|Mining the “Gold Rush” of Immunotherapy Clinical Trials|
As the number of immunotherapy clinical trials grows, so do the obstacles and challenges – including the need to ensure meaningful results.
Entering A New Era of Immunotherapy
The first approval of a chimeric antigen receptor T-cell therapy marks a shift in the future of the immunotherapy field.
|The Year in Drug Approvals|
The excitement over immunotherapy for cancer treatment shows no signs of waning, with several agents approved by the U.S. Food and Drug Administration this year.
|The Immunotherapy Pipeline|
Dozens of immunotherapeutic agents are under investigation for the treatment of malignant and non-malignant hematologic conditions.
All good stuff...
The American Society of Hematology sent me a few snippets today:
It is World Thrombosis Day today. Rather than posting all sorts of learned journal references I shall instead post something that a friend posted to Facebook this morning:
“World Thrombosis day today... Shortly I’ve got Nurses coming out to try and take my blood and see if My DDimer has gone back down after it was raised again on Saturday. It’s almost been 2 months since I was rushed to A&E with Blood Clots on my Lungs and me and my hubby sat in tears last night thinking how much our life has changed! I hope one day for everyone’s sake I can get some normality back in my life.”
This rather put it all into perspective for me today…
The IBMS sent me an email today outlining their strategy for the next few years. You can read it by clicking here.
I have read it. Several times. There are six pages of words… In all honesty it means nothing to me. Once I was an IBMS rep; we all knew what the IBMS was, and what it did. It didn’t have (or need) mission statements.
It is nonsense like this which puts me off of getting involved too much with the IBMS.
Is that wrong of me?
Here’s a rather silly poll I received from the Lablogatory people today. “How many cases of thalassemia does your laboratory see per year?”
I suspect they mean “thalassaemia major”; beta thalassaemia minor isn’t uncommon, and come to that neither is alpha thalassaemia minor. I peobably see a case of each at least once a week…
The Transfusion Evidence Library people sent me their monthly update today… loads of articles. Some of interest, others not (quite) so…
Click on any of the links below to view the article in the Transfusion Evidence Library database. Enjoy your update!
- Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial
Zergani FJ; Shaiesthe AA; Hajiani E; Hashemi J; Masjedizadeh R; Sebghatollahei V; Alavinejad P; Kadkhodaei A; Akhavan K; Seyyedian S
Przeglad Gastroenterologiczny. 2017;12(-2):128-134
- Intra-articular application is more effective than intravenous application of tranexamic acid in total knee arthroplasty: a prospective randomized controlled trial
Wang J; Wang Q; Zhang X; Wang Q
The Journal of Arthroplasty. 2017
- Intravenous tranexamic acid bolus plus infusion is not more effective than a single bolus in primary hip arthroplasty: a randomized controlled trial
Zufferey PJ; Lanoiselee J; Chapelle C; Borisov DB; Bien JY; Lambert P; Philippot R; Molliex S; Delavenne X; Deygas B; Donnat M; Techer J; Tordella L; Fort JN; Barbe N; Gavory J; Passot S; Burnol L; Seve S
- Desmopressin use for minimising perioperative blood transfusion
Desborough MJ; Oakland K; Brierley C; Bennett S; Doree C; Trivella M; Hopewell S; Stanworth SJ; Estcourt LJ
The Cochrane Database of Systematic Reviews. 2017;(-7):CD001884
- Tranexamic acid in total knee arthroplasty: mixed treatment comparisons and recursive cumulative meta-analysis of randomized, controlled trials and cohort studies
Sridharan K; Sivaramakrishnan G
Basic & Clinical Pharmacology & Toxicology. 2017
- [Comparison between the effect of endoscopic-assisted low temperature plasma and electric planer on the treatment of adenoid hypertrophy: a Meta-analysis]
Xie S; Zhang Y; Xu Z; Zhang J; Wu X; Sun H
Zhong Nan Da Xue Xue Bao. Yi Xue Ban = Journal of Central South University. Medical Sciences. 2017;42(-6):706-712
- Comparison of 12-hour with 72-hour terlipressin therapy for bleeding esophageal varices
Salim A; Malik K; Haq IU; Butt AK; Alam A
Journal of the College of Physicians and Surgeons--Pakistan : Jcpsp. 2017;27(-6):334-337
- Blood transfusion and mortality in myocardial infarction: an updated meta-analysis
Yin Z; Yu B; Liu W; Lan K
- The impact of immunoglobulin in acute HIV infection on the HIV reservoir: a randomized controlled trial
Tiraboschi J; Ray S; Patel K; Teague A; Pace M; Phalora P; Robinson N; Hopkins E; Meyerowitz J; Wang Y; Cason J; Kaye S; Sanderson J; Klenerman P; Fidler S; Frater J; Fox J
Hiv Medicine. 2017
- Perioperative management of haemophilia B: a critical appraisal of the evidence and current practices
Neufeld EJ; Solimeno L; Quon D; Walsh C; Seremetis S; Cooper D; Iyer NN; Hoxer CS; Giangrande P
Haemophilia : the Official Journal of the World Federation of Hemophilia. 2017
- Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial
Innerhofer P; Fries D; Mittermayr M; Innerhofer N; von Langen D; Hell T; Gruber G; Schmid S; Friesenecker B; Lorenz IH; Strohle M; Rastner V; Trubsbach S; Raab H; Treml B; Wally D; Treichl B; Mayer A; Kranewitter C; Oswald E
The Lancet. Haematology. 2017
- Efficacy and safety of fibrinogen concentrate in surgical patients: a meta-analysis of randomized controlled trials
Fominskiy E; Nepomniashchikh VA; Lomivorotov VV; Monaco F; Vitiello C; Zangrillo A; Landoni G
Journal of Cardiothoracic and Vascular Anesthesia. 2016
- Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials
Ker K; Shakur H; Roberts I
Bjog : an International Journal of Obstetrics and Gynaecology. 2016
- Transfusion-related adverse events in the Platelet Dose study
Kaufman RM; Assmann SF; Triulzi DJ; Strauss RG; Ness P; Granger S; Slichter SJ
- Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME)
Muller MC; Arbous MS; Spoelstra-de Man AM; Vink R; Karakus A,Straat M; Binnekade JM; de Jonge E; Vroom MB; Juffermans NP
The Oncologist Newsletter appeared in my in-box this morning:
Precision Medicine Clinic: Molecular Tumor Board
Revathi Kollipara, Bryan Schneider, Milan Radovich, Sunil Babu, Patrick J. Kiel
This article describes the case of a 52-year-old male who was diagnosed with anaplastic thyroid cancer. The patient harbored a V600E mutation in BRAF and a PD-L1 positivity in both the tumor and the tumor infiltrating lymphocytes. Diagnosis and treatment details are reported.
Clinical Trial Results
A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas
Gregg Shepard, Edward R. Arrowsmith, Patrick Murphy, John H. Barton, Jr., James D. Peyton, Mark Mainwaring, Laura Blakely, Noel A. Maun, Johanna C. Bendell
Pregabalin for the Prevention of Oxaliplatin-Induced Painful Neuropathy: A Randomized, Double-Blind Trial
Daniel Ciampi de Andrade, Manoel Jacobsen Teixeira, Ricardo Galhardoni, Karine S.L. Ferreira, Paula Braz Mileno, Nathalia Scisci, Alexandra Zandonai, William G.J. Teixeira, Daniel F. Saragiotto, Valquíria Silva, Irina Raicher, Rubens Gisbert Cury, Ricardo Macarenco, Carlos Otto Heise, Mario Wilson Iervolino Brotto, Alberto Andrade de Mello, Marcelo Zini Megale, Luiz Henrique Curti Dourado, Luciana Mendes Bahia, Antonia Lilian Rodrigues, Daniella Parravano, Julia Tizue Fukushima, Jean-Pascal Lefaucheur, Didier Bouhassira, Evandro Sobroza, Rachel P. Riechelmann, Paulo M. Hoff, and PreOx Workgroup (Fernanda Valério da Silva, Thais Chile, Camila S. Dale, Daniela Nebuloni, Luiz Senna, Helena Brentani, Rosana L. Pagano, Ângela M. de Souza)
A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia
William Donnellan, Jesus G. Berdeja, Diana Shipley, Edward R. Arrowsmith, David Wright, Scott Lunin, Richard Brown, James H. Essell, Ian W. Flinn
Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08-20
Yehuda Patt, Cristhiam Rojas-Hernandez, Houman Mohammad Fekrazad, Pranshu Bansal, Fa Chyi Lee
Efficacy and Safety of Pertuzumab and Trastuzumab Administered in a Single Infusion Bag, Followed by Vinorelbine: VELVET Cohort 2 Final Results
Michael Andersson, José M. López-Vega, Thierry Petit, Claudio Zamagni, Valerie Easton, Julia Kamber, Eleonora Restuccia, Edith A. Perez
The final efficacy and safety results are reported for the VELVET Cohort 2 trial, which investigated the coinfusion of pertuzumab and trastuzumab in a single infusion bag, followed by vinorelbine.
Randomized Controlled Trial of a Home-Based Walking Program to Reduce Moderate to Severe Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors
Kirsten A. Nyrop, Leigh F. Callahan, Rebecca J. Cleveland, Liubov L. Arbeeva, Betsy S. Hackney, Hyman B. Muss
For most breast cancer survivors experiencing aromatase inhibitor-associated arthralgia (AIAA), pharmacological remedies such as analgesics and antidepressants provide little or no joint symptom relief, and these medications have their own adverse side effects. There is a need to identify effective, easy-to-use, sustainable, and safe alternative or adjunctive approaches to AIAA management. This article describes an evidence-based walking program that is effective in reducing symptoms in adults with arthritis and investigates whether the program could have similar benefits for women experiencing AIAA.
Cancer Diagnostics and Molecular Pathology
Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients; Utility of Targeted Deep Sequencing for Biomarker-Selected Clinical Trial
Seung Tae Kim, Kyoung-Mee Kim, Nayoung K.D. Kim, Joon Oh Park, Soomin Ahn, Jae-Won Yun, Kyu-Tae Kim, Se Hoon Park, Peter J. Park, Hee Cheol Kim, Tae Sung Sohn, Dong Il Choi, Jong Ho Cho, Jin Seok Heo, Wooil Kwon, Hyuk Lee, Byung-Hoon Min, Sung No Hong, Young Suk Park, Ho Yeong Lim, Won Ki Kang, Woong-Yang Park, Jeeyun Lee
Advances in sequencing technologies and improved algorithms for detecting specific molecular aberrations make it possible to perform biomarker-driven clinical trials. The analytical sensitivity and clinical validity have not yet been demonstrated in a large cohort. This article describes the implementation of a targeted-sequencing panel in a precision oncology clinic and the feasibility of a clinic-based molecular screening program.
Li Liu, Cheng Liu, Omid Fotouhi, Yidong Fan, Kun Wang, Chuanyou Xia, Benkang Shi, Guangyong Zhang, Kexin Wang, Feng Kong, Catharina Larsson, Sanyuan Hu, Dawei Xu
This study aimed to determine whether the TERT promoter methylation differs between gastrointestinal cancer and normal gastrointestinal tissues and, if so, whether the TERT promoter methylation analysis in stool is useful for screening of gastrointestinal cancer.
Association of Pre-Chemotherapy Peripheral Blood Pro-Inflammatory and Coagulation Factors with Physical Function in Women with Breast Cancer
Yuan Yuan, Nilesh Vora, Can-Lan Sun, Daneng Li, David Smith, Joanne Mortimer, The-Hang Luu, George Somlo, James Waisman, Joseph Chao, Vani Katheria, Timothy Synold, Vivi Tran, Shu Mi, Tao Feng, Abrahm Levi, Anait Arsenyan, Jennifer Choi, Laura Zavala, Susan Yost, Arti Hurria
Breast cancer is a disease associated with aging. Before initiation of chemotherapy, an assessment of functional reserve is needed; however, simple performance assessment scores may not reflect the diverse nature of physical function and risk of toxicity among older adults. The focus of this article is on understanding the association between pre-chemotherapy biomarkers (IL-6, CRP, and D-dimer) and measures of physical function.
Global Health and Cancer
Implementation of a School-Based Educational Program to Increase Breast Cancer Awareness and Promote Intergenerational Transmission of Knowledge in a Rural Mexican Community
Enrique Soto-Perez-de-Celis, David D. Smith, Maria Patricia Rojo-Castillo, Arti Hurria, Alba Milena Pavas-Vivas, Rina Gitler-Weingarten, Alejandro Mohar, Yanin Chavarri-Guerra
Breast cancer mortality rates in low- and middle-income countries are higher than in the developed world. Programs aimed at enhancing education and awareness of breast cancer are a critical strategy to overcoming barriers to timely diagnosis in these countries. This article reports a program designed to educate adolescents on breast cancer with the end goal of promoting intergenerational transmission of breast cancer-related knowledge to their older female relatives.
Marij A. Hillen, Niki M. Medendorp, Joost G. Daams, Ellen M.A. Smets
An increasing number of cancer patients appears to seek a second opinion about diagnosis or treatment. This systematic review examines the available empirical evidence on patient-initiated second opinions in oncology and provides recommendations to clinicians for optimal communication about second opinions.
New Drug Development and Clinical Pharmacology
Jeroen J.M.A. Hendrikx, John B.A.G. Haanen, Emile E. Voest, Jan H.M. Schellens, Alwin D.R. Huitema, Jos H. Beijnen
In the field of oncology, most drugs are administered in a body–size-based dosing schedule instead of a fixed dose for all patients. This article presents the advantages of fixed dosing of monoclonal antibodies, arguing in favor of fixed dosing schemes for all currently approved antibodies in oncology.
Pulmonary Function Changes After Radiotherapy for Lung or Esophageal Cancer: A Systematic Review Focusing on Dose-Volume Parameters
Anne G.H. Niezink, Renske A. de Jong, Christina T. Muijs, Johannes A. Langendijk, Joachim Widder
Radiation-induced lung toxicity remains a challenge in thoracic radiotherapy. This systematic review focuses on radiation dose-volume histogram parameters for lung and heart as predictors for changes in FEV1 and diffusion capacity after radiotherapy for lung or esophageal cancer.
Localized Adult Ewing Sarcoma: Favorable Outcomes with Alternating Vincristine, Doxorubicin, Cyclophosphamide, and Ifosfamide, Etoposide (VDC/IE)-Based Multimodality Therapy
Jennifer L. Pretz, Constance M. Barysauskas, Suzanne George, Jason L. Hornick, Chandrajit. P. Raut, Yen-Lin E. Chen, Karen J. Marcus, Edwin Choy, Francis Hornicek, John E. Ready, Thomas F. DeLaney, Elizabeth H. Baldini
Although typically considered a pediatric disease, Ewing sarcoma can occur adults. Current standard treatment for localized Ewing sarcoma is a multimodality approach, combining chemotherapy and local therapy consisting of surgery and/or radiation therapy. This article evaluates outcomes for adults with localized Ewing sarcoma treated exclusively with cyclophosphamide, doxorubicin, and vincristine followed by ifosfamide and etoposide in combination with local therapy.
Michael J. Wagner, Vancheswaran Gopalakrishnan, Vinod Ravi, J. Andrew Livingston, Anthony P. Conley, Dejka Araujo, Neeta Somaiah, Maria A. Zarzour, Ravin Ratan, Wei-Lien Wang, Shreyaskumar R. Patel, Alexander Lazar, Joseph A. Ludwig, Robert S. Benjamin
Ewing sarcoma is rare in adults, and there are no dedicated clinical trials in the adult population. This article reviews the results of therapy with vincristine, ifosfamide, and doxorubicin in the multidisciplinary treatment of adults with Ewing sarcoma.
Symptom Management and Supportive Care
A Predictive Score for Thrombosis Associated with Breast, Colorectal, Lung, or Ovarian Cancer: The Prospective COMPASS–Cancer-Associated Thrombosis Study
Grigoris T. Gerotziafas, Ali Taher, Hikmat Abdel-Razeq, Essam AboElnazar, Alex C. Spyropoulos, Salem El Shemmari, Annette K. Larsen, Ismail Elalamy, on behalf of the COMPASS–CAT Working Group
The COMPASS-CAT study was undertaken in outpatients with breast, colon, lung, or ovarian cancer. The aim of the study was to identify the most relevat risk factors for symptomatic thromboembolism and to develop a risk assessment model applicable to patients after the initiation of anticancer treatment.
Immune-Related Adverse Events as a Biomarker in Non-Melanoma Patients Treated with Programmed Cell Death 1 Inhibitors
Julia Judd, Matthew Zibelman, Elizabeth Handorf, John O'Neill, Chethan Ramamurthy, Sasini Bentota, Jamie Doyle, Robert G. Uzzo, Jessica Bauman, Hossein Borghaei, Elizabeth R. Plimack, Ranee Mehra, Daniel M. Geynisman
Immune checkpoint inhibitors are a novel class of immunotherapeutic agents being used in clinical practice for many advanced malignancies. Checkpoint blockade targeting the programmed cell death 1 receptor or its primary ligand with pembrolizumab, nivolumab, or atezolizumab has received U.S. Food and Drug Administration approval for the treatment ofmetastatic melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin's lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma. Considering that checkpoint blockade treatments now extend to tumor types beyond melanoma, a study was conducted to evaluate whether the development of immune-related adverse events correlates with treatment response in other cancer subtypes.
Narratives in Oncology
Nora K. Murphy
Originally presented as part of the 20th Anniversary of Palliative Care at Massachusetts General Hospital, this narrative is one patient's story of stage IV cancer.
Labels: oncologist newsletter