scholarly journals Chemotherapy in combination with pembrolizumab and antiangiogenesis in young patients with advanced primary pulmonary mucinous adenocarcinoma: Two case reports

2021 ◽  
Vol 104 (4) ◽  
pp. 003685042110619
Author(s):  
Daibing Zhou ◽  
Wumaier Gulinuer ◽  
Ning Zhu
Keyword(s):  
Mucinous Adenocarcinoma ◽  
Case Reports ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Young Patients ◽  
Growth Factor Receptor ◽  
Angiogenesis Inhibitors ◽  
Young Age ◽  
Ecog Performance Status ◽  
Anaplastic Lymphoma

Primary pulmonary mucinous adenocarcinoma is an unusual histological type of non-small cell lung cancer and has a rare prevalence at a young age. There is no standard first-line therapy for advanced primary pulmonary mucinous adenocarcinoma in children and young adults—this study reports two rare cases of primary pulmonary mucinous adenocarcinoma with wild-type anaplastic lymphoma kinase and epidermal growth factor receptor ( EGFR) genes. One is a 13-year-old boy ( Case#1 ), and another is a 27-year-old male ( Case#2). Both two cases were treated with antibiotics for suspected pulmonary infection. In our hospital, they were diagnosed with advanced primary pulmonary mucinous adenocarcinoma, the Eastern Cooperative Oncology Group (ECGO) performance status was three scores. We chose pembrolizumab and chemotherapy plus angiogenesis inhibitors for Case#1 and Case#2. The two patients' symptoms improved and presented with a partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria，the scores of ECOG performance status were two for Case#1 and one for Case#2. This study illustrates a promising outcome for advanced primary pulmonary mucinous adenocarcinoma with immunotherapy and chemotherapy plus angiogenesis inhibitors at a young age.

scholarly journals Palliative Performance Scale: Polish validation in hospice setting - a prospective observational study

2020 ◽  
Author(s):  
Tomasz Dzierżanowski ◽  
Tomasz Gradalski ◽  
Michael Kozlowski
Keyword(s):  
Palliative Care ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Karnofsky Performance Score ◽  
Care Providers ◽  
Free Standing ◽  
Ecog Performance Status ◽  
Rehabilitation Outcomes ◽  
Ecog Ps ◽  
Performance Scale

Abstract Background: Measuring functional status in palliative care may help clinicians to assess a patient’s prognosis, recommend adequate therapy, avoid futile or aggressive medical care, consider hospice referral, and evaluate provided rehabilitation outcomes. An optimized, widely used, and validated tool is preferable. The Palliative Performance Scale Version 2 (PPSv2) is currently one of the most commonly used performance scales in palliative settings. The aim of this study is the translation and validation process of a Polish translation of this tool (PPSv2-Polish). Methods: Two hundred patients consecutively admitted to a free-standing hospice were evaluated twice during 2 consecutive days for test-retest reliability. In the first evaluation, two different care providers independently evaluated the same patient to establish inter-rater reliability values. PPS-Polish was compared with the Karnofsky Performance Score (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG PS), and Barthel Activities of Daily Living (ADL) Index to determine its construct validity. Results: A high level of full agreement between test and retest was seen (63%), and a good intra-class correlation coefficient of 0.85 (P<0.0001) was achieved. Excellent agreement between raters was observed when using PPSv2-Polish (Cohen’s kappa 0.91; P<0.0001). Satisfactory correlations with the KPS and good correlations with ECOG PS and Barthel ADL were noticed. Persons who had shorter prognoses and were predominantly bedridden also had lower scores measured by the PPSv2-Polish, KPS and Barthel ADL. A strong correlation of 0.77 between PPSv2-Polish scores and survival time was noted (P<0.0001). Moderate survival correlations were seen between KPS, ECOG PS, and Barthel ADL of 0.41; -0.62; and 0.58, respectively (P<0.0001). Conclusion: PPSv2-Polish is a valid and reliable tool measuring performance status in a hospice population and can be used in daily clinical practice in palliative care and research.

Anlotinib plus sintilimab in patients with recurrent advanced endometrial cancer: A prospective open-label, single-arm, phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5583-5583
Author(s):  
Wei Wei ◽  
Xiaohua Ban ◽  
Fan Yang ◽  
Yongwen Huang ◽  
Jibin Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Endometrial Cancer ◽  
Growth Factor ◽  
Systemic Chemotherapy ◽  
Kinase Inhibitor ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Growth Factor Receptor

5583 Background: Endometrial cancer is one of the most common gynecologic malignancies in the world. however, the effects of systemic chemotherapy are limited. The combination of targeted therapy with immunotherapy is a new research field in the treatment of malignant tumors. Anlotinib is a novel tyrosine kinase inhibitor with highly selective inhibition effects on multi-targets, especially on vascular endothelial growth factor receptor, Platelet-derived growth factor receptor and Fibroblast growth factor receptor. Sintilimab is a highly selective, fully humanized, monoclonal antibody, which blocks the interaction between Programmed death 1 and its ligands. This research aimed to evaluate the efficacy and safety of the combination of anotinib and sintilimab in patients with recurrent advanced endometrial cancer. Methods: Patients who received at least one platinum-based systemic chemotherapy, had an Eastern Cooperative Oncology Group performance status of 0 or 1 were considered eligible for enrollment. Sintilimab was administered intravenously (200mg，q3w); anlotinib was taken orally (12mg qd, d1-14, 21 days per cycle). The treatment was continued until disease progression, death or intolerant toxicity. The primary endpoint was objective response rate (ORR) and the secondary endpoints included duration of response, disease control rate (DCR), progression-free survival (PFS), overall survival and safety. Results: From November 2019 to to September 2020, 23 patients with a median age of 56 years (range: 37-70), FIGO stage IA (21.7%), IB (8.7%), II (4.4%), IIIA (13.1%)，IIIC (30.4%), IVB (21.7%) were enrolled. Among these participants, 22 patients were evaluable. The therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progression disease was 13.6%, 63.7%, 13.6% and 9.1% respectively, yielding the ORR of 77.3% (95%CI: 58.3%-96.3%) and the DCR of 91.7% (95%CI: 79.8%-100%). ≥1 and ＜1 Combined Positive Score of PD-L1 expression were observed in 66.7% (14/21) and 33.3% (7/21) patients respectively, and the ORR was 92.9% (95%CI: 77.4%-100%) and 57.1% (95%CI: 18.4%-90.1%) in the two groups. The median time of the first response was 1.5 months (range, 0.7-12.8). The median PFS was not reached. Most of the occurring adverse events (AEs) were grade 1 or 2. Grade 3 AEs included ileus (4.3%), immune myocarditis (4.3%) immune peritonitis (4.3%), hand-foot syndrome (8.7%), neutropenia (4.3%), neutrophils decrease (4.3%), and hypertension (4.3%); Grade 4 AE was lymphocytosis (4.3%). Neither unexpected safety signals nor treatment-related death occurred. Conclusions: Anlotinib plus sintilimab showed a promising antitumor activity with a favorable toxicity profile for patients with recurrent advanced endometrial cancer. We will report more data in the future. Clinical trial information: NCT04157491.

Clinical evaluation of recombinant interferon alfa-2a (Roferon-A) in metastatic melanoma using two different schedules .

1987 ◽  
Vol 5 (8) ◽  
pp. 1240-1246 ◽  
Author(s):  
S S Legha ◽  
N E Papadopoulos ◽  
C Plager ◽  
S Ring ◽  
S P Chawla ◽  
...  
Keyword(s):  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Interferon Alfa ◽  
Fixed Dose ◽  
Ecog Performance Status ◽  
Recombinant Interferon ◽  
Level Of Activity ◽  
Daily Schedule ◽  
Major Toxicity

Based on the reports of activity of interferons against metastatic melanomas, we conducted a phase II study of recombinant interferon alfa-2a (Roferon-A, Hoffmann-La Roche, Nutley, NJ) in 66 patients with disseminated melanoma. All patients had excellent Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1), and no evidence of brain metastases. Thirty patients had previously received chemotherapy and the remainder were untreated. The first 35 patients were treated on a daily schedule starting with a Roferon-A dose of 3 X 10(6) U/d and escalating to a maximum of 36 X 10(6) U/d over a period of 12 days. Because of excessive toxicity, the second group of 31 patients were treated on a fixed dose of 18 X 10(6) U/d [corrected] three times weekly (TIW). Among the 62 evaluable patients, five achieved an objective response for a response rate of 8% (95% confidence limits, 3% to 18%). Four patients had minor regressions and eight patients had stability of disease. The responses were evenly distributed between the two dose schedules. The major toxicity of interferon consisted of a constitutional syndrome of anorexia, fever, weight loss, and fatigue, which required a dose reduction in 75% of the patients on the daily schedule. Our data revealed a modest level of activity, which was not influenced by prior treatment or by the dose or schedule of interferon. Because of substantial toxicity with the daily schedule, we recommend a dose of 18 X 10(6) U/d [corrected] if interferon is used in the treatment of patients with melanoma.

Effect of Age on Heart Rate Variability Analysis in Breast Cancer Patients

2020 ◽  
pp. 141-167
Author(s):  
Reema Shyamsunder Shukla ◽  
Yogender Aggarwal ◽  
Rakesh Kumar Sinha ◽  
Shreeniwas S. Raut
Keyword(s):  
Breast Cancer ◽  
Standard Deviation ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Age Groups ◽  
Heart Rate Variability Analysis ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Poincaré Plot ◽  
Index Ratio

Breast Cancer (BC) is the leading cause of death in women, worldwide. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of BC can be studied using HRV measures. The main purpose of this chapter is to give an insight to clinicians via HRV measures with respect to age to make them understand the PS of patients. Data from 114 BC patients was segregated into two age groups, G1 (20 to 40 years) and G2 (41 to 75 years). The 5-minute electrocardiogram of the subjects was taken and HRV measures were extracted. One-way ANOVA with Posthoc Tukeys' HSD test was done. Triangular Index, Ratio of standard deviation of poincare plot perpendicular to the line of identity to the standard deviation along line of identity, Detrended Fluctuation Analysis descriptors, Approximate Entropy, Sample Entropy and Correlation Dimension significantly decreased from ECOG0 to 4 and from G1 to G2. The sympathetic activity increased with vagal withdrawal as age advanced.

scholarly journals Toxicity management of regorafenib in patients with gastro-intestinal stromal tumour (GIST) in a tertiary cancer centre

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Florence Chamberlain ◽  
Sheima Farag ◽  
Constance Williams-Sharkey ◽  
Cecilia Collingwood ◽  
Lucia Chen ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Individual Risk ◽  
Duration Of Treatment ◽  
Ecog Performance Status ◽  
Third Line ◽  
Grade 3 ◽  
Dose Reductions

Abstract Background Regorafenib is a multi-kinase inhibitor approved as third line treatment for metastatic GIST. Dose limiting toxicities are frequently seen and many patients require dose reductions. This study aimed to evaluate regorafenib toxicities and their management in a real-world GIST population. Methods Retrospective review of a prospectively maintained database identified 50 patients with GIST treated with regorafenib at our centre between March 2013 and September 2018. Results Median progression free survival (PFS) was 7.7 months [interquartile range (IQR) 2.8–14.4 months]. Median overall survival (OS) from start of regorafenib to death or last follow up was 15.7 months (IQR 9.2–28.4 months). Baseline median Eastern Cooperative Oncology Group (ECOG) performance status on starting regorafenib was 1. The main reason for discontinuing regorafenib was progressive disease (PD) (31/50 [62%]) rather than toxicity (10/50 [20%]). Grade 3–4 adverse events (AEs) were seen in 23/50 (46%) patients; palmar-plantar erythrodysesthesia (PPE) was most frequently seen (9/50 (18%)). Two patients died whilst on treatment with regorafenib from multi-organ failure secondary to sepsis (4%). Dose reductions were required in 19/50 patients (38%) and 8/50 (16%) patients started regorafenib at a lower dose band than the recommended dose (160 mg) due to comorbidities or concern over a higher individual risk of toxicity. Conclusion Although PD was the main reason for discontinuing treatment, toxicity management and dosing of regorafenib remains critical. Median duration of treatment was longer compared to previous studies suggesting a durable clinical benefit with regorafenib with rigorous toxicity management.

Safe use of Peripherally Inserted Central Catheters for chemotherapy of solid malignancies in adult patients: A 1-year monocentric, prospectively-assessed, unselected cohort of 482 patients

2020 ◽  
pp. 112972982096290
Author(s):  
Alessio Piredda ◽  
Davide Radice ◽  
Claudia Zencovich ◽  
Martina Cerri ◽  
Lucia Aventino ◽  
...  
Keyword(s):  
Hematological Malignancies ◽  
Blood Stream Infection ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Adult Patients ◽  
Time Interval ◽  
Ecog Performance Status ◽  
Peripherally Inserted Central Catheters ◽  
Central Catheters ◽  
Unselected Cohort

Introduction: Aim of this study was to analyze the overall complication and failure rates of Peripherally Inserted Central Catheters (PICCs), in a 1-year consecutive unselected cohort of 482 adult patients, affected by non-hematological malignancies undergoing chemotherapy. Methods: Adult outpatients (aged 18–75 years), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, bearing solid tumors and candidates for intravenous chemotherapy were eligible for the study. Exclusion criteria were active infections, coagulopathy (defined as platelet count <50,000/μL and/or prothrombin time more than 18 s), life expectancy <6 months, or inability to give written informed consent. Devices were all implanted in an outpatients’ hospital facility, following predefined evidence-based institutional guidelines and protocols by a PICC-dedicated team at the European Institute of Oncology in Milan, Italy, during the 12-month period from January 1 to December 31, 2019. Results: Five-hundred PICCs were implanted in a cohort of 482 patients during the time interval of this study. Thirty devices were overall removed (6.2%), 23 as a consequence of a complication occurred, and seven inadvertently. The inserted PICCs accounted for a total of 49,718 catheter days in situ, median duration was 85.5 days [interquartile range (IQR): 56–146]. Overall there were 42 (8.7%) complications, corresponding to 0.84 catheter-adverse events (CAE)/1000 PICC-days (95% CI: 0.61–1.14). There were N = 13 (2.7%) thromboses, N = 11 (2.3%) irreversible occlusions, N = 7 (1.5%) accidental removals, N = 5 (1.0%) infections [two Catheter Related Blood Stream Infection (CRBSI) and three exit site/local infection], N = 3 (0.6%) ruptures and N = 3 (0.6%) primary or secondary malpositions. Conclusion: This large prospective study supports the increasing use of PICCs in adult oncology outpatients treated in specialized centers with chemotherapy for non-hematological malignancies. In this clinical setting, PICC failure occurred in 6% only of the inserted devices.

scholarly journals Real-World Experience of Pembrolizumab Monotherapy in Patients with Recurrent or Persistent Cervical Cancer: A Korean Multi-Center Retrospective Study (KGOG1041)

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3188 ◽  
Author(s):  
Min Chul Choi ◽  
Yong-Man Kim ◽  
Jeong-Won Lee ◽  
Yong Jae Lee ◽  
Dong Hoon Suh ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Retrospective Study ◽  
Antitumor Activity ◽  
Real World ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Safety Data ◽  
Ecog Performance Status ◽  
Recurrent Cervical Cancer

This study investigated the antitumor activity and safety of pembrolizumab in patients with recurrent cervical cancer in real-world practice. We conducted a multi-center retrospective study of patients with recurrent or persistent cervical cancer treated with pembrolizumab at sixteen institutions in Korea between January 2016 and March 2020. The primary endpoints were the objective response rate (ORR) and safety. Data were available for 117 patients. The median age was 53 years (range, 28–79). Sixty-four (54.7%) patients had an Eastern Cooperative Oncology Group (ECOG) performance status of ≥2. Forty-nine (41.9%) patients were stage ≥III at diagnosis. Eighty-eight (75.2%) patients had squamous cell carcinoma. The median number of prior chemotherapy lines was two (range, 1–6). During the median follow-up of 4.9 months (range, 0.2–35.3), the ORR was 9.4%, with three complete responses and eight partial responses. The median time to response was 2.8 months (range 1.3–13.1), and the median duration of response (DOR) was not reached. In the population of patients with favorable performance status (ECOG ≤1) (n = 53), the ORR was 18.9%, and the median DOR was 8.9 months (range, 7.3–10.4). Adverse events occurred in 55 (47.0%) patients, including eight (6.8%) patients who experienced grade ≥3 events, and two of them were suspicious treatment-related deaths. Pembrolizumab had modest antitumor activity in patients with recurrent cervical cancer comparable to that found in previously reported clinical trials. However, in patients with favorable performance status, pembrolizumab showed effective antitumor activity. Some safety profiles should be carefully monitored during treatment.

scholarly journals Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial

2013 ◽  
Vol 31 (11) ◽  
pp. 1405-1414 ◽  
Author(s):  
Athanassios Argiris ◽  
Musie Ghebremichael ◽  
Jill Gilbert ◽  
Ju-Whei Lee ◽  
Kamakshi Sachidanandam ◽  
...  
Keyword(s):  
Head And Neck ◽  
Disease Progression ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Oncology Group ◽  
Ecog Performance Status ◽  
Grade 3

Purpose We hypothesized that the addition of gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, to docetaxel would enhance therapeutic efficacy in squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods Patients with recurrent or metastatic SCCHN with Eastern Cooperative Oncology Group (ECOG) performance status of 2, or patients with ECOG performance status of 0 to 2 but were previously treated with chemotherapy, were randomly assigned to receive weekly docetaxel plus either placebo (arm A) or gefitinib 250 mg/d, orally (arm B) until disease progression. At the time of progression, patients in the placebo arm could receive single-agent gefitinib. EGFR, c-MET, and KRAS mutations and polymorphisms in drug metabolizing enzymes and transporters were evaluated by pyrosequencing. Results Two hundred seventy patients were enrolled before the study was closed early at interim analysis (arm A, n = 136; arm B, n = 134). Median overall survival was 6.0 months in arm A versus 7.3 months in arm B (hazard ratio, 0.93; 95% CI, 0.72 to 1.21; P = .60). An unplanned subset analysis showed that gefitinib improved survival in patients younger than 65 years (median 7.6 v 5.2 months; P = .04). Also, there was a trend for improved survival in patients with c-MET wild-type (5.7 v 3.6 months; P = .09) regardless of treatment. Grade 3/4 toxicities were comparable between the two arms except that grade 3/4 diarrhea was more common with docetaxel/gefitinib. Of 18 eligible patients who received gefitinib after disease progression in arm A, one patient had a partial response. Conclusion The addition of gefitinib to docetaxel was well tolerated but did not improve outcomes in poor prognosis but otherwise unselected patients with SCCHN.

scholarly journals Prognostic Significance of p16INK4A and Human Papillomavirus in Patients With Oropharyngeal Cancer Treated on TROG 02.02 Phase III Trial

2010 ◽  
Vol 28 (27) ◽  
pp. 4142-4148 ◽  
Author(s):  
Danny Rischin ◽  
Richard J. Young ◽  
Richard Fisher ◽  
Stephen B. Fox ◽  
Quynh-Thu Le ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Oropharyngeal Cancer ◽  
Performance Status ◽  
Cell Cancer ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Significance ◽  
Multivariable Analysis ◽  
Phase Iii ◽  
Significant Prognostic Factor ◽  
Ecog Performance Status

Purpose To determine the prognostic importance of p16 and human papillomavirus (HPV) in patients with oropharyngeal cancer treated on a phase III concurrent chemoradiotherapy trial. Patients and Methods Patients with stage III or IV head and neck squamous cell cancer were randomly assigned to concurrent radiotherapy and cisplatin with or without tirapazamine. In this substudy, analyses were restricted to patients with oropharyngeal cancer. p16 was detected by immunohistochemistry, and HPV was detected by in situ hybridization and polymerase chain reaction. Results Slides were available for p16 assay in 206 of 465 patients, of which 185 were eligible, and p16 and HPV were evaluable in 172 patients. One hundred six (57%) of 185 were p16-positive, and in patients evaluable for both p16 and HPV, 88 (86%) of 102 p16-positive patients were also HPV-positive. Patients who were p16-positive had lower T and higher N categories and better Eastern Cooperative Oncology Group (ECOG) performance status. p16-positive tumors compared with p16-negative tumors were associated with better 2-year overall survival (91% v 74%; hazard ratio [HR], 0.36; 95% CI, 0.17 to 0.74; P = .004) and failure-free survival (87% v 72%; HR, 0.39; 95% CI, 0.20 to 0.74; P = .003). p16 was a significant prognostic factor on multivariable analysis (HR, 0.45; 95% CI, 0.21 to 0.96; P = .04). p16-positive patients had lower rates of locoregional failure and deaths due to other causes. There was a trend favoring the tirapazamine arm for improved locoregional control in p16-negative patients (HR, 0.33; 95% CI, 0.09 to 1.24; P = .13). Conclusion HPV-associated oropharyngeal cancer is a distinct entity with a favorable prognosis compared with HPV-negative oropharyngeal cancer when treated with cisplatin-based chemoradiotherapy.

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