Clinical Oncology Research Articles

Membrane-camouflaged biomimetic nanoplatform with arsenic complex for synergistic reinforcement of liver cancer therapy.

Aim: Arsenic has excellent anti-advanced liver cancer effects through a variety of pathways, but its severe systemic toxicity forces the need for a safe and effective delivery strategy.Methods: Based on the chelating metal ion properties of polydopamine (PDA), arsenic was immobilized on an organic carrier, and a M1-like macrophage cell membrane (MM)-camouflaged manganese-arsenic complex mesoporous polydopamine (MnAsOx@MP@M) nanoplatform was successfully constructed. MnAsOx@MP@M was evaluated at the cellular level for tumor inhibition and tumor localization, and in vivo for its anti-liver cancer effect in a Hepa1-6 tumor-bearing mouse model.Results: The nanoplatform targeted the tumor site through the natural homing property of MM, completely degraded and released drugs to kill tumor cells in an acidic environment, while playing an immunomodulatory role in promoting tumor-associated macrophages (TAMs) repolarization.Conclusion: MnAsOx@MP@M has synergistically enhanced the targeted therapeutics against liver cancer via nanotechnology and immunotherapy, and it is expected to become a safe and multifunctional treatment platform in clinical oncology.

Safety and outcome of children, adolescents and young adults participating in phase I/II clinical oncology trials: a 9-year center experience.

Enrolling children with cancer in early phase trials is crucial to access innovative treatments, contributing to advancing pediatric oncology research and providing tailored therapeutic options. Our objective is to analyze the impact of these trials on patient outcomes and safety, and to examine the evolution and feasibility of trials in pediatric cancer over the past decade. All patients recruited in pediatric anticancer phase I/II clinical trials from January 2014 to December 2022 were included. Clinical records and trial protocols were analyzed. A total of 215 patients (median age 11.2 years, range 1-29.5) were included in 52 trials (258 inclusions). Patients with extracranial solid tumors (67%), central nervous system (CNS) tumors (24%), and leukemia (9%) were included. The most common investigational drugs were small molecules (28.3%) and antibodies (20.5%). Serious adverse events were experienced by 41% of patients, 4.4% discontinued treatment because of toxicity and two had toxic deaths. Median event-free survival was 3.7 months (95%CI: 2.8-4.5), longer in phase II trials than in phase I (2 vs. 6.3 months; p ≤ 0.001). Median overall survival was 12 months (95%CI: 9-15), higher in target-specific vs. non-target-specific trials (14 vs. 6 months; p ≤ 0.001). A significant and increasing number of patients have been included in early clinical trials, suggesting that both oncologists and families consider it valuable to be referred to specialized Units to access new therapies. Moreover, our data suggests that participation in early clinical trials, although not without potential toxicities, might have a positive impact on individual outcomes.

Cost-effectiveness analysis of first-line sintilimab plus chemotherapy vs. chemotherapy alone for unresectable advanced or metastatic gastric or gastroesophageal junction cancer in China.

The Chinese Society of Clinical Oncology (CSCO) has recommended sintilimab plus chemotherapy (SINT + Chemo) as a standard first-line therapy for advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC), based on the proven effectiveness and safety in the ORINT-16 trail. Its cost-effectiveness, however, remains to be evaluated. We established a partitioned survival approach (PartSA) model with a 10-year time horizon to determine whether SINT + Chemo (vs. chemotherapy) was more cost-effective as a first-line treatment for unresectable advanced or metastatic GC/GEJC. Survival data was generated from the ORIENT-16 trail. Cost calculation was limited to direct medical costs. Database of Hunan Public Resources Trading Service Platform was used as the source for obtaining drug prices. Other cost and utility values were gathered from established literature. Incremental cost-effectiveness ratio (ICER) was the primary output. Additionally, we conducted sensitivity analysis, subgroup analysis, and scenario analysis. In the base-case analysis, group SINT + Chemo showed an increase in utility value by 0.32 quality-adjusted life-years (QALYs) at an extra cost of $7988.43, resulting in an ICER of $25239.29/QALY, below the Chinese cost-effective willingness-to-pay (WTP) threshold of $38223.34. Upon further subgroup analysis according to patients' programmed death 1 ligand (PD-L1) combined positive score (CPS), the ICERs were $26341.01/QALY for patients highly expressing PD-L1 (CPS ≥5) and $17658.26/QALY for patients lowly expressing PD-L1 (CPS <5). Based on the sensitivity analysis, we found the PFS utility was the parameter that had the most significant impact on the model's outcomes. Moreover, in scenario analysis, the results remained consistent despite variations in the model's time frame. In China, SINT + Chemo is a more cost-effective option (vs. chemotherapy) as a first-line therapy for unresectable advanced or metastatic GC/GEJC, irrespective of PD-L1 expression levels.

How We Monitor Cardiac Health in Breast Cancer Survivors.

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice.

Cost of medical care for malignant brain tumors at hospitals in the Japan Clinical Oncology Group brain-tumor study group.

This study aimed to investigate what treatment are selected for malignant brain tumors, particularly glioblastoma (GBM) and primary central nervous system lymphoma (PCNSL), in real-world Japan and the costs involved. We conducted a questionnaire survey regarding treatment selections for newly diagnosed GBM and PCNSL treated between July 2021 and June 2022 among 47 institutions in the Japan Clinical Oncology Group-Brain Tumor Study Group. We calculated the total cost and cost per month of the initial therapy for newly diagnosed GBM or PCNSL. The most used regimen (46.8%) for GBM in patients aged ≤74years was 'Surgery + radiotherapy concomitant with temozolomide'. This regimen's total cost was 7.50 million JPY (Japanese yen). Adding carmustine wafer implantation (used in 15.0%), TTFields (used in 14.1%), and bevacizumab (BEV) (used in 14.5%) to the standard treatment of GBM increased the cost by 1.24 million JPY for initial treatment, and 1.44 and 0.22 million JPY per month, respectively. Regarding PCNSL, 'Surgery (biopsy) + rituximab, methotrexate, procarbazine, and vincristine (R-MPV) therapy' was the most used regimen (42.5%) for patients of all ages. This regimen incurred 1.07 million JPY per month. The three PCNSL regimens based on R-MPV therapy were in ultra-high-cost medical care (exceeding 1 million JPY per month). Treatment of malignant brain tumors is generally expensive, and cost-ineffective treatments such as BEV are frequently used. We believe that the results of this study can be used to design future economic health studies examining the cost-effectiveness of malignant brain tumors.

Clinician perspectives on delivering primary and specialty palliative care in community oncology practices.

Clinical guidelines recommend early palliative care for patients with advanced lung cancer. In rural and underserved community oncology practices with limited resources, both primary palliative care from an oncologist and specialty palliative care are needed to address patients' palliative care needs. The aim of this study is to describe community oncology clinicians' primary palliative care practices and perspectives on integrating specialty palliative care into routine advanced lung cancer treatment in rural and underserved communities. Participants were clinicians recruited from 15 predominantly rural community oncology practices in Kentucky. Participants completed a one-time survey regarding their primary palliative care practices and knowledge, barriers, and facilitators to integrating specialty palliative care into advanced-stage lung cancer treatment. Forty-seven clinicians (30% oncologists) participated. The majority (72.3%) of clinicians worked in a rural county. Over 70% reported routinely asking patients about symptom and physical function concerns, whereas less than half reported routinely asking about key prognostic concerns. Roughly 30% held at least one palliative care misconception (e.g., palliative care is for only those who are stopping cancer treatment). Clinician-reported barriers to specialty palliative care referrals included fear a referral would send the wrong message to patients (77%) and concern about burdening patients with appointments (53%). Notably, the most common clinician-reported facilitator was a patient asking for a referral (93.6%). Educational programs and outreach efforts are needed to inform community oncology clinicians about palliative care, empower patients to request referrals, and facilitate patients' palliative care needs assessment, documentation, and standardized referral templates.

Co-delivery of siRNA and cisplatin via electrospun Nanofibrous membranes for synergistic treatment of malignant melanoma

Tumor recurrence and metastasis remain formidable challenges in clinical oncology. Although surgery is an effective treatment for early-stage solid tumors, residual cancer cells can lead to subsequent recurrence or metastasis. Conventional treatments for melanoma, such as anti-tumor medications and gene therapy, have distinct limitations. The rapid systemic distribution of anti-tumor drugs poses a significant challenge, often resulting in notable side effects and inadequate drug concentrations at the tumor site. Melanoma (MM), a deadly form of skin cancer, is known for its high mortality rate. In this study, we propose a novel strategy for treating MM by combining the controlled release of chemotherapeutic drugs encapsulated within Metal-Organic Frameworks (MOFs) and liposomes with gene therapy targeting Minichromosome Maintenance Proteins 4 (MCM4) using electrospinning and surface modification techniques. In vitro and in vivo results confirmed that this hierarchical membrane system can effectively deliver therapeutic MCM4 siRNA and release cisplatin to inhibit tumor growth. Furthermore, we demonstrated that MCM4 silencing promoted the sensitivity of melanoma cells to ferroptosis both in vitro and in vivo. The proposed strategy, by allowing for a controlled and sustained release of medication, could alleviate the challenges in drug delivery and aid in prevent tumor recurrence.

Travel-associated carbon emissions of patients receiving cancer treatment from an urban safety net hospital

BackgroundHealthcare transportation, particularly the transportation of patients to access healthcare services, is a significant source of carbon emissions. This study aims to estimate the carbon emissions of patient transportation among patients receiving cancer care at an urban community safety net hospital. Materials and MethodsWe conducted a retrospective study of patients seen at the oncology clinic of an urban community safety net hospital between 1 July 2022 and 30 June 2023. Patients with at least one in-person visit in 1 year, documented home addresses, and oncologic diagnoses were included in the study. The distance between each patient's home address and the hospital was calculated using the Google Map API key and a macro to calculate distance in metres. The total estimated carbon emissions were calculated using the EPA equivalencies calculator. The primary outcome was carbon emissions from patients' round-trip travel from home to hospital. ResultsFrom 1 July 2022 to 30 June 2023, 13,970 visits were made to the oncology clinic. Of these, 8,235 visits made by 1,080 patients met the criteria for inclusion in the final analysis. Of the 8,235 visits recorded, 5,095 (61.8%) were follow-up/laboratory visits. The 1,080 patients who attended the clinic had a mean age of 63.8 years; 700 (64.8%) were male, and 525 (48.6%) were Black or African-American. Breast cancer was the most common diagnosis, accounting for 423 (39.2%) of cancer diagnoses. Each patient travelled 4.8 (0.3–149.3) miles for a one-way trip and 9.6 (0.7–298.6) miles for a round trip to receive cancer care. Approximately 1,520 (280–119,440) g carbon were emitted per patient visit. A total of 79,582 round-trip miles was calculated for the 8,235 visits made by all patients within 1 year, which corresponds to 31,832 kg CO2 emissions equivalent to 35,658 pounds of coal burned, 1,462 propane cylinders used for a home, or 3,872,250 smartphones charged. ConclusionTravel to receive cancer care is associated with significant carbon emissions and poses a climate and public health risk. Efforts to decrease the overall carbon footprint of cancer treatment are needed to minimise the contributions of cancer treatment to climate change.

311. PROGNOSTIC VALUE OF DIFFERENT CIRCUMFERENTIAL MARGIN SITES IN OESOPHAGEAL CANCER: A 10-YEAR COHORT STUDY

Abstract Background There’s a growing interest towards the prognostic value of circumferential resection margin (CRM) involvement in oesophageal cancers. However, there is no sufficient data about the association of the site-specific CRM and survival. In this study, we analysed the influence of different involved CRM sites on survival. Methods This study included patients who had curative oesophagectomy for oesophageal cancer between 2010 till June 2021. Follow up till April 2022 was achieved. Patients with involved proximal or distal margins were excluded. The sites of CRM were defined anatomically to anterior (pericardial), posterior (aorta), lateral (pleurae). The outcomes between different CRM margins were retrospectively analysed. The long-term follow up data was obtained via direct contact with the patients during our oncological clinics, cross-checked with our hospital/national patients’ electronic databases. Results 117 patients had CRM-positive after curative oesophagectomy during the study period. 33 cases had multi-involved CRM sites, while 84 patients had single involved CRM site. Posterior margins were the most common involved site 37/117 (31.6%). No differences in baseline pathological criteria (pT, pN stages and type of cancer) and neoadjuvant therapy. Positive anterior margins carried the worst overall (OS) and disease-free (DFS) survival compared to lateral and posterior margins (OS: 29 vs 41 vs 32 months respectively, p-value 0.37, DFS: 19.2 vs 32.1 vs 28.7 months respectively, p-value 0.39). Multi-involved CRM sites led to worse OS and DFS in comparison with single involved CRM site (OS: 19 vs 32 months respectively, p-value 0.008, DFS: 12.1 months vs 27.6 months respectively, p-value 0.05). Conclusion The site of involved CRM should be rigorously assessed in oesophagectomy specimens. The involved margin sites within CRM had different survival rates, with inferiority towards anterior resection margins. Larger studies are required to better evaluate the prognostic significance of various CRM sites.

The Effect of Shared Decision-making on Decision Self-efficacy and Decisional Conflict of Women with Low-grade Squamous Intraepithelial Lesion in Cervical Cytology: An Experimental Study

Background: Women often face decisional challenges and hesitation while choosing the appropriate method to follow up on their abnormal results of cervix cytology. Objective: The present study aimed to determine the effect of shared decision-making (SDM) on decision self-efficacy (DSE) and decisional conflict (DC) about follow-up methods among women with abnormal cervix cytology results. Methods: This interventional study was performed on 54 women referred to the subspecialty clinic of gynecologic oncology. The women were assigned into intervention and control groups using a randomized block design with block sizes of 4 and 6 and an allocation ratio of 1:1. The intervention group received counseling based on the SDM and a decision aid (DA) booklet. The data collection tools included the questionnaires of the demographic and obstetrics characteristics, DC, DSE, and Decision Regret. The collected data were analyzed using SPSS24 software, and independent t-tests and ANCOVA were used. Results: After the intervention, the total mean score of the DC in the intervention group was significantly lower than that in the control group [MD: -22.84 with 95% CI: -23.52 to -21.95, (P &lt;0.001)]. The mean score of DSE in the intervention group was significantly higher than that in the control group [MD: 14.56 with 95% CI: 21.47 to 7.65, (P &lt;0.001)]. Conclusion: The present study results indicated that counseling based on the SDM effectively promotes DSE and reduces DC among women with minor abnormal cervical cytology. Therefore, it is recommended that healthcare providers use SDM for women with abnormal cervical cancer screening results.

Impact of Androgen Deprivation Therapy on Cognitive Function of Elderly Men With Prostate Cancer.

Background Prostate cancer affects millions of men worldwide. Androgen deprivation therapy is the most prescribed medication for elderly men with prostatic cancer to slow and suppress the disease progression. Androgen deprivation therapy works on decreasing testosterone levels, and that can cause multiple side effects, including potential cognitive affection in the form of accelerating cognitive aging and potentially increasing the risk of dementia. This study is aimed at evaluating the impact of androgen deprivation therapy on the cognitive function of elderly men recently diagnosed with prostate cancer. Methods The current research is a prospective cohort study conducted on 85 elderly patients recently diagnosed with prostate cancer who are about to start androgen deprivation therapy within two weeks of the diagnosis. These patients were recruited from the oncology and geriatrics outpatient clinics of Ain Shams University hospitals and were followed up on androgen deprivation therapy for at least six months. Cognitive and depression assessments were done using the Montreal Cognitive Assessment Test and Montreal Cognitive Assessment Test-Basic (according to their education) and the Patient Health Questionnaire-9. The cases were assessed at the start, after two months, and after six months of androgen deprivation therapy use. Cognitively impaired or depressed patients were excluded at the beginning of the study. Results This study showed that 49 out of 85 (57.6%) of the studied participants had a lower Montreal cognitive assessment test score average after six months, indicating mild cognitive impairment. Cognitive domains such as visuospatial, language, and attention were affected. About one-third of the participants were diagnosed with depression after six months of the androgen deprivation therapy. All the depressed participants had cognitive impairment. Conclusion The use of androgen deprivation therapy carries the risk of cognitive decline and regression of some of the cognitive domains such as language, visuospatial, attention, and depression in the elderly with recently diagnosed prostate cancer who received ADT for six months. Conversely, depression could not be linked to cognitive decline. Further research should continue exploring the relationship between cognitive decline and ADT and seek strategies to mitigate these effects, ensuring comprehensive patient care targetingcognitive and psychological well-being.

Neoadjuvant Chemotherapy in Colon Cancer: More Than Just an Optical Illusion.

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice.

Large language model in head and neck research: evaluating the similarity of the American Society of Clinical Oncology (ASCO) with ChatGPT 4.0 answers

Large language model in head and neck research: evaluating the similarity of the American Society of Clinical Oncology (ASCO) with ChatGPT 4.0 answers

Assessment of sexual function and quality of life in breast cancer patients before and after the occurrence of therapy-related skin changes

Background Patients with breast cancer (BC) who receive adjuvant chemotherapy or other treatment modalities may potentially benefit from an enhanced prognosis of survival. Physical or aesthetic complications may, nevertheless, result in significant distress as a consequence of adverse dermatologic responses. There has been a heightened focus on matters related to quality of life (QoL) as the number of BC survivors has risen. Sexual disorders are reported by as many as 75% of women who undergo treatment for BC. Despite this, the majority of oncologists lack the necessary training to identify patients who are particularly susceptible to developing sexual disorders. Patients diagnosed with BC frequently experience female sexual dysfunction. Objective To compare and evaluate the impact of skin changes induced by different treatment modalities in BC patients on their sexual function and QoL. Patients and methods This is a prospective cohort research on 58 cases diagnosed with BC, which was conducted in the outpatient clinic of the Clinical Oncology department, Faculty of Medicine, Menoufia University from April 2022 to February 2023. The calculated sample size for the current study using Epi info 7 programs was 56 women. The power of the study is 80% with a confidence level of 95% as determined by the Public Health and Community Medicine Department, Faculty of Medicine, Menoufia University. Both sexual function and QoL were assessed before and 3–6 months after the occurrence of skin changes related to different treatment modalities using validated questionnaires irrespective of their tumor stage. Results Of the 58 patients, there was statistically significant variance regarding dermatological life quality index (DLQI) (P&lt;0.001), with 8.6% of patients experiencing a very large influence on their QoL, which increased to 19%. However, the number of patients having an extremely large influence on their quality of life changed from 0 to 5.2%. There was statistically significant variance (P&lt;0.001) regarding female sexual function index values among the six domains of female sexual function index before and after the occurrence of skin changes. There is a negative correlation between DLQI score and desire, arousal, lubrication, orgasm, and satisfaction scores, while there is a positive correlation between DLQI score and pain score. QoL was negatively affected by the occurrence of such skin lesions. Conclusion There was a significant negative impact of skin changes induced by different treatment modalities in BC patients on their sexual function and QoL.

A new perspective on antiangiogenic antibody drug resistance: Biomarkers, mechanisms, and strategies in malignancies.

Drug resistance of malignant tumor leads to disease progression be the bottleneck in clinical treatment. Antiangiogenic therapy, which aims to "starve" the tumor by inhibiting angiogenesis, is one of the key strategies in clinical oncology treatments. Recently, dozens of investigational antibody drugs and biosimilars targeting angiogenesis have obtained regulatory approval for the treatment of various malignancies. Moreover, a new generation of bispecific antibodies based on the principle of antiangiogenesis are being advanced for clinical trial to overcome antiangiogenic resistance in tumor treatment or enhance the efficacy of monotherapy. Tumors often develop resistance to antiangiogenesis therapy, presenting as refractory and sometimes even resistant to new therapies, for which there are currently no effective management strategies. Thus, a detailed understanding of the mechanisms mediating resistance to antiangiogenesis antibodies is crucial for improving drug effectiveness and achieving a durable response to antiangiogenic therapy. In this review, we provide a novel perspective on the tumor microenvironment, including antibody structure, tumor stroma, and changes within tumor cells, to analyze the multifactorial reasons underlying resistance to antiangiogenesis antibodies. The review also enumerates biomarkers that indicate resistance and potential strategies for monitoring resistance. Furthermore, based on recent clinical and preclinical studies, we summarize potential strategies and translational clinical trials aimed at overcoming resistance to antiangiogenesis antibodies. This review provides a valuable reference for researchers and clinical practitioners involved in the development of new drugs or therapeutic strategies to overcome antiangiogenesis antibodies resistance.

Long-term survival and post-hoc analysis of toripalimab plus definitive chemoradiotherapy for oesophageal squamous cell carcinoma: insights from the EC-CRT-001 phase II trial

In the EC-CRT-001 phase II study, the combination of toripalimab (an anti-programmed death-1 antibody) and definitive chemoradiotherapy (CRT) has shown promising efficacy in patients with locally advanced oesophageal squamous cell carcinoma (ESCC). Here, we reported the long-term outcomes and post-hoc exploratory analyses. This single-arm, phase II trial enrolled 42 patients diagnosed with unresectable stage I-IVA ESCC was conducted at Sun Yat-sen University Cancer Center between November 2019 and January 2021. Treatment consisted of chemotherapy (weekly 50mg/m2 of paclitaxel and 25mg/m2 of cisplatin for five cycles), concurrent radiotherapy (50.4Gy in 28 fractions), and toripalimab (240mg every 3 weeks for up to 1 year). The primary endpoint was clinical complete response (CR) rate at 3 months after CRT completion. The 3-year overall survival (OS) and progression-free survival (PFS) rates were evaluated. Additionally, the exploratory objectives included analysing recurrence patterns, assessing the associations between immune-related adverse events (irAEs) and efficacy, and identifying potential predictors for irAEs. The trial was registered with ClinicalTrials.gov (NCT04005170). With a median follow-up of 44.3 months (IQR 40.8-46.1), the 3-year OS and PFS rates were 44.8% (95% CI 31.9-62.8) and 35.7% (95% CI 23.8-53.6), respectively. Patients who failed to achieve a clinical complete response (CR) demonstrated significantly worse OS (hazard ratio [HR]=13.73, 95% CI 4.43-42.54, P<0.0001) and PFS (HR=32.08, 95% CI 8.57-120.10, P<0.0001). Disease recurrence occurred in 23 of 42 patients (55%), with recurrences being earlier and more frequent in the non-CR group compared to the CR group. Patients experiencing irAEs showed a significantly higher CR rate (72% vs. 39%, P=0.082) and better PFS (HR=0.43, 95% CI 0.19-0.93, P=0.027) than those without irAEs. GON4L mutation was associated with a lower incidence of irAEs (P=0.036). The updated survival outcomes confirmed the efficacy of toripalimab plus definitive CRT in locally advanced ESCC. Moreover, the development of irAEs may predict a more favourable prognosis. National Natural Science Foundation of China, Beijing Xisike Clinical Oncology Research Foundation, and Sci-Tech Project Foundation of Guangzhou.

Retrospective ِِAnalysis of The Prognostic Impact Of Lymph Node Ratio (mLNR) In Colorectal Cancer at Clinical Oncology Department, Ain Shams University Hospitals and Damanhur Oncology Center

Retrospective ِِAnalysis of The Prognostic Impact Of Lymph Node Ratio (mLNR) In Colorectal Cancer at Clinical Oncology Department, Ain Shams University Hospitals and Damanhur Oncology Center

CN49 Staying or leaving the pediatric oncology clinic: Nurses' challenges in care and voices of struggle: A qualitative study

CN49 Staying or leaving the pediatric oncology clinic: Nurses' challenges in care and voices of struggle: A qualitative study

PATTERN OF HER-2 EXPRESSION WITH SPECIAL REFERENCE TO LOW HER-2 EXPRESSION IN IHC SAMPLES OF BREAST CANCER PATIENTS AT TERTIARY CANCER HOSPITAL HCG AHMEDABAD

Background: Breast cancer is the 2nd most common cancer worldwide and number one cancer in women. As per American Society of Clinical Oncology 2018 guidelines, HER2 classification is binary HER2 positive and HER2 negative. DESTINY-Breast04 trial (2022), the FDA expanded the approval of the HER2 antibody-drug conjugate (T-Dxd) from metastatic breast cancer patients with HER2 protein over-expression/amplification, to also include metastatic patients with HER2 IHC 1+ or 2+ &amp; ISH negative results. This clinical trial adopted a new terminology, HER2 Low, which successfully prolonged both progression-free survival (PFS) and overall survival (OS). Material and Method: A descriptive and retrospective analysis was performed, including all patients diagnosed with Invasive breast cancer in HCG cancer Centre, Ahmedabad- Triesta Laboratory between 1st July 2022 to 31st June 2023. Total of 395 patients of both genders were studied. All those individuals who were diagnosed with Invasive breast carcinoma according to WHO and CAP guideline by H&amp;E, IHC and FISH test were included in our study and those with missing data were excluded from our study. Result: This was a descriptive and retrospective study where 395 cases were diagnosed as breast cancer. HER2 low pattern was found commonly in 4th and 6th decades of life. In our study, out of 395 cases, 34.9% (n = 138) were HER2-negative, 39.5% (n = 156) were HER2-low, and 25.6% (n = 101) were HER2-positive. Among 156 HER2-low cases, 15.4% (24/156) cases were hormone negative, and 84.6% (132/156) cases were hormone positive. Conclusion: We observed that approximately 40 % of the cases were recategorized to be HER2 low which were classified HER2 negative according to old guidelines. Approximately 84% cases of HER2 low group were hormone positive. With the development of novel ADCs and other targeted agents, the treatment strategies for HER2-low breast cancer are expanding, and hence detecting low expression levels of HER2 is important.

ONCOLINER: A new solution for monitoring, improving, and harmonizing somatic variant calling across genomic oncology centers

The characterization of somatic genomic variation associated with the biology of tumors is fundamental for cancer research and personalized medicine, as it guides the reliability and impact of cancer studies and genomic-based decisions in clinical oncology. However, the quality and scope of tumor genome analysis across cancer research centers and hospitals are currently highly heterogeneous, limiting the consistency of tumor diagnoses across hospitals and the possibilities of data sharing and data integration across studies. With the aim of providing users with actionable and personalized recommendations for the overall enhancement and harmonization of somatic variant identification across research and clinical environments, we have developed ONCOLINER. Using specifically designed mosaic and tumorized genomes for the analysis of recall and precision across somatic SNVs, insertions or deletions (indels), and structural variants (SVs), we demonstrate that ONCOLINER is capable of improving and harmonizing genome analysis across three state-of-the-art variant discovery pipelines in genomic oncology.