FDA grants fast track designation to NBTXR3 in locally advanced head and neck cancers

Source: www.targetedonc.com Author: Nichole Tucker An FDA Fast Track Designation was granted to the first-in-class radioenhancer NBTXR3 with or without cetuximab (Erbitux) for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy, according to a press release from Nanobiotix.1 NBTXR3 showed preliminary signals of antitumor activity in this patient population in a phase I study of 12 patients with advanced-stage head and neck squamous cell carcinoma (HNSCC). Specifically, 10 of the 11 evaluable patients had a complete response (CR) or a partial response to treatment, which included 2 CRs at dose levels ≤10% and 5 CRs at dose levels >10%.2 Treatment with NBTXR3 was also found to be safe and tolerable in patients with HNSCC. There were no serious adverse events or dose-limiting toxicities (DLTs) observed, which allowed patients to continue with their treatment as planned. The adverse events found to be related to injection with NBTXR3 included grade 1/2 injection pain and tumor hemorrhage. Patients in the study received either a single intratumor injection or single-arterial injection of NBTXR3 on day 1 followed by intensity-modulated radiation therapy 2 hours later, which lasted for up to 7 weeks. Radiotherapy was continued in all patients unless their tumor did not shrink by 50% of the baseline size. Those patients who did achieve the tumor shrinkage goals then received salvage tumor surgery. The primary end point of the study was the determination of the recommended dose of the drug and early [...]

2020-02-11T08:31:16-07:00February, 2020|Oral Cancer News|

Standard chemotherapy treatment for HPV-positive throat cancer remains the most effective, study finds

Source: www.eurekalert.org Author: press release, University of Birmingham A new study funded by Cancer Research UK and led by the University of Birmingham has found that the standard chemotherapy used to treat a specific type of throat cancer remains the most effective. The findings of the trial, which aimed to compare for the first time the outcomes of using two different kinds of treatment for patients with Human papillomavirus (HPV)-positive throat cancer, are published today (November 15th) in The Lancet. Throat cancer is one of the fastest rising cancers in Western countries. In the UK, incidence was unchanged between 1970 and 1995, then doubled between 1996 and 2006, and doubled again between 2006 and 2010. The rise has been attributed to HPV, which is often a sexually transmitted infection. Most throat cancers were previously caused by smoking and alcohol and affected 65 to 70 year old working class men. Today, HPV is the main cause of throat cancer and patients are middle class, working, have young children and are aged around 55. HPV-positive throat cancer responds well to a combination of cisplatin chemotherapy and radiotherapy, and patients can survive for 30 to 40 years, but the treatment causes lifelong side effects including dry mouth, difficulty swallowing, and loss of taste. The De-ESCALaTE HPV study, which was sponsored by the University of Warwick, compared the side effects and survival of 164 patients who were treated with radiotherapy and cisplatin, and 162 who were given radiotherapy and cetuximab. The patients were enrolled [...]

2018-11-16T09:36:03-07:00November, 2018|Oral Cancer News|

No De-escalation of Therapy for HPV+ Throat Cancer

Source: www.medscape.com Author: Alexander M. Castellino, PhD Another trial has shown that de-escalating therapy does not work in patients with good prognosis human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma or throat cancers. Results from the De-ESCALaTE HPV study show that using the targeted drug cetuximab with radiotherapy does not improve side effects and, more importantly, has worse survival compared with the standard of care — chemotherapy with cisplatin and radiotherapy. The finding echoes the results from the US National Cancer Institute's Radiation Therapy Oncology Group (RTOG) 1016 trial, the top-line results of which were released earlier this year, and details of which were presented this week at the American Society of Radiation Oncology (ASTRO) 2018 meeting. "Do not change your clinical practice of using cisplatin with radiotherapy in these patients," cautioned Hisham Mehanna, MBChB, PhD, chair of head and neck surgery at the University of Birmingham, United Kingdom, and lead investigator of the De-ESCALaTe study. He presented the results during a presidential session here at the European Society for Medical Oncology (ESMO) 2018 Congress (abstract LBA9). "Cetuximab did not cause less toxicity and resulted in worse overall survival and more cancer recurrence than cisplatin. This was a surprise — we thought it would lead to the same survival rates but better toxicity. Patients with throat cancer who are HPV+ should be given cisplatin, and not cetuximab, where possible," Mehanna said in a statement. Hope for Fewer Side Effects Cetuximab with radiation is already approved by the US Food and Drug [...]

2018-10-28T11:45:33-07:00October, 2018|OCF In The News, Oral Cancer News|

Patients with HPV-positive oropharynx cancer should receive chemoradiation

Source: medicalxpress.com Author: provided by European Society for Medical Oncology Patients with human papilloma virus (HPV)-positive throat cancer should receive chemoradiotherapy rather than cetuximab with radiotherapy, according to late-breaking research reported at the ESMO 2018 Congress in Munich. "Many patients have been receiving cetuximab with radiotherapy on the assumption that it was as effective as chemotherapy with radiotherapy and caused less side effects but there has been no head-to-head comparison of the two treatments," said study author Prof Hisham Mehanna, Chair, Head and Neck Surgery, Institute of Cancer and Genomic Sciences, University of Birmingham, UK. Throat cancer is rapidly becoming more common in Western countries. For example in the UK, incidence was unchanged in 1970 to 1995, then doubled in 1996 to 2006, and doubled again in 2006 to 2010.The rise has been attributed to HPV, a sexually transmitted infection. Most throat cancer was previously caused by smoking and alcohol and affected 65-70 year-old working class men. Today HPV is the main cause and patients are around 55, middle class, working, and have young children. HPV-positive throat cancer responds well to a combination of cisplatin chemotherapy and radiotherapy, and patients can survive for 30-40 years, but the treatment causes lifelong side effects including dry mouth, difficulty swallowing, and loss of taste. Patients deemed unable to tolerate chemotherapy, for example because of poor kidney function or older age, receive cetuximab, an epidermal growth factor receptor (EGFR) inhibitor, and radiotherapy. This study compared side effects and survival with the two treatments in [...]

HMB/Arg/Gln does not reduce oral mucositis incidence in head and neck cancer

Source: www.oncologynurseadvisor.com Author: James Nam, PharmD The addition of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine (HMB/Arg/Gln) to opioid-based pain control (OBPC) and oral care programs does not effectively prevent chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients with head and neck cancer (HNC), according to a study published in Supportive Care in Cancer. Chemoradiotherapy with a cisplatin-based chemotherapy regimen is the standard of care for patients with HNC, but is associated with a high incidence of CRT-induced OM. OBPC and oral care programs are insufficient in reducing OM incidence; there is a need for additional interventions to prevent and treat OM. For this phase 2 study, researchers treated 35 patients with HNC scheduled to receive definitive or postoperative cisplatin-based CRT with oral or percutaneous endoscopic gastrostomy-delivered HMB/Arg/Gln; all patients underwent OBPC and oral care programs. Results showed that 45.7% (16) of patients developed symptomatic or functional grade 3 or worse OM. Grade 1 or less OM occurred in 51.1% of patients at 2 weeks and in 82.9% of patients at 4 weeks postradiotherapy completion. Clinical examination, however, revealed that 28.6% (10) of patients developed grade 3 or worse OM, and the incidence of grade 1 or less OM was 80.0% and 100% at 2 weeks and 4 weeks after completing radiotherapy, respectively. The most frequently reported adverse events included diarrhea and an increase in blood urea nitrogen, but were easily managed with standard care. Evidence from the study demonstrates that HMB/Arg/Gln does not effectively decrease OM incidence; however, the authors concluded that “the [...]

Study Identifies Potential Cause of Hearing Loss from Cisplatin

Author: NCI Staff Date: January 26, 2018 Source: National Cancer Institute (https://www.cancer.gov/news-events) Results from a new study may explain why many patients treated with the chemotherapy drug cisplatin develop lasting hearing loss. Researchers found that, in both mice and humans, cisplatin can be found in the cochlea—the part of the inner ear that enables hearing—months and even years after treatment. By contrast, the drug is eliminated from most organs in the body within days to weeks after being administered. The study, led by researchers from the National Institute on Deafness and other Communication Disorders (NIDCD), part of the National Institutes of Health, was published November 21 in Nature Communications. Cisplatin, a platinum-based chemotherapy drug, is commonly used for the treatment of many cancers, including bladder, ovarian, and testicular cancers. But cisplatin and other similar platinum-containing drugs can damage the cochlea, leaving 40%–80% of adults, and at least 50% of children, with significant permanent hearing loss, a condition that can greatly affect quality of life. “This study starts to explain why patients who receive the drug sustain hearing loss,” said Percy Ivy, M.D., associate chief of NCI’s Investigational Drug Branch, who was not involved in the study. “This is very important, because as we come to understand how cisplatin-related hearing loss occurs, over time we may figure out a way to block it, or at least diminish its effects.” A New Approach to Researching Cisplatin-Induced Hearing Loss The new study differs from previous research because it is a comprehensive look at the pharmacokinetics, or concentration, of the [...]

2018-02-06T14:57:52-07:00January, 2018|Oral Cancer News|

Personalised cancer treatment

Source: medicalxpress.com Author: University of Oslo In Norway, more and more people are being affected by cancer of the mouth and throat. In recent years, the incidence has increased but the mortality has remained the same. Cisplatin is one of the most commonly administered cytostatics for this patient group. At the start of treatment, the drug works well. Gradually, though, most patients experience that the tumour develops resistance against this drug and the prognosis for survival then becomes very poor. In her PhD thesis, Jian Gao wanted to find out how the cancer cells could protect themselves against this cytostatic i.e. what is the underlying mechanism of resistance. She therefore cultured various cancer cell lines derived from oral cavity which were given differing doses of the cytostatic cisplatin. A cancer cell line is cultured from patients' cancerous tumours and can live indefinitely in the laboratory. These types of cell lines are used to examine the biology and the changes that have resulted in the development of cancer. Because the cancer cell lines divide in the laboratory, they can also adapt to new growth conditions, for example by becoming resistant to the cytostatic cisplatin in the same way as the cancer tissue in the patients. "First, I had to find those cancer cells that were sensitive to the cytostatic," explains Jian Gao. By identifying the sensitive cancer cell lines that I could make resistant in the laboratory, I could then study which changes took place in the cells as they changed [...]

2017-09-04T14:06:02-07:00September, 2017|Oral Cancer News|

Beating HPV-positive throat cancer

Source: www.huffingtonpost.com Author: Pamela Tom, Contributor National Oral, Head, and Neck Cancer Awareness Week is April 12-18, 2017 For at least two years, 47 year-old Rob Clinton of Rochester, NY, would choke on post nasal drip in the shower. He knew something was wrong in his throat but he didn’t feel any pain. Did he have cancer? Clinton smoked cigarettes for 30 years and worked in an auto body shop where he was regularly exposed to carcinogens, but he wasn’t experiencing the typical symptoms of throat cancer. These include hoarseness or a change in the voice, difficulty swallowing, a persistent sore throat, ear pain, a lump in the neck, cough, breathing problems, and unexplained weight loss. In November 2015, Clinton went to the dentist to have his teeth cleaned. His dentist felt Clinton’s swollen neck and recommended that he visit a medical doctor. Clinton heeded the advice and sought the opinion of an ear, nose, and throat specialist at Strong Memorial Hospital in Rochester, NY. The ENT doctor sent Clinton to have a CAT scan and when he scoped Clinton’s throat, the doctor said, “I see something in there.” What he saw was a tumor and there were a few other things going on too. The Diagnosis The biopsy showed that Clinton had Stage IVa oral squamous cell carcinoma (OSCC) at the base of his tongue—and the cancer was HPV positive. HPV stands for the human papillomavirus and a recent survey found that more than 42% of Americans are infected [...]

Type 2 diabetes drug could be beneficial for head and neck cancer patients

Source: www.eurekalert.org Author: press release Researchers at the University of Cincinnati (UC) College of Medicine have found that adding increasing doses of an approved Type 2 diabetes drug, metformin, to a chemotherapy and radiation treatment regimen in head and neck cancer patients is not well tolerated if escalated too quickly, but allowing slower escalation could be beneficial. These findings are being presented via poster June 4 at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting: Collective Wisdom, being held June 3-7 in Chicago. Trisha Wise-Draper, MD, PhD, assistant professor in the Division of Hematology Oncology at the UC College of Medicine, a member of both the Cincinnati Cancer Center and UC Cancer Institute and principal investigator on this study, says retrospective studies have shown improved outcomes in tumors treated with chemotherapy and radiation if they were also on metformin for diabetes. "In head and neck squamous cell carcinoma, which develops in the mucous membranes of the mouth, nose and throat, diabetic patients taking a medication called metformin had better overall survival compared to those not on metformin when also treated with chemotherapy and radiation," she says. "Additionally, pancreatic cancer patients treated with chemotherapy and metformin required higher doses of metformin--1,000 milligrams twice a day--to experience positive results. "In basic science studies, metformin has been shown to stop mTOR, a molecular pathway present and active in this type of head and neck cancer, and pretreatment with metformin resulted in a decrease in the occurrence of oral cavity tumors in [...]

Cetuximab plus RT linked with high toxicity in head and neck cancer

Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD The combination of radiation therapy plus the EGFR inhibitor cetuximab had higher rates of acute toxicity among patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with radiation therapy plus the chemotherapy cisplatin, according to results of a phase II trial based in Italy. Efficacy was similar with both combination therapies. According to Stefano Maria Magrini, MD, professor of radiotherapy at the Università degli Studi di Brescia in Italy, and colleagues, this is the first clinical trial to directly compare radiation therapy plus cetuximab to a chemoradiation regimen for SCCHN. The results of the randomized trial are published in the Journal of Clinical Oncology. Cetuximab was approved in combination with radiation therapy by the US Food and Drug Administration in 2006 for the treatment of unresectable SCCHN. Despite a goal of recruiting 130 patients, only 70 patients were recruited between 2011 and 2014. The 1- and 2-year overall survival rates were 75% and 68% in the cetuximab arm compared with 78% in the cisplatin arm. The 1- and 2-year local control rates were 64% and 53% in the cetuximab arm and 84% and 80% in the cisplatin arm, yet the differences between arms were not statistically significant (P = .073), reflecting the inadequate statistical power of the relatively small trial. Compliance in both treatment arms was relatively low. Only 28% of patients in the cetuximab arm and 20% of patients in the cisplatin arm received at least 7 cycles [...]

2015-12-13T09:06:40-07:00December, 2015|Oral Cancer News|
Go to Top