Comment on: Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors

Drugs ◽  
2017 ◽  
Vol 77 (10) ◽  
pp. 1137-1138 ◽  
Author(s):  
David A. Schoenfeld
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Targeted Therapy ◽  
Solid Tumors ◽  
Progression Free Survival ◽  
Advanced Solid Tumors ◽  
Free Survival

scholarly journals Advanced melanoma, a pharmacological evaluation

2021 ◽  
Vol 31 (Supplement_2) ◽  
Author(s):  
Anabela Andrade ◽  
Jorge Balteiro
Keyword(s):  
Overall Survival ◽  
Targeted Therapy ◽  
Braf Inhibitor ◽  
Progression Free Survival ◽  
Mek Inhibitor ◽  
Advanced Melanoma ◽  
New Drugs ◽  
High Rate ◽  
Free Survival ◽  
Dismal Prognosis

Abstract Background Cutaneous melanoma is an aggressive cancer that occurs in melanocytes, located in the epidermis. Historically it has a high rate of morbidity and mortality, due to the resistance and toxicity of traditional therapies. Its incidence has increased annually by 4% to 8%. Until 2011 it was still considered a devastating and almost always fatal disease in a few months. Advances in therapies have significantly improved the results of most patients with advanced melanoma, especially those with a BRAFV600 mutation, which account for almost 50% of tumors. Before the recent evolution in treatment, the prognosis and overall survival were considered very bad. The introduction of new drugs has improved progression-free survival and overall survival, as well as producing faster clinical responses. Methods Comparison of endpoints such as progression-free survival and overall melanoma survival from the Summary of Product Characteristics (SPC) studies of each drug in the therapeutic groups under assessment used in the disease. The variables used were the Endpoints Global Survival at various times (12 months, 24 months, 36 months and the median) and Progression-Free Survival. Results Combined immunotherapy (Nivolumab and Ipilimumab) improves overall survival and progression-free survival, achieving better results than targeted therapy. In this, the combination of a BRAF inhibitor and a MEK inhibitor, presents better results with the combination of Encorafenib and Binimetinib. Conclusions Both targeted therapy and immunotherapy transform melanoma with a dismal prognosis into a life-threatening illness.

Therapeutic efficacy of specific immunotherapy for glioma: a systematic review and meta-analysis

2018 ◽  
Vol 29 (4) ◽  
pp. 443-461 ◽  
Author(s):  
Sara Hanaei ◽  
Khashayar Afshari ◽  
Armin Hirbod-Mobarakeh ◽  
Bahram Mohajer ◽  
Delara Amir Dastmalchi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Clinical Trials ◽  
Specific Immunotherapy ◽  
Data Extraction ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Control Group ◽  
Free Survival ◽  
Median Difference

Abstract Although different immunotherapeutic approaches have been developed for the treatment of glioma, there is a discrepancy between clinical trials limiting their approval as common treatment. So, the current systematic review and meta-analysis were conducted to assess survival and clinical response of specific immunotherapy in patients with glioma. Generally, seven databases were searched to find eligible studies. Controlled clinical trials investigating the efficacy of specific immunotherapy in glioma were found eligible. After data extraction and risk of bias assessment, the data were analyzed based on the level of heterogeneity. Overall, 25 articles with 2964 patients were included. Generally, mean overall survival did not statistically improve in immunotherapy [median difference=1.51; 95% confidence interval (CI)=−0.16–3.17; p=0.08]; however, it was 11.16 months higher in passive immunotherapy (95% CI=5.69–16.64; p<0.0001). One-year overall survival was significantly higher in immunotherapy groups [hazard ratio (HR)=0.69; 95% CI=0.52–0.92; p=0.01]. As the hazard rate in the immunotherapy approach was 0.83 of the control group, 2-year overall survival was significantly higher in immunotherapy (HR=0.83; 95% CI=0.69–0.99; p=0.04). Three-year overall survival was significantly higher in immunotherapy as well (HR=0.67; 95% CI=0.48–0.92; p=0.01). Overall, median progression-free survival was significantly higher in immunotherapy (standard median difference=0.323; 95% CI=0.110–0.536; p=0.003). However, 1-year progression-free survival was not remarkably different between immunotherapy and control groups (HR=0.94; 95% CI=0.74–1.18; p=0.59). Specific immunotherapy demonstrated remarkable improvement in survival of patients with glioma and could be a considerable choice of treatment in the future. Despite the current promising results, further high-quality randomized controlled trials are required to approve immunotherapeutic approaches as the standard of care and the front-line treatment for glioma.

scholarly journals Personalized Medicine in the Oncology Clinic: Implementation and Outcomes of the Johns Hopkins Molecular Tumor Board

2017 ◽  
pp. 1-19 ◽  
Author(s):  
W. Brian Dalton ◽  
Patrick M. Forde ◽  
Hyunseok Kang ◽  
Roisin M. Connolly ◽  
Vered Stearns ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Targeted Therapies ◽  
Progression Free Survival ◽  
Molecular Profiling ◽  
Tumor Board ◽  
Free Survival ◽  
Off Label ◽  
Tumor Boards ◽  
Molecular Tumor Board

Purpose Tumor genomic profiling for personalized oncology therapy is being widely applied in clinical practice even as it is being evaluated more formally in clinical trials. Given the complexities of genomic data and its application to clinical use, molecular tumor boards with diverse expertise can provide guidance to oncologists and patients seeking to implement personalized genetically targeted therapy in practice. Methods A multidisciplinary molecular tumor board reviewed tumor molecular profiling reports from consecutive referrals at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins over a 3-year period. The tumor board weighed evidence for actionability of genomic alterations identified by molecular profiling and provided recommendations including US Food and Drug Administration–approved drug therapy, clinical trials of matched targeted therapy, off-label use of such therapy, and additional tumor or germline genetic testing. Results One hundred fifty-five patients were reviewed. Actionable genomic alterations were identified in 132 patients (85%). Off-label therapies were recommended in 37 patients (24%). Eleven patients were treated off-label, and 13 patients were enrolled onto clinical trials of matched targeted therapies. Median progression-free survival of patients treated with matched therapies was 5 months ( 95% CI, 2.9 months to not reached), and the progression-free survival probability at 6 months was 43% (95% CI, 26% to 71%). Lack of locally available clinical trials was the major limitation on clinical actionability of tumor profiling reports. Conclusion The molecular tumor board recommended off-label targeted therapies for a quarter of all patients reviewed. Outcomes were heterogeneous, although 43% of patients receiving genomically matched therapy derived clinical benefit lasting at least 6 months. Until more data become available from precision oncology trials, molecular tumor boards can help guide appropriate use of tumor molecular testing to direct therapy.

scholarly journals Systematic Review and Meta-Analysis of Correlation of Progression-Free Survival-2 and Overall Survival in Solid Tumors

2020 ◽  
Vol 10 ◽  
Author(s):  
Simon Chowdhury ◽  
Paul Mainwaring ◽  
Liangcai Zhang ◽  
Suneel Mundle ◽  
Eneida Pollozi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Free Survival

Clinical Experience with Azacitidine In Chronic Myelomonocytic Leukemia (CMML) in Spain

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 5040-5040
Author(s):  
Pablo Gonzalez Navarro ◽  
Regina García Delgado ◽  
Alicia Bailén Garcia ◽  
Juan Antonio Múñoz Múñoz
Keyword(s):  
Bone Marrow ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Experience ◽  
Peripheral Blood ◽  
Progression Free Survival ◽  
Complete Response ◽  
Chronic Myelomonocytic Leukemia ◽  
Free Survival ◽  
Myelomonocytic Leukemia

Abstract Abstract 5040 Clinical Experience with Azacitidine In Chronic myelomonocytic leukemia (CMML) in Spain Pablo González Navarro 1*, Regina García Delgado 2*, Alicia Bailén Garcia 3*, Juan Antonio Muñoz Muñoz 4* 1MD, PhD. Hospital San Cecilio, 18014 Granada, Spain, Teléfono: 958023600 [email protected]; 2Hospital Virgen De La Victoria, Málaga, Spain; 3Hospital Carlos Haya, Málaga, Spain; 4MD, PhD. Hospital Universitario Puerta del Mar, Cádiz, Spain Introduction: Chronic myelomonocytic leukemia (CMML) is a clonal disorder of hematopoietic stem cells often occurring in elderly patients. In the new WHO classification, CMML has been reclassified as a myelodysplastic/myeloproliferative disease. CMML has been subdivided in two subclasses: CMML-1:<5% blasts in peripheral blood and 5–9% blasts in bone marrow, and CMML-2: <10% blasts in peripheral blood and 10–19% blasts in bone marrow (Greco et al. Mediterr J Hematol Infect Dis.2011). Azacitidine (AZA) is an hypomethylating agent approved in Europe for the treatment of myelodysplastic syndromes, with an intermediate to high risk of progressing to AML or death; chronic myelomonocytic leukemia (CMML) and AML that has developed from a myelodysplastic syndrome (prescribing information EMEA 2011). Until its approval in May 2009, AZA was used in Spain under compassionate use in clinical trials. AZA produce a direct decrease of DNA methyltransferase activity, reverting aberrant DNA methylation and increasing the expression of silenced genes, leading to celular differentiation and/or apoptosis (Greco et al. Mediterr J Hematol Infect Dis. 2011). Materials and Methods: We report the results of a retrospective, longitudinal, multicenter Spanish study of 27 patients to assess the effectiveness of AZA to treat CMML. We present results of: Response, Overall Response, Overall Survival and Progression Free Survival. Results: Eighteen of the patients (69.23%) had Chronic Myelomonocytic Leukemia (CMML) type 1 and nine (30.77%) CMML type 2. Median age at diagnosis was 69 years. Male/female ratio: 19/8. ECOG performance status score 1–2 was 78%, twenty patients (74%) received an initial dose of 75 mg/m2 of AZA, whereas three patients (11%) received 50mg/ m2. The mean number of cycles received was 8.32, 95%IC (5.91; 10.73). Overall response to treatment was 53% (CR+PR+HI+mCR): 14.81% complete response, 7.4% partial response, 3,7% Medular complete response and 29,62% Hematological Improvement. In addition, 18,51% had stable disease. Thirty-six percent of patients were alive at the end of treatment with AZA. Median Overall Survival and Progression Free Survival were 17.47 months (95%CI 9.33, upper limit not reached) and 10.97 (95%IC 3.97, 17.47) respectively (Figure 1, 2). Conclusion: Our results show that AZA is an active drug in the treatment of patients with CMML, with similar response rates in the published literature. More data from this study and further investigation with different clinical trials are needed to confirm these outcomes as well as safety and effectiveness of this treatment. Disclosures: García Delgado: Celgene and Novartis: Speakers Bureau.

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