Adjuvant and Neoadjuvant Treatment: Standard Treatment and Clinical Trials in the East

2015 ◽  
pp. 303-306
Author(s):  
Mitsuru Sasako
Keyword(s):  
Clinical Trials ◽  
Standard Treatment ◽  
Neoadjuvant Treatment ◽  
Treatment Standard

scholarly journals Immunological Backbone of Uveal Melanoma: Is There a Rationale for Immunotherapy?

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1055 ◽  
Author(s):  
Ernesto Rossi ◽  
Giovanni Schinzari ◽  
Ilaria Grazia Zizzari ◽  
Brigida Anna Maiorano ◽  
Monica Maria Pagliara ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Uveal Melanoma ◽  
Clinical Benefit ◽  
Standard Treatment ◽  
Checkpoint Inhibitors ◽  
Phase Iii ◽  
Phase Iii Clinical Trials

No standard treatment has been established for metastatic uveal melanoma (mUM). Immunotherapy is commonly used for this disease even though UM has not been included in phase III clinical trials with checkpoint inhibitors. Unfortunately, only a minority of patients obtain a clinical benefit with immunotherapy. The immunological features of mUM were reviewed in order to understand if immunotherapy could still play a role for this disease.

Adaptive Learning of Drug Quality and Optimization of Patient Recruitment for Clinical Trials with Dropouts

2021 ◽  
Author(s):  
Zhili Tian ◽  
Weidong Han ◽  
Warren B. Powell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Dynamic Programming ◽  
Value Function ◽  
Standard Treatment ◽  
Treatment Effectiveness ◽  
Interim Analyses ◽  
Clinical Trial Program ◽  
Patient Enrollment ◽  
The Value Function

Problem definition: Clinical trials are crucial to new drug development. This study investigates optimal patient enrollment in clinical trials with interim analyses, which are analyses of treatment responses from patients at intermediate points. Our model considers uncertainties in patient enrollment and drug treatment effectiveness. We consider the benefits of completing a trial early and the cost of accelerating a trial by maximizing the net present value of drug cumulative profit. Academic/practical relevance: Clinical trials frequently account for the largest cost in drug development, and patient enrollment is an important problem in trial management. Our study develops a dynamic program, accurately capturing the dynamics of the problem, to optimize patient enrollment while learning the treatment effectiveness of an investigated drug. Methodology: The model explicitly captures both the physical state (enrolled patients) and belief states about the effectiveness of the investigated drug and a standard treatment drug. Using Bayesian updates and dynamic programming, we establish monotonicity of the value function in state variables and characterize an optimal enrollment policy. We also introduce, for the first time, the use of backward approximate dynamic programming (ADP) for this problem class. We illustrate the findings using a clinical trial program from a leading firm. Our study performs sensitivity analyses of the input parameters on the optimal enrollment policy. Results: The value function is monotonic in cumulative patient enrollment and the average responses of treatment for the investigated drug and standard treatment drug. The optimal enrollment policy is nondecreasing in the average response from patients using the investigated drug and is nonincreasing in cumulative patient enrollment in periods between two successive interim analyses. The forward ADP algorithm (or backward ADP algorithm) exploiting the monotonicity of the value function reduced the run time from 1.5 months using the exact method to a day (or 20 minutes) within 4% of the exact method. Through an application to a leading firm’s clinical trial program, the study demonstrates that the firm can have a sizable gain of drug profit following the optimal policy that our model provides. Managerial implications: We developed a new model for improving the management of clinical trials. Our study provides insights of an optimal policy and insights into the sensitivity of value function to the dropout rate and prior probability distribution. A firm can have a sizable gain in the drug’s profit by managing its trials using the optimal policies and the properties of value function. We illustrated that firms can use the ADP algorithms to develop their patient enrollment strategies.

Analysis of two consecutive series of unresectable high-grade glioma (HGG) patients (pts) treated with or without neoadjuvant chemotherapy before estandar radiochemotherapy (CRT) and adjuvant temozolamide (TMZ).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e12504-e12504
Author(s):  
Laia Capdevila ◽  
Sara Cros ◽  
Nuria Pardo ◽  
Jose Luis Cuadra ◽  
Olatz Etxaniz ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Neoadjuvant Therapy ◽  
Barthel Index ◽  
Standard Treatment ◽  
Negative Impact ◽  
Neoadjuvant Treatment ◽  
Group Versus ◽  
Consecutive Series ◽  
Multifocal Lesions ◽  
Small Series

e12504 Background: Standard treatment of HGG is based in CRT with TMZ. Neoadjuvant treatment before radiotherapy has been studied in small series. Methods: We retrospectively analyzed 2 consecutive series of non-resectable HGG pts treated with neoadjuvant chemotherapy (TMZ & cisplatin) before the 2005 with those treated with TMZ and concurrent and adjuvant TMZ & radiotherapy (after 2005). Results: 46pts diagnosed between August 2003 and October 2010 were selected. 23 received neoadjuvant therapy with TMZ (200mg/m2/d x 5d) and cisplatin (75mg/m2) followed by radiotherapy -60Gy 6w- (NA group), and the remaining 23pts received standard treatment with concomitant TMZ and radiotherapy -60Gy 6w- and adjuvant TMZ (CRT group). In the NA group, 87% of pts were ≥50 years, 43.5% were men, 65.2% had performance status (PS) <2, 38.4% Barthel index <70. Histology: 78.3% were glioblastoma (GB). 30.4% of pts had multifocal lesions and 43.5% had seizures at the diagnosis. 95.7% of pts required dexamethasone. In the CRT group, 91.3% of pts were ≥50 years, 78.3% were men, PS was <2 in 60.9% and Barthel index <70 in 21.7% of cases. Histology: 69.6% were GB, 26.1% pts had multifocal lesions and 26.1% had seizures at diagnosis. 87% of pts required dexamethasone. All factors were uniformly distributed in the two groups. 82.6% of pts completed scheduled radiotherapy in NA group in front 91.3% in the CRT group (P= 0.66). PFS was 2.9 months (m) (CI 95%: 0.5 – 5.5) in NA group versus 5.1m (CI 95%: 3.1 – 7.1) in the CRT group (p=0.62), OS was 8.5m (CI 95%: 4.0 – 12.9) vs 8.2m (CI 95%: 1.2 – 15.2) respectively (p=0.45). Conclusions: No differences were found in either PFS or OS between the two treatment groups. The administration of neoadjuvant therapy does no have a negative impact on the ability to receive radiotherapy. These results provide a basis to justify clinical trials in this setting with promising drugs before radiotherapy treatment.

scholarly journals Anti-VEGF Treatment in Chronic Persistent Diabetic Macular Oedema

2018 ◽  
Vol 12 (1) ◽  
pp. 21
Author(s):  
Kevin J Blinder ◽  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Clinical Trials ◽  
Growth Factor ◽  
Treatment Regimen ◽  
Macular Oedema ◽  
Standard Treatment ◽  
Diabetic Macular Oedema ◽  
Vascular Endothelial ◽  
Endothelial Growth Factor ◽  
Standard Treatment Regimen

We have seen the efficacy of anti-vascular endothelial growth factor (VEGF) therapy in the treatment of diabetic macular oedema (DMO) as demonstrated by the major clinical trials, but what do we do for those that respond poorly to the standard treatment regimen? Let’s discuss this issue and others as it pertains to the treatment of DMO.

Overall survival (OS) by line of therapy (LOT) in Medicare-enrolled glioblastoma multiforme (GBM) patients (pts).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2039-2039
Author(s):  
Abdalla Aly ◽  
Prianka Singh ◽  
Beata Korytowsky ◽  
Homa Dastani ◽  
Lisa Ling ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Standard Treatment ◽  
Unmet Need ◽  
Additional Treatment ◽  
Second Line ◽  
First Line ◽  
Kaplan Meier ◽  
Comorbidity Index ◽  
Line Of Therapy

2039 Background: In clinical trials, the median OS of elderly GBM pts on standard treatment (tx) is ~9 months (mos) from diagnosis (dx), but has not been described in the real world (RW). This analysis describes RW OS for US Medicare GBM pts by LOT. Methods: GBM pts aged ≥66 years (y) were identified in SEER-Medicare (2007–2011). Pts were followed from dx to death, Medicare disenrollment or 12/31/2013. Systemic tx patterns were characterized as untreated (0L), ≥first line (1L+) and ≥second line (2L+). OS was estimated by the Kaplan-Meier method from dx for 0L, and from LOT start for 1L+ and 2L+. Results: Among 2533 eligible GBM pts (median age: 74 y; Charlson comorbidity index [CCI] ≥2: 13%), 49.9% received 1L+ and only 16.3% received 2L+. Median (1-year) OS for all pts was 5.3 mos (26%), range 1.6–10.7 mos (3–45%) depending on LOT, surgical resection (R) or Biopsy alone (B), tumor size, age, and CCI (Table). Conclusions: Receipt of tx has a significant impact on OS in Medicare GBM pts. This RW study shows that only 50% of pts receive tx, even though each LOT is associated with additional OS benefit. This suggests an unmet need for more efficacious therapies to allow additional treatment and improve outcomes. [Table: see text]

Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience

2002 ◽  
Vol 20 (5) ◽  
pp. 1215-1221 ◽  
Author(s):  
Andrew Seidman ◽  
Clifford Hudis ◽  
Mary Kathryn Pierri ◽  
Steven Shak ◽  
Virginia Paton ◽  
...  
Keyword(s):  
New York ◽  
Clinical Trials ◽  
Cardiac Dysfunction ◽  
Standard Treatment ◽  
Metastatic Breast ◽  
Heart Association ◽  
Increased Risk ◽  
New York Heart Association ◽  
Product Limit ◽  
Phase Ii And Iii

PURPOSE: This study sought to estimate cardiac dysfunction (CD) risk for patients receiving trastuzumab; to characterize observed CD by severity, treatment, and clinical outcome; to assess effects of baseline clinical risk factors on CD; and to assess effects of cumulative doses of anthracyclines and trastuzumab on CD. PATIENTS AND METHODS: A retrospective review of records for patients enrolled onto any of seven phase II and III trastuzumab clinical trials was performed. Predefined criteria were used for the diagnosis, and the New York Heart Association functional classification system was used to document CD severity. Product-limit estimates were used to summarize the cumulative anthracycline and trastuzumab doses at the time of CD onset. RESULTS: Patients treated with trastuzumab were found to be at an increased risk for CD. The incidence was greatest in patients receiving concomitant trastuzumab and anthracycline plus cyclophosphamide (27%). The risk was substantially lower in patients receiving paclitaxel and trastuzumab (13%) or trastuzumab alone (3% to 7%); however, most of these patients had received prior anthracycline therapy. CD was noted in 8% of patients receiving anthracycline plus cyclophosphamide and 1% receiving paclitaxel alone. Most trastuzumab-treated patients developing CD were symptomatic (75%), and most improved with standard treatment for congestive heart failure (79%). CONCLUSION: Trastuzumab is associated with an increased risk of CD, which is greatest in patients receiving concurrent anthracyclines. In most patients with metastatic breast cancer, the risk of CD can be justified given the improvement in overall survival previously reported with trastuzumab.

Recommendations From an International Expert Panel on the Use of Neoadjuvant (Primary) Systemic Treatment of Operable Breast Cancer: An Update

2006 ◽  
Vol 24 (12) ◽  
pp. 1940-1949 ◽  
Author(s):  
Manfred Kaufmann ◽  
Gabriel N. Hortobagyi ◽  
Aron Goldhirsch ◽  
Suzy Scholl ◽  
Andreas Makris ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Standard Treatment ◽  
Expert Panel ◽  
Systemic Treatment ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Research Groups ◽  
International Panel ◽  
New Treatments

Neoadjuvant (primary systemic) treatment is the standard treatment for locally advanced breast cancer and a standard option for primary operable disease. Because of new treatments and new understandings of breast cancer, however, recommendations published in 2003 regarding neoadjuvant treatment for operable disease required updating. Therefore, a second international panel of representatives of a number of breast cancer clinical research groups was convened in September 2004 to update these recommendations. As part of this effort, data published to date were reviewed critically and indications for neoadjuvant treatment were newly defined.

scholarly journals Neoadjuvant Treatment in Rectal Cancer: Actual Status

2011 ◽  
Vol 2011 ◽  
pp. 1-12 ◽  
Author(s):  
Ingrid Garajová ◽  
Stefania Di Girolamo ◽  
Francesco de Rosa ◽  
Jody Corbelli ◽  
Valentina Agostini ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Volume ◽  
Standard Treatment ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Local Control Rate ◽  
Concomitant Chemoradiotherapy ◽  
International Union ◽  
Clinical Stages ◽  
Reduce Tumor Volume

Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) has become a standard treatment of locally advanced rectal adenocarcinomas. The clinical stages II (cT3-4, N0, M0) and III (cT1-4, N+, M0) according to International Union Against Cancer (IUCC) are concerned. It can reduce tumor volume and subsequently lead to an increase in complete resections (R0 resections), shows less toxicity, and improves local control rate. The aim of this review is to summarize actual approaches, main problems, and discrepancies in the treatment of locally advanced rectal adenocarcinomas.

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