scholarly journals Comparing Efficacy of Punctum-incised Surgery versus Punctum- Sparing Surgery in Primary Canaliculitis Patients

2021 ◽  
Author(s):  
Zhongcheng Shen ◽  
Qin Zhang ◽  
Fangting Li ◽  
Mingwu Li ◽  
Min Wang ◽  
...  
Keyword(s):  
Disease Onset ◽  
Common Symptom ◽  
Lacrimal Duct ◽  
First Line ◽  
Recurrence Rates ◽  
First Line Therapy ◽  
Operative Outcomes ◽  
Significant Difference ◽  
Multiple Treatments ◽  
Onset Location

Abstract Purpose: This study aims to describe the characteristics of canaliculitis patients and compare the operative outcomes between punctum-sparing canaliculotomy and traditional punctum-incised canaliculotomy.Methods: The medical records of 58 patients who were diagnosed with canaliculitis were reviewed from March 1, 2010, to December 31, 2020. The demographic characteristics, symptoms, time to disease onset, location of involvement, operation information, and prognosis were recorded and analyzed.Results: Canaliculitis showed a female (67%) predominance. Epiphora with discharge was the most common symptom which happened in 56 (97%) patients. The recurrence rates of the punctum-incised group and the punctum-sparing group were 5% and 9% respectively, and there was no significant difference between the two groups. (p=0.514)Conclusion: The recurrence rate of the punctum-sparing group showed no significant difference with punctum-incised group. Patients with recurrence finally recovered after multiple treatments. Squeezing by tweezers was a good way to locate the infected lacrimal duct. Punctum-incised surgery can be the first-line therapy for canaliculitis.

scholarly journals 1338. Analysis of Prescription Guideline Adherence in Pediatric Outpatient Pneumonia Treatment

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S680-S681
Author(s):  
Carly Heck ◽  
Judith Martin ◽  
Marcia Kurs-Lasky
Keyword(s):  
Drug Allergy ◽  
Health Concern ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Comparison Results ◽  
Significant Difference ◽  
Recommended Therapy

Abstract Background Background: Antibiotic resistance is a major public health concern. A modifiable intervention is outpatient antibiotic stewardship. The goal of this study was to review the electronic health records (EHR) of children diagnosed with community acquired pneumonia (CAP) to compare patients who received non-guideline concordant therapy with those prescribed recommended therapy. Methods Methods: This was a retrospective chart review of 300 children (6 months to 6 years old) with an outpatient diagnosis of CAP between July 2017 and June 2019. 45 Children’s Hospital of Pittsburgh (CHP) and UPMC Children’s Community Pediatrics (CCP) practices were included. CHP practices are academic-based with trainees involved in visits, while CCP practices do not include trainees. First-line recommended therapy was defined as amoxicillin, second-line therapy as azithromycin or amoxicillin-clavulanate, and all other prescriptions were defined as other. Patients prescribed first-line therapy were compared to patients with second-line therapy or other. If first-line therapy was not prescribed, the EHR was manually reviewed for justification. If drug allergy was listed, the medication allergy and type of reaction were recorded. Results Results: In this study the minority of children (43%) were prescribed first-line therapy. This group was younger (57 vs. 63 months of age), more likely to be Non-white (80%), and seen at the CHP locations than those prescribed non-guideline concordant therapy. The average symptom duration was shorter, heart rate and respiratory rate were higher and the presence of fever was more common in the first-line therapy group. Justification for non-guideline therapy was most often reported as to provide coverage for atypical organisms. The most common drug allergy recorded was amoxicillin, and urticaria with unknown timing was the most common type of reaction. Demographics Comparison Results Justification for Second-line / Other Therapy and Drug Allergy Results Conclusion This project observed a high proportion of children being prescribed non-guideline concordant therapy for a diagnosis of CAP. Age, race, practice location, and severity of illness measures showed a statistically significant difference between groups. This study highlights the importance of education which reviews the current guidelines and the most likely pathogens for children with CAP. Disclosures All Authors: No reported disclosures

Comparison of First-line Pazopanib and Sunitinib in Metastatic Renal Cell Carcinoma: Experiences of the Urologic Cancer Centre for Research and Innovation

2019 ◽  
Author(s):  
Emily C.L. Wong ◽  
Camilla Tajzler ◽  
Gaurav Vasisth ◽  
Amanda Zhu ◽  
Mathilda Chow ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Side Effects ◽  
Cell Carcinoma ◽  
Disease Progression ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

Abstract Background: Sunitinib and pazopanib are orally-administered tyrosine kinase receptor inhibitors (TKIs) approved as first-line therapy for the treatment of metastatic renal cell carcinoma (mRCC). The IMDC criteria are a predictive prognostic model for patients with mRCC when stratified into three prognosis groups: favourable, intermediate and poor. We retrospectively compared the efficacy and safety of sunitinib and pazopanib as first-line therapy for patients with mRCC in our single institution database. Methods: Retrospective analysis was done to compare progression-free survival (PFS) and side effects of sunitinib and pazopanib as first-line therapy in patients with mRCC. Patients were stratified into prognosis groups according to IMDC criteria. Disease assessment was performed on measurable aspects of disease based on computed tomography or magnetic resonance imaging reports. Survival analysis was performed using the Kaplan-Meier method and Cox regression, with disease progression as the endpoint.Results: Data was obtained from 228 patients with mRCC who were treated with either pazopanib (n=57) or sunitinib (n=171). No significant difference in PFS was found between sunitinib and pazopanib (HR for disease progression or all-cause death, 1.10; 95%CI: 0.76-1.57, p=0.62). Median PFS time for patients receiving sunitinib was 9.4 months and for pazopanib, 8.5 months. Median PFS for patients with intermediate-risk disease was similar between groups (9.4 months vs. 9.2 months, respectively, p=0.93). However, patients treated with sunitinib experienced a greater number of side effects compared to pazopanib. Conclusions: Sunitinib and pazopanib are similarly efficacious as first-line therapy for mRCC. However, adverse events are lower with pazopanib.

90Yttrium-Ibritumomab-Tiuxetan As First-Line Therapy Or As Consolidation Treatment In Advanced Stage Follicular Non-Hodgkin Lymphoma: Long-Term Results After a Median Follow-Up Of 61 Months

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5123-5123
Author(s):  
Katharina Troppan ◽  
Angelika Valentin ◽  
Werner Linkesch, MD
Keyword(s):  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Consolidation Treatment ◽  
Non Hodgkin Lymphoma ◽  
First Line Therapy ◽  
Significant Difference ◽  
Long Term Follow Up

Abstract Purpose Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells. 90Y-Ibritumomab-Tiuxetan (90YIT) is a murine anti-CD20 monoclonal antibody engaged for radioimmunotherapeutic targeting of CD20+ lymphoma cells. We report on our long-term follow-up data of 90YIT as first-line or consolidation treatment in advanced stage follicular Non-Hodgkin lymphoma (FL). Patients & Methods Between March 2004 and October 2010, forty-seven patients with CD20+ FL grade 1 to 3a in stages II, III, or IV were treated with a single dose of 90Yttrium-Ibritumomab-Tiuxetan (90YIT) at our institution. The median age was 61 years (range 41-83; male 55%) and 77% (n=36) of patients were in an advanced stage of the disease (stage III/IV). 90YIT was administered on an outpatient basis on day 8 after pretreatment with Rituximab (250mg/m²) on day 1. A mean of 1122 MBq (range 680-240) 90YIT was administered. Fourteen patients received 90YIT as first-line therapy, twenty-seven patients were treated with 90YIT after a median of 2 pretreatment courses (range 1-5) as consolidation therapy in remission (15 patients in CR, 12 patients in PR), and six patients showed progressive disease (PD) at time of 90YIT treatment. Median follow-up was 61 months (range 0-111). Results After a median follow-up of 61 months (range 0-111 months), 32 patients are still alive, including 21 patients in CR since 90YIT treatment. There was no significant difference concerning PFS and OS between first-line treatment and consolidation treatment, but we found a significant difference, comparing these two groups versus PD (PFS 51 months vs. 48 months vs. 8 months, p<0.023; OS 59 months vs. 71 months vs. 10 months, p<0.002) (figure 1 & 2). Survival rates were 85% (first-line), 67% (consolidation) and 33% (PD), respectively. Patients who maintained a CR after 90YIT treatment, showed significantly longer OS compared to patients with relapse after 90YIT (71 months vs. 52 months, p<0.001). No significant difference in PFS and OS was seen, concerning sex, age, or clinical stage. No unexpected toxicities emerged during long-term follow-up. Conclusion 90YIT as first-line, as well as consolidation therapy after achieving at least PR, provides a cost-efficient, long progression-free and overall survival in advanced stage FL. No benefit is shown in patients with PD, where we don't recommend 90YIT treatment. Disclosures: No relevant conflicts of interest to declare.

Health related quality of life (HRQOL) evaluated with the EORTC C30 questionnaire in first line therapy of elderly patients with chronic lymphocytic leukemia (CLL): Results of a phase III trial of the German CLL Study Group (GCLLSG)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7572-7572 ◽  
Author(s):  
B. F. Eichhorst ◽  
R. Busch ◽  
M. Hallek
Keyword(s):  
Social Functioning ◽  
Age Groups ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Response To Treatment ◽  
First Line ◽  
Elderly Age ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

7572 Background: The GCLLSG evaluated the efficacy of fludarabine (F) versus (vs.) chlorambucil (Clb) in first line therapy of older patients with advanced CLL. HRQOL was evluated by using the EORTC C30 questionnaire. Methods: Pts were randomized to receive 6 courses of F (25 mg/m²/day (d) IV for 5d; 92 pts) or 12 months (mo) of Clb (0.4–0.8 mg/kg/d PO, every 15d; 99 pts). All pts were previously untreated, aged between 65 and 79 years and in advanced stage Binet C or symptomatic Binet B or A. Primary endpoints were overall survival (OS) and progression free survival (PFS), secondary endpoint was HRQOL. The EORTC C30 questionnaire (version 2.0) was sent to all patients at baseline and after 6, 12 and 24 mo. Scores (0–100) for 15 different measures (1 global HRQOL, 5 functional, 3 symptom and 6 single item scales) were evaluated at each time point. Results: F induced significantly higher response rates and prolonged the PFS, while no significant difference in OS was observed. At baseline 130 of 191 pts (68%) completed the questionnaires followed by more than 80% at mo 6 to 24. Compliance rates were similar in both treatment arms. Between pts completing questionnaires or not no statistically significant differences in perfomance status, age, stage or response to treatment were observed. HRQOL differences in comparison to baseline values were significantly improved after F treatment in global HRQOL, role and social functioning after 12 months as shown by the table. Responders had a significantly better global HRQOL and social functioning as well. Except for an impaired physical functioning no differences in HRQOL were observed between different age groups (65–69, 70–74, 75–79). Conclusion: Elderly F treated patients with CLL showed improvement inglobal HRQOL. Elderly age groups had a similar HRQOL as younger age groups. [Table: see text] [Table: see text]

A retrospective study of first-line combination chemotherapy in advanced colorectal cancer: A Korean single-center experience.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 623-623
Author(s):  
S. Lee ◽  
J. Park ◽  
S. Park ◽  
W. Kang ◽  
H. Lim ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Folinic Acid ◽  
Combination Chemotherapy ◽  
Advanced Colorectal Cancer ◽  
First Line ◽  
Single Center Experience ◽  
First Line Therapy ◽  
Significant Difference ◽  
Line Setting ◽  
Unacceptable Toxicity

623 Background: Fluoropyrimidine-based combination chemotherapy, in combination with either oxaliplatin or irinotecan, have demonstrated efficacy and tolerability against advanced colorectal cancer (ACC). Methods: Between Jan 2006 and Dec 2007, 478 ACC patients were treated with combination chemotherapy in first-line setting: 5-fluorouracil, folinic acid plus oxaliplatin (FOLFOX, n=172), 5-fluorouracil, folinic acid plus irinotecan (FOLFIRI, n=95), capecitabine plus oxaliplatin (XELOX, n=155), and capecitabine plus irinotecan (XELIRI, n=56). FOLFOX and FOLFIRI were repeated every 2 weeks, whereas XELOX and XELIRI were repeated every 3 weeks until disease progression or unacceptable toxicity occurred or until a patient chose to discontinue treatment. Results: The median age was 58 years (range, 19-84 years) and the median chemotherapy duration for FOLFOX, FOLFIRI, XELOX and XELIRI were 4.9, 4.5, 5.7 and 5.4 months, respectively. Combination chemotherapy regimens were generally well tolerated. The estimated median PFS for all patients was 6.8 months (95% confidence interval, 6.3-7.3 months). No statistically significant difference in PFS was found each regimen used as first-line chemotherapy. Sixty-percent (n=290) of patients received second or further lines of therapy after failure. Conclusions: Fluoropyrimidine-based combination chemotherapy regimens appear to be equally active and tolerable as first-line therapy for ACC. No significant financial relationships to disclose.

Whether mCRC patients with other RAS mutations benefit from the addition of bevacizumab as first-line therapy.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 579-579
Author(s):  
Mingyi Zhou ◽  
Ping Yu ◽  
Kezuo Hou ◽  
Xiujuan Qu ◽  
Yunpeng Liu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Large Sample Size ◽  
First Line ◽  
Exon 2 ◽  
Ras Mutations ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Ras Status ◽  
Kras Exon

579 Background: It is not clear whether Bevacizumab plus chemotherapy could improve the prognosis of mCRC patients with other RAS mutations beyond KRAS exon 2. Methods: The MEDLINE, EMBASE, Cochrane databases, and Clinical Trials databases were reviewed to September 2015. The data of patients with KRAS exon 2 mutations was only available in FIRE3 study. So we could not perform the meta-analysis by KRAS exon 2 mutations. The data of patients with other RAS mutations beyond KRAS exon 2 were available in PEAK and FIRE3 studies. Hazard ratio (HR) was used to analyze the progressive-free survival (PFS) and overall survival (OS). Relative risk (RR) was used to analyze overall response rate (ORR). Results: Patients with other RAS mutations beyond KRAS exon 2 benefited from the addition of Bevacizumab. Bevacizumab + chemotherapy significantly improved the PFS compared with anti-EGFR moAb + chemotherapy (HR: 1.82, CI: 1.20–2.77, P =.005). The addition of Bevacizumab tended to improve ORR, though there is no significant difference (RR: 0.83, CI: 0.58–1.18, P =.288). But the OS tended to be shorter in Bevacizumab + chemotherapy arm than anti-EGFR moAb + chemotherapy arm without significant difference (HR: 0.72, CI: 0.25–2.05, P =.534). Conclusions: Patients with other RAS mutations beyond KRAS exon 2 could choose Bevacizumab plus chemotherapy as first-line therapy. But there is still no adequate evidence to reject or support the predictive value of RAS status in the effect of the addition of Bevacizumab. Moreover, which is the better primary endpoint, PFS or OS? Which is the better consequence of strategy, anti-EGFR moAb followed by Bevacizumab or Bevacizumab followed by anti-EGFR moAb? RCTs with large sample size comparing the efficacy of anti-VEGF moAb + chemotherapy and chemotherapy alone by RAS status as the first-line therapy in mCRC patients are required in the future.

scholarly journals Location of accessory pathways and its radiofrequency ablation in Wolf-Parkinson-White syndrome

2006 ◽  
Vol 134 (9-10) ◽  
pp. 386-392 ◽  
Author(s):  
Dejan Vukajlovic ◽  
Lazar Angelkov ◽  
Aleksandar Neskovic
Keyword(s):  
Radiofrequency Ablation ◽  
Interface Temperature ◽  
Success Rates ◽  
Recurrence Rates ◽  
Accessory Pathways ◽  
First Line Therapy ◽  
Total Procedure Time ◽  
Significant Difference ◽  
Primary Success ◽  
The Right

Introduction: Radiofrequency ablation (RFA) of accessory pathways (AP) is the first line therapy in symptomatic patients with preexcitation syndrome, resistant to medical therapy. Objective: To evaluate the influence of AP location on RFA effectiveness. Method: The study compared RFA results of AP located on the left side, right side, and in septal area of the heart in the first 101 consecutive patients treated at Dedinje Cardiovascular Institute in Belgrade. Results: There was no significant difference between the right-, left- and septal-AP in relation to primary success rates (66.7%, 84.3%, 73.7%, respectively, p=0.285), recurrence rates (12.5%, 6.97%,14.3%, p=0.591), and final success rates (66%, 84.3%, 78.9%, p=0.37). Maximally achieved interface temperature was lowest at right-sided AP (49.8?1.9?C) as compared to the left (53.0?3.5?C) or septal AP (52.9?3.0?C) (p<0.01). Fluoroscopy time did not differ significantly (p=0.062), while total procedure time and the number of applied RF pulses was higher in the left-sided AP as compared to other two (104.6?44.9 for the left, 98.9?47.5 for the right and 80.7?39.8 minutes for the septal AP, p<0.05; 11.0?8.8 pulses for the left, 6.5?3.8 for the right and 6.4?5.0 for septal AP, p<0.01). Two major complications developed: one third-degree AV block after ablation of midseptal AP, and one pericardial effusion without tamponade, with spontaneous regression. Conclusion: The success rate of RFA of the right-, left- and septal-AP was similar. Heating of the tissue was weakest during RFA of the right-sided AP.

Comparison of clinical outcome between gefitinib and erlotinib treatment in patients with non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 or exon 21 mutations.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19051-e19051
Author(s):  
Sung Hee Lim ◽  
Ji Yoon Lee ◽  
Jong-Mu Sun ◽  
Jin Seok Ahn ◽  
Keunchil Park ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Ecog Performance Status ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Egfr Tki

e19051 Background: Gefitinib and erlotinib are small-molecule kinase inhibitors that inhibit signaling via EGFR and both agents showed dramatic response rate and prolonged PFS in patients harboring activating EGFR mutation. We investigated the clinical outcomes between gefitinib- and erlotinib-treated patients with recurrent or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations. Methods: A total 375 patients with recurrent or metastatic NSCLC who had either an exon 19 deletion or L858R mutation on exon 21 and received gefitinib (n=228) or erlotinib (n=147) therapy between August 2007 and December 2011 were retrospectively reviewed. By using a matched-pair case-control study design, 121 pairs of gefitinib-treated and erlotinib-treated patients were matched according to sex, smoking history, ECOG performance status, and types of EGFR mutation. Results: The median age of all patients was 58 years (range, 30-84) and more than half of patients were never smokers (63.6%). Most patients had adenocarcinoma (98.3%) and good ECOG performance status (0, 1) (90.9%). Of 242 patients, 64 (26.4%) received an EGFR TKI as first line therapy. The overall response rates and disease control rates in the gefitinib-treated and erlotinib-treated groups were 85.5% versus 79.8 % (p=.375) and 94.0% versus 89.1%, respectively (p=.242). There was no statistically significant difference noted with regard to OS (median, 38.9 vs 37.5; p=.642) and PFS (median, 12.9 vs 10.1; p=.135) between the gefitinib-treated and erlotinib-treated groups. For a subgroup which patients were treated with TKI as first line therapy, the overall response rates were higher than those of patients who had progressed on prior chemotherapy (90.3% vs 79.9%; p=.063). However, there was no significant difference in PFS (median, 13.3 vs 10.3; p=.134) between subjects with first line TKI therapy and more than second line treatment. Conclusions: Both gefitinib and erlotinib showed similar effective activity in selected population of NSCLC that harbored an EGFR mutation and further studies are needed to evaluate the efficacy of EGFR TKI as first line treatment.

Efficacy of platinum-based regimens as the first-line therapy in Chinese patients with advanced TNBC and deleterious BRCA1/2 mutations.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12565-e12565
Author(s):  
Nan Wang ◽  
Kun Li ◽  
Wei-Yao Kong ◽  
Xiao-Ran Liu ◽  
Meng-Yao Tan ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Line Treatment ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Peking University ◽  
Grade 3 ◽  
First Line Treatment

e12565 Background: Platinum-based therapy remains an effective treatment for triple-negative breast cancer (TNBC), however, the usage is largely limited due to its side effect and rapidly developed drug resistance. High prevalence of BRCA1/2 mutations are reported in TNBC. Here we explored efficacy of platinum-based regimens as the first-line treatment for Chinese patients (pts) with advanced TNBC, and analyzed its association with mutations of germline BRCA1/2 (gBRCA). Methods: We retrospectively analyze 220 patients diagnosed as advanced TNBC who were treated at the Dept. of Breast Oncology, Peking University Cancer Hospital in 2013-2018, and routinely evaluated by RECIST 1.1. Statistical analysis is performed in R 3.5.1. Cox proportional-hazard models are used for survival analysis. Results: 129 pts received non-platinum chemotherapy (NPCT) as the first-line therapy, and 91 pts received platinum-based chemotherapy (PBCT). The clinical benefit rate (CBR) and median PFS were not statistically different between NPCT and PBCT groups The median OS was 30.0 and 22.5 months for PBCT and NPCT group respectively (P = 0.09, HR = 0.70). Among them, 114 pts had BRCA gene tested, of which 14 had deleterious gBRCA mutations, 7 in each group. In PBCT group, the CBR was 85.7% and 35.1% for pts with and without deleterious gBRCA mutations respectively (P = 0.04). The median PFS, OS were 14.9 months and 5.3months (P = 0.001), 26.5 and 15.5 months (P = 0.16) for pts with and without the gBRCA mutations. No significant difference was observed between NPCT pts with and without gBRCA mutations as regards the CBR, PFS and OS. PBCT Pts had significantly more grade 3-4 anaemia (5.5% vs 0%) and thrombocytopenia (8.8% vs 0%) while higher percentage of palmar-plantar erythrodysesthesia (PPE) (12.4% vs 0%) and peripheral neuropathy (8.6% vs 1.1%) were observed in NPCT pts. Conclusions: The efficacy of platinum-based regimens as the first-line treatment of advanced TNBC insignificantly differs from that of non-platinum therapy. However, they are more effective for patients with deleterious gBRCA mutations, suggesting a BRCA1/2 genetic testing may be warranted for such patients.

Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 168-168
Author(s):  
Wasat Mansoor ◽  
Amit S. Kulkarni ◽  
Ken Kato ◽  
Jong-Mu Sun ◽  
Manish A. Shah ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Iii ◽  
Advanced Esophageal Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Pain Subscale ◽  
Significant Difference ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

168 Background: In the randomized, international, double-blind, placebo-controlled KEYNOTE-590 (NCT03189719) study, pembrolizumab (pembro) + chemotherapy (chemo) provided statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs placebo + chemo as first-line therapy for patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). Here we report HRQoL outcomes in KEYNOTE-590. Methods: 749 pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2y + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires were administered at baseline, every 3 weeks (Q3W) up to week 24, and then Q9W up to 1 year or end of treatment, and at the 30-d safety follow-up visit. HRQoL was assessed in all treated patients who completed ≥1 HRQoL assessment (N = 711: 356 for pembro + chemo; 355 for chemo). Change from baseline to week 18 in EORTC-QLQ-C30 global health status (GHS)/QoL and physical functioning, and in QLQ-OES18 scores were prespecified secondary endpoints. Change from baseline to week 18 in EQ-5D scores was an exploratory endpoint. Time to deterioration (TTD) was evaluated for all endpoints. Least square mean (LSM) change from baseline (95% CI) was compared using a constrained longitudinal data analysis model. TTD was compared using a stratified log rank test and Cox proportional hazards model. P-values are nominal and two-sided. Results: QLQ-C30, QLQ-OES18 and EQ-5D-5L compliance was ≥90% in both arms at baseline and at week 18. There was no significant difference in least squares mean (LSM) change from baseline to week 18 in GHS/QoL status between arms (LSM difference [95% CI] -0.10 [-3.40-3.20]; P = 0.9530). Median TTD in GHS/QoL was similar between arms (HR, 0.86 [95% CI, 0.66-1.13]; P = 0.2864). Outcomes were similar in ESCC PD-L1 CPS ≥10, ESCC, and PD-L1 CPS ≥10 patient populations. LSM change from baseline to week 18 for QLQ-OES18 pain subscale was better for pembro + chemo (-4.78) vs chemo (-1.85 ) (-2.94, -5.86 to -0.02; P = 0.0487). There was no significant difference in LSM change from baseline to week 18 between arms for reflux (-1.19; -4.49-2.10; P = 0.4781) or dysphagia (-2.35; -7.78-3.07; P = 0.3945). VAS LSM change from baseline to week 18 was similar between arms (1.20, -1.61-4.01; P = 0.4016). Conclusions: HRQoL was stable and similar over 18 weeks in the pembro + chemo and chemo arms. Together with superior OS, PFS, and ORR and a manageable safety profile with pembro + chemo, these results support the clinically meaningful benefit of pembro + chemo in patients with advanced esophageal cancer including EGJ adenocarcinoma. Clinical trial information: NCT03189719.

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