scholarly journals Clinical characteristics and prognosis of 50 patients with a myeloproliferative syndrome and deletion of part of the long arm of chromosome 5

Blood ◽  
1985 ◽  
Vol 66 (1) ◽  
pp. 189-197 ◽  
Author(s):  
GW Dewald ◽  
MP Davis ◽  
RV Pierre ◽  
JR O'Fallon ◽  
HC Hoagland

Of 50 consecutive patients (30 female and 20 male; median age,70 years) with a myeloproliferative disorder and a 5q- chromosome, 12 (24%) had refractory anemia, 16 (32%) had refractory anemia with excess blasts, 13 (26%) had acute nonlymphocytic leukemia, six (12%) had the 5q- syndrome, and three (6%) had an unclassifiable myeloproliferative disease. Twenty-five patients had only a 5q- anomaly (group 1), and 25 had a 5q- plus additional chromosome abnormalities (group 2). Four types of 5q- anomalies were recognized: a del(5)(q13q33) occurred in 39 patients, a del(5)(q31q35) in nine, a del(5)(q22q33) in one, and a del(5)(q13q35) in one. The survival distribution for patients in group 1 was significantly better (P = .012) than for those in group 2. Cox- model analyses indicated that having a 5q- chromosome and other abnormalities is significantly (P less than .01) associated with poor survival even after adjustment for the effects of other important factors such as type of disease, age, and sex. The two groups had similar distributions of most variables, including age, sex, and disease types. However, patients in group 1 had a significantly higher platelet count and mean corpuscular volume than those in group 2. Only two patients in group 1 had had prior chemotherapy, but nine in group 2 had had either prior chemotherapy or radiation or both, and one patient in group 2 had had heavy exposure to pesticides.

Blood ◽  
1985 ◽  
Vol 66 (1) ◽  
pp. 189-197 ◽  
Author(s):  
GW Dewald ◽  
MP Davis ◽  
RV Pierre ◽  
JR O'Fallon ◽  
HC Hoagland

Abstract Of 50 consecutive patients (30 female and 20 male; median age,70 years) with a myeloproliferative disorder and a 5q- chromosome, 12 (24%) had refractory anemia, 16 (32%) had refractory anemia with excess blasts, 13 (26%) had acute nonlymphocytic leukemia, six (12%) had the 5q- syndrome, and three (6%) had an unclassifiable myeloproliferative disease. Twenty-five patients had only a 5q- anomaly (group 1), and 25 had a 5q- plus additional chromosome abnormalities (group 2). Four types of 5q- anomalies were recognized: a del(5)(q13q33) occurred in 39 patients, a del(5)(q31q35) in nine, a del(5)(q22q33) in one, and a del(5)(q13q35) in one. The survival distribution for patients in group 1 was significantly better (P = .012) than for those in group 2. Cox- model analyses indicated that having a 5q- chromosome and other abnormalities is significantly (P less than .01) associated with poor survival even after adjustment for the effects of other important factors such as type of disease, age, and sex. The two groups had similar distributions of most variables, including age, sex, and disease types. However, patients in group 1 had a significantly higher platelet count and mean corpuscular volume than those in group 2. Only two patients in group 1 had had prior chemotherapy, but nine in group 2 had had either prior chemotherapy or radiation or both, and one patient in group 2 had had heavy exposure to pesticides.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2929-2929
Author(s):  
Isabelle A. Bence-Bruckler ◽  
Sheryl McDiarmid ◽  
Harold L. Atkins ◽  
Mitchell Sabloff ◽  
Isabelle Gauthier ◽  
...  

Abstract The optimal dose and schedule of granulocyte colony-stimulating factor (G-CSF) for peripheral blood progenitor cell (PBPC) mobilization is unclear. When PBPC mobilization is performed using chemotherapy and growth factor priming, growth factors are often initiated early (day +1) upon completion of chemotherapy. Several small trials report safe and successful PBPC collection after delayed G-CSF initiation. We evaluated two schedules of G-CSF administration in patients with lymphoma and myeloma undergoing PBPC collection. We compared CD34+ cell yields obtained in each group and number of G-CSF doses required. Secondary end points were post-transplant neutrophil and platelet recovery and duration of febrile neutropenia, IV antibiotic administration and hospitalization. We studied patients with lymphoma and myeloma referred for ASCT. Eligible patients had not received more than two prior chemotherapy regimens or pelvic irradiation. Priming chemotherapy was DHAP (lymphoma) or cyclophosphamide 2.5 gm/m2 (myeloma and lymphoma). Rituximab was combined with chemotherapy for certain lymphoma patients for purposes of in vivo purging. G-CSF was initiated either 24 hours (day +1) post completion of chemotherapy (Group 1), or on the 5th day (day +5) after chemotherapy (Group 2). The dose of G-CSF was 300 ug sc daily for patients weighing 70 kg or less, and 480 ug sc daily if > 70 kg. Leukapheresis was initiated when the WBC count was >2.0 x 109/l and the CD34+ count was >10/microliter. Single or serial daily leukaphereses were performed until a minimum of 2 x 106 CD34+ cells/kg were obtained. There were eighty-one consenting patients: 30 with nonHodgkin’s lymphoma, 37 with myeloma and 14 with Hodgkin’s lymphoma. Priming was done with DHAP in 33 and with cyclophosphamide in 46. Forty-two were randomized to day +1 G-CSF initiation (Group1) and 39 to day +5 (Group 2). Diagnosis, prior chemotherapy or priming regimen did not vary among the study groups. Three patients in Group 1 did not proceed to collection (two due to disease progression, the third withdrew consent). All patients in Group 1 were successfuly mobilized, while in group 2, two were not successfully mobilized (p=0.49). Of these patients, one underwent marrow harvest while the other was transplanted with a suboptimal CD34+ cell count. In Group 1, 32 of 39 were mobilized with a single leukapheresis and 7 required two; in Group 2, 25 of 37 were mobilized in 1 day, 11 in 2 days and one patient required 4 days (p=0.2).The median number of CD34+ cells collected was 10.6 x 106/kg in Group 1 versus 7.9 x 106/kg in Group 2 (p=.04). The median number of doses of G-CSF administered was 9 in Group 1 and 6 in Group 2 (p<.0001). The time to neutrophil and platelet recovery were 11 and 11.5 days respectively and did not differ amoung the groups. There was no difference in the number of platelet transfusions, duration of febrile neutropenia, antibiotic use or length of hospitalization. The number of units of RBC transfused in Group 1 was 4 (range; 0–11) versus 2 in Group 2 (range; 0–21; p=.04). Stem cell mobilization using delayed G-CSF initiation was as effective as early initiation, and required a median of 9 vs 6 doses of drug. Despite lower CD34+ yields in the delayed G-CSF group, the outcome of mobilization was not compromised and post-transplant engraftment, infectious complications and hospitalization were comparable.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1033-1033 ◽  
Author(s):  
S. L. Moulder ◽  
A. O’Neill ◽  
C. Arteaga ◽  
M. Pins ◽  
J. Sparano ◽  
...  

1033 Background: Activation of EGF receptor has been associated with resistance to trastuzumab in breast cancer cell lines. EGFR tyrosine kinase inhibitors inhibit HER2 phosphorylation and synergize with trastuzumab in HER2+ cell lines that co-express EGFR. Methods: Pts with MBC and HER2 overexpression by immunohistochemistry (3+) and/or HER2 gene-amplification by FISH, 0–2 prior chemotherapy regimens for met disease, LVEF 50%, and no prior trastuzumab were treated with trastuzumab 2 mg/kg/wk and gefitinib 250- 500 mg/day until disease progression, unacceptable toxicity or withdrawal of consent. The phase I portion of the trial used a 3+3 design to determine MTD. In the phase II portion of the trial, patients were stratified based upon prior chemotherapy exposure (Group 1= no prior exposure to chemotherapy, Group 2= prior exposure to 1–2 chemotherapy regimens). Response measured using RECIST criteria. The primary endpoint was to increase proportion progression free from 50 to 65% at 6 months in Group 1 and from 50 to 70% at 3 months in Group 2. Results: Phase I: DLT (Grade 3 diarrhea) occurred in 2/3 patients treated at the 500 mg/day dose level of gefitinib in combination with weekly trastuzumab. 0/3 patients treated at the 250 mg/day dose level experienced DLT. This was considered MTD and was the dose selected for the Phase II portion of the trial. Phase II: 36 eligible pts were enrolled. Most patients were ECOG PS of 0 and had visceral organ involvement. Of the patients enrolled in Group 1, one pt achieved a CR, one PR and 7 had SD (≥ 24 weeks). Median time to progression (TTP) was 2.9 months (95% CI, 2.5–4). In Group 2 no responses were observed with a median TTP of 2.5 months (95% CI, 1.5- 2.7). Most common severe toxicities were rash (grade 3, 14%) and diarrhea (grade 3, 30%). No grade 3 cardiac toxicity was encountered. Conclusions: Trastuzumab in combination with gefitinib at doses of 250 mg/day demonstrated an acceptable toxicity profile; however, during planned interim analysis, the TTP did not meet predetermined statistical endpoints required for study continuation. These results do not support the further use of this combination and have implications for other trials using trastuzumab and EGFR TK inhibitors simultaneously. [Table: see text]


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 5070-5070
Author(s):  
Mauricette Michallet ◽  
Mohamad Sobh ◽  
Stéphane Morisset ◽  
Carine Champigneulle ◽  
Florence Ranchon ◽  
...  

Abstract Abstract 5070 In a recent phase III trial, azacitidine was demonstrated to significantly prolong OS compared with conventional care regimens in patients classified in intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS) (Fenaux et al. 2009). This study used the French- American-British (FAB) classification for MDS and included approximately one third of patients with refractory anemia with excess blasts in transformation (RAEB-t; 20% to 30% bone marrow blasts). WHO criteria now define AML as ≥20% BM blasts. Using those criteria, RAEB-t is now considered as AML. We conducted a retrospective analysis on patients who received azacitidine between August 2005 and November 2011 at our institution for MDS or AML. Patients were identified through the hospital database and individual charts were reviewed. The primary objective was to investigate the outcome of patients receiving azacitidine in a daily clinical practice in high risk MDS and AML patients and to evaluate its impact on overall survival (OS). Secondary objectives were hematological response rate and transfusion spare. Patients were included if they received at least one cycle of azacitidine. Disease status was defined by both the French American British (FAB) and the World Health Organization (WHO) classification systems, and risk was scored by the International Prognostic Scoring System (IPSS). All analyses were conducted using R statistical software. Descriptive statistics were used for baseline characteristics. Kaplan-Meier estimates were used to calculate overall survival (OS). There were 79 patients, 51 (65%) males and 28 (35%) females with a median age of 70 years (32–85). The indication of azacitidine was the first line treatment use for MDS, mainly refractory anemia with excess blasts, in 40 (51%) patients (group1) and treatment for patients who had AML and transformed, in 39 (49%) patients (group2). (post chemotherapy: n=16, first line: n=23). Patient characteristics, prognostic factors according to FAB classification, ISPP risk and cytogenetics for both groups are shown in table1. The median number of azacitidine cycles in groups 1 and 2 was 8 (1–30) and 3 (1–29) respectively. Evaluation after 6 cycles showed 55% of responders in group 1 and 31% in group 2; the rest of patients have progressed. The median OS for the group 1 was 24. 5 months (17. 8-NR) while in group2; it was 15. 5 months (11. 2-NR) for patients who received AZA in first line and 6 months (3. 9-NR) for patients with previous chemotherapy. In terms of transfusions number, we did not find any significant spare in terms of both RBC and platelets transfusion in group1 while there was a significant spare of 33% of red blood cells transfusions (p=0. 05) and 42% of platelets transfusions only in group 2 (p=0. 04). The multivariate analysis studying the impact of different variables on OS showed: a worse OS in AML patients with previous chemotherapy (HR= 9. 84 [ 3. 56 – 27. 19 ], p< 0. 001), a worse OS in patients with unfavorable caryotype (HR= 7. 30 [ 2. 13 – 24. 98 ], p< 0. 001), and a better OS in female patients (HR= 0. 31 [ 0. 14 – 0. 68 ], p= 0. 003). Our study confirmed results from previous prospective study in MDS patients while AML patients not receiving azacitidine in first line do not seem to benefit from this treatment. Cytogenetics remain a major factor impacting OS with no significant impact of IPSS. Disclosures: Nicolini: Novartis, Bristol Myers-Squibb, Pfizer, ARIAD, and Teva: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.


2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi132-vi132
Author(s):  
Yang Liu ◽  
Myla Strawderman ◽  
Kwanza Warren ◽  
Margie Richardson ◽  
Jennifer Serventi ◽  
...  

Abstract Recent clinical trials demonstrated that adding tumor treating fields (TTF) to radiotherapy and temozolomide chemotherapy (the Stupp protocol) increased survival for glioblastoma (GBM) patients. However, data is lacking on the magnitude of this survival effect when the regimen is used outside of a clinical trial as part of routine clinical practice. In the present study, we retrospectively identified adult patients with newly diagnosed GBM (n = 240) treated with the Stupp protocol at our institution from January 2005 to July 2017. We grouped patients into two time periods for comparison: 2005–2013 (group 1, Stupp protocol) and 2014–2017 (group 2, TTF+ Stupp protocol). Thirty-six percent (37/104) of patients in group 2 received TTF in conjunction with the Stupp protocol. Within group 2, the 37-patients who received TTF + Stupp had increased 6-month and 1-year survival rates compared to the 67-patients who received Stupp alone (97.1% vs. 75.7%, p = 0.006; 67.6% vs. 53.7%, p = 0.170, respectively). The improvement of survival rate at 6-month was further confirmed by a modified Poisson model (RR: 1.23, p = 0.010) adjusting for sex, age, performance status and extent of resection. However, we did not observe improvements in overall survival (OS) with a Cox model with TTF treatment modeled as a time-dependent covariate (HR = 0.87, p = 0.599). Furthermore, we did not find that the addition of TTF as a treatment option in our center significantly improved OS for patients in group 2 when compared to those in group 1 (429.0 vs. 395.0 days, p = 0.138). Therefore, while adding TTF to the Stupp protocol appeared to benefit patients with newly diagnosed GBM, this effect may be largely due to selection bias. Comprehensive studies including large number of patients as well as longer follow-up time are needed to validate our results.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18108-e18108
Author(s):  
Natalie Maimon ◽  
Daniel Keizman ◽  
Maya Gottfried

e18108 Background: The EGFR inhibitor erlotinib is a standard second line tx for mNSCLC. Statins are used in the tx of hyperlipidemia. Pre-clinical and clinical studies in several cancer types have shown that they may inhibit tumor growth. Their effect on the outcome of erlotinib as second line tx in mNSCLC is poorly defined. We aimed to study the effect of statins on the outcome of erlotinib as second line tx for mNSCLC. Methods: We performed a retrospective study of an unselected cohort of pts with mNSCLC, who were treated continuously with 150mg of oral erlotinib. Pts were divided into 2 groups: (1) statins users and (2) statins naive. The effect of statins use on objective response, progression free survival (PFS) and overall survival (OS), was tested with adjustment of other known confounding risk factors using a chisquare test and partial likelihood test from cox model. Results: Between 2005-2011, 107 pts with mNSCLC were treated with second line erlotinib. There were 51 statins users (group 1) and 56 nonusers (group 2). All users started statins before erlotinib tx initiation. The groups were balanced regarding the following known clinical prognostic factors: female gender, ECOG performance status, active smoking, anemia, adenocarcinoma histology type, EGFR mutation (positive vs negative + unknown). Objective response in group 1 vs 2 was partial response (PR) 41% vs 29% (p=0.15), stable disease (SD) 41% vs 25% (p=0. 11), and progressive disease (PD) 18% vs 46% (OR=2.5, p=0.07). Median PFS was 12 vs 3 ms (HR 0.44 in statins users, p=0.02). Median OS was 35 vs 19 ms (HR 0.63, p=0.1). Conclusions: Statins may improve the outcome of pts with mNSCLC that are treated with erlotinib as second line tx. This should be investigated prospectively, and if validated, applied in clinical practice and clinical trials.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S580-S581
Author(s):  
Rinda Mousa ◽  
Xing Song ◽  
Lisa A Clough ◽  
Ajoy Dias ◽  
Fernando Merino ◽  
...  

Abstract Background There is a paucity of outcome studies on HIV-associated lymphoma treated with chemotherapy with or without autologous hematopoietic stem cell transplantation (autoHSCT) in comparison to HIV-uninfected individuals with similar histology. Methods In our retrospective matched cohort study, we enrolled adult HIV-positive patients with lymphoma treated with chemotherapy with (group 2) or without autoHSCT (group 1) between January 1, 2007 to December 31, 2018 at the University of Kansas Medical Center and followed until May 1, 2020. Group 1 were matched 1:1 to HIV-negative patients based on age, gender, lymphoma histology, stage at diagnosis, year of lymphoma diagnosis, and Group 2 were matched 1:2 to HIV-negative patients based on age at autoHSCT, gender, lymphoma histology, stage at diagnosis and year of transplantation. Overall survival (OS) and progression-free survival (PFS) at 2 years were calculated using Kaplan-Meier (KM) analysis, and adjustment for ECOG and IPI/IPS scores was done using multivariate Cox model. Results We had 37 HIV+ patients with lymphoma in our cohort: 9 Hodgkin’s disease (HD), 28 Non Hodgkin’s Lymphoma (NHL). Eleven underwent autoHSCT (3 HD, 8 NHL). The majority were white (76.2%), non-hispanic (92.9%), males (90.5%) and mean age was 46 years. Median CD4 was 172.5, HIV viral load was &lt; 50 copies/mL in 43..2%, and 76.2% were on antiretroviral therapy (ART) at diagnosis. ART was interrupted in 14.6% and adjusted in 40.5% of patients. After excluding rare histological types, 22 in group 1 and 9 in group 2 were included in the matched analysis. On KM survival at 2-years, group 1 had worse OS (75% vs 95%, p=0.02), and a trend for worse PFS (75% vs 90%, p=0.07) than the matched referent group, while group 2 had similar OS (100% vs 94%, p= 0.47) and better PFS (100% vs 70%, p=0.02) than the matched referent group. On Cox models adjusting for ECOG and IPI/IPS, HIV status was no longer independently associated with OS in group 1 or PFS in group 2. Group 1 HIV lymphoma cases and controls characteristics Group 2 HIV lymphoma with HSCT cases and controls characteristics Conclusion In patients with HIV and lymphoma treated with chemotherapy with or without autoHSCT, the outcomes are comparable to those without HIV in our single center contempory cohort. Disclosures Wissam El Atrouni, MD, ViiV (Advisor or Review Panel member)


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1711-1711
Author(s):  
Eugenia S. Polushkina ◽  
Roman G. Shmakov ◽  
Maria A. Vinogradova ◽  
Manana A. Sokolova ◽  
Nina D. Khoroshko

Abstract Background Myeloproliferative diseases (MPD) rarely occur in women of reproductive age. But in recent years it becomes more often that young women suffer from these diseases. The development of new drugs and therapeutic strategies provides good results in survival rate and life prognosis for these patients. All this requires special options for management of pregnancy in women with MPD. Aims To develop the protocol of preconception planning and pregnancy management and to evaluate pregnancy outcomes and complications in women with MPD. Methods We have analyzed 110 pregnancies in 90 women. The prospective group (group 1) included 67 women who were treated according to our algorithm. Retrospectively we have analyzed 43pregnancies in 23 women (group 2) who did not receive a special treatment of MPD during pregnancy. Our trial included women with main MPD: essential thrombocythemia, polycythemia vera, primary myelofibrosis. Pregnancy management included examination of blood cell count and hemostasis system twice a month, besides this the inherited trombophylia testing, lupus anticoagulant, homocystein level, antiphospholipid syndrome diagnostics and hematologic examination including trepanobiopsy and JAK2V617F mutation. Besides thorough laboratory examination our algorithm of pregnancy planning and management included cytoreductive therapy, antiaggregants, low molecular weight heparin, plasmapheresis, vitamins of group B. For the cytoreductive therapy we prescribed Interferon alfa which is the safest option in preconception planning and pregnancy management for women with MPD. Results Termination of pregnancy was made in 2 (3%) women of group 1 and in 3 (6,9%) women of group 2 (OR – 2,44; 95% C.I.: 0,265; 30,109). In the group of women who were treated according to our algorithm 6% of women (4 pregnancies) developed spontaneous abortions. In group 2 without special treatment spontaneous miscarriages occurred in 62,8% in comparison with group 1 (OR – 16,88; 95% C.I.: 4,655; 74,177). First and second trimester spontaneous abortions in group 2 prevailed among all the miscarriages – 15 (34,9%) cases, stillbirth occurred in 12 (27,9%) cases. Preterm labor were in 5 (7,4%) and 6 (14%) pregnancies in 1 and 2 groups respectively (OR – 2,01; 95% C.I.: 0,471; 8,899). Full-term delivery occurred in 83,6% (56 pregnancies) and 16,3% of cases (7 pregnancies) in two groups (OR – 26,18; 95% C.I.: 8,441; 85,448). Complications of pregnancy were analysed in 61 and 13 women in 1 and 2 groups respectively. Pregnancy was uncomplicated in 21 (34,4%) and 2 (15,4%) cases in 1 and 2 groups respectively (OR – 2,89; 95% C.I.: 0,544; 28,852). The most often pregnancy complications were threatening miscarriage - 25 (41%) and 10 (76,9%) cases (OR – 0,21; 95% C.I.: 0,034; 0,937), anemia – 22 (36%) and 4 (30,8%) cases in 1 and 2 groups respectively (OR – 1,27; 95% C.I.: 0,307; 6,289). Although all pregnancies in group 1 were carefully observed and treated 14,8% of them (9 pregnancies) were complicated by placental isufficiency with IUGR in 5 (8,2%) cases. Placental insufficiency complicated 30,8% pregnancies (4 cases) including intrauterine growth retardation (IUGR) in 2 cases in group 2 (OR – 0,95; 95% C.I.: 0,161; 10,263). Conclusion Thus pregnancy losses in women suffering from MPD occur in 62,8% without special treatment and complications of pregnancy – in 84,6% cases. The development of algorithm for preconception planning and pregnancy management resulted in considerable decrease in miscarriages to 6% (P<0,001) and reduction of pregnancy complications to 65,6% (P=0,3). Disclosures: No relevant conflicts of interest to declare.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1034-1034 ◽  
Author(s):  
J. L. Blum ◽  
B. Pruitt ◽  
C. J. Fabian ◽  
R. R. Rivera ◽  
D. E. Shuster ◽  
...  

1034 Background: Eribulin is a structurally simplified analog of halichondrin B, which inhibits microtubule dynamics via a novel mechanism characterized by suppression of microtubule growth, lack of effect on microtubule depolymerization, and sequestration of tubulin into nonfunctional aggregates. This study was designed to assess the activity and tolerance of eribulin in chemotherapy refractory patients with advanced breast cancer. Methods: Eribulin was evaluated in a single-arm Phase II trial in female patients with refractory breast cancer, ECOG performance status of 0–1, measurable disease, and neuropathy ≤ Grade 2. Patients received ≥ 1 prior chemotherapy regimen, including an anthracycline and a taxane. Eribulin was administered as a 2–5 min IV bolus of 1.4 mg/m2 on Days 1, 8, and 15 of a 28-Day cycle (Group 1). The schedule was modified to Days 1 and 8 of a 21-Day cycle (Group 2), because of dose delays. The primary efficacy endpoint was ORR according to RECIST criteria based upon independent review (IR) of tumor assessment. Results: Of 104 patients enrolled, 103 received eribulin treatment: 70 in Group 1, 33 in Group 2. Median age was 55 yrs (range 32–84). Patients had received a median of 4 prior chemotherapy regimens (range 1–11). Sixty-one percent of tumors were ER+, 14% Her2/neu 3+, and 29% were triple (ER, PR, Her-2) negative. The incidence of dose interruption, delay, or omission during Cycle 1 was 63% (Group 1) and 18% (Group 2). The most common drug related toxicities were neutropenia (75%, Grades 3: 31%, Grade 4: 30%, febrile neutropenia: 3.9%), fatigue (52%, Grade 3: 2.9%, no Grade 4), alopecia (Grade 1/2: 41%), nausea (37%, Grade 3: 1%, no Grade 4), and anemia (36%, Grade 3: 1%, no Grade 4). Peripheral neuropathy occurred in 34% of patients (Grade 3: 3.9%, no Grade 4). Best overall response rate (all PR) by IR was 14.5% and 15.2% in Groups 1 and 2, respectively; the combined ORR was 14.7% (95 % CI: 9–23%). Median PFS was 85 days, and the 6 mo PFS rate was 31%. Conclusions: Eribulin given as a 2–5 min IV infusion on Days 1, 8 of a 21-Day cycle or Days 1, 8, 15 of a 28-Day cycle exhibited a 15% PR rate by IR and a low incidence of Grade 3 neuropathy in this heavily chemotherapy pretreated population. The most common toxicity was neutropenia. The 21-Day schedule had an acceptable toxicity profile. No significant financial relationships to disclose.


VASA ◽  
2020 ◽  
Vol 49 (4) ◽  
pp. 281-284
Author(s):  
Atıf Yolgosteren ◽  
Gencehan Kumtepe ◽  
Melda Payaslioglu ◽  
Cuneyt Ozakin

Summary. Background: Prosthetic vascular graft infection (PVGI) is a complication with high mortality. Cyanoacrylate (CA) is an adhesive which has been used in a number of surgical procedures. In this in-vivo study, we aimed to evaluate the relationship between PVGI and CA. Materials and methods: Thirty-two rats were equally divided into four groups. Pouch was formed on back of rats until deep fascia. In group 1, vascular graft with polyethyleneterephthalate (PET) was placed into pouch. In group 2, MRSA strain with a density of 1 ml 0.5 MacFarland was injected into pouch. In group 3, 1 cm 2 vascular graft with PET piece was placed into pouch and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. In group 4, 1 cm 2 vascular graft with PET piece impregnated with N-butyl cyanoacrylate-based adhesive was placed and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. All rats were scarified in 96th hour, culture samples were taken where intervention was performed and were evaluated microbiologically. Bacteria reproducing in each group were numerically evaluated based on colony-forming unit (CFU/ml) and compared by taking their average. Results: MRSA reproduction of 0 CFU/ml in group 1, of 1410 CFU/ml in group 2, of 180 200 CFU/ml in group 3 and of 625 300 CFU/ml in group 4 was present. A statistically significant difference was present between group 1 and group 4 (p < 0.01), between group 2 and group 4 (p < 0.01), between group 3 and group 4 (p < 0.05). In terms of reproduction, no statistically significant difference was found in group 1, group 2, group 3 in themselves. Conclusions: We observed that the rate of infection increased in the cyanoacyrylate group where cyanoacrylate was used. We think that surgeon should be more careful in using CA in vascular surgery.


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