stage iiib
Recently Published Documents


TOTAL DOCUMENTS

1021
(FIVE YEARS 230)

H-INDEX

48
(FIVE YEARS 6)

2022 ◽  
pp. ijgc-2021-003168
Author(s):  
Koji Matsuo ◽  
Maximilian Klar ◽  
Shin Nishio ◽  
Mikio Mikami ◽  
Lynda D Roman ◽  
...  

ObjectiveThe International Federation of Gynecology and Obstetrics (FIGO) revised the vulvar cancer staging schema in 2021. Previous stage IIIA–B diseases were reclassified based on nodal size (≤5 mm for stage IIIA compared with >5 mm for stage IIIB), and previous stage IVA1 disease based on non-osseous organ extension was reclassified to stage IIIA whereas osseous extension remained as stage IVA. This study sought to validate the 2021 FIGO vulvar cancer staging schema.MethodsThis retrospective cohort study examined 889 women with stage III–IV vulvar cancer from 2010 to 2015 in the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. Stage shift and overall survival were assessed by comparing the 2021 and 2009 FIGO staging schemas.ResultsStage shift occurred in 229 (25.8%) patients (upstaged 17.7% and downstaged 8.1%). When comparing the new and previous staging schemas, 5 year overall survival rates were 45.6% versus 48.9% for stage IIIA, 47.0% versus 44.2% for stage IIIB, and 13.9% versus 25.1% (interval change −11.2%) for stage IVA diseases. According to the revised staging schema, 5 year overall survival rates were similar for stage IVA and IVB diseases (13.9% vs 14.5%) and for stage IIIA and IIIB disease (45.6% vs 47.0%). For new stage IIIA disease, 5 year overall survival rates differed significantly based on the staging factors (nodal involvement vs non-nodal organ involvement, 48.9% vs 38.7%, difference 10.2%, p=0.038).ConclusionThe 2021 FIGO staging schema results in one in four cases of advanced vulvar cancer being reclassified. Survival rates of patients with new stage IVA disease worsened significantly whereas those of patients with new stage IIIA disease were heterogenous based on the staging factors. The discriminatory ability of the revised 2021 FIGO staging schema for 5 year overall survival rate between patients with stage IIIA and IIIB tumors and those with IVA and IVB tumors is limited in this study population.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1673-1673
Author(s):  
Ashutosh D. Wechalekar ◽  
John Silowsky ◽  
Eileen Daniel ◽  
Mark Harnett ◽  
Michael Spector ◽  
...  

Abstract Background: Light-chain amyloidosis (AL-A) is a rare, severe, progressive, systemic disorder with high mortality caused by immunoglobulin (Ig) light chains that misfold and aggregate into amyloid fibrils that deposit in multiple organs, leading to progressive organ dysfunction/damage and death. Prognosis is poor for patients with cardiac involvement (characterized by high levels of cardiac troponin T and N-terminal brain natriuretic peptide). Median survival is 24 and 4 months for Mayo Stage IIIa and IIIb AL-A, respectively, based on the 2013 European Modification of the 2004 Mayo Staging system. For most patients, standard of care (SOC) is anti-plasma cell dyscrasia (PCD) therapy to suppress plasma cell proliferation, halt generation of amyloidogenic free light chains, and stop deposition of new amyloid fibrils and further organ decline. However, a critical need exists for therapies that accelerate the removal of deposited fibrils. CAEL-101 is a monoclonal antibody that binds to misfolded Ig light chains in amyloid fibrils. In Phase 1 and 2, CAEL-101 (with and without concurrent PCD SOC) was well tolerated up to 1000 mg/m 2. Preliminary Phase 2 data (NCT04304144) suggest improvements in cardiac and renal biomarkers in some patients. Objective: To evaluate the efficacy and safety of CAEL-101 versus placebo when administered concurrently with SOC anti-PCD therapy in treatment-naïve patients with cardiac AL-A, Mayo Stages IIIb (NCT04504825; Study 1) or IIIa (NCT04512235; Study 2). Methods: These international, multicenter, double-blind, randomized, phase 3 trials, initiated in 2020, are enrolling patients at over 70 sites in 14 countries. Newly diagnosed adults with AL-A stage IIIb or IIIa based on the 2013 European Modification of 2004 Mayo Staging (Wechalekar AD et al. Blood 2013;121:3420. Dispenzieri A, et al. J Clin Oncol. 2004; 22:3751), measurable hematologic disease, and histopathological diagnosis of amyloidosis with cardiac involvement are eligible. Patients cannot have any other form of amyloidosis, symptomatic orthostatic hypotension, or supine systolic blood pressure <90 mmHg. Patients in Mayo Stages IIIb (N=111) and IIIa (N=267) are randomized 2:1 to receive once-weekly intravenous infusions of CAEL-101 (1000 mg/m 2) or placebo for 4 weeks, followed by maintenance dosing every 2 weeks. In these event-driven studies, treatment will continue to a minimum of 54 deaths for Study 1 and 77 deaths for Study 2 (a minimum treatment duration of 12 months is expected). Patients will receive concurrent anti-PCD therapy per the institutional protocol for SOC and will be followed to death from any cause or until end of study (Figure). The primary endpoint is overall survival (defined as the time from first dose of study drug to date of death, with censoring at last known living date), and will be analyzed via time-to-event log-rank statistics. Functional, quality of life, and echocardiography measures are targeted secondary endpoints. Results: Patient baseline characteristics and demographics are presented (Table). As of July 17, 2021, 9/13 (69.2%) patients in Study 1 and 23/39 (59%) patients in Study 2 have received at least 4 doses of CAEL-101 concurrently with anti-PCD therapy. Discussion: These ongoing trials will evaluate the efficacy and safety of CAEL-101 as first-in-class treatment to reduce amyloid burden in patients with cardiac AL-A. Notably, Study 1 (Mayo Stage IIIb) is the first randomized, placebo-controlled efficacy clinical trial to formally assess the effects of a pharmacological in this severely ill population. Because the median expected survival for Mayo Stage IIIb patients is far shorter than for Mayo Stage IIIa patients, the resulting sample size required for the Mayo Stage IIIB study is less (111 patients) than for the Mayo Stage IIIA study (267 patients). Importantly, these studies include patients identified as Stage III and IV based on the 2012 Mayo staging system (Kumar S. et al. J Clin Oncol. 2012;30:989). These trials are ongoing in a challenging environment. The approval of daratumumab in 2021 changed the landscape and modified the SOC, requiring appropriate protocol amendments. While the COVID pandemic affected all people, it had a greater impact on patients with AL amyloidosis, a rare disease that can only be treated effectively by a coordinated team of experts at centers of excellence. Figure 1 Figure 1. Disclosures Wechalekar: Alexion, AstraZeneca Rare Disease: Consultancy; Caelum Biosciences: Other: Clinical Trial Funding; Janssen: Consultancy; Celgene: Honoraria; Takeda: Honoraria; Amgen: Research Funding. Silowsky: Caelum Biosciences: Current Employment. Daniel: Caelum Biosciences: Current Employment. Harnett: Caelum Biosciences: Current Employment. Spector: Caelum Biosciences: Current Employment. Sobolov: Caelum Biosciences: Current Employment. Quarta: Alexion, AstraZeneca Rare Disease: Current Employment. Kurman: Caelum Biosciences: Other: Medical Monitor. Tulchinskiy: Caelum Biosciences: Consultancy. Bhattacharyya: Alexion, AstraZeneca Rare Disease: Current Employment. Liedtke: Karyopharm: Membership on an entity's Board of Directors or advisory committees; Kite: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Kura Oncology: Membership on an entity's Board of Directors or advisory committees; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Alnylam: Membership on an entity's Board of Directors or advisory committees; Caelum: Membership on an entity's Board of Directors or advisory committees, Other: Clinical Trial Funding.


2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A484-A484
Author(s):  
Michael Boyer ◽  
Sandip Patel ◽  
Thomas Marron ◽  
Nick Pavlakis ◽  
Sagun Parakh ◽  
...  

BackgroundProgrammed cell death protein 1 (PD-1) inhibitors as monotherapy or in combination with chemotherapy have become a standard of care first-line therapy for Stage IIIB/IV non-small cell lung cancer (NSCLC). However, many patients experience disease progression and require subsequent therapy within the first year of treatment.1 For patients requiring salvage chemotherapy, prognosis is poor, with a median progression-free survival (PFS) and overall survival (OS) of 4.0 and 8.5 months, respectively.2 Combinations of PD-1 blockade using sasanlimab (PF-06801591) and other immune and/or targeted therapies may be able to achieve clinical response in patients who have progressed on standard chemoimmunotherapy.MethodsLANDSCAPE 1011 (NCT04585815) is a prospective, open-label, multi-center, parallel group, phase 1b/2 umbrella study evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of sasanlimab in combination with other therapies, in patients with Stage IIIB/IV NSCLC. The study is expected to enrol ~375 patients age 18 years or older diagnosed with stage IIIB/IV NSCLC. During phase 1b, the safety of each sub-study combination with subcutaneous sasanlimab will be assessed and the recommended phase 2 dose determined for each combination. Phase 2 will further evaluate safety and anti-tumor activity of each combination using the respective recommended phase 2 dose (figure 1). Up to 5 parallel sub-studies are planned. Currently, 2 sub-studies are ongoing. Sub-Study A will investigate sasanlimab, encorafenib (a BRAF inhibitor), and binimetinib (a MEK inhibitor) in patients with BRAF^V600E mutations (only including treatment-naïve patients in phase 2). Sub-Study B will investigate sasanlimab, axitinib (a vascular endothelial growth factor receptor inhibitor), and SEA-TGT (an anti-TIGIT antibody). In phase 2, this will involve treatment-naïve patients without oncogene drivers who have PD ligand 1-positive tumors or whose disease has progressed on prior immune checkpoint inhibitor-containing regimens. The primary phase 1b endpoint is the dose-limiting toxicity during the first cycle (28 days). The primary phase 2 endpoint in Sub-Study A is durable objective response (OR) defined as confirmed complete response or partial response lasting 10 or more months; and in Sub-Study B, OR defined as confirmed complete response or partial response, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints include adverse events and laboratory abnormalities, duration of response, time to tumor response, PFS, OS, OR by PD-L1 expression at baseline, pharmacokinetic parameters, incidence of anti-drug antibodies and neutralizing antibodies, and health-related quality of life. The first patient was enrolled in November 2020.Abstract 456 Figure 1LANDSCAPE 1011 study overviewAcknowledgementsThis study was sponsored by Pfizer. Medical writing and editorial support was provided by Simon Stones at Engage Scientific Solutions, and funded by Pfizer. The authors would like to acknowledge the late Aron Thall, who was highly devoted to the execution and success of this study.Trial RegistrationClinicalTrials.gov NCT04585815ReferencesGandhi L, Rodriguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med 2018;378:2078–92.Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387:1540–50.Ethics ApprovalThe study is approved at each study site according to local regulations.


Author(s):  
Immanni S. M. Giridhar ◽  
C. Deepak Yadlapalli ◽  
Muralidhar Gullipalli ◽  
Venkatesh Mushini ◽  
Yerraguntla S. Sarma ◽  
...  

Background: Multiple myeloma (MM) evolves from Monoclonal gammopathy of unknown significance (MGUS), a premalignant clinical condition. Second to non-Hodgkin’s lymphoma, MM is the most common haematological malignancy. The aim of the study was to review the clinical profile and response of individuals treated for MM from this part of country.Methods: We evaluated data of patients with MM managed between 2013 and 2019 at a tertiary care cancer hospital in Rajamahenderi, India. Data regarding demographic variables, clinical features, disease characteristics and treatment details were collected and analysed.Results: Total of 54 patients with MM were managed. Mean age was 59.4 years. Males accounted for 63%. Bone pain (90%) was the most common symptom. Elevated serum creatinine was noted in 16.7% and M band in 42 (77.8%). X-ray of skull showed lytic lesions in 41 (75.9%). Mean haemoglobin value was 8.8±1.9 g/dl and serum calcium was 9.12 mg/dl. Majority of subjects, 44 (81.48%) belong to stage IIIA, 9 (16.67%) to stage IIIB, and 1.85% to stage IIA of Durie Salmon staging system. No response was noted in 17 (31.5%), 4 (7.4%) subjects had a progressive disease even on treatment, and 8 (14.8%) subjects had a very good partial response. Median survival of subjects belonging to DSS stage II was 17 months, IIIA was 11.037 months and stage IIIB was 17.463 months.Conclusions: MM has an early onset in India. Though MM is an incurable disease, many promising treatment options are there which lead to increase in survival. Early treatment helps in improving mortality rates, better quality of life and decreases disease burden.


2021 ◽  
Vol 16 (10) ◽  
pp. S1104
Author(s):  
P. Souquet ◽  
S. Kim ◽  
B. Solomon ◽  
J. Vansteenkiste ◽  
M. Carbini ◽  
...  

2021 ◽  
Vol 27 (10) ◽  
pp. 1789-1796
Author(s):  
R. Dummer ◽  
D. E. Gyorki ◽  
J. Hyngstrom ◽  
A. C. Berger ◽  
R. Conry ◽  
...  

2021 ◽  
Vol 16 (10) ◽  
pp. S1019-S1020
Author(s):  
S. Lu ◽  
X. Yu ◽  
J. Wang ◽  
J. Zhao ◽  
Y. Yu ◽  
...  
Keyword(s):  

2021 ◽  
Author(s):  
Xiaoyan Chen ◽  
Lisha Hou ◽  
Jianqun Li ◽  
Yanjiao Shen ◽  
Fucha Tan ◽  
...  

Abstract Objective: To evaluate the accuracy of baselineserum uric acid(BSUA) in estimating adverse effects (AE) and all-cause mortality (ACM) in older males with stage IIIB or IV non-small cell lung cancer (NSCLC) diagnosis.Study design:This is a single-center retrospective examination, conducted at the West China Hospital, Sichuan University in Chengdu, Sichuan Province, China, between the duration of January 2010 and December 2017.Primary outcome and measures:: All patients data was obtained based on medical reports and mortality information was gathered via telephone interviews. BUSA was assessed prior to chemotherapy. Additionally, the end points of this study included chemotherapy-mediated AE and ACM. Binarylogistic regression analysis was used to explore the correlation between BSUA and AE. Lastly, Cox regression analysis was utilized to examine theimpactof BSUA on ACM.Results: 317 male patients with NSCLC were eligible for this study. Within this population, 18.3% had stage IIIB and 81.7% had stage IV NSCLC. Moreover, 81.39% suffered from adenocarcinoma lung cancer (ACLC), whereas 18.61% suffered from squamous cell carcinoma lung cancer (SCCLC). As of March 1, 2019, 257 (81.07%) patients expired. Following the initial chemotherapeutic course, short-term AE like bone marrow suppression, all infection, liver dysfunction, and digestive reactions, wereobserved in 13.25%, 7.26%, 5.36%, and 4.1% of cases, respectively. Upon normalizing with confounding factors, the adjustedlogistic regression model demonstrated thatthe moderate BSUA was independently linked to a lower risk of bone marrow suppression (OR=0.407,95% CI:0.178-0.931; p=0.033).Moreover, based on the Cox regression analysis, moderate BSUAwas also independently correlated with a low mortality risk (HR=0.705,95% CI:0.518-0.959; p=0.026).Conclusion:In males patients withstage IIIB or IV NSCLC, BSUA is intimately linked to chemotherapy-driven AE and ACM.


Sign in / Sign up

Export Citation Format

Share Document