irinotecan / Generic mfg. - LARVOL DELTA

M24-311: Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab (clinicaltrials.gov) - P2 | N=280 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Colorectal Cancer • Oncology • Solid Tumor

Impacts of polymorphisms in drug-metabolizing enzyme and transporter genes on irinotecan toxicity and efficacy in Thai colorectal cancer patients. (PubMed, PLoS One) - "UGT1A1*6 and ABCC2 -24C > T variants emerge as potential predictors of irinotecan-induced neutropenia, while UGT1A1*6 and SLCO1B1 521T > C may serve as markers of prolonged PFS in Thai patients. Validation through larger prospective studies is essential to confirm and refine these genetic associations."

Journal • Retrospective data • Colorectal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • ABCB1 • ABCC2 • ABCC5 • ABCG1 • ABCG2 • CYP3A4 • CYP3A5 • UGT1A1

Surgery for Locally Advanced Pancreatic Cancer: Oncological Landmarks for Venous and Arterial Reconstruction. (PubMed, Ann Surg Oncol) - "We implement an extended neoadjuvant regimen-typically a minimum of eight cycles of FOLFIRINOX-aiming for normalization of CA19-9 levels...IMV, inferior mesenteric vein; LGV, left gastric vein; SMA, superior mesenteric artery artery; SV, splenic vein; SMV, superior mesenteric vein; RHA, right hepatic artery Prioritizing tumor biology, meticulous preoperative planning, and attention to key vascular technical details to ensure radical resection represent our three core oncologic landmarks. Further international, multicenter studies are needed to validate and promote the standardization of surgery for BR-PC and LAPC."

Journal • Hepatocellular Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

Trilaciclib for the prevention of chemotherapy-induced myelosuppression: A systematic review and meta-analysis (ASH 2025) - "Chemotherapy regimens were heterogeneous and included etoposide-platinum (E/P) (either cisplatin or carboplatin) (n=5), gemcitabine/carboplatin (GCb) (n=2), topotecan (n=2), FOLFOXIRI (n=1), and Carboplatin/Paclitaxel/Tislelizumab (n=1)...It also showed a positive impact on progression-free and overall survival, without compromising chemotherapy effectiveness or increasing toxicity. These findings highlight Trilaciclib's potential as a valuable adjunct to chemotherapy in appropriately selected patients."

Retrospective data • Review • Breast Cancer • Colorectal Cancer • Febrile Neutropenia • Infectious Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer

Finding ferritin footprints in 5-fluorouracil-induced cardiotoxicity (ASH 2025) - "MethodsWe performed a retrospective chart review on patients aged 18 and older receiving 5-FU-basedintravenous chemotherapy (including 5-FU, FOLFOXIRI, FOLFIRI, FOLFIRINOX) at a single academic centerfrom June 1, 2022 to June 1, 2024...Should ferritin be elevated, we advise clinicians to maintaina high index of suspicion for obstructive CAD and heart failure. Larger multi-institutional studies onbiomarkers predicting cancer therapy-related cardiovascular toxicity or treatment failure rates meritfuture consideration."

Congestive Heart Failure • Coronary Artery Disease • Gastrointestinal Cancer • Heart Failure

CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis (ASH 2025) - "We hypothesized that by protecting HSPCs from the cytotoxic effects of chemotherapy,trilaciclib might also reduce the clonal expansion of TP53-mutant CH during chemotherapy.We obtained serial blood samples from healthy controls (n=176) and three placebo-controlledrandomized clinical trials of trilaciclib including patients with (1) SCLC (n=65) receiving carboplatin andetoposide, (2) metastatic colorectal cancer (mCRC) (n=125) receivingleucovorin/fluorouracil/oxaliplatin/irinotecan (FOLFOXIRI) plus bevacizumab, and (3) metastatic triplenegative breast cancer (mTNBC) (n=34) receiving gemcitabine and carboplatin...Similar effectswere seen with the oral CDK4/6 inhibitor palbociclib and using a dominant negative form of CDK6introduced into p53 mutant HSPCs.Single cell RNA-seq of chimeric mice treated with carboplatin with trilaciclib or single agent controlsrevealed that CDK4/6 inhibition treatment promotes HSC and myeloid progenitor quiescence whilemitigating the myeloid..."

Breast Cancer • Colorectal Cancer • Eye Cancer • Hematological Malignancies • Lung Cancer • Retinal Disorders • Retinoblastoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • PTPRC • TP53

Overall survival (OS) in patients with metastatic colorectal cancer (mCRC) following persistent chemotherapy-induced thrombocytopenia (pCIT) (ASH 2025) - "pCIT was defined as the first occurrence of a platelet countmeasurement ≤85×109/L, ≥13 days after the nearest prior chemotherapy administration with fluorouraciland oxaliplatin (FOLFOX) or fluorouracil, irinotecan, and oxaliplatin (FOLFOXIRI); or ≥ 20 days afteroxaliplatin and capecitabine (CAPOX)... The median OS for mCRC patients following the first pCIT ranges from 9.7 to 23.5 months,with 6-month survival probabilities between 64% and 90%, across different LOTs. Multiple factors, suchas LOT, ECOG, age, CIT grade, and bevacizumab use, are associated with clinically relevant differences insurvival in patients with pCIT. These findings provide clinically relevant benchmarks for survival and maybe useful in assessing the need for supportive therapy."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • Thrombocytopenia

Tisotumab vedotin vs investigator's choice of chemotherapy as second- or third-line (2L/3L) treatment for Chinese patients (pts) with recurrent or metastatic cervical cancer (r/mCC) in innovaTV 301 (ESMO Asia 2025) - P3 | "This report presents the first analysis of efficacy and safety of TV in Chinese pts with r/mCC, based on data from both global and China extension portions within innovaTV 301. Eligible pts had r/mCC with disease progression following standard chemotherapy doublet ± bevacizumab ± anti-PD-(L)1 therapy, measurable disease per RECIST v1.1, and an ECOG performance status of 0-1. Pts were randomised 1:1 to receive TV monotherapy or investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed... TV as 2L/3L treatment demonstrated clinically meaningful improvements in OS, PFS, and ORR vs chemotherapy, with a manageable safety profile, for Chinese pts with r/mCC."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

A prospective randomized, double-blind controlled trial of olanzapine versus placebo in addition to ondansetron plus dexamethasone as antiemetic prophylaxis in patients receiving moderately emetogenic chemotherapy (ESMO Asia 2025) - "Given the comparable efficacy of olanzapine, this study evaluated the effectiveness of 5 mg olanzapine (OLN) in combination with ondansetron and dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) in patients undergoing MEC. This double-blind, randomized controlled trial included patients receiving their first cycle of oxaliplatin-, carboplatin-, or irinotecan-based chemotherapy. Olanzapine (5 mg) combined with ondansetron and dexamethasone significantly improved prevention of CINV in patients receiving MEC. This regimen may serve as a new standard of care."

Clinical • Chemotherapy-Induced Nausea and Vomiting • Oncology

Frequency of dihydropyrimidine dehydrogenase (DPD) deficiency in patients receiving fluoropyrimidine-based chemotherapy for solid tumors: A single-centre experience in Dubai, UAE (ESMO Asia 2025) - "Background: Dihydropyrimidine dehydrogenase (DPD) deficiency, caused by variants in the DPYD gene, is found in 3-5% of the population and significantly increases the risk of severe toxicity in patients receiving fluoropyrimidine chemotherapy such as 5-fluorouracil (5-FU)...The most frequently used regimens were CAPOX (n = 34, 33%), FOLFOX (n = 32, 31%), single-agent capecitabine (n = 18, 17%), FOLFIRINOX (n = 8, 8%), and FLOT (n = 5, 4%)... In our cohort, the prevalence of clinically significant DPYD mutations was lower than reported in global literature. These findings highlight the need for larger, region-specific studies to better understand DPYD variant frequencies in the Gulf region and to optimize individualized chemotherapy dosing."

Clinical • Colorectal Cancer • Oncology • Solid Tumor • DPYD

Beyond-line immunotherapy in ES-SCLC: Efficacy and Safety of second-line PD-1/PD-L1 inhibitors after progression on first-line PD-1/PD-L1 inhibitors plus platinum-etoposide chemotherapy (ESMO Asia 2025) - "Funding: Has not received any funding. This study demonstrated that continuation of second-line PD-1/PD-L1 inhibitors beyond progression showed an improving trend in terms of ORR, DCR, PFS, and OS, without statistical significance. Statistically significant PFS benefits were observed in specific patient subgroups."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

First-line irinotecan plus platinum-based versus etoposide plus platinum-based chemotherapy for extensive-stage small-cell lung cancer: A meta-analysis of randomized controlled trials (ESMO Asia 2025) - "In patients with ES-SCLC, using IP over EP showed similar efficacy. However, EP causes more hematological toxicity, while IP is linked to higher gastrointestinal side effects. These results prompt to use a personalized approach in choosing first-line regimen based on patient tolerance and comorbidities."

Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Effect of concomitant chemotherapy on edoxaban plasma concentration in patients with colorectal cancer (ESMO Asia 2025) - "In patients with CRC, edoxaban plasma concentration did not change after chemotherapy irrespective of the regimen administered, implying that drug–drug interaction between edoxaban and anti-cancer agents was minimal."

Clinical • Colorectal Cancer • Oncology • Solid Tumor

First real-world evidence comparing EVA, an indigenous made-in-India scalp cooling system, with paxman for chemotherapy-induced alopecia in cancer patients. Data from cancer center India (ESMO Asia 2025) - "Treatment regimens: Anthracycline, Taxane, Irinotecan, Cyclophosphamide. This is the first comparison between EVA & Paxman scalp cooling systems, though retrospective, it is from the same centre. In this real-world comparative analysis, EVA, Indian scalp cooling Machine demonstrated similar efficacy to Paxman in preventing CIA. With high patient satisfaction and documented hair regrowth."

Clinical • HEOR • Real-world • Real-world evidence • Endometrial Cancer • Oncology • Solid Tumor

Adjuvant chemotherapy for operated amPullary AdenoCarcinomas based on histology and intensification – A two arm non - randomized open label prospective parallel adaptive design phase II clinical trial (APACHI) (ESMO Asia 2025) - "Intervention Patients with non-metastatic operated ampullary adenocarcinomas (AC), either Stage II or Stage III will be divided into 2 groups – AC – PB (pancreatobiliary subtype) & AC – IT (intestinal subtype) Patient with AC- PB subtypes will receive mFOLFIRINOX chemotherapy for 6 cycles. RFS with gemcitabine chemotherapy (historical cohort) is 75%, a study with a power of 80% and two - sided alpha of 10% will require 126 patients to show an improvement in 2yr RFS to 85% with CAPOX. The statistical assumptions have included a 10% lost to follow up rate for the study and will require a total of 193 patients for enrolment."

Clinical • P2 data • Ampulla of Vater Adenocarcinoma • Ampulla of Vater Carcinoma • Oncology

Physician choice multi-agent chemotherapy versus gemcitabine monotherapy for advanced pancreatic adenocarcinomas in frail or elderly patients - A randomized phase III clinical trial (ESMO Asia 2025) - "Background: Pancreatic ductal adenocarcinomas (PDAC) frequently present in an advanced unresectable stage (80-85%).Patients with ECOG PS 2 as well as elderly frail patients are underrepresented in trials evaluating advanced PDAC or patients who are not fit for intensive protocols like FOLFIRINOX...we wish to evaluate the benefit of giving a two-drug regimen in these patients versus administering only gemcitabine.Trial design: Phase III, Randomized, Open-label, parallel design, superiority study Histologically confirmed unresectable or metastatic adenocarcinoma of the pancreas or ampulla, with an ECOG PS 2 and age >/= 18 years OR Age >=70 with G8 screening score < 14 and intermediate/high risk on CARG score and adequate haematological, hepatic and renal function are randomized into one of two arms - Arm A (Physician choice multiagent chemotherapy) The treatment regimens allowed are 1.Gemcitabine 1000 mg/m2 IV plus Nab-paclitaxel 125 mg/m2 IV D1, D 8 and D15 q 28..."

Clinical • Metastases • Monotherapy • P3 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

IDeate-Esophageal01: A phase III, randomized, open-label study of ifinatamab deruxtecan (I-DXd) in patients (pts) with pretreated advanced/metastatic esophageal squamous cell carcinoma (ESCC) (ESMO Asia 2025) - P1/2, P3 | "Pts (N≈510) are randomized 1:1 to receive I-DXd 12 mg/kg intravenously every 3 weeks or investigator's choice of chemotherapy (paclitaxel, docetaxel, or irinotecan) until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Other secondary endpoints include duration of response and disease control rate by BICR, patient-reported outcomes, biomarker analysis, and safety. Enrollment is ongoing."

Clinical • IO biomarker • Metastases • P3 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • CD276

Real-world effectiveness of chemotherapy regimens in advanced pancreatic cancer: A nationwide, population-based cohort study in Taiwan (ESMO Asia 2025) - "Individuals receiving systemic chemotherapy within 90 days of diagnosis were categorized into treatment groups based on initial regimens: gemcitabine alone, gemcitabine plus nab-paclitaxel, S-1 alone, S-1 plus gemcitabine, FOLFIRINOX, GSL (gemcitabine plus S-1 plus leucovorin), 5-FU–based (5-FU with or without leucovorin), or other... This real-world study highlights the comparative effectiveness of chemotherapy regimens in APC and supports gemcitabine-based combinations as important options in East Asian clinical practice."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Multi-centre experience of tolerability of Zolbetuximab (Zolb) in combination with chemo for advanced gastroesophageal adenocarcinoma (GEA) in Singapore (SGP) (ESMO Asia 2025) - "Chemo backbones: SOX/CAPOX (36%), mFOLFOX6 (36%), FP + i.p Paclitaxel (14%), mFOLFIRI (9%) and mFOLFOX6 + Nivolumab (5%)...From cycle 2, 10/18 pts (59%) had infusion rates lengthened; 5/18 pts (28%) received extra antiemetics (4 olanzapine, 1 lorazepam)... IRRs with Zolb were manageable and lower than phase III studies due to triplet antiemetic prophylaxis in cycle 1. Adjusting Zolb infusion rate and antiemetics further reduced IRRs. Zolb plus chemo had manageable AEs, supporting its use in SGP."

Clinical • Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

Combined oncolytic virus and immuno/chemotherapy in pancreatic cancer: A systematic review and meta-analysis of clinical outcomes (ESMO Asia 2025) - "This proportion meta-analysis evaluated clinical outcomes of OV therapy combined with either immunotherapy or chemotherapy in pancreatic cancer patients. A literature search was conducted in PubMed, ScienceDirect, ProQuest, and ClinicalTrials.gov up to July 31, 2025, using terms including "pancreatic cancer," "oncolytic virus," and "oncolytic immunotherapy." Eligible studies involved OVs used with checkpoint inhibitors or chemotherapeutic agents (e.g., gemcitabine, FOLFIRINOX)... OV-based combinations show potential benefit with acceptable safety, but heterogeneity limits certainty. These findings provide benchmark efficacy and safety rates to guide future trials, improve patient selection, and support integration into treatment strategies. Standardized reporting and larger trials are needed to confirm these results."

Clinical data • Oncolytic virus • Retrospective data • Review • Oncology • Pancreatic Cancer • Solid Tumor

Real-world evidence on KRAS mutation status in the Japanese population with pancreatic ductal adenocarcinoma (ESMO Asia 2025) - "Inclusion criteria were (1) KRAS-WT or a solitary KRAS-mutated (MT) cases (2) patients who received either gemcitabine plus nab-paclitaxel (GnP) or fluorouracil, folinic acid, irinotecan, and oxaliplatin (FOLFIRINOX) as first-line therapy. KRAS mutation status alone may not predict treatment efficacy in Japanese PDAC patients, but KRAS WT tumors represent a molecularly distinct subset characterized by enriched actionable alterations and immunogenic features."

Clinical • HEOR • Real-world • Real-world evidence • Microsatellite Instability • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • BRAF • BRCA2 • CDKN2A • KRAS • MSI • PIK3CA • SMAD4 • TMB • TP53

Comparison of S-1 with concurrent radiotherapy or gemcitabine plus nab-paclitaxel combination therapy in patients with locally advanced pancreatic cancer: An integrated analysis of two phase II trials (JCOG2408A) (ESMO Asia 2025) - "JCOG1407 was conducted to evaluate the efficacy and safety of GnP and modified FOLFIRINOX... S-1+RT and GnP, whereas OS and DMFS tended to be longer with GnP. Considering that subsequent treatment was less intensive in S-1+RT group, its OS may have been underestimated, suggesting that S-1+RT remains a potential option for patients with LAPC."

Clinical • Combination therapy • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Cetuximab combined with chemotherapy in RAS wild-type metastatic colorectal cancer: A real-world study in Indian settings (ESMO Asia 2025) - "In the induction phase, most patients received FOLFOX (67), followed by FOLFIRI (18), with smaller numbers on CAPOX (3), IRIS (1), and 12 missing... This real-world evidence analysis reinforces the established benefit of cetuximab combined with chemotherapy in RAS WT, left-sided mCRC patients. These findings are aligned with the outcomes from major trials such as CALGB 80405 (PFS: 10.45 months) and ASCO 2016 analyses (PFS: 11.4 months). Notably, this is the first such study from the Indian subcontinent, reflecting outcomes in a heterogeneous patient population and adding valuable regional RWD to the global evidence base."

Clinical • Metastases • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Chemotherapy retreatment versus regorafenib in third-line metastatic colorectal cancer: Survival outcomes, prognostic model, and toxicity profile (ESMO Asia 2025) - "Regorafenib is a standard third-line agent, but head-to-head data with retreatment are scarce. Multycentral retrospective analysis of mCRC patients treated with retreatment or regorafenib in 3rd line.Retreatment included prior fluoropyrimidine-, irinotecan-, or oxaliplatin-based chemotherapy plus anti-VEGF or anti-EGFR antibodies. In 3rd line mCRC, retreatment achieved superior OS and PFS vs regorafenib. AE patterns were typical for the above mentioned options."

Metastases • Colorectal Cancer • Oncology • Solid Tumor

Real-world observational study of fruquintinib in combination with irinotecan and capecitabine as second-line treatment in patients with advanced colorectal cancer (ESMO Asia 2025) - P | "11 (52.4%) and 4 (19.0%) patients had received bevacizumab and cetuximab as part of their first-line treatment. These results show the preliminary efficacy and safety of fruquintinib in combination with irinotecan and capecitabine as a second-line treatment for patients with advanced colorectal cancer."

Clinical • Combination therapy • Metastases • Observational data • Real-world • Real-world evidence • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • UGT1A1