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


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  • ||||||||||  irinotecan / Generic mfg.
    Review, Journal:  How we treat metastatic colorectal cancer. (Pubmed Central) -  Jul 21, 2021   
    In later lines, when improving quality of life become predominant, regorafenib and trifluridine/tipiracil demonstrated survival benefit, while re-challenge therapies represent an option only in selected patients. In patients with BRAFV600E-mutant tumour or with MSI, new therapies showed survival gain and probably will be a new piece in the treatment algorithm.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka, Cometriq (cabozantinib capsule) / Exelixis, Cabometyx (cabozantinib tablet) / Exelixis
    Enrollment open, Metastases:  Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy (clinicaltrials.gov) -  Jul 20, 2021   
    P1,  N=12, Recruiting, 
    Capecitabine/bevacizumab can be selected as a subsequent maintenance therapy without irinotecan and oxaliplatin because FTD/TPI has no cross-resistance with 5-fluorouracil. Not yet recruiting --> Recruiting
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TTY Biopharm
    Clinical, Clinical Trial,Phase III, Journal, Circulating tumor DNA:  CIRCULATE-Japan: Circulating tumor DNA-guided adaptive platform trials to refine adjuvant therapy for colorectal cancer. (Pubmed Central) -  Jul 10, 2021   
    The ALTAIR trial is a double-blind, phase III study designed to establish the superiority of trifluridine/tipiracil as compared with placebo in patients with resected colorectal cancer who show circulating tumor-positive status in the GALAXY study...Therefore, CIRCULATE-Japan encompasses both "de-escalation" and "escalation" trials for circulating tumor DNA-negative and positive patients, respectively, and helps to answer whether measuring circulating tumor DNA postoperatively has prognostic and/or predictive value. Our circulating tumor DNA -guided adaptive platform trials will accelerate clinical development toward further precision oncology in the field of adjuvant therapy.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Clinical, Journal:  Evaluation of RAS mutational status through BEAMing assay to monitor disease progression of metastatic colorectal cancer: a case report. (Pubmed Central) -  Jul 1, 2021   
    Then, the patient consecutively received FOLFOX bevacizumab, TAS-102, regorafenib and FOLFIRI followed by de Gramont maintenance treatment...The longitudinal assessment of RAS status offers considerable advantages in order to avoid side effects and economic costs for ineffective treatment choices. Liquid biopsy could help better monitor the disease and provide molecularly guided treatments.
  • ||||||||||  Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
    Review, Journal:  Metastatic colorectal cancer: Advances in the folate-fluoropyrimidine chemotherapy backbone. (Pubmed Central) -  Jun 30, 2021   
    Subsequent efforts to optimise 5-FU-based treatments have focused on 5-FU analogues, initially capecitabine and the combination drug tegafur/gimeracil/oteracil (S-1) and then TAS-102, which has recently been evaluated in phase 3 clinical trials for refractory colorectal cancer...Pharmacokinetic variability caused by the requirement for metabolic conversion of leucovorin has been central to recent research, and the development of agents such as arfolitixorin which bypass the need for metabolic conversion remains promising for future therapeutic candidates. In this review, we summarise the evidence leading to the current treatment regimens employing 5-FU and leucovorin, focusing on recent approaches taken to optimise and refine treatments to improve clinical outcomes in patients with mCRC.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TTY Biopharm
    Clinical, P2 data, Journal:  Phase II Trial of Trifluridine/Tipiracil in Patients with Advanced, Refractory Biliary Tract Carcinoma. (Pubmed Central) -  Jun 22, 2021   
    Panitumumab plus FTD/TPI exhibited favourable anti-tumour activity with a manageable safety profile and may be a therapeutic option for pre-treated mCRC patients. FTD/TPI demonstrated promising antitumor activity, with acceptable toxicity, in heavily pretreated patients with advanced BTC.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TTY Biopharm, Stivarga (regorafenib) / Bayer
    Journal, HEOR:  Dose-escalation strategy in refractory metastatic colorectal cancer: A change in terms of cost-effectiveness. (Pubmed Central) -  Jun 22, 2021   
    Both regorafenib and trifluridine/tipiracil can be considered economically sustainable treatments for refractory mCRC, apparently with a lower cost of trifluridine/tipiracil. The adoption of a dose-escalation strategy (ReDOS trial) could reverse the situation making regorafenib more cost-effective than trifluridine/tipiracil.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka, Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  ACCRU-GI-1618: Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer (clinicaltrials.gov) -  Jun 18, 2021   
    P2,  N=101, Active, not recruiting, 
    The pre-treatment LMR is a valid predictive and prognostic biomarker for mCRC patients undergoing TAS-102 and bevacizumab treatment. Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Feb 2021
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka
    Trial completion, Metastases:  A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment (clinicaltrials.gov) -  Jun 16, 2021   
    P1,  N=43, Completed, 
    Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Feb 2021 Active, not recruiting --> Completed
  • ||||||||||  Avastin (bevacizumab) / Roche
    Clinical, Journal:  Monitoring FTD in the PBMCs of elderly patients with mCRC administered FTD plus bevacizumab as 1st-line treatment. (Pubmed Central) -  Jun 11, 2021   
    Receiver operating characteristic analysis revealed that the percentage of FTD-positive PBMCs on day 8 (the end of the first week of treatment), had moderate ability to accurately diagnose the occurrence of severe neutropenia and leukopenia within 1 month (area under the curve = 0.778 (95% confidence interval, 0.554-0.993)). This result suggests that excess FTD incorporation into PBMCs at the initial phase of FTD/TPI plus bevacizumab treatment is a risk factor for early onset of severe hematological adverse events.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Clinical, Review, Journal:  Combination of Anti-EGFR and Anti-VEGF Drugs for the Treatment of Previously Treated Metastatic Colorectal Cancer: A Case Report and Literature Review. (Pubmed Central) -  Jun 11, 2021   
    The standard third-line treatment of metastatic colorectal cancer (mCRC) includes the small-molecule anti-vascular drugs (Regofenib and Fruquintinib) and the chemotherapy drug trifluridine and tipiracil hydrochloride (TAS-102)...In this study, we report a case of mCRC with RAS/BRAF wild-type, who was successfully treated using cetuximab in combination with fruquintinib after resistance to chemotherapy, bevacizumab, cetuximab and regorafenib...Finally, we discuss the clinical explorations of using combination of anti-EGFR with small-molecule anti-VEGF drugs and their potential benefits. The clinical effects of small-molecule anti-vascular drugs in combination with anti-EGFR in the treatment of CRC warrant further explored.
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TTY Biopharm, Stivarga (regorafenib) / Bayer
    Regorafenib is not "lonsurf" (Twitter) -  Jun 10, 2021   
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Colorectal Cancer (CRC) () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5885;    
    Some data suggest that treatments beyond the third-line setting might also improve outcome. Clinical and biologic factors influencing the selection and sequencing of therapy for patients with CRC Key efficacy and safety results from the Phase III KEYNOTE-177 study of first-line pembrolizumab versus chemotherapy for patients with MSI-high/mismatch repair-deficient (MSI-H/dMMR) unresectable or metastatic CRC; FDA approval of pembrolizumab as first-line therapy and implications for clinical practice Correlation between the location of the primary tumor and outcomes with EGFR antibody-based regimens; optimal incorporation of cetuximab and panitumumab into current metastatic CRC treatment algorithms Current clinical role of anti-PD-1 monotherapy (eg, nivolumab, pembrolizumab) and nivolumab/ipilimumab in the care of patients with MSI-H/dMMR relapsed or refractory metastatic CRC Ongoing investigations of immune checkpoint inhibitors alone or in combination with other systemic approaches (eg, chemotherapy, targeted therapy) in MSI-H/dMMR early-stage and advanced CRC (eg, CheckMate 8HW) Optimal selection of first-line therapy for patients with BRAF wild-type, microsatellite stable (MSS) metastatic CRC Biologic rationale for, available data with and ongoing Phase III investigations combining an anti-angiogenic agent with an immune checkpoint inhibitor (eg, LEAP-017) for patients with previously treated MSS metastatic CRC Findings from early-phase studies (eg, REGOMUNE, CAVE, ILLUMINATE-206) and ongoing evaluation of regimens combining immune checkpoint inhibitors with different systemic therapies (eg, regorafenib, cetuximab) in MSS metastatic CRC Key efficacy and safety findings from the Phase III BEACON CRC trial of encorafenib/cetuximab with or without binimetinib for patients with BRAF V600E-mutant metastatic CRC; FDA approval of encorafenib/cetuximab and appropriate integration into clinical practice Design, eligibility criteria and available efficacy results from the Phase II ANCHOR-CRC trial evaluating encorafenib, binimetinib and cetuximab in patients with previously untreated BRAF V600E-mutant metastatic CRC Incidence of HER2 overexpression and HER2 mutations in CRC; key efficacy findings from the Phase II DESTINY-CRC01 study of T-DXd for patients with HER2-expressing advanced CRC Spectrum, incidence and severity of toxicities associated with T-DXd in the DESTINY-CRC01 trial Available data with and ongoing investigations of HER2-directed approaches in advanced CRC (eg, HERACLES, DASH, DESTINY-CRC02, MOUNTAINEER) Long-term efficacy and safety findings with and clinical, biologic and/or practical factors influencing the sequencing of regorafenib and TAS-102 Available data with and potential role of TAS-102 in combination with bevacizumab or other systemic agents in metastatic CRC and/or in earlier disease stages Mechanism of action of napabucasin; implications of the negative results from the Phase III CanStem303C trial of napabucasin in combination with FOLFIRI with or without bevacizumab for previously treated metastatic CRC Other promising agents and strategies under investigation in CRC
  • ||||||||||  Lonsurf (trifluridine/tipiracil) / Otsuka, Talzenna (talazoparib) / Pfizer
    Enrollment open, Metastases:  Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer (clinicaltrials.gov) -  Jun 2, 2021   
    P1,  N=21, Recruiting, 
    Clinical and biologic factors influencing the selection and sequencing of therapy for patients with CRC Key efficacy and safety results from the Phase III KEYNOTE-177 study of first-line pembrolizumab versus chemotherapy for patients with MSI-high/mismatch repair-deficient (MSI-H/dMMR) unresectable or metastatic CRC; FDA approval of pembrolizumab as first-line therapy and implications for clinical practice Correlation between the location of the primary tumor and outcomes with EGFR antibody-based regimens; optimal incorporation of cetuximab and panitumumab into current metastatic CRC treatment algorithms Current clinical role of anti-PD-1 monotherapy (eg, nivolumab, pembrolizumab) and nivolumab/ipilimumab in the care of patients with MSI-H/dMMR relapsed or refractory metastatic CRC Ongoing investigations of immune checkpoint inhibitors alone or in combination with other systemic approaches (eg, chemotherapy, targeted therapy) in MSI-H/dMMR early-stage and advanced CRC (eg, CheckMate 8HW) Optimal selection of first-line therapy for patients with BRAF wild-type, microsatellite stable (MSS) metastatic CRC Biologic rationale for, available data with and ongoing Phase III investigations combining an anti-angiogenic agent with an immune checkpoint inhibitor (eg, LEAP-017) for patients with previously treated MSS metastatic CRC Findings from early-phase studies (eg, REGOMUNE, CAVE, ILLUMINATE-206) and ongoing evaluation of regimens combining immune checkpoint inhibitors with different systemic therapies (eg, regorafenib, cetuximab) in MSS metastatic CRC Key efficacy and safety findings from the Phase III BEACON CRC trial of encorafenib/cetuximab with or without binimetinib for patients with BRAF V600E-mutant metastatic CRC; FDA approval of encorafenib/cetuximab and appropriate integration into clinical practice Design, eligibility criteria and available efficacy results from the Phase II ANCHOR-CRC trial evaluating encorafenib, binimetinib and cetuximab in patients with previously untreated BRAF V600E-mutant metastatic CRC Incidence of HER2 overexpression and HER2 mutations in CRC; key efficacy findings from the Phase II DESTINY-CRC01 study of T-DXd for patients with HER2-expressing advanced CRC Spectrum, incidence and severity of toxicities associated with T-DXd in the DESTINY-CRC01 trial Available data with and ongoing investigations of HER2-directed approaches in advanced CRC (eg, HERACLES, DASH, DESTINY-CRC02, MOUNTAINEER) Long-term efficacy and safety findings with and clinical, biologic and/or practical factors influencing the sequencing of regorafenib and TAS-102 Available data with and potential role of TAS-102 in combination with bevacizumab or other systemic agents in metastatic CRC and/or in earlier disease stages Mechanism of action of napabucasin; implications of the negative results from the Phase III CanStem303C trial of napabucasin in combination with FOLFIRI with or without bevacizumab for previously treated metastatic CRC Other promising agents and strategies under investigation in CRC Not yet recruiting --> Recruiting