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  • ||||||||||  Cyramza (ramucirumab) / Eli Lilly
    Phase II study of FOLFIRI plus ramucirumab with recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin/fluoropyrimidine (RAINCLOUD) () -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_245;    
    Background The RAISE study demonstrated the superiority of FOLFIRI plus ramucirumab (Ram) to FOLFIRI in second-line metastatic colorectal cancer (CRC) patients progressed after oxaliplatin, fluoropyrimidine with bevacizumab...FOLFIRI plus Ram were administered as follows; each 2-week cycle, patients received either 8 mg/kg ramucirumab intravenous infusion, followed by the FOLFIRI regimen (150~180 mg/m2 intravenous irinotecan concurrent with 200 mg/m2 intravenous leucovorin followed by 400 mg/m2 fluorouracil given as an intravenous bolus then 2400 mg/m2 given as a continuous infusion over 48 h)...Conclusions Our data suggested that FOLFIRI plus Ram was effective and tolerable for patients with recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin plus fluoropyrimidine. The results of the pre-planned translational research will be available soon.
  • ||||||||||  5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
    FOLFIRI or FOLFOX in second line of advanced biliary tract cancer: A retrospective analysis () -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_221;    
    Methods Single center retrospective study of metastatic or irresectable CCA treated with Cisplatin and Gemcitabine in first-line setting, further exposed to second line treatment with 5-Fluorouracil and Irinotecan (FOLFIRI) or FOLFOX...A p value < 0.05 was considered significant. Conclusions Despite the limitations of retrospective single center study, analysis shows that FOLFIRI may be a safe second-line treatment for metastatic cholangiocarcinoma.
  • ||||||||||  First-line (1L) treatment patterns in advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma (GC/GEJC/EAC): Data from the Spanish AGAMENON-SEOM registry () -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_201;    
    P
    Secondary endpoints included subgroup analyses in patients with human epidermal growth factor receptor 2 (HER2)-negative status and in patients who met the eligibility criteria of the CheckMate 649 study (Janjigian YY et al, Lancet 2021; 398:27-40) and were treated with FOLFOX or XELOX (hereafter, CheckMate 649-matched subgroup)...Conclusions In this real-world observational study of the Spanish AGAMENON-SEOM registry, PFS and OS outcomes for 1L treatment of advanced GC/GEJC/EAC were comparable to those of historical studies. With an estimated median OS of < 1 year from 1L therapy initiation, better treatment options for patients with advanced GC/GEJC/EAC remain an unmet need and deserve further investigation.
  • ||||||||||  Modified GTX second-line therapy in pancreatic adenocarcinoma: An updated analysis () -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_174;    
    [1] The use of a modified regimen of Gemcitabine, Docetaxel, and Capecitabine (GTX) has been suggested following considerable evidence which showed GTX-induced synergistic apoptosis of human pancreatic cancer cells...Conclusions GTX could be used as second-line therapy in advanced pancreatic adenocarcinoma with a tolerable toxicity profile. Further prospective studies with larger samples should be performed for better assessment.
  • ||||||||||  Vectibix (panitumumab) / Amgen, Takeda
    Modified FOLFOXIRI plus panitumumab (mFOLFOXIRI/PAN) versus mFOLFOX6/PAN as initial treatment of unresectable RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients: results of the phase III randomized TRIPLETE study by GONO (Auditorium A; Level 0) -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_170;    
    P3
    Background The association of a chemotherapy doublet (FOLFOX/FOLFIRI) with an anti-EGFR monoclonal antibody (cetuximab or panitumumab) is an upfront option for the treatment of RAS and BRAF wt mCRC patients...Methods TRIPLETE is a prospective, open label, phase III trial in which previously untreated patients with unresectable RAS and BRAF wt mCRC were randomized to receive mFOLFOX6/pan (arm A) or mFOLFOXIRI (irinotecan 150 mg/sqm, oxaliplatin 85 mg/sqm, L-leucovorin 200 mg/sqm, 5-fluoruracil 2400 mg/sqm 48 h infusion)/pan (arm B) up to 12 cycles, followed by 5FU/LV/pan until disease progression...Clinical trial info: NCT03231722. Conclusions The intensification of the upfront chemotherapy backbone in combination with panitumumab in molecularly selected and mostly (88%) left-sided mCRC patients does not provide any benefit in terms of treatment activity at the price of a non-negligible increase in gastrointestinal toxicity.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Discussant: SO-16, SO-17 (Auditorium B; Level 0) -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_114;    
    Conclusions The intensification of the upfront chemotherapy backbone in combination with panitumumab in molecularly selected and mostly (88%) left-sided mCRC patients does not provide any benefit in terms of treatment activity at the price of a non-negligible increase in gastrointestinal toxicity. Learning Objectives: SO-16: FIRE-4 (AIO-KRK-0114): Randomized study for a switch maintenance concept with 5-FU plus bevacizumab after induction treatment with FOLFIRI plus cetuximab versus continued treatment with FOLFIRI plus cetuximab-secondary endpoint - Volker Heinemann, et al SO-17: A randomized, open-label, multicenter, phase 3 study of high-dose vitamin C plus FOLFOX +/- bevacizumab versus FOLFOX +/- bevacizumab as first-line treatment in patients with unresectable metastatic colorectal cancer - Feng Wang, et al
  • ||||||||||  Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
    Discussant: LBA SO-34, SO-35, SO-36 (Auditorium B; Level 0) -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_67;    
    Learning Objectives: SO-16: FIRE-4 (AIO-KRK-0114): Randomized study for a switch maintenance concept with 5-FU plus bevacizumab after induction treatment with FOLFIRI plus cetuximab versus continued treatment with FOLFIRI plus cetuximab-secondary endpoint - Volker Heinemann, et al SO-17: A randomized, open-label, multicenter, phase 3 study of high-dose vitamin C plus FOLFOX +/- bevacizumab versus FOLFOX +/- bevacizumab as first-line treatment in patients with unresectable metastatic colorectal cancer - Feng Wang, et al Learning Objectives: SO-34: Impact of BRAF-V600E mutation on immunologic characteristics of the tumor microenvironment (TME) and associated genomic alterations in patients with microsatellite instability-high (MSI-H) or mismatch-repair–deficient (dMMR) colorectal cancer (CRC) - Mohamed Salem, et al SO-35: T-cell abundance measured by immunoSEQ predicts overall survival in colorectal cancer - Stephen Gruber, et al SO-36: An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: a translational analysis of the phase II randomized AtezoTRIBE study - Carlotta Antoniotti, et al
  • ||||||||||  Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
    Discussant: SO-29, SO-30 (Auditorium A; Level 0) -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_21;    
    Learning Objectives: SO-34: Impact of BRAF-V600E mutation on immunologic characteristics of the tumor microenvironment (TME) and associated genomic alterations in patients with microsatellite instability-high (MSI-H) or mismatch-repair–deficient (dMMR) colorectal cancer (CRC) - Mohamed Salem, et al SO-35: T-cell abundance measured by immunoSEQ predicts overall survival in colorectal cancer - Stephen Gruber, et al SO-36: An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: a translational analysis of the phase II randomized AtezoTRIBE study - Carlotta Antoniotti, et al Learning Objectives: SO-29: Dihydropyrimidine dehydrogenase (DPD) genotype and phenotype among Danish cancer patients: Prevalence and correlation between DPYD-genotype mutations and P-uracil concentrations - Niels Paulsen, et al SO-30: Impact of single heterozygous UGT1A1 on the clinical outcomes of nano-liposomal irinotecan plus 5-fluorouracil/leucovorin for patients with pancreatic ductal adenocarcinoma - Kazuaki Harada, et al
  • ||||||||||  Avastin (bevacizumab) / Roche, Vectibix (panitumumab) / Amgen, Takeda
    First-line panitumumab versus bevacizumab in combination with mFOLFOX6 for RAS wild-type metastatic colorectal cancer: PARADIGM trial results (Auditorium A; Level 0) -  May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_5;    
    P3
    Key secondary endpoints included progression-free survival (PFS), response rate (RR), and curative resection (R0) rate in the left-sided and overall mCRC population. Conclusions In patients with RAS WT and left-sided mCRC, the combination of panitumumab with mFOLFOX6 significantly improved OS vs bevacizumab with mFOLFOX6, establishing a standard first-line combination regimen for this population.
  • ||||||||||  Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Avastin (bevacizumab) / Roche
    P2 data, Journal:  Sequential Treatment Strategy Using Fluoropyrimidine plus Bevacizumab Followed by Oxaliplatin for Metastatic Colorectal Cancer: A Phase II Study (OGSG 1107). (Pubmed Central) -  May 10, 2022   
    The purpose of this study was to investigate the feasibility and effectiveness of a sequential treatment strategy consisting of an initial therapy (capecitabine, S-1, or 5-fluorouracil with leucovorin [LV/5-FU] plus bevacizumab) and subsequent therapy (i.e., initial therapy plus oxaliplatin) for mCRC...Although our data are limited and preliminary, the sequential treatment strategy may provide a survival benefit in patients with mCRC. Further investigation of this treatment approach is warranted.
  • ||||||||||  5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
    DOES ONE CYCLE OF FFX TREATMENT CHANGE THE BLOOD IMMUNE PROFILE IN PDAC PATIENTS? (Bayview Ballroom) -  May 10, 2022 - Abstract #APCM2022APCM_93;    
    This is the first study that describes the earliest effect of FFX chemotherapy on the immune-related genes and cells in blood samples of PDAC patients. The data helps in predicting the response to FFX treatment which avoids giving ineffective but toxic treatment to PDAC patients.
  • ||||||||||  HYPERGLYCEMIA IS ASSOCIATED WITH IMPROVED SURVIVAL AMONG PATIENTS WITH METASTATIC PANCREATIC CANCER TREATED WITH CHEMOTHERAPY () -  May 10, 2022 - Abstract #APCM2022APCM_75;    
    We hypothesize that higher peripheral glucose levels may result in higher glucose concentrations in the tumor microenvironment, with resulting alterations in cancer cell proliferation or metabolism that enhance chemotherapy efficacy. These data require further investigation to determine if a novel therapeutic combination (i.e., induced hyperglycemia and multi-agent chemotherapy) could improve outcomes in this difficult to treat disease.
  • ||||||||||  oxaliplatin / Generic mfg.
    Liver isolation oxaliplatin (LIOX) for continued treatment with platinum agents () -  May 9, 2022 - Abstract #ECIO2022ECIO_78;    
    Initial management with FOLFOX and bevacizumab for 8 cycles, with good effect, was halted due to neurotoxic effects...The patient’s CT scan after the final treatment confirmed a reduction in the target lesions (47mm and 32mm) and another scan 3 months later with continued response. The patient’s tolerance to the same chemotherapy administered through LIOX, which could no longer be tolerated intravenously, is suggestive of the role of LIOX.
  • ||||||||||  Clinical, Journal:  Adjuvant Therapy for Stage II Colon Cancer: ASCO Guideline Update. (Pubmed Central) -  May 6, 2022   
    Patients with mismatch repair deficiency/microsatellite instability tumors should not be routinely offered ACT; if the combination of mismatch repair deficiency/microsatellite instability and high-risk factors results in a decision to offer ACT, oxaliplatin-containing chemotherapy is recommended. Duration of oxaliplatin-containing chemotherapy is also addressed, with recommendations for 3 or 6 months of treatment with capecitabine and oxaliplatin or fluorouracil, leucovorin, and oxaliplatin, with decision making informed by key evidence of 5-year disease-free survival in each treatment subgroup and the rate of adverse events, including peripheral neuropathy.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
  • ||||||||||  Retrospective data, Journal:  Survival and Robotic Approach for Pancreaticoduodenectomy: A Propensity Score-Match Study. (Pubmed Central) -  May 6, 2022   
    Patients that underwent robotic pancreaticoduodenectomy had longer operations, less estimated blood loss, shorter length of stay, and fewer 30-day readmissions; they lived much longer than patients who underwent open pancreaticoduodenectomy. We believe that robotic pancreaticoduodenectomy provides salutary and survival benefits for reasons yet unknown.
  • ||||||||||  Natrunix (vilamakitug) / XBiotech
    Trial completion date, Trial primary completion date:  1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov) -  May 6, 2022   
    P1/2,  N=69, Recruiting, 
    We believe that robotic pancreaticoduodenectomy provides salutary and survival benefits for reasons yet unknown. Trial completion date: Oct 2022 --> Aug 2023 | Trial primary completion date: Apr 2022 --> Jul 2023
  • ||||||||||  Lynparza (olaparib) / Merck (MSD), AstraZeneca
    Retrospective data, Journal, BRCA Biomarker, PARP Biomarker:  Optimizing Chemotherapy of Pancreatic Acinar Cell Carcinoma: Our Experiences and Pooled Analysis of Literature. (Pubmed Central) -  May 6, 2022   
    The patients receiving fluoropyrimidine-based regimen (n = 3) had a better median disease-free survival (mDFS) than those with gemcitabine-based regimen (n = 5) (unreached vs 27 months)...One patient who had responded to the first-line FOLFIRINOX (5-fluorouracil + oxaliplatin + leucovorin + irinotecan) regimen received olaparib as maintenance treatment for 5 months with good tolerance...Eight of 11 patients treated with the FOLFIRINOX regimen achieved partial response (PR). For patients with metastasis, a fluorouracil-based regimen such as FOLFIRINOX may be preferred, and maintenance treatment of poly ADP-ribose polymerase (PARP) inhibitors after effective platinum-containing treatment for breast cancer susceptibility gene (BRCA) mutation patients must be assessed.
  • ||||||||||  Effect of Duration of Adjuvant Chemotherapy for Patients with Colorectal Cancer on the Deterioration of Glomerular Filtration Rate (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_1875;    
    Patients underwent CTH either with regimens containing oxaliplatin and 5-fluorouracil/capecitabine (FOLFOX—31.3%; or XELOX—18.8%) or regimens containing 5-fluorouracil only (5-FU/LV; 50%)...The assessment of eGFR after 3 months of CTH is a predictor of further eGFR decline. Further investigation is needed to conclude if the shortage of CTH duration from 6 to 3 months may be beneficial for older patients in the context of nephrotoxicity.
  • ||||||||||  Trial completion date, Trial primary completion date:  Colon Neoadjuvant FOLFOXIRI Study (clinicaltrials.gov) -  May 5, 2022   
    P2,  N=40, Active, not recruiting, 
    FOLFIRINOX is recommended as a second-line chemotherapy regimen for patients with pancreatic cancer that have failed on gemcitabine-based first-line therapy.Research Registry number: reviewregistry1300. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022