head and neck cancer

Immunotherapy Continues to Advance in Head and Neck Cancer

Source: www.onclive.com
Author: Megan Garlapow, PhD
 

Concomitant administration of motolimod with cetuximab (Erbitux) increases the innate and adaptive immune response in the blood and the tumor microenvironment in head and neck squamous cell carcinoma (HNSCC), overcoming negative prognostic biomarkers of cetuximab therapy alone, according to the biomarker data from a recent phase Ib clinical trial that was presented at the 2016 Head and Neck Cancer Symposium. The trial was recently amended to add nivolumab to the combination of cetuximab and motolimod.

Robert-FerrisDr. Robert Ferris, MD PhD

 

“We know that PD-1 and PD-L1 are overexpressed in head and neck cancer, and so it was somewhat irresistible to combine our baseline treatment of cetuximab and motolimod with the PD-L1 inhibition pathway. EGFR itself drives PD-L1, so combining cetuximab with anti-PD-1 inhibitor makes sense. So, we’ve amended this trial. We’re now accruing to treatment with cetuximab, motolimod, and the anti–PD-L1 nivolumab in this trial,” said lead author Robert Ferris, MD, PhD, professor, Departments of Otolaryngology, Radiation Oncology, and Immunology, Cancer Immunology Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.

According to the authors of the phase Ib data presented at the symposium, the rationale for combining cetuximab with motolimod (VTX2337) as neoadjuvant therapy was that cetuximab induces cellular immunity that correlates with neoadjuvant clinical response. The phase I dose-escalation and safety of the combination had been established (NCT 01334177).

This study of neoadjuvant cetuximab and motolimod had accrued 14 patients with HNSCC that was stage II-IV, resectable, and located in the oropharynx, oral cavity, hypopharynx, or larynx. These patients were biopsied, treated with cetuximab and motolimod for 4 weeks, and then underwent surgery. The endpoints of the trial were the modulation of immune biomarkers.

Interferon-inducible cytokine IP-10 increased after the patients were administered neoadjuvant cetuximab and motolimod (P = .0001). After the neoadjuvant treatment, the peripheral blood lymphocytes had an increased frequency of EGFR-specific CD8 T cells. After the neoadjuvant treatment, regulatory T cells had decreased suppressive receptors and transforming growth factor-β, which induces Foxp3. Also, after the neoadjuvant treatment, circulating MDSCs had decreased PD-L1 (P <.07) and macrophages had increased CD16 expression (P <.07).

After the neoadjuvant treatment with cetuximab and motolimod, genotyping of T-cell receptors showed increased clonality in peripheral blood lymphocytes (P = .003 by Wilcox signed rank test) and tumor-infiltrating lymphocytes (P = .081 by Wilcox signed rank test). Most patients are more oligoclonal than healthy individuals, and some are very clonal with highly prominent expanded clones. Genotyping of T-cell receptors found that clonality was increased by the combination of cetuximab and motolimod compared with treatment with cetuximab alone.

Recent studies have indicated that the PD-1/PD-L1 pathway is upregulated in the HNSCC microenvironment, and that EGFR blockade prevents interferon-γ-mediated upregulation of PD-L1. Thus, this study has been amended to add nivolumab to the adjuvant treatment with cetuximab and motolimod. The endpoints are still the modulation of immune biomarkers.

The aim is to target the tumor microenvironment, such that tumor immune escape is reversed and T cells eliminate HNSCC. Antitumor T cells are reprogrammed to reverse inhibitory signals. Combining the toll-like receptor agonist, motolimod, with cetuximab and with PD-1 pathway inhibitors, such as nivolumab, may enhance the priming and activity of T cells.

“Targeting the tumor microenvironment requires understanding as well as reversal of immune escape mechanisms in the cellular compartment. Reprogramming antitumor T cells to reverse inhibitory signals can be done by directly disrupting those inhibitory signals, the so-called checkpoint receptor field, and can be done potentially by combining proinflammatory signals, such as toll-like receptor agonists, to chemo-attract cells into the microenvironment and to create good inflammation to overcome suppressive factors,” said Ferris.

Recent findings have shown tremendous promise for nivolumab in head and neck cancer. Bristol-Myers Squibb (BMS) announced in January 2016 that nivolumab improved overall survival versus investigator’s choice of therapy for patients with platinum-refractory squamous cell carcinoma of the head and neck in the phase III CheckMate-141 trial. Findings from the study are being discussed with the FDA and other health authorities, according to BMS.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
February, 2016|Oral Cancer News|

Study: HPV vaccine reduces HPV incidence in teenage girls

Source: www.upi.com
Author: Stephen Feller
 
Study-HPV-vaccine-reduces-HPV-incidence-in-teenage-girlsJust over half of girls have received the HPV vaccination, but a new CDC study shows it has significantly reduced prevalence of the cancer-causing STI among females who have received the vaccine when compared with those who have not. Photo by Adam Gregor/Shutterstock

 

WASHINGTON, Feb. 22 (UPI) — The prevalence of human papillomavirus infection among teenage and young adult women is down nearly two-thirds since the U.S. Centers for Disease Control and Prevention started recommending vaccine in 2006, according to a new study.

The study is the first to show a drop in prevalence among women in their 20s, and continues to show decreases seen in smaller studies during the last few years, but researchers say the effect could be much stronger.

The vaccine is recommended by the CDC and other organizations for girls and boys starting at age 11, experts say, in order to protect children from HPV before they become sexually active and can become infected.

Concerns that the vaccine would influence teens’ sexual practices have also been unfounded, as research has shown the vaccine does not make children more likely to engage in risky sexual behavior, based on a the lack of an increase in other STI incidence among vaccinated girls.

“It’s just like putting on your seatbelt before turning on the car,” Dr. Alix Casler, medical director of pediatrics for Orlando Health, told UPI. She suggests separating the adolescents’ eventual discovery of sex from the effort to prevent life-threatening diseases.

Recommendations for the HPV vaccine — Cervarix, Gardasil and Gardasil 9 — have been expanded to boys, because of the wide range of cancers for which HPV increases risk, including cervical, anal, head and neck cancer, though a 2015 study showed vaccination rates remain relatively low, with just 57 percent of eligible girls and 35 percent of boys vaccinated.

“We are continuing to see decreases in the HPV types that are targeted by the vaccine,” Dr. Lauri Markowitz, a medical epidemiologist at the CDC, told CBS News. “We have seen declines in genital warts [caused by HPV] already. The next thing we expect to see is a decline in pre-cancers, then later on declines in cancer.”

For the study, published in the journal Pediatrics, used survey information collected as part of the National Health and Nutrition Examination Survey between 2003 and 2006 and between 2009 and 2012 on females between the ages of 14 and 34.

The researchers compared prevalence of HPV between the pre-vaccine group before 2006 and post-vaccine group after the vaccine was introduced, finding HPV prevalence declined by 64 percent, from 11.5 percent to 4.3 percent, in girls between age 14 and 19, and by 34 percent, from 18.5 percent to 12.1 percent, among women age 20 to 24.

Among women aged 14 to 24, the prevalence of HPV among vaccinated women, at 2.1 percent, was also significantly lower than the 16.9 percent of unvaccinated women with the STI.

The research is based on the 4vHPV vaccine, which protects against the four most common forms, though the 9vHPV vaccine was approved by the FDA for use to prevent more forms of HPV.

Casler said data in the next several years is likely to show continuing decreases in HPV prevalence as more adolescents receive the vaccine, however some pediatricians are hesitant because of personal bias. Many parents also are nervous the vaccine will act as a message to teens that sex is OK, making some parents want to delay vaccination until their adolescents are sexually active — by which time it may be too late.

“The infection is sexually transmitted, but that doesn’t need to be part of the conversation,” Dr. Joseph A. Bocchini, a pediatric infectious disease specialist at Louisiana State University, told the New York Times. “If a parent is concerned, physicians should be prepared to talk about it. But we don’t really discuss how people become infected with every vaccine-preventable disease.”

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

February, 2016|Oral Cancer News|

Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

Source: www.Targetedonc.com
Author: Laura Panjwani
 

“To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer.” – Robert Ferris, MD, PhD

With the phase III CheckMate-141 trial being stopped early due to the anti–PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn’t be more elated.

“This is what I’ve devoted my career to, and it is gratifying to see that really come to pass,” said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology.

“To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer. There is now hope for a lot of patients and physicians who have been frustrated by this difficult-to-treat disease. This opens up a whole new class of therapies for this population.”

Ferris, who acted as cochair/coprimary investigator for the trial alongside Maura Gillison, MD, PhD, Ohio State University, said the trial pitted nivolumab against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).

Eligible patients who are still enrolled in the study are now able to continue their current treatment regimen, or switch over to nivolumab. Ferris says the prospect of having a new drug available for SCCHN is exciting, especially considering the last FDA approval for the disease type came in 2006.

“It was 2006 when cetuximab was approved and that was a relatively modest advance, although it was the first targeted therapy. We have a population without any other therapeutic options and a very rapid progression,” he said.

“Anti–PD-1 agents have had promising data in melanoma and squamous non–small cell lung cancer (NSCLC). Squamous NSCLC genomically resembles HPV-negative head and neck cancer in its behavior regarding carcinogen exposure. Therefore, we felt it might respond well to anti–PD-1 agents, too. We designed the study to hopefully create something new and effective for an essentially hopeless palliative group of patients.”

The phase III data have not yet been released from the trial, though early discontinuation has generated significant excitement in the field. The trial was scheduled to run until October 2016, has generated significant excitement in the field, says Ferris, who is a primary author on the abstract submitted for presentation at the ASCO Annual Meeting.

Ferris says the study was designed reflect the idea that there are different standards of care for SCCHN throughout the world, which is why cetuximab, methotrexate, or docetaxel were chosen for the control arms.

“We still don’t have public data for what all of the standard of care selections were, but we do know that cetuximab tends to be used more in North America. Meanwhile, the other 2 agents are more likely to be used in Europe and other countries because cetuximab is not approved there,” he said.

“The benefits are really very modest with those single-agent treatments and they are toxic. There is very much a need for a new treatment. We are very interested in the toxicity profile of nivolumab, as it has proven to be well tolerated in other cancers.”

Ferris adds that the excitement generated in the field stems from the revelation of efficacy for pembrolizumab (Keytruda) at the 2015 ASCO Annual Meeting, saying the data from both pembrolizumab and nivolumab “appear to be very similar.”

“There was a suspicion that nivolumab would be promising in head and neck cancer, as well. There is a great deal of buzz from medical oncology leaders all over the country regarding this. People have really been waiting with bated breath for something for our patients. This is a real win for the community and for a population of patients with a devastating disease in a very important area of the body,” he said.

“This disease can disrupt speaking, drinking, swallowing, and has catastrophic consequences. I expect enthusiasm and support from the community regarding this.”

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

February, 2016|Oral Cancer News|

Expanded age indication cleared for Gardasil 9 in males

Source: www.FormularyJournal.ModernMedicine.com
Author: Erin Bastick
 

FDA approved an expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males.

Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52, and 58) cause approximately 90% to 95% of HPV-related anal cancers, 90% of cervical cancers, and 80% of high-grade cervical lesions worldwide.These 7 types also cause the majority of HPV-related vulvar and vaginal cancers. Gardasil 9 includes the greatest number of HPV (Human Papillomavirus) types of any available HPV vaccine.

Gardasil 9 was previously approved for use in girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 22, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. As for use in male patients, the vaccine was previously approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

With the newest approval, Gardasil 9 is now also indicated for use in males aged 16 to 26 years for the prevention of these diseases. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage in males is especially low in males. The approval of the expanded age indication in male patients was based on results from a clinical trial program for Gardasil 9 that was designed to build upon the safety and efficacy established in clinical trials with Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant].

“Any health plans that have not yet made a decision regarding coverage for Gardasil 9 for males 16-26 can do so now that that the vaccine is indicated in this population,” according to a company statement from Merck. “Most managed care plans have already made decisions to cover the cost of Gardasil 9, including for males 16 through 26 years of age, making the number of plans covering Gardasil 9 similar to the number covering the cost of Gardasil. The approval of Gardasil 9 for males 16 through 26 years of age is a milestone in the planned transition from Gardasil to Gardasil 9, as both products are now approved for the same populations.”

The most common adverse reactions associated with the use of Gardasil 9 in males aged 16 to 26 years included injection-site pain, swelling, and erythema. Not all vulvar, vaginal and anal cancers are caused by HPV; Gardasil 9 only protects against those cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil.

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

December, 2015|Oral Cancer News|

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|

Head, Neck Cancer Patients May Be at Higher Risk for Suicide: Study

Source: www.health.usnews.com
Author: Robert Preidt
 

THURSDAY, Nov. 12, 2015 (HealthDay News) — Head and neck cancer patients may be at raised risk for suicide, new research suggests.

However, the overall risk is still small, the findings showed.

The study included over 350,000 patients in the United States diagnosed with head and neck cancer between 1973 and 2011. Of those patients, 857 died by suicide.

The investigators found that the suicide rate among head and neck cancer patients was three times higher than in the general population. And suicide rates were higher among patients treated with radiation alone compared to surgery alone.

Suicide rates were highest among those with cancers of the lower part of the throat, including the larynx (“voice box”) and hypopharynx, at five times and 12 times higher, respectively, than in the general population.

“This may be linked to these anatomic sites’ intimate relationship with the ability to speak and/or swallow. Loss of these functions can dramatically lower patients’ quality of life,” Dr. Richard Chan Woo Park, of Rutgers New Jersey Medical School, and colleagues wrote.

“It is possible that the increased rates of tracheostomy [breathing tube] dependence and dysphagia [difficulty swallowing] and/or gastrostomy [feeding] tube dependence in these patients are . . . factors in the increased rate of suicide observed,” the authors added.

The study was published online Nov. 12 in the journal JAMA Otolaryngology–Head & Neck Surgery.

“While there is a considerable body of research that examines survival outcomes for patients with head and neck cancer, additional research and effort should also be devoted to the psychological toll that the cancer, treatments and resulting morbidity have on patients,” the researchers concluded.

Suicide is the 10th leading cause of death in the United States and cancer patients are at increased risk for suicide, the study authors pointed out in a journal news release.

More information

The American Cancer Society offers resources on coping with cancer.

Copyright © 2015 HealthDay. All rights reserved.

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

November, 2015|Oral Cancer News|

Why groundbreaking new cancer drugs still don’t work for most patients

Source: www.news.doximity.com
Author: Brady Dennis

imrs

Immunotherapy, which aims to harness the body’s immune system to fight off certain cancers, has received plenty of attention, praise and investment in recent years. Breakthrough treatments for melanoma and other cancers have shown startling results, giving some patients months and often years of life they almost certainly would not otherwise have had.

Yet, for all their promise, immune therapies have not produced such dramatic results for the majority of patients. The same drug that causes metastatic melanoma to vanish in one patient might have no effect on another. At best, only one or two patients out of five will respond to immunotherapy treatments — remarkable numbers compared to past standards, but still far lower than anyone would like.

New research published Monday in the journal Nature explores the molecular mechanisms that prevent immunotherapy drugs from working in some patients, and researchers hope the findings will help make the treatments more effective over time.

In short, the researchers studied why certain tumors were able to evade immune therapies designed to unleash the body’s defenses to fight cancer. They noted that tumors with a high concentration of “T cells,” a type of white blood cell essential to the human immune system, were more responsive to the treatments. Tumors with a low number of T cells inside what researchers call the “cancer microenvironment” were far less responsive to the new drugs.

“The tumors are acting to protect themselves,” said Weiping Zou, a senior author of the study and a professor of surgery, immunology and biology at the University of Michigan’s medical school. “If the T cells cannot get in, they have no way to kill the tumors.”

Using human and mouse models of ovarian cancer cells, he and other scientists experimented with specific drugs aimed at helping generate more T cells within a tumor, so that it would then be more responsive to immunotherapy. Although it’s early, the approach seems to have promise.

Immune therapies have rapidly become a pillar of cancer treatment in recent years, and numerous trials are underway in hopes of expanding the successes to bladder cancer, breast cancer, Hodgkin’s lymphoma, head and neck tumors, and other types of the disease. Researchers also are testing the new drugs in combination with one another and with other therapies.

The main obstacle has been the realization that some cancers have proved less susceptible to immune therapies, and some patients have fared far better than others. If researchers such as Zou and his colleagues can engineer ways to make game-changing immune therapies effective in more patients, that would be a game-changing feat.

“How can we make the responders more responsive, and make the non-responders become responders?” Zou said. “That’s the whole goal.”

October, 2015|Oral Cancer News|

Less Is More for HPV Oropharyngeal Cancer Reduced-intensity regimen clears disease in 86% of cases

Source: www.medpagetoday.com
Author: Charles Bankhead
 

SAN ANTONIO — Less intense treatment of low-risk human papillomavirus (HPV)-related oropharyngeal cancer achieved a high rate of pathologic complete response (pCR) and favorable patient-reported outcomes, a preliminary trial showed.

Overall, 37 of 43 (86%) patients achieved pCR with deintensified chemoradiation, including all but one evaluable primary tumor. The pCR rate was virtually identical to historical rates achieved with standard regimens, according to Bhishamjit Chera, MD, of the University of North Carolina (UNC) at Chapel Hill, and colleagues.

Selected patient-reported adverse events peaked during the first 6 to 8 weeks and then declined thereafter. About 40% of patients required feeding tubes for a median duration of 15 weeks, but no patients required permanent feeding tubes, they reported here at the American Society for Radiation Oncology meeting.

The regimen consists of lower doses of radiotherapy and concurrent cisplatin, administered over 6 weeks. With high-dose therapy, the radiation protocol requires an additional week.

“Though we have limited follow-up, the pathological complete response rate with this reduced-intensity chemoradiotherapy regimen is very high in patients with favorable-risk oropharyngeal squamous-cell carcinoma,” Chera said. “The early quality-of-life measurements are encouraging, particularly the data on swallowing. We are optimistic that these results with reduced-intensity treatment will translate into good long-term disease control with less toxicity.”

The study reflects the current trend and momentum in the management of HPV-positive oropharyngeal cancer, said Zain Husain, MD, of Yale Cancer Center in New Haven, Conn.

“This is the second study to show that de-escalation of therapy might work, and so far, the results really look good,” Husain told MedPage Today. “This is a really important issue, and all of our trials are moving in that direction.”

NRG Oncology (formerly RTOG) has already launched a trial using the UNC regimen, “which gives us a lot of confidence that this is a good regimen,” Husain added. Nonetheless, reduced-intensity treatment remains investigational and should not be used in clinical practice. Randomized clinical trials with adequate follow-up will be required to determine the ultimate role of less intense therapy for HPV-positive oropharyngeal cancer, he said.

Background

HPV-positive oropharyngeal cancer accounts for 60% to 70% of new cases of oropharyngeal cancer in the U.S., and the incidence has continued to rise. In general, HPV-positive disease has a more favorable prognosis as compared with HPV-negative oropharyngeal cancer.

At many institutions, standard therapy for newly diagnosed HPV-positive oropharyngeal cancer consists of total-dose radiotherapy of 70 Gy administered over 7 weeks, and concurrent cisplatin 100 mg/m2 for 3 weeks. The regimen achieves a high rate of pCR but causes substantial toxicity. Given the overall favorable prognosis of HPV-positive oropharyngeal cancer, many specialists have begun to ask whether reduced-intensity treatment might be just as effective with less toxicity.

Chera reported findings from a prospective phase II trial of reduced-intensity chemoradiation for low-risk HPV-positive oropharyngeal cancer. Eligible patients had diagnoses of T0-3, N0-2c, M0 disease associated with minimal or negative smoking history. Treatment consisted of a total radiation dose of 60 Gy administered in 2-Gy fractions daily for 6 weeks, plus concurrent weekly cisplatin 30 mg/m2. The regimen represented a 10-Gy reduction in the usual radiation dose and a 40% reduction in the usual chemotherapy dose, Chera said.

The primary outcome was pCR and was based on experience with usual high-dose therapy, which has been associated with a pCR rate of 87%. Patients undergo biopsy of the primary site 6 to 14 weeks after completing chemoradiation, as well as resection of any initially-positive lymph nodes. Secondary endpoints included toxicity, quality of life (QOL), and clinical outcomes of treatment.

Key Findings

The 86% pCR rate compared favorably with the 87% rate demonstrated by historical data. The overall results included pCR in 40 of 41 evaluable primary tumors (two of which were stage T0 at baseline) and pCR in the neck in 33 of 39 patients (four of whom had N0 status at baseline).

After a median follow-up of 21 months, all 43 patients remain alive and without evidence of disease, including 38 patients who have at least 1 year of follow-up.

Investigators evaluated QOL by means of an instrument developed by the European Organization for Research and Treatment of Cancer (EORTC QLQ H&N-35). Focusing on common adverse effects of chemoradiation for head and neck cancer, Chera noted that the severity score for dry mouth, sticky saliva, and swallowing all increased during the first 6 to 8 weeks, particularly dry mouth and sticky saliva.

The score for dry mouth peaked at about 70 on the 100-point scale and the score for sticky saliva rose to a maximum of about 60. Score for dry mouth remained at about 60 at 12 months, whereas the saliva score declined to about 40. The effect on swallowing was less severe, reaching a maximum of about 20 and then declining to less than 10 at 12 months.

Patient-reported symptoms exhibited a similar pattern as the dry mouth score averaged less than 0.5 (0 to 4 scale) at baseline, increasing to almost 2.5 at 6 to 8 weeks, and then declining to less than 2.0 by 1 year. Patient-rated swallowing difficulty was less than 0.5 at baseline, about 1.0 at 6 to 8 weeks, and slightly less than 1.0 at 1 year.

Physician-rated grade 3/4 toxicity and patient-rated severe/very severe toxicity included mucositis (34%/45%), pain (5%/48%), nausea (18%/52%), vomiting (5%/34%), dysphagia (39%/55%), and xerostomia (2%/75%).

Chera and colleagues have already closed enrollment for another phase II trial that will evaluate a reduced-intensity regimen that makes surgery optional, omits chemotherapy for patients with T1-2 N0-1 disease, and includes patients with as much as a 30 pack-year smoking history but who have a 5-year period of abstinence.

A planned “third-generation” phase II trial will evaluate the feasibility of cancer genetics risk-based stratification of patients and examine more specifically the question of whether reduced-intensity treatment is possible for patients with a >10 pack-year smoking history.

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

October, 2015|Oral Cancer News|

SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Source: www.woai.com
Author: News Radio 1200 WOAI Staff

 

1229_1264794779Keytruda, a cancer drug developed largely at San Antonio’s START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter’s treatment.  Now, News Radio 1200 WOAI reports Keytruda has been given ‘fast track’ approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States.

Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing.

“Close to 40% of those patients will receive a response,” she said.  “And of those patients who receive a response, about 80% of those patients will have a long term response.”

The life saving potential of Keytruda in fighting non small cell lung tumors is obvious.  An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually.

Dr. Patnaik says Keytruda is becoming the most successful of what are known as ‘targeted therapies,’ drugs which trigger the body to take action to fight the cancer.  She says both melanoma and lung cancer work essentially the same way to undermine the body’s defenses.

“The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system.”

She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the cancer.

That means the treatment takes place without chemotherapy.

“Thus avoiding some of the toxicities associated with chemotherapy including hair loss, fatigue, a drop in counts, nausea and vomiting, and the spectrum of negative side effects you get with chemo.”

Dr. Patnaik says several other types of cancers work the same way, ‘turning off’ the body’s natural immune systems, and she says there are indications that Keytruda will work for those cancers as well.

“Keytruda is showing activity in about ten or more other cancers, including liver cancer, head and neck cancer, and in a rare form of breast cancer.”

The FDA granted Keytruda ‘breakthrough therapy designation’ because of demonstrated preliminary clinical evidence that the drug may ‘offer a substantial improvement over available therapies.’

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

October, 2015|Oral Cancer News|

Patient Support in Oral Cancer: From Sydney to New York to London, survivors and patients interact through an important portal to get through difficult times

Source: www.prnewswire.com
Author: Press Release
 

NEWPORT BEACH, Calif., Sept. 28, 2015 — The word “cancer” will incite fear in anyone. When that word comes at the end of a sentence that began with your name, the impact can be life changing. “I had a great job, a beautiful house and a happy family life,” recalls oral cancer survivor and Oral Cancer Foundation (OCF) Director of Patient Support Services, Christine Brader. “All that changed once I got sick.” Those affected by oral cancer, like Christine, are saddled not only with the physical challenges of treating and surviving the disease, but they must also live with the emotional uncertainty and anxiety that accompanies a diagnosis. OCF’s Patient Support Forum (oralcancersupport.org) was created specifically to provide patients with the information, guidance, and support they need to face a cancer diagnosis. Now in its 15th year, it has helped tens of thousands navigate a difficult path.

It was nearly 16 years ago that oral cancer survivor and OCF founder Brian Hill began his search for answers. “When I was first diagnosed,” Hill recalls, “I was scrambling for the right information. Once inside the treatment world I was faced with decisions about which treatment path was right for me, uncertainties of what would lay ahead, the arrival of complications unexpected, pain, and ultimately a sense of the loss of control and a resulting fear.” While hospital support groups and some online chat rooms existed at the time, they fell short of providing the insights, guidance and accessibility necessary to have real benefit to a newly diagnosed cancer patient undergoing treatment. “My problems were complex and changing daily. Every day it seemed that something new was occurring that complicated matters, and I needed to talk with someone who could help me digest everything from the new medical terminology, to dealing with side effects of what I was undergoing.” It was through building relationships with other survivors and exchanging stories and information that Hill was able regain hope and envision life after cancer.

In 2001, seeing a need for patients to connect with one another, Hill worked to develop an interactive online forum where patients and survivors could share their knowledge and tell their stories. Christine Brader joined the forum after her first oral cancer diagnosis in 2007. “When I was diagnosed I didn’t know which way to turn, and by finding others who had gone through it, I gained significant peace of mind,” she recalls. “After my third cancer recurrence, I lost 65 pounds, was hospitalized twice for dehydration and malnutrition and was ready to quit. The doctors don’t always prepare patients for the realities of the difficult treatments.” It was the advice from other survivors, words of encouragement and support from the OCF forum community that convinced Christine to continue her treatments and gave her hope. “There’s a whole world of people who have gotten through it and survived, they are living in a world after cancer and are thriving” she says. “Given the extensive disfiguring surgeries, and compromises that I would be forced to live with, I was uncertain if there was even a place for me in the world after fighting to survive. Single, unable to work in my previous vocation, I could not wrap my mind around how I would fit back into a world where everything from esthetics, to the ability to speak clearly carry so much weight. But through this online vehicle, I built friendships, and through one person in particular I was repeatedly told that there can be a rich vibrant life after this terrible cancer, which can leave its visible damage even after survival, no matter how different I was after it all. The transition was not easy, but they were right. Life after my battle is rich in relationships, and meaningful work.” Now, as the patient support administrator for OCF, Christine offers her experience-based insights and emotional support to others just beginning their own battles.

Unlike public chat rooms and social media based groups, OCF’s Patient Support Forum was designed with the users’ privacy and safety in mind. OCF’s forum users’ personal information will never be marketed to by outside companies, and they will never be exposed to advertising; both considerations associated with social media platforms. Anonymous screen names protect privacy and facilitate an open dialogue for difficult topics such as intimacy and depression. “It was important to develop rules to ensure that the information on the forum is reputable, and accurate. Misinformation can facilitate poor decision making, and harm people,” says Hill. To that end, the forum is heavily monitored by volunteer staff with diverse medical backgrounds including dentistry, oncology, research, and nursing and of course long term survivors themselves. Both Hill and Brader agree that the survivors are often the most adept at answering questions correctly and sensitively. “Survivors direct experience many times trumps clinical experience of professionals, though we would never suggest that they have the same level of knowledge. But living on the receiving end of the treatment process definitely provides you with a much different perspective. We don’t let inaccurate information live on our boards,” says Hill, “and we will correct or eliminate the information/comments that are incorrect or scientifically unsupported.”

It is this kind of monitoring and oversight that earned OCF’s websites, oralcancer.org and oralcancersupport.org, Health on the Net’s HONcode certification. The HONcode is a designation reserved for online publishers of trustworthy and reliable medical and health information who have volunteered to adhere to hundreds of strict guidelines and Health on the Net’s code of ethics. This certification is an oversight process that is ongoing, to ensure the consumer that information presented is trustworthy and scientifically accurate; and that protocols for proper informed interaction are in place. With the understanding that poor information can lead to poor choices, OCF has gone to great lengths to protect its members from misleading information.

Today, the Oral Cancer Foundation is working hard to make patients and their families aware that support and answers are available online, for free, 24 hours a day by visiting the web based forum. In keeping with OCF’s missions to reduce suffering and save lives through prevention, education, research, advocacy, and patient support, the forum has been designed to fulfill the need for reliable medical information and emotional support. With over 10,000 active members, thousands more who visit the site, read the threads of discussion without becoming members or posting themselves, and over a quarter million archived threads of information, the forum has grown into the largest and most well curated databases of oral cancer information and emotional support on the internet. Members now span across the globe and dozens of countries. Even oncology researchers have looked to this online community to develop answers and insights into understanding the patient experience, and improving the ways in which they interact with patients, and anticipate their needs both physical and emotional.

When discussing the relationships he’s made on the forum, Ed Brown, now a 12-year oral cancer survivor says, “Finding each other is the greatest thing that has ever happened to us. When you feel like you’re some kind of freak and struggling alone with your issues, it’s the best feeling to find out there is someone else out there who has dealt with the same thing, someone who knows what it’s like, someone who understands the “work-arounds” for some of the complications of treatments that we all deal with. Thanks to the forum I now know 10,000 survivors who because of our shared experiences are a resource I can turn to.”  Few people can comprehend the pain and hardship of undergoing treatment for a life threatening illness, fewer are aware of the emotional isolation and lonesomeness that accompanies the disease. Only survivors, other patients, and their caregivers live the intimate struggles and battles of will that take place when fighting for your life.

“The support forum became a second family really, not just a bunch of patients or survivors, but a community that I was a part of. We’ve all shared a common experience, endured treatment, survival, complications, and funerals. The camaraderie in the community is the heart and soul of what OCF really is – a group of people helping other people,” says Hill. The individuals who use the support forum have made lifelong friendships and passed along their experiences and knowledge to others.  Brown says, “For every success I’ve had on this journey, likely a thousand people will have known about it.” Sharing in the successes of others and giving back to a community that has embraced you during your difficult times are important reasons why many of the thousands of forum users continue to use the site after they’ve been declared “disease free.”

Hill has called the patient support forum the “heart and soul” of the foundation. Given the foundations many diverse activities; from sponsoring research to advocacy, those that populate the OCF forum, who choose to spend part of their new lives in service to those behind them on the path, he feels they are the palpable core of what OCF is. Few face-to-face support groups can deal with the daily needs of patient ups and downs, as they most often meet once a month, and have less depth of experience to draw from as there are fewer individuals to share their experiences, and fewer survivors attending as they move on from their cancer experience. The OCF forum idea, created well before Google was the major search engine we know today, and before any social media companies like Facebook even existed, has a decade and a half of experience as an Internet based platform to help others… as often as they find a need for it.

Oral cancer is not fought with treatment staff and medicine alone, but in conjunction with reliable medical information to facilitate good decision making, and emotional support and guidance when the questions and weight of the experience seem overwhelming. OCF’s Patient Support Forum is a resource rich with answers, accessible anytime, from nearly anywhere, anonymous, monitored and safe, and free to anyone in need.

For more information about the Oral Cancer Foundation and the Patient Support Forum, please visit oralcancer.org and oralcancersupport.org.

About the Oral Cancer Foundation:
The Oral Cancer Foundation, founded by oral cancer survivor Brian R. Hill, is an IRS registered non-profit 501(c)(3) public service charity that provides information, patient support, sponsorship of research, and advocacy related to oral cancer. Oral cancer is the largest group of those cancers that fall into the head and neck cancer category. Common names for it include such things as mouth cancer, tongue cancer, head and neck cancer, and throat cancer. The Oral Cancer Foundation maintains the web sites: www.oralcancer.org, www.oralcancernews.org, www.donate.oralcancer.org, www.oralcancersupport.org and www.ocfstore.org, which receive millions of hits per month. Supporting the foundation’s goals is a scientific advisory board composed of leading cancer authorities from varied medical and dental specialties, and from prominent educational, treatment, and research institutions in the United States. The foundation also manages the Bruce Paltrow Oral Cancer Fund, a collaboration between the Paltrow family represented by Ms. Blythe Danner (Paltrow), Gwyneth Paltrow, Jake Paltrow and the Oral Cancer Foundation.