Chemotherapy and radiation therapy issues: What audiologists need to know

Source: journals.lww.com Author: A. Croutch, Carl AuD With hearing loss, tinnitus, and imbalance as among the numerous side-effects of cancer treatment,1 audiologists play a critical role in monitoring patients receiving chemotherapy and radiation therapy. Sensorineural hearing loss (SNHL) attributed to chemotherapy and radiation therapy is usually permanent, making audiometric monitoring essential to detect its early occurrence.2 Cisplatin, carboplatin & radiation therapy Chemotherapy is used to treat cancer, control the growth and spread of cancer cells, and ease cancer symptoms. Cisplatin and carboplatin are two common antineoplastic agents used to treat testicular, ovarian, breast, esophageal, lung, and head and neck cancers among others. Besides hearing loss, these can cause other side effects including kidney, gastrointestinal disorders, allergic reactions, decreased immunity to infections, and hemorrhaging. Cisplatin was first found to have cytotoxic properties in the 1960s, and in 1978 was the first platinum compound approved by the FDA for cancer treatment.3 On the other hand, carboplatin is less potent than cisplatin and does have fewer side effects, especially on kidney problems.3 Both drugs work by interfering with DNA repair mechanisms causing DNA damage and inducing apoptosis in cancer cells. Cancerous cells cannot limit cell division as do normal cells. Normal cells cease dividing when they encounter similar cells whereas cancerous cells do not. The effectiveness of chemotherapy is determined by its ability to damage the RNA or DNA that gives the cell instructions to copy itself. The cells will die if they are unable to divide. The more quickly they are dividing, [...]

2021-09-09T06:48:49-07:00September, 2021|Oral Cancer News|

Positive data announced for Reolysin in head and neck cancers

Source: www.empr.com Author: staff Oncolytics Biotech announced positive top line data in its double-blinded randomized Phase 3 clinical study examining Reolysin in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers. Reolysin is a proprietary formulation of the human reovirus. A first analysis compared the relative percentages of patients in the test and control arms with tumors that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumor stabilization was restricted to 0% growth only. Of the 105 total patients with evaluable metastatic tumors, 86% (n=50) of those in the test arm of the study exhibited tumor stabilization or shrinkage, compared with 67% of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025. A second analysis examined the magnitude of tumor response on a per patient basis using a comparison of percentage tumor shrinkage at six weeks in each patient with evaluable metastatic tumors. This analysis showed that Reolysin in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumors, yielding a p-value of 0.03

2012-12-23T08:28:26-07:00December, 2012|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 [...]

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

Oncolytics’ Phase III borrows adaptive design in SPA trial

Source: www.bioworld.com Author: Catherine Hollingsworth Oncolytics Biotech Inc. reached agreement with the FDA on the design of a Phase III trial of Reolysin in head and neck cancer, marking the first such agreement for an intravenously administered oncolytic virus. The Phase III trial will be conducted in two stages and will cost an estimated $15 million, Matt Coffey, Oncolytics' chief operating officer, told BioWorld Today. The Calgary, Alberta-based company has the cash to get through the first half of the study on its own, but it hopes to secure a partner to take Reolysin the rest of the way, he said. The trial uses an adaptive design in which "the endpoint is not fixed going in," CEO Brad Thompson said during a conference call. He said it was "a major advantage" getting the FDA to sign off on the study design up front under a special protocol assessment. Thompson said that the adaptive design already is in use in the area of infectious disease, and he said he believes that there will be "a big push" by the FDA for more adaptive trials to be conducted in oncology. The trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone. The drug likely will be studied in about 275 patients whose cancer has progressed while on or after prior platinum-based chemotherapy. The first stage of the trial is nonadaptive and is designed to enroll 80 patients. The second stage is adaptive, and [...]

Oncolytics Biotech(R) Inc. collaborators present positive head and neck results in phase I/II combination

Source: pr-canada.net Author: press release Oncolytics Biotech Inc. announced that interim clinical results from its Phase I/II U.K. trial of Reolysin(R) combined with paclitaxel/carboplatin for patients with advanced cancers were presented at the Fifth International Meeting on Replicating Oncolytic Virus Therapeutics. The meeting is being held in Banff, Alberta from March 18th to 22nd, 2009. The principal investigator for the trial is Dr. Kevin Harrington of The Institute of Cancer Research. To date, fifteen head and neck cancer patients have been treated in the Phase I/II trial. All but one patient had prior platinum treatment. Of 12 patients evaluable for clinical response, five have experienced Partial Response (PR) and four have experienced Stable Disease (SD) ranging from two to six months. For patients who have been followed for at least six months since their initial treatment, the median progression-free survival (PFS) is currently six months, while the overall survival is currently seven months. The literature suggests that platinum refractory patients typically have a PFS of approximately two months and a median survival ranging from 4.5 to 6.5 months. The overall survival figure may evolve as many of the patients are still alive. "In patients previously treated with platinum agents, where the response rate (PR and Complete Response (CR)) is generally in the 3-10% range, a response rate of 42% and a 75% clinical benefit rate (SD, PR, and CR) are dramatic," said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics. The Phase I/II trial has two components. The first is [...]

New platinum-phosphate compounds kill ovarian vancer cells, other cancer cells

Source: www.sciencedaily.com Author: staff A new class of compounds called phosphaplatins can effectively kill ovarian, testicular, head and neck cancer cells with potentially less toxicity than conventional drugs, according to a new study published in the journal Proceedings of the National Academy of Sciences. The compounds could be less harmful than current cancer treatments on the market such as cisplatin and carboplatin because they don’t penetrate the cell nucleus and attach to DNA, said lead author Rathindra Bose. Conventional drugs can interfere with the functions of the cell’s enzymes, which lead to side effects such as hearing and hair loss and kidney dysfunction. Though scientists don’t fully understand the mechanism by which the phosphaplatins kill cancer cells, they suspect that the compounds bind to the cell surface membrane proteins and transmit a “death signal” to the interior of the cell, Bose said. The compounds are created by attaching platinum to a phosphate ligand, which can readily anchor to the cell membrane. Future studies will focus on identifying the exact process. “The findings suggest a paradigm shift in potential molecular targets for platinum anticancer drugs and in their strategic development,” said Bose, a professor of biomedical sciences and chemistry and vice president for research at Ohio University who conducted the work while at Northern Illinois University. The first drug developed for the treatment of ovarian and testicular cancers, cisplatin, was approved for use in 1982. Though it’s 95 percent effective, it works best during the early stages of the disease, and [...]

2008-11-22T08:00:49-07:00November, 2008|Oral Cancer News|

Virus accomplice helps drugs fight cancer

Source: www.newscientist.com Author: Andy Coghlan A virus that harmlessly infects most people at some time in their lives appears to help anti-cancer drugs destroy tumours, or at least keep them in check. Known as a reovirus, it destroys tumour cells because they lack the cellular machinery that keeps the virus in check in healthy cells. Results released last week from two studies in which patients with head and neck cancer were injected with the virus alongside anti-cancer drugs reveal that cancers either stopped growing or shrank in almost all recipients. Furthermore, the patients had cancers that had become resistant to all existing therapies. "Some patients had very aggressive tumour shrinkage of as much as 95%," says Brad Thompson, CEO of Canadian company Oncolytics Biotech, which has been developing the virus as a product called Reolysin. In one trial, led by Kevin Harrington at the Royal Marsden Hospital in London, 8 out of 9 patients responded positively after the virus plus two standard anti-cancer drugs, paclitaxel and carboplatin, had been infused into their bloodstream. In four, tumours stopped growing, and in another four, tumours shrank dramatically. In the other trial, also near London at the Royal Surrey Hospital, 9 out of 11 patients responded well after receiving the virus plus the anti-cancer drug docetaxel. Genetic flaw Taken together, the results suggest the virus does help in some way. "Usually, only 10% of patients respond when the cancer comes back and they're having their second course of treatment," says Thompson. The virus [...]

2008-11-07T14:05:54-07:00November, 2008|Oral Cancer News|

Oncolytics reports positive results from phase I/II cancer studies

Source: www.pharmaceutical-business-review.com Author: staff Oncolytics Biotech has announced positive interim results in its Phase I and Phase II UK combination Reolysin and paclitaxel/carboplatin clinical trials for patients with advanced cancers. Four of the responding patients continue on study, while a fifth patient is too early to evaluate for response, the company said. These results appear to confirm preclinical evidence of synergy for Reolysin and platinum/taxane combinations. A US Phase II trial has now been opened in this patient population utilizing this regimen. The Phase I trial has two components. The first is an open-label, dose- escalating, non-randomized study of Reolysin given intravenously to patients with paclitaxel and carboplatin every three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are delivered to patients with escalating dosages of Reolysin intravenously. The second component of the trial includes the enrollment of a further nine patients at the top dose of Reolysin in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors such as melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The Phase II trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative [...]

2008-11-04T13:40:52-07:00November, 2008|Oral Cancer News|

Oncolytics Biotech Inc. starts patient enrolment in U.S. phase 2 clinical trial investigating Reolysin(R) in combination with paclitaxel and carboplatin

Source: www.marketwatch.com Author: press release Oncolytics Biotech Inc. announced today that that it has started patient enrollment in a Phase 2 clinical trial using intravenous administration of Reolysin(R) in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The Principal Investigator is Dr. Monica Mita of the Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio. "We are extremely pleased to open the second disease-directed study with Reolysin(R)," said Dr. Mita. "This study represents a promising option for patients with head and neck tumors refractory to standard chemotherapy and we are happy to have the opportunity to offer this option to our patients." This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin(R) given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of Reolysin(R) when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers. About Oncolytics Biotech Inc. Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of Phase [...]

2008-09-12T12:44:22-07:00September, 2008|Oral Cancer News|

Platinum-based chemotherapy plus cetuximab in head and neck cancer

Source: New England Journal of Medicine, Volume 359:1116-1127, September 11, 2008, Number 11 Authors: Jan B. Vermorken, M.D., Ph.D. et al. Background: Cetuximab is effective in platinum-resistant recurrent or metastatic squamous-cell carcinoma of the head and neck. We investigated the efficacy of cetuximab plus platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck. Methods: We randomly assigned 220 of 442 eligible patients with untreated recurrent or metastatic squamous-cell carcinoma of the head and neck to receive cisplatin (at a dose of 100 mg per square meter of body-surface area on day 1) or carboplatin (at an area under the curve of 5 mg per milliliter per minute, as a 1-hour intravenous infusion on day 1) plus fluorouracil (at a dose of 1000 mg per square meter per day for 4 days) every 3 weeks for a maximum of 6 cycles and 222 patients to receive the same chemotherapy plus cetuximab (at a dose of 400 mg per square meter initially, as a 2-hour intravenous infusion, then 250 mg per square meter, as a 1-hour intravenous infusion per week) for a maximum of 6 cycles. Patients with stable disease who received chemotherapy plus cetuximab continued to receive cetuximab until disease progression or unacceptable toxic effects, whichever occurred first. Results: Adding cetuximab to platinum-based chemotherapy with fluorouracil (platinum–fluorouracil) significantly prolonged the median overall survival from 7.4 months in the chemotherapy-alone group to 10.1 months in the group that received chemotherapy plus cetuximab (hazard [...]

2008-09-11T08:55:37-07:00September, 2008|Oral Cancer News|
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