- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Metastases: MATEO: Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer (clinicaltrials.gov) - Mar 26, 2021 P2, N=242, Completed, The ongoing phase I trial will help provide safety and initial efficacy data once completed. Active, not recruiting --> Completed | N=400 --> 242 | Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: Apr 2020 --> Oct 2020
- |||||||||| oxaliplatin / Generic mfg., irinotecan / Generic mfg., gemcitabine / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: NEOPAN: A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma (clinicaltrials.gov) - Mar 24, 2021 P3, N=170, Recruiting, The safety profile of the combination of cetuximab and FOLFOXIRI was acceptable and promising anti-tumor activity was demonstrated, supporting further study in patients with RAS wild-type mCRC. Trial completion date: Mar 2022 --> Sep 2024 | Trial primary completion date: Mar 2021 --> Sep 2023
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, HEOR: Evaluation of the Cost-effectiveness of Doublet Therapy in Metastatic BRAF Variant Colorectal Cancer. (Pubmed Central) - Mar 16, 2021 This study found that doublet therapy for metastatic BRAF variant colorectal cancer was unlikely to be cost-effective under current pricing. Cost-effectiveness needs to be considered in clinical trial design, particularly when combining new therapies with non-cost-effective treatments that are coadministered without a fixed duration.
- |||||||||| vactosertib (TEW-7197) / National OncoVenture, Medpacto
[VIRTUAL] Beneficial effect of vactosertib combined with nal-IRI5-FU/LV in pancreatic cancer treatment () - Mar 13, 2021 - Abstract #AACR2021AACR_4262; Recently, nanoliposomal iriotecan (nal-IRI), 5-flourouracil (5-FU) and leucovorin (LV) adjuvant therapy has been applied for pancreatic cancer patients’ treatment...In conclusion, the combination treatment with vactosertib with nal-IRI/5-FU/LV improved pancreatic cancer survival by inhibiting tumor invasion and inducing apoptosis. These results indicate that combination therapy can be applied to clinical trials in pancreatic cancer patient.
- |||||||||| mitazalimab (ADC-1013) / J&J, Alligator Biosci
[VIRTUAL] Mitazalimab, a potent CD40 agonist with potential for combination with chemotherapy () - Mar 11, 2021 - Abstract #AACR2021AACR_1416; P1 Further, it was also demonstrated that mitazalimab induced a concentration-dependent activation of tumor-associated macrophages (TAMs), purified from human tumor samples, into a more tumoricidal M1 like phenotype, by upregulation of cell surface markers such as CD83.In conclusion, mitazalimab re-directs human macrophages into a M1 like tumoricidal, less immunosuppressive phenotype, and synergizes effectively with chemotherapy, leading to induction of a long-term survival in a preclinical tumor mouse model. These preclinical data, together with the clinical data of mitazalimab from the phase 1 study (NCT02829099) where mitazalimab was well tolerated up to 1200 μg/kg with manageable side effects, support further clinical development of mitazalimab in combination with chemotherapy in pancreatic cancer.
- |||||||||| irinotecan / Generic mfg.
[VIRTUAL] Tumoral expression of folate-associated genes is associated with progression-free survival of patients with advanced colorectal cancer () - Mar 11, 2021 - Abstract #AACR2021AACR_293; The aim of the present study was to determine the association between expression of the folate-associated genes ABCC3, MTHFD2, SLC19A1, SLC25A32, SLC46A1, and TYMS and outcome of patients with metastatic colorectal cancer subjected to palliative chemotherapy.Patients and Methods - A total of 290 patients treated with FLV (n = 113), FLOX (n = 102) or FLV + irinotecan (FLIRI, n = 75) were included...Multivariate models showed that low TYMS and high SLC25A32 expression in subgroup 1 and high ABCC3 expression in subgroup 2 correlated significantly with better PFS (Hazard Ratio (HR) = 0.75 (95% CI = 0.57-1.0), HR = 2.21 (95% CI = 1.37-3.6), and HR = 1.34 (95% CI = 1.08 -1.7), respectively).Conclusion - Expression of TYMS, the target enzyme of 5-FU, was strongly associated with clinical benefit in the whole group, whereas expression of TYMS and the folate transporters SLC25A32, and ABCC3 was associated with PFS in the subgroups (stage I-III and stage IV), respectively. The prospective global phase III study AGENT is presently conducted on patients with advanced colorectal cancer, to determine whether expression of these genes can predict response to 5-FU-based chemotherapy that includes LV or the novel folate arfolitixorin.
- |||||||||| Trial completion date, Trial primary completion date: IPLUS: Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 (clinicaltrials.gov) - Mar 9, 2021
P1/2, N=43, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Journal: The effect of chemotherapy on olfactory function and mucociliary clearance. (Pubmed Central) - Mar 9, 2021
This might reflect the collective negative effect of chemotherapy on olfactory function, not only through the neurocytotoxic effect but also the cytotoxic effect on the nasal mucosa. In addition, the reduction in olfactory threshold and total olfactory function scores was seen to be more profound in younger patients, which could have been due to higher initial scores.
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