Head And Neck Cancer Symposium

SCOTTSDALE, ARIZ. – Concurrent chemoradiation offered better overall survival and disease-free survival than accelerated radiotherapy in patients with moderately advanced squamous cell carcinomas of the head and neck, investigators reported at the Multidisciplinary Head and Neck Symposium.

Actuarial rates of 2-year overall survival and disease-free survival in patients treated with concurrent chemoradiation (CCR) were significantly better than for patients treated with accelerated radiotherapy alone, reported Dr. Krzysztof Skladowski of the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Gliwice, Poland.

"CCR with conventional 7 weeks of fractionation and at least two courses of high-dose cisplatin is more effective than 6 weeks of accelerated radiotherapy alone," he said.

Even if patients can tolerate only a single course of cisplatin, CCR is still superior to accelerated radiation, he added.

The findings suggest that accelerated radiation protocols should be reserved for patients with more favorable prognosis, such as those with stage T2 disease with limited nodal involvement, and those who are positive for the human papillomavirus (HPV) p16 protein, Dr. Skladowski said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

The findings are "concordant with data that has been emerging now over approximately 10-14 years of the value of concurrent chemoradiation in head and neck cancer for a substantial cohort of patients over radiation alone," said Dr. Paul Harari of the University of Wisconsin, Madison, and the invited discussant.

Although a previous meta-analysis (Lancet 2006; 368:843-54) suggested that accelerated or hyperfractionated radiotherapy was associated with a 3.4% advantage in overall survival, compared with conventional radiotherapy over 5 years, there have been no randomized studies comparing accelerated radiotherapy protocols with concurrent chemoradiation in this population, Dr. Skladowski said.

He and colleagues compared the two modalities in 101 patients with moderately advanced cancers of the oropharynx (46 patients), hypopharynx (19), and larynx (36).

They defined moderately advanced cancers as stage T2N1-2, T3N0-2, or T4AN0-2 if the involved nodes are not larger than 3 cm in diameter. Patients with oropharyngeal cancers were tested for expression of the human papillomavirus (HPV) p16 protein.

Patients were randomly assigned to receive either concurrent chemoradiation with intensity-modulated radiation therapy–delivered doses of 66-70 Gy divided into 33-35 daily fractions over 45-49 days plus cisplatin 100 mg/m², delivered on days 1, 2 and 43, or to accelerated radiotherapy delivered via intensity-modulated radiation therapy in 1.8 Gy fractions 7 days/week to a total dose of 66.2-72 Gy.

Five patients in the CCR arm received only one dose of cisplatin, 30 received two doses, and 13 received the planned three doses.

At a median follow-up of 30 months, actuarial rates of 2-year overall survival of patients treated with CCR were 81%, compared with 62% for patients treated with accelerated radiation (P = .02). Disease-free survival rates were 75% and 60%, respectively (P = .05).

Acute adverse events were similar, with approximately 80% of patients in each treatment arm experiencing confluent mucositis, and about 10% having grade 3 dysphagia. There were no grade 4 toxicities.

The majority of treatment failures in each group were local, occurring in 21 of 52 patients treated with radiation alone, and in 11 of 49 patients treated with CCR (P = .03).

Significantly more deaths occurred in the radiation alone arm: 20 vs. 9 (P =.02).

The 2-year disease-free survival rate among patients in the CCR arm was dose dependent, at 60% of patients who received one course of cisplatin, 77% of those who received two courses, and 79% for those who received all three.

At the time of the analysis, all patients with oropharyngeal cancer who were positive for HPV p16 (five treated with accelerated radiation and six with CCR) were alive with no treatment failure. The overall survival rate for HPV-positive patients was 60% in the radiation only arm, and 80% in the CCR arm.

The study was supported by the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology. Dr. Skladowski reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – Concurrent chemoradiation offered better overall survival and disease-free survival than accelerated radiotherapy in patients with moderately advanced squamous cell carcinomas of the head and neck, investigators reported at the Multidisciplinary Head and Neck Symposium.

Actuarial rates of 2-year overall survival and disease-free survival in patients treated with concurrent chemoradiation (CCR) were significantly better than for patients treated with accelerated radiotherapy alone, reported Dr. Krzysztof Skladowski of the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Gliwice, Poland.

"CCR with conventional 7 weeks of fractionation and at least two courses of high-dose cisplatin is more effective than 6 weeks of accelerated radiotherapy alone," he said.

Even if patients can tolerate only a single course of cisplatin, CCR is still superior to accelerated radiation, he added.

The findings suggest that accelerated radiation protocols should be reserved for patients with more favorable prognosis, such as those with stage T2 disease with limited nodal involvement, and those who are positive for the human papillomavirus (HPV) p16 protein, Dr. Skladowski said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

The findings are "concordant with data that has been emerging now over approximately 10-14 years of the value of concurrent chemoradiation in head and neck cancer for a substantial cohort of patients over radiation alone," said Dr. Paul Harari of the University of Wisconsin, Madison, and the invited discussant.

Although a previous meta-analysis (Lancet 2006; 368:843-54) suggested that accelerated or hyperfractionated radiotherapy was associated with a 3.4% advantage in overall survival, compared with conventional radiotherapy over 5 years, there have been no randomized studies comparing accelerated radiotherapy protocols with concurrent chemoradiation in this population, Dr. Skladowski said.

He and colleagues compared the two modalities in 101 patients with moderately advanced cancers of the oropharynx (46 patients), hypopharynx (19), and larynx (36).

They defined moderately advanced cancers as stage T2N1-2, T3N0-2, or T4AN0-2 if the involved nodes are not larger than 3 cm in diameter. Patients with oropharyngeal cancers were tested for expression of the human papillomavirus (HPV) p16 protein.

Patients were randomly assigned to receive either concurrent chemoradiation with intensity-modulated radiation therapy–delivered doses of 66-70 Gy divided into 33-35 daily fractions over 45-49 days plus cisplatin 100 mg/m², delivered on days 1, 2 and 43, or to accelerated radiotherapy delivered via intensity-modulated radiation therapy in 1.8 Gy fractions 7 days/week to a total dose of 66.2-72 Gy.

Five patients in the CCR arm received only one dose of cisplatin, 30 received two doses, and 13 received the planned three doses.

At a median follow-up of 30 months, actuarial rates of 2-year overall survival of patients treated with CCR were 81%, compared with 62% for patients treated with accelerated radiation (P = .02). Disease-free survival rates were 75% and 60%, respectively (P = .05).

Acute adverse events were similar, with approximately 80% of patients in each treatment arm experiencing confluent mucositis, and about 10% having grade 3 dysphagia. There were no grade 4 toxicities.

The majority of treatment failures in each group were local, occurring in 21 of 52 patients treated with radiation alone, and in 11 of 49 patients treated with CCR (P = .03).

Significantly more deaths occurred in the radiation alone arm: 20 vs. 9 (P =.02).

The 2-year disease-free survival rate among patients in the CCR arm was dose dependent, at 60% of patients who received one course of cisplatin, 77% of those who received two courses, and 79% for those who received all three.

At the time of the analysis, all patients with oropharyngeal cancer who were positive for HPV p16 (five treated with accelerated radiation and six with CCR) were alive with no treatment failure. The overall survival rate for HPV-positive patients was 60% in the radiation only arm, and 80% in the CCR arm.

The study was supported by the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology. Dr. Skladowski reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – Concurrent chemoradiation offered better overall survival and disease-free survival than accelerated radiotherapy in patients with moderately advanced squamous cell carcinomas of the head and neck, investigators reported at the Multidisciplinary Head and Neck Symposium.

Actuarial rates of 2-year overall survival and disease-free survival in patients treated with concurrent chemoradiation (CCR) were significantly better than for patients treated with accelerated radiotherapy alone, reported Dr. Krzysztof Skladowski of the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Gliwice, Poland.

"CCR with conventional 7 weeks of fractionation and at least two courses of high-dose cisplatin is more effective than 6 weeks of accelerated radiotherapy alone," he said.

Even if patients can tolerate only a single course of cisplatin, CCR is still superior to accelerated radiation, he added.

The findings suggest that accelerated radiation protocols should be reserved for patients with more favorable prognosis, such as those with stage T2 disease with limited nodal involvement, and those who are positive for the human papillomavirus (HPV) p16 protein, Dr. Skladowski said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

The findings are "concordant with data that has been emerging now over approximately 10-14 years of the value of concurrent chemoradiation in head and neck cancer for a substantial cohort of patients over radiation alone," said Dr. Paul Harari of the University of Wisconsin, Madison, and the invited discussant.

Although a previous meta-analysis (Lancet 2006; 368:843-54) suggested that accelerated or hyperfractionated radiotherapy was associated with a 3.4% advantage in overall survival, compared with conventional radiotherapy over 5 years, there have been no randomized studies comparing accelerated radiotherapy protocols with concurrent chemoradiation in this population, Dr. Skladowski said.

He and colleagues compared the two modalities in 101 patients with moderately advanced cancers of the oropharynx (46 patients), hypopharynx (19), and larynx (36).

They defined moderately advanced cancers as stage T2N1-2, T3N0-2, or T4AN0-2 if the involved nodes are not larger than 3 cm in diameter. Patients with oropharyngeal cancers were tested for expression of the human papillomavirus (HPV) p16 protein.

Patients were randomly assigned to receive either concurrent chemoradiation with intensity-modulated radiation therapy–delivered doses of 66-70 Gy divided into 33-35 daily fractions over 45-49 days plus cisplatin 100 mg/m², delivered on days 1, 2 and 43, or to accelerated radiotherapy delivered via intensity-modulated radiation therapy in 1.8 Gy fractions 7 days/week to a total dose of 66.2-72 Gy.

Five patients in the CCR arm received only one dose of cisplatin, 30 received two doses, and 13 received the planned three doses.

At a median follow-up of 30 months, actuarial rates of 2-year overall survival of patients treated with CCR were 81%, compared with 62% for patients treated with accelerated radiation (P = .02). Disease-free survival rates were 75% and 60%, respectively (P = .05).

Acute adverse events were similar, with approximately 80% of patients in each treatment arm experiencing confluent mucositis, and about 10% having grade 3 dysphagia. There were no grade 4 toxicities.

The majority of treatment failures in each group were local, occurring in 21 of 52 patients treated with radiation alone, and in 11 of 49 patients treated with CCR (P = .03).

Significantly more deaths occurred in the radiation alone arm: 20 vs. 9 (P =.02).

The 2-year disease-free survival rate among patients in the CCR arm was dose dependent, at 60% of patients who received one course of cisplatin, 77% of those who received two courses, and 79% for those who received all three.

At the time of the analysis, all patients with oropharyngeal cancer who were positive for HPV p16 (five treated with accelerated radiation and six with CCR) were alive with no treatment failure. The overall survival rate for HPV-positive patients was 60% in the radiation only arm, and 80% in the CCR arm.

The study was supported by the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology. Dr. Skladowski reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – The addition of the experimental targeted agent zalutumumab to primary curative chemoradiation for head and neck cancers did not improve locoregional control, disease-specific survival, or overall survival at 3 years of follow-up.

The only thing that zalutumumab added to therapy was a skin rash in the large majority of patients who received it, reported Dr. Jens Overgaard, of the department of experimental clinical oncology at Aarhus University, Denmark.

Response to zalutumumab, a monoclonal antibody targeted to the epidermal growth factor receptor (EGFR), was not related to tumor human papillomavirus 16 (HPV/p16) status or to chemoradiotherapy, Dr. Overgaard reported at the Multidisciplinary Head and Neck Cancer Symposium.

The results of the DAHANCA 19 trial echo those of the RTOG (Radiation Oncology Therapy Group) trial 0522, which found no benefit from the addition of the EGFR inhibitor cetuximab (Erbitux) to accelerated cisplatin-based chemoradiotherapy, said Dr. Paul Harari, an invited discussant from the University of Wisconsin, Madison.

"Where I think we have a lot of unanswered questions is acknowledging how little we actually understand about EGFR biology, despite now 40 years of progressive knowledge," Dr. Harari said.

"We’re now seeing very clearly in molecular and clinical correlate studies that the more we suppress the EGFR, the more we see collateral overexpression of additional RTKs [receptor tyrosine kinases], including members of the HER family, such as HER-3, that enable an escape mechanism for tumors that become resistant to EGFR inhibition," he said.

Dr. Overgaard and his colleagues in the Danish Head and Neck Cancer Group conducted an open-label, phase III trial in which 619 patients with nonmetastatic squamous cell carcinomas of the larynx, oropharynx, hypopharynx, or oral cavity were randomly assigned to received 66-68 Gy of accelerated radiotherapy with or without zalutumumab 8 mg/kg weekly, with the first dose given a week before the start of radiation. The radiation was given concomitantly with the radiosensitizer nimorazole and, in patients with involved lymph nodes, cisplatin.

A total of 301 patients who received zalutumumab and 307 controls were included in the final intention-to-treat analysis.

At 3-year follow-up, there were no significant differences in either the primary endpoint of locoregional control (76% in zalutumumab-treated patients and 77% of controls) or in the secondary endpoints of disease-specific survival (82% and 85%, respectively) or overall survival (72% and 79%), Dr. Overgaard reported at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

Overall, patients who were positive for the HPV/p16 biomarker fared better than p16-negative patients, with an odds ratio for the probability of local control in negative patients of 0.52 (95% confidence interval, 0.36-0.73; P value not reported).

However, regardless of HPV 16 status, the addition of zalutumumab made no difference in the primary endpoint.

In a proportional hazard analysis, factors significantly associated with worse outcomes included worse World Health Organization performance status, higher disease stage, nodal involvement, and HPV/p16 negative status.

Although zalutumumab was generally well tolerated, 94% of patients who received it developed a rash, and of this group, 29% had grade 3 or 4 rash. In all, 11% of patients assigned to zalutumumab had to stop the drug because of rash.

The trial was sponsored by the Danish Head and Neck Cancer Group. Dr. Overgaard reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – The addition of the experimental targeted agent zalutumumab to primary curative chemoradiation for head and neck cancers did not improve locoregional control, disease-specific survival, or overall survival at 3 years of follow-up.

The only thing that zalutumumab added to therapy was a skin rash in the large majority of patients who received it, reported Dr. Jens Overgaard, of the department of experimental clinical oncology at Aarhus University, Denmark.

Response to zalutumumab, a monoclonal antibody targeted to the epidermal growth factor receptor (EGFR), was not related to tumor human papillomavirus 16 (HPV/p16) status or to chemoradiotherapy, Dr. Overgaard reported at the Multidisciplinary Head and Neck Cancer Symposium.

The results of the DAHANCA 19 trial echo those of the RTOG (Radiation Oncology Therapy Group) trial 0522, which found no benefit from the addition of the EGFR inhibitor cetuximab (Erbitux) to accelerated cisplatin-based chemoradiotherapy, said Dr. Paul Harari, an invited discussant from the University of Wisconsin, Madison.

"Where I think we have a lot of unanswered questions is acknowledging how little we actually understand about EGFR biology, despite now 40 years of progressive knowledge," Dr. Harari said.

"We’re now seeing very clearly in molecular and clinical correlate studies that the more we suppress the EGFR, the more we see collateral overexpression of additional RTKs [receptor tyrosine kinases], including members of the HER family, such as HER-3, that enable an escape mechanism for tumors that become resistant to EGFR inhibition," he said.

Dr. Overgaard and his colleagues in the Danish Head and Neck Cancer Group conducted an open-label, phase III trial in which 619 patients with nonmetastatic squamous cell carcinomas of the larynx, oropharynx, hypopharynx, or oral cavity were randomly assigned to received 66-68 Gy of accelerated radiotherapy with or without zalutumumab 8 mg/kg weekly, with the first dose given a week before the start of radiation. The radiation was given concomitantly with the radiosensitizer nimorazole and, in patients with involved lymph nodes, cisplatin.

A total of 301 patients who received zalutumumab and 307 controls were included in the final intention-to-treat analysis.

At 3-year follow-up, there were no significant differences in either the primary endpoint of locoregional control (76% in zalutumumab-treated patients and 77% of controls) or in the secondary endpoints of disease-specific survival (82% and 85%, respectively) or overall survival (72% and 79%), Dr. Overgaard reported at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

Overall, patients who were positive for the HPV/p16 biomarker fared better than p16-negative patients, with an odds ratio for the probability of local control in negative patients of 0.52 (95% confidence interval, 0.36-0.73; P value not reported).

However, regardless of HPV 16 status, the addition of zalutumumab made no difference in the primary endpoint.

In a proportional hazard analysis, factors significantly associated with worse outcomes included worse World Health Organization performance status, higher disease stage, nodal involvement, and HPV/p16 negative status.

Although zalutumumab was generally well tolerated, 94% of patients who received it developed a rash, and of this group, 29% had grade 3 or 4 rash. In all, 11% of patients assigned to zalutumumab had to stop the drug because of rash.

The trial was sponsored by the Danish Head and Neck Cancer Group. Dr. Overgaard reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – The addition of the experimental targeted agent zalutumumab to primary curative chemoradiation for head and neck cancers did not improve locoregional control, disease-specific survival, or overall survival at 3 years of follow-up.

The only thing that zalutumumab added to therapy was a skin rash in the large majority of patients who received it, reported Dr. Jens Overgaard, of the department of experimental clinical oncology at Aarhus University, Denmark.

Response to zalutumumab, a monoclonal antibody targeted to the epidermal growth factor receptor (EGFR), was not related to tumor human papillomavirus 16 (HPV/p16) status or to chemoradiotherapy, Dr. Overgaard reported at the Multidisciplinary Head and Neck Cancer Symposium.

The results of the DAHANCA 19 trial echo those of the RTOG (Radiation Oncology Therapy Group) trial 0522, which found no benefit from the addition of the EGFR inhibitor cetuximab (Erbitux) to accelerated cisplatin-based chemoradiotherapy, said Dr. Paul Harari, an invited discussant from the University of Wisconsin, Madison.

"Where I think we have a lot of unanswered questions is acknowledging how little we actually understand about EGFR biology, despite now 40 years of progressive knowledge," Dr. Harari said.

"We’re now seeing very clearly in molecular and clinical correlate studies that the more we suppress the EGFR, the more we see collateral overexpression of additional RTKs [receptor tyrosine kinases], including members of the HER family, such as HER-3, that enable an escape mechanism for tumors that become resistant to EGFR inhibition," he said.

Dr. Overgaard and his colleagues in the Danish Head and Neck Cancer Group conducted an open-label, phase III trial in which 619 patients with nonmetastatic squamous cell carcinomas of the larynx, oropharynx, hypopharynx, or oral cavity were randomly assigned to received 66-68 Gy of accelerated radiotherapy with or without zalutumumab 8 mg/kg weekly, with the first dose given a week before the start of radiation. The radiation was given concomitantly with the radiosensitizer nimorazole and, in patients with involved lymph nodes, cisplatin.

A total of 301 patients who received zalutumumab and 307 controls were included in the final intention-to-treat analysis.

At 3-year follow-up, there were no significant differences in either the primary endpoint of locoregional control (76% in zalutumumab-treated patients and 77% of controls) or in the secondary endpoints of disease-specific survival (82% and 85%, respectively) or overall survival (72% and 79%), Dr. Overgaard reported at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

Overall, patients who were positive for the HPV/p16 biomarker fared better than p16-negative patients, with an odds ratio for the probability of local control in negative patients of 0.52 (95% confidence interval, 0.36-0.73; P value not reported).

However, regardless of HPV 16 status, the addition of zalutumumab made no difference in the primary endpoint.

In a proportional hazard analysis, factors significantly associated with worse outcomes included worse World Health Organization performance status, higher disease stage, nodal involvement, and HPV/p16 negative status.

Although zalutumumab was generally well tolerated, 94% of patients who received it developed a rash, and of this group, 29% had grade 3 or 4 rash. In all, 11% of patients assigned to zalutumumab had to stop the drug because of rash.

The trial was sponsored by the Danish Head and Neck Cancer Group. Dr. Overgaard reported having no financial disclosures. Dr. Harari has received research funding from Amgen.

SCOTTSDALE, ARIZ. – Patients positive for the human papillomavirus have nearly twice the overall survival rate from recurrent oropharyngeal cancers as HPV-negative patients, Dr. Carole Fakhry reported at the 2014 Multidisciplinary Head and Neck Cancer Symposium.

Two years after a diagnosis of recurrence, 54.6% of HPV-positive patients were alive, compared with 27.6% of HPV-negative patients (P less than .001), according to a retrospective analysis of data from two clinical trials of 181 patients with stage III-IV oropharyngeal squamous cell carcinomas and known HPV status (measured by p16 protein expression).

"Tumor p16 status is independently associated with overall survival among oropharyngeal cancer patients with disease progression," said Dr. Fakhry of Johns Hopkins Medicine in Baltimore.

The analysis shows that "unquestionably, HPV-positive patients have a different molecular disease than their HPV-negative, tobacco-related counterparts. They are different with respect to specific tumor suppressor genes, and they are different in respect to specific activating oncogenes," noted Dr. Ezra Cohen of the University of California San Diego Moores Cancer Center, who was the invited discussant.

Dr. Fakhry and her colleagues looked at data on patients treated in the RTOG 0129 and 0522 trials.

Median time to progression was similar between the groups (8.2 months for HPV+ patients and 7.3 months for HPV–; P = .67), with the majority of disease progressions occurring within the first year (65% and 63%, respectively), reported Dr. Fakhry at the symposium, cosponsored by the American Society for Radiation Oncology and American Society of Clinical Oncology.

Factors associated with better overall survival in multivariate analysis included HPV+ status, salvage surgery, local-regional vs. distant progression, lower T stage at enrollment, and less than 20 smoking pack-years.

The study was supported by the National Cancer Institute and Bristol-Myers Squibb. Dr. Fakhry reported having no financial disclosures. Dr. Cohen disclosed serving as a consultant and adviser to BMS.

SCOTTSDALE, ARIZ. – Patients positive for the human papillomavirus have nearly twice the overall survival rate from recurrent oropharyngeal cancers as HPV-negative patients, Dr. Carole Fakhry reported at the 2014 Multidisciplinary Head and Neck Cancer Symposium.

Two years after a diagnosis of recurrence, 54.6% of HPV-positive patients were alive, compared with 27.6% of HPV-negative patients (P less than .001), according to a retrospective analysis of data from two clinical trials of 181 patients with stage III-IV oropharyngeal squamous cell carcinomas and known HPV status (measured by p16 protein expression).

"Tumor p16 status is independently associated with overall survival among oropharyngeal cancer patients with disease progression," said Dr. Fakhry of Johns Hopkins Medicine in Baltimore.

The analysis shows that "unquestionably, HPV-positive patients have a different molecular disease than their HPV-negative, tobacco-related counterparts. They are different with respect to specific tumor suppressor genes, and they are different in respect to specific activating oncogenes," noted Dr. Ezra Cohen of the University of California San Diego Moores Cancer Center, who was the invited discussant.

Dr. Fakhry and her colleagues looked at data on patients treated in the RTOG 0129 and 0522 trials.

Median time to progression was similar between the groups (8.2 months for HPV+ patients and 7.3 months for HPV–; P = .67), with the majority of disease progressions occurring within the first year (65% and 63%, respectively), reported Dr. Fakhry at the symposium, cosponsored by the American Society for Radiation Oncology and American Society of Clinical Oncology.

Factors associated with better overall survival in multivariate analysis included HPV+ status, salvage surgery, local-regional vs. distant progression, lower T stage at enrollment, and less than 20 smoking pack-years.

The study was supported by the National Cancer Institute and Bristol-Myers Squibb. Dr. Fakhry reported having no financial disclosures. Dr. Cohen disclosed serving as a consultant and adviser to BMS.

SCOTTSDALE, ARIZ. – Patients positive for the human papillomavirus have nearly twice the overall survival rate from recurrent oropharyngeal cancers as HPV-negative patients, Dr. Carole Fakhry reported at the 2014 Multidisciplinary Head and Neck Cancer Symposium.

Two years after a diagnosis of recurrence, 54.6% of HPV-positive patients were alive, compared with 27.6% of HPV-negative patients (P less than .001), according to a retrospective analysis of data from two clinical trials of 181 patients with stage III-IV oropharyngeal squamous cell carcinomas and known HPV status (measured by p16 protein expression).

"Tumor p16 status is independently associated with overall survival among oropharyngeal cancer patients with disease progression," said Dr. Fakhry of Johns Hopkins Medicine in Baltimore.

The analysis shows that "unquestionably, HPV-positive patients have a different molecular disease than their HPV-negative, tobacco-related counterparts. They are different with respect to specific tumor suppressor genes, and they are different in respect to specific activating oncogenes," noted Dr. Ezra Cohen of the University of California San Diego Moores Cancer Center, who was the invited discussant.

Dr. Fakhry and her colleagues looked at data on patients treated in the RTOG 0129 and 0522 trials.

Median time to progression was similar between the groups (8.2 months for HPV+ patients and 7.3 months for HPV–; P = .67), with the majority of disease progressions occurring within the first year (65% and 63%, respectively), reported Dr. Fakhry at the symposium, cosponsored by the American Society for Radiation Oncology and American Society of Clinical Oncology.

Factors associated with better overall survival in multivariate analysis included HPV+ status, salvage surgery, local-regional vs. distant progression, lower T stage at enrollment, and less than 20 smoking pack-years.

The study was supported by the National Cancer Institute and Bristol-Myers Squibb. Dr. Fakhry reported having no financial disclosures. Dr. Cohen disclosed serving as a consultant and adviser to BMS.

SCOTTSDALE, ARIZ. – A home humidification device can reduce the symptom burden of mucositis in patients undergoing radiation for head and neck cancers, but the technology only works when patients actually use it, reported investigators at the Multidisciplinary Head and Neck Cancer Symposium.

In a randomized phase III trial, patients assigned to daily humidification of the mouth and throat beginning on the first day of radiation had a 45% reduction in risk for acute hospitalization and had about half the symptom-related hospital days of patients who did not receive daily humidification, reported Dr. Andrew Macann from Auckland (New Zealand) City Hospital.

However, compliance with the humidification protocol was spotty, with only 42% of patients assigned to the therapy using it according to study protocol, Dr. Macann noted.

"The efficacy signals were seen across clinician-reported, independent, and patient-reported outcomes, and although in the main these signals were seen in the per-protocol analysis, the result which is perhaps most influential in considering whether domiciliary humidification could be cost effective, was the reduction in inpatient hospital days, where there was significant reduction in both the intention-to-treat and per protocol analyses," he said at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology .

The device used in the study was a humidifier/flow generator with a plastic face apparatus that delivered 44 mg of water per liter of air at a rate of 30 L/min. The flow was designed to slightly exceed inspiratory flow so that there was no entrainment of nonhumidified air.

In the trial, conducted by the Trans Tasman Radiation Oncology Group, 210 patients with cancers of the nasopharynx, oropharynx, oral cavity, larynx or hypopharynx were randomly assigned to receive humidification plus the institutional standard of care for mucositis management, or standard of care alone. Patients assigned to humidification were supposed to continue on the protocol until resolution of the ulcerative component of clinical mucositis.

A total of 103 patients assigned to humidification and 100 controls were available for the intention-to-treat (ITT) analysis.

Humidification compliance was electronically recorded, with full compliance consisting of more than 4 hours of daily use. The investigators calculated compliance ratios based on the number of full compliance days divided by the total days from the start of therapy to resolution of ulcerative mucositis. They determined high compliance to be a ratio greater than 0.67, and medium compliance to be a ratio of 0.34-0.66. High and medium compliers (23 and 20 patients, respectively) were included in the per-protocol analysis.

Although the humidification protocol did not meet the primary endpoint (area under the curve for a clinical mucositis score of 2 or greater according to Common Terminology Criteria for Adverse Events) in either the ITT or per-protocol analysis, there was a significant reduction in clinician-assessed functional mucositis symptom burden among the compliant patients (P = .009).

Additionally, total days in hospital were significantly lower among patients on the experimental protocol in both the ITT and per-protocol analyses. Control patients spent a geometric mean 4.10 days in hospital compared with 2.32 in ITT (P = .017), and 1.65 in per-protocol (P = .006). The investigators calculated that all patients treated with humidification spent only 57% of the hospital days of controls, and that compliant patients spent only 40% of those days.

Compliant patients were also significantly less likely than controls to require a feeding tube, with an odds ratio for never needing a tube of 2.50 (P = .035).

Patient-reported impression of symptom burden as rated on the McMaster University Head and Neck Questionnaire trended toward favoring the humidification protocol but there were no significant differences between the groups.

Simple strategies such as humidification can add value to head and neck cancer therapy, commented Dr. Paul M. Harari of the University of Wisconsin, Madison.

"I would love to see this humidification developed in a way that would be more compliant for patients, because I have no doubt that it could be valuable," he said.

The study was funded by the New Zealand Ministry of Science and Innovation, Fisher and Paykel Healthcare, Baxter Healthcare, and Auckland Hospital Charitable Trust. Dr. Macann and Dr. Harari reported having no conflicts of interest.

SCOTTSDALE, ARIZ. – A home humidification device can reduce the symptom burden of mucositis in patients undergoing radiation for head and neck cancers, but the technology only works when patients actually use it, reported investigators at the Multidisciplinary Head and Neck Cancer Symposium.

In a randomized phase III trial, patients assigned to daily humidification of the mouth and throat beginning on the first day of radiation had a 45% reduction in risk for acute hospitalization and had about half the symptom-related hospital days of patients who did not receive daily humidification, reported Dr. Andrew Macann from Auckland (New Zealand) City Hospital.

However, compliance with the humidification protocol was spotty, with only 42% of patients assigned to the therapy using it according to study protocol, Dr. Macann noted.

"The efficacy signals were seen across clinician-reported, independent, and patient-reported outcomes, and although in the main these signals were seen in the per-protocol analysis, the result which is perhaps most influential in considering whether domiciliary humidification could be cost effective, was the reduction in inpatient hospital days, where there was significant reduction in both the intention-to-treat and per protocol analyses," he said at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology .

The device used in the study was a humidifier/flow generator with a plastic face apparatus that delivered 44 mg of water per liter of air at a rate of 30 L/min. The flow was designed to slightly exceed inspiratory flow so that there was no entrainment of nonhumidified air.

In the trial, conducted by the Trans Tasman Radiation Oncology Group, 210 patients with cancers of the nasopharynx, oropharynx, oral cavity, larynx or hypopharynx were randomly assigned to receive humidification plus the institutional standard of care for mucositis management, or standard of care alone. Patients assigned to humidification were supposed to continue on the protocol until resolution of the ulcerative component of clinical mucositis.

A total of 103 patients assigned to humidification and 100 controls were available for the intention-to-treat (ITT) analysis.

Humidification compliance was electronically recorded, with full compliance consisting of more than 4 hours of daily use. The investigators calculated compliance ratios based on the number of full compliance days divided by the total days from the start of therapy to resolution of ulcerative mucositis. They determined high compliance to be a ratio greater than 0.67, and medium compliance to be a ratio of 0.34-0.66. High and medium compliers (23 and 20 patients, respectively) were included in the per-protocol analysis.

Although the humidification protocol did not meet the primary endpoint (area under the curve for a clinical mucositis score of 2 or greater according to Common Terminology Criteria for Adverse Events) in either the ITT or per-protocol analysis, there was a significant reduction in clinician-assessed functional mucositis symptom burden among the compliant patients (P = .009).

Additionally, total days in hospital were significantly lower among patients on the experimental protocol in both the ITT and per-protocol analyses. Control patients spent a geometric mean 4.10 days in hospital compared with 2.32 in ITT (P = .017), and 1.65 in per-protocol (P = .006). The investigators calculated that all patients treated with humidification spent only 57% of the hospital days of controls, and that compliant patients spent only 40% of those days.

Compliant patients were also significantly less likely than controls to require a feeding tube, with an odds ratio for never needing a tube of 2.50 (P = .035).

Patient-reported impression of symptom burden as rated on the McMaster University Head and Neck Questionnaire trended toward favoring the humidification protocol but there were no significant differences between the groups.

Simple strategies such as humidification can add value to head and neck cancer therapy, commented Dr. Paul M. Harari of the University of Wisconsin, Madison.

"I would love to see this humidification developed in a way that would be more compliant for patients, because I have no doubt that it could be valuable," he said.

The study was funded by the New Zealand Ministry of Science and Innovation, Fisher and Paykel Healthcare, Baxter Healthcare, and Auckland Hospital Charitable Trust. Dr. Macann and Dr. Harari reported having no conflicts of interest.

SCOTTSDALE, ARIZ. – A home humidification device can reduce the symptom burden of mucositis in patients undergoing radiation for head and neck cancers, but the technology only works when patients actually use it, reported investigators at the Multidisciplinary Head and Neck Cancer Symposium.

In a randomized phase III trial, patients assigned to daily humidification of the mouth and throat beginning on the first day of radiation had a 45% reduction in risk for acute hospitalization and had about half the symptom-related hospital days of patients who did not receive daily humidification, reported Dr. Andrew Macann from Auckland (New Zealand) City Hospital.

However, compliance with the humidification protocol was spotty, with only 42% of patients assigned to the therapy using it according to study protocol, Dr. Macann noted.

"The efficacy signals were seen across clinician-reported, independent, and patient-reported outcomes, and although in the main these signals were seen in the per-protocol analysis, the result which is perhaps most influential in considering whether domiciliary humidification could be cost effective, was the reduction in inpatient hospital days, where there was significant reduction in both the intention-to-treat and per protocol analyses," he said at the symposium, cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology .

The device used in the study was a humidifier/flow generator with a plastic face apparatus that delivered 44 mg of water per liter of air at a rate of 30 L/min. The flow was designed to slightly exceed inspiratory flow so that there was no entrainment of nonhumidified air.

In the trial, conducted by the Trans Tasman Radiation Oncology Group, 210 patients with cancers of the nasopharynx, oropharynx, oral cavity, larynx or hypopharynx were randomly assigned to receive humidification plus the institutional standard of care for mucositis management, or standard of care alone. Patients assigned to humidification were supposed to continue on the protocol until resolution of the ulcerative component of clinical mucositis.

A total of 103 patients assigned to humidification and 100 controls were available for the intention-to-treat (ITT) analysis.

Humidification compliance was electronically recorded, with full compliance consisting of more than 4 hours of daily use. The investigators calculated compliance ratios based on the number of full compliance days divided by the total days from the start of therapy to resolution of ulcerative mucositis. They determined high compliance to be a ratio greater than 0.67, and medium compliance to be a ratio of 0.34-0.66. High and medium compliers (23 and 20 patients, respectively) were included in the per-protocol analysis.

Although the humidification protocol did not meet the primary endpoint (area under the curve for a clinical mucositis score of 2 or greater according to Common Terminology Criteria for Adverse Events) in either the ITT or per-protocol analysis, there was a significant reduction in clinician-assessed functional mucositis symptom burden among the compliant patients (P = .009).

Additionally, total days in hospital were significantly lower among patients on the experimental protocol in both the ITT and per-protocol analyses. Control patients spent a geometric mean 4.10 days in hospital compared with 2.32 in ITT (P = .017), and 1.65 in per-protocol (P = .006). The investigators calculated that all patients treated with humidification spent only 57% of the hospital days of controls, and that compliant patients spent only 40% of those days.

Compliant patients were also significantly less likely than controls to require a feeding tube, with an odds ratio for never needing a tube of 2.50 (P = .035).

Patient-reported impression of symptom burden as rated on the McMaster University Head and Neck Questionnaire trended toward favoring the humidification protocol but there were no significant differences between the groups.

Simple strategies such as humidification can add value to head and neck cancer therapy, commented Dr. Paul M. Harari of the University of Wisconsin, Madison.

"I would love to see this humidification developed in a way that would be more compliant for patients, because I have no doubt that it could be valuable," he said.

The study was funded by the New Zealand Ministry of Science and Innovation, Fisher and Paykel Healthcare, Baxter Healthcare, and Auckland Hospital Charitable Trust. Dr. Macann and Dr. Harari reported having no conflicts of interest.

SCOTTSDALE, ARIZ. – Although radiation oncologists have typically worried that, in patients with oral cancers, leaving contralateral submandibular glands untreated could lead to tumor involvement of nearby lymph nodes, those worries may soon be put to rest, suggest results of a small retrospective study.

Among 71 patients with locally advanced cancers of the tongue base or tonsils who underwent radiation therapy that avoided targeting the contralateral submandibular glands, there were no cancer recurrences in contralateral level 1B nodes after a median 27.3 months of follow-up, reported Dr. Tyler Robin of the University of Colorado at Denver, Aurora.

"We’re interested in sparing the contralateral submandibular gland because we’re interested in minimizing xerostomia. Xerostomia is a significant morbidity of head and neck cancer radiotherapy, and it has substantial impact on patient quality of life," Dr. Robin said at the Multidisciplinary Head and Neck Cancer Symposium.

Intensity-modulated radiation therapy (IMRT) allows treatment beams to be shaped to avoid the parotid glands with no subsequent increase in regional lymph node failures and preservation of parotid salivary flow. But patient-reported xerostomia and quality-of-life outcomes with parotid-sparing techniques have been mixed, Dr. Robin said.

"Interestingly, an earlier study looking at predictors of xerostomia found that dose to the submandibular gland was a stronger predictor of xerostomia than dose to the parotids, and this may be because of the role of the submandibular gland in unstimulated salivary flow," he said.

The submandibular gland is located near level IB lymph nodes, but the risk of contralateral level IB involvement in oropharyngeal (OP) cancers is low, on the order of 0%-2%. Gland-sparing therapy with IMRT has previously been shown to mitigate xerostomia and to be safe, but primarily in patients with early-stage disease, prompting the investigators to examine whether it would also be safe and effective in patients with locally advanced tumors.

The question is particularly relevant at a time when the epidemiology of OP cancers is shifting toward patients who are positive for the human papillomavirus, who are more likely to have good therapeutic outcomes and who may live for many decades beyond an initial diagnosis, Dr. Robin said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

His team reviewed records of 71 patients treated for primary OP cancers at the University of Colorado and at Memorial Sloan-Kettering Cancer Center in New York.

In all, 40 patients had tonsillar cancers, 28 had base-of-tongue lesions, and 3 had cancers involving both sites.

They considered gland-sparing procedures as those in which total doses delivered to the contralateral submandibular gland during bilateral neck radiotherapy were not more than 39 Gy.

Of the 71 patients, 61 (85.9%) had stage IVA disease, 6 (8.5%) had stage III cancers, and 3 (4.2%) had stage IVB disease. The majority of patients had significant nodal involvement, with 46 (64.8%) having stage N2b; 7 (9.9%) N2c; and 3 (4.2%) having staging N3 disease.

The respective mean and median doses to the contralateral glands were 33.04 and 34.21 Gy.

At median follow-up of 27.3 months, there were 12 treatment failures: 1 local, 6 regional, and 5 distant failures. However, there were no cases of disease recurrence in contralateral level IB nodes, the investigators found. There was, however, one documented case of recurrence in contralateral level IIa lymph nodes.

"We believe this is evidence that contralateral submandibular gland sparing can be feasible and safe even in advanced node-positive head and neck cancers, including base- of-tongue lesions," Dr. Robin said,

The data suggest the need for a large prospective trial specifically addressing the safety and efficacy of contralateral submandibular gland-sparing therapy in patients with locally advanced head and neck cancers. Such studies should incorporate existing xerostomia-based quality-of-life assessments and formal sialometry studies, he added.

While the study shows that contralateral submandibular gland sparing is feasible, it raises the question of whether the technique might increase the dose to the muscles of the floor of the mouth, said Dr. Harry Quon of Johns Hopkins University in Baltimore, the invited discussant.

"There is emerging data that our chemoradiation approaches, with long-term follow-up maybe increases [patients’] risk of death, and one hypothesis that has been put forward is chronic aspiration with secondary injury to the lungs," he said.

Radiation injury to the floor-of-mouth muscles appears to be a significant risk factor for aspiration, indicating that future conformal approaches to treating cancers of the tonsils and tongue base should attempt to avoid delivering excessive doses to the midline mucosa, Dr. Quon said.

The study was internally funded. Dr. Robin and Dr. Quon reported having no financial disclosures.

SCOTTSDALE, ARIZ. – Although radiation oncologists have typically worried that, in patients with oral cancers, leaving contralateral submandibular glands untreated could lead to tumor involvement of nearby lymph nodes, those worries may soon be put to rest, suggest results of a small retrospective study.

Among 71 patients with locally advanced cancers of the tongue base or tonsils who underwent radiation therapy that avoided targeting the contralateral submandibular glands, there were no cancer recurrences in contralateral level 1B nodes after a median 27.3 months of follow-up, reported Dr. Tyler Robin of the University of Colorado at Denver, Aurora.

"We’re interested in sparing the contralateral submandibular gland because we’re interested in minimizing xerostomia. Xerostomia is a significant morbidity of head and neck cancer radiotherapy, and it has substantial impact on patient quality of life," Dr. Robin said at the Multidisciplinary Head and Neck Cancer Symposium.

Intensity-modulated radiation therapy (IMRT) allows treatment beams to be shaped to avoid the parotid glands with no subsequent increase in regional lymph node failures and preservation of parotid salivary flow. But patient-reported xerostomia and quality-of-life outcomes with parotid-sparing techniques have been mixed, Dr. Robin said.

"Interestingly, an earlier study looking at predictors of xerostomia found that dose to the submandibular gland was a stronger predictor of xerostomia than dose to the parotids, and this may be because of the role of the submandibular gland in unstimulated salivary flow," he said.

The submandibular gland is located near level IB lymph nodes, but the risk of contralateral level IB involvement in oropharyngeal (OP) cancers is low, on the order of 0%-2%. Gland-sparing therapy with IMRT has previously been shown to mitigate xerostomia and to be safe, but primarily in patients with early-stage disease, prompting the investigators to examine whether it would also be safe and effective in patients with locally advanced tumors.

The question is particularly relevant at a time when the epidemiology of OP cancers is shifting toward patients who are positive for the human papillomavirus, who are more likely to have good therapeutic outcomes and who may live for many decades beyond an initial diagnosis, Dr. Robin said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

His team reviewed records of 71 patients treated for primary OP cancers at the University of Colorado and at Memorial Sloan-Kettering Cancer Center in New York.

In all, 40 patients had tonsillar cancers, 28 had base-of-tongue lesions, and 3 had cancers involving both sites.

They considered gland-sparing procedures as those in which total doses delivered to the contralateral submandibular gland during bilateral neck radiotherapy were not more than 39 Gy.

Of the 71 patients, 61 (85.9%) had stage IVA disease, 6 (8.5%) had stage III cancers, and 3 (4.2%) had stage IVB disease. The majority of patients had significant nodal involvement, with 46 (64.8%) having stage N2b; 7 (9.9%) N2c; and 3 (4.2%) having staging N3 disease.

The respective mean and median doses to the contralateral glands were 33.04 and 34.21 Gy.

At median follow-up of 27.3 months, there were 12 treatment failures: 1 local, 6 regional, and 5 distant failures. However, there were no cases of disease recurrence in contralateral level IB nodes, the investigators found. There was, however, one documented case of recurrence in contralateral level IIa lymph nodes.

"We believe this is evidence that contralateral submandibular gland sparing can be feasible and safe even in advanced node-positive head and neck cancers, including base- of-tongue lesions," Dr. Robin said,

The data suggest the need for a large prospective trial specifically addressing the safety and efficacy of contralateral submandibular gland-sparing therapy in patients with locally advanced head and neck cancers. Such studies should incorporate existing xerostomia-based quality-of-life assessments and formal sialometry studies, he added.

While the study shows that contralateral submandibular gland sparing is feasible, it raises the question of whether the technique might increase the dose to the muscles of the floor of the mouth, said Dr. Harry Quon of Johns Hopkins University in Baltimore, the invited discussant.

"There is emerging data that our chemoradiation approaches, with long-term follow-up maybe increases [patients’] risk of death, and one hypothesis that has been put forward is chronic aspiration with secondary injury to the lungs," he said.

Radiation injury to the floor-of-mouth muscles appears to be a significant risk factor for aspiration, indicating that future conformal approaches to treating cancers of the tonsils and tongue base should attempt to avoid delivering excessive doses to the midline mucosa, Dr. Quon said.

The study was internally funded. Dr. Robin and Dr. Quon reported having no financial disclosures.

SCOTTSDALE, ARIZ. – Although radiation oncologists have typically worried that, in patients with oral cancers, leaving contralateral submandibular glands untreated could lead to tumor involvement of nearby lymph nodes, those worries may soon be put to rest, suggest results of a small retrospective study.

Among 71 patients with locally advanced cancers of the tongue base or tonsils who underwent radiation therapy that avoided targeting the contralateral submandibular glands, there were no cancer recurrences in contralateral level 1B nodes after a median 27.3 months of follow-up, reported Dr. Tyler Robin of the University of Colorado at Denver, Aurora.

"We’re interested in sparing the contralateral submandibular gland because we’re interested in minimizing xerostomia. Xerostomia is a significant morbidity of head and neck cancer radiotherapy, and it has substantial impact on patient quality of life," Dr. Robin said at the Multidisciplinary Head and Neck Cancer Symposium.

Intensity-modulated radiation therapy (IMRT) allows treatment beams to be shaped to avoid the parotid glands with no subsequent increase in regional lymph node failures and preservation of parotid salivary flow. But patient-reported xerostomia and quality-of-life outcomes with parotid-sparing techniques have been mixed, Dr. Robin said.

"Interestingly, an earlier study looking at predictors of xerostomia found that dose to the submandibular gland was a stronger predictor of xerostomia than dose to the parotids, and this may be because of the role of the submandibular gland in unstimulated salivary flow," he said.

The submandibular gland is located near level IB lymph nodes, but the risk of contralateral level IB involvement in oropharyngeal (OP) cancers is low, on the order of 0%-2%. Gland-sparing therapy with IMRT has previously been shown to mitigate xerostomia and to be safe, but primarily in patients with early-stage disease, prompting the investigators to examine whether it would also be safe and effective in patients with locally advanced tumors.

The question is particularly relevant at a time when the epidemiology of OP cancers is shifting toward patients who are positive for the human papillomavirus, who are more likely to have good therapeutic outcomes and who may live for many decades beyond an initial diagnosis, Dr. Robin said at the symposium cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

His team reviewed records of 71 patients treated for primary OP cancers at the University of Colorado and at Memorial Sloan-Kettering Cancer Center in New York.

In all, 40 patients had tonsillar cancers, 28 had base-of-tongue lesions, and 3 had cancers involving both sites.

They considered gland-sparing procedures as those in which total doses delivered to the contralateral submandibular gland during bilateral neck radiotherapy were not more than 39 Gy.

Of the 71 patients, 61 (85.9%) had stage IVA disease, 6 (8.5%) had stage III cancers, and 3 (4.2%) had stage IVB disease. The majority of patients had significant nodal involvement, with 46 (64.8%) having stage N2b; 7 (9.9%) N2c; and 3 (4.2%) having staging N3 disease.

The respective mean and median doses to the contralateral glands were 33.04 and 34.21 Gy.

At median follow-up of 27.3 months, there were 12 treatment failures: 1 local, 6 regional, and 5 distant failures. However, there were no cases of disease recurrence in contralateral level IB nodes, the investigators found. There was, however, one documented case of recurrence in contralateral level IIa lymph nodes.

"We believe this is evidence that contralateral submandibular gland sparing can be feasible and safe even in advanced node-positive head and neck cancers, including base- of-tongue lesions," Dr. Robin said,

The data suggest the need for a large prospective trial specifically addressing the safety and efficacy of contralateral submandibular gland-sparing therapy in patients with locally advanced head and neck cancers. Such studies should incorporate existing xerostomia-based quality-of-life assessments and formal sialometry studies, he added.

While the study shows that contralateral submandibular gland sparing is feasible, it raises the question of whether the technique might increase the dose to the muscles of the floor of the mouth, said Dr. Harry Quon of Johns Hopkins University in Baltimore, the invited discussant.

"There is emerging data that our chemoradiation approaches, with long-term follow-up maybe increases [patients’] risk of death, and one hypothesis that has been put forward is chronic aspiration with secondary injury to the lungs," he said.

Radiation injury to the floor-of-mouth muscles appears to be a significant risk factor for aspiration, indicating that future conformal approaches to treating cancers of the tonsils and tongue base should attempt to avoid delivering excessive doses to the midline mucosa, Dr. Quon said.

The study was internally funded. Dr. Robin and Dr. Quon reported having no financial disclosures.