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424 Diseases |  |
808 Trials |
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808 Trials |  |
14431 News |  |
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- docetaxel / Generic mfg.
[VIRTUAL] Response to neoadjuvant chemotherapy in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma with FLOT-regimen in our setting () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_221;
Conclusions The results of this study are in accordance with those obtained in the published series, as the pathological response to neoadjuvant with FLOT in tumors with intestinal histology has been better than the response in diffuse/mixed (90.9% R0-resection and 36.3% pRC; 71.4% R0-resection and 4.7% pRC). However, the pRC rates and complete resection rates were lower for GEJ than gastric tumors (44.5% R0-resection and 11.1% pRC; 84% R0-resection and 16% pRC).
- Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
[VIRTUAL] Experience in our center of bone events not related to the disease in patients with locally advanced or metastatic adenocarcinoma of the pancreas () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_219;
The median of number of cycles received was 8.4 cycles for FOLFIRINOX and 9.6 cycles for gemcitabine-abraxane...Real-life evaluations are essential to confirm and sustain indications for treatment and support current clinical practice. More prolonged follow-up and an increased study population will be important for clearer results.
- Imfinzi (durvalumab) / AstraZeneca
[VIRTUAL] MATTERHORN: A phase 3 study of efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_216;
P3
Thus, immune checkpoint inhibitors such as durvalumab (an anti programmed death ligand-1 antibody), in combination with cytotoxic chemotherapy may result in increased efficacy. MATTERHORN (NCT04592913) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of neoadjuvant-adjuvant durvalumab or placebo with FLOT followed by adjuvant durvalumab or placebo in patients with resectable GC/GEJC.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Doxycycline as preventive treatment of skin toxicity in patients with metastatic colorectal cancer treated with an anti-EGFR and chemotherapy () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_213;
P2
Background Anti-EGFR therapies, like cetuximab or panitumumab, are amongst the most extensively used therapies for metastatic colorectal cancer (mCRC), but both are associated with the development of skin toxicities...To treat skin- or nail- related toxicities, 3 (30%) of the patients that received doxycycline 50 mg/day received topical antibiotics and 7 (70%) corticosteroids; 5 (21%) of the patients that received doxycycline 100 mg/day received topical antibiotics and 10 (12%) corticosteroids. Conclusions Taking in consideration the results of this study, where doxycycline 100 mg/day for 6 weeks has reduced the incidence of grade 2 skin toxicities to 21%, this would be considered the recommended dose/frequency of doxycycline as prophylaxis to prevent anti-EGFR skin toxicities.
- Cyramza (ramucirumab) / Eli Lilly
[VIRTUAL] US real-world ramucirumab and immune checkpoint inhibitor treatment sequences in advanced gastric, gastroesophageal junction, or esophageal cancer () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_211;
Background Ramucirumab plus paclitaxel (RAM+pac) and RAM monotherapy have demonstrated survival benefit in advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma following fluoropyrimidine/platinum...For ICI RAM, the most common sequence for first three lines was 1L fluoropyrimidine+platinum, 2L ICI, 3L RAM+taxane, and most common regimens were 1L FOLFOX (38%), 2L pembrolizumab (38%), 3L RAM+pac (38%)...Conclusions In real-world clinical practice, when patients receive both RAM and ICIs for advanced gastric/GEJ/esophageal cancer, patients most commonly receive RAM prior to ICI. Whether prior to or after ICI, the most common RAM regimen is RAM+pac, with numerically similar time on RAM, regardless of sequence.
- Cyramza (ramucirumab) / Eli Lilly
[VIRTUAL] Study of paclitaxel and ramucirumab as second-line therapy after failure of FOLFOX-6 regimen in metastatic stomach carcinoma patients () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_202;
The majority of patients (48%) had grade 1/2 peripheral neuropathy. Conclusions Ramucirumab and paclitaxel combination is an effective and well tolerated regimen as a second-line treatment in metastatic gastric adenocarcinoma patients.
- 5-fluorouracil / Generic mfg.
[VIRTUAL] 5-fluorouracil bolus use in infusional regimens among oncologists: A survey by Brazilian Group of Gastrointestinal Tumors () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_201;
Conclusions Our survey indicates that experience in oncology practice and percentage of time dedicated to treat GI cancers influence the prescription of 5-FU bolus in Brazil, with more frequent withdrawing among experienced GI specialists, particularly in the metastatic setting. DPYD testing is very low in routine practice before fluoropyrimidine initiation.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Reduced-dose of doublet chemotherapy combined with anti-EGFR antibodies as treatment option in vulnerable older patients with metastatic colorectal cancer: A retrospective cohort study () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_196;
Methods A retrospective cohort study of the hospital medical records of RAS and BRAF wild-type, vulnerable patients aged 70 years with previously untreated mCRC was performed to assess the safety and efficacy profile of a doublet chemotherapy administered at reduced doses of 20% (FOLFOX or FOLFIRI) when combined with anti-EGFR antibodies (cetuximab or panitumumab)...Conclusions This study shows that with an appropriate design, including reduced doses, vulnerable older patients best tolerate chemotherapy when combined with anti-EGFR antibodies. Larger confirmatory prospective studies are expected in the future.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] Efficacy of FOLFOX4 regimen with advanced hepatocellular carcinoma and prognostic factors for survival () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_167;
Conclusions These results of PFS, OS and RR, suggest that FOLFOX4 regimen may confer some benefit and can be an option for treatment of advanced HCC in those who cannot access targeted therapy. Poor prognostic factors for survival could be useful for clinicians considering treatment decisions.
- oxaliplatin / Generic mfg.
[VIRTUAL] Prevalence and risk factors of chronic neuropathy in 225 colorectal cancer patients treated with oxaliplatin-based regimens in Tunisia () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_164;
Conclusions The incidence of chronic oxaliplatin-induced neuropathy was high and contributed to treatment delay and modification in many cases. Diabetes and cumulative dose of oxaliplatin were associated with chronic neuropathy.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] The use of complementary and alternative medicine among colorectal cancer patients in Tunisia () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_159;
Conclusions The prevalence of CAM use is relatively high in our population despite its expensive costs, side effects, and potential interactions with conventional treatments. Communication between doctors and patients regarding CAM use is mandatory.
- Avastin (bevacizumab) / Roche
[VIRTUAL] Retrospective comparative analysis of K-ras G12C vs other K-ras mutations in metastatic colorectal cancer patients treated with first-line chemotherapy doublet + bevacizumab () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_153;
Conclusions K-ras G12C mutations are associated with worse response rates compared to other K-ras isoforms when treated with standard chemotherapy doublet+bevacizumab. New agents, such as G12C selective inhibitors, or different treatment strategies (such as using FOLFOXIRI+bevacizumab) should be tested in this patient population to improve these results.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] Impact of RAS status, prior targeted therapy, age, and gender on the activity of aflibercept plus FOLFIRI in patients with metastatic colorectal cancer: Real-world data from the QoLiTrap study () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_151;
It is approved in combination with FOLFIRI for treatment of metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen...Conclusions Aflibercept plus FOLFIRI, mainly prescribed in second-line mCRC, retains its activity irrespective of RAS status, prior targeted therapy, age, or gender. The safety profile was manageable.
- Tukysa (tucatinib) / Seagen, Herceptin (trastuzumab) / Roche
[VIRTUAL] MOUNTAINEER: Open-label, phase 2 study of tucatinib combined with trastuzumab for HER2-positive metastatic colorectal cancer (SGNTUC-017, trial in progress) () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_149;
P2
Interim analysis of the initial 26 pts enrolled in MOUNTAINEER demonstrated an objective response rate (ORR) of 52.2% (12 partial responses [PRs] in 23 evaluable pts), median duration of response of 10.4 months, with a median PFS of 8.1 months and a median overall survival (OS) of 18.7 months (Strickler 2019). Based on these results, the trial was expanded to enable better estimation of ORR and safety.
- | methotrexate / Generic mfg., irinotecan / Generic mfg.
Journal: Mixed oleic acid-erucic acid liposomes as a carrier for anticancer drug. (Pubmed Central) - Jun 1, 2021
Using a 3-(4, 5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay, the median inhibitory concentration (IC50) values of mixed oleic acid-erucic acid encapsulating hydrophilic drugs was remarkably reduced at the end of 24 hours of incubation with the human lung carcinoma cell line A549. The results suggest that mixed oleic acid-erucic acid liposomes are a potential new approach to further develop as an alternative vehicle of various drugs for cancer treatment.
- || docetaxel / Generic mfg.
Biomarker, Clinical, Review, Journal: Neoadjuvant and perioperative treatment of gastric cancer, current studies and new biomarkers (Pubmed Central) - Jun 1, 2021
The recommendation of perioperative treatment applies to all histopathological subtypes of gastric cancer. The article summarizes the contemporary data and provides an outlook on current progress in the field of medicinal perioperative treatment.
- || docetaxel / Generic mfg., epirubicin / Generic mfg.
Clinical, Retrospective data, Journal: Predictors and significance of histologic response to neoadjuvant therapy for gastric cancer. (Pubmed Central) - Jun 1, 2021
In this cohort, 46% of patients had no histologic response to therapy. SRC histology, and possibly race, should be considered in determination of optimal multidisciplinary regimens and in amount of therapy to be given upfront, as patients with SRC histology and those of non-Asian race are less likely to respond to standard regimens.
- | Trial completion date, Trial withdrawal, Trial primary completion date, Metastases: PANC-001: Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma (clinicaltrials.gov) - Jun 1, 2021
P1, N=0, Withdrawn, Sponsor: Roger Williams Medical Center
SRC histology, and possibly race, should be considered in determination of optimal multidisciplinary regimens and in amount of therapy to be given upfront, as patients with SRC histology and those of non-Asian race are less likely to respond to standard regimens. Trial completion date: Jan 2022 --> May 2021 | Suspended --> Withdrawn | Trial primary completion date: Jan 2022 --> May 2021
- || paclitaxel / Generic mfg.
Clinical, Journal: Neutropenic enterocolitis-induced sepsis and disseminated intravascular coagulation after chemotherapy: a case report. (Pubmed Central) - Jun 1, 2021
Our observations suggest that postoperative ileus may be one of the possible causes of NE. Patients who experience postoperative ileus must be carefully monitored while undergoing chemotherapy.
- | New P2 trial, Checkpoint inhibition, IO biomarker, Metastases: Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - Jun 1, 2021
P2, N=124, Recruiting, Sponsor: Tianjin Medical University Cancer Institute and Hospital
- | Nexavar (sorafenib) / Bayer, Amgen
Journal: Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, Fluorouracil, and Leucovorin With or Without Sorafenib as Initial Treatment for Advanced Hepatocellular Carcinoma. (Pubmed Central) - Jun 1, 2021
In the propensity-score matched cohorts (93 pairs), the overall survival, the progression free survival and disease control rates in the soraHAIC group were also better than those in the HAIC group (P<0.05). HAIC plus sorafenib may improve overall survival and progression free survival compared with HAIC alone as initial treatment for advanced hepatocellular carcinoma.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] FivepHusion () - May 31, 2021 - Abstract #BIO2021BIO_339;
The FDA has acknowledged bio-equivalence of Deflexifol™ to 5-FU/LV, and its suitability for the 505(b)(2) registration pathway. FivepHusion is seeking investment and strategic partners to pursue registration and commercialisation of Deflexifol™ as the new standard of care for solid tumor treatment.
- docetaxel / Generic mfg.
[VIRTUAL] Expression and content of the LC3B protein in gastric cancers, relationship to mTOR, AMPK expression, clinical and morphological parameters, and the tumor response to neoadjuvant chemotherapy () - May 30, 2021 - Abstract #EACR2021EACR_3370;
An increase in the protein level in patients with partial regression and stabilization of the tumor process by 3.65 and 5.78 times compared with patients with complete tumor regression was noted. Conclusion The development of the disease and the prediction of anticancer therapy's effectiveness are directly related to the expression level of LC3B, mTOR, and AMPK.
- docetaxel / Generic mfg.
[VIRTUAL] Expression and content of the LC3B protein in gastric cancers, relationship to mTOR, AMPK expression, clinical and morphological parameters, and the tumor response to neoadjuvant chemotherapy () - May 30, 2021 - Abstract #EACR2021EACR_3369;
An increase in the protein level in patients with partial regression and stabilization of the tumor process by 3.65 and 5.78 times compared with patients with complete tumor regression was noted. Conclusion The development of the disease and the prediction of anticancer therapy's effectiveness are directly related to the expression level of LC3B, mTOR, and AMPK.
- docetaxel / Generic mfg.
[VIRTUAL] Expression and content of the LC3B protein in gastric cancers, relationship to mTOR, AMPK expression, clinical and morphological parameters, and the tumor response to neoadjuvant chemotherapy () - May 30, 2021 - Abstract #EACR2021EACR_3368;
An increase in the protein level in patients with partial regression and stabilization of the tumor process by 3.65 and 5.78 times compared with patients with complete tumor regression was noted. Conclusion The development of the disease and the prediction of anticancer therapy's effectiveness are directly related to the expression level of LC3B, mTOR, and AMPK.
- docetaxel / Generic mfg.
[VIRTUAL] Expression and content of the LC3B protein in gastric cancers, relationship to mTOR, AMPK expression, clinical and morphological parameters, and the tumor response to neoadjuvant chemotherapy () - May 30, 2021 - Abstract #EACR2021EACR_3367;
An increase in the protein level in patients with partial regression and stabilization of the tumor process by 3.65 and 5.78 times compared with patients with complete tumor regression was noted. Conclusion The development of the disease and the prediction of anticancer therapy's effectiveness are directly related to the expression level of LC3B, mTOR, and AMPK.
- oxaliplatin / Generic mfg.
[VIRTUAL] Oxaliplatin- induced neuropathy and peripheral nerve hyperexcitability in a patient with gastric cancer (CBW Room) - May 30, 2021 - Abstract #EAN2021EAN_1957;
He had gastric adenocarcinoma with metastasis to the liver and abdominal lymph nodes, which had been treated with a modified FOLFOX-6 regimen containing oxaliplatin, fluorouracil, and folinic-acid. ENMG has a key role in diagnosis, classification of acute/chronic neurotoxicity, and identification of reversibility, whereas follow up and research studies may enlighten the transition between these processes.
- leucovorin calcium / Generic mfg.
[VIRTUAL] Cerebral folate deficiency: case report of a potentially disabling but also treatable neuropsychiatric disorder (Room Oslo) - May 30, 2021 - Abstract #EAN2021EAN_626;
Since CFD can be managed with calcium folinate, it is important to identify patients with this condition as early as possible so that they can better benefit from treatment. Recommendations regarding the use of oral or intravenous calcium folinate are not yet available, thus it is important to collect the experience of different centres.
- || oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Review, Journal, HEOR: Health Economic Models for Metastatic Colorectal Cancer: A Methodological Review. (Pubmed Central) - May 29, 2021
Model-based cost-effectiveness analyses of systemic mCRC treatments have adopted varied modelling methods and structures, resulting in substantially different outcomes. As models generally focus on first-line treatment without consideration of downstream treatments, there is a profound source of structural uncertainty implying that the cost-effectiveness of treatments across the mCRC pathway remains uncertain.
- | leucovorin calcium / Generic mfg.
Journal: Treatable Cause of Pancytopenia, Recurrent Infections and Refractory Epilepsy: Secondary to Hereditary Folate Malabsorption (HFM) Due to Novel Pathogenic Variant. (Pubmed Central) - May 28, 2021
Her diagnosis was confirmed by whole-exome sequencing which revealed a novel pathogenic homozygous frameshift insertion variation (c.620dupG) in the exon 2 of the SLC46A1 gene which was further confirmed by Sanger sequencing. The child improved significantly except for a partial improvement in neurological symptoms.
- | Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Mismatch repair, Tumor mutational burden: Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair (clinicaltrials.gov) - May 27, 2021
P3, N=700, Recruiting, Sponsor: National Cancer Institute (NCI)
The child improved significantly except for a partial improvement in neurological symptoms. Trial completion date: Dec 2021 --> Apr 2024 | Trial primary completion date: Dec 2021 --> Apr 2024
- Tyvyt (sintilimab) / Eli Lilly
[VIRTUAL] Hepatic arterial infusion chemotherapy in combination with PD-1 inhibitor as conversion therapy in locally advanced, potentially resectable hepatocellular carcinoma: A phase II study () - May 26, 2021 - Abstract #EASLILC2021EASL_ILC_1409;
FOLFOX-HAIC in combination with sintilimab showed high conversion rate and good safety profile. The combined strategy may be considered as an optimal treatment choice to provide chance of cure in locally advanced and potentially resectable HCC.
- | leucovorin calcium / Generic mfg.
Biomarker, Journal: EPA and DHA as markers of nutraceutical treatment response in major depressive disorder. (Pubmed Central) - May 26, 2021
The combined strategy may be considered as an optimal treatment choice to provide chance of cure in locally advanced and potentially resectable HCC. Changes in fatty acid levels resulting from a nutraceutical combination containing EPA and DHA provide a response biomarker in treating depression.
- |||| Biomarker, Trial completion: MODUL: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - May 26, 2021
P2, N=609, Completed, Sponsor: Hoffmann-La Roche
Changes in fatty acid levels resulting from a nutraceutical combination containing EPA and DHA provide a response biomarker in treating depression. Active, not recruiting --> Completed
- || irinotecan / Generic mfg.
Clinical, Review, Journal: Pathological complete response after neoadjuvant therapy for pancreatic ductal adenocarcinoma does not equal cure. (Pubmed Central) - May 25, 2021
Active, not recruiting --> Completed Despite the excellent long-term outcomes, a pCR does not equal cure because this cohort of patients still has a significant risk of recurrence.
- | docetaxel / Generic mfg.
Retrospective data, Journal: Staged laparoscopic management of locally advanced gastric cancer with outlet obstruction. (Pubmed Central) - May 25, 2021
Despite the excellent long-term outcomes, a pCR does not equal cure because this cohort of patients still has a significant risk of recurrence. This case series showed that curative surgical resection was feasible as a staged approach for patients with locally advanced gastric cancer with outlet obstruction, after initial staged gastrojejunostomy and chemotherapy.
- | Trial initiation date: PANCREAS: PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples (clinicaltrials.gov) - May 25, 2021
P2, N=41, Not yet recruiting, Sponsor: Medical College of Wisconsin
This case series showed that curative surgical resection was feasible as a staged approach for patients with locally advanced gastric cancer with outlet obstruction, after initial staged gastrojejunostomy and chemotherapy. Initiation date: Feb 2021 --> Jun 2021
- |||| olaptesed pegol (NOX-A12) / TME Pharma
New P2 trial: OPTIMUS: Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer (clinicaltrials.gov) - May 25, 2021
P2, N=68, Not yet recruiting, Sponsor: NOXXON Pharma AG
- | leucovorin calcium / Generic mfg., temozolomide / Generic mfg.
Trial completion date, Trial termination, Combination therapy: FOLAGLI: Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (clinicaltrials.gov) - May 24, 2021
P1, N=24, Terminated, Sponsor: Institut Cancerologie de l'Ouest
Initiation date: Feb 2021 --> Jun 2021 Trial completion date: Sep 2021 --> Dec 2020 | Recruiting --> Terminated; changing the standard of care
- | Enrollment open, Surgery, Metastases: NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer (clinicaltrials.gov) - May 24, 2021
P2, N=40, Recruiting, Sponsor: OHSU Knight Cancer Institute
Trial completion date: Sep 2021 --> Dec 2020 | Recruiting --> Terminated; changing the standard of care Not yet recruiting --> Recruiting
- || Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Avastin (bevacizumab) / Roche
P1 data, Journal: Phase I Study of Alternate-Day Administration of S-1, Oral Leucovorin, and Bevacizumab for Refractory Metastatic Colorectal Cancer. (Pubmed Central) - May 22, 2021
The recommended S-1 dose was 40 mg/m , twice daily on Monday, Wednesday, Friday, and Sunday, with 25 mg oral leucovorin twice daily and 5 mg/kg bevacizumab every 2 weeks. Compared with the daily administration, alternate-day administration may reduce mucositis with promising antitumor activity in refractory mCRC.
- || irinotecan / Generic mfg.
Clinical, Journal: FOLFIRINOX de-escalation in advanced pancreatic cancer: a multicenter real-life study. (Pubmed Central) - May 22, 2021
Survivals in patients with maintenance therapy are clinically meaningful. Fluoropyrimidine monotherapy maintenance seems to be as efficient as FOLFIRI and should be a reference arm in future pancreatic cancer maintenance trials.
- leucovorin calcium / Generic mfg., prednisone / Generic mfg., omeprazole / Generic mfg.
[VIRTUAL] HIGH DOSE INTRAVENOUS PULSE METHOTREXATE IN REFRACTORY EOSINOPHILIC FASCIITIS: WHAT ARE THE ADVERSE EVENTS? (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2753;
This is in line with studies performed with patients with trophoblast disease. One episode of reversible AKI occurred that seemed to be related to high body weight and the use of concomitant medication.
- || bemarituzumab (FPA-144) / Amgen
Clinical, P1 data, P2 data, PK/PD data, Journal: Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. (Pubmed Central) - May 21, 2021
P1, P2
One episode of reversible AKI occurred that seemed to be related to high body weight and the use of concomitant medication. A projected dose and schedule to achieve the target C was validated in phase 1 of the FIGHT trial which supported selection of the phase 2 dose and schedule for bemarituzumab.
- || 5-fluorouracil / Generic mfg.
Clinical, Journal: Successful management of hyperammonemia with hemodialysis on day 2 during 5-fluorouracil treatment in a patient with gastric cancer: a case report with 5-fluorouracil metabolite analyses. (Pubmed Central) - May 21, 2021
A projected dose and schedule to achieve the target C was validated in phase 1 of the FIGHT trial which supported selection of the phase 2 dose and schedule for bemarituzumab. HD on day 2 instead of 3 may prevent hyperammonemia in 5FU/LV therapy.
- || docetaxel / Generic mfg.
Clinical, Retrospective data, Journal: Body Composition Changes in Gastric Cancer Patients during Preoperative FLOT Therapy: Preliminary Results of an Italian Cohort Study. (Pubmed Central) - May 21, 2021
Preoperative FLOT was associated with a further reduction in SMI, BMI, and VAI. These changes were not associated with short-term outcomes.
- | pegilodecakin (LY3500518) / Eli Lilly
Trial completion date: A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - May 21, 2021
P1, N=350, Active, not recruiting, Sponsor: Eli Lilly and Company
These changes were not associated with short-term outcomes. Trial completion date: May 2021 --> Nov 2021
- |||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial primary completion date: CheckMate 649: Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (clinicaltrials.gov) - May 21, 2021
P3, N=2031, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Trial completion date: May 2021 --> Nov 2021 Trial primary completion date: May 2021 --> May 2020
- || Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
Clinical, Journal: Efficacy and tolerability of the combination of nano-liposomal irinotecan and 5-fluorouracil/leucovorin in advanced pancreatic adenocarcinoma: post-approval clinic experience. (Pubmed Central) - May 21, 2021
Grade 3/4 toxicities were reported in only 19% patients. Our report suggests that nal-IRI + 5-FU/LV offers a modest survival benefit with a tolerable safety profile as an advanced line of treatment in patients with advanced PAC.
- | relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Enrollment change: IMAGINE: Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG (clinicaltrials.gov) - May 20, 2021
P2, N=44, Recruiting, Sponsor: University Hospital, Essen
Our report suggests that nal-IRI + 5-FU/LV offers a modest survival benefit with a tolerable safety profile as an advanced line of treatment in patients with advanced PAC. N=88 --> 44