scholarly journals Adjuvant anti‐PD‐1 antibody treatment in stage III/IV melanoma: real‐world experience and health economic considerations

Author(s):  
Peter Koelblinger ◽  
Magdalena Hoellwerth ◽  
Marie‐Therese Dernoscheg ◽  
Lukas Koch ◽  
Erika Richtig ◽  
...  
2021 ◽  
Vol 16 (3) ◽  
pp. S284
Author(s):  
L. Kathmann ◽  
J. Roeper ◽  
K. Wedeken ◽  
K. Willborn ◽  
F. Griesinger

2021 ◽  
Vol 11 ◽  
Author(s):  
Alessio Bruni ◽  
Vieri Scotti ◽  
Paolo Borghetti ◽  
Stefano Vagge ◽  
Salvatore Cozzi ◽  
...  

IntroductionFor unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter, retrospective cohort.MethodsTwo hundred thirty-eight patients have been included. We collected data on systemic therapy, radiation therapy, the timing between CRT and durvalumab, number of durvalumab cycles, reasons for non-starting or discontinuation, incidence and grade of adverse events (AEs), and progression-free survival (PFS) and overall survival (OS).ResultsOne hundred fifty-five patients out of 238 (65.1%) received at least one durvalumab dose: 91 (58.7%) after concomitant CRT (cCRT) and 64 (41.3%) after sequential CRT (sCRT). Programmed-death ligand 1 (PD-L1) status was unknown in 7/155 (4.5%), negative in 14 (9.1%), and positive ≥1% in 134/155 (86.4%). The main reasons for non-starting durvalumab were progression (10.1%), PD-L1 negativity (7.5%), and lung toxicity (4.6%). Median follow-up time was 14 months (range 2–29); 1-year PFS and OS were 83.5% (95%CI: 77.6–89.7) and 97.2% (95%CI: 94.6–99.9), respectively. No significant differences in PFS or OS were detected for cCRT vs. sCRT, but the median PFS was 13.5 months for sCRT vs. 23 months for cCRT. Potentially immune-related AEs were recorded in 76/155 patients (49.0%). Pneumonitis was the most frequent, leading to discontinuation in 11/155 patients (7.1%).ConclusionsDurvalumab maintenenace after concurrent or sequential chemoradiation for unresectable, stage III NSCLC showed very promising short-term survival results in a large, multicenter, restrospective, real-world study. Durvalumab was the first drug obtaining a survival benefit over CRT within the past two decades, and the present study contributes to validating its use in clinical practice.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18774-e18774
Author(s):  
Ivo Julião ◽  
Jose Luis Cunha ◽  
Patricia Redondo ◽  
Jessica Rodrigues ◽  
Tiago Figueiredo ◽  
...  

e18774 Background: Malignant melanoma (MM) is one of the most aggressive skin cancers and its incidence has been increasing worldwide. Deep understanding of patient characteristics and the course of the disease, specially through the evaluation of real-world evidence, is extremely relevant for an adequate treatment approach and better outcomes. This study aims to comprehensively evaluate demographic and clinical characteristics and also treatment outcomes of patients with stage III and IV MM, treated at a Portuguese institution. Methods: Retrospective cohort study of patients with de novo MM stage III/IV or that evolved from earlier MM stages, between 2015 and 2017 (considered the index date). Patients were followed until 12/31/2019. Demographic, clinical and treatment characteristics were evaluated. Survival was assessed, from the index date, using the Kaplan Meier method and log-rank test to compare groups. Results: We included 215 patients with a median age of 66 years (20-96) and 50.2% (n = 108) were male. At index date, 63.7% (n = 137) were stage III. From those, 41.6% (n = 57) progressed to stage IV during follow-up. At diagnosis, the majority of patients had ulceration (53.3%; n = 119), normal LDH ( < 248 U/L; 56.3%; n = 121) and from 110 patients tested for BRAF, 45.4% (n = 50) had a mutation. In earlier stages, 41.8% (n = 81) performed sentinel LN only and from those 61.7% (n = 50) had latter metastatic disease. Complete LND was performed in 49% (n = 95) and 58.9% (n = 56) had a distant relapse. Brain metastasis were diagnosed in 28.4% (n = 61) of the patients, and 50.8% (n = 31) were not eligible for any treatment due to poor clinical status. Systemic treatment was performed in 70 patients with advanced disease. In 1st line, 34 (48.6%) patients underwent anti-PD-1, 28 (40.0%) BRAF/MEKi, 5 (7.1%) BRAFi and 3 (4.3%) chemotherapy. A 2nd line treatment was performed in 21 (30.0%) patients and 2 (9.5%) underwent 3rd line treatment. With a median follow-up of 29 months OS for all patients at 24 months was 54.9% (95% CI; 48.6-62.0): 69.3% (95% CI; 62.0-77.5) for stage III patients and 29.5% (95% CI; 20.9-41.6) for stage IV patients. OS was worst for known risk factors (ulceration, mitotic rate and LDH). OS at 24 months for patients under systemic treatment was 37.4% (95% CI; 26.9-52.0), with no differences between immunotherapy and targeted therapy. Finally, 22 patients were submitted to limb perfusion with an OS of 58.1% (95% CI; 41.2-81.9) at 24 months and a median PFS of 7.4 months (95% CI; 3.9-11.3). Conclusions: Analysis of real-world data is a solid tool in the evaluation, development and improvement of treatment strategies. Demographic and clinical characteristics are comparable to those of other studied cohorts. Longer follow-up of this population and the inclusion of new patients submitted to contemporary approaches will allow improving knowledge and care for melanoma patients in Portugal.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3596-3596
Author(s):  
Jemma Megan Boyle ◽  
Angela Kuryba ◽  
Thomas E Cowling ◽  
Jan van der Meulen ◽  
Nicola S Fearnhead ◽  
...  

3596 Background: The optimal duration of adjuvant combination chemotherapy administered to patients with stage III colon cancer is debated. Our study assessed the effect of completed chemotherapy cycles on 3-year colon cancer-specific mortality, as well as the effect of dose reduction and early discontinuation of oxaliplatin in patients with 100% completion, within a real-world population. Methods: 4,147 patients undergoing major resection between 01 June 2014 and 30 April 2017 with pathological stage III colon cancer in the English National Health Service were identified. Chemotherapy data were obtained from linked administrative hospital records and a national chemotherapy dataset. Patients were stratified according to completion of < 50% ( < 6 FOLFOX cycles or < 4 CAPOX cycles), 50-92% (6-11 FOLFOX cycles or 4-7 CAPOX cycles) or 100% of cycles (12 FOLFOX cycles or 8 CAPOX cycles). Competing-risk regression analysis for 3-year colon cancer-specific death was performed with adjustment for patient, tumour and hospital-level characteristics to estimate subdistribution hazard ratios (sHR) as a measure of relative risk. Results: Patients included within our study were less fit and had increased rates of high-risk disease (T4 and/or N2 pathological staging) compared to the IDEA study. For FOLFOX, the 3-year cumulative incidence of colon cancer-specific death in patients completing 100% of cycles was 15.1% (95% CI, 12.8% to 17.6%), 18.2% (95% CI, 15.3% to 21.3%) for 50-92% of cycles and 26.4% (95% CI, 20.6% to 32.5%) for < 50% of cycles. For CAPOX, this was 12.0% (95% CI, 10.2% to 14.0%) for 100% completion of cycles, 18.2% (95% CI, 15.6% to 21.0%) for 50-92% of cycles, and 19.8% (95% CI, 15.8% to 24.1%) for < 50% cycles. Compared to 100% completion of FOLFOX cycles, colon cancer-specific death was higher in patients recorded as completing < 50% (sHR 2.17; 95% CI, 1.56 to 3.03; P = < 0.001) and 50-92% of FOLFOX cycles (sHR 1.40; 95% CI, 1.09 to 1.78; P = 0.007). Compared to 100% completion of CAPOX cycles, colon cancer-specific death was higher in patients recorded as completing < 50% (sHR 2.02; 95% CI 1.53 to 2.67; P< 0.001) and 50-92% of CAPOX cycles (sHR 1.63; 95% CI 1.27 to 2.10; P< 0.001). Dose reduction and early discontinuation of oxaliplatin did not have a statistically significant effect on mortality. Conclusions: Patients within the real world setting were more likely to have poor prognostic factors. Those who completed adjuvant chemotherapy for stage III colon cancer had improved survival rates regardless of dose reduction or early discontinuation of oxaliplatin.


Author(s):  
Thomas Rapp ◽  
Pauline Chauvin ◽  
Nadège Costa ◽  
Laurent Molinier

2019 ◽  
Vol 14 (8) ◽  
pp. 1430-1439 ◽  
Author(s):  
Sara Moore ◽  
Bonnie Leung ◽  
Jonn Wu ◽  
Cheryl Ho

Sign in / Sign up

Export Citation Format

Share Document