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424 Diseases |  |
809 Trials |
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809 Trials |  |
14393 News |  |
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- The Optimal Timing of Surgery Following Stereotactic Body Radiation Therapy for Borderline Resectable or Locally Advanced Pancreatic Cancer (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1383;
Prolongation of time from SBRT to surgery may be associated with improved local progression free survival. Further study is warranted to understand the factors that may contribute to differential local control rates based on time from SBRT to surgery.
- Toxicity Following Multimodal Treatment of Pancreatic Cancer (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1373;
In this study with high luminal bowel V50% and D0.03cc, RT was relatively safe with few high grade toxicities. Further study is warranted to better characterize bowel constraints at intermediate and high dose levels along with prospective evaluation of dose-escalated radiotherapy.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
FOLFOX-Based Chemoradiation as Non-Operative Management for Esophageal Adenocarcinoma (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1320;
Survival outcomes with this approach appear favorable, particularly among patients with negative post-CRT biopsy. This data suggests that patients achieving clinical complete response to FOLFOX-RT can have excellent prognosis even without surgery.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Modeling Potential Lymphocyte-Sparing Effect of Involved-Field Radiotherapy in Rectal Cancer (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1271;
This in turn led to improved predicted lymphocyte-sparing and 40% absolute reduction in the risk of predicted grade 3 lymphopenia. These results will be validated in a larger cohort and will help design a prospective study investigating lymphocyte-sparing radiotherapy for rectal cancer patients.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., capecitabine / Generic mfg.
Are We Overestimating Rectal Cancer Nodal Involvement? (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1268;
While this finding is in line with the results of major randomized trials such as RAPIDO, it confirms a 65% rate of ypN0 disease following neoadjuvant treatment for cN+ rectal cancer in the setting of a 70% specificity of MRI for rectal cancer nodal staging. cN2 disease predicts for residual pathologic LN disease.
- Avastin (bevacizumab) / Roche
Descriptive Statistics for Patients with Glioblastoma Associated with Germline Mismatch Repair Gene Mutation (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_645;
Seven patients received adjuvant radiation therapy (RT): n=5 received concurrent TMZ- 1 with concurrent bevacizumab, 5-fluorouracil, and leucovorin due to synchronous metastatic colon cancer, 1 received no chemotherapy. In this small series, patients with mismatch repair mutation associated glioblastoma had especially poor outcomes and a rapidly progressive disease course.
- ||| spevatamig (PT886) / Phanes Therap
New P1 trial, Checkpoint inhibition: Spevatamig (PT886) for Treatment of Patients with Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov) - Aug 1, 2022
P1, N=58, Not yet recruiting, Sponsor: Phanes Therapeutics
- | 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Trial completion, Trial completion date, Metastases: BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial (clinicaltrials.gov) - Aug 1, 2022
P2, N=50, Completed, Sponsor: Brown University
In this small series, patients with mismatch repair mutation associated glioblastoma had especially poor outcomes and a rapidly progressive disease course. Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Mar 2022
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
High Baseline TNF-α Levels may Associate with Poor Outcomes after Total Neoadjuvant Therapy for Gastroesophageal Cancer: Initial Biomarker Analysis from a Prospective Study (Henry B. Gonzalez Convention Center, Exhibit Hall 1) - Aug 1, 2022 - Abstract #ASTRO2022ASTRO_1328;
P1
Among patients with gastroesophageal adenocarcinoma treated with total neoadjuvant therapy, higher baseline of circulating TNF-α may be associated with worse PFS. Further exploration of TNF-a as a biomarker or therapeutic target in model systems may be warranted to further understand our observations.
- | oxaliplatin / Generic mfg., irinotecan / Generic mfg., capecitabine / Generic mfg.
Retrospective data, Journal: Safety and efficacy of irinotecan, oxaliplatin, and capecitabine (XELOXIRI) regimen with or without targeted drugs in patients with metastatic colorectal cancer: a retrospective cohort study. (Pubmed Central) - Jul 30, 2022
Further exploration of TNF-a as a biomarker or therapeutic target in model systems may be warranted to further understand our observations. The use of the XELOXIRI regimen with or without a targeted drug was effective, with a manageable toxicity profile in Chinese patients with mCRC.
- | 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Journal, HEOR, Real-world evidence: Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study. (Pubmed Central) - Jul 29, 2022
Aflibercept plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer after the failure of oxaliplatin-containing therapy...The safety profile was consistent with previously reported data. Aflibercept plus FOLFIRI given in daily practice maintained QoL in mCRC patients, was associated with a high objective tumor response, and retained its activity regardless of sex, RAS status, and prior EGFR-I therapy.
- | Preclinical, Journal: Zebrafish Patient-Derived Xenograft Model to Predict Treatment Outcomes of Colorectal Cancer Patients. (Pubmed Central) - Jul 29, 2022
zPDXs were exposed to chemotherapy regimens (5-FU, FOLFIRI, FOLFOX, FOLFOXIRI) for 48 h. We used a linear mixed effect model to evaluate the zPDX-specific response to treatments showing for 4/36 zPDXs (11%), a statistically significant reduction of tumor size compared to controls...In 6/8 (75%) we registered a concordance between the response of the patient and the outcomes reported in the corresponding zPDX. Our results provide evidence that the zPDX model can reflect the outcome in mCRC patients, opening a new frontier to personalized medicine.
- | irinotecan / Generic mfg.
Journal: Integrated Bioinformatics Analysis of the Hub Genes Involved in Irinotecan Resistance in Colorectal Cancer. (Pubmed Central) - Jul 29, 2022
These results indicated that in vitro models are highly limited and favor different mechanisms than in vivo, patient-derived ones. Thus, cell lines can be perfectly utilized to analyze specific mechanisms on their molecular levels but cannot mirror the complicated drug resistance network observed in patients.
- | 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Journal: Probiotic Supplementation Suppresses Tumor Growth in an Experimental Colorectal Cancer Liver Metastasis Model. (Pubmed Central) - Jul 29, 2022
Reduced tumor volume was achieved by inhibiting angiogenesis, as tumor microvascular density was significantly lower in rats receiving probiotic supplementation. This study shows that a multispecies probiotic mixture significantly reduces angiogenesis and inhibits CRC liver metastasis growth in an experimental rat model.
- || ginisortamab (UCB6114) / UCB
Trial completion date, Trial primary completion date, Metastases: ONC001: A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors (clinicaltrials.gov) - Jul 29, 2022
P1/2, N=240, Recruiting, Sponsor: UCB Biopharma SRL
This study shows that a multispecies probiotic mixture significantly reduces angiogenesis and inhibits CRC liver metastasis growth in an experimental rat model. Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
- | AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma
New P2a trial, Metastases: FIND: mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - Jul 29, 2022
P2a, N=18, Not yet recruiting, Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
- |||| sirexatamab (DKN-01) / Leap Therap
New P2 trial, Metastases: DeFianCe: Phase 2 Study of DKN-01 in Colorectal Cancer (clinicaltrials.gov) - Jul 29, 2022
P2, N=150, Not yet recruiting, Sponsor: Leap Therapeutics, Inc.
- | Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Trial completion, Enrollment change, Metastases: Locally Advanced or Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - Jul 29, 2022
P2, N=49, Completed, Sponsor: National Health Research Institutes, Taiwan
Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Jan 2024 Enrolling by invitation --> Completed | N=88 --> 49
- | oxaliplatin / Generic mfg., capecitabine / Generic mfg.
Journal: Genetic variation in ST6GAL1 is a determinant of capecitabine and oxaliplatin induced hand-foot syndrome. (Pubmed Central) - Jul 29, 2022
ST6GAL1 was associated with T2D (lead SNP rs3887925, OR=0.94, 95%CI=0.92-0.96, P=1.2x10 ) and the rs6783836-T allele was associated with lowered HbA1c levels (P=5.9x10 ) and lymphocyte count (P=2.7x10 ), and psoriasis (P=7.5x10 ) beyond thresholds for multiple testing. In conclusion, HFS is a biomarker of treatment outcome and rs6783836 in ST6GAL1 is a potential biomarker for HFS with links to T2D and inflammation.
- | 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., albumin-bound paclitaxel / Generic mfg.
Journal: The Brown University Oncology Group Experience With FOLFOX + Nab-paclitaxel [FOLFOX-A] for Metastatic and Locally Advanced Pancreatic, BrUOG-292 and BrUOG-318. (Pubmed Central) - Jul 29, 2022
In conclusion, HFS is a biomarker of treatment outcome and rs6783836 in ST6GAL1 is a potential biomarker for HFS with links to T2D and inflammation. The combination of FOLFOX-A has promising activity in PDAC and may represent an alternative to FOLFIRINOX when reduction of gastrointestinal toxicity is required.
- || 5-fluorouracil / Generic mfg.
Clinical, Review, Journal: A Systematic Review of Conversion to Resectability in Unresectable Metastatic Colorectal Cancer Chemotherapy Trials. (Pubmed Central) - Jul 29, 2022
C2R occurs infrequently and variably in clinical trials enrolling patients with unresectable mCRC. Prioritization of chemotherapeutic agents that enhance C2R might improve OS of patients.
- | 5-fluorouracil / Generic mfg.
Journal: Matairesinol Induces Mitochondrial Dysfunction and Exerts Synergistic Anticancer Effects with 5-Fluorouracil in Pancreatic Cancer Cells. (Pubmed Central) - Jul 29, 2022
Finally, matairesinol exerts a synergistic effect with 5-FU, a standard anticancer agent for PDAC. These results demonstrate the therapeutic potential of matairesinol in the treatment of PDAC.
- AiTan (rivoceranib) / HLB Bio Group, Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Apatinib plus POF (paclitaxel plus FOLFOX) in patients (pts) with treatment-naïve advanced gastric cancer (TNAGC): Update from the phase I study (SYLT 007) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3377;
P1
The study included 6 escalating dl of apatinib (250, 375, 500, 625, 750, and 850mg daily) plus POF, consisted of paclitaxel 135 mg/m 2 , followed by mFOLFOX6 omitted 5-Fu bolus, every 14 days repeated...Five evaluable pts in dl 850mg were all PR and 3 of them survived more than 30 months. Conclusions High-dose apatinib plus POF had encouraging antitumor activity with manageable safety profile in TNAGC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Randomized phase II trial of upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy versus preoperative chemoradiotherapy followed by surgery and adjuvant chemotherapy in locally advanced rectal cancer: KCSG-CO14-10 (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3346;
P2
In 8 (18.2%) patients (18.2%) in experimental group, postoperative pathologic stage was confirmed as stage 0 (n=1) and 1 (n=7) and these patients did not receiving adjuvant chemotherapy as well as radiotherapy. Conclusions Upfront surgery followed by adjuvant FOLFOX chemotherapy might be considered as an alternative treatment option in in locally advanced rectal cancer with tumor-MRF distance ≥ 2 mm assessed by MRI.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Impact of age on treatment strategies in RAS/BRAF wild-type metastatic colorectal cancer (mCRC): A prespecified subgroup analysis of the GERCOR-PRODIGE STRATEGIC-1 phase III study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3329;
P3
STRATEGIC-1 compared FOLFIRI-cetuximab followed by mFOLFOX6-bevacizumab (Arm A) to OPTIMOX-bevacizumab followed by FOLFIRI-bevacizumab and EGFR monoclonal antibody +/- irinotecan (Arm B) in pts with previously untreated RAS/BRAF wild-type unresectable mCRC...The best choice of first-line chemotherapy in older pts remains unclear. The COLAGE GERCOR study, assessing the quality of life in elderly treated by FOLFOX-bevacizumab vs the standard first-line treatment (capecitabine-bevacizumab), and further studies are needed to better target elderly with mCRC.
- oxaliplatin / Generic mfg.
Prediction of poor response to oxaliplatin by an RNA signature derived and validated in colorectal cancer clinical trials (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3302;
Conclusions A new RNA signature has been generated and validated in high quality clinical trial CRC data identifying patients with early progression on oxaliplatin + 5FU/FA. Despite heterogeneity in the clinical settings used, this signature has the potential to provide useful information for oxaliplatin stratification in future clinical trials.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Prognostic and predictive value of Immunoscore in stage III colorectal cancer in the combined SCOT and IDEA-HORG studies (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3279;
Conclusions This study confirms the prognostic value of IS in patients with stage III CRC treated with CAPOX or FOLFOX and suggests that IS low cases may gain greater benefit from receiving CAPOX than FOLFOX. Validation of this result is merited.
- bemarituzumab (AMG 552) / Amgen
Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): Results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6 (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3262;
P2, P3
Table: 1221P Conclusions In FIGHT, the addition of BEMA to mFOLFOX6 improved clinical outcomes, with no deterioration in HRQoL. HRQoL will be further evaluated in the ongoing confirmatory phase III FORTITUDE-101 trial (NCT05052801).
- Bavencio (avelumab) / EMD Serono, Pfizer
Selection of PD-L1 escape variants in microsatellite stable metastatic colorectal cancer on avelumab treatment (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3208;
P2
The patient received 4 cycles of FOLFIRI/cetuximab, followed by 4 cycles FOLFIRI/cetuximab + avelumab, followed by avelumab maintenance treatment for 10 weeks until end of treatment (EOT) due to progression in week 19...Together with the emergence of truncated PD-L1 variants, regulation of PD-L1 availabilty but not epitope disruption appears to be the key mechanistic principle towards PD-L1 escape. Future trials confirming this principle in other entities are warranted especially in patient subpopulations with rs396991.
- A prospective comparative study on biweekly docetaxel, cisplatin, 5-fluorouracil, leucovorin (TPFL) versus triweekly TPF as an induction chemotherapy in locally advanced squamous cell carcinoma of head and neck (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3147;
Table: 673P Conclusions Biweekly regimen had better response rates with lesser toxicities. Thus, biweekly TPF could be a feasible regimen in locally advanced SSCHN.
- Bavencio (avelumab) / EMD Serono, Pfizer, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Avelumab added to FOLFIRI plus cetuximab followed by avelumab maintenance in patients with previously untreated RAS wild-type colorectal cancer: The phase-II FIRE-6 (AIO KRK-0118) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3107;
FOLFIRI/Cet plus avelumab is safe and feasible as no unexpected toxicities occurred. FIRE-6 avelumab confirms the efficacy with respect to tumor response and disease control of FOLFIRI plus cetuximab as first-line treatment of patients with RAS wild-type mCRC.
- Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead, Avastin (bevacizumab) / Roche, Padcev (enfortumab vedotin) / Seagen, Astellas
Trop2 and Nectin4 immunohistochemical expression in metastatic colorectal cancer: An exploratory analysis of the TRIBE2 study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2981;
P3
Indeed, sacituzumab govitecan, an anti-Trop2 antibody–drug conjugate (ADC), and enfortumab vedotin, an anti-Nectin4 ADC, were recently approved for the treatment of triple-negative breast cancer and urothelial carcinoma, respectively...Methods Tumor samples of patients (pts) randomized in the phase III TRIBE2 study comparing upfront FOLFOXIRI/bevacizumab (bev) vs FOLFOX/bev, were assessed for Trop2 and Nectin4 expression (exp)...Conclusions In mCRC, exp levels of Trop2 and Nectin4 are heterogeneous, suggesting a target-driven development of anti-Trop2 and anti-Nectin4 ADCs. Medium/high Trop2 exp is associated with worse prognosis and higher benefit from chemotherapy intensification.
- 5-fluorouracil / Generic mfg., irinotecan / Generic mfg.
Phase I study of intraperitoneal irinotecan in combination with standard systemic chemotherapy in patients with extensive peritoneal metastases of colorectal origin: The INTERACT trial (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2854;
The IP formation of SN-38 results in a prolonged high IP exposure while the systemic exposure to SN-38 is low. Highly promising antitumor activity was seen, and therefore a phase II study has recently started.
- NIS793 / Novartis
Biomarker assessments in daNIS-3: A phase II study of NIS793 and other new investigational drug combinations with standard-of-care (SoC) therapy vs SoC alone for the second-line treatment of patients (pts) with metastatic colorectal adenocarcinoma (mCRC) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2843;
P2
SRI data will be analyzed after ≥6 pts in each regimen have received NIS793 (intravenous [IV] 2100 mg every 2 weeks or every 4 weeks) + bevacizumab (5 mg/kg) + FOLFIRI or NIS793 + bevacizumab + modified FOLFOX6 on Days 1 and 15 of each 28-day cycle...Upon dose confirmation, further SRI of NIS793 + SoC + tislelizumab (tisle; 300 mg Q4W) will be performed, before pts (n=∼226) are randomized to resume the same investigational drug(s) + SoC (n=∼150) or SoC (n=∼76) alone...daNIS-3 (NCT04952753) is an ongoing study, with pts from 87 sites planned, across 20 countries. The study start date was November 15, 2021.
- Sequential therapy of metastatic pancreatic ductal adenocarcinoma (PDAC) after failure of gemcitabine plus nab-paclitaxel with either 5-FU/folinic acid (5FU/LV) plus irinotecan (FOLFIRI) followed by 5FU/LV plus oxaliplatin (OFF) or the reverse sequence: The PANTHEON trial (AIO PAK 0116) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2840;
Conclusions The exploratory analysis of this early terminated trial suggests that FOLFIRI and OFF have similar efficacy as second-line therapy of PDAC after failure of gemcitabine/nab-paclitaxel. The frequency of patients receiving crossover third-line therapy and the frequency of grade 3-5 events were also comparable.
- Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
Nivolumab (NIV) plus FOLFOXIRI/bevacizumab (BEV) as first-line (1L) in metastatic colorectal cancer (mCRC) RAS/BRAF mutated (mut) patients, regardless of microsatellite status: Results of phase II NIVACOR Trial (GOIRC-03-2018) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2774;
P2
Methods The NIVACOR was a single-arm, open-label, multicenter, phase II trial in which mCRC RAS/BRAF mut pts in 1L received NIV 240 mg, FOLFOXIRI (IRI 165 mg/m 2 , OXA 85 mg/m 2 , leucovorin 200 mg/m 2 , and 5-FU 3,200 mg/m 2 IC for 48 h) plus BEV 5 mg/kg IV q14 days for 8 cycles and then, NIV/BEV as maintenance until PD or unacceptable toxicities...Promising activity was observed in the MSS pts. These data sustenance the conduction of a randomized-controlled phase III study.
- oxaliplatin / Generic mfg.
Five-year efficacy and safety in a randomized phase III trial investigating duration of adjuvant oxaliplatin-based therapy (3- vs. 6-months) for patients with high-risk stage II colon cancer: ACHIEVE-2 trial (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2729;
Conclusions The incidence of long-lasting PSN was significantly lower at 3 months than at 6 months of therapy. As the shortened therapy duration did not compromise the outcomes, a 3-month CAPOX therapy may be appropriate for high-risk stage II CC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., azacitidine / Generic mfg.
Epigenetic engineering on CDX2 allows to determine the interplaying consequences with other genetic and transcriptomic events in colorectal cancer (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2683;
Azacytidine treatment showed a dose-dependent correlation between methylation and expression (p<0.001)...Loss of CDX2 interacts with immune and proliferation pathways at genomic and transcriptomic levels, conferring an agresive phenotype. Epigenetic engineering modifications of CDX2 could favor increase the sensitivity to standar therapy in this setting.
- oxaliplatin / Generic mfg., irinotecan / Generic mfg.
Irinotecan is superior to oxaliplatin in KRAS-G12C-mutated (K-G12C-m) colorectal cancer (CRC) and should be preferred in combination strategies with K-G12C inhibitors. A multicenter propensity score-matched (PSM) retrospective analysis (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2674;
Only pts treated with first-line FOLFIRI or FOLFOX +/- bevacizumab (bev) were included...Conclusions Irinotecan (i.e. FOLFIRI+/-bev) was significantly superior to oxaliplatin (i.e. FOLFOX+/-bev) in K-G12C-m CRC pts, with a subset of pts (32%) achieving a long-lasting (> 2 yrs) PFS. Irinotecan should be the preferred chemotherapy to be used in combination strategies with K-G12C inhibitors.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
A randomized controlled trial to compare laparoscopic surgery with open surgery for symptomatic, non-curable stage IV colorectal cancer (CRC): First efficacy results from Japan clinical oncology group study JCOG1107 (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2671;
Patients received mFOLFOX6+BEV or CapeOX+BEV after surgery...Postoperative complications (G2-G4) included ileus (OP 12.0%, LAP 5.1%), wound infection (OP 2.2%, LAP 2.0%), and anastomotic leakage (OP 0%, LAP 2.0%). Conclusions LAP is acceptable as a standard treatment for symptomatic, non-curable stage IV CRC.
- albumin-bound paclitaxel / Generic mfg.
Comparison of tumour size on outcomes for patients with unresectable locally advanced pancreatic adenocarcinoma (LAPC) receiving P-32 microparticles with standard-of-care chemotherapy (SoC CT) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2645;
P=N/A
Methods Eligible patients (pts) with uLAPC and ECOG 0-1 received either gemcitabine/nab-paclitaxel (GNP) or FOLFIRINOX (FFX) CT...Conclusions Although cohort size is limited, the results suggest that the potential benefits of adding P-32 microparticles to SoC CT for unresectable LAPC may be similar for patients treated with smaller (≤4 cm) or larger (4–7 cm) tumours. Further clinical studies are in development.
- Avastin (bevacizumab) / Roche
Primary tumor resection (PTR) in metastatic colorectal cancer (mCRC) patients (pts) treated with upfront chemotherapy (CT) + bevacizumab (BEV): A pooled analysis of TRIBE and TRIBE2 studies (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2618;
P3
Methods This pooled-analysis included pts enrolled in the phase III TRIBE (NCT00719797) and TRIBE-2 (NCT02339116) studies that compared upfront FOLFOXIRI + BEV to FOLFIRI or FOLFOX + BEV, respectively...No statistically significant differences were noted in incidence of bleeding (p = 0.427). Conclusions PTR impacted positively on prognosis of mCRC pts, and it was associated with less incidence of serious gastrointestinal and surgical adverse events during upfront CT plus BEV.
- Avastin (bevacizumab) / Roche
Impact of a centralized tumour board on secondary intervention rate in patients with RAS mutant metastatic colorectal cancer after first-line treatment with FOLFOXIRI plus bevacizumab (FIRE-7, AIO-KRK-0120) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2569;
P
Currently, 9 out of the planned 40 German study sites are opened for recruitment and 5 patients have been randomized. The primary study endpoint is estimated to be evaluated in 2025.
- Keytruda (pembrolizumab) / Merck (MSD)
First-line lenvatinib (Len) + pembrolizumab (Pembro) + chemotherapy (Chemo) vs chemo in advanced/metastatic gastroesophageal adenocarcinoma: LEAP-015 safety run-in (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2560;
P3
Conclusions In the safety run-in of LEAP-015, len + pembro + chemo was associated with a manageable safety profile in the first-line treatment of advanced/metastatic gastroesophageal adenocarcinoma. Part 2 is currently enrolling and will evaluate the efficacy and safety of len + pembro + chemo vs chemo in this same pt population.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
A multicenter phase II clinical study evaluating the efficacy and safety of perioperative encorafenib, binimetinib plus cetuximab combination treatment in patients with surgically resectable BRAF V600E-mutant colorectal oligometastases (NEXUS) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2554;
On the other hand, a combination of encorafenib (ENCO), binimetinib (BINI) plus cetuximab (CETUX) was reported to prolong OS compared with FOLFIRI (Irinotecan) + CETUX in pts with previously treated unresectable BRAF V600E-mutatnt colorectal cancer (BEACON CRC trial)...The study started in April 2022. The results will be compared with a real-world data of pts who undergo surgery for BRAF V600E-mutatnt CROM that is retrieved from the regulatory-conformed national registry (Circulate-Japan GALAXY study).
- Herceptin (trastuzumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Prognostic potential of liquid biopsy in advanced HER2 positive esophagogastric adenocarcinoma under HER2 blockade and immune checkpoint therapy (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2511;
P2
Methods In the work presented here, we explored the prognostic value of liquid biopsy in patients with advanced HER2+ esophagogastric adenocarcinoma (EGA) receiving first-line treatment of trastuzumab (αHER2) and nivolumab (αPD-1) in combination with ipilimumab (αCTLA-4) or FOLFOX as translational part of the INTEGA trial (NCT03409848)...Moreover, the crude amount of cfDNA per ml blood plasma after 2-3 weeks significantly correlated with response to treatment. Conclusions Thus, the quantification of cfDNA could offer a relevant prognostic parameter to be implemented into the clinical praxis without the need for time-consuming and cost-intensive analyses.
- Avastin (bevacizumab) / Roche, Vectibix (panitumumab) / Amgen, Takeda
Early tumor shrinkage (ETS) and depth of response (DpR) analyses in metastatic colorectal cancer (mCRC) treated with first-line mFOLFOX6 plus panitumumab (PAN) or bevacizumab (BEV): Results from the phase III PARADIGM trial (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2510;
P3
In right-sided pts, ETS was only predictive with PAN, warranting further biomarker analysis to predict PAN benefit. Table: 388P
- Opdivo (nivolumab) / Ono Pharma, BMS, Stivarga (regorafenib) / Bayer
Regorafenib (REGO) with nivolumab (NIVO) and FOLFOX in HER2 negative esophagogastric cancer (EGC) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2413;
P2
We noted a lower-than-expected CPS>5 positive rate in our cohort using PD-L1 IHC E1L3N compared to Checkmate 649 (PDL1 IHC 28.8) and Orient 16 (PD-L1 IHC 22C3) cohorts. The majority of patients had a response, irrespective of PDL1 status, with no new safety signals.
- onvansertib (PCM-075) / Cardiff Oncology
Early decreases in KRAS mutant allele frequency (MAF) predicts clinical benefit to the PLK1 inhibitor onvansertib in combination with FOLFIRI/bev in 2L treatment of metastatic colorectal carcinoma (mCRC) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2410;
P1b/2
Stratification of pts based on KRAS MAF changes in ctDNA after 1 treatment cycle identified a subset of pts (∼50%) with increased clinical benefit (ORR and PFS). This data supports the use of KRAS MAF changes in liquid biopsies as a response biomarker to Onv+FOLFIRI/bev in future clinical studies.
- onvansertib (PCM-075) / Cardiff Oncology
The PLK1 inhibitor onvansertib overcomes irinotecan resistance in RAS-mutated (mRAS) metastatic colorectal cancer (mCRC) in vivo and in patients (pts) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2407;
Early changes in KRAS MAF were associated with increased benefit to Onv+FOLFIRI/bev. Additional studies are warranted to ascertain the clinical benefit of Onv+FOLFIRI/bev for mKRAS mCRC pts progressing on SoC and the use of KRAS MAF as a response biomarker.