ResearchPad - head-and-neck-cancer https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Early institutional head and neck oncologic and microvascular surgery practice patterns across the United States during the SARS‐CoV‐2 (COVID19) pandemic]]> https://www.researchpad.co/article/elastic_article_16684 The SARS‐CoV‐2 (COVID‐19) pandemic has caused rapid changes in head and neck cancer (HNC) care. “Real‐time” methods to monitor practice patterns can optimize provider safety and patient care.MethodsHead and neck surgeons from 14 institutions in the United States regularly contributed their practice patterns to a shared spreadsheet. Data from 27 March 2020 to 5 April 2020 was analyzed.ResultsAll institutions had significantly restricted HNC clinic evaluations. Two institutions stopped free‐flap surgery with the remaining scheduling surgery by committee review. Factors contributing to reduced clinical volume included lack of personal protective equipment (PPE) (35%) and lack of rapid COVID‐19 testing (86%).ConclusionsThe COVID‐19 pandemic has caused a reduction in HNC care. Rapid COVID‐19 testing and correlation with infectious potential remain paramount to resuming the care of patients with head and neck cancer. Cloud‐based platforms to share practice patterns will be essential as the pandemic evolves. ]]> <![CDATA[Should we wait or not? The preferable option for patients with stage IV oral cancer in COVID‐19 pandemic]]> https://www.researchpad.co/article/elastic_article_16669 The coronavirus infection is rapidly spreading, putting a strain on health care services across the globe. Patients with oral cancer are susceptible often immunosuppressed due to the disease and/or the treatment received.MethodsWe performed a simulation of the currently available data using a multistate and hazards model to provide an objective model for counseling and decision making for health care workers.ResultsStage IV patients with oral cancer who did not receive treatment had progression of disease and an increased mortality rate compared to patients who receive treatment but did not contract COVID‐19. The patients who received treatment and got affected with COVID‐19 had a far worse impact and higher mortality rate than all other groups.ConclusionIsolation and deferring treatment for stage IV patients with oral cancer, so as to avoid hospital visits and contraction of COVID‐19, is an advisable strategy based on this model. ]]> <![CDATA[Ethical framework for head and neck cancer care impacted by COVID‐19]]> https://www.researchpad.co/article/elastic_article_16576 The COVID‐19 pandemic has upended head and neck cancer care delivery in ways unforeseen and unprecedented. The impact of these changes parallels other fields in oncology, but is disproportionate due to protective measures and limitations on potentially aerosolizing procedures and related interventions specific to the upper aerodigestive tract. The moral and professional dimensions of providing ethically appropriate and consistent care for our patients in the COVID‐19 crisis are considered herein for head and neck oncology providers.

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<![CDATA[Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer]]> https://www.researchpad.co/article/N13fb250b-0dd1-4dce-b226-7fb5f6e526ba

PURPOSE

Plasma circulating tumor human papillomavirus DNA (ctHPVDNA) is a sensitive and specific biomarker of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). We investigated whether longitudinal monitoring of ctHPVDNA during post-treatment surveillance could accurately detect clinical disease recurrence.

METHODS AND MATERIALS

A prospective biomarker clinical trial was conducted among patients with nonmetastatic HPV-associated (p16-positive) OPSCC. All patients were treated with curative-intent chemoradiotherapy (CRT). Patients underwent a 3-month post-CRT positron emission tomography/computed tomography scan and were thereafter clinically evaluated every 2-4 months (years 1-2), then every 6 months (years 3-5). Chest imaging was performed every 6 months. Blood specimens were collected every 6-9 months for analysis of plasma ctHPVDNA using a multianalyte digital polymerase chain reaction assay. The primary endpoint was to estimate the negative predictive value (NPV) and positive predictive value (PPV) of ctHPVDNA surveillance.

RESULTS

One hundred fifteen patients were enrolled, and 1,006 blood samples were analyzed. After a median follow-up time of 23 months (range, 6.1-54.7 months), 15 patients (13%) developed disease recurrence. Eighty-seven patients had undetectable ctHPVDNA at all post-treatment time points, and none developed recurrence (NPV, 100%; 95% CI, 96% to 100%). Twenty-eight patients developed a positive ctHPVDNA during post-treatment surveillance, 15 of whom were diagnosed with biopsy-proven recurrence. Sixteen patients had 2 consecutively positive ctHPVDNA blood tests, 15 of whom developed biopsy-proven recurrence. Two consecutively positive ctHPVDNA blood tests had a PPV of 94% (95% CI, 70% to 99%). Median lead time between ctHPVDNA positivity and biopsy-proven recurrence was 3.9 months (range, 0.37-12.9 months).

CONCLUSION

Detection of ctHPVDNA in two consecutive plasma samples during post-treatment surveillance has high PPV and NPV for identifying disease recurrence in patients with HPV-associated oropharyngeal cancer and may facilitate earlier initiation of salvage therapy.

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<![CDATA[Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer]]> https://www.researchpad.co/article/N1c72b055-2681-4cf6-8805-b210397d821e

PURPOSE

Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM).

PATIENTS AND METHODS

A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading.

RESULTS

Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing.

CONCLUSION

GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.

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<![CDATA[Long term results of comparison of concurrent low-dose daily cisplatin versus the standard weekly cisplatin with six fractions per week radiotherapy in locally advanced head neck cancer]]> https://www.researchpad.co/article/5afe39e2463d7e12df772be4

Aim and Objective:

Weekly administration of cisplatin (cis-diamminedichloroplatinum [CDDP]) appears more feasible and substantially more popular than the 3 weekly schedules due to better compliance. Different concurrent cisplatin schedules have been attempted including a daily schedule. We did a comparison of two consecutive single arm studies, i.e., use of weekly cisplatin versus daily cisplatin when used with concurrently with a moderately accelerated radiotherapy (RT) schedule.

Patients and Methods:

Two prospective feasibility, safety and efficacy studies were carried out consecutively within the department. The weekly CDDP study was done from August 2003 to August 2005 and daily CDDP study was conducted from November 2005 to June 2007. Both studies included locally advanced stage III and IV squamous cell carcinoma of the head and neck region with RT dose of 70 Gy. Concurrent single-agent cisplatin was administered weekly (35 mg/m2) in the first and daily (6 mg/m2) in the second study.

Results:

Weekly cisplatin study had 68 and daily CDDP study had 52 patients. The median follow-up in the two studies was 93 and 63 months, respectively. Compliance in the two studies was comparable. Acute Grade III/IV mucositis and dysphagia were significantly higher in weekly cisplatin study. Late Grade II/III toxicities such as xerostomia, dysphagia, ototoxicity and nephrotoxicity were similar. The 5 years locoregional control was 18% and 25% and 5 years overall survival rate was 32% and 31% in weekly and daily cisplatin studies, respectively.

Conclusions:

Modest acceleration along with either weekly or daily cisplatin, whichever is possible in one's setup, is do-able, provided due attention is paid to patient selection and supportive care.

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