survival

Depressed Head and Neck Cancer Patients Have Lower Survival and Higher Recurrence Risk

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

Depression is a significant predictor of 5-year survival and recurrence in patients with head and neck cancer, according to a new study published in Pyschosomatic Medicine (doi: 10.1097/PSY.0000000000000256). These findings represent one of the largest studies to report on the impact of depression on cancer survival.

Although depression can have obvious detrimental effects on a person’s quality of life, its impact on cancer patients is more apparent, explained lead author Eileen Shinn, PhD, assistant professor of Behavioral Science at The University of Texas MD Anderson Cancer Center, in Houston. Increasing evidence shows modest associations between elevated symptoms of depression and greater risk for mortality among patients with lung, breast, ovarian, and kidney cancers.

The research team sought to clarify the influence of depression on survival, focusing their analysis on a single cancer type. By limiting the sample set and adjusting for factors known to affect outcome, such as age, tumor size, and previous chemotherapy, they were able to uncover a more profound impact of depression.

The researchers followed 130 patients at MD Anderson with newly diagnosed oropharyngeal squamous cell carcinoma (OSCC), a type of cancer in which the tumor originates at the back of the throat and base of the tongue.

At the beginning of their radiation therapy, Patients completed a validated questionnaire at the beginning of their radiation therapy to identify symptoms of clinical depression. Researchers monitored the participants, all of whom completed treatment, until their last clinic visit or death, a median period of 5 years.

“The results of this study were quite intriguing, showing depression was a significant factor predicting survival at 5 years, even after controlling for commonly accepted prognostic factors,” said senior author Adam Garden, MD, professor, Radiation Oncology. Furthermore, depression was the only factor shown to have a significant impact on survival.

Patients who scored as depressed on the questionnaire were 3.5 times less likely to have survived to the 5-year interval compared with those who did not score as depressed. The degree of depression was also found to be significant, as every unit increase on this scale indicated a 10% higher risk for reduced survival.

The results were replicated with a different psychological health survey and were not influenced by how soon following diagnosis the depression assessment was done.

OSCC is diagnosed in 10 000 to 15 000 Americans each year. Major risk factors known to be associated with OSCC include smoking and tobacco use, alcohol consumption, and human papillomavirus (HPV) infection. Incidence of OSCC has doubled in the last 20 years due to increasing HPV infection rates, noted Shinn.

Neither alcohol nor tobacco use, also surveyed in this group, had a significant impact on survival. HPV infection status, when available, also did not appear correlated.

Despite a high cure rate, normally 60% to 80%, recurrence rate of disease is unusually high in these patients (approximately 30%). The researchers also investigated a potential link between depression and disease recurrence.

“When we controlled for all variables, depression was linked with a nearly 4 times higher risk of recurrence,” said Shinn. In addition, never smokers had a 73% lower chance of recurrence, compared with current smokers. Those were the only two factors associated with cancer recurrence.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

December, 2015|Oral Cancer News|

Depression and smoking linked to worse prognosis in oral cancer

Source: medicalresearch.com
Author: staff

MedicalResearch.com Interview with: Dr. Eileen H. Shinn PhD
Assistant Professor, Department of Behavioral Science
Cancer Prevention and Population Sciences, MD Anderson Cancer Center

Medical Research:
What is the background for this study? What are the main findings?

Dr. Shinn:
Recent studies with leukemia, breast, lung, renal and liver cancer patients have shown that patients with depression have worsened survival. These effect sizes are small, but independent of any of the traditional factors that are known to impact survival, such as extent of cancer, types of treatment administered and baseline health and age of the patient. The current thinking is that cancer patients who are depressed have chronically heightened responses to stress; the constant release of stress hormones trigger changes in the tumor itself (such as noradrenergically-driven tumor angiogenesis) or may weakens the body’s immune function and ability to resist tumor growth.

When we measured depression in newly diagnosed patients with oropharyngeal cancer (cancer of the base of tongue and tonsil), we found that those patients who scored as depressed were 3.5 times more likely to have died within the five year period after their diagnosis, compared to non-depressed patients. We also found that patients who were depressed were also 3.8 times more likely to have their cancer recur within the first five years after diagnosis. We also found that patients who continued to smoke after diagnosis were more likely to recur within the first five years. These effect sizes were larger than those typically found in recent studies. We believe that the larger effect size may be due to the tight eligibility criteria ( e.g., we did not include patients who already had recurrent disease, we only included patients with one specific type of head and neck cancer, oropharyngeal) and also due to controlling other known factors (all patients completed individualized treatment regimens of radiation/ chemoradiation at a comprehensive cancer center and patients with more advanced disease stage were more likely to have received treatment intensification compared to patients with early stage disease). In all, we had 130 patients, one of the largest prospective studies with oropharyngeal cancer to examine the effect of depression on cancer outcome.

Medical Research:
What should clinicians and patients take away from your report?

Dr. Shinn:
With important factors, such as careful diagnosis, staging and individualized multidisciplinary treatment plans, being equal, depression status may impact patient recurrence and survival in oropharyngeal cancer.

Medical Research:
What recommendations do you have for future research as a result of this study?

Dr. Shinn:
These results need to be replicated in a larger study, with particular attention paid to repeated measures of depression as well as possible bio-behavioral markers of tumor growth and chronic stress.

December, 2015|Oral Cancer News|

Factors linked with better survival in oral cancer identified

Source: www.cancertherapyadvisor.com
Author: staff

Factors associated with improved survival in oral cavity squamous cell cancer (OCSCC) include neck dissection and treatment at academic or research institutions, according to a study published in JAMA Otolaryngology-Head & Neck Surgery.

Alexander L. Luryi, from the Yale University School of Medicine in New Haven, Conn., and colleagues analyzed correlations between treatment variables and survival in patients with stages I and II OCSCC. Data were included for 6,830 patients.

The researchers found that five-year survival was 69.7 percent. Treatment factors that correlated with improved survival on univariate analysis included treatment at academic or research institutions, no radiation therapy, no chemotherapy, and negative margins (all P < 0.001).

Improved survival was also seen in association with neck dissection (P = 0.001). Treatment at academic or research institutions correlated with increased likelihood of receiving neck dissection and decreased likelihood of receiving radiation therapy or having positive margins.

Neck dissection and treatment at academic or research institutions correlated with improved survival on multivariate analysis (hazard ratios, 0.85 and 0.88, respectively), while compromised survival was seen for positive margins, insurance through Medicare, and adjuvant radiation therapy or chemotherapy (hazard ratios, 1.27, 1.45, 1.31, and 1.34, respectively).

“Overall survival for early OCSCC varies with demographic and tumor characteristics but also varies with treatment and system factors, which may represent targets for improving outcomes in this disease,” the authors write.

Reference
Luryi, Alexander L., BS, et al. “Treatment Factors Associated With Survival in Early-Stage Oral Cavity Cancer: Analysis of 6830 Cases From the National Cancer Data Base.” JAMA Otolaryngology – Head & Neck Surgery. doi:10.1001/jamaoto.2015.0719. [epub ahead of print]. May 14, 2015.

Possibility of cure For HPV positive throat cancer patients—new research

Source: au.ibtimes.com
Author: Samantha Richardson

A new research conducted by Dr. Sophie Huang, assistant professor in the Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Canada revealed that throat cancer caused by the Human Papilloma virus (HPV+) can possibly be cured. The research is of utmost importance as it is the first to provide substantial evidence to prove that patients suffering from oropharynx cancer can be healed.

The disease also spreads to other parts of the body. The press release disclosed that the tumours remain passive and go undetected for over two years in most case, which makes it incurable. The research was presented at the 5th International Conference on Innovative Approaches in Head and Neck Oncology (ICHNO) on Friday. She states that cure is possible among patients suffering from oropharyngeal cancer is possible for the first time.

“Our research, the largest study to date to explore survival predictors for metastatic HPV+ and HPV- oropharyngeal cancer patients,” says Dr. Huang.

For the research, 934 patients suffering from HPV+ OPC were studied. All subjects were patients treated at the Princess Margaret Cancer Centre between 2000 and 2011. The researchers found two types of distinct metastases or tumours in other parts of the body away from the source in HPV+ patients: “explosive” and “indolent” metastases. The former grows and spreads quicker while the latter is slower and manifests itself as oligometastasis. However, they found the lung as the most common metastatic site in both HPV+ and HPV- patients. According to Dr. Huang, more aggressive treatments solely aimed at disease control resulted in a long term disease-free period, suggesting that some may be cured.

“In the HPV+ group with oligometases 25% were still alive after three years, whereas the percentage in the HPV- group was 15%,” the press release stated. The reason for higher survival rates among HPV+ patients is the younger age of the patients. In addition, the cancer is more sensitive to radiotherapy and chemotherapy. Those who receive treatment are at an advantage and can survive longer than those who do not undergo the process. Early detection of metastases and aggressive treatment can cure the patient.

Dr. Huang explained that they were aware of the correlation between the initial stages and the risk of a tumour on another site of the body. However, the degree by which they are related remains unknown. She highlights that identifying such relationships could help find an appropriate treatment at an early stage.

Professor Jean Bourhis, co-chair of the conference scientific committee, says that this is a very important research with respect to finding the cure of oropharynx cancer. He states that it provides hope in both the treatment and diagnosis of the patients.

February, 2015|Oral Cancer News|

Coupling head and neck cancer screening and lung cancer scans could improve early detection, survival

Source: www.medicalnewstoday.com
Author: staff

Adding head and neck cancer screenings to recommended lung cancer screenings would likely improve early detection and survival, according to a multidisciplinary team led by scientists affiliated with the University of Pittsburgh Cancer Institute (UPCI), a partner with UPMC CancerCenter.

In an analysis published in the journal Cancer and funded by the National Institutes of Health (NIH), the team provides a rationale for a national clinical trial to assess the effectiveness of adding examination of the head and neck to lung cancer screening programs. People most at risk for lung cancer are also those most at risk for head and neck cancer.

“When caught early, the five-year survival rate for head and neck cancer is over 83 percent,” said senior author Brenda Diergaarde, Ph.D., assistant professor of epidemiology at Pitt’s Graduate School of Public Health and member of the UPCI. “However, the majority of cases are diagnosed later when survival rates generally shrink below 50 percent. There is a strong need to develop strategies that will result in identification of the cancer when it can still be successfully treated.”

Screening patients for head and neck cancer and lung cancer could improve early detection and survival.

Screening patients for head and neck cancer and lung cancer could improve early detection and survival.

Head and neck cancer is the world’s sixth-most common type of cancer. Worldwide every year, 600,000 people are diagnosed with it and about 350,000 die. Tobacco use and alcohol consumption are the major risk factors for developing the cancer.

The early symptoms are typically a lump or sore in the mouth or throat, trouble swallowing or a voice change, which are often brushed off as a cold or something that will heal. Treatment, particularly in later stages, can be disfiguring and can change the way a person talks or eats.

Dr. Diergaarde and her team analyzed the records of 3,587 people enrolled in the Pittsburgh Lung Screening Study (PLuSS), which consists of current and ex-smokers aged 50 and older, to see if they had a higher chance of developing head and neck cancer.

In the general U.S. population, fewer than 43 per 100,000 people would be expected to develop head and neck cancer annually among those 50 and older. Among the PLuSS participants, the rate was 71.4 cases annually per 100,000 people.

Recently, the U.S. Preventive Services Task Force*, as well as the American Cancer Society and several other organizations, recommended annual screening for lung cancer with low-dose computed tomography in people 55 to 74 years old with a smoking history averaging at least a pack a day for a total of 30 years. The recommendation came after a national clinical trial showed that such screening reduces lung cancer mortality.

“Head and neck cancer is relatively rare, and screening the general population would be impractical,” said co-author David O. Wilson, M.D., M.P.H., associate director of UPMC’s Lung Cancer Center. “However, the patients at risk for lung cancer whom we would refer for the newly recommended annual screening are the same patients that our study shows also likely would benefit from regular head and neck cancer screenings. If such screening reduces mortality in these at-risk patients, that would be a convenient way to increase early detection and save lives.”

Dr. Diergaarde’s team is collaborating with otolaryngologists to design a national trial that would determine if regular head and neck cancer screenings for people referred for lung cancer screenings would indeed reduce mortality.

January, 2015|Oral Cancer News|

Experience counts with radiation for head and neck cancer

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

When it comes to specialized cancer surgery, the more experienced the surgeon, the better the outcome is generally true. The same might hold true for radiation therapy used to treat head and neck cancer, according to a new study.

Published in the Journal of Clinical Oncology(1) with an accompanying editorial(2), the study compared survival and other outcomes in 470 patients treated with radiation therapy at 101 treatment centers through a clinical trial held from 2002 to 2005. The trial was sponsored by the National Cancer Institute and organized by the Radiation Therapy Oncology Group (RTOG). It was conducted by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital in Columbus.

The findings indicated that patients treated at the less-experienced centers were more likely to have cancer recurrence compared with highly experienced centers (62% vs 42%, respectively, at 5 years) and had poorer overall survival compared with those at the highly experienced centers (51% vs 69% 5-year survival, respectively).

“Our findings suggest that institutional experience strongly influences outcomes in patients treated with radiation therapy for head and neck cancer,” said first author Evan Wuthrick, MD. “They indicate that patients do better when treated at centers where more of these procedures are performed versus centers that do fewer.”

Radiation therapy for head and neck cancer requires complex treatment planning that can vary considerably between institutions and physicians. In addition, significant short-term and long-term side effects can occur that require management by a carefully coordinated multidisciplinary care team.

National Comprehensive Cancer Network (NCCN) guidelines recommend that head and neck cancer patients receive treatment at experienced centers, but whether provider experience affects outcomes was previously unknown.

The research team used participation in previous RTOG head and neck cancer clinical trials as a surrogate for experience. They identified 88 low-accruing centers that enrolled an average of four patients yearly to the trials, and 13 high-accruing centers that enrolled an average of 65 patients annually. Next, the researchers compared outcomes based on whether patients were treated at the high-accruing (more experienced) or low-accruing (less experienced) centers.

They found that 5-year local recurrence rates were higher among patients treated at less experienced centers versus more experienced centers (36% vs 21%). The radiation therapy plan was more likely to deviate from protocol at less experienced centers (18% vs 6%).

Treatment at low-accruing centers was associated with a 91% increased risk of death and an 89% increase in progression or death when compared with high-accruing centers.

Institutional elements not assessed by the study that can also influence outcomes included use of a tumor board, the number of colleagues and their years of practice, and ancillary services such as speech and swallowing therapy, diet and nutrition support, and specialized nursing.

References:
1. (2014; doi:10.1200/JCO.2014.56.5218)
2. (doi:10.1200/JCO.2014.58.2239)

January, 2015|Oral Cancer News|

Study suggests that experience counts when it comes to head and neck cancer treatments

Source: medicalxpress.com
Author: staff
 

When it comes to specialized cancer surgery, it’s generally true that the more experienced the surgeon, the better the outcome. The same might hold true for radiation therapy used to treat head and neck cancer, according to a new study led by researchers Evan Wuthrick, MD, assistant professor of radiation oncology at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and Maura Gillison, MD, PhD, professor of internal medicine and epidemiology at the OSUCCC – James.

Published in the Journal of Clinical Oncology with an accompanying editorial, the study compared survival and other outcomes in 470 patients treated with radiation therapy at 101 treatment centers through a clinical trial held from 2002 to 2005. The trial was sponsored by the National Cancer Institute and organized by the Radiation Therapy Oncology Group (RTOG).

The findings indicated that patients treated at the less-experienced centers were more likely to have cancer recurrence (62 percent versus 42 percent at five years) and had poorer overall survival compared with those at the highly-experienced centers (51 percent versus 69 percent five-year survival, respectively).

“Our findings suggest that institutional experience strongly influences outcomes in patients treated with radiation therapy for head and neck cancer,” says Wuthrick, the paper’s first author. “They indicate that patients do better when treated at centers where more of these procedures are performed versus centers that do fewer.”

Radiation therapy for head and neck cancer requires complex treatment planning that can vary considerably between institutions and physicians. In addition, significant short-term and long-term side effects can occur that require management by a carefully coordinated multidisciplinary care team. National Comprehensive Cancer Network guidelines recommend that head and neck cancer patients receive treatment at experienced centers, but whether provider experience affects outcomes was previously unknown.

Wuthrick, Gillison and their colleagues used participation in previous RTOG head and neck cancer clinical trials as a surrogate for experience. They identified 88 low-accruing centers that enrolled an average of four patients yearly to the trials, and 13 high-accruing centers that enrolled an average of 65 patients annually. Next, the researchers compared outcomes based on whether patients were treated at the high-accruing (more experienced) or low-accruing (less experienced) centers.

The study’s key findings include:

  • Five-year local recurrence rates were higher among patients treated at less experienced centers versus more experienced centers (36 percent and 21 percent, respectively);
  • The radiation therapy plan was more likely to deviate from protocol at less experienced centers (18 percent versus 6 percent);
  • Treatment at low-accruing centers was associated with a 91-percent increased risk of death and an 89-percent increase in progression or death when compared with high-accruing centers.

Institutional elements not assessed by the study that can also influence outcomes included use of a tumor board, the number of colleagues and their years of practice, and ancillary services such as speech and swallowing therapy, dietetic and nutritional support, and specialized nursing.

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

Antacids may improve head and neck cancer survival

Source: www.webmd.com
Author: Robert Preidt

Using antacids to control acid reflux may improve head and neck cancer patients’ chances of survival, a new study suggests.

The researchers examined the effects that two types of antacids — proton pump inhibitors and histamine 2 blockers — had on head and neck cancer patients. More than two-thirds of the nearly 600 patients in the study took one or both types of the antacids after their cancer diagnosis.

Acid reflux — commonly known as heartburn — is a common side effect of chemotherapy or radiation treatment, according to the researchers. Proton pump inhibitors include drugs such as Prilosec, Nexium and Prevacid, while histamine 2 blockers include drugs such as Tagamet, Zantac and Pepcid.

Compared to patients who didn’t take antacids, those who took proton pump inhibitors had a 45 percent lower risk of death, according to the researchers. They also found that those who took histamine 2 blockers had a 33 percent lower risk of death.

The study is published in the December issue of the journal Cancer Prevention Research.

“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,” study author Dr. Silvana Papagerakis, research assistant professor of otolaryngology–head and neck surgery at the University of Michigan Medical School, said in a university news release.

It’s not clear why antacids may improve survival. But, the researchers have started looking for answers to that question.

“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.

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

The researchers also want to investigate if the use of antacids by people with reflux disease or with precancerous lesions might reduce their risk of developing head and neck cancer.

December, 2014|Oral Cancer News|

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.”