chemotherapy

Patients undergoing radiation therapy benefit from animal assisted therapy

Source: radiationtherapynews.com
Author: staff

According to a recent study published in the Journal of Community and Supportive Oncology, therapy dogs can help improve the emotional state of some cancer patients undergoing radiation therapy.

The study, developed by Mount Sinai Beth Israel researchers, found that cancer patients who are undergoing intensive multi-modal concomitant radiation therapy together with chemotherapy for gastrointestinal, head and neck cancers, benefited from therapy dog’s visits in terms of their emotional well-being and life quality, even during therapy phases where physical decline was more pronounced.

This research was funded by The Good Dog Foundation, a provider of professionally trained therapy dogs, Zoetis, an animal health company and the Pfizer Foundation.

dog

“This study is the first such definitive study in cancer, and it highlights the merits of animal- assisted visits using the same scientific standards as we hold for the cancer treatment itself. It shows the importance of an innovative environmental intervention during cancer treatment,” Stewart B. Fleishman, MD, principal investigator and Founding Director of Cancer Supportive Services at Mount Sinai Beth Israel, said in a news release. “Having an animal-assisted visit significantly improved their quality of life and ‘humanized’ a high-tech treatment,” he said. “Patients said they would have stopped their treatments before completion, except for the presence of the certified Good Dog Foundation therapy dog and volunteer handler.”

“Thanks to this rigorously designed study, we now have strong evidence that pet therapy is an effective tool to help cancer patients get through challenging treatments,” added Gabriel A. Sara, MD, Medical Director, Infusion Suite at Mount Sinai Roosevelt, and Assistant Clinical Professor of Medicine, Icahn School of Medicine at Mount Sinai.

Researchers evaluated the outcome of certified therapy animal-assisted visits on patient’s life quality as they were undergoing multi-modal treatment for head and neck and gastrointestinal cancers. A total of 37 patients completed the study, receiving 15 to 20 minutes of animal-assisted visits every day throughout 6 weeks.

Most patients received 30 radiation therapy treatments in addition to their chemotherapy sessions, and presented signals of fatigue, fear, weight loss, and many patients had feeding tubes.

The results showed that patients significantly increased their social and emotional well-being.

“There is mounting evidence in human and veterinary medicine that the emotional bond between people and companion animals can have a positive impact of emotional and physical health,” J. Michael McFarland, DVM, DABVP, Zoetis group director of Companion Animal Veterinary Operations, said in the news release. “These new results help advance our understanding of the value of animal-assisted therapy in cancer treatment and point to the ways the oncology and animal health communities can work together in supporting cancer patients achieve the best possible treatment outcomes.”

Rachel McPherson, Executive Director and Founder of The Good Dog Foundation added, “We are excited to see the results of this peer-reviewed study, which bears out scientifically what we have seen for more than sixteen years at The Good Dog Foundation, which is that highly trained and fully certified therapy dogs can provide critical healing services to help change cancer patients’ experiences for the better as they receive treatment.”

January, 2015|Oral Cancer News|

Antacids linked to better survival in patients with head and neck cancer

Source: www.oncologynurseadvisor.com
Author: Kathy Boltz, PhD

Patients with head and neck cancer who used antacid medicines to control acid reflux had better overall survival, according to a new study.

Reflux can be a common side effect of chemotherapy or radiation treatment for head and neck cancer. Doctors at the University of Michigan Comprehensive Cancer Center in Ann Arbor frequently prescribe two types of antacids, proton pump inhibitors or histamine 2 blockers, to help treat this side effect.

The researchers reviewed 596 cases of head and neck cancer. More than two-thirds of the patients took one or both types of antacid medication after their diagnosis.

Patients who were taking antacids had significantly better overall survival than those who did not take them. Proton pump inhibitors, including drugs such as Prilosec, Nexium, and Prevacid, had the biggest effect: a 45% decreased risk of death compared with patients who did not take antacids. Patients taking histamine 2 blockers, such as Tagamet, Zantac, or Pepcid, saw a 33% decreased risk of death.

“We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better,” said lead study author Silvana Papagerakis, MD, PhD, research assistant professor of otolaryngology–head and neck surgery at the University of Michigan (U-M) Medical School and an adjunct clinical assistant professor at the U-M School of Dentistry.

Results of the study were published in Cancer Prevention Research (2014; doi:10.1158/1940-6207.CAPR-14-0002).

The researchers are not clear why these medications affect the cancer, although they have begun additional work to understand the mechanisms involved.

“Currently, patients might be on and off of this medication according to their symptoms of acid reflux. We believe this medication can also be beneficial at stopping cancer progression. Perhaps longer duration of treatments may have significant effect in terms of outcome survival,” Papagerakis said.

In addition, the researchers would like to understand if using antacids in people with reflux disease or people with precancerous lesions might reduce their risk of developing head and neck cancer.

Antacids are seen as relatively safe and typically have little or no adverse side effects. More importantly, Papagerakis noted, patients with head and neck cancer are already taking these medications.

“What this study makes clear is these medications may be more beneficial to the patients than just controlling side effects,” she said.

December, 2014|Oral Cancer News|

Revolutionary new approach uses advanced technology to remove head and neck cancer tumors

Source: www.news-medical.net
Author: staff

In a groundbreaking new study, UCLA researchers have for the first time advanced a surgical technique performed with the help of a robot to successfully access a previously-unreachable area of the head and neck.

This pioneering method can now be used safely and efficiently in patients to remove tumors that many times were previously thought to be inoperable, or necessitated the use of highly-invasive surgical techniques in combination with chemotherapy or radiation therapy.

Developed by Dr. Abie Mendelsohn, UCLA Jonsson Comprehensive Cancer Center member and director of head and neck robotic surgery at UCLA, this new approach provides the surgical community with a leading-edge technology roadmap to treat patients who had little or no hope of living cancer-free lives.

“This is a revolutionary new approach that uses highly advanced technology to reach the deepest areas of the head and neck,” said Mendelsohn, lead author of the study. “Patients can now be treated in a manner equivalent to that of a straightforward dental procedure and go back to leading normal, healthy lives in a matter of days with few or even no side effects.”

A New Approach to Saving Lives
The parapharyngeal space is pyramid-shaped area that lies near the base of the human skull and connects several deep compartments of the head and neck. It is lined with many large blood vessels, nerves and complex facial muscles, making access to the space via traditional surgical options often impossible or highly invasive.

Current surgical techniques can necessitate external incisions be made to the patient’s neck, or the splitting of their jaw bone or areas close to the voice box. Chemotherapy and radiation therapy are also often required, further complicating recovery and potentially putting patients at risk for serious (or even lethal) side effects.

Approved by the U.S. Food & Drug Administration in 2009, Trans Oral Robotic Surgery (or TORS) utilizes the Da Vinci robotic surgical system, the state-of-the-art technology that was developed at UCLA by the specialized surgical program for the head and neck. TORS uses a minimally invasive procedure in which a surgical robot, under the full control of a specially trained physician, operates with a three-dimensional, high-definition video camera and robotic arms.

These miniature “arms” can navigate through the small, tight and delicate areas of the mouth without the need for external incisions. A retraction system allows the surgeon to see the entire surgical area at once. While working from an operating console just steps away from the patient’s bed, every movement of the surgeon’s wrists and fingers are transformed into movement of the surgical instruments.

Currently, Mendelsohn’s new procedure largely benefits patients with tumors located in the throat near the tonsils and tongue, but it continues to be adapted and expanded in scope and impact.

“We are tremendously excited about the possibilities for the surgical community with this new advancement of TORS,” said Mendelsohn. “Now patients have options they never had before, and we can even develop potential applications for the procedure beyond the surface of the head and neck.”

The study was published online ahead of print in the journal Head & Neck

David Alpern: One Patient’s Story
In 2012, David Alpern received devastating news. He was diagnosed with throat cancer, and the treatment options given to him by his doctors sound worse than the disease.

“They described a procedure where your face is split in half and it’s basically reconstructive surgery. I was completely freaked out,” said Alpern, a husband and father of two.

After careful examination and imaging by Dr. Abie Mendelsohn at UCLA, the doctor determined David was a perfect candidate for TORS. The husband and father of two was soon up and about in a matter of days following the procedure. Like the over 100 similar TORS surgeries performed with Dr. Mendelsohn at the controls, David’s tumor was removed and he’s now completely cancer free.

“I try not to get too cocky or excited that I beat cancer, but I think I did,” said David. “There are no side effects at this point. My hopes are just to watch my kids grow up and enjoy my family and my life.”

Source: UCLA’s Jonsson Comprehensive Cancer Center

December, 2014|Oral Cancer News|

Critical Outcome Technologies and MD Anderson Cancer Center to evaluate COTI-2 in treating head and neck cancers

Source: www.marketwatch.com
Author: press release

Critical Outcome Technologies Inc. (“COTI”), the bioinformatics and accelerated drug discovery company, announced today that it recently executed a material transfer agreement (“MTA”) with Dr. Jeffery Myers, MD, PhD, FACS of The University of Texas MD Anderson Cancer Center for the continued evaluation of COTI-2 in the potential treatment of patients with head and neck squamous cell cancer (“HNSCC”).

There are approximately 500,000 new cases worldwide of HNSCC a year, making it the sixth leading cancer in terms of new cases. In the United States, HNSCC is considered to be a rare disease and therefore represents a second “Orphan Disease” opportunity for COTI-2.

If HNSCC is caught at an early stage, current therapies, which include surgery and radiation followed by chemotherapy, can be effective. Unfortunately, HNSCC tumors with p53 mutations tend to be more difficult to treat with such mutations occurring in 30-70% of HNSCC tumors. These mutations are associated with poorer patient outcomes as traditional chemotherapy, using the current first line chemotherapy, cisplatin, is often ineffective. The overall five-year survival rate of patients with HNSCC is 40-50%.

As a small molecule activator of misfolded mutant p53 protein, COTI-2 has demonstrated in preclinical studies its ability to restore p53 function and thus induce cancer cell death for many common p53 mutations. As previously announced, the Company is planning a Phase 1 study in gynecological cancers (ovarian, cervical and endometrial) at MD Anderson with Dr. Gordon Mills and his team and these studies in HNSCC with Dr. Myers will seek to extend the understanding of COTI-2’s ability to treat p53 mutations across multiple cancer types.

Dr. Jeffrey Myers, leader of MD Anderson’s Multi-Disciplinary Head and Neck Cancer Research Program, has been studying the impact of p53 mutation, a common event in HNSCC, on tumor progression and response to therapy. His group has evaluated a number of single agent and combination treatments for p53 mutant tumors, and his preliminary findings with single agent COTI-2 in HNSCC in vitro tumor models show tremendous promise. In addition to seeing sensitivity of HNSCC cells to COTI-2, his group has found that this drug sensitivity is associated with activation of p21, an important mediator of p53’s response to cellular DNA damage. This response is consistent with the p53-dependent mechanism of action studied by Dr. Mills in ovarian cancer. Dr. Myers and his colleagues are planning more extensive studies of COTI-2 and its dependence on p53 re-activation for its effects in both in vitro and in vivo HNSCC tumor models.

“We look forward to further exploring COTI-2’s impact on HNSCC tumors,” said Dr. Wayne Danter, President and CEO. “We continue to believe that COTI-2 represents a potential breakthrough treatment given the central importance of p53 gene mutations in many cancers, including HNSCC. This second indication would broaden the treatment opportunities for our lead oncology asset, which has already been granted the Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of ovarian cancer.”

October, 2014|Oral Cancer News|

Many head and neck cancer patients can avoid neck surgery

Source: medicalxpress.com
Author: Staff
 

A new study shows that patients with human papillomavirus (HPV) – the same virus associated with both cervical and head and neck cancer – positive oropharyngeal cancer see significantly higher rates of complete response on a post-radiation neck dissection than those with HPV-negative oropharyngeal cancer. Fox Chase Cancer Center researchers presented the findings at the American Society for Radiation Oncology’s 56th Annual Meeting on Wednesday, September 17.

“For patients that achieve a complete response, neck surgery is probably unnecessary,” says Thomas J. Galloway, MD, Attending Physician and Director of Clinical Research at Fox Chase and lead author on the study.

After radiation and chemotherapy to remove tumors from the tonsils or back of the tongue, many head and neck cancer patients still have persistent lumps in their neck, albeit perhaps smaller than when they were first diagnosed. “The question is: Do we need to remove those lumps, as well, or can we just let them dissolve on their own?” asks Dr. Galloway.

To investigate, he and his colleagues reviewed the medical records from 396 patients whose oropharyngeal tumors had spread to at least one lymph node. Within 180 days after completing radiation therapy, 146 patients underwent neck surgery. For 99 patients, their records indicated whether or not their tumors had likely been triggered by HPV.

Interestingly, patients with HPV often respond better to treatment for their oropharyngeal tumors than those without. The researchers noted the same trend here – people who tested positive for HPV (measured by the presence of a protein called p16) were less likely to have a recurrence of their cancers, regardless of whether or not the tumors had completely disappeared following treatment. Indeed, patients’ HPV status was the strongest predictor of whether or not they were alive at the end of the study.

Among the patients who underwent neck surgery, any lingering bumps were more likely to be benign if patients were infected with HPV. “The bump might have become a permanent scar, or in some cases, it would have eventually disappeared,” says Dr. Galloway.

Currently, it is not routine to consider a patients’ HPV status before making the decision to perform neck surgery (the decision is based on physical examination and imaging studies), which can cause problems in the shoulder and neck, including swallowing, says Dr. Galloway; these findings suggest they should. “There’s good reason to avoid neck surgery if we can.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
 
September, 2014|Oral Cancer News|

Many throat cancer patients can skip neck surgery

Source: medicalxpress.com
Author: Fox Chase Cancer Center

A new study shows that patients with human papillomavirus (HPV) – the same virus associated with both cervical and head and neck cancer – positive oropharyngeal cancer see significantly higher rates of complete response on a post-radiation neck dissection than those with HPV-negative oropharyngeal cancer. Fox Chase Cancer Center researchers presented the findings at the American Society for Radiation Oncology’s 56th Annual Meeting on Wednesday, September 17.

“For patients that achieve a complete response, neck surgery is probably unnecessary,” says Thomas J. Galloway, MD, Attending Physician and Director of Clinical Research at Fox Chase and lead author on the study.

After radiation and chemotherapy to remove tumors from the tonsils or back of the tongue, many head and neck cancer patients still have persistent lumps in their neck, albeit perhaps smaller than when they were first diagnosed. “The question is: Do we need to remove those lumps, as well, or can we just let them dissolve on their own?” asks Dr. Galloway.

To investigate, he and his colleagues reviewed the medical records from 396 patients whose oropharyngeal tumors had spread to at least one lymph node. Within 180 days after completing radiation therapy, 146 patients underwent neck surgery. For 99 patients, their records indicated whether or not their tumors had likely been triggered by HPV.

Interestingly, patients with HPV often respond better to treatment for their oropharyngeal tumors than those without. The researchers noted the same trend here – people who tested positive for HPV (measured by the presence of a protein called p16) were less likely to have a recurrence of their cancers, regardless of whether or not the tumors had completely disappeared following treatment. Indeed, patients’ HPV status was the strongest predictor of whether or not they were alive at the end of the study.

Among the patients who underwent neck surgery, any lingering bumps were more likely to be benign if patients were infected with HPV. “The bump might have become a permanent scar, or in some cases, it would have eventually disappeared,” says Dr. Galloway.

Currently, it is not routine to consider a patients’ HPV status before making the decision to perform neck surgery (the decision is based on physical examination and imaging studies), which can cause problems in the shoulder and neck, including swallowing, says Dr. Galloway; these findings suggest they should. “There’s good reason to avoid neck surgery if we can.”

September, 2014|Oral Cancer News|

Three shots that could stop cancer

Source: tucson.com
Author: Meredith Wadman

Not so long ago, when my sons still had smooth cheeks and children’s voices, I had them vaccinated against human papillomavirus, the most common sexually transmitted disease. It was late 2011, and the Centers for Disease Control and Prevention had just recommended that boys join girls in being vaccinated at age 11 or 12. I was certainly receptive: HPV, as it’s commonly called, causes cervical cancer, cancer of the tonsils, cancer of the back of the tongue and, less often, cancers of the vulva, vagina, anus and penis. It seemed important to ensure that my kids were protected.

Yet numbers released last month by the CDC show that my sons, now 14 and 15, are among a small minority of adolescent males who have been vaccinated. In 2013, just 14 percent of American boys ages 13 to 17 had received all three recommended doses of the HPV vaccine. (The CDC also recommends “catch-up” vaccination for males up to age 21.)

Not that parents are rushing to have their girls vaccinated either, even though the CDC first recommended the vaccine for prepubescent girls in 2007 and virtually all insurers pay for it. In 2013, fewer than 38 percent of American girls between 13 and 17 had received the full three-dose course.

It is heartbreaking to watch a safe, effective vaccine go unused. Consider this: The CDC estimates that increasing the vaccination rate of American girls to 80 percent would prevent 53,000 cervical cancers during the lifetimes of girls who are now 12 and younger.

When I had my sons vaccinated, it was partly with girls in mind. After all, if fewer young men are infected, fewer young women will be exposed to the virus that causes cervical cancer — currently the most common cancer prevented by the vaccine. But now I am realizing that HPV poses a growing risk to boys.

A new breed of cancer of the back of the tongue and tonsils, caused by HPV, is rising in incidence — likely caused, researchers suspect, by increases in premarital sex and oral sex over the past several decades. These cancers afflict men far more often than women, and at relatively younger ages than do other head and neck cancers, which typically appear in men older than 60. Middle-aged men who don’t die from their HPV-linked cancer often must live for years with the side effects of intensive chemotherapy and radiation delivered to the back of the throat. These can include the permanent inability to swallow and the appearance later of new, aggressive, radiation-induced cancers.

If this trend continues, we are going to see more cancer of the back of the tongue and the tonsils caused by HPV. One recent analysis of 30 studies, conducted by University of Wisconsin researchers, found that the proportion of such cancers caused by HPV rose from 21 percent before 1990 to 65 percent after 2000. Anil Chaturvedi of the National Cancer Institute and his colleagues have estimated, based on recent trends, that by 2020 there will be more new cases of these HPV-induced throat cancers in the United States each year than new cervical cancer cases.

So the actor Michael Douglas did us all a service when he was so frank with Britain’s Guardian newspaper last year. When asked if his throat cancer had been caused by heavy drinking and smoking, which are also risk factors for the disease, the actor replied: “No. I mean, without getting too specific, this particular cancer in tests is caused by something called HPV, which actually comes about from cunnilingus.”

Many parents don’t like to think of their 11- and 12-year-olds as sexual creatures. Ironically, the CDC recommendation assumes not that kids are sexually active at this tender age but rather that they are not: The point of vaccination is to close the door before the horse is out of the barn.

It’s no use telling yourself that your child isn’t “that kind” of kid. The fact is, HPV is so common that almost all sexually active adults are infected at some point. Last year, the CDC estimated that about 79 million Americans were infected, most of them in their late teens and early 20s.

Most people who get HPV have a transient infection that their immune system clears with no lasting damage. But in some people, the virus takes up residence and goes on to cause cancer. I am grateful that, thanks to the HPV vaccine, I will never have to find out if my sons fell into that second, unlucky group.

August, 2014|Oral Cancer News|

Blood test could predict oral cancer recurrence

Source: www.livescience.com
Author: Rachael Rettner, Senior Writer

A new blood and saliva test that looks for traces of the human papillomavirus (HPV) can predict whether some people with oral cancers will have their cancer come back, early research suggests.

It helps to know as soon as possible that cancer has returned, because tumors that are caught early are easier to treat.

In the study, the researchers analyzed blood and saliva samples from 93 people with head and neck cancers; about 80 percent of these patients had cancers that tested positive for HPV. All of their cancers had previously been treated with surgery, radiation or chemotherapy.

The researchers looked for fragments of DNA from HPV-16, a strain of the virus that is strongly linked with head and neck cancer. The virus may be found in cancer cells that linger in the body after treatment, the researchers said.

Among people with HPV-positive tumors, the new test identified 70 percent of those whose cancer returned within three years, the researchers said.

“Until now, there has been no reliable biological way to identify which patients are at higher risk for recurrence, so these tests should greatly help [to] do so,” study researcher Dr. Joseph Califano, professor of otolaryngology at Johns Hopkins School of Medicine, said in a statement.

Patients with head and neck cancer typically visit the doctor every one to three months during the first year after their diagnoses to check for cancer recurrence. But new tumors in the tonsils, throat and base of the tongue can be difficult to spot, and are often not detected early, the researchers said.

Still, more research is needed to confirm the findings, Califano said. Because HPV infection is common, the test may identify HPV infections that are not related to the cancer. “We can’t be sure our test results are cancer-specific, and not due to other forms of HPV infection or exposure,” Califano said.

The researchers are now looking for additional genetic markers that would increase the accuracy of their test.

Note:
The study is published today in the journal JAMA Otolaryngology–Head & Neck Surgery.

August, 2014|Oral Cancer News|

University of Michigan researchers find protein that fuels repair of treatment-resistant cancer cells

Source: http://www.dentistryiq.com/
Author: DentistryIQ Editors

Imagine that you’re fighting for your life, but no matter how hard you hit, your opponent won’t go down.

The same can be said of highly treatment-resistant cancers, such as head and neck cancer. During radiation and chemotherapy, some cancer cells repair themselves to survive and thrive. Head and neck cancer is the sixth most common cancer in the world, but the late detection and treatment resistance result in a high mortality rate.

Now, University of Michigan researchers have found that a particular protein – TRIP13 – encourages those cancer cells to repair themselves, and they have identified an existing chemical that blocks this mechanism for cell repair.

protein1

Left: Untreated head and neck cancer cells are tagged fluorescent green. Right: Shows cells treated with the chemical inhibitor that blocks TRIP13, which results in a dramatically smaller tumor.

“This is a very significant advance because identifying the function of the protein that fuels the repair of cancer cells and having an existing chemical that blocks the process could speed the process of moving to clinical trials,” said principal investigator Nisha D’Silva, University of Michigan professor of dentistry and associate professor of pathology.

Typically, if scientists discover a promising drug therapy target, it takes years to develop drug compounds from scratch and move these into clinical trials.

protein2

Top: Cancer cells with TRIP13, the protein that encourages cancer cells to repair themselves. Bottom: Cancer cells in which researchers have removed or decreased TRIP13, which results in fewer cells due to cell death.

If cell DNA is damaged, and the cell cannot repair the damage, the cell dies. In head and neck cancers, D’Silva and colleagues showed how cancer cells that overexpress TRIP13 were able to repair their DNA enough to survive and continue to grow as cancer.

“Targeting this repair mechanism with specific drugs could increase effectiveness of treatment and improve survival of cancer patients,” D’Silva said. “And given the overexpression of TRIP13 in several treatment-resistant cancers, this strategy will likely be important for multiple cancers.”

Note:
Rajat Banerjee of the University of Michigan School of Dentistry is the first author of the study, “TRIP13 promotes error-prone nonhomologous end joining and induces chemoresistance in head and neck cancer,” which appeared online on July 31 in Nature Communications.

August, 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.”