chemoradiotherapy – Page 3 – Oral Cancer News

Palifermin decreases severe oral mucositis after radiotherapy

Source: www.drbicuspid.com Author: Will Boggs, MD Palifermin (Kepivance) helps reduce the rate, severity, and duration of severe oral mucositis in head and neck cancer patients receiving chemoradiotherapy, two new studies show. "Combined data from both studies consistently indicated that palifermin has activities against radiochemotherapy-induced mucositis," said Dr. Quynh-Thu Le, who led one of the studies, in email to Reuters Health. "However, the lack of improvement in some of the secondary end points suggests that the doses and schedules tested were inadequate to overcome the severe mucositis brought on by concurrent radiochemotherapy." The recombinant keratinocyte growth factor palifermin is FDA-approved to treat severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. But Dr. Le said that unlike the mucositis related to chemotherapy for bone marrow transplant, mucositis from chemoradiotherapy is more severe and persistent and "may require more drug administered at a higher frequency." Dr. Le, from Stanford University, California, and colleagues tested palifermin, 180 mcg/kg IV once weekly, in 188 patients with locally advanced head and neck cancer receiving definitive chemoradiotherapy. The incidence of severe oral mucositis (grade 3 or 4) was significantly lower with palifermin versus placebo (54% versus 69%; p = 0.041). In addition, the median duration of severe oral mucositis was shorter in the palifermin group (5 versus 26 days), according to a report published online June 13 in the Journal of Clinical Oncology. But mouth and throat soreness (MTS) scores averaged only slightly lower in the palifermin arm, and [...]

Oral Cancer Foundation News Team - A2011-06-14T10:16:17-07:00June, 2011|Oral Cancer News|

Larynx preservation studies should consider treatment impact

Source: www.internalmedicinenews.com Author: Sara Freeman, Internal Medicine News Digital Network Almost one-quarter of patients who had been given induction chemotherapy before radiotherapy for head and neck cancer experienced long-term swallowing difficulties, with another 15% experiencing voice disabilities that correlated with the mobility of the vocal cords. Long-term data from the GORTEC (Groupe Oncologie Radiothérapie Tête et Cou) 2000-01 larynx preservation trial also show that approximately two-thirds of long-term head and neck cancer survivors experienced severe problems with sticky saliva and dry mouth, which were in turn linked to nutritional problems. These findings, reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference, further confirm that studies looking at the effects of chemoradiotherapy on the larynx in head and neck cancer need to consider prospective assessment of laryngeal function, rather than just looking at anatomical preservation, according to a French radiation oncologist. Dr. Gilles Calais of the Centre Hôpitalier Régional et Universitaire de Tours (France) presented data from a prospective analysis of 61 patients who had participated in the original 213-patient GORTEC 2000-01 trial. He also presented updated results from the trial using a recently developed composite end point. "Larynx preservation can be achieved for most of our [head and neck] patients by using three different strategies: induction chemotherapy, concomitant [chemoradiotherapy], or alternating chemoradiotherapy," Dr. Calais observed. Indeed, larynx preservation is a possibility in approximately 80% of patients, he said. However, anatomical preservation does not mean that laryngeal function is maintained, especially with respect to the ability [...]

Oral Cancer Foundation News Team - A2011-05-21T14:31:34-07:00May, 2011|Oral Cancer News|

CEL-SCI gets Israeli nod to commence phase III trial of multikine in head and neck cancer

Source: www.pharmabiz.com Author: staff CEL-SCI Corporation announced that the State of Israel's Ministry of Health has given approval to begin enrolment of subjects for a phase III clinical trial of Multikine in Israel. Israel is one of nine countries to participate in this global phase III trial. The phase III trial will be conducted in approximately 48 clinical centres. CEL-SCI's partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centers in Israel. The phase III trial started in the United States in late December 2010 and is expected to commence in other countries around the world within the next 30-60 days. Multikine is the company's flagship immuno-therapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI's phase III clinical trial is an open-label, randomized, controlled, multi-centre study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only. CEL-SCI's 880 patient phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the [...]

Oral Cancer Foundation News Team - A2011-04-03T09:45:51-07:00April, 2011|Oral Cancer News|

Head and neck cancer guidelines ‘streamlined’

Source: www.medscape.com Author: Fran Lowry Modest changes in the 2011 National Comprehensive Cancer Network (NCCN) Head and Neck Cancers Guidelines will refine and improve the treatment of these complex, challenging, and relatively rare cancers, according to the panel chief reporting here at the NCCN 16th Annual Conference. One of the main changes is a new "suggestion" that the workup for cancer of the oropharynx include testing of the tumor for human papillomavirus (HPV). "Immunohistochemical testing for HPV p16 is recommended," said David G. Pfister, MD, from Memorial Sloan-Kettering Cancer Center in New York City, and chair of the NCCN Head and Neck Cancers Guidelines Committee. "Although not used to guide treatment, HPV testing is valuable prognostically. The results should not change management decisions," he emphasized. HPV-related oropharyngeal cancer appears to be a new and distinct disease entity, and is associated with better survival than non-HPV head and neck cancers, Dr. Pfister noted. HPV Has a Clear Impact on Prognosis "Our understanding of the human papillomavirus as a risk factor for head and neck cancer has evolved. Now we see that it has a clear impact on prognosis," Dr. Pfister said in an interview with Medscape Medical News. Because of their improved prognosis, these patients might require different treatment, he said. "There is a great interest in better understanding HPV-related cancers and how we treat the disease down the road. Right now we have insufficient data to change how we treat these patients, but clinical trials are being designed to assess the optimal treatment [...]

Oral Cancer Foundation News Team - A2011-03-18T12:17:56-07:00March, 2011|Oral Cancer News|

Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial

Source: annonc.oxfordjournals.org Authors: M. R. Posner et al. Background: The association between human papillomavirus (HPV) and overall survival (OS) in oropharynx cancer (OPC) was retrospectively examined in TAX 324, a phase III trial of sequential therapy for locally advanced head and neck cancer. Methods: Accrual for TAX 324 was completed in 2003 and data updated through 2008. Pretherapy tumor biopsies were studied by PCR for human papillomavirus type 16 and linked to OS, progression-free survival (PFS) and demographics. Results: Of 264 patients with OPC, 111 (42%) had evaluable biopsies; 56 (50%) were HPV+ and 55 (50%) were HPV−. HPV+ patients were significantly younger (54 versus 58 years, P = 0.02), had T1/T2 primary cancers (49% versus 20%, P = 0.001), and had a performance status of zero (77% versus 49%, P = 0.003). OS and PFS were better for HPV+ patients (OS, hazard ratio = 0.20, P

Oral Cancer Foundation News Team - A2011-02-12T15:06:18-07:00February, 2011|Oral Cancer News|

Good speaking, swallowing after chemoradiotherapy for head/neck cancer

Source: www.medscape.com Author: Fran Lowry Most patients with locoregionally advanced head and neck cancer who were successfully treated with intensive chemoradiotherapy had no residual deficits in speaking or swallowing after their treatment, according to the results of a study done by University of Chicago researchers. The study appears in the December issue of the Archives of Otolaryngology–Head & Neck Surgery. Of 163 patients with head and neck cancer who were assigned a speaking score an average of 35 months after completing treatment, 84.7% were found to have no lasting difficulties and were given a score of 1 on a scale of 1 to 4, with 1 being the best and 4 being the worst function. In addition, among 166 patients who were assigned a swallowing score an average of 35 months after treatment, 63.3% were found to have no lasting difficulties swallowing and were given a score of 1. "We weren't surprised by our findings," senior author Joseph K. Salama, MD, told Medscape Medical News. "However, it was nice to quantify formally our clinical impressions—that most patients in the long run do well." Dr. Salama was with the University of Chicago, Illinois, at the time the study was conducted and is now at Duke University Medical Center in Durham, North Carolina. Expert Disagrees However, Robert L. Ferris, MD, PhD, professor and vice chair of the Department of Otolaryngology at the University of Pittsburgh Medical Center in Pennsylvania, disagreed with the view that so many patients with head and neck cancer [...]

Oral Cancer Foundation News Team - A2010-12-27T21:20:46-07:00December, 2010|Oral Cancer News|

Organ preservation for advanced resectable cancer of the base of tongue and hypopharynx: a Southwest Oncology Group trial

Source: J Clin Oncol 23:88-95 Author: Susan G. Urba et al. Purpose: The Southwest Oncology Group designed a phase II trial for patients with base of tongue or hypopharyngeal cancer to evaluate the complete histologic response rate at the primary site after induction chemotherapy followed by chemoradiotherapy for responders. Secondary end points were the rate of organ preservation and the need for salvage surgery. Patients and Methods: Fifty-nine eligible patients were enrolled; 37 had base of tongue cancer, and 22 had hypopharynx cancer. Forty-two percent had stage III disease, and 58% had stage IV disease. Induction chemotherapy was two cycles of cisplatin 100 mg/m2 and fluorouracil 1,000 mg/m2/d for 5 days. Patients who had a greater than 50% response at the primary site were treated with radiation 72Gy and concurrent cisplatin 100 mg/m2 for three cycles. Patients with less than partial response at the primary had immediate salvage surgery. Results: Forty-five patients (76%) had a greater than 50% response at the primary after induction chemotherapy; 43 went on to receive definitive chemoradiotherapy. Thirty-two patients (54%) achieved a histologic complete response at the primary site, and an additional nine patients had a complete clinical response, but biopsy was not done. Seventy-five percent of patients did not require surgery at the primary tumor site. The 3-year overall survival was 64%. The 3-year progression-free survival with organ preservation was 52%. Conclusion: Patients with base of tongue or hypopharyngeal cancer treated with this regimen of induction chemotherapy followed by definitive chemoradiotherapy have a good [...]

Oral Cancer Foundation News Team - A2010-09-07T07:46:33-07:00September, 2010|Oral Cancer News|

SciClone announces topline results from Phase 2 clinical trial of SCV-07 for prevention of oral mucositis

Source: CNNMoney.com Author: press release SciClone Pharmaceuticals, Inc. today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies. Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM (WHO scale, grades 2 to 4), an expanded measure of OM. In this analysis, the low dose treatment arm appeared similar or slightly better than placebo. "We are encouraged that the trial provides an indication of a biological signal, in the high dose arm, for the pre-specified primary endpoint of the study," said Stephen T. Sonis, DMD, DMSc, Senior Physician, Brigham and Women's [...]

Oral Cancer Foundation News Team - A2010-04-01T19:51:55-07:00April, 2010|Oral Cancer News|

Induction chemotherapy before concomitant chemoradiotherapy improves outcomes of patients with locally advanced head and neck cancer

Source: CancerConsultants Author: Staff Researchers from Italy have reported that induction (neoadjuvant) chemotherapy prior to concomitant chemoradiotherapy improves outcomes of patients with locally advanced head and neck cancer. The details of this Phase II randomized trial were published early online in the Annals of Oncology on December 23, 2009.[1] There have been several randomized and non-randomized clinical trials suggesting that the concomitant administration of platinum-based chemotherapy and radiotherapy is superior to radiotherapy alone for the treatment of patients with advanced head and neck cancer for local and regional control. Most trials, but not all, have also shown a survival advantage for combined treatment. Two randomized trials in the May 7, 2004 issue of the New England Journal of Medicine documented the effects of adding platinum-based chemotherapy to post-operative radiotherapy for the treatment of patients with advanced head and neck cancers. A recent large randomized trial performed by the UK Head and Neck (UKHAN1) trial reported that concurrent chemoradiotherapy reduces recurrences and death in patients with advanced head and neck cancer. However, researchers are still attempting to determine the optimal way to administer radiotherapy and chemotherapy to improve outcomes of patients with advanced head and neck cancer. Previous Phase II non-randomized studies have suggested benefit from neoadjuvant induction chemotherapy prior to the administration of definitive concomitant chemoradiotherapy for treatment of patients with locally advanced head and neck cancer. The current study involved 101 patients with locally advanced head and neck cancer who were randomly allocated to treatment with concomitant chemoradiotherapy alone or to [...]

Charlotte Parker2010-03-05T07:37:01-07:00February, 2010|Oral Cancer News|

Neck response to chemoradiotherapy

Source: Arch Otolaryngol Head Neck Surg. 2009;135(11):1133-1136 Author: Alexander Langerman, MD et al. Complete Radiographic Response Correlates With Pathologic Complete Response in Locoregionally Advanced Head and Neck Cancer Objective: The role of neck dissection following chemoradiotherapy (CRT) for locoregionally advanced head and neck cancer is an area of active debate. Patients who have a complete radiographic response may not need dissection, and the extent of neck dissection necessary for those patients with residual disease is unclear. Design: Retrospective review of data from a prospectively collected database of patients with locoregionally advanced head and neck cancer treated as part of a phase 2 study of induction chemotherapy followed by concurrent CRT. The results of post-CRT neck computed tomography (CT) imaging and pathologic analysis of the neck dissection specimens were compared to evaluate correlation between radiographic and pathologic response. Results: Forty-nine patients underwent 61 hemineck dissections. Overall, 209 neck levels were dissected. Radiologic complete response in the neck was achieved in 39 patients, all of whom had pathologic specimens negative for tumor cells. Ten patients (20%) had a total of 14 neck levels with residual disease on CT imaging. Five (50%) of these 10 patients were found to have residual tumor cells on pathologic analysis. Tumor cells were contained only to those levels found positive on CT imaging; they were present in 7 (50%) of the 14 positive levels. Conclusions: Neck levels with residual disease on post-CRT CT imaging warrant removal. However, neck levels without evidence of disease on post-CRT CT imaging [...]

Oral Cancer Foundation News Team - A2009-11-17T19:34:20-07:00November, 2009|Oral Cancer News|