Treatment and prognosis of advanced triple-negative breast cancer patients with HER2-low expression: A 15-year retrospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13046-e13046
Author(s):  
Jiangping Yang ◽  
Xi Yan ◽  
Jinlan He ◽  
Ting Luo ◽  
Xiaorong Zhong ◽  
...  
Keyword(s):  
Triple Negative ◽  
Early Stage ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Baseline Characteristics ◽  
Low Expression ◽  
First Line Treatment

e13046 Background: There is some tumor defined HER2 1+ or 2+ by IHC and negative in FISH as HER2 low expression in common triple-negative breast cancer (TNBC). This subset is considered to be a new subtype of HER2-low BC, which might benefit from HER2-targeted antibody drug conjugate (ADC). Therefore, it could preliminarily understand on treatment status and treatment needs of HER2-low BC by analysis of the distribution, treatment patterns and prognosis of HER2-low BC in advanced TNBC. Methods: This was a retrospective study which included HR-negative, HER2 IHC 0/1+/2+ and FISH negative ABC patients (pts) diagnosed from June 2006 to September 2020, with recurrence and de novo metastatic cancer at a single institution in China. The cut-off date of follow-up was 31 December 2020. The baseline characteristics, first- and second-line therapies and the clinical outcomes were reported. Results: In total of 195 pts with complete follow-up data were included into final analysis. HR-negative, HER2 IHC 0 pts (triple negative, TN pts) were 61.5% (n = 120), and HR- negative, HER2 IHC 1 + / 2 + and FISH negative pts (HER2-low pts) were 38.5% (n = 75). The baseline characteristics and treatment patterns of HER2-low pts and TN pts were similar. The median age of pts at diagnosis was 48 years old while 54.4% pts were premenopausal. About 80% pts were recurrence, and 27.6% of them received neoadjuvant chemotherapy. The median disease-free interval (DFI) in early stage was 15.5 months, with 66.0% pts for DFI≥12 months. 56.4% of the pts presented with visceral metastasis. The most common sites of metastasis were lung (35.4%), lymph node (27.7%), soft tissue (24.1%), liver (20.5%), bone (20.5%), and brain (6.2%). The most commonly used regimens for first- and second-line were combination chemotherapy, which were 74.7% and 65.3%, respectively; paclitaxel (55.6%) and platinum (43.8%) were the most commonly used drugs for the first-line treatment. Only 14.4% and 3.6% pts received targeted combination therapy and immunotherapy in advanced setting, respectively. In TN and HER2-low ABC pts, the median PFS of first-line treatment were both 7.2 months, and the median OS was 17.2 months and 17.0 months, respectively. In DFI≥12 months and DFI<12 months subgroup, the median PFS was 8.4 months vs. 4.7 months, with a median OS of 17.8 months vs. 14.4 months, respectively. No significant different was observed between HER2-low pts and TN pts. Conclusions: Based on this observational cohort study, there is no significant difference in the current treatment patterns and prognosis between HER2-low pts and TN pts. However, with the emergence of HER2-targeted ADC therapy, HER2-low ABC pts which were commonly defined as TNBC may benefit from these novel therapies. The recurrence subgroup with DFI≥12 months presented a trend of longer OS, suggesting the therapy mode and response in early stage should be considered in advanced TNBC treatment.

scholarly journals Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada

2019 ◽  
Vol 26 (2) ◽  
Author(s):  
K. Byrne ◽  
P. Hallworth ◽  
A. Abbas Tahami Monfared ◽  
A. Moshyk ◽  
J. W. Shaw
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Practice ◽  
Drug Treatment ◽  
Real World ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Line Drug ◽  
First Line Treatment

Background In the present study, we examined real-world treatment patterns for squamous cell carcinoma of the head and neck (scchn) in Canada, which are largely unknown.Methods Oncologists across Canada provided data for disease history, characteristics, and treatment patterns during May–July 2016 for 6–8 consecutive patients receiving first-line or second-line drug treatment for scchn (including locally advanced and recurrent or metastatic disease).Results Information from 16 physicians for 109 patients receiving drug treatment for scchn was provided; 1 patient was excluded from the treatment-pattern analysis. Median age in the cohort was 63 years [interquartile range (iqr): 57–68 years], and 24% were current smokers, with a mean exposure of 26.2 ± 12.7 pack–years. The most common tumour site was the oropharynx (48%). Most patients (84%) received platinum-based regimens as first-line treatment (44% received cisplatin monotherapy). Use of cetuximab-based regimens as first-line treatment was limited (17%). Of 53 patients receiving second-line treatment, 87% received a first-line platinum-based regimen. Median time between first-line treatment with a platinum-based regimen and initiation of second-line treatment was 55 days (iqr: 20–146 days). The most common second-line regimen was cetuximab monotherapy (43%); platinum-based regimens were markedly infrequent (13%).Conclusions Our analysis provides real-world insight into scchn clinical practice patterns in Canada, which could inform reimbursement decision-making. High use of platinum-based regimens in first-line drug treatment was generally reflective of treatment guidelines; cetuximab use in the second-line was higher than anticipated. Additional real-world studies are needed to understand the effect of novel therapies such as immuno-oncology agents on clinical practice and outcomes, particularly for recurrent or metastatic scchn.

scholarly journals Predictors of Glucocorticoid Responsiveness in Multicentric Castleman's Disease

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 31-32
Author(s):  
Kazutoshi Ebisawa ◽  
Arika Nukina Shimura ◽  
Akira Honda ◽  
Yosuke Masamoto ◽  
Fumio Nakahara ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Castleman’S Disease ◽  
Line Treatment ◽  
Second Line ◽  
Castleman's Disease ◽  
First Line ◽  
Advisory Committees ◽  
First Line Treatment

Background: Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disease accompanying various symptoms and multi-organ dysfunctions. Although anti-interleukin-6 monoclonal antibodies, tocilizumab and siltuximab are recommended as a therapeutic option, these treatments require patients to visit hospitals at least once a month for many years, and the drug costs are quite high. In Japan, where tocilizumab is the only biological agent covered by the medical insurance, glucocorticoid monotherapy is still an important treatment option. In fact, a part of MCD patients initially treated with glucocorticoids could be successfully controlled without adding or switching to other agents. Considering that emergence of neutralizing anti-drug antibodies which reduced therapeutic efficacy could also be a clinical problem in MCD, there would be a rationale for reserving newer agents for future relapse by using glucocorticoids as first-line treatment for potential responders. Here, we retrospectively analyzed clinical characteristics of MCD patients treated in our institution to explore factors predicting who could be successfully treated with glucocorticoid monotherapy. Methods: We retrospectively reviewed histologically confirmed Castleman's disease patients who visited the Department of Hematology and Oncology of the University of Tokyo Hospital from January 2000 to March 2020. Based on the diagnostic criteria of Castleman Disease Collaborative Network (CDCN), MCD was diagnosed when enlarged lymph nodes were present in more than 2 lymph node stations and laboratory and/or clinical diagnostic criteria were met. Unicentric Castleman's disease (UCD) was diagnosed when only one single lymph node region was involved. MCD patients who were initially treated with prednisolone (PSL) were divided into two groups: patients who continued PSL until the latest follow-up (PSL-only group) and patients who received subsequent treatment (Second-line group). Results: 8 patients with UCD and 27 patients with MCD were included in our analysis. With a median follow-up of 5.2 years, 21 MCD patients underwent first-line treatment (PSL, n=18; tocilizumab, n=3). Compared to patients who did not receive any treatment, patients who underwent treatment had marginally higher levels of CRP (7.15 mg/dl vs 4.17 mg/dl, respectively; p=0.066) and significantly lower levels of hemoglobin (9.5 g/dl vs 12.5 g/dl, respectively; p=0.036). Seven out of 18 patients initially treated with PSL had received subsequent treatments (tocilizumab, n=6; rituximab, n=1). Among the PSL-only group, biochemical responses at the latest follow-up could be assessed for 10 in 11 patients: two in complete response, five in partial response, two in stable disease, and one in progressive disease, based on the response criteria of CDCN. Compared to PSL-only group, patients classified into second-line group had higher levels of CRP (11.88 mg/dl vs 6.24 mg/dl, respectively; p=0.024) and lower hemoglobin levels (6.4 g/dl vs9.4 g/dl, respectively; p=0.033). Patients whose CRP levels were lower than 12 mg/dl before starting PSL had significantly longer time to next treatment (TTNT) (median not reached vs 0.88 years; HR, 0.078 [95%CI: 0.013-0.48], p=0.00044). Similarly, patients whose hemoglobin levels were more than 8 g/dl had marginally longer TTNT (median not reached vs 2.63 years; HR, 0.22 [95%CI: 0.040-1.17], p=0.054). In addition, patients with either Hb &lt; 8 g/dl or CRP ≧12 mg/dl had significantly shorter TTNT (median not reached vs 2.12 years; HR, 0.090 [95%CI: 0.010-0.77], p=0.0074). The median PSL dose at the latest follow-up in PSL-only group was 3 mg per day [interquartile range: 0-5 mg per day], which would be comparably safe considering previous reports indicating that PSL dose of less than 5 mg per day was associated with lower incidence of adverse events. Conclusion: Out data suggest that glucocorticoid monotherapy has a good potential to induce sustained disease control for MCD patients with higher Hb or lower CRP levels. Furthermore, PSL doses could be tapered to safer doses among patients who could continue PSL until the latest follow-up. In contrast, the efficacy of glucocorticoids for MCD patients with lower Hb or higher CRP levels were limited. Such patients would be good candidates for novel agents such as tocilizumab or rituximab. Disclosures Honda: Nippon Shinyaku Co., Ltd.: Speakers Bureau; ONO PHARMACEUTICAL CO., LTD.: Speakers Bureau. Nakahara:Eisai Co., Ltd.: Honoraria; Astellas Pharma Inc.: Honoraria; Bristol-Myers Squibb Company: Honoraria. Kurokawa:Chugai: Consultancy, Research Funding, Speakers Bureau; Sanwa-Kagaku: Consultancy; Pfizer: Research Funding; Otsuka: Research Funding, Speakers Bureau; Astellas: Research Funding, Speakers Bureau; Kyowa Kirin: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Takeda: Research Funding, Speakers Bureau; Teijin: Research Funding; Eisai: Research Funding, Speakers Bureau; Sumitomo Dainippon Pharma: Research Funding, Speakers Bureau; Nippon Shinyaku: Research Funding, Speakers Bureau; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Bioverativ Japan: Consultancy; Shire Plc: Speakers Bureau; Jansen Pharmaceutical: Speakers Bureau; Ono: Research Funding, Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; MSD: Consultancy, Research Funding, Speakers Bureau.

IMvigor130 clinical trial in patients (pts) with metastatic urothelial carcinoma (mUC): Analysis of upper tract (UT) and lower tract (LT) subgroups.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 551-551 ◽  
Author(s):  
Maria De Santis ◽  
Enrique Grande ◽  
Marina Mencinger ◽  
Jian-Ri Li ◽  
Javier Puente ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Line Treatment ◽  
First Line ◽  
Recist 1.1 ◽  
Platinum Based Chemotherapy ◽  
Metastatic Urothelial Carcinoma ◽  
Baseline Characteristics ◽  
Clinical Trial Information ◽  
First Line Treatment

551 Background: IMvigor130 demonstrated a statistically significant improvement in PFS in pts receiving atezolizumab (atezo; anti–PD-L1) + platinum-based chemotherapy (plt/gemcitabine [gem]; Arm A) vs placebo + plt/gem (Arm C) as first-line treatment for mUC (Grande et al. 2019). Exploratory analyses examined efficacy outcomes in UT and LT mUC subgroups. Methods: Pts with UT and LT mUC from Arm A and Arm C were included. Chemotherapy was gem + investigator choice of plt (cisplatin or carboplatin). Tumors were assessed at baseline and every 9 wk until investigator-assessed PD per RECIST 1.1 or other events. PFS, OS and ORR in UT and LT subgroups are shown. Results: Baseline characteristics were comparable between Arm A and Arm C in the UT and LT subgroups; however, slight imbalances were noted, such as higher PD-L1–positive status (IC2/3) and lower Bajorin risk score in UT Arm A pts. With a median follow-up of 11.8 mo, median PFS was8.2 vs 6.2 mo in Arm A vs Arm C in UT pts (HR, 0.69 [95% CI: 0.51, 0.94]) and 8.1 vs 6.5 mo, respectively, in LT pts (HR, 0.85 [95% CI: 0.70, 1.02]). Interim median OS was 16.9 vs 13.5 mo in Arm A vs Arm C in UT pts (HR, 0.78 [95% CI: 0.54, 1.12]) and 15.8 vs 13.4 mo, respectively, in LT pts (HR, 0.87 [95% CI: 0.70, 1.08]). See table for additional efficacy results. Conclusions: Exploratorysubgroup analyses suggest activity of atezo + plt/gem in both UT and LT mUC, with outcomes in UT pts comparable to those seen in the LT and ITT populations. Clinical trial information: NCT02807636. [Table: see text]

Management of unusual not scar ectopic pregnancy: a multicentre retrospective case series

2021 ◽  
Vol 17 ◽  
Author(s):  
Federico Ferrari ◽  
Silvia Ficarelli ◽  
Benedetta Cornelli ◽  
Filippo Alberto Ferrari ◽  
Antonino Farulla ◽  
...  
Keyword(s):  
Medical Treatment ◽  
Surgical Approach ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Normal Menstrual Cycle ◽  
Β Hcg ◽  
Surgical Group ◽  
First Line Treatment

Background: Management of unusual not scar ectopic pregnancies (UNSEPs) is an unexplored clinical field because of their low incidence and lack of guidelines. Objective: To report the clinical presentation, the first- and second-line treatment and outcomes of UNSEPs. Methods: We retrospectively collected patients treated for UNSEP (namely cervical, interstitial, ovarian, angular, abdominal, cornual and intramural), their baseline characteristics, risk factors, symptoms, diagnostic pathway and the type of first-line treatment (medical, surgical or combined). We further collected treatment failures and the type of second-line treatment. We assessed treatment outcomes, time to serum beta human chorionic gonadotropin (β-hCG) level negativity, length of recovery, follow up and return to a normal menstrual cycle. Results: From 2009 to 2019, we collected 79 cases. Of them, 27 (34%), 23 (29%), 12 (15%), 8 (10%), 6 (8%) and 3 (4%) were respectively cervical, interstitial, ovarian, angular, abdominal and cornual. Forty women (50.6%) were submitted to medical treatment, mostly methotrexate based; conversely, 36 patients (45.6%) underwent surgery and only 3 women (3.8%) received a combined treatment. Successful of first-line treatment rate, regardless of UNSEP location, was respectively 53% and 89% for medical and surgical treatment. Treatment failures (21 patients) were submitted to second-line treatment, respectively 47.6% and 52.4% to medical and surgical approach. Of interest, cervical pregnancies achieved the lowest rate of first-line medical treatment success (22%) and received more frequently (69%) a subsequent surgical approach with no hysterectomy. Interstitial pregnancies were submitted to surgery mostly for a matter of urgency (71%), otherwise they were treated with medical approach both at first- and second-line treatment. Ovarian pregnancies were treated with ovariectomy in 44% of the cases submitted to surgery. Angular pregnancies underwent surgery more often, while all the abdominal pregnancies underwent endoscopic or open surgery. Cornual pregnancies received cornuostomy in 75% of the cases. Overall, need for blood transfusion was 23.1% among the patients submitted to surgery. The median length of hospitalisation was shorter for women submitted to surgical first-line treatment (5 vs 10 days; p = 0.002). In case of first-line medical treatment and in case of failure, we found respectively an increase of 3 days (CI95% 0.6-5.5; p = 0.01) and of 3.6 days (CI95% 0.89-6.30; p = 0.01) in the length of hospitalisation. Negative β-HCG levels were obtained earlier in the surgical group (median 25 vs 51 days; p = 0.001), as well as the return to normal menstrual cycle (median 31 vs 67 days; p = 0.000). Post-treatment follow-up, regardless of the failure of first-line treatment, was shorter in the surgical group (median 32 versus 68 days; p= 0.003). Conclusion: Cervical pregnancies were successfully managed with surgical approach without hysterectomy, and hence we suggest avoiding medical treatment. No consensus emerged for other UNSEPs. Ovarian, angular and interstitial pregnancies are burdened by a non-conservative approach on the utero-ovarian structures. Surgical approach led to shorter recovery, earlier β-hCG negativity and shorter follow-up, even though there is an increased risk for blood transfusion.

scholarly journals Physicians' Behavior, Diagnostics and Treatment Patterns in Multiple Myeloma Management in Belarus: Nation-Wide Survey

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5853-5853
Author(s):  
Ihar Iskrou ◽  
Anatoly Uss ◽  
Sergey Golubev ◽  
Vitali Papok
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Board Of Directors ◽  
Plasma Cells ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Advisory Committees ◽  
First Line Treatment

Abstract Background: Although multiple myeloma (MM) remains an incurable disease, its management progressed during the last decade owing to novelties in diagnostics and new therapeutic options. There is a general belief in heterogeneity of the novel technologies penetration among countries and regions, such differences should be studied. Information on physicians' knowledge, preferences and satisfaction is limited worldwide and may provide important insights for explanation of differences in clinical decision making in routine practice. Moreover, data on typical diagnostic and treatment patterns in real-world clinical setting are particular scarce in the Eastern European and Eurasian region. Methods: A cross-sectional national survey of physicians treating MM in Belarus was performed from October 2017 till January 2018. Among 51 hematologists registered in the country 43 physicians involved in MM management in real clinical settings were approached. Printed forms of 21-item questionnaire containing multiple choice questions were used. We anonymously collected physicians' opinions on typical diagnostics and treatment patterns as well as their clinical reasoning, preferences and satisfaction. We assessed whether practice place and type, practical experience (length of service and average number of MM patients seen per year) and attitude to participation in clinical trials influence answers. Univariate analysis was conducted with Fisher's exact test. Results: All approached physicians completed the survey. Among respondents 17 (40%) belonged to republican specialized centers, 37 (86%) were hospital-based physicians, 23 (53%) had more than 10 years of service, 28 (65%) seen more than 20 MM patients per year. 10 (23%) declared their experience in clinical trials and 20 (46%) had no experience but expressed readiness to be involved in. The clinical uptake of revised ISS for MM was 33%, among adopters physicians with more than 10 years in practice and who sees more than 20 patients per year dominated. The proportions of ISS users which believed that median survival for low-risk, standard-risk and high-risk MM patients to be > 12 months were 100%, 100% and 36%, respectively. For primary MM diagnosis 40% of respondents used MRI and 49% - CT-imaging. Physicians used the next criteria for treatment response : < 5% plasma cells (PCs) in bone marrow (88%), Ig level normalization (74%), absence of clonal PCs in BM (60%), and absence of new lesions (37%). The possibility to perform autologous stem-cells transplantation (ASCT) was revealed as a key factor for first-line treatment choice. Various bortezomib-based regimens were predominant treatment options for first-line treatment of patients eligible for ASCT. Melphalan-containing regimens were more widely spread as first-line treatment of ASCT-ineligible patients. The majority of respondents (52%) practiced first-line treatment of more than 4 months of duration, while 41% of clinicians used second-line therapy of short duration (less than 6 months). In the relapse setting after ASCT the most common regimens were still bortezomib-based as well as schemes with bendamustine. In the second-line setting in patients who did not receive ASCT monotherapy was more commonly reported. In absence of high dose dexamethasone for oral use Belarusian physicians preferred treatment schemes with combination of drugs for IV and per os routes of administration. The predominant factors of drug choice were efficacy (91%) and cost (97%). The respondents reported satisfaction with current situation in diagnostics and treatment in 74% and 65% of cases, respectively. The factors influencing readiness for disease management change were clinical experience, hospital-based practice position and positive attitude to/participation in clinical trials. Conclusions: The study covers the gaps of information about real-world MM management in Belarus. The Belarusian physicians are aware about the modern place of ASCT in MM. Targeted education in specific aspects of MM management (disease biology understanding, clinical guidelines updates, risk evaluation and stratification) may result in wider adoption of innovative diagnostic approaches and treatment technologies. MM management should be further concentrated in large specialized clinical centers for plasma cells disorders. The survey results make possible and warranted further intercountry comparisons. Disclosures Iskrou: Takeda Belarus: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer Belarus: Consultancy, Honoraria, Speakers Bureau; Novartis Belarus: Consultancy, Honoraria, Speakers Bureau; Nativita Belarus: Consultancy, Honoraria, Speakers Bureau; Octapharma Belarus: Consultancy, Honoraria, Speakers Bureau. Uss:Roche Belarus: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda Belarus: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Golubev:Medical department of Takeda Belarus: Employment. Papok:Medical department of Takeda Belarus: Employment.

scholarly journals Treatment Responses, Toxicity and Survival in Patients with Classical Hodgkin Lymphoma Aged 50 Years and Older: A Single-Center Experience over 2 Decades

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4541-4541
Author(s):  
Simay Çokgezer ◽  
Tuğrul Elverdi ◽  
Ayşe Salihoğlu ◽  
Muhlis Cem Ar ◽  
Şeniz Öngören ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Early Stage ◽  
Line Treatment ◽  
First Line ◽  
Hematopoietic Stem ◽  
First Line Therapy ◽  
Line Therapy ◽  
Treatment Responses ◽  
First Line Treatment

Abstract Introduction: The prognosis of classical Hodgkin lymphoma (cHL) is generally inferior in elderly patients (pts) than in younger pts. Tolerance of conventional therapy decreases in elderly pts, and in addition, treatment-related toxicities and death are more common. While the 5-year overall survival (OS) of pts with cHL is 86.6%, this rate is 57.5% in elderly pts. Objective and Methods: The aim of this study was to retrospectively evaluate the demographic, histopathological, clinical, and laboratory features, prognosis determination according to German Hodgkin Study Group (GHSG) in early-stage, International Prognostic Score (IPS)-3 and IPS-7 in advanced-stage, ECOG (Eastern Cooperative Oncology Group) performance scale (PS), Cumulative Disease Rating Score (CIRS) , Charlson Comorbidity Index (CCI), Adult Comorbidity Evaluation-27 (ACE-27) values, treatment responses, toxicities, and survival among cHL pts aged 50 years and older who were diagnosed between 1999 and 2020. Results: There were 101 pts in total, of which 52 were between 50-59 years of age, and 49 pts were ≥60 years. Sixty-two pts were male, and the most common histopathological subtype was mixed cellularity CHL with 58.4%. Fifty-four pts had advanced-stage disease, while there were 31 and 16 pts with early-stage unfavorable and favorable diseases, respectively. Sixty-one pts (60.4%) had B symptoms (Table 1). ECOG PS, CIRS, CCI, and ACE-27 scores were significantly higher in pts aged ≥60 years than those of 50-59 age group (Table 2). While all pts aged 50-59 years received ABVD as first-line therapy, 79% (n=39) of pts aged ≥60 years had ABVD. Among pts receiving ABVD as a first-line treatment, 82% (n=41) of pts aged 50-59 years and 73.2% (n=30) of pts aged ≥60 years had complete response following first-line treatment (p=0.312). Overall, at interim evaluation, response rates to first-line therapy were significantly higher in pts with IPS-7 value 0-3 (71.8%) than those with IPS-7 value 4-7 (42.9%) (p=0.028). While full-dose treatment was administered to 71 pts (70.3%), 30 pts (29.7%) needed a dose reduction. The percentage of pts needed a dose reduction was 38.8% among pts ≥60 years, whereas this was 21.2% for pts aged 50-59 years (p=0.053). During the follow-up, grades 3-4 hematological and non-hematological toxicities were observed in 50 (49.5%) and 15 pts (14.9%), respectively. Age groups were comparable in terms of hematological and non-hematological toxicities (p=0.369, p=0.127, respectively). None of the pts in the ≥60 age group had received high-dose chemotherapy with autologous hematopoietic stem cell transplantation (HDC with AHSCT)/allogeneic hematopoietic stem cell transplantation (allo-HSCT). On the other hand, 8 pts (15.4%) diagnosed between 50-59 years of age underwent HDC with AHSCT, in one patient (1.9%) allo-HSCT was performed, and one patient (1.9%) received both HDC with AHSCT and allo-HSCT (p=0.004). There was no significant difference in terms of OS between those with and without transplantation (p=0.069). In the multivariate analysis, the risk of progression was higher in pts with lymphocyte ≤600/mm 3 and the risk of mortality was higher in pts with B symptoms (p=0.002, p=0.012, respectively). In addition, progression-free survival (PFS) was inferior in pts who were unresponsive to first-line treatment, and worse OS was associated with higher age and CIRS (p&lt;0.001, p=0.001, p=0.038, respectively) (Fig. 1A-C). During their follow-up, 26 pts (25.7%) died, and the causes of death could be determined in 19 of them. The most common cause of death was treatment complications (n=7). Secondary malignancies were detected in 5 pts, of which 3 died. In 2 pts, the cause of death was HL-related, and 7 pts died due to other causes. Conclusion: Although not statistically significant, the percentage of pts needing a dose reduction was higher in pts aged ≥60 years, on the other hand, treatment responses and toxicities were similar in both groups, most probably due to personalized treatment selection and dose reduction according to age, comorbidities, and the performance status. Pts undergoing a transplant had a more favorable outcome than pts without a transplant, but the difference did not reach statistical significance. Response to first-line therapy was associated with superior PFS, and pts with higher age and CIRS had inferior OS. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Gain(1)(q21) Defines Group of Newly Diagnosed Multiple Myeloma Patients with Poor Prognosis.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2820-2820
Author(s):  
Pavel Nemec ◽  
Henrieta Greslikova ◽  
Romana Zaoralova ◽  
Jan Smetana ◽  
Hana Filkova ◽  
...  
Keyword(s):  
Czech Republic ◽  
Plasma Cells ◽  
Chromosomal Abnormalities ◽  
Line Treatment ◽  
Second Line ◽  
Newly Diagnosed ◽  
First Line ◽  
Significant Difference ◽  
First Line Treatment

Abstract Abstract 2820 Poster Board II-796 The presence of chromosomal abnormalities detected by FISH in plasma cells is considered to be an important prognostic factor for patients with multiple myeloma. In this study we analysed the impact of gain(1)(q21), del(13)(q14), del(17)(p13), t(4;14) and (non)hyperdiploidy on prognosis in MM patients. Taking together 194 MM patients (median age 66 years) were successfully examined by FISH for presence of above named chromosomal abnormalities in plasma cells. A total of 47 patients (median follow-up 43.2 months; 91% first line treatment, 9% second line treatment) were treated by peripheral blood stem cells transplantation (PBSCT). A total of 86 patients (median follow-up 38.4 months; 38% first line treatment, 43% second line treatment, 19% >2 previous treatment lines) were treated by thalidomide based regimen (86% together with glucocorticoids and alkylating agens). A total of 61 patients (median follow-up 46.5 months; 16% first line treatment, 36% second line treatment, 33% third line treatment, 15% >3 previous treatment lines) were treated by bortezomib based regimen (53% with glucocorticoids and alkylating agens, 20% with glucocorticoids + anthracycline). Gain(1)(q21) was found in 52% (101/194), del(13)(q14) in 55% (69/125), del(17)(p13) in 12% (13/112), t(4;14) in 20% (18/90) and 44% (56/126) of cases were hyperdiploid. In any of the three treatment based groups of patients we haven't found any significant difference in TTP, OS and treatment response (ORR) between any studied positive/negative chromosomal abnormality except gain(1)(q21). See Table 1 for results overview (TTP only). In patients treated by PBSCT (regardless of their pre-treatment) significant difference in TTP and OS for positive/negative patients was observed (15.6 vs. 27.3 months, p=0.002 for TTP; 47.2 vs. NR months, p=0.001 for OS). Furthermore, we entirely focused on newly diagnosed patients divided them into three subgroups: (1) patients treated by PBSCT in first line (n=42), (2) patients treated by thalidomide based regimen in first line (n=33) and (3) patients treated by bortezomib based regimen in first line (n=10). We confirmed unfavourable impact of gain(1)(q21) in patients treated with PBSCT whereas TTP and OS in gain(1)(q21) positive/negative patients was 15.6 vs. 27.3 months, p=0.003 (TTP); 47.2 vs. 66.9 months, p=0.002 (OS). This difference in TTP/OS among gain(1)(q21) positive/negative patients was observed neither in thalidomide based subgroup [NR vs. 11.7 months, p=0.956 (TTP); NR vs. 34.4 months, p=0.683 (OS)] nor in bortezomib based subgroup [(8.5 vs. 6.5 months, p=0.549 (TTP); NR vs. 6.8, p=0.254 (OS)]. See Table 2 for results overview (TTP only). In this study we revealed gain(1)(q21) almost in one half of MM cases, and we defined the newly diagnosed MM patients carrying gain(1)(q21) as a unique group of patients with poor prognosis. Nevertheless, treatment based on bortezomib / thalidomide combination probably suppresses unfavourable prognostic impact of all studied chromosomal abnormalities including gain(1)(q21). This study was supported by grant LC06027 of Masaryk University, Brno, Czech Republic, and by grants MSM0021622415 and MSM0021622434 of Ministry of Education, Czech Republic, and by IGA grants NR/9317-3 and NS/10207-3/2009 of Ministry of Medicine, Czech Republic. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Immediate hypersensitivity reaction followed by successful oral desensitization to ursodiol

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Erika Yue Lee ◽  
Christine Song
Keyword(s):  
Hypersensitivity Reaction ◽  
Primary Biliary Cholangitis ◽  
Line Treatment ◽  
Second Line ◽  
Immediate Hypersensitivity ◽  
First Line ◽  
Case Presentation ◽  
Desensitization Protocol ◽  
First Line Treatment ◽  
Oral Desensitization

Abstract Background Immediate hypersensitivity reaction to ursodiol is rare and there is no previously published protocol on ursodiol desensitization. Case presentation A 59-year-old woman with primary biliary cholangitis (PBC) developed an immediate hypersensitivity reaction to ursodiol—the first-line treatment for PBC. When she switched to a second-line treatment, her PBC continued to progress. As such, she completed a novel 12-step desensitization protocol to oral ursodiol. She experienced recurrent pruritus after each dose following desensitization, which subsided after a month of being on daily ursodiol. Conclusion Immediate hypersensitivity reaction to ursodiol is uncommon. Our case demonstrated that this novel desensitization protocol to ursodiol could be safely implemented when alternative options are not available or have proven inferior in efficacy.

scholarly journals Patient profiles as an aim to optimize selection in the second line setting: the role of aflibercept

2021 ◽  
Author(s):  
B. González Astorga ◽  
F. Salvà Ballabrera ◽  
E. Aranda Aguilar ◽  
E. Élez Fernández ◽  
P. García-Alfonso ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Therapeutic Option ◽  
Scientific Evidence ◽  
Treatment Options ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Effective Therapeutic Option ◽  
Line Setting ◽  
First Line Treatment

AbstractColorectal cancer is the second leading cause of cancer-related death worldwide. For metastatic colorectal cancer (mCRC) patients, it is recommended, as first-line treatment, chemotherapy (CT) based on doublet cytotoxic combinations of fluorouracil, leucovorin, and irinotecan (FOLFIRI) and fluorouracil, leucovorin, and oxaliplatin (FOLFOX). In addition to CT, biological (targeted agents) are indicated in the first-line treatment, unless contraindicated. In this context, most of mCRC patients are likely to progress and to change from first line to second line treatment when they develop resistance to first-line treatment options. It is in this second line setting where Aflibercept offers an alternative and effective therapeutic option, thought its specific mechanism of action for different patient’s profile: RAS mutant, RAS wild-type (wt), BRAF mutant, potentially resectable and elderly patients. In this paper, a panel of experienced oncologists specialized in the management of mCRC experts have reviewed and selected scientific evidence focused on Aflibercept as an alternative treatment.

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