Improved quality of life for head and neck cancer patients with Nivolumab

Source: www.oncnursingnews.com Author: Jason Harris Patients with head and neck squamous cell carcinoma (HNSCC) saw improved or stable quality of life (QOL) scores following treatment with single-agent nivolumab (Opdivo), according to results published in Lancet Oncology.1 In contrast, patients assigned to investigator’s choice of treatment saw clinical meaningful declines, defined as a decrease in ≥10% from baseline, across 8 of 15 (53%) domains on the EORTC QLQ-C30 questionnaire. “The results of CheckMate-141 suggest that nivolumab is the first PD-1 inhibitor, to our knowledge, to show a significant improvement in overall survival, with better tolerability and a quality-of-life benefit, compared with standard therapy for platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck,” investigators wrote. “In view of the major unmet need in this population and the importance of maintaining or improving quality of life for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, these data support nivolumab as a new standard of care option in this setting.” Investigators evaluated statistical differences in patient-reported adjusted mean changes from baseline between treatment groups as assessed by the EORTC QLQ-C30, EORTC QLQ-H&N35, and EQ-5D-3L at each time point, and the time to clinically meaningful deterioration per each individual scale’s criteria. Patient assessments were conducted before treatment initiation, at week 9, and then every 6 weeks during the treatment period using the EORTC QLQ-C30, EORTC QLQ-H&N35, and EQ-5D-3L questionnaires. Posttreatment assessments were made at follow-up visits 1 and 2 (35 days give or take 7 days [...]

European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy

Source: pipelinereview.com Author: Bristol-Myers Squibb Bristol-Myers Squibb Company today announced that the European Commission (EC) has approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology (I-O) treatment that demonstrated in a Phase 3 trial a significant improvement in overall survival (OS) for these patients. “Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,” said Kevin Harrington, M.D., Ph.D., professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival." The approval was based on results from CheckMate -141, a global Phase 3, open-label, randomized trial, first published in The New England Journal of Medicine last October, which evaluated Opdivo versus investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary or metastatic setting. Investigator’s choice of therapy included methotrexate, docetaxel, or [...]

Second-line afatinib shows promise

Source: www.nature.com Author: David Killock Patients with recurrent and/or metastatic head and neck squamous-cell carcinoma and disease progression after first-line platinum-based chemotherapy have a dismal prognosis. There is no standard second-line therapy; however, afatinib, an irreversible inhibitor of HER family kinases, has shown efficacy in this setting. The LUX-Head & Neck 1 phase III trial randomly assigned patients to afatinib (n = 322) or methotrexate (n = 161) therapy. Median progression-free survival (PFS) was 2.6 months with afatinib versus 1.7 months (P = 0.03). “The study was also powered to detect a difference in overall survival, which was not significantly improved,” explains lead author Jean-Pascal Machiels, “however, patient-reported outcomes were better with afatinib.” Afatinib was associated with delayed deterioration of global health status, less pain, and improved swallowing, potentially related to the prolonged PFS, compared with methotrexate. Furthermore, afatinib toxicity was manageable and deemed favourable to that of methotrexate. The patients were unselected for disease subtype, ~60% had received prior anti-EGFR antibody therapy, and 51% received further lines of treatment, possibly diluting the treatment effect of afatinib acheter levitra en ligne. Notably, patients with human papilloma virus (p16)-negative non-oropharyngeal cancer and local recurrence (rather than metastasis), who had not previously received an anti-EGFR antibody seemed to derive the most benefit in preplanned subgroup analyses. Machiels concludes, “Afatinib has some activity in head and neck cancer, but we need to better understand which patients will benefit from this therapy.” References Machiels, J.-P. H. et al. Afatinib versus methotrexate as second-line treatment [...]

New drug combination could prevent head and neck cancer in high-risk patients

Source: www.sciencedaily.com Author: staff A new drug combination shows promise in reducing the risk for patients with advanced oral precancerous lesions to develop squamous cell carcinoma of the head and neck. The results of the study, which included preclinical and clinical analyses, were published in Clinical Cancer Research, a journal of the American Association for Cancer Research. "Squamous cell carcinoma of the head and neck (SCCHN) is the most common type of head and neck cancer," said Dong Moon Shin, M.D., professor of hematology, medical oncology and otolaryngology at Emory University School of Medicine, and director of the Cancer Chemoprevention Program at Winship Cancer Institute at Emory University in Atlanta, Ga. "The survival rate for patients with SCCHN is very poor. An effective prevention approach is desperately needed, especially since we can identify patients who are at extremely high risk: those with advanced oral precancerous lesions." Based on prior research suggesting a role for epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) in promoting SCCHN, Shin and colleagues believed combining an EGFR inhibitor and a COX-2 inhibitor could provide an effective chemopreventive approach. They found that the combination of the EGFR inhibitor erlotinib and the COX-2 inhibitor celecoxib was more effective for inhibiting the growth of human SCCHN cell lines compared with either drug alone. In addition, treating mice with the drug combination prior to transplanting them with human SCCHN cells more effectively suppressed cancer cell growth than did pretreating the mice with either drug alone. Based on these preclinical [...]

2013-02-20T07:38:26-07:00February, 2013|Oral Cancer News|

Erlotinib dose doubled for smokers with head/neck cancer

Source: www.oncologyreport.com Author: Miriam E. Tucker Giving smokers a higher, short-course dose of erlotinib before definitive surgery for squamous cell carcinoma of the head and neck resulted in favorable responses for the first patients evaluated in a small pilot study. Investigators gave 300 mg of erlotinib (Tarceva) to smokers daily and 150 mg daily to nonsmokers who had a waiting period of more than 14 days before scheduled surgery for head and neck cancer. Seven of the 10 patients evaluated so far had partial responses and 3 had stable disease, according to a poster presented at a head and neck cancer symposium sponsored by the American Society for Radiation Oncology. The study was based on recent data in non–small cell lung cancer (NSCLC) patients showing that smokers metabolize erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, twice as quickly as do nonsmokers (J. Clin. Oncol. 2009;27:1220-6), said lead author Dr. Mercedes Porosnicu of Wake Forest Baptist Medical Center in Winston Salem, N.C. That study established the maximum tolerated dose of erlotinib at 300 mg daily in NSCLC patients who smoke. Dr. Poroniscu’s presentation included the case study of a smoker with a very large oral cavity tumor protruding through his lips. He was described as being in significant pain and unable to eat or chew. The first CT scan showed a tumor of at least 8 cm and there was "significant metabolic activity" on PET scan. "At 6 days of erlotinib treatment, his tumor was obviously smaller and he could [...]

Piramal Life Sciences begins Phase II trial of P276 for head and neck cancer

Source: www.equitybulls.com Author: press release Piramal Life Sciences Ltd has announced that a Phase II study for its lead cancer molecule P276 for the treatment of head and neck cancer has been initiated in India. This Phase II study will evaluate the efficacy of P276 in the treatment of head and neck cancer and will enroll approximately 40 patients in about five centres across India. Approximately 200,000 new cases of head and neck cancer in India and 600,000 cases worldwide have been projected for 2008. P276 is an inhibitor of CDKs, the key enzymes involved in the uncontrolled division and multiplication of cancer cells. The molecule has completed two Phase I studies and is being tested in another Phase I/Il trial for Multiple Myeloma in India. Another trial for Multiple Myeloma will start in the US in the near future. Dr. Swati Piramal, Director, Piramal Group, said, "Piramal Life Sciences aims to reduce the burden of disease by finding new and affordable cures for unmet medical needs. Committed to the Group's values - knowledge, action and care, we nurture breakthrough thinking and follow it up with dynamic, nimble-footed delivery to impact lives of millions of people. We are pleased that our clinical trial application for Phase II of P276 has been accepted by the Indian regulatory authorities." Dr. Somesh Sharma, Managing Director, Piramal Life Sciences, stated, "The unique property of the P276 is that it is a small molecule while current targeted therapy for head and neck cancer is a [...]

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