1667TiP Durvalumab plus platinum-etoposide in first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A Spanish phase IIIb single arm, real-world study
Luís Paz-AresEdurne ArriolaM.R. García CampeloMaría Pilar Diz TaínM.C. Marti BlancoA.L. Moreno VegaLuís LeónV. Gutiérrez CalderónA. Sánchez-HernándezJ.M. Oramas RodriguezMargarita MajemCarlos AguadoR. Álvarez CabellosJ.L. Martí CiriquiánVíctor AmezcuaJosé Luis Fírvida PérezÁ. Callejo MellénLuis BáezDolores Isla
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Introduction: The prominent immune checkpoint molecule, programmed cell death ligand-1 (PD-L1), is the object of increasing attention. Here, we report a meta-analysis investigating the safety and efficacy of durvalumab (MEDI4736), an inhibitor of PD-L1, in various solid tumors. Methods: A systematic search of PubMed, Embase, and related articles was performed. Safety data were analyzed using Comprehensive Meta-Analysis software program version 2. Ultimately, 17 studies with 1,529 patients were included in our analysis. Results: The major adverse events associated with durvalumab were pruritus and fatigue, while pruritus, increased alanine transaminase, and increased aspartate aminotransferase were common among patients treated with a combination of durvalumab and tremelimumab. Higher PD-L1 expression was associated with a superior objective response rate. Conclusion: Durvalumab is safe in patients with many solid cancers and, in combination with tremelimumab, it has a tolerable safety profile and is associated with improved prognosis. PD-L1 expression is a biomarker of the efficacy of durvalumab. Keywords: durvalumab, solid cancers, adverse effects, efficacy, meta-analysis
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Meeting abstracts As single agents, durvalumab (MEDI4736), a human IgG1 anti-PD-L1 antibody, and tremelimumab, a human IgG2 anti-CTLA-4 antibody, have shown acceptable safety profiles and antitumor activity. Similar to other anti-PD-L1/anti-PD-1 monotherapies, durvalumab has shown greater objective
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When resection is not an option, platinum-based chemoradiotherapy (CRT) has been the historic standard of care in non-small cell lung cancer (NSCLC). Prognosis remains poor with CRT alone. Durvalumab has shown significant improvement (versus placebo) in progression-free and overall survival in patients with unresectable stage III NSCLC without progression following CRT.This article aims to provide an overview of the efficacy and safety outcomes with durvalumab in patients with stage III NSCLC and identify management strategies for potential adverse events (AEs).A review of published literature and guidelines was performed to evaluate durvalumab clinical outcomes and AE management strategies.Durvalumab has established efficacy in patients with unresectable stage III NSCLC and is now the standard of care following CRT. Nurses need to be trained to recognize potential immune-related AEs in patients treated with immune checkpoint inhibitors.
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Introduction: The prognosis of patients with advanced non-small cell lung cancer (NSCLC) remains poor, with a 5-year overall survival rate of around 15%. Immune checkpoint inhibitors, such as programmed cell death protein 1 and programmed death-ligand 1 (PD-L1) inhibitors, have opened a new era in the management of NSCLC. Three checkpoint inhibitors (nivolumab, pembrolizumab, and atezolizumab) are currently approved by the US Food and Drug Administration (FDA) for advanced NSCLC. Durvalumab, an anti-PD-L1 antibody, is under investigation in several trials.Areas covered: This article reviews the pharmacological properties, clinical efficacy, and safety of durvalumab as monotherapy and in combination with other drugs for the treatment of locally advanced and advanced NSCLC.Expert opinion: Durvalumab as monotherapy or in combination with tremelimumab was effective with well-tolerated safety profiles for advanced NSCLC in several phase I or II studies. The PACIFIC study assessed the effectiveness of durvalumab as maintenance therapy following definitive chemoradiotherapy for unresectable stage III NSCLC, and met its primary endpoints of progression-free survival and overall survival. These results led to FDA approval for this NSCLC population. It will be exciting to follow ongoing phase III studies assessing how durvalumab fits into the rapidly evolving therapeutic landscape for advanced NSCLC.
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Introduction: Immune checkpoint inhibitors, monoclonal antibodies directed against programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1), have broadened treatment options for patients with non-small cell lung cancer (NSCLC). Durvalumab is a selective, high-affinity, human IgG1 monoclonal anti-PD-L1 antibody that blocks interactions of PD-L1 with PD-1 and CD80.Areas covered: We reviewed clinical data supporting the use of durvalumab as a monotherapy and combination therapy for the treatment of locally advanced and advanced NSCLC.Expert commentary: Durvalumab as a monotherapy or combination therapy has shown well-tolerated safety profiles for NSCLC in several trials. Durvalumab monotherapy in advanced NSCLC patients with PD-L1 ≥ 25% as later line (ATLANTIC study) therapy led to clinically meaningful improvements compared to standard of care. Combination therapy comprising durvalumab plus tremelimumab for advanced NSCLC did not show clinical efficacy in three phase III trials. Durvalumab administered after chemoradiotherapy in stage III NSCLC (PACIFIC study) significantly improved progression-free survival and overall survival. This result has led to approval of durvalumab for patients with locally advanced NSCLC as the standard of care. Ongoing trials provide insight into how durvalumab fits into the rapidly evolving therapeutic landscape for locally advanced or advanced NSCLC.
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Stage III non-small-cell lung cancer (NSCLC) represents a heterogeneous group of disease entities with multimodality treatments. For most patients, platinum-based doublet with concurrent chemoradiotherapy (CRT) has become the first-choice treatment over the past decade. Immune checkpoint inhibition has revolutionized the management of metastatic NSCLC; however, no major advances in systemic therapy for Stage III NSCLC have been made. The following report is the case of a patient with unresectable Stage IIIA NSCLC successfully treated with durvalumab. The patient completed 1 year of treatment without interruptions, and disease control has been maintained for more than 20 months since the start of durvalumab.
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Following the practice-changing results observed in several hematological and solid tumors, immunotherapy with immune checkpoint inhibitors (ICIs) has been tested in cholangiocarcinoma (CCA) patients. However, ICI monotherapy has had disappointing results in CCA, and phase I-III clinical trials have assessed whether combinatorial strategies including immunotherapy plus other anticancer agents may have a synergistic activity. The TOPAZ-1 trial has recently highlighted improved survival in CCA patients receiving first-line durvalumab plus gemcitabine-cisplatin compared with gemcitabine plus cisplatin alone, and several guidelines consider adding durvalumab to the reference doublet as standard of care. This article provides an overview of durvalumab pharmacology, safety and efficacy in CCA, highlighting current and future research directions in this setting.Several treatments have been recently tested for cholangiocarcinoma patients. Among these, interesting results have been reported for immunotherapy with durvalumab, and the combination of immunotherapy plus chemotherapy represents a novel and important option in this setting.
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Introduction: Immune checkpoint inhibitors (ICI) are now a therapeutic option for advanced non-small cell lung cancer (NSCLC) patients. ICI, such as the PD-1 inhibitors nivolumab and pembrolizumab and the PD-L1 inhibitor atezolizumab, have already been marketed for the treatment of pretreated patients with advanced NSCLC. Other notable PD-L1 inhibitors under development include avelumab and durvalumab.Areas covered: This article reviews literature on durvalumab development, from the preclinical data to the results of phase III clinical trials, whether published or presented at international scientific conferences. Ongoing clinical trials were also reviewed.Expert opinion: Early phase trials of durvalumab monotherapy (and in combination) have demonstrated activity in advanced NSCLC patients and it has demonstrated a good safety profile. The authors believe that durvalumab will likely play an important role in future treatment strategies for NSCLC. The PACIFIC trial assessing durvalumab after standard chemoradiotherapy for locally advanced NSCLC has already met its primary endpoint and the potential of durvalumab will be reinforced if phase III randomized studies of first-line (MYSTIC trial) and second or subsequent (ARCTIC trial) lines of therapy demonstrate superiority over the current standard of care.
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