scholarly journals Quimiorradioterapia no doente idoso com cancro do pulmão, onde nos encontramos? – O retrato de um centro

Author(s):  
Raquel Varela ◽  
◽  
Catarina Travancinha ◽  
Filipa Ferreira ◽  
Pedro Americano ◽  
...  

Introdução: O cancro do pulmão (CP) é a neoplasia com maior incidência em todo o mundo e a primeira causa de morte por doença oncológica a nível mundial. O atual standard of care para o CP estádio III é a radioterapia (RT) concomitante com quimioterapia (QT) com dupleto de platina. Apesar da idade média ao diagnóstico ser cerca de 70 anos, o tratamento ideal nos idosos neste estádio, não está ainda completamente estabelecido, por se tratar de um subgrupo de doentes raramente incluídos em ensaios clínicos. Assim, o valor da quimioradioterapia (QRT) nos idosos é ainda pouco claro. Objectivos: Caracterização dos doentes com CP submetidos a QRT, comparação dos subgrupos com idade <65 (grupo A) e ≥65 anos (grupo B) com análise de fatores de prognóstico, sobrevivência global (SG) e sobrevivência livre de progressão (SLP). Material e métodos: Estudo retrospectivo, observacional e unicêntrico que incluiu os doentes com CP submetidos a QRT num hospital português durante 10 anos (2007 -2017). Análise estatística efetuada no programa SPSS v25, utilizando o teste de Kaplan‑Meier para análise de sobrevivência. Valores de p≤0.05 foram considerados estatisticamente significativos. Resultados: Foram incluídos 97 doentes (idades 39 -78 anos), 57 no grupo A e 40 no B. Não foram registadas diferenças estatisticamente significativas entre os grupos a nível de género, performance status, subtipo histológico, estadiamento TNM, comorbilidades, fracionamento e dose de RT, número de ciclos de QT e toxicidade à terapêutica. A única diferença constatada foi relativamente aos fármacos utilizados (p=0.0387), predominando a utilização de cisplatina e vinorrelbina no grupo A (59.6%) e carboplatina e paclitaxel no B (60.0%). Houve ainda diferença na SG (37.1 vs. 27.2 meses; p=0.0449), mas não ao nível da SLP (25.2 vs. 17.2 meses; p=0.0899). Quando avaliado o valor prognóstico, nenhum dos fatores se revelou significativo no grupo B, registando -se apenas uma tendência no número de ciclos de QT (p=0.056). Conclusão: A QRT pode ser uma opção segura e eficaz nos doentes idosos com bom performance status. São necessários estudos que incluam doentes idosos e a sua avaliação de forma dirigida, nomeadamente através dos instrumentos geriátricos desenvolvidos para o efeito.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 51-51 ◽  
Author(s):  
Yelena Yuriy Janjigian ◽  
Dung T Le ◽  
Patrick Alexander Ott ◽  
Beata Korytowsky ◽  
Hannah Le ◽  
...  

51 Background: Treatments for advanced/metastatic (adv/met) GC/GEJC after failure of second-line (2L) chemo are limited. Nivolumab (NIVO) demonstrated encouraging anti-tumor activity and long-term OS in adv/met GC/GEJC Asian patients (pts) in ATTRACTION-2 compared with placebo (12-month OS rate, 26% vs 11%; HR, 0.63; P < .0001) and in CHECKMATE-032 (CM-032) in Western pts (12-months OS rate, 45%). This study explored outcomes in US GC/GEJC pts by establishing real world (RW) standard of care (SOC) comparators, against placebo in Asian pts and NIVO in Western pts. Methods: Data were captured from FH electronic health record database. Median OS, estimated by Kaplan-Meier, was calculated from last treatment for adv/met GC/GEJC to death. To create a US RW SOC arm to the ATTRACTION-2 placebo pts, a 2-step matching process was applied: (1) similar inclusion/exclusion (I/E) criteria (2) frequency matching based on significant differences in baseline characteristics associated with survival, identified by univariate analysis. A similar approach was used to create a US RW SOC arm to NIVO treated pts in CM-032. Results: 742 adv/met GC/GEJC pts with ≥ 2 prior lines of therapy were identified in FH from Jan11-Apr17. Two-step matching resulted in 90 US RW SOC vs. 163 ATTRACTION-2 placebo pts, and 100 US RW SOC vs. 42 CM-032 pts. All pts had ECOG performance status (PS) of 0 or 1. Median OS of US RW SOC arm was similar to matched placebo in ATTRACTION-2. Comparison of RW SOC to NIVO-treated pts in CM-032 showed a favorable median OS with NIVO therapy (Table). Conclusions: These analyses highlight the grave outcomes in US adv/met GC/GEJC pts in FH and signal a need for more effective treatments. The data also suggest favorable outcomes with NIVO vs. SOC in both Asian and Western pts with 3L adv/met GC/GEJC. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8511-8511
Author(s):  
David R. Spigel ◽  
Corinne Faivre-Finn ◽  
Jhanelle Elaine Gray ◽  
David Vicente ◽  
David Planchard ◽  
...  

8511 Background: In the placebo-controlled Phase III PACIFIC trial of patients with unresectable Stage III NSCLC whose disease had not progressed after platinum-based concurrent chemoradiotherapy (cCRT), durvalumab improved overall survival (OS) (stratified hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.53–0.87; p=0.0025; data cutoff [DCO] Mar 22, 2018) and progression-free survival (PFS) (stratified HR 0.52, 95% CI 0.42–0.65; p<0.0001; DCO Feb 13, 2017) based on the DCOs used for the primary analyses, and the degree of benefit remained consistent in subsequent updates. Durvalumab was associated with a manageable safety profile, and did not detrimentally affect patient-reported outcomes, compared with placebo. These findings established consolidation durvalumab after CRT (the ‘PACIFIC regimen’) as the standard of care in this setting. We report updated, exploratory analyses of OS and PFS, assessed approximately 5 years after the last patient was randomized. Methods: Patients with WHO PS 0/1 (and any tumor PD-L1 status) whose disease did not progress after cCRT (≥2 overlapping cycles) were randomized (2:1) 1–42 days following cCRT (total prescription radiotherapy dose typically 60–66 Gy in 30–33 fractions) to receive 12 months’ durvalumab (10 mg/kg IV every 2 weeks) or placebo, stratified by age (<65 vs ≥65 years), sex, and smoking history (current/former smoker vs never smoked). The primary endpoints were OS and PFS (blinded independent central review; RECIST v1.1) in the intent-to-treat (ITT) population. HRs and 95% CIs were estimated using stratified log-rank tests in the ITT population. Medians and OS/PFS rates at 60 months were estimated with the Kaplan–Meier method. Results: Overall, 709/713 randomized patients received treatment in either the durvalumab (n/N=473/476) or placebo (n/N=236/237) arms. The last patient had completed study treatment in May 2017. As of Jan 11, 2021 (median follow-up duration of 34.2 months in all patients; range, 0.2–74.7 months), updated OS (stratified HR 0.72, 95% CI 0.59–0.89; median 47.5 vs 29.1 months) and PFS (stratified HR 0.55, 95% CI 0.45–0.68; median 16.9 vs 5.6 months) remained consistent with the results from the primary analyses. The 60-month OS rates were 42.9% and 33.4% with durvalumab and placebo, respectively, and 60-month PFS rates were 33.1% and 19.0%, respectively. Updated treatment effect estimates for patient subgroups will be presented. Conclusions: These updated survival analyses, based on 5-year data from PACIFIC, demonstrate robust and sustained OS plus durable PFS benefit with the PACIFIC regimen. An estimated 42.9% of patients randomized to durvalumab remain alive at 5 years and approximately a third remain both alive and free of disease progression. Clinical trial information: NCT02125461.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16567-e16567
Author(s):  
Anish B. Parikh ◽  
Sarah P. Psutka ◽  
Yuanquan Yang ◽  
Katharine Collier ◽  
Abdul Miah ◽  
...  

e16567 Background: ICI/TKI combinations are a new standard of care for the initial treatment (tx) of mRCC. Efficacy and toxicity of such combination regimens beyond the first-line (1L) setting remain unknown. Methods: We retrospectively reviewed charts for adult patients (pts) receiving an ICI/TKI combination in any line of tx for mRCC of any histology at one of two academic centers as of May 1, 2020. ICIs included pembrolizumab (Pm), nivolumab (Ni), ipilimumab (Ip), or avelumab (Av); TKIs included sunitinib (Su), axitinib (Ax), pazopanib (Pz), lenvatinib (Ln), or cabozantinib (Ca). Clinical data including pt demographics, histology, International mRCC Database Consortium (IMDC) risk group, tx history, and ICI/TKI tx and toxicity details were recorded. Outcomes included objective response rate (ORR), median progression-free survival (mPFS), and safety, analyzed via descriptive statistics and the Kaplan-Meier method. Results: Of 85 pts, 69 (81%) were male and 67 (79%) had clear cell histology. IMDC risk was favorable (24%), intermediate (54%), poor (20%), and unknown (2%). 39% had ICI/TKI tx in the 1L setting. ICI/TKI regimens included Pm/Ax (33%), Ni/Ca (25%), Ni/Ax (20%), Av/Ax (11%), Ni/Ip/Ca (8%), Ni/Su (2%), and Ni/Ln (1%). ORR and mPFS stratified by line of tx and prior tx are shown in the table. Of 52 pts who received ICI/TKI tx as salvage (after 1L), 52% had a grade 3 or higher (≥G3) adverse event (AE), of which the most common were anorexia (13.5%), diarrhea and hypertension (11.5% each), and fatigue (9.6%). 65% of pts on salvage ICI/TKI tx stopped tx for progression/death, while 16% stopped tx for ≥G3 AE. ≥G3 AE rates by line of tx were 62.5% (2L), 50% (3L), and 45% (≥4L). Conclusions: ICI/TKI combination therapy is effective and safe beyond the 1L setting. Prior tx history appears to impact efficacy but has less of an effect on safety/tolerability. These observations will need to be confirmed in prospective studies.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9510-9510
Author(s):  
Jonathan S. Zager ◽  
Marlana Orloff ◽  
Pier Francesco Ferrucci ◽  
Evan Scott Glazer ◽  
Aslam Ejaz ◽  
...  

9510 Background: Ocular melanoma, the most common intraocular malignancy, frequently metastasizes to the liver but to date there is no established standard of care for hepatic-dominant ocular melanoma patients. The FOCUS trial began as a randomized, phase III trial (301) comparing PHP with best alternative care (BAC). The trial was subsequently amended (301A) to remove the BAC arm due to enrollment concerns. Methods: Eligible patients with hepatic-dominant ocular melanoma were randomized 1:1 to receive PHP or BAC (investigator’s choice of TACE, pembrolizumab, ipilimumab, or dacarbazine) on the 301 trial. All eligible patients received PHP on the 301A trial. PHP patients could receive up to 6 PHP treatments, repeated every 6-8 weeks with melphalan dosed at 3.0mg/kg ideal body weight (IBW). Patients with progressive disease (PD) were discontinued from study treatment and all patients are followed until death. Patientswere imaged every 12 (±2) weeks until PD. The primary endpoint, ORR (per RECIST 1.1) as assessed by Independent Review Committee, will be characterized by the point estimate and 95% CI for each group (PHP and BAC). Categorical efficacy variables will be presented as frequency counts and percentages and 95% CI. Time-to-event variables will be summarized using Kaplan-Meier methods (median and 95% CI). Results: 144 patients were enrolled overall; 102 were assigned to PHP (301: n=43; 301A: n=59) and 42 were assigned to BAC. 91 PHP patients received treatment (301: n=40; 301A: n=51) and 32 BAC patients received treatment. At the time of this analysis, 4 PHP patients were still ongoing on study treatment with a minimum follow-up of 24 weeks. 79 PHP-treated patients and 29 BAC-treated patients were evaluable for response. ORR among PHP patients was 32.9% (26/79; 95% CI: 22.75-40.40%). ORR among BAC patients was 13.8% (4/29; 95% CI: 3.89-31.66%). The median PFS was 9.03 months (95% CI: 6.24-11.83) among PHP patients and was 3.06 months (95% CI: 2.69-5.65) among BAC patients; this difference was statistically significant ( p=0.0004). Among the 94 patients assessed for safety after treatment with PHP, 40.4% of patients experienced a serious treatment-emergent adverse event, the majority of which were hematological and resolved without sequelae. There were no treatment related deaths in the trial. Conclusions: In this analysis of preliminary data from the FOCUS trial, PHP demonstrates a statistically superior ORR and significantly prolonged PFS in comparison with BAC in the treatment of hepatic metastases from ocular melanoma. The data is encouraging as efficacious treatments for hepatic metastases from ocular melanoma are desperately needed. These early data show an improvement over the previous phase III study in terms of both efficacy (ORR and PFS) as well as toxicity using second generation filters. Clinical trial information: NCT02678572.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4039-4039
Author(s):  
Brindley Sonal Hapuarachi ◽  
Rebecca Lee ◽  
Adeel Khan ◽  
Laura Woodhouse ◽  
Valentinos Kounnis ◽  
...  

4039 Background: Despite potentially curative surgery, long-term survival from OGC remains poor due to high relapse rate. Neoadjuvant (naFLOT) and adjuvant (aFLOT) FLOT is currently standard treatment for resectable OGC based on data from the FLOT-4 trial. We explored whether TRG was associated with FLOT-outcome using RWD. Methods: Pts with OGC treated with naFLOT +/- aFLOT at a tertiary UK centre were identified following institutional board approval. Clinical and laboratory data were extracted from the patient record. TRG was evaluated by a histopathologist. Median overall survival (OS) and median progression-free survival (PFS) were evaluated using Kaplan-Meier and Log-rank tests; time taken from start of naFLOT, and associations between factors with Fisher’s exact (FE) test. Results: 171 pts were identified, median FU 30 mths. 144 (84%) male; median age 66 (32-84); oesophagus 66 (38%), junctional (GOJ) 73 (43%), gastric 32 (19%); stage IB 3 (2%), stage IIB 26 (15%), stage III 91 (53%), stage IVA 47 (28%) and unknown 4 (2%). Pts had median of 2 comorbidities (range 0-6); performance status (PS) 0: 95 (56%), PS 1: 71 (41%), PS 2: 3 (2%) and PS unknown 2 (1%). 132/171 pts completed 4 cycles of naFLOT and this was significantly associated with undergoing surgery (p = 0.02). Those who had surgery (140/171) had significantly improved PFS (not reached (NR) vs. 6 mths; 95% CI 2-10; p < 0.001) and OS (NR vs. 12 mths; 95% CI 6-18; p < 0.001). TRG was reported for 126/140 patients who underwent surgery. TRG 1/2 (42/126) vs. TRG ≥3 was significantly associated with improved PFS (NR vs. 35 mths; 95% CI NR; p < 0.001) and OS (median NR either group; p < 0.001). Pts with TRG 1/2 who commenced aFLOT (≥1 cycle; n = 31/42) or completed 4 cycles of aFLOT (17/31) did not have improved PFS or OS vs. those who did not. Those with TRG ≥3 who commenced aFLOT (≥1 cycle; n = 62/85) had improved PFS (median NR vs. 22 mths; 95% CI 13-31 p = 0.006) and OS (median NR vs. 25 mths; 95% CI 18-32 p = 0.019). Those with TRG ≥3 who completed 4 cycles of aFLOT (n = 38/62) had significantly improved PFS (median NR vs. 25 mths; 95% CI 14-36 p = 0.016) and OS (median NR vs. 36 mths; 95% CI 16-55 p = 0.012). There was no difference in PFS or OS in pts with TRG ≥3 who had a dose reduction at any time during aFLOT. Conclusions: TRG is a predictor of outcome following naFLOT + surgery with superior outcomes in those with TRG 1/2. Our analyses suggest that only pts with TRG >3 following naFLOT + surgery benefit from adjuvant FLOT. Prospective randomised studies are required to confirm whether pts with TRG 1/2 require treatment with aFLOT.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5042-5042
Author(s):  
Julie N Graff ◽  
Scott T. Tagawa ◽  
Christopher J. Hoimes ◽  
Winald R. Gerritsen ◽  
Ulka N. Vaishampayan ◽  
...  

5042 Background: KEYNOTE-199 (NCT02787005) is a multicohort phase 2 study to evaluate pembrolizumab (pembro) in mCRPC. A previous analysis of patients with RECIST-measurable (cohort 4 [C4]) or bone-predominant nonmeasurable (cohort 5 [C5]) disease who were chemotherapy-naive and had progression while on enzalutamide (enza) found that pembro + enza showed antitumor activity and manageable safety. Long-term outcomes are of interest with immunotherapy; hence, updated efficacy and safety data after an additional 1 year of follow-up are presented. Methods: Pts were eligible if they had resistance to enza after prior response. Prior treatment with abiraterone was allowed. Pts received pembro 200 mg Q3W for up to 35 cycles + enza QD until progression, unacceptable toxicity, or withdrawal. Primary end point was ORR per RECIST v1.1 by blinded independent central review (BICR) in C4. Secondary end points were DOR (C4), and DCR, rPFS, OS and safety (both cohorts). Results: 126 pts (C4, 81; C5, 45) were treated. Median age was 72 years (range 43-92), 32.5% had visceral disease and 87.3% previously received ≥6 mo of enzalutamide; 121 pts (96.0%) discontinued, most because of progressive disease. Median (range) time from enrollment to data cutoff was 31.7 mo (23.1-37.1) in C4 and 35.5 mo (22.9-37.3) in C5. In C4, confirmed ORR was 12.3% (95% CI 6.1-21.5) (2 CRs, 8 PRs); median (range) DOR was 8.1 mo (2.5+ to 15.2), and 62.5% had a response ≥6 mo (Kaplan-Meier estimate). Additional efficacy analyses are outlined in the table. A total of 27.2% and 28.9% of pts in C4 and C5, respectively, experienced grade ≥3 treatment-related adverse events. Two pts in C4 died of immune-related AEs (Miller Fisher syndrome and myasthenia gravis). Incidence of any-grade (34.1%) and grade 3 or 4 (5.6%) rash, regardless of relatedness to treatment, was higher than previously reported for individual agents but manageable with standard-of-care treatments; 2 pts discontinued because of rash. Conclusions: After an additional 1 year of follow-up, pembro + enza continued to show antitumor activity and a manageable safety profile in pts with mCRPC who became resistant to enza. The treatment combination is being further evaluated in the ongoing phase 3 KEYNOTE-641 trial (NCT03834493). Clinical trial information: NCT02787005. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6061-6061
Author(s):  
Pau Guillen Sentis ◽  
Carmen Castillo Manzano ◽  
Beatriz Quirós ◽  
Francisca Morey Cortes ◽  
Sara Tous ◽  
...  

6061 Background: Treatment (ttm) of cancer patients (pts) was compromised during the first wave of COVID19 pandemic due to collapse of healthcare systems. Standard of care (SOC) for LA-HNSCC pts had to be adapted as operating rooms were temporarily unavailable, and to reduce risk of COVID19 exposure. The IMPACCT study evaluated the outcome of LA-HNSCC pts treated at the Catalan Institute of Oncology during the first semester of 2020 and compared it to a control cohort previously treated in the same institution. Methods: Retrospective single institution analysis of two consecutively-treated cohorts of newly-diagnosed HNSCC pts: from January to June of 2020 (CT20) and same period of 2018 and 2019 (CT18-19). Pt demographics and disease characteristics were obtained from our in-site prospective database. Ttm modifications from SOC as per COVID19-contingency protocol in CT20 for LA-HNSCC were collected. Chi-squared was used to compare variables and ttm response between cohorts. One-year recurrence-free survival (1yRFS) and overall survival (1yOS) of LA-HNSCC pts were estimated by Kaplan-Meier method and compared by Log-rank test. Results: A total of 306 pts were included: CT20=99; CT18-19=207. Baseline characteristics were balanced between cohorts (Table1). In pts treated with conservative ttm (non-surgical approach), persistence disease was higher in CT20 vs CT18-19 (26 vs. 10% p=0.02). Median follow-up of CT20 and CT18-19 was 6.8 months (IQR 5.1-7.9) and 12.3 (6.7-18.4), respectively. A trend towards lower 1yRFS and 1yOS was observed in CT20 vs CT18-19 (72 vs 83% p=0.06; 80 vs 84% p=0.07), respectively. Within CT20, 37 pts (37%) had one or more ttm modifications: switch from surgery to conservative ttm (n=13); altered radiotherapy fractionation (n=14); reduced cisplatin cumulative dose to 200mg/m2 (n=19); no adjuvant ttm (n=1). Pts who received modified ttm had no differences in 1yRFS vs those who did not (80 vs 66% p=0.31), but higher 1yOS was observed (97 vs 67% p<0.01). When stratified by stage, 1yOS difference remained significant in stage III/IVA (100 vs 61% p<0.01) but not in I/II (100 vs 77% p=0.28) or IVB (67 vs 50% p=0.54). Conclusions: COVID19 pandemic had a negative impact on ttm outcomes and survival in LA-HNSCC pts when compared to our historical cohort. Ttm modifications based on COVID19-contingency protocol did not compromise ttm efficacy in terms of RFS and was associated with better OS in Stage III/IVA.[Table: see text]


2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii80-iii80
Author(s):  
M Yahia-Cherif ◽  
O De Witte ◽  
C Mélot ◽  
F Lefranc

Abstract BACKGROUND The aim of this study was i) to analyse the effect of repeat surgeries on the survival of patients with focally recurrent glioblastoma who have benefited from temozolomide treatment and ii) to identify potential prognostic factors for survival. MATERIAL AND METHODS Cases from 2005 to 2014 in the glioblastoma database of our department were retrospectively reviewed. The Kaplan-Meier method was used to estimate overall survival (OS) as a function of time after one, two and three surgical resections. All patients received the standard of care after the first surgery (temozolomide during and after radiotherapy) and adjuvant treatment after repeat surgeries. RESULTS One hundred-thirty-two glioblastoma patients (median age: 57 years) were included in the study. Among them, 68, 53 and 11 patients underwent one, two and three surgical resections, respectively. The median OS was 11, 16 and 18 months, respectively, for patients who underwent one, two and three surgical resections. Patients who underwent two (p<0.001) or three (p<0.01) surgeries survived significantly longer than patients who underwent only one. No significant difference was observed between patients who underwent two versus three surgeries (p=0.76). A second resection performed more than 6 months after the initial resection was the only factor associated with prolonged survival (p=0.008). CONCLUSION Glioblastoma patients who benefited from temozolomide treatment and underwent surgery for recurrent glioblastoma exhibited a significant increase in survival compared with patients who did not undergo a second surgery. By contrast, a third surgery for a second recurrence did not contribute to any significant survival benefit.


2018 ◽  
Vol 45 (5) ◽  
pp. 671-677 ◽  
Author(s):  
Julie E. Davidson ◽  
Qinggong Fu ◽  
Beulah Ji ◽  
Sapna Rao ◽  
David Roth ◽  
...  

Objective.This observational study was a retrospective analysis of prospectively collected Hopkins Lupus Cohort data to compare longterm renal survival in patients with lupus nephritis (LN) who achieved complete (CR), partial (PR), or no remission following standard-of-care LN induction therapy.Methods.Eligible patients with biopsy-proven LN (revised American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) were identified and categorized into ordinal (CR, PR, or no remission) or binary (response or no response) renal remission categories at 24 months post-diagnosis [modified Aspreva Lupus Management Study (mALMS) and modified Belimumab International Lupus Nephritis Study (mBLISS-LN) criteria]. The primary endpoint was longterm renal survival [without endstage renal disease (ESRD) or death].Results.In total, 176 patients met the inclusion criteria. At Month 24 postbiopsy, more patients met mALMS remission criteria (CR = 59.1%, PR = 30.1%) than mBLISS-LN criteria (CR = 40.9%, PR = 16.5%). During subsequent followup, 18 patients developed ESRD or died. Kaplan–Meier plots suggested patients with no remission at Month 24 were more likely than those with PR or CR to develop the outcome using either mALMS (p = 0.0038) and mBLISS-LN (p = 0.0097) criteria for remission. Based on Cox regression models adjusted for key confounders, those in CR according to the mBLISS-LN (HR 0.254, 95% CI 0.082–0.787; p = 0.0176) and mALMS criteria (HR 0.228, 95% CI 0.063–0.828; p = 0.0246) were significantly less likely to experience ESRD/mortality than those not in remission.Conclusion.Renal remission status at 24 months following LN diagnosis is a significant predictor of longterm renal survival, and a clinically relevant endpoint.


2020 ◽  
Vol 09 (01) ◽  
pp. 50-52 ◽  
Author(s):  
Waseem Abbas ◽  
Rudra Prasad Acharya ◽  
Archit Pandit ◽  
Saurabh Gupta ◽  
Ranga Raju Rao

Abstract Background: PDL-1 inhibitors have emerged as the new standard of care for second line treatment of NSCLC. Methods: Eligible patients included, histologically proven NSCLC, ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2, age 18 years and above, availability of pre-treatment tumor specimen, adequate end organ function, at least one prior platinum-based therapy. Patients who received a minimum of 6 doses of nivolumab were eligible. Results: Eleven previously treated patients with chemotherapy, started on nivolumab from April of 2016 to December of 2018, were retrospectively studied and analysed. The median age of patients was 58 years. Eight (72.73%) of the eleven patients were male. Seven (63.64%) of the patients were current or former smokers. Majority of patients had non-squamous histology; seven (63.64%) adenocarcinoma and four (36.36%) squamous cell carcinoma. 5 (45.46%) of the patients received one prior therapy, three (27.27%) received two prior therapies, and three (27.27%) received three prior therapies. Four (36.36%) of the patients had brain metastasis. Two (18.18%) of the patients were more than 70 years of age. Median number of cycles of nivolumab administered were 10 (range, 6 to 21). At the time of analysis, the median PFS was 8 months (95% CI, 1.52-14.47) and median OS was 15 months (95% CI, 6.9-23.09). Treatment was well tolerated and generally side effects were grade 1 and grade 2, except two patients who develop grade 3/4 pneumonitis. Conclusions: This is a real-world study of eleven previously treated patients with chemotherapy, started on Nivolumab from April of 2016 to December of 2018. Although, our sample size was small, our data supports the use of nivolumab as a new treatment option for patients of stage 4 NSCLC.


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