survival

Number of immune cells in tumors could soon help predict and treat cancers

Source: www.science20.com
Authors: Emma King, University of Southampton and Christian Ottensmeier, University of Southampton

Immune cells in the blood primarily defend us against infection. But we’re now learning that these cells can also keep us free from cancer. Patients with less efficient immune systems such as organ transplant recipients or those with untreated HIV, for example, are more susceptible to cancers. It is also becoming increasingly apparent that we can use immune cells to predict survival in people who do develop cancer. And that, in fact, there are immune cells within cancers.

Head and neck cancer underway

Head and neck cancer underway

The number of immune cells inside a tumor can hugely vary: some patients have vast numbers while some have very few. In a recent study, we showed that in head and neck cancers, the survival of a patient depends on how many immune cells are within the tumor. This could be a valuable way of individualizing cancer treatments.

Patients with lots of immune cells, for example, could be offered less toxic cancer treatment while those with few immune cells may need more aggressive treatment to improve their chances of survival.

Not all immune cells within the tumor are able to “attack” the cancer. By looking at specific cell markers – proteins on the cell exterior that allow us to see whether, for example, cells are exhausted – we can determine which individual immune cells in the tumor will be effective in tackling the cancer, or if they are exhausted and not able to perform any useful function. It’s possible that these exhausted cells could be reinvigorated to become useful again with targeted immunotherapy treatments currently in development.

These include vaccines, so if a cancer has been caused by a virus, we can vaccinate the patient with a short segment of the same virus to encourage the immune system to react to it. Around 30% of head and neck cancers, for example, are the result of human papillomavirus (HPV). There has been a 225% increase in these types of cancers over the past 15-20 years and in the US, HPV will cause more of these cancers than cervical ones. In these cases, cancer cells continue to express part of the HPV on their surface. The hope is that following vaccination, immune cells will be better able to identify these HPV cancer cells and kill them.

For people who simply don’t have many immune cells in tumors, specific, targeted immunotherapy could be one option. But also broader “brush stroke” treatments. These broader treatments cover all immunotherapies that encourage a patient’s immune system in a fairly non-specific way. Our immune cells are normally very tightly regulated and include many fail-safe systems to prevent them from over-reacting primarily to infections. General immunotherapy takes the brakes off and allows the immune cells to react to the cancer cells.

It may be that a combination of specific vaccine and non-specific immune treatments could be enough in combination to tip the balance in favor of the patient’s immune system so that it is able to overcome the cancer.

We’re going to further investigate how immune cells might help us to fight cancer and two head and neck cancer immunotherapy trials are due to start at the University of Southampton in the next six months.

One of these trials will look at a HPV cancer vaccine, while the other will investigate a non-specific immunotherapy molecule for those 70% of patients that develop head and neck cancer independent of HPV. Our hope is that within five years the results of these trials could influence the way we treat cancers.The Conversation

Note: This article was originally published on The Conversation.

September, 2014|Oral Cancer News|

Docetaxel regimen tops cisplatin in head and neck cancer

Source: www.cancernetwork.com
Author: Anna Azvolinsky, PhD

A phase II study has demonstrated that combining docetaxel-based chemoradiotherapy and the antibody cetuximab postoperatively in patients with high-risk squamous cell carcinoma of the head and neck led to improved disease-free and overall survival, with no unexpected toxicities. The results of the study were published in the Journal of Clinical Oncology.

Two-hundred and thirty-eight stage III and IV patients were randomized to receive radiation therapy (60 Gy) plus cetuximab and either cisplatin (30 mg/m2) or docetaxel (15 mg/m2) once per week as part of the Radiation Therapy Oncology Group (RTOG) 0234 clinical trial.

The 2-year overall survival (OS) was 69% in the cisplatin treatment arm and 79% in the docetaxel treatment arm. The 2-year disease-free survival (DFS) was 57% and 66% in the cisplatin and docetaxel arms, respectively.

Previously, two large phase III trials, the RTOG 9501 and the European Organisation for Research and Treatment of Cancer (EORTC) 22931 trials, both showed a small but significant survival benefit for postoperative head and neck cancer patients who received adjuvant radiation and chemotherapy concurrently, resulting in the incorporation of cisplatin in an adjuvant regimen for high-risk patients. The drawback was that adding cisplatin to radiation therapy increased toxicity. Many of these patients are not candidates for the combination therapy due to poor performance status, older age, and renal insufficiency. The purpose of the current trial was to test whether combining a molecular therapy such as cetuximab with chemotherapy would improve survival with a better toxicity profile, compared with radiation therapy plus chemotherapy.

After a median follow-up of 4.4 years, 48 patients in the cisplatin arm had a DFS event compared with 51 patients in the docetaxel arm. Cisplatin patients had a 24% reduction (P = .05) and docetaxel patients had a 31% reduction (P = .01) in the DFS failure rate compared with a historical control arm (the RTOG 9501 trial).

Patients who had p16-positive oropharynx tumors (43 of 54 patients) had improved survival compared with those who had p16-negative oropharynx disease.

The most common high-grade non-hematologic adverse events were mucositis, dysphagia, and skin rash, seen in both the cisplatin and docetaxel treatment arms. Patients in the cisplatin arm had a greater frequency of high-grade hematologic toxicities compared with those in the docetaxel arm (27.8% vs 14.2%, respectively). More patients in the docetaxel arm had toxicities deemed unacceptable by those conducting the trial (12.3% in the docetaxel arm vs 9.3% in the cisplatin arm).

Cetuximab is a chimeric human monoclonal antibody against the epidermal growth factor receptor (EGFR).

“The delivery of postoperative chemoradiotherapy (using cisplatin or docetaxel once per week plus 60 Gy radiation) with concurrent once-per-week cetuximab for patients with SCCHN [squamous cell carcinoma of the head and neck] who have high-risk pathologic features is feasible and tolerated with predictable toxicity. The radiation-docetaxel-cetuximab regimen shows particularly promising outcome with improvement in DFS and OS relative to RTOG historical controls and appears worthy of further investigation in high-risk patients with SCCHN,” concluded the authors.

Because the conclusions of this trial rely on a historical control comparison, these results need to be further validated in a phase III control-arm clinical trial. The docetaxel plus cetuximab regimen is currently being tested in a phase II/III clinical trial.

In an editorial, Amanda Psyrri, MD, PhD, and Urania Dafni, MD, both of the University of Athens in Greece, noted that, “In an era when next-generation sequencing is becoming increasingly available, identification of mutations that predict therapeutic response or resistance would be a major advance. Therefore, it seems mandatory that we focus our efforts at identifying an ‘EGFR sensitivity signature.’ Until then, it would seem wise not to conduct large phase III studies with cetuximab in unselected patient populations.”

Chemoradiation offered better survival than accelerated radiation in head and neck squamous cell carcinomas

Source: www.oncologypractice.com
Author: Neil Osterweil, Oncology Report Digital Network

Concurrent chemoradiation offered better overall survival and disease-free survival than accelerated radiotherapy in patients with moderately advanced squamous cell carcinomas of the head and neck, investigators reported at the Multidisciplinary Head and Neck Symposium.

Actuarial rates of 2-year overall survival and disease-free survival in patients treated with concurrent chemoradiation (CCR) were significantly better than for patients treated with accelerated radiotherapy alone, reported Dr. Krzysztof Skladowski of the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Gliwice, Poland.

“CCR with conventional 7 weeks of fractionation and at least two courses of high-dose cisplatin is more effective than 6 weeks of accelerated radiotherapy alone,” he said.

Even if patients can tolerate only a single course of cisplatin, CCR is still superior to accelerated radiation, he added.

The findings suggest that accelerated radiation protocols should be reserved for patients with more favorable prognosis, such as those with stage T2 disease with limited nodal involvement, and those who are positive for the human papillomavirus (HPV) p16 protein, Dr. Skladowski said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

The findings are “concordant with data that has been emerging now over approximately 10-14 years of the value of concurrent chemoradiation in head and neck cancer for a substantial cohort of patients over radiation alone,” said Dr. Paul Harari of the University of Wisconsin, Madison, and the invited discussant.

Although a previous meta-analysis (Lancet 2006; 368:843-54) suggested that accelerated or hyperfractionated radiotherapy was associated with a 3.4% advantage in overall survival, compared with conventional radiotherapy over 5 years, there have been no randomized studies comparing accelerated radiotherapy protocols with concurrent chemoradiation in this population, Dr. Skladowski said.

He and colleagues compared the two modalities in 101 patients with moderately advanced cancers of the oropharynx (46 patients), hypopharynx (19), and larynx (36).

They defined moderately advanced cancers as stage T2N1-2, T3N0-2, or T4AN0-2 if the involved nodes are not larger than 3 cm in diameter. Patients with oropharyngeal cancers were tested for expression of the human papillomavirus (HPV) p16 protein.

Patients were randomly assigned to receive either concurrent chemoradiation with intensity-modulated radiation therapy–delivered doses of 66-70 Gy divided into 33-35 daily fractions over 45-49 days plus cisplatin 100 mg/m2, delivered on days 1, 2 and 43, or to accelerated radiotherapy delivered via intensity-modulated radiation therapy in 1.8 Gy fractions 7 days/week to a total dose of 66.2-72 Gy.

Five patients in the CCR arm received only one dose of cisplatin, 30 received two doses, and 13 received the planned three doses.

At a median follow-up of 30 months, actuarial rates of 2-year overall survival of patients treated with CCR were 81%, compared with 62% for patients treated with accelerated radiation (P = .02). Disease-free survival rates were 75% and 60%, respectively (P = .05).

Acute adverse events were similar, with approximately 80% of patients in each treatment arm experiencing confluent mucositis, and about 10% having grade 3 dysphagia. There were no grade 4 toxicities.

The majority of treatment failures in each group were local, occurring in 21 of 52 patients treated with radiation alone, and in 11 of 49 patients treated with CCR (P = .03).

Significantly more deaths occurred in the radiation alone arm: 20 vs. 9 (P =.02).

The 2-year disease-free survival rate among patients in the CCR arm was dose dependent, at 60% of patients who received one course of cisplatin, 77% of those who received two courses, and 79% for those who received all three.

At the time of the analysis, all patients with oropharyngeal cancer who were positive for HPV p16 (five treated with accelerated radiation and six with CCR) were alive with no treatment failure. The overall survival rate for HPV-positive patients was 60% in the radiation only arm, and 80% in the CCR arm.

Note:
The study was supported by the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology. Dr. Skladowski reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

March, 2014|Oral Cancer News|

Study: Oropharyngeal cancer on the rise in young adults

Source: www.sciencecodex.com
Author: staff

A new study reveals an alarming increase in oropharyngeal cancers among young adults. While the exact cause for this phenomenon is unknown, the human papillomavirus (HPV) may be to blame.

According to researchers from Henry Ford Hospital in Detroit there was an overall 60 percent increase from 1973 and 2009 in cancers of the base of tongue, tonsils, soft palate and pharynx in people younger than age 45. Among Caucasians, there was a 113 percent increase, while among African-Americans the rate of these cancers declined by 52 percent during that period of time. But compared to Caucasians and other races, the five-year survival rate remains worse for African Americans.

The study is published online ahead of print in Otolaryngology-Head and Neck Surgery, the official journal of American Academy of Otolaryngology-Head and Neck Surgery.

“The growing incidence in oropharyngeal cancer has been largely attributed to the sexual revolution of the 1960s and 1970s, which led to an increased transmission of high-risk HPV,” says study lead author Farzan Siddiqui, M.D., Ph.D., director of the Head & Neck Radiation Therapy Program in the Department of Radiation Oncology at Henry Ford Hospital.

“We were interested in looking at people born during that time period and incidence of oropharyngeal cancer. Not only were we surprised to find a substantial increase in young adults with cancer of the tonsils and base of tongue, but also a wide deviation among Caucasians and African Americans with this cancer.”

The American Cancer Society estimates about 36,000 people in the U.S. will get oral cavity and oropharyngeal cancers in 2013; an estimated 6,850 people will die of these cancers. Oropharyngeal cancers are more than twice as common in men as in women, and about equally common in African Americans and Caucasians.

Recent medical research has shown that HPV exposure and infection increases the risk of oropharyngeal squamous cell cancer independently of tobacco and alcohol use, two other important risk factors for the disease, according to the National Cancer Institute. The incidence of oropharyngeal cancer has been growing in recent years due to increasing rates of HPV infection. This has been largely attributed to changes in sexual practices. Studies have shown, however, patients with HPV related head and neck cancer do have a better prognosis and survival.

For the Henry Ford study, Dr. Siddiqui and his colleagues used the SEER (Surveillance Epidemiology and End Results) database to gather information about adults younger than age 45 who had been diagnosed with invasive squamous cell oropharyngeal cancer between1973 and 2009. Since SEER does not record HPV information, the researchers used tumor grade as a surrogate indicator of HPV infection.

Among the study group of more than 1,600 patients, 90 percent were ages 36-44 and the majority (73 percent) was Caucasian. During the 36-year period, the majority of patients (50-65 percent) underwent surgical resection for their tumors. Patients who had both surgery and radiation therapy had the highest five-year survival rate.

“These patients have a favorable prognosis and are likely to live longer while dealing with treatment related side-effects that may impact their quality of life,” notes Dr. Siddiqui.

The five-year survival for the study group was 54 percent. There was no difference in survival based on gender. African Americans, however, had significantly poor survival compared to other races.

“The predominance of oropharyngeal cancer in this age group suggests either non-sexual modes of HPV transfer at a younger age or a shortened latency period between infection and development of cancer,” says Dr. Siddiqui.

Source: Henry Ford Health System

January, 2014|Oral Cancer News|

Certain genetic alterations may explain head and neck cancer survival disparities

Source: www.sciencecodex.com
Author: staff

Certain genetic alterations to the PAX gene family may be responsible for survival disparities seen between African-American and non-Latino white men with head and neck cancer, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9.

“During the last 30 years, the overall five-year relative survival rates for head and neck squamous cell carcinoma (HNSCC) have increased, but despite that, the gap in overall survival rates between non-Latino white patients and African-American patients has remained unchanged,” said Rafael Guerrero-Preston, Dr.P.H., assistant professor at Johns Hopkins University in Baltimore, Md. “This disparity may be due to differences in genetic and epigenetic alterations among African-American patients.”

To test this theory, Guerrero-Preston and colleagues performed a two-stage epigenomic study. In the stage-one discovery phase, the researchers used next-generation sequencing and array-based technologies to evaluate 107 HNSCC samples. In the stage-two validation phase, they validated the findings of the discovery phase and evaluated their effect on survival rates in 279 patient samples from The Cancer Genome Atlas project.

“Our results highlight the differential genomic and epigenomic alterations in PAX, NOTCH, and TP53 pathways between African-American and non-Latino white HNSCC patients, which underlie the complex biology of morphologically similar tumors and explain HNSCC survival disparities,” Guerrero-Preston said. “If further validated in larger cohorts, these discoveries could be used to develop genomic and epigenomic panels that will enable more treatment options, a reduction in treatment cost, and improvement in survival rates for patients with HNSCC.”

The researchers found that African-American HNSCC patients had higher frequencies of p53, FBXW7, and NOTCH1 mutations and no differences in PAX1 or PAX5 methylation across all tumor sites combined. However, when they looked at data based on each tumor site, some differences were discovered.

African-American patients with HNSCC had higher ZIC4, PLCB1, and PAX5 promoter methylation and p53 mutations compared with non-Latino white patients. African-American patients also had no NOTCH1 mutations in nonoropharynx HNSCC. However, in the oropharynx, African-American patients had a higher frequency of combined NOTCH1 mutations and PAX1 methylation.

In contrast, non-Latino white patients with HNSCC had a higher frequency of PAX5 promoter methylation and combined p53 mutation or PAX5 methylation in the oropharynx compared with African-American patients.

All patients with greater PAX5 methylation and p53 mutations had worse overall survival, the researchers found.

Source: American Association for Cancer Research

December, 2013|Oral Cancer News|

Study reveals genetic diversity within tumors predicts outcome in head and neck cancer

Source: bionews-tx.com

Researchers at the Massachusetts General Hospital (MGH) and Massachusetts Eye and Ear Infirmary have developed a new way to predict the survival rate of patients who have squamous cell carcinoma of the head and neck, thanks to a study partially funded by a CPRIT grant. One of the problems with treating cancer is the degree of genetic heterogeneity within a tumor. What this means is that there are sub populations of tumor cells within a given tumor that have different mutations. This makes the cancer difficult to treat because some cells due to their different mutations will be resistant to the same treatment. According to Edmund Mroz, PhD at the MGH center for Cancer Research (lead author of a report in Cancer on May 20, 2013), this new method of measuring genetic heterogeneity can be applied to a wide range of cancers. (Additional co-authors included Curtis Pickering, PhD, and Jeffrey Myers, MD, PhD, both from the University of Texas M.D. Anderson Cancer Center.)

stage-2-head-neck-cancer

Prior to this study, genes and proteins that are involved with treatment resistance have been identified, however, there has been no way to measure tumor heterogeneity to predict patient survival. Mroz and his group of researchers working in the lab of James Rocco, MD, PhD at MGH developed this new measure by looking at advanced gene sequencing data to calculate a number that indicates the genetic variance found in sub populations of cells within a tumor. They dubbed this new procedure as the mutant-allele tumor heterogeneity (MATH). This measure of heterogeneity has the ability to predict not only the number of mutations present but how widely the particular mutations are shared within different sub populations of tumor cells. This research was published in Oral Oncology (March 2013) and was only able to demonstrate that patients with known factors predicting poor outcomes had lower survival rates or what is known as high MATH scores. So, further research was needed.

Mzor and colleagues have now looked at the tumors from 74 patients that had squamous cell head and neck cancer and analyzed their genetic data. These patients had completed their treatment and researchers had the outcome data as well. The MATH measure was applied and these researchers found that higher MATH scores were correlated with shorter survival and with patients who had genetic heterogeneity. This demonstrates that the MATH scores were well correlated with outcomes more so than earlier predictions based on what was known at the time as identifiable risk factors.

At the moment, the take home message is that MATH values along with clinical findings can help predict survivability based on tumor cell heterogeneity. Furthermore, MATH may be able to determine what type of therapy the patient is best suited for. For example, if their MATH score is high, this calls for therapies that are more aggressive to ensure tumor cell resistance doesn’t occur. On the hand, patients who have low MATH scores, need less aggressive therapeutic approaches.

Study examines role of DNA, HPV in oral cancer survival

Source: www.drbicuspid.com
Author: DrBicuspid Staff

High-risk types of human papillomavirus (HPV) are increasingly associated with oropharyngeal squamous cell carcinoma (OPSCC). However, HPV-positive OPSCC is highly curable, and patients with HPV have better survival compared with HPV-negative patients, whose cancers are usually associated with alcohol and tobacco use.

To better understand the molecular mechanisms underlying these differences, Jochen Hess, PhD, and colleagues at University Hospital Heidelberg monitored changes in DNA modifications in HPV-positive and HPV-negative OPSCCs (Journal of Clinical Investigation, May 1, 2013).

They applied an array-based approach to monitor global changes in CpG island hypermethylation between HPV-negative and HPV-positive OPSCCs, and identified a specific pattern of differentially methylated regions that critically depends on the presence of viral transcripts. This DNA modification pattern was significantly correlated with improved survival in three separate groups of OPSCC patients, the researchers noted.

“Our study highlights specific alterations in global gene promoter methylation in HPV-driven OPSCCs and identifies a signature that predicts the clinical outcome in OPSCCs,” they concluded.

HPV-positive African-Americans with throat cancer have better outcomes

Source: www.drbicuspid.com
Author: DrBicuspid Staff

African-Americans with throat cancer who are positive for the human papillomavirus (HPV) have better outcomes than African-Americans without HPV, according to a new study in Clinical Cancer Research (March 26, 2013).

African-Americans who are HPV-negative also fared worse than Caucasians both with and without HPV present in oropharyngeal cancer, concluded lead author Maria Worsham, PhD, from Henry Ford Health System in Detroit, and colleagues.

“This study adds to the mounting evidence of HPV as a racially-linked sexual behavior lifestyle risk factor impacting survival outcomes for both African-American and Caucasian patients with oropharyngeal cancer,” Worsham said in a statement about the study.

To compare survival outcomes in HPV-positive and HPV-negative African-Americans with oropharyngeal cancer, the researchers retrospectively evaluated 118 patients. Among the study group, 67 were HPV-negative and 51 were HPV-positive, and 42% of the patients were African-American.

The study results indicate the following, according to the researchers:

  • African-Americans are less likely to be HPV-positive.
  • Those older than 50 are less likely to be HPV-positive.
  • Those with late-stage oropharyngeal cancer are more likely to be unmarried and more likely to be HPV-positive.
  • HPV-negative patients had 2.7 times the risk of death compared to HPV-positive patients.
  • The HPV race groups differed, with significantly poorer survival for HPV-negative African-Americans versus HPV-positive African-Americans, HPV-positive Caucasians, and HPV-negative Caucasians.

Overall, the study showed that HPV has a substantial affect on overall survival in African-Americans with oropharyngeal cancer, Worsham and colleagues concluded.

April, 2013|Oral Cancer News|

The effect of treating institution on outcomes in head and neck cancer

Source: medicalxpress.com

Patients with head and neck cancer receiving radiation treatment at an academic center have a higher survival rate than those receiving treatment at a community center, according to a study in the December 2012 issue of Otolaryngology–Head and Neck Surgery.

“Despite similar rates of treatment completion and rate of treatment breaks between groups, patients treated in academic centers had more advanced cancer but better survival,” the authors state in their conclusion.

The study evaluated differences in patient characteristics, treatment, and cancer outcomes in the head and neck cancer population at the University of Minnesota from 2002 through 2008. Data were gathered on demographics, general medical data, tumor variables, insurance type, marital status and health behaviors.

The study analyzed 355 patients with mucosal head and neck cancer treated with radiation therapy from 2002 to 2008. One hundred forty-five (41%) received radiation treatment at community hospitals, and 210 (59%) were treated at academic hospitals. Within the academic hospitals group, 197 underwent radiation at the University of Minnesota, and 13 received radiation at an alternative academic center.

Both treatment groups shared similar characteristics in regard to sex, comorbidity, marital status, work status, insurance, and alcohol use. However, the community group had more current smokers and slightly older patients on average. Patients in the academic group were more likely to live in an urban location and had a higher median income. Patients undergoing radiation treatment at university centers had significantly more advanced cancer. After adjusting for these differences in patient characteristics, patients in the academic hospitals had about two-thirds the risk of dying compared with the community hospitals. The five-year survival rate was 53 percent for patients treated in academic centers compared with 33 percent for patients treated in community settings.

As a result of the study, the authors conclude that “more subtle differences in treatment administration and support at academic centers need to be investigated to understand the survival differences.” In addition, the authors note, “Potential disparities in care related to income, socioeconomic status, and geography should be further explored.”

Source: American Academy of Otolaryngology

December, 2012|Oral Cancer News|

Interim results from CEL-SCI’s Multikine Phase III study on head and neck cancer

Source: www.news-medical.net

CEL-SCI Corporation announced today that an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study. CEL-SCI considers the results of the IDMC review to be important since studies have shown that up to 30% of Phase III trials fail due to safety considerations and the IDMC’s safety findings from this interim review were similar to those reported by investigators during CEL-SCI’s Phase I-II trials. Ultimately, the decision as to whether a drug is safe is made by the FDA based on an assessment of all of the data from a trial.

IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients in ongoing trials especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time (3-5 years). The committee’s membership should include physicians and clinical trial scientists knowledgeable in the appropriate disciplines, including statistics. The CEL-SCI IDMC includes prominent physicians and scientists from major institutions in the USA and abroad who are key opinion leaders in head and neck cancer and who are knowledgeable in all of the disciplines related to CEL-SCI’s study, including statistics.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. The universally accepted current standard of care for the patient population being enrolled in the CEL-SCI study is surgery plus radiation or surgery plus concurrent radiation and chemotherapy, dependent on the risk factors for recurrence found after surgery. Multikine treated patients receive 15 local injections of Multikine over a 3 week period prior to standard of care treatment. Multikine injections are administered in the area around the tumor and in the area of the adjacent lymphnodes since those two areas are where the tumor is most likely to recur. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs our body’s natural ability to fight tumors.

Source: CEL-SCI Corporation

October, 2012|Oral Cancer News|