tbuckley/cabot-search huggingface dataset:
RECIST and iRECIST criteria for the evaluation of nivolumab + ipilimumab combination in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI/dMMR) metastatic colorectal cancer (mCRC): Results of the GERCOR NIPICOL phase II study.
Authors: Romain Cohen, Jaafar Bennouna, Julie Henriques, Christophe Tournigand, Christelle De La Fouchardiere, David Tougeron, Christophe Borg, Thibault Mazard, Benoist Chibaudel, Marie-Line Garcia-Larnicol, Magali Svrcek, Dewi Vernerey, Yves Menu, Thierry Andre
Journal: Journal of Clinical Oncology (2020)

101 Background: Immune checkpoint inhibitors (ICKi) are highly effective for MSI/dMMR mCRC pts. RECIST1.1 criteria are reported to underestimate response to ICKi. The GERCOR NIPICOL phase II study aimed to evaluate disease control rate (DCR) using RECIST1.1 and iRECIST for MSI/dMMR mCRC pts treated with nivolumab (NIVO) and ipilimumab (IPI). Methods: MSI/dMMR mCRC pts previously treated with fluoropyrimidines (FP), oxaliplatin (OX) and irinotecan (IRI) ± targeted therapies received NIVO 3 mg/kg + IPI 1 mg/kg Q3W for 4 cycles then NIVO 3 mg/kg Q2W until progression or a maximum of 20 cycles. CT-scan tumor assessments were done every 6 weeks during 24 weeks and then every 12 weeks. Primary objective was DCR at 12 weeks (12wDCR) according to RECIST1.1 and iRECIST by central review. Response rates and progression-free survival (PFS) by central review were secondary objectives. A one-stage Fleming design was used with a targeted improvement of 12wDCR from 70% to 85%. Results: Of 57 pts included between Dec 2017 and Nov 2018, 43.9% had received ≥ 3 prior lines including FP (100%), OX (100%), IRI (95.5%), antiangiogenics (57.9%) and anti-EGFRs (45.6%). 17.5% of pts had BRAF mutation and 27.5% Lynch syndrome. Grade 3-4 treatment-related adverse events were reported in 49.1% of pts, mainly hepatitis (12.3%). 12wDCR was 86.0% and 87.7% using RECIST1.1 and iRECIST respectively, with only 1 pseudo-progression (1.8%) observed during the first 12 weeks, and one later. Kappa coefficient between RECIST and iRECIST 12wDCR was 0.92 (95%CI 0.77-1.0). Best observed responses with RECIST1.1/iRECIST were: 2/2 complete responses (3.5/3.5%), 19/19 partial responses (33.3/33.3%), 30/31 stable diseases (52.6/54.4%) and 3/2 disease progressions (5.3/3.5%), with 3 pts not evaluable (cancer-related deaths before first evaluation). Conclusions: Combination of NIVO and IPI in MSI/dMMR mCRC is associated with a low frequency of pseudo-progression and high DCR rate. PFS will be evaluated in Dec 2019, with all pts having completed the predefined 1-year of ICKi therapy. Clinical trial information: NCT033501260.
Postoperative adjuvant chemotherapy with S-1 versus SOX/XELOX regimens for pStage III gastric cancer: A cohort study.
Authors: Nobuhiro Tsuchiya, Chikara Kunisaki
Journal: Journal of Clinical Oncology (2020)

358 Background: Adjuvant chemotherapy following curative gastrectomy is recommended for patients with pStage II or III, except pT3 (ss), N0 gastric cancer in Japan. This study aimed to compare the efficacy of postoperative adjuvant chemotherapy with S-1 versus SOX/XELOX for pStageIII gastric cancer. Methods: Between January 2015 and December 2018, 51 patients with pStage III gastric cancer underwent curative gastrectomy. The combination therapy group received a combined SOX and XELOX regimen as follows: (1) SOX regimen: 130 mg/m 2 of oxaliplatin on day 1 every 3 weeks combined with 40 mg/m 2 of S-1 twice daily on days 1–14 every 3 weeks; (2) XELOX regimen: 130 mg/m 2 of oxaliplatin on day 1 every 3 weeks combined with 1000 mg/m 2 of capecitabine twice daily on days 1–14 every 3 weeks. We evaluated their hospital records retrospectively. The indication of SOX/XELOX regimens was based on PS and intent of patients. Results: The S-1 group comprised 28 cases (pStage III A/B/C: 12/8/8), while the SOX/XELOX group comprised 23 cases (pStage III A/B/C: 4/10/9). There was no difference in age, sex, comorbidity, prognostic nutritional index and stage between two groups. The 2-year DFS of the S-1 group and the SOX/XELOX group were 58.6% and 71.7%, respectively (p = 0.367). Subgroup analysis showed that the 2-year DFS of patients with pStage IIIC gastric cancer in the S-1 group was significantly lower than the SOX/XELOX group (S-1 vs. SOX/XELOX: 25.9% vs. 78.7%, p = 0.041). As concerns adverse effects (CTCAE ver 4.0), peripheral sensory neuropathy was significantly higher in the SOX/XELOX group than in the S-1 group (S-1: grade I/II 3.6%/0% vs. SOX/XELOX: grade I/II 21.7%/34.8%, p &lt; 0.001), although the other adverse effects did not differ between the two groups. Conclusions: SOX/XELOX therapy may be more useful than S-1 therapy for more advanced tumors among pStage III gastric cancers.
Control of cancer progression by extracorporeal removal of soluble TNF-alpha receptors.
Authors: Steven Josephs, Robert Segal, Marilyn Panahi, Matthew Ong, Mark Kunkel, Amir Jafri, Jonathan D. Foster, Gregory K. Ogilvie
Journal: Journal of Clinical Oncology (2020)

20 Background: Tumor necrosis factor (TNF)-alpha is a potent antineoplastic cytokine which exerts tumor destruction in part through vascular disruption. Local administration of TNF-alpha exerts profound anti-cancer effects as observed in studies using isolated limb perfusion. However, systemic administration of this cytokine is associated with vascular leakage and limits clinical use. Methods: One method of stimulating localized effects of TNF-alpha is through removal of its soluble receptors, sTNF-R1 and sTNF-R2 using extracorporeal apheresis; ie, Immunopheresis. In this comparative oncology study, we utilized the proprietary LW-02 device to remove sTNF-Rs in pet dogs with varying types of solid malignancies (Part A; n = 12) or with oral malignant melanoma (Part B; n = 8). Canine patients received between 12-24 apheresis treatments over the course of 4 to 8 weeks. Results: In the over 300 immunopheresis treatments, no device associated adverse effects were reported. Consistent reduction of sTNF-Rs was observed, as measured by decreased plasma levels during treatment as well as elution of sTNF-Rs from the cartridge. Of 17 evaluable dogs who completed treatment, 7 had disease stabilization or regression as confirmed by cRECIST criteria. Conclusions: These data strongly support the clinical translation of the LW-02 device as a potential therapeutic approach for treating solid malignancies/melanoma, either as mono- or as adjuvant therapy.
Peripheral CD8+ T cell characteristics associated with durable responses to immune checkpoint blockade in patients with metastatic melanoma
Authors: Benjamin P. Fairfax, Chelsea A. Taylor, Robert A. Watson, Isar Nassiri, Sara Danielli, Hai Fang, Elise A. Mahé, Rosalin Cooper, Victoria Woodcock, Zoe Traill, M. Hussein Al-Mossawi, Julian C. Knight, Paul Klenerman, Miranda Payne, Mark R. Middleton
Journal: Nature Medicine (2020)
Translational analysis from SCALOP trial: CCL5 as a prognostic biomarker and a potentially actionable target in locally advanced pancreatic cancer (LAPC).
Authors: Somnath Mukherjee, Simone Lanfredini, Catrin Cox, Asmita Thapa, Sophie Hughes, Fiona Bangs, Frances Willenbrock, Charlotte Wilhelm-Benartzi, Aswin George Abraham, Rob Owens, Ahmad Sabbagh, Tim Maughan, Chris Hurt, Eric O'Neill
Journal: Journal of Clinical Oncology (2020)

740 Background: SCALOP was a multi-centre phase II RCT where 114 patients with LAPC were received 3 cycles of Gemcitabine and Capecitabine (GEMCAP) and those with stable/responding disease (n = 74) were randomised to Gem-RT or Cap-RT. The trial showed superiority of Cap-RT. Baseline blood samples of randomised patients were analysed for 35 circulating biomarkers. In vivo study was undertaken with candidate biomarker (CCL5) to test actionability. Methods: Patient bloods were tested using R&amp;D multiplexed magnetic Luminex assays and IGF-1, TGF-b1 and b-NGF DuoSet ELISA. Orthotropic Kras G12D ;P53 R172H ;PDX cre (KPC) tumors were implanted in Bl6-mice and treated with Gem, CCR5-inhibitor (CCR5i) maraviroc (MV), PD1 inhibitor (PD1i), PD1i+MV alone and in combination with MRI guided small animal Radiotherapy (RT). Immunophenotyping was performed by IHC and Aurora Cytek spectral flow cytometry. Results: Baseline biomarker data was available on 63/74 randomised patients. Of the 35 biomarkers tested, only CCL5 was found to be significantly associated with OS with a median OS of 18.5 (95% CI: 11.76-21.32) vs 11.3 (9.86-15.51) months (low vs high), and HR 1.37 (95% CI:1.04-3.65; p = 0.037) in the Cox multivariable model. Treatment of orthotopic KPC tumors revealed that combination of MV+PD1i+RT resulted in tumour growth inhibition and a switch of tumour macrophages from M2 to M1 accompanied by increase in infiltration of cytotoxic CD8+ Tcells and NK cells. Conclusions: Previous pre-clinical studies reported CCL5-CCR5 axis as a poor prognostic marker and a possible cause of immune-resistance in pancreatic cancer. Herein we have demonstrated in prospectively collected clinical trial blood samples that high circulating CCL5 is associated with poor prognosis in LAPC. CCR5 inhibitor in combination with RT+PD1i may overcome immune-resistance, and should be tested in clinical trials. Clinical trial information: 96169987 .
Extensive peritoneal lavage after curative gastrectomy for gastric cancer study (EXPEL): An international multicenter randomized controlled trial.
Authors: Jimmy Bok Yan So, Jiafu Ji, Sang Uk Han, Masanori Terashima, Guoxin Li, Hyung-Ho Kim, Simon Law, Asim Shabbir, Kyo Young Song, Woo Jin Hyung, Nik Ritza Kosai, Koji Kono, Kazunari Misawa, Hiroshi Yabusaki, Takahiro Kinoshita, Peng Choong Lau, Young Woo Kim, Jaideepraj Rao, Bee Choo Tai, Han-Kwang Yang
Journal: Journal of Clinical Oncology (2020)

279 Background: Peritoneal recurrence of gastric cancer after curative surgical resection is common and portends a poor prognosis. Preliminary studies suggest extensive intraoperative peritoneal lavage (EIPL) may reduce the risk of peritoneal recurrence and improve survival. We sought to perform a randomized phase III study to definitively establish the role of performing EIPL after gastrectomy. Methods: This is a prospective, open-label, phase 3 multicentre randomised controlled trial involving 22 hospitals from Korea. China, Japan, Malaysia and Singapore. Patients aged between 21 to 80 years with cT3/4 stomach cancer undergoing curative resection were randomized to either surgery and EIPL (lavage with 10 litres of saline) or surgery alone. Comparison of DFS and OS were made via log-rank test. The cumulative incidence of peritoneal recurrence was compared using competing risks approach. All analyses were performed based on intention-to-treat. Results: Between March 2015 to August 2018, 800 patients were randomly assigned to surgery alone ( n= 402) or EIPL ( n= 398). Based on a median follow-up duration of 29 months, the 3-year cumulative incidence of all-cause mortality was 23.1% and 23.3% for EIPL and surgery alone respectively (hazard ratio [HR] = 1.09, 95% CI: 0.78 to 1.52, p = 0.615). Similarly, the 3-year cumulative incidence of recurrence were 28.0% and 25.9% respectively (HR = 1.01, 95% CI: 0.74 to 1.37, p = 0.947), and 7.9% and 6.6% respectively for peritoneal recurrence (Subdistribution HR = 1.33, 95% CI: 0.73 to 2.42, p = 0.347). Overall, the risk of adverse events was higher in EIPL as compared to surgery alone (relative risk = 1.58, 95% CI 1.07 to 2.33, p = 0.019). The most common adverse events were anastomotic leak, bleeding and intra-abdominal abscess. At the planned third interim analysis on 28 August 2019, the predictive probability of achieving even a 5% difference in 3-year OS in favour of EIPL at final analysis was &lt; 0.4%. The trial was thus recommended to terminate on the basis of futility. Conclusions: EIPL does not show any survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for cancer. Clinical trial information: NCT02140034.
CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC).
Authors: Anne M. Noonan, Jacob Yount, Jason David, Mindy Hoang, Colin W. Stets, Tanios S. Bekaii-Saab, Ying Huang, Wendy L. Frankel, Cynthia Dawn Timmers, John L. Hays, James Lin Chen
Journal: Journal of Clinical Oncology (2020)

746 Background: Pelareorep is a proprietary formulation of live, replication-competent, naturally occurring Reovirus Type 3 Dearing strain. A randomized phase II trial of pelareorep in combination with carboplatin and paclitaxel in first-line treatment of metastatic PDAC (NCT01280058) was performed. Although pelareorep did not improve the primary endpoint of progression-free survival compared to carboplatin and paclitaxel alone, impressive durable responses were seen in the pelareorep arm in some patients (pts). Further, prior studies have noted the immunomodulatory carcinoembryonic antigen-related cell adhesion molecule (CEACAM6/CD66c) as a receptor for specific viral subtypes. We thus speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity. Methods: Pre-treatment tissue biopsies were collected prior enrolment for all 73 pts on study. Evaluable pts with transcriptomic data was available for only 31 pts. RNA was purified from FFPE tissue and gene expression analysis was performed using SensationPlus FFPE Amplification and WT labelling kit and the Human Transcriptome Array 2.0. CEACAM6 protein expression was determined by immunohistochemistry. Differential gene expression and survival analysis using were performed in R/Bioconductor. Appropriate corrections for multiplicity were performed. Results: When comparing extraordinary responders in the pelareorep treated arm to those with poor outcomes, low levels of CEACAM6 mRNA expression were associated with prolonged PFS in pelareorep-treated pts (adjusted p = 0.05). This effect was not seen in non-pelareorep treated pts. The luminal, but not the cytoplasmic immunohistochemistry score, was highly correlated with mRNA expression levels of CEACAM6, p = 0.001. Modulation of CEACAM6 in vitro and in vivo are underway. Conclusions: CEACAM6 may be a candidate biomarker of sensitivity to pelareorep and, in theory, could improve viral trafficking of this compound in tumor cells. Clinical trial information: NCT01280058 . [Table: see text]
Patient-reported outcomes (PROs) from the Phase III IMbrave150 trial of atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) as first-line treatment (tx) for patients (pts) with unresectable hepatocellular carcinoma (HCC).
Authors: Peter R. Galle, Richard S. Finn, Shukui Qin, Masafumi Ikeda, Andrew X. Zhu, Tae-You Kim, Masatoshi Kudo, Valeriy Vladimirovich Breder, Philippe Merle, Ahmed Omar Kaseb, Daneng Li, Sohail Mulla, Wendy Verret, Derek-Zhen Xu, Sairy Hernandez, Juan Liu, Chen Huang, Ho Yeong Lim, Ann-Lii Cheng, Michel Ducreux
Journal: Journal of Clinical Oncology (2020)

476 Background: Atezo + bev in pts with unresectable HCC who had not received prior systemic therapy has shown statistically significant and clinically meaningful improvement in OS and PFS per independent review facility-assessed RECIST 1.1 vs sor in the Phase III IMbrave150 study (Cheng ESMO Asia 2019). Here, we report PRO data from this trial to show pt perspectives on the overall clinical benefit of atezo + bev. Methods: Pts were randomized 2:1 to receive either atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sor 400 mg PO BID until loss of clinical benefit or unacceptable toxicity. Pts completed the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires before tx, every 3 wk on tx, and every 3 mo after tx discontinuation or disease progression. A pre-specified secondary endpoint was time to deterioration (TTD; first ≥ 10-point decrease from baseline held for 2 consecutive assessments or 1 assessment followed by death within 3 wk) of pt-reported quality of life (QOL), physical functioning, and role functioning. Pre-specified exploratory analyses included TTD of and proportion of pts with a clinically meaningful change (≥ 10 points from baseline) in key pt-reported symptoms. Results: Questionnaire completion rates were ≥ 92% in both arms from baseline through most of the tx period. Compared with sor, atezo + bev delayed TTD of pt-reported QOL (median TTD, 11.2 vs 3.6 mo; HR, 0.63 [95% CI: 0.46, 0.85]), physical functioning (median TTD, 13.1 vs 4.9 mo; HR, 0.53 [95% CI: 0.39, 0.73]), and role functioning (median TTD, 9.1 vs 3.6 mo; HR, 0.62 [95% CI: 0.46, 0.84]). Atezo + bev also delayed TTD in pt-reported appetite loss, fatigue, pain, and diarrhea vs sor; a lower proportion of pts on atezo + bev experienced clinically meaningful deterioration in each of these symptoms vs sor. Conclusions: High-quality PRO results from IMbrave150 showed large and consistent benefits in key aspects of the pt experience with atezo + bev, further supporting its overall clinical benefit in pts with unresectable HCC who have not received prior systemic therapy. Clinical trial information: NCT03434379.
Life as a haematologist
Authors: Jacqui Wise
Journal: BMJ (2020)

Haematologists are specialist doctors who look after and investigate conditions that are associated with blood and bone marrow problems, including diseases such as anaemia, haemophilia, and leukaemia.

The specialty offers a unique split of laboratory work and patient care. Haematologists take an active part in every stage of patient management, from initial patient visit to laboratory assessment and diagnosis, and finally to treatment. For example, haematologists carry out bone marrow biopsies and interpret the morphology. They also perform diagnostic lumbar punctures and give intrathecal chemotherapy.

Blood transfusion is an important responsibility of haematologists. Some have expertise in blood and marrow stem cell transplantation to treat a range of life threatening malignant and non-malignant disorders. Modern genetic testing is also a major feature of all branches of haematology. For example, haematologists’ work on leukaemias and blood cancers help guide decisions for chemotherapy and other treatments.

The working day will vary depending on the sub-specialism of the haematologist. A typical …
Vitamin D receptor agonist paricalcitol plus gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer.
Authors: Kimberly Perez, James M. Cleary, Thomas Benjamin Karasic, Srivatsan Raghavan, Osama E. Rahma, Jonathan Nowak, Erkut Hasan Borazanci, Michael Downes, Jeffrey A. Drebin, David A. Tuveson, David Tsai Ting, Richard Moffitt, Jen Jen Yeh, Andrew Aguirre, Ronald Evans, Daniel D. Von Hoff, Peter J. Odwyer, Brian M. Wolpin
Journal: Journal of Clinical Oncology (2020)

TPS784 Background: Patients(pts) with metastatic pancreatic cancer (PC) have a median survival of less than one year even with use of multiagent chemotherapy programs. Pancreatic tumors are composed of multiple cell types and a dense extracellular matrix that may support cancer cell proliferation and impede chemotherapy delivery. Cancer-associated fibroblasts (CAF’s) in the tumor microenvironment secrete pro-inflammatory factors and components of the extracellular matrix. In PC laboratory models, engagement of the vitamin D receptor (VDR) by VDR agonists shifts CAFs toward a more quiescent phenotype with reduced tumor growth and improved chemotherapy penetration (Sherman. Cell, 2014). Paricalcitol is a synthetic VDR agonist used in patients with secondary hyperparathyroidism due to chronic kidney disease. A prior pilot study evaluated IV paricalcitol with gemcitabine (G) and nab-paclitaxel (A) before surgical resection in patients with resectable PC (NCT02030860). Methods: Pts with previously-untreated metastatic PC will be enrolled in a two-stage study consisting of a safety run-in and a randomized phase 2 study (NCT03520790). In the run-in stage, 36 pts will be randomized 1:1:1 to G (1000 mg/m 2 ) and A (125 mg/m 2 ) given 3 weeks on and 1 week off plus: (a) paricalcitol 25mcg IV thrice weekly, (b) paricalcitol 16mcg oral daily, or (c) placebo oral daily. Grade 3/4 hypercalcemia or genitourinary stones will be considered dose limiting toxicities.Pts will undergo paired pre- and on-treatment tumor biopsies to examine pharmacodynamic (PD) markers by bulk and single cell RNA sequencing and multiplex immunofluoresence.Assuming safety and supportive PD assessments, the phase 2 study will randomize an additional 76 pts to two treatment arms with GA plus: (a) paricalcitol or (b) placebo.Paricalcitol formulation (IV or oral) will be determined based on data from the run-in stage.The primary endpoint of the phase 2 study is overall survival, with a total of 100 pts needed to identify a hazard ratio of 0.6 with 80% power and one-sided alpha of 0.10.Secondary endpoints include safety, response rate, and progression free survival.Trial funding provided by SU2C, CRUK,Lustgarten Foundation, and AACR. Clinical trial information: NCT03520790.
Early Diagnosis: Ultra‐Early Diagnosis of Acute Myocardial Infarction in Rats Using Ultrasound Imaging of Hollow Double‐Layer Silica Nanospheres (Adv. Healthcare Mater. 3/2020)
Authors: Mengzhe Guo, Wencheng Du, Nan Lyu, Xi Chen, Yan Du, Haibo Wang, Dongzhi Yang, Shihua Wu, Jun Liang, Yuanjiang Pan, Daoquan Tang
Journal: Advanced Healthcare Materials (2020)

Timely diagnosis of acute myocardial infarction (AMI) strongly impacts the survival rate of patients. In article number 1901155, Yuanjiang Pan, Daoquan Tang, and co-workers report the development of a two-shell hollow silica contrast agent useful for ultrasound (US) imaging, which is able to provide ultra-early diagnosis of AMI.
Gastric Immune Prognostic Index (GIPI) in metastatic (m) gastro-oesophageal junction (GOJ)/gastric cancer (GC) patients (pts) treated with PD-1/PD-L1 immune checkpoint inhibitors (ICIs).
Authors: Cristina Morelli, Vincenzo Formica, Anna Patrikidou, Carmen Murrias, Sabeeh Butt, Antonella Nardecchia, Jessica Lucchetti, Nicola Renzi, Giovanni Maria Iannantuono, Mario Roselli, Kai-Keen Shiu, Tobias Arkenau
Journal: Journal of Clinical Oncology (2020)

417 Background: ICIs demonstrated improved overall survival (OS) in heavily pre-treated mGOJ/GC pts. Pts selection exclusively based on PD-L1 tissue expression appears to be suboptimal, despite data from subgroup analyses of KEYNOTE trials. Strong rationale suggests a potential predictive role of inflammatory biomarkers in ICIs treated mGOJ/GC pts. Methods: 11 systemic inflammatory markers [platelets, monocytes, neutrophil/lymphocyte ratio (NLR), platelets-lymphocyte ratio, lymphocytes, sum of mononuclear cells, albumin, lactate dehydrogenase, alkaline phosphatase (ALP), c-reactive protein (CRP) and serum globulin] were retrospectively analyzed at baseline in 57 mGOJ/GC pts with unknown PD-L1 status treated in second-line with ICIs, and correlated with OS. Least Absolute Shrinkage and Selection Operator (LASSO) method was used to select variables (preliminarily subject to optimal coding using HR smoothed curves for OS) with the highest prognostic value.Selected variables were then analysed in a multivariate Cox Regression Model and used to build a GIPI nomogram. Results: NLR and CRP taken as continuous variables and ALP categorized as &lt; vs &gt; 150 IU/L were found as the most meaningful independent predictors of OS [(HR 1.30 (95%CI 1.02-1.65), 2.00 (95%CI 1.09-3.66), 2.82 (95%CI 1.29-6.20) and p values 0.04, 0.01, 0.02, respectively)] and used to build the GIPI nomogram. Nomogram-based lowest(l), mid and highest(h) risk tertiles were associated with median(m)OS of 14.5,10.6 and 2.4 months(mos), respectively [HR of l vs h 0.26 (95%CI 0.12-0.53), p 0.0002]. By optimally dichotomizing CRP and NLR, pts with one or more of the following risk factors: NLR &gt; 6, CRP &gt; 15 mg/L, ALP &lt; 150 IU/L (n: 31) had a mOS of 3.9mos vs 14.5mos of pts with no risk factor (n: 26) (HR 2.72, p 0.0005). Conclusions: GIPI, combining NLR, CRP and ALP, is the first inflammatory index with a significant prognostic value in mOGJ/GC pts receiving second line ICIs. Its implementation with analysis of PD-L1 expression in the present cohort is ongoing. GIPI merits validation in external cohorts and prospective clinical trials.