Factors impacting oncologic outcomes after sublobar pulmonary resection: Results from ACOSOG Z4032 (Alliance), a randomized trial for high-risk operable non-small cell lung cancer (NSCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7524-7524
Author(s):  
Michael S Kent ◽  
Rodney Jerome Landreneau ◽  
Sumithra J. Mandrekar ◽  
Francis C Nichols ◽  
Thomas A. DiPetrillo ◽  
...  
Keyword(s):  
High Risk ◽  
Tumor Size ◽  
Pulmonary Resection ◽  
Staple Line ◽  
Statistical Significance ◽  
Oncologic Outcomes ◽  
Progression Rate ◽  
Sublobar Resection ◽  
Local Progression ◽  
Clinical Trial Information

7524 Background: A multicenter study (Z4032) compared sublobar resection (SR) to sublobar resection with brachytherapy (SRB) for stage I NSCLC. Local recurrence (LR) and overall survival (OS) rates at 3-years (3-yr) were similar between arms (see abstract 113613). This analysis combines arms, and evaluates the effect of factors previously reported to impact oncological outcomes after SR. Methods: 213 patients (pts) were evaluable for analysis. LR was defined as recurrence at the staple line (local progression), same lobe away from the staple line, or within hilar nodes. Factors assessed for impact on 3-yr outcomes were: resection type (wedge/segmentectomy), margin size (<1cm /≥1cm), margin:tumor ratio (<1/ ≥1), tumor size (≤2cm/>2cm) and staple line cytology (+/-). Results: LR occurred in 27/213 (12.6%) pts and included local progression in 12/213 (5.6%). OS rate at 3-yr was 152/213 (71.4%). Trends favored the use of segmentectomy, margin:tumor ratio≥1, tumor size ≤2cm and negative staple line cytology; no factor reached statistical significance at 3-yr. The only factor significantly (p=0.02) associated with decreased 3-yr LR was margin size ≥1cm (8.3%) compared to margin<1cm (19.3%). Conclusions: SR is a good option for high-risk pts with NSCLC. The 3-yr OS rate of 71.4% and local progression rate of 5.6% are useful benchmarks to compare to other therapies. A resection margin of at least 1 cm is desirable. Clinical trial information: NCT00107172. [Table: see text]

Impact of brachytherapy on local recurrence after sublobar resection: Results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small cell lung cancer (NSCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7502-7502 ◽  
Author(s):  
Hiran Chrishantha Fernando ◽  
Rodney Jerome Landreneau ◽  
Sumithra J. Mandrekar ◽  
Francis C Nichols ◽  
Shauna L Hillman ◽  
...  
Keyword(s):  
High Risk ◽  
Local Recurrence ◽  
Staple Line ◽  
Randomized Study ◽  
Surgical Margin ◽  
Phase Iii ◽  
Oncologic Outcomes ◽  
Sublobar Resection ◽  
Local Progression

7502 Background: Prior studies suggest that adjuvant brachytherapy reduces local recurrence (LR) after sublobar resection (SR) for NSCLC. A multicenter randomized study was undertaken in patients (pts) with stage I NSCLC ≤3cm comparing SR to SR with brachytherapy (SRB). Methods: High-risk operable patients with NSCLC were randomized to SR or SRB. Brachytherapy involved placement of I125 seeds incorporated into Vicryl sutures or into Vicryl mesh placed over the staple line. Wedge or segmental resection was allowed. The primary endpoint was time to local recurrence (LR) defined as recurrence within the primary tumor lobe at the staple line (local progression), away from the staple line or within hilar nodes. The trial was designed to have 90% power to detect a hazard ratio (HR) of 0.315 in favor of the SRB arm using a one-sided α of 0.05 with a sample size of 100 eligible pts per arm. Follow-up CT scans were obtained serially for 36 months. Results: 224 pts were randomized; 213 (109 SR,104 SRB) were eligible. Median (range) age was 71 (49-87) yrs; 94 (44%) were male. No differences were found in baseline characteristics. Adverse events, previously reported, were not different between arms. Median (range) follow-up was 4.06 (0.04, 5.0) yrs. There was no difference between arms in time to LR (HR = 0.87; 5% CI: 0.41, 1.86, p=0.72) or to LR or death (LRD) (HR = 0.81, 95% CI: 0.50, 1.32, p=0.40). There was no difference between arms in pattern of LR (table). In subgroups of pts with potentially compromised surgical margin (margin < 1cm; margin:tumor ratio <1; positive staple line cytology) SRB did not reduce LR or LRD at 3-yrs. Overall 3-yr survival was similar for SR (71%) and SRB (72%) (p=0.81). Conclusions: LR remains a concern after sublobar resection. However, local progression at the staple line was low. This trial demonstrated that adjuvant brachytherapy does not impact oncologic outcomes. Clinical trial information: NCT00107172. [Table: see text]

scholarly journals Impact of Brachytherapy on Local Recurrence Rates After Sublobar Resection: Results From ACOSOG Z4032 (Alliance), a Phase III Randomized Trial for High-Risk Operable Non–Small-Cell Lung Cancer

2014 ◽  
Vol 32 (23) ◽  
pp. 2456-2462 ◽  
Author(s):  
Hiran C. Fernando ◽  
Rodney J. Landreneau ◽  
Sumithra J. Mandrekar ◽  
Francis C. Nichols ◽  
Shauna L. Hillman ◽  
...  
Keyword(s):  
Lung Cancer ◽  
High Risk ◽  
Local Recurrence ◽  
Small Cell Lung Cancer ◽  
Randomized Trial ◽  
Staple Line ◽  
Small Cell ◽  
Sublobar Resection ◽  
Small Cell Lung ◽  
Local Progression

Purpose A major concern with sublobar resection (SR) for non–small-cell lung cancer (NSCLC) is high local recurrence (LR). Adjuvant brachytherapy may reduce LR This multicenter randomized trial compares SR to SR with brachytherapy (SRB). Patients and Methods High-risk operable patients with NSCLC ≤ 3 cm were randomly assigned to SR or SRB. The primary end point was time to LR, where LR included recurrence at the staple line (local progression), in the primary tumor lobe away from the staple line, and in ipsilateral hilar nodes. The trial was designed to have a 90% power to detect a hazard ratio (HR) of 0.315 in favor of SRB, using a one-sided type I error rate of 0.05 with a sample size of 100 eligible patients in each arm. Results Two hundred twenty-four patients were randomly assigned; 222 patients were evaluable for intent-to-treat analysis. Median age was 71 years (range, 49 to 87 years). No differences were found in baseline characteristics. Median follow-up time was 4.38 years (range, 0.04 to 5.59 years). There was no difference in time to LR (HR, 1.01; 95% CI, 0.51 to 1.98; log-rank P = .98) or in the types of LR. Local progression occurred in only 17 (7.7%) of 222 patients. In patients with potentially compromised margins (margin < 1 cm, margin-to-tumor ratio < 1, positive staple line cytology, wedge resection, nodule size > 2.0 cm), SRB did not reduce LR, although trends favored the SRB arm. This was most marked in 14 patients with positive staple line cytology (HR, 0.22; P = .24). Three-year overall survival rates were similar for patients in the SR (71%) and SRB (71%) arms (P = .97). Conclusion Brachytherapy did not reduce LR after SR. This finding may have been related to closer attention to parenchymal margins by surgeons participating in this study.

Sublobar resection versus lobectomy for early-stage pulmonary carcinoid tumors with three centimeters or less in size: A population-based study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21062-e21062
Author(s):  
Xiongfei Li ◽  
Fan Ren ◽  
Shikang Zhao ◽  
Yanye Wang ◽  
Dian Ren ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Tumor Size ◽  
Early Stage ◽  
Population Based ◽  
Oncologic Outcomes ◽  
Low Grade ◽  
Sublobar Resection ◽  
Rank Tests ◽  
Log Rank Tests

e21062 Background: Pulmonary carcinoids (PCs), comprising of typical carcinoids (TCs) and atypical carcinoids (ACs), are rare low-grade malignant tumors and surgical resection is considered as the standard treatment for early stage PCs. However, it is not clear whether sublobar (Sub-L) resection of PCs would compromise the long-term oncologic outcomes. Here we investigate the equivalency of Sub-L resection versus lobectomy (Lobe) for patients with early stage PCs using the population-based Surveillance, Epidemiology, and End Results (SEER) registry. Methods: The clinical and survival data of early stage PC patients with less or equal 3cm diameter were retrieved. Kaplan-Meier method and log-rank tests were used to assess differences in overall survival (OS). We further performed the subgroup analysis by tumor size (T≤1cm, 1cm < T≤2cm, 2cm < T≤3cm) and patient age ( < 70y and ≥70y). To reduce the bias of inherent retrospective study, we also performed propensity score matching (PSM) analysis by 1:1 fixed ratio nearest neighbor matching using Matchit package in R. Results: In total of 2934 PC patients, including 2741 TCs and 193 ACs, were recruited. 1011(34.46%) and 1923(65.54%) patients received Sub-L resection and lobectomy, respectively. After PSM, there was no significant difference between Sub-L and Lobe group in terms of OS in PC patients (P = 0.33). From the cox regression analysis, it indicated that older age, male gender, larger tumor size, AC histology type and Sub-L surgery were associated with a worse OS. We further performed PSM analysis on TCs and ACs, respectively. For TC patients, it indicated that patients in Lobe group had a much better OS compared to those in Sub-L group (p = 0.0067). In the subgroup analysis, the log-rank tests showed that there was a significant survival advantage for lobectomy in comparison with Sub-L resection for the TC patients with diameter 2cm < T≤3cm (p = 0.0345), but not for those with diameter lower than 2cm. In the subgroup analysis of age, the log-rank test indicated that Lobe group in age < 70 had a better prognosis with statistical difference compared to Sub-L group (p = 0.0032). For ACs, there was no statistic difference between Sub-L and Lobe group after PSM analysis in all the subgroup investigations. Conclusions: Sublobar resection may not significantly compromise the long-term oncologic outcomes in early stage PC patients. However, there is a survival benefit of lobectomy in certain pathological type and population, such as TCs patients with tumor size more than 2cm and age lower than 70-year-old.

scholarly journals Assessment of the value of adjuvant radiotherapy for treatment of gastric adenocarcinoma based on pattern of post-surgical progression

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Peng Wang ◽  
Haihua Zhou ◽  
Gaohua Han ◽  
Qingtao Ni ◽  
Shengbin Dai ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Gastric Adenocarcinoma ◽  
Adjuvant Radiotherapy ◽  
Cox Regression ◽  
Radical Resection ◽  
Progression Rate ◽  
Cox Regression Analysis ◽  
T Stage ◽  
Local Progression ◽  
Degree Of Differentiation

Abstract Purpose To assess the value of adjuvant radiotherapy for treatment of gastric adenocarcinoma and to investigate subgroups of patients suitable for adjuvant radiotherapy. Methods and materials Data from 785 patients with gastric adenocarcinoma who had undergone D1/D2 radical resection and adjuvant chemotherapy were collected, the site of first progression was determined, and the relationship between the rate of local recurrence and clinicopathologic features was analyzed. Results By the end of the follow-up period, progression was observed in 405 patients. Local recurrence was observed as the first progression in 161 cases. The local recurrence rate was significantly lower than the non-local progression rate (20.5% vs 31.5%, p=0.007). Multivariate Cox regression analysis showed a significant relationship among degree of differentiation, T stage, N stage, and rate of local recurrence. Conclusions Not all patients with gastric carcinoma required adjuvant radiotherapy. However, patients with poorly differentiated cancer cells, advanced T stage (T3/T4), and positive lymph nodes, which included patients in the T4N1-2M0 subgroup, were recommended for adjuvant radiotherapy.

scholarly journals Clinical and neurophysiological findings in oligoclonal band negative multiple sclerosis patients

2003 ◽  
Vol 131 (3-4) ◽  
pp. 122-126 ◽  
Author(s):  
Sarlota Mesaros ◽  
Jelena Drulovic ◽  
Zvonimir Levic
Keyword(s):  
Multiple Sclerosis ◽  
Statistical Significance ◽  
Progression Rate ◽  
Positive Group ◽  
Clinical Difference ◽  
Initial Symptoms ◽  
Significant Difference ◽  
Intrathecal Igg Synthesis ◽  
Edss Score ◽  
Multiple Sclerosis Patients

Besides magnetic resonance imaging, the presence of locally produced oligoclonal IgG bands (OCB) in the cerebrospinal fluid (CSF) is the most consistent laboratory abnormality in patients with multiple sclerosis (MS). The most sensitive method for the detection of CSF OCB is isoelectric focusing (IEF) [6]. Occasional patients with clinically definite MS lack evidence for intrathecal IgG synthesis [7, 8]. This study was designed to compare clinical data and evoked potential (EP) findings between CSF OCB positive and OCB negative MS patients. The study comprised 22 OCB negative patients with clinically definite MS [11] and 22 OCB positive controls matched for age, disease duration, activity and course of MS. In both groups clinical assessment was performed by using Expanded Disability Status Scale (EDSS) score [12] and progression rate (PR). All patients underwent multimodal EP: visual (VEPs), brainstem auditory (BAEPs) and median somatosensory (mSEPs). The VEPa were considered abnormal if the P100 latency exceeded 117 ms or inter-ocular difference greater than 8 ms was detected. The BAEPs were considered abnormal if waves III or V were absent or the interpeak latencies I-III, III-V, or I-V were increased. The mSEPs were considerd abnormal when N9, N13 and N20 potentials were absent or when increased interpeak latencies were recorded. The severity of the neurophysiological abnormalities was scored for each modality as follows normal EP score 0; every other EP abnormality except the absence of one of the main waves, score 1; absence of one or more of the main waves, score 2 [13]. Both mean EDSS score (4.0 vs. 3.5) and PR (0.6 vs. 0.5) were similar in OCB positive and OCB negative group, (p>0.05). In the first group males were predominant, but without statistical significance (Table 1). Disease started more often with the brainstem symptoms in the OCB positive than in OCB negative MS group (p=0.028), while there was no differences in other initial symptoms between the groups (Graph 2). The frequency of (multimodal) EP abnormalities was higher in the OCB positive group but the differences were not statistically significant, except for bilateral SEP abnormalities (p=0.012). The severity of the AEPs abnormalities was similar in both groups while for the VEPs and SEPs abnormalities were more pronounced in the OCB positive group but not significantly (Table 2). The male preponderance of OCB negative MS patients in our study is in accordance with previous studies [14, 15]. This finding could be potentially ascribed to the well known gender-related differences in both humoral and cellular immune responses [17]. We found no statistically significant differences in either disability or PR between the two patient groups, although OCB negative MS patients had lower EDSS score and PR than OCB positive cases. In accordance with these findings, Fukazawa et al. also failed to show differences in disability between OCB negative and positive MS patients. On the other hand, few studies reported that OCB negative MS patients have a better prognosis [16 18]. The only clinical difference between two groups of patients that we found was that the disease more often started with brainstem symptoms in OCB positive MS patients (p=0.028). OCB positive MS patients had more often bilateral SEPs abnormalities (p=0.012). There was no statistically significant differences between two groups of patients in the severity of trimodal EPs abnormalities and the frequency of BAEPs and VEPs abnormalities although OCB negative patients had trend towards less pronounced EP disturbancies. In conclusion, our results did not reveal significant difference in clinical and neurophysiological(y) parameters between two groups of patients. However, they indicate a trend towards better prognosis of the disease in OCB negative MS patients.

scholarly journals Application of Geographical Information System Techniques to Determine High Crash-Prone Areas in the Fort Peck Indian Reservation

2020 ◽  
Vol 14 (1) ◽  
pp. 174-185
Author(s):  
Sahima Nazneen ◽  
Mahdi Rezapour ◽  
Khaled Ksaibati
Keyword(s):  
Information System ◽  
High Risk ◽  
Injury Severity ◽  
Statistical Significance ◽  
Temporal Analysis ◽  
The United States ◽  
Geographical Information ◽  
Improvement Program ◽  
Indian Reservation ◽  
Road Segments

Background: Historically, Indian reservations have been struggling with higher crash rates than the rest of the United States. In an effort to improve roadway safety in these areas, different agencies are working to address this disparity. For any safety improvement program, identifying high risk crash locations is the first step to determine contributing factors of crashes and select corresponding countermeasures. Methods: This study proposes an approach to determine crash-prone areas using Geographic Information System (GIS) techniques through creating crash severity maps and Network Kernel Density Estimation (NetKDE). These two maps were assessed to determine the high-risk road segments having a high crash rate, and high injury severity. However, since the statistical significance of the hotspots cannot be evaluated in NetKDE, this study employed Getis-Ord Gi* (d) statistics to ascertain statistically significant crash hotspots. Finally, maps generated through these two methods were assessed to determine statistically significant high-risk road segments. Moreover, temporal analysis of the crash pattern was performed using spider graphs to explore the variance throughout the day. Results: Within the Fort Peck Indian Reservation, some parts of the US highway 13, BIA Route 1, and US highway 2 are among the many segments being identified as high-risk road segments in this analysis. Also, although some residential roads have PDO crashes, they have been detected as high priority areas due to high crash occurrence. The temporal analysis revealed that crash patterns were almost similar on the weekdays reaching the peak at traffic peak hours, but during the weekend, crashes mostly occurred at midnight. Conclusion: The study would provide tribes with the tool to identify locations demanding immediate safety concerns. This study can be used as a template for other tribes to perform spatial and temporal analysis of the crash patterns to identify high risk crash locations on their roadways.

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