scholarly journals Closure of Petersen’s defect in gastrectomy for gastric cancer: an interrupted time series analysis from a high-volume institution in China

2020 ◽  
Author(s):  
Tao Pan ◽  
Hui Wang ◽  
Kai Liu ◽  
Xin-zu Chen ◽  
Wei-han Zhang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Interrupted Time Series ◽  
High Volume ◽  
Rank Test ◽  
Interrupted Time Series Analysis ◽  
Log Rank Test ◽  
Petersen’S Hernia ◽  
Closure Group ◽  
Group 1

Abstract Purpose Petersen’s hernia (PH) is a serious complication after gastrectomy for gastric cancer. The aim of this study was to investigate whether closure of Petersen’s defect (PD) can decrease the rates of PH and suspected Petersen’s hernia (SPH). Methods Patients who underwent gastrectomy with PD were enrolled. From January 2014 to January 2017, we performed gastrectomy without PD closure (non-closure group). From February 2017 to June 2018, we closed PDs during gastrectomy (closure group). The rates of PH and SPH were compared between the two groups. The last follow-up was updated in August 2020. Results Among a total of 1213 patients, 12 patients (1.0%) developed PH, and 23 patients (1.9%) developed SPH. The rate of PH in the closure group was significantly lower than that in the non-closure group (1/385, 0.3% versus 11/828, 1.3%, p = 0.042, log-rank test). The rate of SPH in the closure group was significantly lower than that in the non-closure group (1/385, 0.3% versus 22/828, 2.7%, p = 0.008, log-rank test). Non-closure of PD was a risk factor for PH and SPH (odds ratio (OR) 7.72, 95% CI 1.84–32.35, p = 0.006). Conclusions PD closure is recommended after gastrectomy for gastric cancer, as the rates of PH and SPH were significantly decreased.

scholarly journals Closure of Petersen's defect in gastrectomy for gastric cancer: an interrupted time-series analysis from a high-volume institution in China

2020 ◽  
Author(s):  
Tao Pan ◽  
Hui Wang ◽  
Kai Liu ◽  
Xin-zu Chen ◽  
Wei-han Zhang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Time Series ◽  
Risk Factor ◽  
Internal Hernia ◽  
Odds Ratio ◽  
Interrupted Time Series ◽  
High Volume ◽  
Interrupted Time Series Analysis ◽  
Closure Group ◽  
Group 1

Abstract Background Internal hernia (IH) and small bowel obstruction (SBO) are serious complications after gastrectomy for gastric cancer. Whether closure of Petersen's defect (PD) might reduce the rates is unknown. Methods Patients underwent gastrectomy with PD were enrolled. From January 2014 to January 2017, we performed gastrectomy without closure of PD (non-closure group). From February 2017 to June 2018, we closed PD (closure group). The rates of IH, suspected internal hernia (SIH), and SBO were compared between the two groups. Results Among a total of 1213 patients, 151 patients (12.4%) developed SBO after gastrectomy, 10 patients (0.8%) developed IH and 20 patients (1.6%) developed SIH. The rate of SBO and SIH were 15.0% (124/828) and 2.3% (19/828) respectively in the non-closure group, compared with 7.0% (27/385) and 0.3% (1/385) in the closure group (p = 0.017 and p = 0.015 respectively). The rate of IH in the closure group (1/385, 0.3%) was lower than the non-closure group (9/828, 1.1%). Non-closure of PD was a risk factor for IH and SIH [odds ratio (OR) 6.58, 95%CI 1.56–27.85, p = 0.011]. Conclusions Closure of PD is recommended after gastrectomy, as we noticed a significantly lower rate of SBO and SIH, and a tendency for lower rate of IH.

Updated result on the 2.5-year follow-up of GC0301/TOP-002: Randomized phase III study of irinotecan plus S-1 (IRI-S) versus S-1 alone as first-line treatment for advanced gastric cancer (AGC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4544-4544
Author(s):  
A. Tsuburaya ◽  
H. Narahara ◽  
H. Imamura ◽  
K. Hatake ◽  
H. Imamoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Benefit ◽  
Phase Iii ◽  
Rank Test ◽  
Diffuse Type ◽  
Chi Square ◽  
Log Rank Test ◽  
Chi Square Test ◽  
Significant Superiority

4544 Background: IRI-S had longer in median survival time (MST) than S-1 alone, and was well tolerated in previously untreated AGC, but not statistically significant. Considering 68 patients (pts) were censored, further follow-up was needed to confirm the OS with more precision (Imamura et al. ASCO-GI 2008). We now present updated results of OS and exploratory analysis with the prolonged 2.5 year follow-up data. Methods: Treatments Arm A (oral S-1 80 mg/m2/day from Day 1 to 28, q6w), or Arm B (IRI-S; oral S-1 80 mg/m2/day from Day 1 to 21 and intravenous irinotecan 80 mg/m2 on Days 1 and 15, q5w) were continued until disease progression or unacceptable toxicities were observed. The primary endpoint was to compare OS between groups. This updated result was regarded as exploratory position. Results: Although the MST of Arm A was 319 days (95%Cl: 286–395) and of Arm B was 389 days (95%Cl: 324–459), Arm B didn’t show statistically significant superiority to Arm A (log-rank test p=0.54; hazard ratio (HR) =0.93). The 1-year survival was 45.0% in Arm A and 52.0% in Arm B, and the 2-year survival was 22.5% and 18.0%, respectively. Response rate was significantly different (Arm A/B, 26.9%/41.5%; chi-square test p=0.04) in 187 patient evaluated by RECIST criteria. Time to treatment failure was also favored in Arm B (median=138 days) compared to Arm A (111 days; log-rank test p=0.16; HR=0.85). In subset analyses, two groups showed possibility of clinical benefit in Arm B. The HR of diffuse type group was 0.71 (95%Cl: 0.52–0.96), and of PS1, 2 group was 0.63 (95%Cl: 0.42–0.95). As post protocol treatment, 45.6% of Arm A patients received an irinotecan-based regimen, and the MST of them was 496 days (95%Cl: 395–573). Conclusions: IRI-S did not show statistically significant superiority to S-1 alone in OS with this follow-up data. Post protocol treatment, effective treatment after S-1 failure might have affected survival. According to exploratory analyses, IRI-S may have clinical benefit in early-term of treatment, group of the diffuse type and that of PS1, 2. We need more considering predictive factors, because the gastric cancer is heterogeneous adenocarcinoma. [Table: see text]

scholarly journals Helicobacter pylori dupA and gastric acid secretion are negatively associated with gastric cancer development

2010 ◽  
Vol 59 (12) ◽  
pp. 1484-1489 ◽  
Author(s):  
Shinobu Imagawa ◽  
Masanori Ito ◽  
Masaharu Yoshihara ◽  
Hidetaka Eguchi ◽  
Shinji Tanaka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Duodenal Ulcer ◽  
Gastric Acid ◽  
Acid Output ◽  
Rank Test ◽  
Peptic Ulcers ◽  
Log Rank Test ◽  
H Pylori

Few reports have described the cancer prevalence of peptic ulcer patients with long-term follow-up studies. We have conducted a long-term retrospective cohort study of Japanese peptic ulcer patients and evaluated the risk factors for the occurrence of gastric cancer (GCa). A total of 136 patients diagnosed with peptic ulcers from 1975 to 1983 were enrolled. These 136 cases [102 males and 34 females; 69 gastric ulcer (GU) and 67 duodenal ulcer (DU) patients at the time of enrolment; mean follow-up period of 14.4 years (range 1–30 years)] after being matched with a tumour registry database in Hiroshima prefecture were surveyed for GCa. We investigated Helicobacter pylori duodenal ulcer promoter gene A (dupA) using paraffin-embedded gastric biopsy specimens in 56 cases. Gastric acid secretion and basal acid output (BAO) in 40 cases, and maximal acid output in 68 cases, had been measured at first diagnosis of peptic ulcers. GCa was detected in 24 patients (17 with GU, 7 with DU) during the follow-up. The prevalence of GCa was significantly higher in GU patients than in DU patients (log-rank test P<0.05). dupA-positive H. pylori was detected not only in DU patients (9/20) but also in GU patients (9/36). Gastric acid output was significantly larger in quantity in patients with dupA-positive H. pylori than in those with dupA-negative H. pylori (P<0.05). The occurrence of GCa was significantly lower in patients with dupA-positive H. pylori and a high BAO level (log-rank test P<0.05). DUs, higher acid output and dupA-positive H. pylori were negatively associated with GCa.

Colorectal Liver Metastases - Does the Number of Lesions Determine the Sensibility of Resection?

Swiss Surgery ◽  
2000 ◽  
Vol 6 (1) ◽  
pp. 6-10
Author(s):  
Knoefel ◽  
Brunken ◽  
Neumann ◽  
Gundlach ◽  
Rogiers ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Colorectal Liver Metastases ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Chirurgische Entfernung

Die komplette chirurgische Entfernung von Lebermetastasen bietet Patienten nach kolorektalem Karzinom die einzige kurative Chance. Es gibt jedoch eine, anscheinend unbegrenzte, Anzahl an Parametern, die die Prognose dieser Patienten bestimmen und damit den Sinn dieser Therapie vorhersagen können. Zu den am häufigsten diskutierten und am einfachsten zu bestimmenden Parametern gehört die Anzahl der Metastasen. Ziel dieser Studie war es daher die Wertigkeit dieses Parameters in der Literatur zu reflektieren und unsere eigenen Patientendaten zu evaluieren. Insgesamt konnte von 302 Patienten ein komplettes Follow-up erhoben werden. Die gebildeten Patientengruppen wurden mit Hilfe einer Kaplan Meier Analyse und konsekutivem log rank Test untersucht. Die Literatur wurde bis Dezember 1998 revidiert. Die Anzahl der Metastasen bestätigte sich als ein prognostisches Kriterium. Lagen drei oder mehr Metastasen vor, so war nicht nur die Wahrscheinlichkeit einer R0 Resektion deutlich geringer (17.8% versus 67.2%) sondern auch das Überleben der Patienten nach einer R0 Resektion tendenziell unwahrscheinlicher. Das 5-Jahres Überleben betrug bei > 2 Metastasen 9% bei > 2 Metastasen 36%. Das 10-Jahres Überleben beträgt bislang bei > 2 Metastasen 0% bei > 2 Metastasen 18% (p < 0.07). Die Anzahl der Metastasen spielt in der Prognose der Patienten mit kolorektalen Lebermetastasen eine Rolle. Selbst bei mehr als vier Metastasen ist jedoch gelegentlich eine R0 Resektion möglich. In diesen Fällen kann der Patient auch langfristig von einer Operation profitieren. Das wichtigere Kriterium einer onkologisch sinnvollen Resektabilität ist die Frage ob technisch und funktionell eine R0 Resektion durchführbar ist. Ist das der Fall, so sollte auch einem Patienten mit mehreren Metastasen die einzige kurative Chance einer Resektion nicht vorenthalten bleiben.

The effects of centralizing cancer surgery on postoperative mortality: A systematic review and meta-analysis

2021 ◽  
pp. 135581962110089
Author(s):  
Roberto Grilli ◽  
Federica Violi ◽  
Maria Chiara Bassi ◽  
Massimiliano Marino
Keyword(s):  
Evaluation Studies ◽  
Meta Analysis ◽  
Postoperative Mortality ◽  
Interrupted Time Series ◽  
High Volume ◽  
Cancer Surgery ◽  
Interrupted Time Series Analysis ◽  
Meta Regression ◽  
Meta Regression Analysis ◽  
After Cancer

Objectives To review the evidence of the effects of centralization of cancer surgery on postoperative mortality. Methods We searched Medline, Embase, Cinahl, Cochrane and Scopus (up to November 2019) for studies that (i) assessed the effects of centralization of cancer surgery policies on in-hospital or 30-day mortality, or (ii) described changes in both postoperative mortality for a surgical intervention and degree of centralization using reduction in the number of hospitals or increases in the proportion of patients undergoing cancer surgery at high volume hospitals as proxy. PRISMA guidelines were followed. We estimated pooled odds ratios (OR) and conducted meta-regression to assess the relationship between degree of centralization and mortality. Results A total of 41 studies met our inclusion criteria of which 15 evaluated the effect of centralization policies on postoperative mortality after cancer surgery and 26 described concurrent changes in the degree of centralization and postoperative mortality. Policy evaluation studies mainly used before-after designs (n = 13) or interrupted time series analysis (n = 2), mainly focusing on pancreatic, oesophageal and gastric cancer. All but one showed some degree of reduction in postoperative mortality, with statistically significant effects demonstrated by six studies. The pooled odds ratio for centralization policy effect was 0.68 (95% Confidence interval: 0.54–0.85; I2 = 80%). Meta-regression analysis of the 26 descriptive studies found that an increase of the proportion of patients treated at high volume hospitals was associated with greater reduction in postoperative mortality. Conclusions Centralization of cancer surgery is associated with reduced postoperative mortality. However, existing evidence tends to be of low quality and estimates of the effect size are likely inflated. There is a need for prospective studies using more robust approaches, and for centralization efforts to be accompanied by well-designed evaluations of their effectiveness.

The Relationship between Serum Ferritin Levels and 5-Year All-Cause Mortality in Hemodialysis Patients

2021 ◽  
pp. 1-7
Author(s):  
Emre Erdem ◽  
Ahmet Karatas ◽  
Tevfik Ecder
Keyword(s):  
Serum Ferritin ◽  
Hemodialysis Patients ◽  
Rank Test ◽  
Significant Difference ◽  
All Cause Mortality ◽  
Group 3 ◽  
Group 2 ◽  
The Relationship ◽  
Group 1

<b><i>Introduction:</i></b> The effect of high serum ferritin levels on long-term mortality in hemodialysis patients is unknown. The relationship between serum ferritin levels and 5-year all-cause mortality in hemodialysis patients was investigated in this study. <b><i>Methods:</i></b> A total of 173 prevalent hemodialysis patients were included in this study. The patients were followed for up to 5 years and divided into 3 groups according to time-averaged serum ferritin levels (group 1: serum ferritin &#x3c;800 ng/mL, group 2: serum ferritin 800–1,500 ng/mL, and group 3: serum ferritin &#x3e;1,500 ng/mL). Along with the serum ferritin levels, other clinical and laboratory variables that may affect mortality were also included in the Cox proportional-hazards regression analysis. <b><i>Results:</i></b> Eighty-one (47%) patients died during the 5-year follow-up period. The median follow-up time was 38 (17.5–60) months. The 5-year survival rates of groups 1, 2, and 3 were 44, 64, and 27%, respectively. In group 3, the survival was lower than in groups 1 and 2 (log-rank test, <i>p</i> = 0.002). In group 1, the mortality was significantly lower than in group 3 (HR [95% CI]: 0.16 [0.05–0.49]; <i>p</i> = 0.001). In group 2, the mortality was also lower than in group 3 (HR [95% CI]: 0.32 [0.12–0.88]; <i>p</i> = 0.026). No significant difference in mortality between groups 1 and 2 was found (HR [95% CI]: 0.49 [0.23–1.04]; <i>p</i> = 0.063). <b><i>Conclusion:</i></b> Time-averaged serum ferritin levels &#x3e;1,500 ng/mL in hemodialysis patients are associated with an increased 5-year all-cause mortality risk.

scholarly journals Oncological and functional outcomes of supratotal resection of IDH1 wild-type glioblastoma based on 11C-methionine PET: a retrospective, single-center study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Seiichiro Hirono ◽  
Ko Ozaki ◽  
Masayoshi Kobayashi ◽  
Ayaka Hara ◽  
Tomohiro Yamaki ◽  
...  
Keyword(s):  
Functional Outcomes ◽  
Awake Craniotomy ◽  
Rank Test ◽  
Wild Type ◽  
Log Rank Test ◽  
Positron Emission ◽  
Single Center Study ◽  
Supratotal Resection ◽  
Subcortical Mapping

AbstractThe oncological and functional outcomes in glioblastoma (GBM) patients following supratotal resection (SupTR), involving complete resection of contrast-enhancing enhanced (CE) tumors and areas of methionine (Met) uptake on 11C-met positron emission tomography (Met-PET), are unknown. We conducted a retrospective review in newly diagnosed, IDH1 wild-type GBM patients, comparing SupTR with gross total resection (GTR), in which only CE tumor tissue was resected. All patients underwent standard radiotherapy and temozolomide treatment, and were followed for tumor recurrence and overall survival (OS). Among the 30 patients included in this study, 7 underwent SupTR and 23 underwent GTR. Awake craniotomy with cortical and subcortical mapping was more frequently performed in the SupTR group than in the GTR group. During the follow-up period, significantly different patterns of disease progression were observed between groups. Although more than 80% of recurrences were local in the GTR group, all recurrences in the SupTR group were distant. Median OS in the GTR and SupTR groups was 18.5 months (95% confidence interval [CI] 14.2–35.1) and not reached (95% CI 30.5-not estimable), respectively; this difference was statistically significant (p = 0.03 by log-rank test). No postoperative neurocognitive decline was evident in patients who underwent SupTR. Compared to GTR alone, aggressive resection of both CE tumors and areas with Met uptake (SupTR) under awake craniotomy with functional mapping results in a survival benefit associated with better local control and neurocognitive preservation.

scholarly journals Survival analysis of elderly patients over 65 years old with stage II/III gastric cancer treated with adjuvant chemotherapy after laparoscopic D2 gastrectomy: a retrospective cohort study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yanrui Liang ◽  
Liying Zhao ◽  
Hao Chen ◽  
Tian Lin ◽  
Tao Chen ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cohort Study ◽  
Adjuvant Chemotherapy ◽  
Elderly Patients ◽  
Retrospective Cohort ◽  
Stage Iii ◽  
Rank Test ◽  
Oral Capecitabine ◽  
D2 Gastrectomy ◽  
Log Rank Test

Abstract Background The benefits of adjuvant chemotherapy for elderly patients with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. This study aimed to evaluate the effectiveness and complications of adjuvant chemotherapy in patients > 65 years of age after laparoscopic D2 gastrectomy. Methods This was a single-center retrospective cohort study of elderly patients (> 65 years) with stage II/III GC who underwent curative laparoscopic D2 gastrectomy with R0 resection between 2004 and 2018. The adjuvant chemotherapy regimens included monotherapy (oral capecitabine) and doublet chemotherapy (oral capecitabine plus intravenous oxaliplatin [XELOX] or intravenous oxaliplatin, leucovorin, and 5-fluorouracil [FOLFOX]). The data were retrieved from a prospectively registered database maintained at the Department of General Surgery in Nanfang Hospital, China. The patients were divided as surgery alone and surgery plus adjuvant chemotherapy (chemo group). The overall survival (OS), disease-free survival (DFS), chemotherapy duration, and toxicity were examined. Results There were 270 patients included: 169 and 101 in the surgery and chemo groups, respectively. There were 10 (10/101) and six (6/101) patients with grade 3+ non-hematological and hematological adverse events. The 1−/3−/5-year OS rates of the surgery group were 72.9%/51.8%/48.3%, compared with 90.1%/66.4%/48.6% for the chemo group (log-rank test: P = 0.018). For stage III patients, the 1−/3−/5-year OS rates of the surgery group were 83.7%/40.7%/28.7%, compared with 89.9%/61.2%/43.6% for the chemo group (log-rank test: P = 0.015). Adjuvant chemotherapy was significantly associated with higher OS (HR = 0.568, 95%CI: 0.357–0.903, P = 0.017) and DFS (HR = 0.511, 95%CI: 0.322–0.811, P = 0.004) in stage III patients. Conclusions This study suggested that adjuvant chemotherapy significantly improves OS and DFS compared with surgery alone in elderly patients with stage III GC after D2 laparoscopic gastrectomy, with a tolerable adverse event profile.

scholarly journals Interim Serum Soluble Interleukin-2 Receptor Levels Are Strongly Associated with Prognosis in Newly Diagnosis DLBCL Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4118-4118
Author(s):  
Haruya Okamoto ◽  
Akihiro Miyashita ◽  
Hiroaki Nagata ◽  
Yasuhiko Tsutsumi ◽  
Yuri Kamitsuji ◽  
...  
Keyword(s):  
Poor Prognosis ◽  
Interleukin 2 ◽  
B Cell Lymphoma ◽  
Clinical Variable ◽  
Rank Test ◽  
Prognostic Impact ◽  
Interleukin 2 Receptor ◽  
Log Rank Test ◽  
Soluble Interleukin 2 Receptor

<Background> Serum soluble interleukin-2 receptor (sIL2R) levels are often measured to evaluate the state of lymphoma. The serum sIL2R level at diagnosis has been reported to be correlated with the prognosis of diffuse large B cell lymphoma (DLBCL) patients treated with the R-CHOP regimen. However, it is unclear whether interim sIL2R levels are associated with prognosis in DLBCL. Here, we analyzed the prognostic impact of interim serum sIL2R levels in DLBCL. <Patients and Methods> We retrospectively examined data for DLBCL patients who started receiving chemotherapy at the Japanese Red Cross Society Kyoto Daini Hospital between January 2012 and December 2018. All of the patients received R-CHOP-like regimens (rituximab plus pirarubicin or adriamycin, cyclophosphamide, vincristine, and prednisolone). The interim sIL2R level (I-IL2R) was defined as the value measured after the third chemotherapy cycle. I-IL2R levels of >700 U/ml were regarded as positive. The primary endpoints of this study were progression-free survival (PFS) and overall survival (OS). The unadjusted probabilities of PFS and OS were estimated using the Kaplan-Meier method. The log-rank test and multivariate Cox regression analysis were used to assess the prognostic value of each clinical variable. <Results> In total, 102 patients were enrolled. The patients' median age was 73.5 years (range, 35-88), 58 patients (56.9%) were male, and 52 (51.0%) had poor revised International Prognostic Index scores. The median follow-up time was 25.2 months (range, 3.7-88.6). Twenty-three patients (22.5%) were I-IL2R-positive (>700 U/ml). Univariate analysis revealed that I-IL2R-positivity was associated with a poor prognosis. The 3-y PFS rates of the I-IL2R-negative (<700 U/ml) and I- IL2R-positive (>700 U/ml) patients were 60.4% (95% confidence interval [95%CI], 46.2-71.9) and 37.5% (95%CI, 15.7-59.4; p<0.001, log-rank test), respectively, and their 3-y OS rates were 82.2% (95%CI, 69.7-89.9) and 37.4% (95%CI, 13.8-61.4; p<0.001, log-rank test), respectively. Multivariate analysis confirmed that the I-IL2R level is independently associated with prognosis. <Conclusion> The I-IL2R level of >700 U/ml patients had poor prognosis. The I-IL2R level can be used to predict the outcomes of DLBCL patients. IL2R levels should be measured during chemotherapy, and I-IL2R-positive patients could be targeted with high-dose or novel therapies. As this study was based on a retrospective analysis and involved a small cohort and a limited follow-up period, further studies are needed to confirm the prognostic impact of I-IL2R. Figure Disclosures No relevant conflicts of interest to declare.

T-cell clonality in peripheral blood as a predictor of progression to systemic treatment in patients with stage IB mycosis fungoides (MF).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19538-e19538
Author(s):  
Suravi Raychaudhuri ◽  
Charli-Joseph Yann ◽  
Michelle Mintz ◽  
Laura Pincus ◽  
Chiung-Yu Huang ◽  
...  
Keyword(s):  
T Cell ◽  
Peripheral Blood ◽  
Systemic Treatment ◽  
Rank Test ◽  
P Value ◽  
Advanced Stage ◽  
Stage Ib ◽  
Log Rank Test ◽  
Secondary Outcomes

e19538 Background: A major unmet clinical need in the care of early-stage MF patients is the identification of those with a high risk of failing skin directed therapy or progressing to advanced disease. Herein, we inquired if the identification of a clonal T-cell receptor (TCR) gene rearrangement by PCR in peripheral blood could predict the clinical outcome, particularly the need for systemic treatment, in patients with stage IB MF. Methods: This is a retrospective cohort study of patients with stage IB MF who underwent peripheral blood TCR clonality analysis by PCR. The primary outcome of the study was time from diagnosis to initiation of systemic treatment. Secondary outcomes were: (1) time to progression to advanced-stage disease (stages IIB-IV) and (2) overall survival. Patients were censored at time of last clinical follow up. Log rank test was used to compare the survival distributions of the two groups; p value < 0.05 was considered significant. Results: From May 2014 to October 2019, 56 consecutive stage IB pts with > 6 months follow up were included in this analysis. Peripheral blood TCR clonality status was available in 42 patients: 18 pts had a positive TCR clone and 24 did not. Median follow up time was 36 months (range 8.5 – 198 months). At 3 years, 39% of patients with peripheral clone had progressed to systemic treatment versus 8% of those without a peripheral clone (log rank test, p-value = 0.003). For the secondary outcomes, at 3 years 17% of patients with peripheral clone had progressed to advanced stage versus 4% of those without (log rank test, p-value = 0.10); 5% of patients with peripheral clone had died versus 0% of those without (log rank test, p-value = 0.03). Conclusions: Detection of a predominant TCR clone by PCR in the peripheral blood is an important prognostic marker in the initial workup of MF, as its presence is highly correlated with subsequent progression to systemic treatment and death. If this finding is validated, it can be used to risk stratify and individualize therapy for MF patients.[Table: see text]

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