Detecting Pompe Disease with More Accuracy Key to Urgent Intervention


Credit: Sbarro Health Research Organization (SHRO)
“Vacuolated PAS positive lymphocytes in the peripheral blood of Pompe patients”

Researchers identified a new, more sensitive screening test to recognize Pompe disease, a metabolic disorder affecting cellular processing of glycogen in numerous tissues of the body. The test detects the presence of more than four lymphocytes containing glycogen in blood films of subjects with suspicious neuromuscular disease, and has demonstrated 100% sensitivity and 94% specificity identifying patients with Pompe disease. Moreover, positivity of vacuolated lymphocytes to the Periodic-Acid Schiff staining (PAS) seems to be an hallmark of autophagic myopathies. This new method of detection will allow clinicians to differentiate Pompe disease and autophagic myopathies from other neuromuscular disorders more accurately.

The study was published online in December 2017, in the Journal of Cellular Physiology.

Pompe disease, also known as Glycogen storage disease type II, is a metabolic disorder caused by an accumulation of glycogen in the lysosomes due to a deficiency of alpha-glucosidase, a lysosomal enzyme acid. The build-up of glycogen affects various body tissues, particularly heart, skeletal and respiratory muscles, as well as lymphocytes in peripheral blood. The classic infantile form of Pompe disease, presenting with marked generalized muscle weakness and severe hypertrophic cardiomyopathy, rapidly progresses to a fatal outcome. The late-onset form is characterized by slowly progressive myopathy involving proximal, limb-girdle, paraspinal, and respiratory muscles without cardiac involvement. Vacuolar myopathy typical of Pompe disease is the most frequent myopathy due to an impairment of autophagy, the main natural mechanism necessary to degrade and recycle cellular components.

Enzyme replacement therapy for Pompe disease became available in 2006 and resulted in dramatic reduction of mortality and morbidity for Pompe patients. The discovery and commercialization of this therapy figure prominently in the plot of the 2010 film “Extraordinary Measures,” starring Harrison Ford and Brendan Fraser. Since an early start of therapy is associated with better clinical outcomes, early diagnosis is essential in order to achieve the maximum benefit.

The research was conducted by a team of scientists lead by Dr. Simone Sampaolo and Mariarosa AB Melone, Department of  Medicine, Surgery, Neurology, Metabolic and Aging Science, Reference Center for Neurological and Neuromuscular Rare Disease, University of Campania “Luigi Vanvitelli”, Naples, in collaboration with Dr. Antonio Giordano, Director of the Sbarro Institute for Cancer Research and Department of Biology at Temple University, Philadelphia.

Pompe disease is an underdiagnosed disorder, and considering that therapy is now available, early diagnosis is crucial to obtain the best prognosis. This research proposes a reliable, cheap, simple, first-level screening method to support the diagnosis of autophagic vacuolar myopathy as Pompe disease. The test is minimally invasive and could be used as a screening test in high-risk populations, such as pregnant women and people with a family history of neuromuscular disorders.

Newswise Original Release         PubMed Abstract     Journal of Cellular Physiology

Celebrating Our Women’s Research Team!

At S.H.R.O. we are so proud of the remarkable advances our researchers are contributing to the field of medical research.

Members of our Women’s Research Team are currently studying mechanisms contributing to breast, lung, ovarian, and colon cancer.


GoFundMe to Benefit our Women-Led Research Initiatives and Professional Advances

This month to celebrate our women scientists we are launching a GoFundMe campaign where all proceeds will go towards women-led research projects and further medical education aimed at curing and diagnosing cancer.




Scientist of the Month


Congratulations Mia Robb, Future Dr. Robb and Scientist of the Month!

We are very happy to announce that our scientist Mia Robb was just accepted into PCOM’s medical class of 2018! Mia has worked at S.H.R.O. for the last 9 years and we are so proud of her continued commitment to the field.

As part of our GoFundMe campaign this month we will be donating 25% of all proceeds raised to begin a scholarship fund for Mia’s medical school.


From Medical Discovery to Food and Fine Arts, Italian-American Contributions Celebrated at Annual Foundation Conference


Newswise — At this year’s 42nd annual NIAF Gala Weekend at the Washington Marriott Wardman Park Hotel in D.C., all aspects of Italian heritage were celebrated, including food, the fine arts, and scientific discovery. The weekend’s events included the medical conference, “Mediterranean Diet, Human Health and Longevity,” sharing the latest in research into a vital part of Italian culture –– diet and food. Conference presentations explored how the recipes of Italian grandmothers are among the healthiest in the world and can even help fight disease, such as cancer.

Organized in collaboration with the Sbarro Health Research Organization (SHRO) at Temple University, the November 4, 2017 conference included opening remarks by SHRO President Antonio Giordano, and the presentation of the Giovan Giacomo Giordano NIAF Lifetime Achievement Award for Ethics and Creativity in Medical Research. The award was established in memory of Antonio Giordano’s father, Giovan Giacomo Giordano, a renowned pathologist and former professor  of the Department of Anatomic Pathology at the University of Naples and chairman of the Pathology Department of the National Cancer Institute of Naples “Pascale,” who dedicated much of his life to cancer research.

“Italians have been at the forefront of scientific discovery since the time of the Romans, and this is just an extension of that history,” said Gabriel Battista, Co-Chairman of the NIAF Board of Directors. “For many Italians, this researcher has confirmed what they already knew.”

Battista’s parents were born in Italy and he grew up eating the Mediterranean Diet. Today, his favorite dish consists of his homemade marinara sauce, which is made with tomatoes he finds at a farm, paired with a good bucatini.

“This isn’t a surgical procedure or a pill, it’s really good food,” said Immaculata De Vivo,  professor of medicine at Harvard Medical School, whose research has been dedicated to the mechanisms of cancer. “There really is no downside to promoting this diet.”

De Vivo explained that the Mediterranean Diet consists of little red meat, fish as the main source of protein, olive oil as a source of fat, and lots of grains, fruits and vegetables. She added that this was originally a diet for poor farmers who grew all of their own food and ate in small portions.

In an effort to understand the Mediterranean Diet as it relates to the mechanisms of cancer, De Vivo has conducted research on telomeres, which are found at the ends of human chromosomes.

Over time, a person’s telomeres become shorter as a natural part of aging. However, De Vivo found that an unhealthy diet can contribute to the shortening of telomeres at an unnaturally quick rate, which can make a person more susceptible to disease. When participating in diets such as the Mediterranean Diet, telomeres become stronger and shorten at a normal rate.

“We all knew that the Mediterranean Diet consisted of healthy foods, but this allowed us to look under the hood –– to understand why,” De Vivo said. “We found that it is the synergy of all of these ingredients, and maybe one glass of wine with a meal, that makes the diet healthy.”

As the king of the Mediterranean Diet and the second most-consumed food in the world, the tomato was also studied by the Sbarro Health Research Organization, alongside researchers at the University of Siena in Italy.

Their research found that the genetic characteristics of San Marzano and Corbarino tomatoes help block molecules involved in cell division, slowing or sometimes stopping the spread of cancer cells, such as gastric cancer.

“The term, ‘We are what we eat,’ is true, but we don’t actually understand the meaning of the cliché,” said Antonio Giordano, the founder and director of Sbarro. “We go to a supermarket without truly knowing what is really healthy or what happens to us when we eat certain foods. By conducting this research, we are unveiling exactly what about certain tomatoes makes them healthy.”

The intersection of food and good health in the Italian community was on full display in the NIAF exhibit hall, as a crowd gathered around Romana Sciddurlo, grandmother of Rosella Rago, the host of the Italian cooking show “Cooking with Nonna.” Nonna Sciddurlo kneaded the pile of dough the way her own grandmother had taught her, adding a little water in intervals to ensure a perfect texture. She smiled as she recreated the generations-old pasta recipe from scratch. They cooked and served different recipes of Sciddurlo’s homemade sauce using the same garden-grown ingredients and unique techniques that Italian grandmothers have used for generations.

To them, preserving the recipes of Italian grandmothers means to celebrate the heritage of Italian culture –– a heritage that also includes sophistication, style, community, and scientific discovery.

In addition to the achievements on display at the medical conference, the NIAF Gala Weekend demonstrated how Italian heritage extends beyond good food and scientific discovery to include many aspects of the arts and the business world. Musical performances during the gala included Sicilian-born classical guitarist Tom Sinatra, and acclaimed vocalists Alfio Bonanno, James Valenti, and Vittorio Grigolo. Honoree Jon DeLuca, son of Fred DeLuca, founder of the Subway restaurant chain, addressed the gala pledging a large gift to the foundation’s scholarship program. Emmy-winning actor Michael Badalucco gave the evening’s welcoming remarks, including a recitation of a poem by Sicilian poet Nino Provensano. Fox Business Channel anchor Maria Bartiromo shared co-host duties with NIAF President John Viola, and honored guests in attendance included Supreme Court Justice Samuel Alito.

“[NIAF] does a lot of good by offering scholarships and raising money. But that’s not all this organization is all about,” said Viola. “We are about community and family. We are about remembering where we came from and celebrating our heritage as Italians.”

Original Newswise Post

New Cancer Therapies Earn Sbarro Health Research Organization President Antonio Giordano 2017 CORE Prize for Oncology

The CORE Prize for Oncology 2017 was awarded to Professor Antonio Giordano for his groundbreaking discoveries in the field of the cell cycle, which have established an understanding of the fundamental mechanisms at the basis of cancer and the development of a new class of anticancer therapeutics.


Prof. Carmine Pinto, President of The Italian Society of Clinical Oncologists and Chairman of Oncology at the National Cancer Institute ‘Santa Maria Nuova’ of Reggio Emilia, presents the award to Prof. Giordao


Newswise — Reggio Emilia Italy, 22nd November, 2017 — The 2nd International Congress on “Clinical Needs and Translational Research in Oncology,” was held November 22-23, 2017 at the Centro Oncoematologico Regio Emilia (CORE), of the USL-IRCCS of Reggio Emilia, bringing together prominent oncologists from Europe and the United States.

The CORE Prize for Oncology 2017 was awarded to two prestigious researchers, Professor Luca Gianni, Director of the Department of Oncology of the IRCCS Hospital, S. Raffaele of Milan, and Professor Antonio Giordano, Director of the Sbarro Institute for Cancer Research and Molecular Medicine, Temple University of Philadelphia (USA), and Professor of Anatomy and Pathology of the University of Siena. Prof. Giordano was honored for his groundbreaking discoveries in the field of the cell cycle which have allowed for an understanding of the fundamental mechanisms at the basis of cancer and the development of a new class of anticancer therapeutics.

“It is a privilege for us,” says Dr. Carmine Pinto, Director of Medical Oncology, President of the Conference and former President of the Italian Association of Medical Oncology, “to be able to award the CORE Prize for Oncology 2017 to these two outstanding scientists. The discovery of the tumor suppressor RBL2/p130 by Professor Giordano has paved the way for the identification of key mechanisms underlying cell cycle regulation and new therapeutic possibilities, from molecular drug therapies to the prospects of gene therapy. Two further outcomes of these studies, impacting on care strategies, were then the identification of two additional cyclin dependent kinases, CDK9 and CDK10, and of the NSPs (Novel Structure Proteins) a new protein structure related to cell division.”

Gianni was cited for his international clinical trials for neo-adjuvant breast cancer, which advanced the treatment of breast cancer patients through the creation of a sensitivity/resistance rating for drug therapies used in both HER2 positive and negative patients, changing the paradigm of treatment for these women.

The meeting addressed issues related to the identification of new molecular targets for tumor diagnosis and treatment, and their tissue and blood determinations, combining research, innovative technology, and therapies. One focus was also devoted to immunotherapy, one of the newer areas of promise in cancer care. Participants discussed how to identify the pathologies and the patients who can benefit most from immunotherapy both in terms of healing and prolonged survival. The topic of multidisciplinary integrated treatments, involving both oncologists, radiotherapists and surgeons, for treating rectum tumors, liver metastases from colon cancer, and tumors of the head-neck area will be analyzed also for as concerns the criticalities for resources and organizational aspects. Finally, discussions addressed issues concerning drug access and public health, in order to optimize resources in terms of value, cost and effectiveness, with representatives of the Italian Medicines Agency (AIFA), Oncologic Networks and Regions working together with oncologists, patients and other stakeholders.

This second international meeting is an accomplishment for the department of oncology at Reggio Emilia, which is at the forefront of both cancer research and care. Owing to a well-integrated multidisciplinary approach, including primary prevention, screening, therapy, rehabilitation and palliative care, Reggio Emilia earned the highest rates of survival for certain cancers among other Italian cities and regions. The commitment to clinical research, which introduces new care strategies and makes innovative medicines available to patients, coupled with the results of translational research and the Tumor Registry, make Reggio Emilia an important reference point for Oncology in Italy and internationally.

During the Congress, in conjunction with the scientific work, attendees were also privileged to visit an exhibition of works by the painter Augusto Daolio, made possible by the Association Augusto per la Vita.

Original Newswise release


Italian-American Researchers Present Mediterranean Diet, Health, and Longevity at Annual Medical Conference

Sbarro Health Research Organization President Antonio Giordano introduces program at National Italian American Foundation 42nd Anniversary Gala Weekend In Washington D.C.

The Sbarro Health Research Organization, Inc., in collaboration with the National Italian American Foundation, Temple University’s College of Science and Technology and the Giovan Giacomo Giordano Foundation, also thanks to the kind unconditioned sponsorship of Pastificio di Martino, will organize a medical conference discussing diet and nutrition. “Mediterranean Diet, Human Health and Longevity” will be held in the Roosevelt Room 2 of the Washington Marriott Wardman Park Hotel in Washington, D.C. on November 4 from 9 to 11 a.m. as part of the  NIAF 42nd ANNIVERSARY GALA WEEKEND. (www.

The president of SHRO, Antonio Giordano, MD, PhD, will begin by introducing SHRO’s recent research of the Mediterranean diet as it relates to cancer prevention, followed by the words of guest speakers. Dr Giordano is also the director of the Sbarro Institute for Cancer Research and Center at Temple University in Philadelphia, PA.

The guest speakers for the conference will include Dr Michele Masucci, Vice President for Research Administration at Temple, Dr Immaculata DeVivo,  Professor in Medicine at Harvard Medical School, who’s research has been dedicated to cancer causation, and Dr. Daniela Barone, who will be prized by the scientific committee of the NIAF for her contribution to the elucidation of the biochemical effects of “corbarino” tomato extracts on cancer cells. Mr. Carmine Mariano Esq, chief of the administration of the National Cancer Institute of Naples “Pascale”, in Italy, will attend the ceremony, in recognition of the important collaboration among his Institution and the SHRO in the “Corbarino” “San Marzano” project.

In a side event, the Giovan Giacomo Giordano Foundation will also present Dr Enrico Bucci, Director of the System Biology program at SHRO and well-known research integrity expert, the Giovan Giacomo Giordano NIAF Lifetime Achievement Award for Ethics and Creativity in Medical Research. 

The award was established in memory of Antonio Giordano’s father, Giovan Giacomo Giordano ­­–– the late professor, renowned pathologist and former professor  of the Department of Anatomic Pathology at the University of Naples and chairman of the Pathology Department of the National Cancer Institute of Naples “Pascale”, in Italy, who dedicated much of his life to cancer research.

Original Newswise Post

Muse for cancer-fighting tomatoes study? Italian food

Antonio Giordano, who led the study that showed whole tomato extracts can slow the growth of stomach cancer, says Italian cuisine inspired him to investigate the dietary staple’s cancer-fighting ability.

For his latest research discovery—which showed that certain tomato extracts can slow the growth of gastric cancer—Antonio Giordano’s muse was simple: the food back home.
“What inspired me was my country, Italy,” said Giordano, a world-renowned researcher specializing in cancer and genetics and director of the Sbarro Health Research Organization housed at Temple’s College of Science and Technology. “The Mediterranean diet is considered one of the main reasons why that population has more longevity and lower rates of certain types of cancer.”
Giordano, along with a team of scientists from Temple, the University of Siena in Italy and the National Cancer Institute of Naples in Italy, conducted blind tests on seeds from various species of tomato. The tests showed that two varieties, San Marzano and Corbarino, slowed the growth of gastric cancer cells by blocking the molecules involved in cell division. Though components of tomatoes, such as the antioxidant lycopene, have been studied in the past, Giordano’s research was unique in that it used whole tomato extracts.
“We chose gastric cancer because it is one of the most aggressive types of tumors of which there is little knowledge,” Giordano said. “There are not many therapies.”
His challenge now that he’s demonstrated the ability of the tomato extracts is to explore whether the same varieties of tomato grown outside of specific regions in Italy will maintain those cancer-fighting properties. His team is now growing the tomatoes in Philadelphia and other areas of the country to test seeds germinated in U.S. soil.
“The environment can change the properties,” Giordano explained. “The soil where they grow [in Italy] has a particular richness of minerals, is very watery and is close to Mount Vesuvius, so there is a volcanic type of presence there. That can be a major change in the impact.”
Giordano said he also plans to study the effects of food preparation and cooking on the tomatoes’ ability to fight cancer and, eventually, to explore their effects on other types of cancer, including colon, breast and prostate, as well as on neurological diseases, such as Alzheimer’s. The study’s implications have the potential to be far-reaching—for development of both supplements to current cancer treatments and lifestyle changes aimed at cancer prevention.
“The research suggests that this kind of nutrient in general has the ability to protect our cells in our body,” Giordano said. “That is actually the major discovery.”

Research Reveals Gene Differences in Mouse Model Versus Humans

Retinoblastoma family, Rb2 gene, tumor suppressor gene, senescence, mesenchymal stem cells

The mouse is the most widely used model organism to understand human genetics, biology, and diseases in the research setting. Aspects of gene function in humans can be predicted by studies of the corresponding gene in mice, but new research findings have revealed important divergences between the species which scientists will need to understand better through further investigation.

The research group that made this discovery was lead by Professor Umberto Galderisi at the Department of Experimental Medicine, Campania University “Luigi Vanvitelli” in Naples, Italy, and Antonio Giordano at the Sbarro Institute for Molecular Medicine  department of Biology at Temple University in Philadelphia. Their paper, “Misidentified Human Gene Functions with Mouse Models: The Case of the Retinoblastoma Gene Family in Senescence” by Nicola Alessio et al., has been published in the journal Neoplasia.

These differences can have a significant impact on the efficacy of research findings to infer gene function in humans by means of the so-called knock-out, or in situexperiments carried out in mouse models. In their paper, the authors describe how the retinoblastoma gene family may represent an illustrative example of this possible gene divergence between humans and mice. This gene family comprises three members (RB1, RB2/P130, and P107), which regulate several aspects of cell life, such as cell cycle, apoptosis, senescence, and differentiation.

Researchers analyzed differences in functions between mice and humans in this gene family that cannot be overlooked, if scientists are to be able to interpret mouse model experiments for purposes of diagnosis and treatment of human diseases.

“We decided to investigate the role of retinoblastoma gene family members in the regulation of the senescence process,”  says Galderisi. “Senescence, or cellular aging, is the deterioration of activities that can occur in the cells. This process may have either anti- or pro-cancer functions, depending on context. For this reason, studying molecular mechanisms governing senescence is of great importance for human diseases,” Gladerisi says.

“Our interest resides on the fact that, in human mesenchymal stromal cells (MSCs), the acute silencing of RB1 did not induce unrestricted proliferation as had been described mouse model studies,” says Giordano, “but, rather, resulted in cell cycle arrest and cellular senescence.” In other words, the effect of silencing the RB1 gene had the opposite effect in the mouse model versus human, indicating that the well-known RB1-P16 axis involved in senescence may not have a general role.

The authors believe their study demonstrates that the function of a protein has many aspects that are context-dependent, such as species and cell type.

These findings could be useful as a general paradigm for caution when inferring the role of a gene in humans, based on animal studies. Furthermore, human MSCs are being studied in several ongoing clinical trials, and the drivers of senescence described in this study should be thoroughly understood in order to maintain strict control for their safe and effective use in research.

Original newswise release                      Neoplasia article

Targeting Cell Cycle Reactivation Caused by Inflammation May Provide the Way to Prevent Neuron Death in Alzheimer’s Disease

Newswise — Neurodegenerative disorders such as Alzheimer’s Disease, Parkinson’s Disease, amyotrophic lateral sclerosis (ALS), and Huntington’s Disease are typically characterized by progressive apoptotic death of neurons. Apoptosis, or programmed cell death, in these neurodegenerative disorders is believed to be triggered by a process of cell cycle reactivation, however, the mechanisms involved in this phenomenon remain largely unsolved. Researchers studying the role of inflammation as well as the expression of Rb family proteins (RB1/p105, RBL1/p107 and Rb2/p130) in neuronal death, have discovered a clue to the mechanism for neuronal degeneration and possible target for a therapeutic approach to these disorders.

The research was conducted by a team of scientists lead by Dr. Antonio Giordano, Director of the Sbarro Institute for Cancer Research and Department of Biology at Temple University, Philadelphia in collaboration with University of Siena Italy. Their study was published online on August 2017, in the international journal Cell Cycle. The study was funded in part by a grant from the Ken and Ann Douglas Charitable Foundation.

These findings are significant because mature neuronal cells are in a permanent state of cell cycle arrest, and they do not undergo the same process of cell death and replacement as other tissues throughout the body. Shedding light on the cause for the neurodegeneration occurring in diseases like Alzheimer’s and Parkinson’s, the study authors found that inflammation induced cell cycle re-entry, causing neurons to resume the cell cycle and undergo apoptotic cell death.

The study was performed in an in vitro model of brain inflammation, which revealed an aberrant  expression of p107 and p105 following the inflammatory insult, leading researchers to conclude a possible implication of these factors in the reactivation of the cell cycle in neurons.

The pRB family is comprised of factors well known for their ability to regulate the cell cycle, and has been largely explored in cancers for their role as tumor suppressors.

Dr. Giordano’s team provides novel information on the pleiotropic activity of pRB proteins extending the investigation to fields outside of oncology. The concept emerging from their study could help in formulating innovative therapeutic approaches to halt  neurodegenerative processes like  Alzheimer’s Disease.

“Alzheimer’s Disease, similar to other neurodegenerative diseases, is an incurables disorder affecting populations worldwide,” Dr. Giordano says.  “However, in recent years, scientists have made great advances in uncovering   the cause of these pathologies. As we discover novel elements correlated to the pathways involved in these diseases, we are confident that we will be able to treat and prevent them.  Albeit it is still at an early stage, our study brings to light an important aspect of this mechanism that will speed our progress toward this common goal,” Dr. Giordano concludes.


Original Newswise Release         Cell Cycle Article        PubMed Abstract

Reducing Nephrotoxicity in Cancer Patients Undergoing CT

In frail patients with cancer who are to undergo contrast-enhanced CT, the choice of iodated contrast medium can be key to reducing risk for impaired renal function and the development of contrast-induced nephropathy (CIN).

In a head-to-head comparison of two contrast media, iodixanol (Visipaque, GE Healthcare) appeared to have a better safety profile than iopromide (Ultravist, Bayer Healthcare).

The results come from the blinded, randomized COMEDIANS trial, which was conducted in 504 cancer patients at low risk for CIN who underwent chest-abdomen-pelvic CT. The trial was conducted by Maddalena Barba, MD, of the Regina Elena National Cancer Institute in Rome, Italy, and colleagues.

The study was published online August 4 in the Journal of Cellular Physiology.

Currently, there is no evidence to support the use of a specific contrast medium in cancer patients, the study authors note. They point out that CT is one of the imaging techniques most frequently used in cancer management, from diagnosis and disease staging to evaluation of treatment response and follow-up.

Although CIN can be minor ― defined by the study investigators as a 25% increase in serum creatinine level ― more severe cases can lead to renal failure, the need for dialysis, or death. Patients with cancer who are weakened by disease or treatment may be particularly vulnerable.

“It is our responsibility to focus on the safety of fragile patients, such as those affected by cancer,” coauthor Irene Terrenato, PhD, of the Regina Elena National Cancer Institute in Rome, said in a statement. “Iodated contrast media is essential, and, unfortunately, we often observe adverse events on renal function due to contrast media use, such as CIN.”

“To understand which one [contrast medium] minimizes the incidence of CIN is fundamental, and this study arises from the need to protect our patients as much as possible,” added Stefano Canitano, MD, who is also at the Regina Elena National Cancer Institute.

Cancer Patients Develop CIN

The cancer patients taking part in this study were at low risk of developing neuropathy. At baseline, the patients’ estimated glomerular filtration rate (eGFR) was >60 mL/min.

The researchers report that CIN developed at 24 hours in seven patients in the iopromide group compared to two patients in the iodixanol group (= 0.34).

The same trend was seen with late-occurrence events, with eight patients in the iopromide group developing CIN at 72 hours compared to two in the iodixanol group (= .11).

Overall, 17 patients developed CIN. Among those patients, the event rate was higher in the iopromide arm (= .045), although no cases of permanent CIN or significant differences in adverse events or GFR were observed.

“The distribution of CIN events across the study arms seemed to provide a suggestion in support of the use of iodixanol in light of the more favourable toxicity profile,” the study authors say. “However,” they add, “none of these results reached the predefined cut off for statistical significance.” These findings need to be confirmed and the underlying biological mechanisms clarified in larger trials with a similar design, they emphasize.

“Our results can represent a first indication for radiologists who are responsible for performing CT scans on very compromised patients daily,” commented coauthor Antonio Giordano, MD, PhD, from the University of Siena and Istituto Toscano Tumori, in Siena, Italy, who is also the president of the Sbarro Institute for Cancer Research and Molecular Medicine, Temple University, in Philadelphia, Pennsylvania.

He emphasized that “further studies are strongly recommended to confirm these results.”

Specifically, biomarkers associated with increased risk for CIN need to be identified, Dr Giordano told Medscape Medical News. He noted that “sera from the participants in the COMEDIANS trial are stored at our biorepository.”

Importantly, these results are consistent with those from previously published randomized controlled trials demonstrating less patient discomfort, lower frequency of adverse events, and equivalent or higher CT image quality with iodixanol compared with low-osmolar contrast media, Dr Giordano said.

Study Details

The study enrolled patients from four cancer enters who were to undergo a chest-abdomen-pelvis CT with iodated contrast media. A total of 247 patients were centrally randomly allocated to receive iodixanol; 250 patients received iopromide. Although patients and nurses were blinded to group assignment, the pharmacologist, radiologists, technicians, and statisticians were not.

CIN was defined as a decrease of baseline eGFR of >25%. Serum creatinine was used to assess CIN development in addition to eGFR.

The study design, with its focus on cancer patients at very low risk of developing CIN, “renders our findings worthy of attention,” the study authors say. Previous studies have been largely observational and have varied in size, design, and patient characteristics, they note.

Limitations of the study include its low power and failure to reach the recruitment target of 2868 patients, the study authors acknowledge.

This study was funded by the Italian Agency of Drugs. GE Healthcare provided educational support to the biostatistical and methodologic core of the research group.

Original Medscape Post          PubMed Abstract

Study reveals effectiveness of neoadjuvant chemotherapy in triple-negative breast cancer

Researchers analyzed data confirming the improved outcomes in both short- and long-term survival in patients that underwent neoadjuvant chemotherapy prior to surgery for triple-negative breast cancer. The study included 213 patients at 8 Italian cancer centers whose diagnoses were characterized by clinical, molecular, and therapeutic features of triple-negative breast cancer, an aggressive form of cancer with limited treatment options.

The study, “Neoadjuvant chemotherapy in triple-negative breast cancer: Multicentric retrospective observational study in real-life setting,” was recently published in the Journal of Cellular Physiology, an international, peer-reviewed journal focused on cancer-related issues. The study is authored by a multidisciplinary Italian-American team of scientists who have a long and productive history of collaboration with Prof. Antonio Giordano, Director of the Sbarro Institute for Cancer Research and Department of Biology at Temple University.

“Triple-negative breast cancers account for about 10-15% of breast cancer cases. Their aggressive behavior is well exemplified by the large tumor volume at presentation, along with the quite frequent involvement of regional lymph nodes, and high histological grade,” says co-author Dr. Maddalena Barba, researcher at the IRCCS Regina Elena National Cancer Institute of Rome, Central Italy.

“Currently, there are no approved targeted therapies for triple-negative breast cancers and chemotherapy remains the mainstay of treatment. When compared with other and more frequent breast cancer subtypes, these tumors show higher chemosensitivity, especially when chemotherapy is administered prior to surgery,” adds co-author Dr. Patrizia Vici, clinical researcher at the division of Medical Oncology 2 of the IRCCS Regina Elena National Cancer Institute.

“Results from our study confirmed previous findings from randomized clinical trials on the advantage conferred by more than 6 six cycles of a well characterized regimen of neoadjuvant chemotherapy, that is, the sequential antracycline-taxane regimen,” explains Prof. Antonio Giordano. “In addition, we confirmed the predictive role of some features related to the disease and its potential spread, namely Ki-67 absolute value and its relative measures, on treatment outcomes. Our work on triple negative breast cancer is thus confirmative in nature.

“But, what I would strongly underline, is the need for this sort of confirmative evidence to implement the scientific knowledge stemming from large, well designed and absolutely needed randomized clinical trials. Indeed, breast cancer patients who participate in these trials are selected on the basis of well codified demographic, clinical, and molecular characteristics, which do not necessarily reflect those of patients from the real-world setting who represent the final recipients of our gains in cancer-related knowledge.” concludes Dr. Giordano, a scientist with widely recognized expertise in cancer with a specific focus on translational research. post             Abstract in PubMed        Journal Article