- |||||||||| Hensify (crystalline hafnium oxide) / Nanobiotix, J&J
Trial completion date, Trial primary completion date: NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer (clinicaltrials.gov) - Nov 9, 2023 P1, N=24, Recruiting, Since MALS associated with PC is not a rare disease, the purpose of this study was to keep in mind the possibility of fatal biliary hemorrhage. Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2023 --> Oct 2025
- |||||||||| leucovorin calcium / Generic mfg.
Preclinical, Journal: Prenatal folic acid and vitamin B imbalance alter neuronal morphology and synaptic density in the mouse neocortex. (Pubmed Central) - Nov 8, 2023 Here, we report that excessive amounts of FA decrease arborization of deep layer projection neurons, but not upper layer neurons and that reduced complexity of deep layer neurons is not observed when folic acid is replaced by folinic acid, a stable reduced form of folate...Furthermore, both FA excess and B deficiency affect synaptic density and morphology. Our findings point to neurodevelopmental risks associated with insufficient amounts of prenatal B, particularly in association with high levels of FA intake, suggesting that the neurodevelopmental program is sensitive to an imbalance in the status of these interacting micronutrients.
- |||||||||| 5-fluorouracil / Generic mfg.
Review, Journal: A Systematic Review of Chemotherapeutic Regimens Used in Pancreatic Cancer. (Pubmed Central) - Nov 8, 2023 The appropriateness of the literature abstracts for the pooled analysis was evaluated using different combinations of keywords such as pancreatic cancer, first- and second-line chemotherapy, palliative chemotherapy, gemcitabine and nab-paclitaxel (GnP), FOLFIRINOX (FFX), and fluorouracil...Results of second-line therapy after first-line regime failure are still dismal, and there is still a great deal of doubt regarding the best course of action. More RCTs and real-world evidence studies that address current and innovative regimens, as well as the best order in which to administer them, are required, with a greater emphasis on targeted therapy with fewer side effects.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: Extending the boundaries of cancer therapeutic complexity with literature text mining. (Pubmed Central) - Nov 5, 2023 As the number of possible drug candidates for combinations grows, the development of optimal high complexity combination therapies (involving 4 or more drugs per treatment) such as RCHOP-I and FOLFIRINOX becomes increasingly challenging due to combinatorial explosion...Our results demonstrate that researchers and experts using PB are able to create HCCT plans at much greater speed and quality compared to conventional methods. By releasing PB, we hope to enable more researchers to engage with HCCT planning and demonstrate its clinical efficacy.
- |||||||||| leucovorin calcium / Generic mfg.
Journal: Comment: Amenable Treatable Severe Pediatric Epilepsies. (Pubmed Central) - Nov 5, 2023 The disorders are presented as vitamin responsive epilepsies such as pyridoxine, pyridoxal-5-phosphate, folinic acid, and biotin; transportopathies like GLUT-1, cerebral folate deficiency, and biotin thiamine responsive disorder; amino and organic acidopathies including serine synthesis defects, creatine synthesis disorders, molybdenum cofactor deficiency, and cobalamin deficiencies; mitochondrial disorders; urea cycle disorders; neurotransmitter defects; and disorders of glucose homeostasis. In each case, targeted intervention directed toward the underlying metabolic pathophysiology affords for the opportunity to significantly effect the outcome and prognosis of an otherwise severe pediatric epilepsy.
- |||||||||| Review, Journal: Iron-Dependent Cell Death: A New Treatment Approach against Pancreatic Ductal Adenocarcinoma. (Pubmed Central) - Nov 3, 2023
In addition to surgical resection, there are adjuvant chemotherapy schemes, such as FOLFIRINOX (a mix of Irinotecan, oxaliplatin, 5-Fluorouraci and leucovorin) or gemcitabine-based treatment...However, when a threshold of ROS is exceeded in the tumor cell, the cell's antioxidant systems are overwhelmed, resulting in lipid peroxidation and, ultimately, ferroptosis. In this review, we point out ferroptosis as an approach to consider in PDAC and propose that altering the cellular ROS balance by combining oxidizing agents or with inhibitors of the main cellular detoxifiers triggers ferroptosis in PDAC.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Real-World Experience with RTOG 0227 Induction for First Line Therapy of Primary CNS Lymphoma (PCNSL) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4053; This regimen includes 5 cycles of Methotrexate (MTX) at 3.5 g/m 2 and Rituximab (R) at 375-500 mg/m 2 , and Temozolomide (TMZ) on cycles 2 and 4...All pts received induction regimen consisting of R (dose between 375- 500 mg/m 2 ) and 3.5 g/m 2 of MTX with leucovorin on weeks 1, 3, 5, 7 and 9 along with TMZ daily for 5 days on weeks 4 and 8, followed by consolidation with either WBRT/TMZ or auto-HCT...Most common conditioning regimen prior to auto-HCT was carmustine/thiotepa (BCNU/TT)...PFS and OS at 2 yrs in our cohort exceeds those reported with any prospective clinical trial to date, and with zero TRM to date. This data indicates that the modified RTOG 0227 induction with either WBRT or auto-HCT consolidation represents a very tolerable and highly effective option for first line therapy of PCNSL, for both younger and older pts.
- |||||||||| Outcome of Newly Diagnosed Children and Adolescents with Localized Lymphoblastic Lymphoma Treated on JPLSG-LLB-NHL03 Trial: A Report from the Japan Children's Cancer Group (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3969;
Treatment consisted of 5 phases: induction (prednisolone 60mg/m 2 , day 0-27; vincristine 1.5mg/m 2 , day0,7,14,21; cyclophosphamide 1g/m 2 , day 0; daunorubicin 30mg/m 2 , day 0,7; E.coli L-asparaginase 6,000 units/m 2 , 9 total doses, and intrathecal methotrexate and hydrocortisone, day 0,14), consolidation (mercaptopurine 60mg/m 2 , day 0-27; cyclophosphamide 500mg/m 2 , day0,14; cytarabine 75mg/m 2 , 12 total doses and intrathecal therapy methotrexate and hydrocortisone, day 0,14) , CNS prophylaxis (high dose methotrexate 3g/m 2 , day0,7,14; and intrathecal methotrexate and hydrocortison, day 0. Standard leucovorin dosing, 15mg/m 2 intravenous every 6h, is delivered 36h after the start of the methotrexate infusion and is continued until methotrexate levels are less than 0.1
- |||||||||| Oncaspar liquid (pegaspargase) / Servier
Risk-Adjusted Therapies Yield Equivalent Outcomes for Adolescents and Young Adults (AYAs) Treated for Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) on Children (Grand Hyatt - Grand Hall B) - Nov 3, 2023 - Abstract #ASH2023ASH_3167; Intermediate and high-risk patients were randomized to receive or not receive six 5-day courses of nelarabine (Nel)...Key differences between AALL0434 and AALL1231 ABFM backbones included the use of prednisone in induction in AALL0434 versus dexamethasone in AALL1231, and cranial radiation therapy in the majority of AALL0434 participants versus only in patients with central nervous system involvement in AALL1231...Despite small numbers, CMTX holds a survival advantage for AYA T-ALL patients, with no survival disadvantage seen among AYA T-ALL patients who received Nel. Bortezomib does not offer significant benefit for AYA T-ALL patients.
- |||||||||| methotrexate IV / Generic mfg.
Clinical Outcomes in Patients with High-Dose Methotrexate Toxicity Treated with Vs. without Glucarpidase (Marriott Marquis - Pacific Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_1300; Models were adjusted for age, sex, race, baseline eGFR, body mass index, hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, chronic liver disease, baseline WBC count, serum albumin, and LDH, MTX dose and infusion duration, urine pH, volume of IV fluids administered, leucovorin dose, and maximum fold-change in SCr, oliguria, and receipt of concomitant nephrotoxins in the first 4 days following MTX initiation...The magnitude of association with renal recovery was particularly evident in those treated with glucarpidase in the first 60 hours and in those with AKI stage 3. Though this is an observational study with the potential for residual confounding, our data support use of glucarpidase in patients with HDMTX-AKI, particularly in the first 60 hours following initiation of MTX.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen
Trial completion date, Surgery: acns0333: Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System (clinicaltrials.gov) - Nov 2, 2023 P3, N=70, Active, not recruiting, Though this is an observational study with the potential for residual confounding, our data support use of glucarpidase in patients with HDMTX-AKI, particularly in the first 60 hours following initiation of MTX. Trial completion date: Aug 2023 --> Aug 2024
- |||||||||| Vyloy (zolbetuximab-clzb) / Astellas
Biomarker, Trial completion date, Trial primary completion date, Monotherapy: ILUSTRO: A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer (clinicaltrials.gov) - Nov 1, 2023 P2, N=143, Recruiting, Suspended --> Recruiting Trial completion date: Jul 2024 --> Dec 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
- |||||||||| nisevokitug (NIS793) / Novartis
Trial completion date, Trial termination, Trial primary completion date, Combination therapy: A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer (clinicaltrials.gov) - Nov 1, 2023 P2, N=8, Terminated, Trial completion date: Jul 2024 --> Dec 2026 | Trial primary completion date: Apr 2024 --> Apr 2025 Trial completion date: Dec 2027 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Aug 2023; Novartis, the drug manufacturer of NIS793, notified Dana Farber Cancer Institute that they are stopping all clinical development of NIS793 in pancreatic cancer, effective immediately.
- |||||||||| leucovorin calcium / Generic mfg., cisplatin / Generic mfg., gemcitabine / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant (clinicaltrials.gov) - Oct 31, 2023 P2, N=46, Active, not recruiting, Trial primary completion date: Mar 2024 --> Oct 2023 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| 5-fluorouracil / Generic mfg.
Journal, IO biomarker: A case of pancreatic cancer treated with chemotherapy combined with immunotherapy and targeted therapy. (Pubmed Central) - Oct 30, 2023 The patient received two cycles of modified FOLFIRINOX plus immune checkpoint inhibitor (penpulimab)...Three cycles of combined therapy were adopted after surgery followed by maintenance therapy with anlotinib plus penpulimab. There was no evidence of tumor recurrence during the follow-up (nearly 19 months since diagnosis).
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Review, Journal: Bioactive Compounds of Dietary Origin and Their Influence on Colorectal Cancer as Chemoprevention. (Pubmed Central) - Oct 28, 2023 These compounds can promote apoptosis and inhibit cell growth, proliferation, and migration. Combined with oncologic treatment, a sensitization to first-line colorectal chemotherapy schemes, such as FOLFOX and FOLFIRI, is observed, making them an attractive and natural support in the oncologic treatment of CRC.
- |||||||||| 5-fluorouracil / Generic mfg.
Review, Journal, Metastases: Selection of Chemotherapy in Advanced Poorly Differentiated Extra-Pulmonary Neuroendocrine Carcinoma. (Pubmed Central) - Oct 28, 2023 In the first-line setting, etoposide and platinum chemotherapy or irinotecan and platinum have been demonstrated to be equivalent in a large phase III trial...Available data support the potential role of the Ki-67 index as a predictive biomarker for chemotherapy response. A more personalised approach to management in future studies will be essential, and comprehensive multi-omic approaches are required to understand tumour somatic genetic changes in relation to their effects on the surrounding microenvironment.
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