Long-term outcomes in patients (pts) with ipilimumab (ipi)-naive advanced melanoma in the phase 3 KEYNOTE-006 study who completed pembrolizumab (pembro) treatment.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9504-9504 ◽  
Author(s):  
Caroline Robert ◽  
Georgina V. Long ◽  
Jacob Schachter ◽  
Ana Arance ◽  
Jean Jacques Grob ◽  
...  
Keyword(s):  
Tumor Imaging ◽  
Final Analysis ◽  
Complete Response ◽  
Advanced Melanoma ◽  
Long Term Outcomes ◽  
Duration Of Treatment ◽  
Phase 3 ◽  
Best Response

9504 Background: Pembro demonstrated superior PFS and OS vs ipi in ipi-naive pts with advanced melanoma in the phase 3 KEYNOTE-006 study (NCT01866319). Here, we present long-term outcomes for all pts and in those pts who completed pembro therapy. Methods: Eligible pts (N = 834) were randomized 1:1:1 to pembro 10 mg/kg Q2W, pembro 10 mg/kg Q3W, or ipi 3 mg/kg Q3W for 4 doses. Treatment was continued for 2 yr (pembro only) or until disease progression, intolerable toxicity, or pt/investigator decision to discontinue. Per protocol, pts could interrupt pembro for ≤12 wk before discontinuation was required. Tumor imaging was performed at wk 12, then every 6 wk up to wk 48 and every 12 wk thereafter. After the prespecified final analysis, response assessments were per immune-related response criteria (irRC) by investigator review. Results: As of the data cutoff (Nov 3, 2016), median follow-up in the total population was 33.9 mo (range, 32.1-37.6). 33-mo OS rates were 50% in the pooled pembro arms (n = 556) and 39% in the ipi arm (n = 278); 33-mo PFS rates were 31% and 14%. ORR was 42% and 16%. Median duration of response was not reached for pembro (range 1.0+ to 33.8+ mo) or ipi (1.1+ to 34.8+ mo); 46 (68%) pembro-treated pts and 7 (58%) ipi-treated pts had a response lasting ≥30 mo. Among the 104/556 (19%) pts who completed pembro, median exposure to pembro was 24.0 mo (range 22.1-25.9). After a median follow-up of 9.0 mo after completion of pembro, 102 (98%) pts were alive. Responses were durable in pts who completed pembro; 9.7 mo after completion of pembro, estimated PFS (95% CI) was 91% (80-96) in all 104 pts, 95% (69-99) in pts with complete response (n = 24), 91% (74-97) in pts with partial response (n = 68), and 83% (48-96) in pts with stable disease (n = 12). Conclusions: Pembro provides durable efficacy after stopping the protocol-specified duration of treatment in pts with ipi-naive advanced melanoma in KEYNOTE-006. The estimated risk for progression or death nearly 10 mo after completing pembro is 9% and does not appear to differ by best response to pembro. Clinical trial information: NCT01866319.

scholarly journals Long-Term Outcomes and Responses to Retreatment in Patients With Melanoma Treated With PD-1 Blockade

2020 ◽  
Vol 38 (15) ◽  
pp. 1655-1663 ◽  
Author(s):  
Allison Betof Warner ◽  
Jessica S. Palmer ◽  
Alexander N. Shoushtari ◽  
Debra A. Goldman ◽  
Katherine S. Panageas ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Complete Response ◽  
Median Number ◽  
Long Term Outcomes ◽  
Duration Of Treatment ◽  
Unresectable Stage

PURPOSE To analyze long-term outcomes after treatment discontinuation of anti–programmed death-1 (anti–PD-1) therapy in a cohort of patients with melanoma with the longest follow-up yet available to our knowledge, including a majority of patients treated outside of a clinical trial. We also assessed efficacy of retreatment with anti–PD-1 therapy with or without ipilimumab in relapsing patients. METHODS We retrospectively analyzed all patients with nonuveal, unresectable stage III/IV melanoma treated with single-agent anti–PD-1 therapy at Memorial Sloan Kettering from 2009-2018 who had discontinued treatment and had at least 3 months of follow-up after discontinuation (n = 396). Overall survival for patients with complete response (CR) was calculated from time of CR. Time to treatment failure for patients with CR was time from CR to the next melanoma treatment or death. RESULTS CRs were seen in 102 of 396 patients (25.8%). The median number of months of treatment after CR was zero (range, stopped before CR to 26 months after CR). With a median follow-up of 21.1 months from time of CR in patients who did not relapse, the probability of being alive and not needing additional melanoma therapy at 3 years was 72.1%. There was no significant association between treatment duration and relapse risk. In multivariable analysis, CR was associated with M1b disease and cutaneous versus mucosal or acral primaries. Among the 78 patients (of 396) retreated after disease progression, response was seen in 5 of 34 retreated patients with single-agent anti–PD-1 therapy and 11 of 44 patients escalated to anti–PD-1 plus ipilimumab. CONCLUSION In our cohort, most patients discontinued treatment at the time of CR. Most CRs were durable but the probability of treatment failure was 27% at 3 years. Responses to retreatment were infrequent. The optimal duration of treatment after CR is not yet established.

scholarly journals Pediatric-Onset Evans Syndrome Is Associated with Broad Immunopathological Manifestations, High Treatment Burden and Mortality in Long-Term Follow-up

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 20-22
Author(s):  
Thomas Pincez ◽  
Helder Fernandes ◽  
Thierry Leblanc ◽  
Gérard Michel ◽  
Vincent Barlogis ◽  
...  
Keyword(s):  
Complete Response ◽  
Second Line ◽  
Treatment Burden ◽  
Recurrent Infections ◽  
Evans Syndrome ◽  
Long Term Outcomes ◽  
Pediatric Onset ◽  
Over Time

Introduction Pediatric-onset Evans syndrome (pES) is defined by the association between immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA) before the age of 18 years and may be associated to various immunopathological manifestations (IMs). No comprehensive study of this rare disease exists, and its long-term outcomes are poorly described. Methods Patients from the nationwide French prospective OBS'CEREVANCE cohort with pES and more than 5 years of follow-up were included (excepted pES secondary to bone marrow transplantation or primary immunodeficiencies known at the inclusion). All patients, including those with less than 5 years of follow-up, were included in survival analyses. Multivariate Cox proportional hazards model was used to analyze factors associated with time-dependent variables. Results Of the 216 patients with pES in the cohort, 151 (88 males and 63 females) were included with a median (min-max) follow-up time after first cytopenia diagnosis of 11.3 (5.1-38) years. Median age at final follow-up was 18.5 (6.8-50.0) years. The proportion of patients achieving a sustained complete response (i.e. persisting until final follow-up) increased after cytopenia onset (Fig. 1A). ITP and AIHA were in complete remission in 40.5% and 54.5%, 74.1% and 62.3%, and 78.4% and 86% of patients at 5, 10, and 15 years, respectively. Clinical IMs (cIMs) developed in 100/151 patients (66%), before the first diagnosis of cytopenia in 21/100 cases. The number of cIMs increased over time (Fig. 1B). The proportions of patients with one and more than one cIM were 50% and 14%, 57% and 19%, and 81% and 44% at 5, 10, and 15 years after the first cytopenia diagnosis, respectively. A broad spectrum of cIMs were present, lymphoproliferation (n = 71), dermatological (n = 26), gastrointestinal/hepatic (n = 23), and pneumological manifestations (n = 16) being the most common. Three patients had a hematological malignancy. Biological IMs (bIMs) were diagnosed in 101/151 patients (67%) and also increased over time, with hypogammaglobulinemia (n = 54) being the most common. Autoimmune neutropenia developed in 43 patients (28.5%) and was independently associated with the number of cIMs (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.5-3.8; p = 0.0002). Severe or recurrent infections were present in 53 patients (35%). The number of second-line treatments received (i.e. other than steroids and immunoglobulins) increased over time without reaching a plateau (Fig. 1C). Half of the patients had received at least one, two, and three different treatments at 2.7, 10.5, and 14.7 years after the first cytopenia diagnosis, respectively. The number of cIMs was independently associated with the number of second-line treatments received (HR, 1.3; 95% CI, 1.08-1.6; p = 0.006). Systemic lupus erythematosus (SLE) was diagnosed in 11/151 patients (7.3%, 1/88 males and 10/63 females) and autoimmune lymphoproliferative syndrome (ALPS) in six (4.0%). Sixteen of the 151 patients followed for more than 5 years (10.6%) died, and seven died before the fifth year of follow-up (23 deaths in total). Survival at 5, 10, and 15 years after the first cytopenia was 97%, 92%, and 84%, respectively (Fig. 1D). Deaths occurred regularly throughout the follow-up period, at a median age of 18.0 (1.7-31.5) years. The most frequent cause of death was infections (n = 12, 52%). Four patients (18%) died of hemorrhage, all were less than 13 years old. The numbers of second-line treatments (HR, 1.3; 95% CI, 1.1-1.6; p = 0.004) and severe or recurrent infections (HR, 3.4; 95% CI, 1.2-9.7; p = 0.02) were independently associated with mortality after 5 years of follow-up. Overall, 20-year-old compared to 10-year-old patients more frequently showed a sustained complete response for AIHA (72% vs. 30%) and ITP (50% vs. 26%), but more frequently had cIMs (74% vs. 37%), bIMs (75% vs. 39%), and ongoing second-line treatments (88% vs. 47%; p < 0.001 for all comparisons). Conclusions Long-term outcomes of pES were associated to IMs and second-line treatment burden, not active cytopenia. The significant mortality rates, mostly among adolescents and young adults, were linked to drug-induced and/or constitutive immunodeficiencies. Few cases were associated with SLE or ALPS, which is consistent with a heterogeneous genetic background. These results highlight the importance of multidisciplinary care during the transition from childhood to adulthood. Figure 1 Disclosures No relevant conflicts of interest to declare.

Responders to anti-PD1 therapy: Long-term outcomes and responses to retreatment in melanoma (mel).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9513-9513 ◽  
Author(s):  
Allison Betof Warner ◽  
Jessica S. Palmer ◽  
Alexander Noor Shoushtari ◽  
Debra A Goldman ◽  
Katherine Panageas ◽  
...  
Keyword(s):  
Median Duration ◽  
Progressive Disease ◽  
Single Agent ◽  
Optimal Strategies ◽  
Complete Response ◽  
Tumor Shrinkage ◽  
Duration Of Treatment ◽  
Residual Tissue

9513 Background: Little is known about patients (pts) who discontinue anti-PD1 therapy after a complete response (CR) outside of clinical trials. There are also limited data about retreatment with a second course of anti-PD1 upon disease progression. Methods: We retrospectively studied pts (n = 398) at MSKCC with unresectable mel (non-uveal) who received ≥1 dose of single-agent anti-PD1 and were followed ≥3 months (mos) after treatment cessation. CR was defined radiographically or by a negative biopsy of residual tissue. Overall survival (OS) and time to treatment failure (TTF, time until next therapy or death) were calculated from time of CR. When to stop therapy and whether to retreat after progressive disease (PD) were at the discretion of the treating oncologist. A subset of pts received a second course of single-agent anti-PD1 ≥3 months after initial discontinuation; retreated pts were evaluable if they had radiographic or clinical evaluation to assess retreatment efficacy. Results: 102 pts (25.6%) achieved CR (n = 89 radiographic, n = 13 pathologic). Median follow-up was 22.6 mos for survivors who had a CR. Estimated 3-year OS from time of CR was 82.5% (95% CI 67.4-91.0). For pts who had a CR, therapy was discontinued due to CR (n = 72), toxicity (n = 24), or other reasons (n = 6). The median duration of treatment for CR pts was 9.4 mos (range 1.6-36.1). 20 CR pts later had progressive disease (PD). Median TTF has not been reached; at 3-years the estimated treatment-free survival for CR pts was 72.3% (95% CI 60.2-81.3). 34 pts received a second course of anti-PD1 for PD after a median of 11.6 mos off treatment (range 3.5-28.6). Best responses to the second course of treatment were: 2 CRs (5.9%), 3 with tumor shrinkage (8.8%), 9 (26.5%) with SD, and 20 with PD (58.8%). Of these pts who had had a CR (n = 8) or some lesser degree of tumor shrinkage (n = 13) to the initial course of anti-PD1 treatment, only 1 and 2 pts responded, respectively, to retreatment. Median duration of retreatment was 10.9 wks. Conclusions: In this largest dataset to knowledge of mel pts treated with a second course of anti-PD1, response rate was low, even in pts who had achieved a response initially. Further study is needed into the necessary duration of initial anti-PD1 treatment and optimal strategies for initial responders who discontinue and later develop PD.

Six Year Follow-Up Results of a Phase II Study of Imatinib in Late Chronic Phase (L-CP) Chronic Myeloid Leukemia (CML) Post Interferon-A (IFN) Refractoriness/Intolerance.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 428-428 ◽  
Author(s):  
Hagop M. Kantarjian ◽  
Charles Sawyers ◽  
Andreas Hochhaus ◽  
Charles A. Schiffer ◽  
Francois Guilhot ◽  
...  
Keyword(s):  
Overall Survival ◽  
Blast Crisis ◽  
Survival Rates ◽  
Chronic Phase ◽  
Dose Intensity ◽  
Long Term Outcomes ◽  
Duration Of Treatment ◽  
Laboratory Values

Abstract Background: Imatinib is a selective inhibitor of the Bcr-Abl tyrosine kinase indicated for the treatment of all phases of Ph+ CML. This study updates the results up to more than 60 months (mos) after last patient (pt) started treatment. Methods: Imatinib 400 mg/d was first administered to 454 patients with L-CP CML between December 1999 and May 2000. Median time since diagnosis was 34 months (mos). Pts had received a median of 14 mos of prior IFN treatment before entering the study but were hematologically (n=133) or cytogenetically resistant/refractory (n=160) or intolerant (n=161) to IFN. Dose escalation up to 800 mg/d was allowed for lack of efficacy. Pts were evaluated for best major and complete cytogenetic response (MCyR and CCyR), time to progression to accelerated phase (AP) or blast crisis (BC), and overall survival (OS). Beyond July 31, 2002, no adverse events or laboratory values were collected. Results: As of July 31, 2005, median duration of treatment was 60 mos (with average of 48 mos). A total of 244 (54%) pts had their dose increased to 600 or 800 mg/d, 42% received 800 mg/d at least once. Of 227 pts who are still on treatment, 85 (37%) had their dose increased to 600 mg/d or 800 mg/d for lack of efficacy. Overall actual dose intensity was 444 mg/d (median 400mg/d). The table below summarizes reasons for discontinuation, best observed responses rates and estimated long term outcomes at 60 mos. n (%) [95% conf. intervals] N=454 Still on treatment 227 (50) Discontinued 227 (50) Unsatisfactory therapeutic effect 117 (26) Deaths from any cause 18 (4) AEs & abnormal laboratory values 33 (7) BMT 5 (1) Withdrew consent/Lost/Others 54 (12) Pts with MCyR (incl CCyR) 304 (67) Pts with CCyR 259 (57) % Estimated freedom of progression to AP/BC at 60 mos 69% [64–74] % Estimated OS at 60 mos 79% [75–83] The MCyR (CCyR) rate was 57% (48%) for hematologic failures to IFN, 70% (60%) in cytogenetic failures to IFN and 72% (62%) in IFN intolerant pts. A CCyR was achieved after more than 36 mos of treatment in 28 pts; 22 (79%) of these pts had achieved CCyR after dose increase to 600 or 800 mg. Landmark analyses confirmed the effect of cytogenetic responses on long-term outcomes. The estimated survival rates free of AP/BC at 60 mos were 91%, 82%, 77%, 62% and 42% for pts who by 12 months achieved CCyR, PCyR, Minor CyR, Minimal CyR and no CyR, respectively (p<0.001). This corresponds to a rate of 88% in pts with MCyR at 12 mos. The estimated overall survival rates at 60 mos were 93%, 92%, 88%, 71% and 64% for pts who achieved CCyR, PCyR, Minor CyR, Minimal CyR and no CyR at this landmark, respectively (p<0.001). This corresponds to an overall survival rate of 93% in patients who had achieved MCyR at 12 mos. Conclusion: Imatinib substantially improves the duration of CP-CML in pts who previously failed IFN. The follow-up confirms the beneficial effect of cytogenetic responses on long-term outcomes with imatinib. These results will be updated for the meeting to include 72 mos data up to July 31, 2006.

Long-Term Outcomes in the Treatment of Classical Trigeminal Neuralgia by Gamma Knife Radiosurgery

Neurosurgery ◽  
2016 ◽  
Vol 79 (6) ◽  
pp. 879-888 ◽  
Author(s):  
Nuria E. Martínez Moreno ◽  
Jorge Gutiérrez-Sárraga ◽  
Germán Rey-Portolés ◽  
Adolfo Jiménez-Huete ◽  
Roberto Martínez Álvarez
Keyword(s):  
Trigeminal Neuralgia ◽  
Gamma Knife ◽  
Gamma Knife Radiosurgery ◽  
Response Rates ◽  
Complete Response ◽  
Long Term Outcomes ◽  
Classical Trigeminal Neuralgia ◽  
Facial Numbness

Abstract BACKGROUND: Gamma knife radiosurgery (GKRS) is one of the alternatives for treatment for classical trigeminal neuralgia (TN). OBJECTIVE: To retrospectively analyze long-term outcomes for TN using GKRS achieved at our institution. METHODS: One hundred seventeen patients with medically refractory TN treated by GKRS at our institution were followed up between 1993 and 2011. Mean maximum dose was 86.5 Gy (range: 80-90 Gy; median: 90 Gy). Clinical response was defined based on the Burchiel classification. We considered classes I and II as a complete response. For toxicity, we use the Barrow Neurological Institute facial numbness scale. Mean duration of follow-up was 66 months (range: 24-171 months). RESULTS: Complete response at last follow-up in our patients was 81%, with an excellent response while off medication in 52%. Pain-free rates without medication (class I) were 85% at 3 years (confidence interval [CI]: 78%-94%), 81% at 5 years (CI: 72%-91%), and 76% at 7 years (CI: 65%-90%). Complete response rates (classes I-II) were 91% at 3 years (CI: 86%-97%), 86% at 5 years (CI: 79%-93%), and 82% at 7 years (CI: 72%-93%). Poor treatment response rates differed significantly between patients who had undergone previous surgery and were refractory to management with medication prior to GKRS. New or worsening facial numbness was reported in 32.5% (30% score II and 2.5% score III). No anesthesia dolorosa was reported. Permanent recurrence pain rate was 12%. CONCLUSION: GKRS achieved favorable outcomes compared with surgery in terms of pain relief and complication rates in our cohort of patients, notwithstanding decreasing pain-free survival rates over time. We consider GKRS to be an initial treatment in the management of medically intractable TN in selected patients.

scholarly journals Daratumumab plus RVd for newly diagnosed multiple myeloma: final analysis of the safety run-in cohort of GRIFFIN

2021 ◽  
Vol 5 (4) ◽  
pp. 1092-1096
Author(s):  
Peter M. Voorhees ◽  
Cesar Rodriguez ◽  
Brandi Reeves ◽  
Nitya Nathwani ◽  
Luciano J. Costa ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Residual Disease ◽  
Survival Rates ◽  
Final Analysis ◽  
Complete Response ◽  
High Dose ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Best Response

Abstract The phase 2 GRIFFIN study of daratumumab plus lenalidomide/bortezomib/dexamethasone (D-RVd) for transplant-eligible, newly diagnosed multiple myeloma included a safety run-in phase followed by a randomized phase. The ongoing randomized phase has met its prespecified primary end point of an improved stringent complete response (sCR) rate after consolidation for D-RVd (reported elsewhere). Final analysis of the safety run-in cohort is reported herein and provides longer follow-up (median, 40.8 months) encompassing daratumumab plus lenalidomide (D-R) maintenance therapy. Patients in the safety run-in cohort (N = 16) received 4 induction cycles (D-RVd), high-dose melphalan supported by autologous stem cell transplant, 2 consolidation cycles (D-RVd), and 24 months of maintenance (D-R). By the end of consolidation, all patients had responded, with a best response of sCR in 9 (56.3%) patients; 8 (50.0%) patients were minimal residual disease (MRD) negative (10‒5 threshold). After maintenance, 15 (93.8%) patients had achieved a best response of sCR, and 13 (81.3%) patients were MRD (10‒5) negative. Estimated 36-month progression-free and overall survival rates were 78.1% and 93.8%, respectively. One death from progressive disease occurred in the patient who did not achieve sCR. Observed safety profiles were consistent with daratumumab and RVd. With >3 years of median follow-up, D-RVd achieved durable responses that deepened with D-R maintenance. This study was registered at www.clinicaltrials.gov as #NCT02874742.

S285 – Long-Term Efficacy of RF Turbinoplasty for Allergic Rhinitis

2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P170-P170
Author(s):  
Hsin-Ching Lin ◽  
Michael Friedman
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Obstruction ◽  
Medical Therapy ◽  
Adverse Reactions ◽  
Final Analysis ◽  
Long Term Outcomes ◽  
Long Term Study ◽  
Clinical Benefits

Objectives To study the long-term outcomes of radiofrequency turbinoplasty for the treatment of allergic rhinitis. Methods 146 consecutive patients who underwent radio-frequency turbinoplasty due to allergic rhinitis refractory to medical therapy were enrolled in this study. A 0–10 visual analog scale (VAS) was used to assess the allergic symptoms including nasal obstruction, rhinorrhea, sneezing, itchy nose, and itchy eyes preoperatively and 5 years postoperatively. The long-term clinical benefits and complications were reviewed. Statistical analysis was determined by paired t-test. Results None of the patients had obvious discomfort except mild numbness over the teeth (27/146, 18.5%) during operation. No long-term adverse reactions, including bleeding, infection, adhesion, or olfactory change were encountered. 119 patients had a minimum follow-up of 5 years and complete data available for analysis. The response rate was 60.5% (72/119). 18 patients received additional nasal surgery due to no obvious response to the surgery. These patients were excluded from the final analysis. 5 years after the treatment, the other 101 patients obtained improvement of nasal obstruction, with the VAS degree changing from 6.65 ± 1.92 to 4.45 ± 2.54 (p<0.0001). The VASs of rhinorrhea, sneezing, itchy nose, and itching eyes changed from 5.90 ± 2.79 to 3.79 ± 2.97, 5.15 ± 2.77 to 3.50 ± 2.77, 3.67 ± 3.03 to 2.41 ± 2.30 and 2.94 ± 3.02 to 2.02 ± 2.42, respectively (all p<0.0001). Conclusions The long-term study demonstrated that radiofrequency turbinoplasty appears to still be effective and safe for treating allergic rhinitis refractory to medical therapy.

Single Treatment with Rituximab Monotherapy for Low-Tumor Burden Follicular Lymphoma (FL): Survival Analyses with Extended Follow-Up (F/Up) of 7 Years.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 486-486 ◽  
Author(s):  
Philippe Colombat ◽  
Nicole Brousse ◽  
Franck Morschhauser ◽  
Patricia Franchi-Rezgui ◽  
Pierre Soubeyran ◽  
...  
Keyword(s):  
Sleep Apnea Syndrome ◽  
Response Duration ◽  
Final Analysis ◽  
Initial Response ◽  
Tumor Burden ◽  
Best Response ◽  
Duration Of Response ◽  
Study Population

Abstract As previously reported (Colombat, Blood2001;97:101), rituximab (4 weekly doses of 375mg/m²) can lead to high response rates (RR) and prolonged remissions with minimal toxicity as 1st line therapy for low tumor burden FL. We report the final analysis of a trial evaluating long term efficacy and safety of rituximab in untreated low tumor burden FL (GELF criteria). 49 patients (pts) were included in the initial trial (median age 52 yrs), 2 refused consent for the extended F/Up period, and 1 pt died at M12. Molecular bcl2-JH rearrangement was assessed throughout the study. The median F/up was 83.8 mths. Overall best RR, complete/unconfirmed RR and partial RR at D78 were 74%, 50% and 24% respectively. Median PFS was 23.5 mths for the study population. Median duration of response (34 responders at D78, i.e 6 weeks after the last rituximab dose) was 28.6 mths, but response was still maintained without any further treatment in 11 pts after 5 years (24%) and in 7 pts after 7 years (15%). 31/46 pts were bcl2 positive in blood and/or marrow samples before rituximab: 11 (35%) became negative at D50, and 20 remained positive (65%). Median PFS was 37 mths for bcl2-negative pts at D50, and 12 mths for patients remaining positive (p=0.018 Log-rank). Of the 7 pts with sustained response after 7 years, 5 were bcl2 positive at D0, 2/5 became negative at D50, and 5/5 were still negative at M84. At year 7, 4/46 pts have died (1 from myelodysplasia, 3 from NHL), 35/42 have progressed, and 7 have never progressed without any other treatment than the initial rituximab therapy. Time to progression was significantly longer in the bcl2-negative population at D50 (p= 0.018, Log-rank). Duration of response was not correlated with bcl2 status at D50, but was associated with ‘Best response CR/Cru’ (p=0.007 Log-rank). Long-term tolerance was good, with only 13 SAE observed in 13 pts during the additional 4 years of F/Up (4 surgeries for non NHL-related pathologies, 1 node biopsy, 1 sleep apnea syndrome, 1 ischemic cardiopathy, 2 deaths from NHL, 1 depression, 1 pneumonia, 1 erysipela, 1 bronchitis). This long-term update confirms that a single 4-dose rituximab treatment yields durable benefits without the toxicity of chemotherapy for pts with low burden FL : Median PFS of 23.5 mths for the cohort, 28.6 mths for responders and 37 mths for pts turning bcl2-negative at D50, 15% of pts have maintained their response after 7 years, (2bis) the quality (CR/Cru) of the initial response was associated with a longer response duration high overall survival is observed with 4 deaths/46 pts (8.6%).

scholarly journals Real-World Survival in Patients with Metastatic Melanoma after Discontinuation of Anti-PD-1 Immunotherapy for Objective Response or Adverse Effects: A Retrospective Study

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Julie Valentin ◽  
Thomas Ferté ◽  
Valérie Dorizy-Vuong ◽  
Léa Dousset ◽  
Sorilla Prey ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Metastatic Melanoma ◽  
Single Agent ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Advanced Melanoma ◽  
Discontinuation Of Treatment

Objective. Anti-PD-1 has dramatically improved the survival of patients with advanced melanoma. However, there is a lack of data on maintenance of the response after treatment discontinuation. We aimed to evaluate the progression-free survival (PFS) of patients with metastatic melanoma after anti-PD-1 interruption for objective response (OR) or limiting toxicity during clinical trials. Methods. All patients with advanced melanoma who stopped single-agent anti-PD-1 antibodies for objective response or toxicity were included between April 2014 and January 2019 in our institution (data cut-off, September 10th, 2019). Clinical and biological factors associated with relapse were studied. Results. The median follow-up after introduction of treatment was 36.5 months [4.6–62.4], and the median follow-up after discontinuation of treatment was 15.7 months (2.5–45.1). Out of 65 patients, 28 patients stopped immunotherapy for limiting adverse effects (AEs) (43.1%), 25 for complete response (CR) (38.4%), and 12 for partial response (PR) or long-term stable disease (SD) (18.5%). Twelve patients relapsed (18.5%) after a median time of 9 months [1.9–40.9 months]. Seven relapsed after discontinuation for AEs, 3 after discontinuation for CR, and 2 after discontinuation for PR/SD. The median PFS after therapy discontinuation was not reached. No statistical association was found between recurrence and age, sex, increased LDH, BRAF status, presence of brain metastases, previous treatments, radiotherapy, or time on anti-PD-1 treatment. Conclusion. This cohort shows a global recurrence rate of 18.5% and confirms a long-lasting response after anti-PD-1 cessation regardless of the cause of discontinuation.

Periprocedural risk and long-term outcome of intracranial angioplasty based on a single-centre experience

VASA ◽  
2013 ◽  
Vol 42 (4) ◽  
pp. 264-274
Author(s):  
Dagmar Krajíčková ◽  
Antonín Krajina ◽  
Miroslav Lojík ◽  
Martina Mulačová ◽  
Martin Vališ
Keyword(s):  
Death Rate ◽  
Long Term Outcomes ◽  
Single Centre ◽  
Intracranial Atherosclerotic Stenosis ◽  
Atherosclerotic Stenosis ◽  
Angioplasty And Stenting ◽  
Aggressive Medical Management ◽  
Stroke Death

Background: Intracranial atherosclerotic stenosis is a major cause of stroke and yet there are currently no proven effective treatments for it. The SAMMPRIS trial, comparing aggressive medical management alone with aggressive medical management combined with intracranial angioplasty and stenting, was prematurely halted when an unexpectedly high rate of periprocedural events was found in the endovascular arm. The goal of our study is to report the immediate and long-term outcomes of patients with ≥ 70 % symptomatic intracranial atherosclerotic stenosis treated with balloon angioplasty and stent placement in a single centre. Patients and methods: This is a retrospective review of 37 consecutive patients with 42 procedures of ballon angioplasty and stenting for intracranial atherosclerotic stenosis (≥ 70 % stenosis) treated between 1999 and 2012. Technical success (residual stenosis ≤ 50 %), periprocedural success (no vascular complications within 72 hours), and long-term outcomes are reported. Results: Technical and periprocedural success was achieved in 90.5 % of patients. The within 72 hours periprocedural stroke/death rate was 7.1 % (4.8 % intracranial haemorrhage), and the 30-day stroke/death rate was 9.5 %. Thirty patients (81 %) had clinical follow-up at ≥ 6 months. During follow-up, 5 patients developed 6 ischemic events; 5 of them (17 %) were ipsilateral. The restenosis rate was 27 %, and the retreatment rate was 12 %. Conclusions: Our outcomes of the balloon angioplasty/stent placement for intracranial atherosclerotic stenosis are better than those in the SAMMPRIS study and compare favourably with those in large registries and observational studies.

Sign in / Sign up

Export Citation Format

Share Document