Lonsurf (trifluridine/tipiracil) / Otsuka 
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 6 Diseases   125 Trials   125 Trials   2571 News 


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  • ||||||||||  Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Tomudex (raltitrexed) / Pfizer, AstraZeneca, Elunate (fruquintinib) / Takeda
    Clinical, Journal, Metastases:  Using a combination of fruquintinib, raltitrexed, and S-1 as a third-line treatment for metastatic colorectal cancer with co-existence of Hodgkin lymphoma: a case report. (Pubmed Central) -  Mar 15, 2023   
    Fruquintinib, regorafenib, trifluridine/tipiracil (TAS-102), panitumumab and cetuximab combined with single-agent chemotherapy regimens are currently recommended as third-line therapies for patients exhibiting disease progression...The mFOLFOX6 regimen was administered...Liver metastases (intestinal-type adenocarcinoma) were detected in November 2018, and second-line therapy with the FOLFIRI regimen was initiated in January 2019...Third-line therapy with fruquintinib, raltitrexed, and S-1 achieved a PR that permitted surgical resection and enabled a relatively long progression-free survival. The findings suggest that the three agents regimen might be clinically effective as late-line therapy for mCRC.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
    The combination of Trifluridine/Tipiracil and a WEE1 inhibitor is an effective and tolerable candidate strategy against ESCC (Section 17; Poster Board #16) -  Mar 14, 2023 - Abstract #AACR2023AACR_8339;    
    CHK1 inhibitor was considered to be the candidate, because combination treatment with FTD/TPI and prexasertib showed potent antitumor effects in p53-mutant ESCC cells through the synthetic lethality (Ohashi S, et al. FTD/TPI and WEE1i combination showed potent cytotoxicity, and is considered as a candidate treatment strategy against ESCC.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
    TAS102 synergizes with regorafenib against colorectal and gastric cancer cells (Section 38; Poster Board #28) -  Mar 14, 2023 - Abstract #AACR2023AACR_7092;    
    FTD can synergize with nintedanib to inhibit the growth of colorectal cancer xenografts(Suzuki, Nakagawa, Matsuoka, & Takechi, 2016)...Collectively, TAS102 plus regorafenib is asynergistic drug combination in preclinical models of GI cancer, with regorafenib suppressing TAS102-induced increase in microvessel density and p-ERK as contributing mechanisms. The drug combination may be further tested in gastric and other GI cancers.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
    Evaluation of a novel two-drug combination strategy for p53-deficient colorectal and pancreatic cancers (Section 44; Poster Board #7) -  Mar 14, 2023 - Abstract #AACR2023AACR_4722;    
    Further, deoxyuridine analogues such as TFT-containing TAS102 induced buildup of DNA damage in p53-deficient cancer cells...Notably, the two-drug therapy did not exhibit significant toxicity in mouse models. In summary, this work demonstrates that our novel inducer-amplifier strategy provides effective treatment option for aggressive p53-deficient CRC and PDAC cancers while limiting adverse toxic events and improving the quality of life for cancer patients.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Trial primary completion date, Minimal residual disease, Circulating tumor DNA:  Study of CtDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas (clinicaltrials.gov) -  Mar 13, 2023   
    P1,  N=22, Recruiting, 
    In summary, this work demonstrates that our novel inducer-amplifier strategy provides effective treatment option for aggressive p53-deficient CRC and PDAC cancers while limiting adverse toxic events and improving the quality of life for cancer patients. Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
    Comparing the Effectiveness of Tipiracil/Trifluridine Vs. Regorafenib in Elderly Metastatic Colon Cancer Patients () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_908;    
    Although our study was limited by sample size, the results were consistent with previous studies in other populations, which found similar survival rates when using Tipiracil/Trifluridine vs. Regorafenib. Incidence rates of AEs should be considered while making patient-centered treatment decisions.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Trial completion date, Trial primary completion date:  LONGBOARD: LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy (clinicaltrials.gov) -  Mar 6, 2023   
    P2,  N=250, Recruiting, 
    N=220 --> 300 | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025 Trial completion date: Jun 2022 --> Jun 2024 | Trial primary completion date: Nov 2021 --> Jul 2023
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
    Journal, Metastases:  Codon-specific KRAS mutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer. (Pubmed Central) -  Mar 3, 2023   
    In conclusion, these data show that KRAS mutations are biomarkers for reduced OS benefit of FTD/TPI treatment, with potential implications for approximately 28% of patients with mCRC under consideration for treatment with FTD/TPI. Furthermore, our data suggest that genomics-based precision medicine may be possible for a subset of chemotherapies.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer (clinicaltrials.gov) -  Mar 1, 2023   
    P2,  N=50, Recruiting, 
    Furthermore, our data suggest that genomics-based precision medicine may be possible for a subset of chemotherapies. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Trial completion date, Trial primary completion date, Metastases:  TIBET: TAS102 in Patients with ER-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) -  Feb 22, 2023   
    P2,  N=50, Recruiting, 
    Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023 Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Sep 2023
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial (clinicaltrials.gov) -  Feb 22, 2023   
    P1/2,  N=10, Terminated, 
    Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Sep 2023 N=122 --> 10 | Trial completion date: Jun 2024 --> Sep 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Sep 2022; Due to the amended therapy strategies for rectal cancer recently, it was decided not to transfer the study to the phase II part, as superiority over standard chemoradiation and transfer to a new therapy standard are increasingly unlikely.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka, Cyramza (ramucirumab) / Eli Lilly
    Enrollment closed, Combination therapy, Monotherapy, Metastases:  RAMTAS: RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients (clinicaltrials.gov) -  Feb 21, 2023   
    P3,  N=430, Active, not recruiting, 
    N=122 --> 10 | Trial completion date: Jun 2024 --> Sep 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Sep 2022; Due to the amended therapy strategies for rectal cancer recently, it was decided not to transfer the study to the phase II part, as superiority over standard chemoradiation and transfer to a new therapy standard are increasingly unlikely. Recruiting --> Active, not recruiting
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
    Journal, MSi-H Biomarker, IO biomarker, Metastases:  Survival improvement for patients with metastatic colorectal cancer over twenty years. (Pubmed Central) -  Feb 13, 2023   
    Notably, survival improved for patients with BRAF mutant as well as microsatellite unstable (MSI-H) tumors. Multivariate regression analysis identified surgical resection of liver metastasis (HR?=?0.26, 95% CI, 0.19-0.37), use of immunotherapy (HR?=?0.44, 95% CI, 0.29-0.67) and use of third line chemotherapy (regorafenib or trifluridine/tipiracil, HR?=?0.74, 95% CI, 0.58-0.95), but not year of diagnosis (HR?=?0.99, 95% CI, 0.98-1), as associated with better survival, suggesting that increased use of these therapies are the drivers of the observed improvement in survival.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka, Opdivo (nivolumab) / BMS
    Trial completion date, Trial initiation date, Trial primary completion date:  LOGICAN: Oxaliplatin  (clinicaltrials.gov) -  Feb 13, 2023   
    P2,  N=118, Recruiting, 
    Multivariate regression analysis identified surgical resection of liver metastasis (HR?=?0.26, 95% CI, 0.19-0.37), use of immunotherapy (HR?=?0.44, 95% CI, 0.29-0.67) and use of third line chemotherapy (regorafenib or trifluridine/tipiracil, HR?=?0.74, 95% CI, 0.58-0.95), but not year of diagnosis (HR?=?0.99, 95% CI, 0.98-1), as associated with better survival, suggesting that increased use of these therapies are the drivers of the observed improvement in survival. Trial completion date: Oct 2027 --> Jan 2027 | Initiation date: Dec 2022 --> Mar 2023 | Trial primary completion date: Oct 2026 --> Jan 2026