- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
Journal: Optimizing administration of third-line treatment in metastatic colorectal cancer. (Pubmed Central) - Mar 23, 2022
Other approaches to optimize patient outcomes with regorafenib and trifluridine/tipiracil include the use of novel combinations with immune checkpoint inhibitors or other targeted agents. Further results of clinical trials will allow clinicians to better manage these patients, ultimately improving outcomes while maintaining quality of life.
- |||||||||| 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 18, 2022
P2, N=50, Recruiting,
These factors should be considered along with the patient's preferences and individual treatment goals. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka
Trial completion, Real-world evidence, Real-world, Metastases: RETRO-TAS: A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece (clinicaltrials.gov) - Mar 7, 2022
P=N/A, N=200, Completed,
Our study, examining a practical issue of how to sequence second- and third-line therapies, documents that one sequence versus the other does not compromise patient outcomes and overall, our patients had an outstanding OS of beyond 19 months when they receive third-line therapy. Recruiting --> Completed
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
Journal: Curcumin: A therapeutic strategy for colorectal cancer? (Pubmed Central) - Mar 5, 2022
In this review we discuss the possibility of incorporating curcumin in the treatment of CRC; specifically, we review preclinical and clinical data supporting its possible combination with current therapies as well as new formulations under clinical study. It is time for the golden spice revolution.
- |||||||||| irinotecan / Generic mfg.
Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Evolving therapies in advanced oesophago-gastric cancers and the increasing role of immunotherapy. (Pubmed Central) - Mar 4, 2022
Results from the trials KEYNOTE-059, ATTRACTION-2, and TAGS have established the use of immune checkpoint inhibitors and trifluridine/tipiracil as a third-line treatment...Recent advances in the treatment of chemo-refractory oesophago-gastric cancer add to the improving survival of patients with this disease. Further research is needed to guide better patient selection to therapies and the earlier incorporation of these agents in the treatment journey.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer (clinicaltrials.gov) - Mar 4, 2022
P2, N=28, Active, not recruiting,
Further research is needed to guide better patient selection to therapies and the earlier incorporation of these agents in the treatment journey. Suspended --> Active, not recruiting | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
- |||||||||| AiTan (rivoceranib) / HLB Bio Group
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - Mar 3, 2022
P1b/2, N=29, Active, not recruiting,
Trial primary completion date: Dec 2021 --> Mar 2022 Recruiting --> Active, not recruiting | N=127 --> 29 | Trial completion date: Dec 2020 --> Apr 2023 | Trial primary completion date: Dec 2020 --> Apr 2023
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
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) - Feb 22, 2022
P2, N=101, Active, not recruiting,
Recruiting --> Active, not recruiting | N=127 --> 29 | Trial completion date: Dec 2020 --> Apr 2023 | Trial primary completion date: Dec 2020 --> Apr 2023 Trial primary completion date: Feb 2021 --> Aug 2021
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Mekinist (trametinib) / Novartis, BeiGene
Trial completion date, Trial primary completion date, Combination therapy, Surgery, Metastases: Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Feb 21, 2022
P1, N=26, Active, not recruiting,
Trial primary completion date: Feb 2021 --> Aug 2021 Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka
Trial completion, Trial completion date, Surgery, Metastases: TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Feb 21, 2022
P1, N=7, Completed,
Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Apr 2021
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Elunate (fruquintinib) / Hutchmed, Stivarga (regorafenib) / Bayer
Review, Journal: Selection of Oral Therapeutics in China for the Treatment of Colorectal Cancer. (Pubmed Central) - Feb 1, 2022
The availability of oral capecitabine has improved the tolerability and simplified combination schedules...In general, third-line treatment options for mCRC are mainly regorafenib, fruquintinib, and chemo/targeted therapy reintroduction, while FTD/TPI was rarely used in China probably due to poor accessibility...New drugs of clinical trials were more recommended for the patients with BRAF mutant tumor, and those with good previous treatment efficacy tended to be recommended for chemo/targeted therapy reintroduction. The management of mCRC is evolving, and it must be emphasized that the consideration and recommendations presented here reflect current treatment practices in China and thus might change according to new clinical data as well as the availability of new oral drugs.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Trial 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) - Jan 28, 2022
P2, N=101, Active, not recruiting,
Not yet recruiting --> Recruiting Trial completion date: Apr 2023 --> Oct 2022
- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, PD(L)-1 Biomarker: Case of Unresectable Gastric Mixed Neuroendocrine Neoplasm(MiNEN)Treated with Chemotherapy (Pubmed Central) - Jan 21, 2022
A 68-year-old man diagnosed with gastric mixed neuroendocrine-non-neuroendocrine neoplasia(MiNEN)concomitant with liver metastasis received chemotherapy using ramucirumab and paclitaxel...Although liver metastases were reduced after 2 courses of nivolumab, the patient developed new liver lesions after 18 courses of treatment; irinotecan, S-1 and oxaliplatin, and trifluridine/tipiracil were then administered...Gastric MiNEN usually shows poor prognosis, and there is lack of consensus regarding optimal treatment. Ramucirumab and nivolumab are relatively well-tolerated and may be effective for chemotherapy.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Trial primary completion date, Combination therapy, Metastases: TAS102 in Combination With NAL-IRI in Advanced GI Cancers (clinicaltrials.gov) - Jan 13, 2022
P1/2, N=64, Recruiting,
The present study is the first one to compare the activity of the two agents in a large cohort of chemo-refractory mCRC patients providing more details about the best sequence, to be incorporated in clinical practice. Trial primary completion date: Nov 2021 --> Nov 2022
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
Clinical, Review, Journal: TAS-102: A resurrected novel Fluoropyrimidine with expanding role in the treatment of gastrointestinal malignancies. (Pubmed Central) - Jan 12, 2022
The current article presents an overview of the pharmacology, clinical development of TAS-102, and its emerging role in the treatment of GI cancers. In addition, we discussed the rationale underlying the ongoing clinical trials investigating various combinations of TAS-102 with other anticancer agents, including targeted therapies, in a wide range of GI tumors.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical Investigator Perspectives on the Management of Patients with Gastroesophageal Cancers (Part 2 of a 3-Part Series) (San Francisco Marriott Marquis – Yerba Buena Ballroom – Salon 9 (Lower B2 Level)) - Jan 8, 2022 - Abstract #ASCOGI2022ASCO_GI_757;
Not yet recruiting --> Recruiting MODULE 1: Current and Future Front-Line Management of Advanced Gastric and Gastroesophageal Junction (GEJ) Cancer Available efficacy and safety results from the Phase III CheckMate 649 study comparing first-line nivolumab in combination with chemotherapy or ipilimumab to chemotherapy alone for advanced gastric/GEJ adenocarcinoma; FDA approval and patient selection for up-front nivolumab/chemotherapy Mechanism of action of sintilimab; recently presented results from the Phase III ORIENT-16 trial comparing sintilimab with chemotherapy to chemotherapy alone as first-line treatment Biologic rationale for targeting claudin 18.2 in gastric/GEJ cancers; mechanism of antitumor activity of zolbetuximab Available efficacy and safety findings with first-line zolbetuximab/chemotherapy in patients with advanced claudin 18.2-positive gastric/GEJ adenocarcinoma; ongoing Phase III SPOTLIGHT and GLOW studies Frequency of FGFR2b overexpression in gastroesophageal cancers; mechanism of action of bemarituzumab Major efficacy and safety data from the Phase II FIGHT trial evaluating bemarituzumab/chemotherapy versus chemotherapy alone as first-line therapy for patients with FGFR2b-positive metastatic gastric/GEJ cancer; FDA breakthrough therapy designation MODULE 2: Contemporary Management of HER2-Positive Advanced Gastric and GEJ Cancer Principal outcomes from the Phase III KEYNOTE-811 trial supporting the FDA approval of first-line pembrolizumab/trastuzumab/chemotherapy for metastatic HER2-positive disease Updated results, including overall survival outcomes, from the Phase II DESTINY-Gastric01 study of trastuzumab deruxtecan (T-DXd) for patients with progressive HER2-positive gastric/GEJ cancer FDA approval of T-DXd for patients with HER2-positive gastric/GEJ cancer who have previously received a trastuzumab-based regimen; optimal incorporation into routine practice Recently presented efficacy and safety findings from the Phase II DESTINY-Gastric02 trial evaluating T-DXd in Western patients with HER2-positive gastric/GEJ cancer previously treated with a trastuzumab-based regimen Ongoing studies with T-DXd in earlier lines of treatment and/or in combination with other systemic therapies MODULE 3: Selection and Sequencing of Therapy for Relapsed Gastric and GEJ Cancer Optimal integration of ramucirumab into current clinical algorithms for metastatic gastric/GEJ cancer Available data with and ongoing investigation of novel ramucirumab-combination regimens Clinical research supporting the use of TAS-102 for heavily pretreated metastatic gastric/GEJ cancer; patient selection for treatment with TAS-102 Current role, if any, of anti-PD-1 monotherapy for patients with recurrent metastatic gastric/GEJ cancer; clinical implications of the voluntary withdrawal of third-line pembrolizumab Other promising agents and strategies under investigation for advanced gastric/GEJ cancer MODULE 4: Key Findings Informing the Treatment of Localized and Advanced Esophageal Cancer Design, eligibility criteria and primary findings from the Phase III KEYNOTE-590 study leading to the FDA approval of first-line pembrolizumab/chemotherapy for advanced esophageal and GEJ cancer; patient selection for this approach Major findings from the Phase III CheckMate 648 study evaluating nivolumab/chemotherapy, nivolumab/ipilimumab and chemotherapy alone for patients with unresectable advanced or metastatic squamous cell carcinoma of the esophagus Available Phase III clinical trial findings (eg, JUPITER-06, ORIENT-15) with investigational anti-PD-1 antibodies with chemotherapy as first-line treatment for esophageal squamous cell carcinoma Key efficacy and safety outcomes from the Phase III CheckMate 577 study of adjuvant nivolumab for patients with resected esophageal or GEJ cancer; recent FDA approval and appropriate integration into management algorithms
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
Clinical, P3 data, Journal: Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer: a subgroup analysis from the phase 3 TAGS study. (Pubmed Central) - Jan 4, 2022
MODULE 1: Current and Future Front-Line Management of Advanced Gastric and Gastroesophageal Junction (GEJ) Cancer Available efficacy and safety results from the Phase III CheckMate 649 study comparing first-line nivolumab in combination with chemotherapy or ipilimumab to chemotherapy alone for advanced gastric/GEJ adenocarcinoma; FDA approval and patient selection for up-front nivolumab/chemotherapy Mechanism of action of sintilimab; recently presented results from the Phase III ORIENT-16 trial comparing sintilimab with chemotherapy to chemotherapy alone as first-line treatment Biologic rationale for targeting claudin 18.2 in gastric/GEJ cancers; mechanism of antitumor activity of zolbetuximab Available efficacy and safety findings with first-line zolbetuximab/chemotherapy in patients with advanced claudin 18.2-positive gastric/GEJ adenocarcinoma; ongoing Phase III SPOTLIGHT and GLOW studies Frequency of FGFR2b overexpression in gastroesophageal cancers; mechanism of action of bemarituzumab Major efficacy and safety data from the Phase II FIGHT trial evaluating bemarituzumab/chemotherapy versus chemotherapy alone as first-line therapy for patients with FGFR2b-positive metastatic gastric/GEJ cancer; FDA breakthrough therapy designation MODULE 2: Contemporary Management of HER2-Positive Advanced Gastric and GEJ Cancer Principal outcomes from the Phase III KEYNOTE-811 trial supporting the FDA approval of first-line pembrolizumab/trastuzumab/chemotherapy for metastatic HER2-positive disease Updated results, including overall survival outcomes, from the Phase II DESTINY-Gastric01 study of trastuzumab deruxtecan (T-DXd) for patients with progressive HER2-positive gastric/GEJ cancer FDA approval of T-DXd for patients with HER2-positive gastric/GEJ cancer who have previously received a trastuzumab-based regimen; optimal incorporation into routine practice Recently presented efficacy and safety findings from the Phase II DESTINY-Gastric02 trial evaluating T-DXd in Western patients with HER2-positive gastric/GEJ cancer previously treated with a trastuzumab-based regimen Ongoing studies with T-DXd in earlier lines of treatment and/or in combination with other systemic therapies MODULE 3: Selection and Sequencing of Therapy for Relapsed Gastric and GEJ Cancer Optimal integration of ramucirumab into current clinical algorithms for metastatic gastric/GEJ cancer Available data with and ongoing investigation of novel ramucirumab-combination regimens Clinical research supporting the use of TAS-102 for heavily pretreated metastatic gastric/GEJ cancer; patient selection for treatment with TAS-102 Current role, if any, of anti-PD-1 monotherapy for patients with recurrent metastatic gastric/GEJ cancer; clinical implications of the voluntary withdrawal of third-line pembrolizumab Other promising agents and strategies under investigation for advanced gastric/GEJ cancer MODULE 4: Key Findings Informing the Treatment of Localized and Advanced Esophageal Cancer Design, eligibility criteria and primary findings from the Phase III KEYNOTE-590 study leading to the FDA approval of first-line pembrolizumab/chemotherapy for advanced esophageal and GEJ cancer; patient selection for this approach Major findings from the Phase III CheckMate 648 study evaluating nivolumab/chemotherapy, nivolumab/ipilimumab and chemotherapy alone for patients with unresectable advanced or metastatic squamous cell carcinoma of the esophagus Available Phase III clinical trial findings (eg, JUPITER-06, ORIENT-15) with investigational anti-PD-1 antibodies with chemotherapy as first-line treatment for esophageal squamous cell carcinoma Key efficacy and safety outcomes from the Phase III CheckMate 577 study of adjuvant nivolumab for patients with resected esophageal or GEJ cancer; recent FDA approval and appropriate integration into management algorithms As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Avastin (bevacizumab) / Roche
Review, Journal, Combination therapy, Monotherapy: TAS-102 Monotherapy and Combination Therapy with Bevacizumab for Metastatic Colorectal Cancer. (Pubmed Central) - Jan 1, 2022
TAS-102+B vs. TAS-102 (OR = 0.41, 95% CI: 0.18-0.93; OR = 0.72, 95% CI: 0.63-0.83) and TAS-102 vs. placebo (OR = 0.44, 95% CI: 0.29-0.67; OR = 0.51, 95% CI: 0.42-0.62) were studied to actively prevent the occurrence of neutropenia, leukopenia, febrile neutropenia, anemia, and vomiting. TAS-102 monotherapy and combination therapy with bevacizumab can significantly improve the survival of patients and prevent specific adverse events from happening.
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