Stereotactic body radiotherapy (SBRT) and medical inoperability of early stage non-small cell lung cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17074-17074
Author(s):  
K. N. Franks ◽  
A. Bezjak ◽  
S. Pearson ◽  
B. C. Cho ◽  
D. Payne ◽  
...  
Keyword(s):  
High Risk ◽  
Early Stage ◽  
Incidental Finding ◽  
Tumour Size ◽  
Performance Status ◽  
Alternative Therapy ◽  
Average Risk ◽  
Early Stage Nsclc ◽  
Co Morbidity ◽  
New Treatment

17074 Background: Early stage NSCLC is commonly diagnosed in elderly patients who often have significant medical co-morbidity. SBRT is emerging as a treatment alternative that can provide 80–97% local control for peripheral tumors. We performed a literature review and a retrospective review of 24 patients referred to Princess Margaret Hospital for consideration of SBRT to assess what criteria were used to determine patient selection for this new treatment. Methods: Published papers reporting treating stage I NSCLC with SBRT were reviewed. Clinical and demographic characteristics of patients referred for consideration of SBRT over the last 15 months were analyzed. All patients were assessed by experienced thoracic surgeons to determine their operability status. Patients were retrospectively scored as average or high risk for surgery on the basis of accepted PFT guidelines (FEV1 and DLCO <40% predicted); Charlson Index of Comorbidity (CCI) was calculated (score >2 associated with impaired survival). Results: Of 13 papers reporting Stage 1 SBRT results, 8 included details of medical inoperability. 2 papers had strict guidelines for PFTs, in addition to other criteria. In 6 studies reporting 276 pts, the most common reason for inoperability was non-specific medical comorbidity (60%). Our cohort (24 patients) referred for SBRT (median age 75, range 57–89) had a mean tumour size of 2.32cm (S.D. 1.11); 50% of patients had a good (0–1) Zubrod Performance status. Based upon PFT tests alone 10 patients (42%) were high risk and 5 (21%) average risk for surgery. The CCI score was ≥3 in 10 patients (42%). 3 patients who scored average risk and CCI ≤2 were deemed medically inoperable due a single severe medical comorbity. In 23/24 pts the surgeon recommended against surgery; one patient refused surgery. Conclusions: With an aging population and increased detection due to incidental finding or screening, it is important to know that there is effective alternative therapy for patients deemed too high risk for surgical resection. Comorbidity is an important factor influencing surgical mortality; defining explicit criteria for inoperability remains a clinical challenge. No significant financial relationships to disclose.

Pretreatment prognostic factors associated with outcomes for first-line FCR-based treatments in previously untreated CLL.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6517-6517
Author(s):  
William G. Wierda ◽  
Susan Mary O'Brien ◽  
Stefan Faderl ◽  
Alessandra Ferrajoli ◽  
Jan Andreas Burger ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
High Risk ◽  
Performance Status ◽  
Absolute Lymphocyte Count ◽  
Patient Characteristics ◽  
Treatment Modalities ◽  
First Line ◽  
Liver Size ◽  
Improved Outcomes ◽  
New Treatment

6517 Background: First-line chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) demonstrated improved outcomes, including survival, for fit patients (pts) with CLL. Modifications of this regimen, including intensified rituximab (FCR3), addition of mitoxantrone (FCMR) or addition of alemtuzumab fir high-risk CLL (CFAR), were evaluated but did not improve outcomes in historic comparisons. Methods: We correlated outcomes, including complete remission (CR), time-to-treatment failure (TTF) and overall survival (OS), with new and traditional pretreatment prognostic factors to identify high-risk pts. Results: All pts (N=473) had an NCI-WG indication for treatment and received a first-line FCR-based regimen on trial; the intended treatment was 6 courses. Patient characteristics correlated with outcomes are presented in the table. Factors not associated with outcomes included absolute lymphocyte count; platelet count; performance status; spleen size; liver size; and number of involved lymph node sites. Conclusions: We identified the following as high-risk pretreatment features for patients going on first-line FCR-based therapy: advanced age, presence of 17p del, high B2M (≥4mg/l), and unmutated IGHV gene. Pts with these features should be pursued with new treatment modalities and novel agents in order to improve outcomes. [Table: see text]

Effects of early discontinuation of adjuvant chemotherapy (EDAC) and the timing of treatment on outcomes in patients with early-stage pancreatic cancer (ESPC): Result from a population-based retrospective cohort study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 694-694
Author(s):  
Javeria Muhammadzai ◽  
Michael Moser ◽  
Kamal Haider ◽  
John Shaw ◽  
Haji I. Chalchal ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Median Time ◽  
Early Stage ◽  
Performance Status ◽  
Single Agent ◽  
Pancreatic Head ◽  
Adjuvant Radiation ◽  
Curative Surgery ◽  
Risk Of Recurrence

694 Background: Although evidence suggests that a delay in initiation of adjuvant chemotherapy (AC) results in inferior outcomes in some cancers, little is known about its detrimental effects in patients with ESPC. Moreover, it is not known if EDAC has been associated with high risk of recurrence and poor survival. The current study aims to determine association between timing and completion of AC and outcomes in ESPC. Methods: Patients with ESPC who were diagnosed from Jan 2007 to Dec 2017 and underwent complete resection in the province of Saskatchewan were examined. Kaplan Meier methods and log rank tests were performed for survival analyses. Cox proportional multivariate analyses were performed for correlation with recurrence and survival. Results: A total 168 patients with ESPC were identified. 97 (57%) patients were excluded as they did not receive AC, were found to have metastatic disease, did not have curative surgery or had received preoperative chemotherapy. Of 71 eligible patients with median age of 69 years (IQR: 57-73), 52% were male, 31% had WHO performance status of 0 and 92% had a comorbid illness. 78% had pancreatic head tumor, 66% had T3 tumor and 63% had node-positive disease. Median time to start of AC from surgery was 73 days (IQR: 59-89). 32% were started AC within 60 days of surgery. 89% received single-agent chemotherapy and 25% received adjuvant radiation. 69% completed planned treatment. Median time to recurrence in group which completed treatment was 22 months (95%CI:15.8-28.2) vs. 9 months (3.3-14.7) if treatment was discontinued early (P < 0.001). Median overall survival of the group that completed treatment was 33 months (17.5-48.5) vs. 16 months (17.5-48.5) if it was stopped early (P < 0.001). On multivariate analysis, EDAC was significantly correlated with recurrent disease (HR = 3.0; 1.6-5.5), P = 0.0001 and inferior survival (HR = 3.2; 1.68-6.12), P < 0.001. No correlation between AC timing and survival was noted. Conclusions: Although timing of AC does not correlate with inferior outcomes, EDAC has been associated with high risk of recurrence and inferior survival in ESPC.

Checkmate 77T: A phase III trial of neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) followed by adjuvant nivo in resectable early-stage NSCLC.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS9076-TPS9076
Author(s):  
Tina Cascone ◽  
Mariano Provencio ◽  
Boris Sepesi ◽  
Shun Lu ◽  
Nivedita Aanur ◽  
...  
Keyword(s):  
Oral Presentation ◽  
Lung Tumor ◽  
Early Stage ◽  
Performance Status ◽  
Unmet Need ◽  
Phase Iii ◽  
Rational Approach ◽  
Controlled Study ◽  
Double Blind ◽  
Early Stage Nsclc

TPS9076 Background: Although surgery for early NSCLC is potentially curative, 5-year overall survival (OS) rates for patients with stage IIA–IIIB disease are historically < 50%, representing a population of high unmet need. Conventional neoadjuvant or adjuvant chemo provides only a 5% absolute improvement in OS at 5 years. A rational approach to improve survival in these patients is to eradicate micrometastatic disease and potentially induce anti-tumor immunity to minimize the risk of relapse with peri-operative regimens including NIVO, a fully human anti–programmed death receptor-1 antibody. Early phase trials indicate that NIVO-based regimens have the potential to deepen pathological responses and extend survival in this setting (Reuss JE et al. Poster presentation at ASCO 2019. Abstract 8524; Cascone T et al. Oral presentation at ASCO 2019. Abstract 8504; Provencio M et al. Oral presentation at WCLC 2019. Abstract OA13.05). Data from the phase 2 single-arm NADIM trial (NCT03081689) demonstrated the highly encouraging major pathological response (MPR) rate of 83% with neoadjuvant NIVO plus chemo followed by adjuvant NIVO in patients with resectable stage IIIA NSCLC (Provencio M et al. Oral presentation at WCLC 2019. Abstract OA13.05). These results require validation in a large randomized controlled study. CheckMate 77T (NCT04025879) is a phase 3, randomized, double-blind trial evaluating neoadjuvant NIVO plus chemo followed by adjuvant NIVO in resectable early stage NSCLC. Methods: Approximately 452 patients aged ≥ 18 years with resectable stage IIA–IIIB (T3N2 only) NSCLC, ECOG performance status 0–1, and available lung tumor tissue will be enrolled at 113 sites in North America, South America, Europe, Asia, and Australia. Patients with EGFR/ALK mutations, brain metastasis, prior systemic anti-cancer treatment or radiotherapy, and autoimmune disease are excluded. Patients will be randomized to receive neoadjuvant NIVO plus carboplatin- or cisplatin-based doublet chemo followed by surgery and adjuvant NIVO, or neoadjuvant placebo plus carboplatin- or cisplatin-based doublet chemo followed by surgery and adjuvant placebo. The primary endpoint is event-free survival, assessed by blinded independent central review. Secondary endpoints include OS, pathological complete response and MPR assessed by blind independent pathological review, safety and tolerability. The start date was September 2019. The estimated primary completion date is May 2023. Clinical trial information: NCT04025879.

scholarly journals Primary Treatment Options for High-Risk/Medically Inoperable Early Stage NSCLC Patients

2015 ◽  
Vol 16 (6) ◽  
pp. 413-430 ◽  
Author(s):  
Guy C. Jones ◽  
Jason D. Kehrer ◽  
Jenna Kahn ◽  
Bobby N. Koneru ◽  
Ram Narayan ◽  
...  
Keyword(s):  
High Risk ◽  
Early Stage ◽  
Treatment Options ◽  
Primary Treatment ◽  
Early Stage Nsclc ◽  
Nsclc Patients

S9900: Surgery alone or surgery plus induction (ind) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): Follow-up on a phase III trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7520-7520 ◽  
Author(s):  
K. Pisters ◽  
E. Vallieres ◽  
P. A. Bunn ◽  
J. Crowley ◽  
K. Chansky ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Early Stage ◽  
Clinical Stage ◽  
Performance Status ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Phase Iii ◽  
Early Stage Nsclc ◽  
Superior Sulcus

7520 Background: Small randomized and non-randomized studies suggest induction chemotherapy may improve survival in early stage NSCLC. The primary objective of this study was to determine if induction PC could improve survival over surgery alone. Preliminary results of this trial were reported at ASCO 2005 (J Clin Oncol, ASCO Proc 23(16S) 2005:7012). Median time for patients alive at last contact is now 46 months (mos). Methods: Consenting patients with clinical stage T2N0, T1–2N1 and T3N0–1 NSCLC (excluding superior sulcus tumors) were stratified by clinical stage (IB/IIA vs. IIB/IIIA) and randomized to induction PC (P:225 mg/m2 over 3 hours, C:AUC=6) on day 1, every 3 weeks × 3 or surgery alone. Eligible patients had a performance status 0–1, age =18 years (yrs), predicted post- resection FEV1 =1.0L. Surgery was at least a lobectomy and mediastinal nodal sampling. The primary endpoint was a 33% increase in overall survival over expected 2.7 yrs median for surgery. Planned sample size was 600 patients, 81% power, 1-sided test, 0.025 significance. Results: S9900 closed 07/04 when adjuvant chemotherapy became standard. 354 patients had accrued; 174-surgery alone, 180- induction PC; 19 were ineligible. Median age 65 yrs, 66% male, 70% IB/IIA, 30% IIB/IIIA. Major radiographic response to induction PC was 41%. Treatment-related deaths: 3 during induction PC, 11 within 30 days of surgery (7-induction PC arm, 4-control). Progression-free survival (PFS), overall (OS) survival rates and hazard ratios (HR) are shown. Conclusions: PFS and OS continue to trend in favor of induction PC with HR similar to those observed in adjuvant trials, supporting the role of chemotherapy in operable NSCLC. Randomized trials comparing induction to adjuvant chemotherapy are warranted. Supported by SWOG CA30102. [Table: see text] [Table: see text]

scholarly journals Toll-like receptor 3 as a new marker to detect high risk early stage Non-Small-Cell Lung Cancer patients

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Francesca Bianchi ◽  
Massimo Milione ◽  
Patrizia Casalini ◽  
Giovanni Centonze ◽  
Valentino M. Le Noci ◽  
...  
Keyword(s):  
High Risk ◽  
Tumor Cells ◽  
Immune Cells ◽  
Prognostic Value ◽  
Early Stage ◽  
Prognostic Significance ◽  
Stage I ◽  
Poor Overall Survival ◽  
Early Stage Nsclc ◽  
Tlr3 Expression

Abstract Immune and epithelial cells express TLR3, a receptor deputed to respond to microbial signals activating the immune response. The prognostic value of TLR3 in cancer is debated and no data are currently available in NSCLC, for which therapeutic approaches that target the immune system are providing encouraging results. Dissecting the lung immune microenvironment could provide new prognostic markers, especially for early stage NSCLC for which surgery is the only treatment option. In this study we investigated the expression and the prognostic value of TLR3 on both tumor and immune compartments of stage I NSCLCs. In a cohort of 194 NSCLC stage I, TLR3 immunohistochemistry expression on tumor cells predicted a favorable outcome of early stage NSCLC, whereas on the immune cells infiltrating the tumor stroma, TLR3 expression associated with a poor overall survival. Patients with TLR3-positive immune infiltrating cells, but not tumor cells showed a worse prognosis compared with all other patients. The majority of TLR3-expressing immune cells resulted to be macrophages and TLR3 expression associates with PD-1 expression. TLR3 has an opposite prognostic significance when expressed on tumor or immune cells in early stage NCSCL. Analysis of TLR3 in tumor and immune cells can help in identifying high risk stage I patients for which adjuvant treatment would be beneficial.

scholarly journals Perception and Practice of Bangladeshi Adults Towards the Prevention of COVID-19: A Statistical Analysis

2021 ◽  
Vol 10 ◽  
pp. 107-117
Author(s):  
Md. Abdul Wadood ◽  
Lai Lee Lee ◽  
Md. Monimul Huq ◽  
Asma Mamun ◽  
Suhaili Mohd ◽  
...  
Keyword(s):  
Risk Perception ◽  
High Risk ◽  
Rural Areas ◽  
Urban Areas ◽  
Risk Perceptions ◽  
Early Stage ◽  
Good Practice ◽  
General Question ◽  
Average Risk ◽  
Study Results

Background: The coronavirus disease 2019 (COVID-19) has continued to spread across the world with increasing numbers of confirmed cases and deaths. Due to outbreaks of new variants of the virus and limited treatment options, positive perception and good practice of preventive guidelines have remained essential measures for the prevention of the disease and slowing down its transmission. We aimed to study perception towards COVID-19 and the practice of guidelines for preventing the disease among Bangladeshi adults during the early stage of the rapid rise of the outbreak. Methods: Data was collected data from 320 participants. For measuring their level of practice, we asked a general question: “Are you properly following the WHO-recommended guidelines to avoid COVID-19?” The frequency distribution, Chi-square (χ2) test and binary logistic regression model were used in this study. Results: The average risk perception among the participants was 3.05±0.75 (median, 3.00) (95% CI of mean: 2.96-3.13) where the score ranges from 0 (no risk) to 4 (high risk). More than 27% of participants showed high-risk perceptions. Males (p<0.05), high educated (p<0.05), rich (p<0.01), service holders (p<0.05), and younger adults (p<0.05) had higher odds of high-risk perception. More than 71% of participants had a good practice of always following the WHO guidelines to prevent COVID-19 and living locations in urban areas (p<0.01), high education (p<0.01), rich (p<0.01), and joint family (p<0.01) had the most contributions to good practice. Conclusions: The study findings revealed that special attention should be given to rural areas, and individuals of low literacy, education and socioeconomic level to more effectively prevent COVID-19.

High-risk uveal melanoma: A prospective study evaluating the role of magnetic resonance imaging of the liver.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8564-8564
Author(s):  
Ernest Marshall ◽  
Chris Romaniuk ◽  
Paula Ghaneh ◽  
Helen Wong ◽  
Marie McKay ◽  
...  
Keyword(s):  
High Risk ◽  
Uveal Melanoma ◽  
Early Stage ◽  
Histological Grade ◽  
Performance Status ◽  
Chromosome 3 ◽  
Trial Participation ◽  
Liver Mri ◽  
Relapse Free Survival ◽  
Free Survival

8564 Background: Almost 50% of uveal melanomas are fatal. Metastatic death occurs almost exclusively with tumours showing chromosome 3 loss and 8q gain. Metastases, which almost always involve the liver, are resectable in some patients. They are rarely detectable when the patient presents with the primary ocular tumour. Screening is therefore necessary, but there is no consensus as to who should be screened, how often, and for how long. Methods: Uveal melanoma patients with ECOG performance status 0-2 were eligible if their risk of metastatic death at 5 years exceeded 50%. Survival probability was estimated by multivariate analysis of tumour stage, histological grade and genetic tumour type. Patients underwent screening 6monthly, clinical examination, non-contrast liver MRI and liver function tests for at least five years. Results: Between Jan 2000 and November 2010, 279 high-risk patients were referred for screening. Of these, 188 (84 male, 104 female) accepted screening and underwent as least 1 MRI. The median age was 63 years (IQR 16.5). Median basal tumour diameter was 16.5mm (IQR 5.25). Chromosome 3 loss was detected in 175 tumours. Median follow up time was 28.8 months (IQR 29.1). Median relapse-free survival was 33 months (95% CI 28-38) with a 35% relapse-free survival at 5 years. After a median of 18 months (IQR 20), screening detected metastases in 90/188 (48%), 83 of whom were asymptomatic. 12 patients underwent R0 liver resection, which increased the median survival from 10 (95% CI 8.1 - 11.9) to 24 (95% CI 20.2- 27.8) months. The screening programme stimulated a UK NCRI portfolio of clinical trials in which 23 of these patients were subsequently treated. Conclusions: Six-monthly liver MRI detects metastases from uveal melanoma at an early stage, thereby enhancing opportunities for surgical metastatectomy, clinical trial participation and prolonging life.

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