Eastern Cooperative Oncology Group Performance Score Research Articles

Evaluation of Different Regimens of Palliative Radiation Therapy for Symptomatic Bone Metastases: An Audit From a Tertiary Care Hospital in Jharkhand, India.

Background This study aimed to assess the efficacy of different radiation therapy regimens in treating patients with symptomatic bone metastases. Methodology A retrospective study was conducted by assigning patients with symptomatic bone metastases from different primary cancers into three groups, namely, Arms A, B, and C. The radiation dose delivered in each arm was as follows: 8 Gray (Gy) in a single fraction for Arm A, 20 Gy in five fractions at the rate of 4 Gy per fraction for Arm B, and 30 Gy in 10 fractions at the rate of 3 Gy per fraction for Arm C. Each arm consisted of 15 patients. A comparison was conducted across all three arms to evaluate pain relief based on the Visual Analog Scale (VAS), performance score improvement based on the Eastern Cooperative Oncology Group (ECOG), and analgesic requirement based on the World Health Organization (WHO) step ladder at one week, one month, and three months. Results The pain relief was measured using the VAS in three different arms, i.e., Arm A, B, and C. After one week, the pain relief was 66.67%, 60%, and 60%, respectively. After one month, it was 73.33% in all three arms. At three months, it was 80%, 86.67%, and 86.67%, respectively. The study also measured the improvement in the ECOG performance score. The improvement in all three arms was 60% after one week and 66.67% in Arm A and 73.33% in Arms B and C after one month. After three months, the improvement was 73.33%, 80%, and 80% in Arms A, B, and C, respectively. The decrease in analgesic usage was also measured in all three arms. After one week, it was 60% in all three arms. After one month, it was 66.67%, 73.33%, and 73.33% in Arms A, B, and C, respectively. At three months, it was 73.33%, 80%, and 80% in Arms A, B, and C, respectively. No significant statistical difference was found between the three arms. Conclusions The efficacy of a single 8 Gy arm was almost equivalent to that of other arms of multifractionated regimens in terms of improvement in pain and performance score and decreased use of analgesics for a short duration of follow-up. For high-volume cancer centers and patients with economic constraints, a single-fraction regime provides effective palliation for painful bone metastases.

Predictors of Complete Pathological Response with Chemoimmunotherapy in Triple-Negative Breast Cancer: A Meta-Analysis

Background: Multiple randomized controlled trials (RCTs) have investigated the impact of adding checkpoint inhibitors to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC) patients. However, there is a lack of biomarkers that can help identify patients who would benefit from combination therapy. Our research identifies response predictors and assesses the effectiveness of adding immunotherapy to neoadjuvant chemotherapy for TNBC patients. Methods: We identified eligible RCTs by searching PubMed, Cochrane CENTRAL, Embase, and oncological meetings. For this meta-analysis, we obtained odds ratios using the standard random effects model. To assess the heterogeneity of the study outcomes, the I2 statistic was obtained. Potential bias was assessed using a funnel plot and the corresponding Egger’s test. Results: In total, 1637 patients with TNBC were included from five RCTs. Neoadjuvant chemoimmunotherapy significantly improved pCR when compared to neoadjuvant chemotherapy alone. In the subgroup analysis, neoadjuvant chemoimmunotherapy showed higher pCR rates in both Programmed death-ligand 1 (PD-L1)-positive and PD-L1-negative TNBC patients. An Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 correlated with increased pCRs (OR = 1.9, p < 0.001) in neoadjuvant chemoimmunotherapy vs. neoadjuvant chemotherapy, but no benefit was observed for patients with ECOG PS 1. Nodal positivity was significantly associated with pCR (OR = 2.52, p < 0.001), while neoadjuvant chemoimmunotherapy did not benefit patients with negative lymph nodes. Conclusions: Checkpoint inhibition and neoadjuvant chemotherapy significantly increased pCRs in TNBC patients, regardless of their PDL-1 status. Additional checkpoint inhibitors improved pCR rates, mainly for patients with ECOG PS 0 and lymph node-positive disease.

Clinico-Hematological Profile of Acute Myeloid Leukemia: Experience From a Tertiary Care Cancer Center in North India.

Complete diagnosis of acute myeloid leukemia (AML) requires knowledge of clinical information combined with morphologic evaluation, immunophenotyping, karyotyping, and molecular genetic testing. The study intends to evaluate the demographic profile, clinical workup, and investigation, including flow cytometric immunophenotyping, in adult and pediatric age groups of AML. This is a retrospective study of AML patients treated between January 2017 and December 2021. Clinical and demographic characteristicsand investigation findings were recorded from case files and the hematology database. A total of 896 cases of AML were registered during the given period, of which 819 cases were de-novo AML. Among those 819 cases, more than two-thirds of cases, i.e., 78.9% (N = 646), received induction chemotherapy. A significantly higher male-to-female ratio was observed (1.5:1). The median age was 22 years. The median time for diagnosis was three days and the median time for treatment intervention was four days. There were significant differences in the Eastern Cooperative Oncology Group (ECOG) performance status scores between pediatric and adult AML patients. Pediatric AML patients presented with better ECOG performance scores (ECOG performance scores 0 and 1) than adult patients (74.76% vs. 43.14%, p < 0.001). Further comparing adult vs. pediatric AML patients, normal karyotype (60.56% vs. 31.93%, p < 0.001) and NPM1 (22.25% vs. 6.72%, p < 0.001)and FLT3-ITD mutations (20.28% vs. 7.98%, p<0.001) were more common in the adult group, whereas AML-ETO (40.76% vs. 16.34%, p < 0.001) was more common in the pediatric group. The study highlights the presenting age is lower than global figures. The median time for initial diagnosis and the start of treatment is within the acceptable norms. Normal karyotype andNPM1and FLT3 mutations were common in adult AML patients, whereas AML-ETO was more common in the pediatric cohort. These findings will help plan prospective studies and see the correlation with treatment outcomes. The laboratory workup practice currently complies with the standard guidelines at our center.

Clinical and radiological outcomes of n-HA/PA66 cages in anterior spine reconstruction following total en bloc spondylectomy for tumors.

This retrospective monocentric study was conducted to evaluate the clinical and radiological outcomes of the nano-hydroxyapatite/polyamide66 (n-HA/PA66) cage in reconstructing the anterior column of the spine following total en bloc spondylectomy (TES). A cohort of 24 patients, 20 diagnosed with primary malignant tumors and 4 with metastatic malignancies, was selected based on specific inclusion criteria. All were subjected to TES and anterior column reconstruction with the n-HA/PA66 cage from January 2013 to July 2023 at a single institution. Pre-operative embolization was performed on all patients. Documented factors included operation duration, intraoperative blood loss, length of hospital stay, treatment history, and involved level. Mechanical complications and radiological parameters such as the local kyphotic angle (LKA), anterior vertebral height (AVH), posterior vertebral height (PVH), cage subsidence, and bone fusion time were evaluated. Quality of life and neurological function were gauged using tools like the Visual Analog Scale (VAS), Eastern Cooperative Oncology Group (ECOG) performance score, Karnofsky Performance Score (KPS) scale, and American Spinal Injury Association (ASIA) grading. All patients were followed up for 12-127 months, with an average period of 39.71 months. An average operation time of approximately 8.57 h and a blood loss volume of about 1,384 ml were recorded. No instances of tumor recurrence or multiple organ metastases were reported, though recurrence was detected in 2 living patients. Solid fusion was achieved in all patients at a mean time of 6.76 ± 0.69 months. Cage breakage or migration was not observed. Subsidence into the adjacent vertebral bodies was identified in 3 patients but was deemed clinically irrelevant. Significant improvements in VAS, ECOG performance score, KPS scale, and ASIA scores were noted from pre- to post-surgery (P < 0.05). A marked enhancement in the AVH was observed from before surgery to immediately after (P < 0.05). LKA, AVH, and PVH values between postoperative and final follow-up showed no significant variance (P > 0.05). The integration of TES and the n-HA/PA66 cage was found to yield promising clinical and radiological outcomes in anterior column spine reconstruction. The use of this material did not hinder oncological care, including the provision of adjuvant treatments (chemo/radiotherapy), ultimately contributing to the enhanced long-term quality of life for spinal tumor patients.

Transcatheter arterial chemoembolisation combined with lenvatinib plus camrelizumab as conversion therapy for unresectable hepatocellular carcinoma: a single-arm, multicentre, prospective study

The synergistic effect of locoregional therapy in combination with systemic therapy as a conversion therapy for unresectable hepatocellular carcinoma (uHCC) is unclear. The purpose of this study was to evaluate the efficacy and safety of transcatheter arterial chemoembolisation (TACE) combined with lenvatinib and camrelizumab (TACE+LEN+CAM) as conversion therapy for uHCC. This single-arm, multicentre, prospective study was conducted at nine hospitals in China. Patients (aged 18-75 years) diagnosed with uHCC, an Eastern Cooperative Oncology Group performance score (ECOG-PS) of 0-1 and Child-Pugh class A received camrelizumab (200mg, every 3 weeks) and lenvatinib (bodyweight ≥60kg: 12mg/day; <60kg: 8mg/day) after TACE treatment. Surgery was performed after tumour was assessed as meeting the criteria for resection. Patients who did not meet the criteria for surgery continued to receive triple therapy until disease progression or intolerable toxicity. Primary endpoints were objective response rate (ORR) according to the modified Response Evaluation Criteria in Solid Tumours (mRECIST) and safety. Secondary endpoints included the surgical conversion rate, radical (R0) resection rate, and disease control rate (DCR). This study was registered with Chinese Clinical Trial Registry (ChiCTR2100050410). Between Oct 25, 2021, and July 20, 2022, 55 patients were enrolled. As of the data cutoff on June 1, 2023, the median follow-up was 13.3 months (IQR 10.6-15.9 months). The best tumour response to triple therapy was complete response (CR) in 9 (16.4%) patients, partial response (PR) in 33 (60.0%) patients, stable disease (SD) in 5 (9.1%) patients, or progressive disease (PD) in 7 (12.7%) patients. The ORR was 76.4% (42/55, 95% CI, 65.2-87.6%), and the DCR was 85.5% (47/55, 95% CI, 76.2-94.8%) per mRECIST. Twenty-four (43.6%) of the 55 patients suffered from grade 3-4 treatment-related adverse events (TRAEs). No grade 5 TRAEs occurred. A total of 30 (30/55, 54.5%) patients were converted to resectable HCC and 29 (29/55, 52.7%) patients underwent resection. The R0 resection rate was 96.6% (28/29). The major pathologic response (MPR) and pathologic complete response (pCR) rates in the surgery population were 65.5% (19/29) and 20.7% (6/29), respectively. Only one patient developed a Clavien-Dindo IIIa complication (abdominal infection). No Clavien-Dindo IIIb-V complications occurred. The median OS and median PFS were not reached. The triple therapy (TACE+LEN+CAM) is promising active for uHCC with a manageable safety. Moreover, triple therapy has good conversion efficiency and the surgery after conversion therapy is feasible and safe. To elucidate whether patients with uHCC accepting surgical treatment after the triple therapy can achieve better survival benefits than those who receive triple therapy only, well-designed randomised controlled trials are needed. This study was funded by the Natural Science Foundation of Fujian Province, China (2022J01691) and the Youth Foundation of Fujian Province Health Science and Technology Project, China (2022QNA035).

Surgical Strategy for Recurrent Giant Cell Tumor in the Thoracolumbar Spine.

Recurrent giant cell tumor (RGCT) of the spine represents a clinical challenge for surgeons, and the treatment strategy remains controversial. This study aims to describe the long-term follow-up outcomes and compare the efficacy of en bloc spondylectomy versus piecemeal spondylectomy in treating RGCT of the thoracolumbar spine. A total of 32 patients with RGCT of the thoracolumbar spine treated from June 2012 to June 2019 were retrospectively reviewed. A total of 15 patients received total en bloc spondylectomy (TES) with wide or marginal margin while 17 patients received total piecemeal spondylectomy (TPS) with intralesional margin. Postoperative Eastern Cooperative Oncology Group Performance Score (ECOG-PS), Frankel classification and recurrence-free survival (RFS) were evaluated after surgery. Survival curves were estimated by the Kaplan-Meier method and differences were analyzed with the log-rank test. Multivariate analysis was performed with Cox regression to identify the independent prognostic factors affecting RFS. During a median follow-up of 41.9 ± 17.5 months, all patients with compromised neurologic functions exhibit significant improvement, with the mean ECOG-PS decreasing from 1.5 ± 1.3 to 0.13 ± 0.3 (p < 0.05). Among the 17 patients treated with TPS, eight patients developed local recurrence after a median time of 15.9 ± 6.4 months and four patients died from progressive disease. On the other hand, local recurrence were well managed with TES, since only one out of 15 patients experienced local relapse and all patients are alive with satisfied function at the latest follow-up. The median RFS for patients receiving TES and TPS are 75.0 months (95% CI: 67.5-82.5 m) and 38.3 months (95% CI: 27.3-49.3 m) respectively (p = 0.008). Multivariate analysis shows that the Ki67 index (p = 0.016), resection mode (p = 0.022), and denosumab (p = 0.039) are independent risk factors affecting RFS. TES with wide/marginal margin should be offered to patients with RGCT whenever feasible, given its long-term benefits in local control and symptom alleviation. Additionally, patients with lower Ki67 index and application of denosumab tend to have a better prognosis.

Outcomes of Chimeric Antigen Receptor (CAR) T-Cell Therapy in Patients with Large B-Cell Lymphoma (LBCL): A Single-Institution Experience.

Chimeric antigen receptor T-cell (CAR T-cell) therapy has revolutionized the treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We describe the real-world baseline characteristics, efficacy, safety, and post-relapse outcomes of adult patients with R/R LBCL who received CAR T-cell therapy at the University of California San Diego. A total of 66 patients with LBCL were treated with tisagenlecleucel or axicabtagene ciloleucel. The median age was 59.5, and 21% were over 70 years old. Additionally, 20% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance score of ≥2. Cytokine release syndrome incidence was 88%; immune effector cell-associated neurotoxicity syndrome incidence was 56%. All-grade infection occurred in 48% of patients and in 79% of patients > 70 years old. Complete response (CR) was achieved in 53% and partial response in 14%. Median progression-free survival (PFS) was 10.3 months; median overall survival (OS) was 28.4 months. Patients who relapsed post-CAR T-cell therapy had poor outcomes, with a median OS2 of 4.8 months. Upon multivariate analysis, both ECOG (HR 2.65, 95% CI: 1.30-5.41; p = 0.007) and ≥2 sites of extranodal involvement (HR 2.22, 95% CI: 1.15-4.31; p = 0.018) were significant predictors of PFS. Twenty-six patients were R/R to CAR T-cell therapy; six patients were in remission at the time of data cut off, one of whom received allogeneic transplant. Overall, older patients can safely undergo CAR T-cell therapy, despite the increased risk of all-grade infection. In our cohort, ECOG performance score and ≥2 sites of extranodal disease are significant predictors of PFS.

Brain Metastases, Large Cell Neuroendocrine Carcinomas and Prognosis

Objective: Pulmonary large cell neuroendocrine carcinomas (LNECs) are not common but brain metastases are common in LNEC patients. Because of their rarity, there are no randomized controlled trials on optimal treatment. Generally available data are based on case reports and retrospective studies. For this reason, we retrospectively analyzed patients with LNEC that we followed up for brain metastases to contribute to the literature.&#x0D; Methods: Between 2009 and 2020, 38 patients with brain metastases diagnosed with LNEC in our center were reviewed retrospectively.&#x0D; Results: 38 patients were evaluated. The mean survival time was 5.17 months (95% confidence interval (CI) : 3.17-7.13). In multivariate analysis showed us that; shorter overal survival is associated with age (p=0.001), uncontrol of primary cancer (p=0.014), presence of metachronous metastases (p=0.003), poor Eastern Cooperative Oncology Group (ECOG) performance score (p=0.025), and high uric acid level (p=0.001) and high lactate dehydrogenase (LDH) levels (p=0.009).&#x0D; Conclusion: LNECs are rare but aggressive cancers. LNECs often metastasize to the brain. According to our study, high LDH, high uric acid, poor ECOG performance score, ≥65 years, metachronous metastasis, uncontrolled primary tumor are associated poor prognosis. LDH, uric acid, age, presence of metachron metastasis, controbility of primary tumor can be used as easy and inexpensive biomarkers to determine the prognosis and in the follow-up and treatment of patients with LNECs with brain metastases as metastases seen of other cancers.

Abstract OT3-21-01: A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system

Abstract Introduction- Robotic mastectomy is a novel breast surgery approach accessed from a concealable anterior axillary incision showing better cosmetic outcomes with a scarless front view. The oncological safety awaits further follow-up from clinical trials or registered studies to mature. Compared to older da Vinci systems with multiple arms, the new SP system is single-armed, equipped with flexible instruments and a camera that may avoid instrument collision and dead spots in the surgical field. This trial (NCT05448963) is not only the leading SP mastectomy trial in Asia but also the first one that incorporates autologous flap reconstruction. Methods- -Objectives: To determine the performance, technical algorithm, safety data, and patient-reported outcomes in single-port-accessed nipple-sparing mastectomy using da Vinci SP® system. -Study design: This study is a pilot clinical study conducted in a single-arm, non-randomized design with a goal to recruit 30 participants. The da Vinci SP ® surgical robot is applied in the nipple-sparing mastectomy and axillary lymph node dissection (if indicated) of each enrolled patient in Chang Gung Memorial Hospital Linkou Medical Center. The post-mastectomy reconstructive method may use autologous flaps or implants depending on the type of build, technical feasibility, and flap site availability of the patient. The eligibility criteria include: I. Meet at least one of the following indications of NSM for breast cancer: 1. Preoperative clinical tumor sizes less than 5 cm, with an adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image 2. Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meeting criteria 1. 3. Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with a breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure II. Age equal to or above 20 years III. ECOG (Eastern Cooperative Oncology Group) performance score 0-1 IV. ASA anesthesia risk class 1~2, and with adequate organ functions Endpoint measures: -Primary endpoint: Ability to complete nipple-sparing mastectomy with da Vinci SP system in the per-protocol population. -Secondary endpoints: Safety measured by adverse events through 30-day post-operative follow up -Exploratory endpoints: Surgical time, blood loss, hospital stay, breast specimen weight, cancer resection margin, nipple-preservation rate morbidity and mortality rate within 30 days of operation, and reoperation within 30 days post-surgery -Statistical analysis: Point estimation with a 95% confidence interval will be used to analyze the mean or proportion of key performance parameters. No interim analysis will be performed due to the limited number intended to recruit. -Trial status: Active recruitment Conclusion: The single-port robotic system features single port access with multi-jointed instruments which is particularly designed for narrow surgical spaces such as mastectomy. The feasibility of applying da Vinci SP systems to robotic nipple-sparing mastectomy and robiotic axillary lymph node dissection will be demonstrated in this study. Citation Format: Wen-Ling Kuo, Chia-Huei Chu, Jung-ju Huang. A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-21-01.

Relationship between brain metastasis and thyroid transcription factor 1

Brain metastases (BMs) are common in lung adenocarcinomas (ACs). Thyroid transcription factor 1 (TTF-1) is important in the diagnosis of AC. This study aimed to examine the relationship between TTF-1 and BM for the first time in literature. The data of 137 patients with AC that developed BM between 2009 and 2020 were retrospectively analyzed. A total of 137 patients, 120 (87.6%) male, and 17 (12.4%) female were examined. Their mean age was 59.78 ± 0.82 years. The Eastern Cooperative Oncology Group (ECOG) performance score was 0–1 (< 2) for 39 (28.5%) patients and 2–4 (≤ 2) for 98 (71.5%). TTF-1 was positive in 100 (73%) patients and negative in 37 (27%). More than five BMs were present in 102 (74.4%) patients and less than five in 35 (25.6%). All the patients received whole-brain radiotherapy. None of the patients was suitable for surgery or radiosurgery. The median survival time was 6.4 [95% confidence interval (CI), 5.67–7.1] months. The survival time was 7 (95% CI, 5.91–8.09) months for the TTF-1 (+) patients and 5.8 (95% CI, 4.1–7.5) months for the TTF-1 (−) patients. In the univariate analysis, there was a significant relationship between survival time and age (p = 0.047), TTF-1 (p = 0.024), and ECOG performance score (p = 0.002). The multivariance analysis revealed a significant relationship between survival and TTF-1 (p = 0.034) and ECOG score (p = 0.007). We found a correlation between survival time and ECOG performance score and TTF-1. TTF-1 can be used as a biomarker to monitor prognosis in the follow-up and treatment of patients with AC that develop BM.

Improvement of sleep quality in isolated metastatic patients with spinal cord compression after surgery

BackgroundThis study aimed to assess changes in quality of sleep (QoS) in isolated metastatic patients with spinal cord compression following two different surgical treatments and identify potential contributing factors associated with QoS improvement.MethodsWe reviewed 49 patients with isolated spinal metastasis at our spinal tumor center between December 2017 and May 2021. Total en bloc spondylectomy (TES) and palliative surgery with postoperative stereotactic radiosurgery (PSRS) were performed on 26 and 23 patients, respectively. We employed univariate and multivariate analyses to identify the potential prognostic factors affecting QoS.ResultsThe total Pittsburgh Sleep Quality Index (PSQI) score improved significantly 6 months after surgery. Univariate analysis indicated that age, pain worsening at night, decrease in visual analog scale (VAS), increase in Eastern Cooperative Oncology Group performance score (ECOG-PS), artificial implant in focus, and decrease in epidural spinal cord compression (ESCC) scale values were potential contributing factors for QoS. Multivariate analysis indicated that the ESCC scale score decreased as an independent prognostic factor.ConclusionsPatients with spinal cord compression caused by the metastatic disease had significantly improved QoS after TES and PSRS treatment. Moreover, a decrease in ESCC scale value of > 1 was identified as a favorable contributing factor associated with PSQI improvement. In addition, TES and PSRS can prevent recurrence by achieving efficient local tumor control to improve indirect sleep. Accordingly, timely and effective surgical decompression and recurrence control are critical for improving sleep quality.

LKB1 Loss Assessed by Immunohistochemistry as a Prognostic Marker to First-Line Therapy in Advanced Non-Small-Cell Lung Cancer.

(1) Background: Liver kinase B1 (LKB1) is a tumor suppressor gene involved in cell growth and metabolism. However, its alterations are not routinely assessed for guiding therapy in clinical practice. We assessed LKB1 expression by immunohistochemistry as a potential biomarker. (2) Methods: This bicentric retrospective cohort study analyzed data from patients with advanced NSCLC who initiated platinum-based chemotherapy or epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) between January 2016 and December 2020. Kaplan-Meier and Cox regression models were used for survival curves and multivariate analysis. (3) Results: 110 patients were evaluated, and the clinical stage IV predominated the lung adenocarcinoma histology. LKB1 loss was observed in 66.3% of cases. LKB1 loss was associated with non-smokers, the absence of wood smoke exposure and an EGFR wild-type status. The median progression-free survival (PFS) and overall survival (OS) in the population were 11.1 and 26.8 months, respectively, in the loss group, compared with cases exhibiting a positive expression. After an adjustment by age, smoking status, Eastern Cooperative Oncology Group Performance Score (ECOG-PS), EGFR status and type of administered therapy, LKB1 loss was significantly associated with worse PFS and OS. (4) Conclusion: Patients with an LKB1 loss had worse clinical outcomes. This study warrants prospective assessments to confirm the prognostic role of the LKB1 expression in advanced NSCLC.

Treatment Response and Impact Factor of Venetoclax Based Regimens in the Frontline Treatment of Newly Diagnosed Unfit Acute Myeloid Leukemia in the Real World of China

Purpose: Aim to assess the efficacy and safety of venetoclax (VEN) based regimens in the frontline treatment of newly diagnosed (ND) unfit acute myeloid leukemia (AML), and then explore the impact factors of the efficacy in the real world of China. Method: All patients with ND-unfit-AML being frontline treated with VEN-based regimens from July 2019 to February 2022 in Nanfang Hospital were included and analyzed their treatment response, safety and the impact factors of efficacy. Results: Totally 73 patients with a median age of 64(13-84) years old (54(74.0%) patients with Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0-2 and 19(26.0%) with ECOG PS of 3-4) were frontline treated with a median of 2(1-8) cycles of VEN-based therapy, including 68(93.2%) with VEN+azacytidine and 5(6.8%) with VEN+decitabine. 32(43.8%) patients terminated VEN-based therapy, including 26(35.6%) cases were adjusted their treatment strategy, and 20(27.4%) patients were bridged to allogeneic hematopoietic stem cell transplantation (allo-HSCT). With a median follow-up of 8.0(1.0-31.0) months, a total of 56(76.7%) patients acquired treatment response, including 48(65.8%) with complete remission (CR)/CR with incomplete count recovery (CRi) and 30/71(42.3%) with measurable residual disease (MRD) negative. The median time of acquiring CR/CRi was 1(1-5) cycle of therapy. The rate of CR/CRi and MRD negative were increasing with rising cycles of therapy. Patients with low risk (vs intermediate risk and high risk) according to European Leukemia Net stratification, mutation of IDH1/2, NPM1 and FLT3-ITD/TKD, and 28 days of VEN (vs 14-21 days) had better response to VEN-based therapy. There were not significantly different in the rate CR/CRi and MRD negative between the patients with de novo versus secondary/treatment-related AML, the dose of VEN with 400mg/d versus 100-200mg/d (co-administered with posaconazoleorvoriconazole). The median overall survival (mOS) was 20.3±1.8 months. The rate of one year OS was 62.5%±7.5%. The patients with acquiring CR/CRi (P<0.001) or MRD negative (P=0.001 had significantly better mOS than those without. The patients with treatment strategy adjustment had much longer mOS (P=0.011) and lower rate of relapse (p=0,020) than those with continuous VEN-based therapy, especially remarkably in the patients with the age <60 years old or high risk. Bridging to allo-HSCT further improved mOS versus those without (P=0.010). The safety of VEN-based therapy was well tolerated and the incidence of ≥3 grade adverse events was low. Conclusion: VEN-based therapy as the frontline treatment of ND-unfit-AML in the real world was effective and safe. Molecular abnormalities, treatment strategy and whether standardized use of VEN or not could significantly impact the efficacy of VEN-based therapy. Key words: Venetoclax, unfit, acute myeloid leukemia, efficacy, safety

Clinicopathological characteristics and management of patients with early readmission to our surgical oncology clinic

Objectives: This study aimed to discuss the frequency of early readmission to the hospital after discharge in our oncology clinic, clinicopathological features, and management of these patients in light of current literature. Methods: The medical records of 237 early readmitted patients within 30 days of discharge in our clinic were retrospectively reviewed. The patients were categorized according to their first diagnosis, Eastern Cooperative Oncology Group (ECOG) performance status, demographic, clinicopathological characteristics, readmission reasons, first treatment type, postoperative complications, the time of application after discharge and the type of treatment after admission.Results: The mean age of the patients was 58.45 years, 57.4% were female, and the mean readmission time after discharge was 11.54 days. The most common primary diagnosis was gastric cancer (35.9%), and the most common emergency pathology requiring hospitalization was ileus-subileus (45.1%). After readmission, 42.6% of the patients received medical treatment. 60% of the readmitted patients had postoperative complications before discharge. Patients who had postoperative complications during the first hospitalization were more likely to have major or minor interventions after readmission (p &amp;lt; 0.01). Admission with a diagnosis of bowel obstruction was associated with the probability of major intervention (p &amp;lt; 0.01). Patients with an ECOG performance score of ≥2 was more frequently administered medical treatment (p = 0.001). Patients admitted with the diagnosis of anastomotic leak/abscess had a higher probability of having postoperative complications (p = 0.001). Conclusions: Readmissions are a concern for all healthcare providers, including comprehensive cancer centers. Recent health policies strive to reduce preventable admissions. Hence, we believe focusing on postoperative complications, and palliative care services is necessary.

Effects of neuromuscular electrical stimulation combined with resistance exercises on muscle strength in adult hematological cancer patients: A randomized controlled study

ObjectiveWe compared the effects of resistance exercise (REx) and resistance exercise combined with neuromuscular electrical stimulation (NMES+REx) on muscle strength, functional lower extremity strength, and mobility in hematological cancer patients during chemotherapy. MethodsForty-three adult patients were recruited and randomized into the REx group versus personalized and progressive NMES+REx. The lower extremity muscle strength (digital hand dynamometer) test and functional and mobility tests [30-s sit-to-stand test, Timed Up and Go test (TUG)] were performed pre-and postintervention. ResultsThe Eastern Cooperative Oncology Group-Performance Score (ECOG-PS) of 90% of all patients was ≥2. Increases in steroid dose after transplantation were associated with decreases in hip flexion and knee extension muscle strength values (respectively; rs:-0.468, p:0.008; rs:-0.527, p: 0.002). There was a significant improvement in strength measurement, functional and mobility tests, and ECOG-PS in both groups (p<0.05). The NMES+REx group had significantly higher hip flexion and knee extension values than the REx group (respectively; p=0.001; p=0.048). ConclusionREx training given to hematological cancer patients receiving intensive chemotherapy after hematopoietic stem cell transplantation improved muscle weakness. The combination of NMES training with resistance exercises resulted in significant results comparable to REx training alone in adult hematological patients with moderate-low ECOG-PS.

A prospective phase II study of biweekly S-1, leucovorin, and gemcitabine in elderly patients with locally advanced or metastatic pancreatic adenocarcinoma – The Taiwan Cooperative Oncology Group T1217 study

BackgroundElderly patients with advanced pancreatic adenocarcinoma (APC) are conceived to be frailer and susceptible to treatment toxicity that has led to disparity in lower likelihood of receiving chemotherapy and survival. Optimal chemotherapy is an unmet medical need for elderly patients with APC. Patients and methodsPatients with chemo-naive APC, age ≥70 years, and Eastern Cooperative Oncology Group (ECOG) performance score ≤2 were eligible. The treatment was consisted of biweekly gemcitabine 800 mg/m2, 10 mg/m2/min infusion on day 1 plus oral S-1 and leucovorin (40–60 and 30 mg, respectively) twice daily on days 1–7, the GSL regimen. The primary end-point was progression-free survival with an interested P1 of 5.0 months. ResultsOf the 49 enrolled patients, the median age was 76 years, ECOG performance score ≥1 in 59.2%, metastatic diseases in 65.3%, Vulnerable Elders Survey-13 score ≥3 in 71.4%, and Geriatric 8 score ≤14 in 93.9%. After a median 11 cycles of treatment, the overall response rate and disease control rate were 26.5% and 75.5%, respectively. The median progression-free and overall survivals were 6.6 months (95% confidence interval [CI], 5.4–9.2) and 12.5 months (95% CI, 8.9–14.7), respectively. The most common grade 3–4 treatment-related toxicities were anaemia (20.4%), neutropenia (18.4%), and mucositis (12.2%). Patients had improved emotional function and global health status scores during the GSL treatment. ConclusionThe study met its primary end-point, which supports further investigation on the merit of GSL in Asian elderly APC patients.

Real-world efficacy of ribociclib (RIB) plus aromatase inhibitor (AI)/fulvestrant (FUL), or endocrine monotherapy (ET), or chemotherapy (CT) as first-line (1L) treatment (tx) in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC): Results of fourth interim analysis (IA) from RIBANNA.

1065 Background: RIBANNA is a real-world, noninterventional study conducted in Germany evaluating efficacy, safety, and tolerability of RIB in combination with AI/FUL aiming to gain insights into routine clinical practice for pts with HR+, HER2– ABC. Here, we present results of the fourth IA from RIBANNA. Methods: Pre-, peri- and postmenopausal pts who received 1L tx with RIB+AI/FUL, or ET or CT for HR+, HER2– ABC were included in accordance with the German tx guideline. The effect of baseline demographic characteristics, including histological grade, age, previous adjuvant tx, Eastern Cooperative Oncology Group-performance score (ECOG-PS), and metastatic sites on progression-free survival was evaluated using Cox regression model. Results: At data cutoff October 11, 2021, 2598 pts were enrolled in the study (RIB+AI/FUL, n = 2177; ET, n = 239; CT, n = 182). Data from 1L tx were available for 2492 pts (95.9%), second-line tx for 689 pts (26.5%), third-line tx for 263 pts (10.1%), and fourth-line tx for 94 pts (3.6%). Significant differences were observed in baseline mean age and metastatic sites for pts in RIB+AI/FUL cohort vs ET and CT cohorts (both &lt; 0.001). At baseline, the mean (SD) ages of pts were 65.5 (11.6), 70.7 (11.5) and 61.6 (11.6) years in RIB+AI/FUL, ET, and CT cohorts, respectively. While comparing the performance status, 44.2% of pts in RIB+AI/FUL, 34.7% of pts in ET and 42.1% of pts in CT cohort were fully active with ECOG-PS = 0. CNS, liver, or lung metastases were recorded in 42.6% of pts in RIB+AI/FUL, 26.8% of pts in ET and 67.1% of pts in CT cohort. Bone only metastases were reported in 30.8%, 47.9% and 15.0% of pts in RIB+AI/FUL, ET, and CT cohorts, respectively. Overall, 32.1%, 37.7%, and 52.7% of pts discontinued the study in RIB+AI/FUL, ET, and CT cohorts, respectively, the most common reasons being deaths (16.1%,17.2%, and 31.9%, respectively) and lost to follow-up (5.9%, 8.8%, and 9.3%, respectively). The most common tx-emergent adverse event (grade 3 or 4) observed in RIB+AI/FUL cohort was neutropenia (14.8%), while 6.6% and 6.9% of pts in ET and CT cohorts, respectively, experienced neutropenia. The efficacy results from all 3 cohorts, including Kaplan-Meier curves, will be presented during ASCO 2022. Conclusions: RIBANNA study showed diverse population characteristics among pts who received RIB tx in a real-world setting. Overall higher number of pts were treated in 1L with RIB+AI/FUL followed by ET and CT. The differences in baseline characteristics on metastatic pattern, age, and ECOG-PS reflect different selection strategies for 1L tx decision. No new safety signals were identified. Clinical trial information: CLEE011ADE03.

Predictors of Hepatic Decompensation after TACE for Hepatocellular Carcinoma Secondary to Chronic Hepatitis C

Objectives: The aim of this study is to evaluate the risk factors which lead to post-trans arterial chemoembolization (TACE) hepatic decompensation. Methods: This was a prospective study took place between December 2021 and August 2022 at PEMH, Rawalpindi. After informed consent, 122 patients suffering from hepatocellular carcinoma secondary to chronic hepatitis C were included who were eligible for TACE as per Barcelona Liver Cancer Algorithm. The baseline variables and post-treatment 30-day variables were noted. Decompensation was assessed using the Child Pugh Score and the ECOG performance score. Baseline variables and demographic variables were compared in patients who developed and did not develop hepatic decompensation. Results: Among the total 122 patients in the study, 95 were males and 64 were older than the age of 50 years. Hepatic decompensation was reported in 54.1% of the total participants. Analysis showed significant association of hepatic decompensation with pre-TACE bilirubin levels, age >50, and pre-TACE alpha-fetoprotein levels. A patient with alphafetoprotein (AFP) levels >3200 ng/mL is 2.043 times likely and a patient with age >50 is 4.173 times more likely to have hepatic decompensation after TACE. After TACE, there is increased incidence of ascites and encephalopathy. Conclusion: Hepatic decompensation is commonly encountered in patient’s post-TACE. The predictive factors are age >50, raised bilirubin levels and AFP. >3200 ng/dL. Keywords: Child-pugh score, Hepatic decompensation, Trans-Arterial Chemoembolization (TACE), Hepatocellular Carcinoma (HCC), ECOG (Eastern Cooperative Oncology Group)

The effect of preoperative prognostic nutritional index on outcome in glioblastoma multiforme patients

Background/Aim: Glioblastoma multiforme (GBM) is the most common primary malignant brain tumor subtype with a poor prognosis despite various treatments. Some prognostic markers on survival (such as age, Eastern Cooperative Oncology Group Performance Score (ECOG-PS), isocitrated hydrogenase (IDH) status, alpha thalassemia/mental retardation syndrome X-linked (ATRX) mutation status, possibility of extensive surgery) have been defined. Prognostic Nutritional Index (PNI) has been evaluated in various cancers (such as lung, esophagus, and pancreas), and patients with a low PNI score have been associated with a poor prognosis for overall survival (OS). Our study aimed to examine the effectiveness of molecular and demographic characteristics and preoperative PNI score that may affect OS in GBM patients. Methods: In this retrospective cohort study, GBM diagnosed patients who were 18 years old or older, were included in the study. We measured their pretreatment PNI score and performed multivariate Cox regression analyses of OS in GBM patients. Results: A total of 107 patients were included in the study. Median age was 58 (range, 32-83) years. 72 patients (67.3%) were male and 35 patients (32.7%) were female. The mean preoperative PNI level was calculated as 50.5. The median overall-survival (mOS) was 19.7 months and the median time to progression (mTTP) was 8.1 months. There was no statistically significant result on overall survival in the univariate analysis of patients with PNI>50.5 (P=0.121). In multivariate analysis, being 70 years or older (P=0.012), IDH-1 wild and ATRX mutant patients (P=0.016), IDH-1 mutant and ATRX wild patients (P=0.037), and TTP 12 months and older (P<0.001) were considered as independent risk factors on overall survival. Conclusions: In our study, the effect of preoperative PNI score on survival could not be demonstrated. Further studies are needed to elucidate the potential impact of PNI on outcomes in patients with GBM.

Impact of FLT3 Mutation Clearance after Front-Line Treatment with Gilteritinib Plus Azacitidine, or Gilteritinib or Azacitidine Alone in Patients with Newly Diagnosed AML: Results from the Phase 2/3 Lacewing Trial

Impact of FLT3 Mutation Clearance after Front-Line Treatment with Gilteritinib Plus Azacitidine, or Gilteritinib or Azacitidine Alone in Patients with Newly Diagnosed AML: Results from the Phase 2/3 Lacewing Trial