PFS and OS were significantly longer in the long- than in the short CFI group. Conclusions Irinotecan plus cetuximab rechallenge as third-line treatment for KRAS wild-type mCRC was safe and had promising activity, especially in those with a long CFI, warranting further investigation in a Phase 3 randomised trial. Clinical trial registration UMIN000010638
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Article-2
ObjectType-Feature-1
content type line 23
ISSN:0007-0920
1532-1827
1532-1827
DOI:10.1038/s41416-020-01042-w