De‐Escalated Adjuvant Therapy After Transoral Robotic Surgery for Human Papillomavirus‐Related Oropharyngeal Carcinoma: The Sinai Robotic Surgery (SIRS) Trial
Background Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced‐dose adjuvant therapy for early and interme...
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| Published in | The oncologist (Dayton, Ohio) Vol. 26; no. 6; pp. 504 - 513 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hoboken, USA
John Wiley & Sons, Inc
01.06.2021
Oxford University Press |
| Subjects | |
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| Abstract | Background
Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced‐dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression‐free survival (PFS) and overall survival while reducing toxicity.
Methods
This study was a nonrandomized phase II trial for early‐stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced‐dose radiotherapy. Patients with previously untreated p16‐positive HPVOPC and <20 pack years’ smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50‐Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56‐Gy chemoradiotherapy with weekly cisplatin).
Results
Fifty‐four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow‐up was 43.9 months (9.6–75.8). Disease‐specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan‐Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6–59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0–42.7 months); one subject remains alive with disease.
Conclusion
The results indicate that upfront surgery with neck dissection with reduced‐dose radiation for T1–2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de‐escalation strategy in HPVOPC.
Implications for Practice
Transoral robotic surgery can provide a safe platform for de‐escalation in carefully selected patients with early‐stage human papillomavirus‐related oropharyngeal cancer. In this clinical trial, disease‐specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged.
Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma results in high survival rates but unnecessary toxicity. The SIRS trial investigated the use of transoral robotic surgery with selective neck dissection, followed by reduced‐dose adjuvant therapy, to reduce toxicity and maintain overall and progression‐free survival rates. |
|---|---|
| AbstractList | Background
Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced‐dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression‐free survival (PFS) and overall survival while reducing toxicity.
Methods
This study was a nonrandomized phase II trial for early‐stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced‐dose radiotherapy. Patients with previously untreated p16‐positive HPVOPC and <20 pack years’ smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50‐Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56‐Gy chemoradiotherapy with weekly cisplatin).
Results
Fifty‐four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow‐up was 43.9 months (9.6–75.8). Disease‐specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan‐Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6–59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0–42.7 months); one subject remains alive with disease.
Conclusion
The results indicate that upfront surgery with neck dissection with reduced‐dose radiation for T1–2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de‐escalation strategy in HPVOPC.
Implications for Practice
Transoral robotic surgery can provide a safe platform for de‐escalation in carefully selected patients with early‐stage human papillomavirus‐related oropharyngeal cancer. In this clinical trial, disease‐specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged.
Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma results in high survival rates but unnecessary toxicity. The SIRS trial investigated the use of transoral robotic surgery with selective neck dissection, followed by reduced‐dose adjuvant therapy, to reduce toxicity and maintain overall and progression‐free survival rates. Background. Treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced-dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression-free survival (PFS) and overall survival while reducing toxicity. Methods. This study was a nonrandomized phase II trial for early-stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced-dose radiotherapy. Patients with previously untreated p16-positive HPVOPC and <20 pack years' smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50-Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56-Gy chemoradiotherapy with weekly cisplatin). Results. Fifty-four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow-up was 43.9 months (9.6-75.8). Disease-specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan-Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6-59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0-42.7 months); one subject remains alive with disease. Conclusion. The results indicate that upfront surgery with neck dissection with reduced-dose radiation for T1-2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de-escalation strategy in HPVOPC. Key Words. Oropharynx cancer * Human papillomavirus * Transoral robotic surgery * De-escalation Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma results in high survival rates but unnecessary toxicity. The SIRS trial investigated the use of transoral robotic surgery with selective neck dissection, followed by reduced‐dose adjuvant therapy, to reduce toxicity and maintain overall and progression‐free survival rates. Treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced-dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression-free survival (PFS) and overall survival while reducing toxicity.BACKGROUNDTreatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced-dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression-free survival (PFS) and overall survival while reducing toxicity.This study was a nonrandomized phase II trial for early-stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced-dose radiotherapy. Patients with previously untreated p16-positive HPVOPC and <20 pack years' smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50-Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56-Gy chemoradiotherapy with weekly cisplatin).METHODSThis study was a nonrandomized phase II trial for early-stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced-dose radiotherapy. Patients with previously untreated p16-positive HPVOPC and <20 pack years' smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50-Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56-Gy chemoradiotherapy with weekly cisplatin).Fifty-four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow-up was 43.9 months (9.6-75.8). Disease-specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan-Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6-59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0-42.7 months); one subject remains alive with disease.RESULTSFifty-four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow-up was 43.9 months (9.6-75.8). Disease-specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan-Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6-59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0-42.7 months); one subject remains alive with disease.The results indicate that upfront surgery with neck dissection with reduced-dose radiation for T1-2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de-escalation strategy in HPVOPC.CONCLUSIONThe results indicate that upfront surgery with neck dissection with reduced-dose radiation for T1-2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de-escalation strategy in HPVOPC.Transoral robotic surgery can provide a safe platform for de-escalation in carefully selected patients with early-stage human papillomavirus-related oropharyngeal cancer. In this clinical trial, disease-specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged.IMPLICATIONS FOR PRACTICETransoral robotic surgery can provide a safe platform for de-escalation in carefully selected patients with early-stage human papillomavirus-related oropharyngeal cancer. In this clinical trial, disease-specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged. Treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary toxicity. We hypothesized that upfront surgery and neck dissection followed by reduced-dose adjuvant therapy for early and intermediate HPVOPC would ultimately result in equivalent progression-free survival (PFS) and overall survival while reducing toxicity. This study was a nonrandomized phase II trial for early-stage HPVOPC treated with transoral robotic surgery (TORS) followed by reduced-dose radiotherapy. Patients with previously untreated p16-positive HPVOPC and <20 pack years' smoking history were enrolled. After robotic surgery, patients were assigned to group 1 (no poor risk features; surveillance), group 2 (intermediate pathologic risk factors [perineural invasion, lymphovascular invasion]; 50-Gy radiotherapy), or group 3 (poor prognostic pathologic factors [extranodal extension [ENE], more than three positive lymph nodes and positive margin]; concurrent 56-Gy chemoradiotherapy with weekly cisplatin). Fifty-four patients were evaluable; there were 25 in group 1, 15 in group 2, and 14 in group 3. Median follow-up was 43.9 months (9.6-75.8). Disease-specific survival was 98.1%, and PFS was 90.7%. PFS probability via Kaplan-Meier was 91.3% for group 1, 86.7% for group 2, and 93.3% for group 3. There were five locoregional failures (LRFs), including one distant metastasis and one contralateral second primary. Average time to LRF was 18.9 months (9.6-59.0); four LRFs were successfully salvaged, and the patients remain disease free (11.0-42.7 months); one subject remains alive with disease. The results indicate that upfront surgery with neck dissection with reduced-dose radiation for T1-2, N1 stage (by the eighth edition American Joint Committee on Cancer staging manual) HPVOPC results in favorable survival with excellent function in this population. These results support radiation dose reduction after TORS as a de-escalation strategy in HPVOPC. Transoral robotic surgery can provide a safe platform for de-escalation in carefully selected patients with early-stage human papillomavirus-related oropharyngeal cancer. In this clinical trial, disease-specific survival was 100%, over 90% of the cohort had a reduction of therapy from standard of care with excellent functional results, and the five patients with observed locoregional failures were successfully salvaged. |
| Audience | Professional Academic |
| Author | Genden, Eric M. Som, Peter M. Chai, Raymond L. Miles, Brett A. Posner, Marshall R. Teng, Marita S. Misiukiewicz, Kryzsztof J. Dayal, Bheesham Sobotka, Stanislaw Gupta, Vishal Sikora, Andrew G. Kim‐Schulze, Seunghee Sharma, Sonam Westra, William H. Yao, Mike Bakst, Richard L. |
| AuthorAffiliation | 4 Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai New York New York USA 6 Department of Immune Monitoring, Icahn School of Medicine at Mount Sinai New York New York USA 2 Department of Otolaryngology, Icahn School of Medicine at Mount Sinai New York New York USA 5 Department of Pathology, Icahn School of Medicine at Mount Sinai New York New York USA 3 Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai New York New York USA 7 Department of Biostatistics, Icahn School of Medicine at Mount Sinai New York New York USA 1 Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai New York New York USA 8 Department of Radiology, Icahn School of Medicine at Mount Sinai New York New York USA 9 Department of Otolaryngology, Baylor College of Medicine Houston Texas USA |
| AuthorAffiliation_xml | – name: 2 Department of Otolaryngology, Icahn School of Medicine at Mount Sinai New York New York USA – name: 5 Department of Pathology, Icahn School of Medicine at Mount Sinai New York New York USA – name: 1 Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai New York New York USA – name: 6 Department of Immune Monitoring, Icahn School of Medicine at Mount Sinai New York New York USA – name: 3 Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai New York New York USA – name: 9 Department of Otolaryngology, Baylor College of Medicine Houston Texas USA – name: 8 Department of Radiology, Icahn School of Medicine at Mount Sinai New York New York USA – name: 7 Department of Biostatistics, Icahn School of Medicine at Mount Sinai New York New York USA – name: 4 Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai New York New York USA |
| Author_xml | – sequence: 1 givenname: Brett A. orcidid: 0000-0002-4880-6172 surname: Miles fullname: Miles, Brett A. email: brett.miles@mountsinai.org organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai – sequence: 2 givenname: Marshall R. surname: Posner fullname: Posner, Marshall R. organization: Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai – sequence: 3 givenname: Vishal surname: Gupta fullname: Gupta, Vishal organization: Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai – sequence: 4 givenname: Marita S. surname: Teng fullname: Teng, Marita S. organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai – sequence: 5 givenname: Richard L. surname: Bakst fullname: Bakst, Richard L. organization: Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai – sequence: 6 givenname: Mike surname: Yao fullname: Yao, Mike organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai – sequence: 7 givenname: Kryzsztof J. surname: Misiukiewicz fullname: Misiukiewicz, Kryzsztof J. organization: Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai – sequence: 8 givenname: Raymond L. surname: Chai fullname: Chai, Raymond L. organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai – sequence: 9 givenname: Sonam surname: Sharma fullname: Sharma, Sonam organization: Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai – sequence: 10 givenname: William H. surname: Westra fullname: Westra, William H. organization: Department of Pathology, Icahn School of Medicine at Mount Sinai – sequence: 11 givenname: Seunghee surname: Kim‐Schulze fullname: Kim‐Schulze, Seunghee organization: Department of Immune Monitoring, Icahn School of Medicine at Mount Sinai – sequence: 12 givenname: Bheesham surname: Dayal fullname: Dayal, Bheesham organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai – sequence: 13 givenname: Stanislaw surname: Sobotka fullname: Sobotka, Stanislaw organization: Department of Biostatistics, Icahn School of Medicine at Mount Sinai – sequence: 14 givenname: Andrew G. surname: Sikora fullname: Sikora, Andrew G. organization: Department of Otolaryngology, Baylor College of Medicine – sequence: 15 givenname: Peter M. surname: Som fullname: Som, Peter M. organization: Department of Radiology, Icahn School of Medicine at Mount Sinai – sequence: 16 givenname: Eric M. surname: Genden fullname: Genden, Eric M. organization: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai |
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| Keywords | Oropharynx cancer De-escalation Human papillomavirus Transoral robotic surgery |
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| PublicationDate | June 2021 |
| PublicationDateYYYYMMDD | 2021-06-01 |
| PublicationDate_xml | – month: 06 year: 2021 text: June 2021 |
| PublicationDecade | 2020 |
| PublicationPlace | Hoboken, USA |
| PublicationPlace_xml | – name: Hoboken, USA – name: England |
| PublicationTitle | The oncologist (Dayton, Ohio) |
| PublicationTitleAlternate | Oncologist |
| PublicationYear | 2021 |
| Publisher | John Wiley & Sons, Inc Oxford University Press |
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Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly... Treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly unnecessary... Background. Treatment of human papillomavirus-related oropharyngeal squamous cell carcinoma (HPVOPC) results in unprecedented high survival rates but possibly... Treatment of human papillomavirus‐related oropharyngeal squamous cell carcinoma results in high survival rates but unnecessary toxicity. The SIRS trial... |
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| SubjectTerms | Adjuvant treatment Alphapapillomavirus Cancer Carcinoma, Squamous Cell - pathology Care and treatment Complications and side effects De‐escalation Diagnosis Head and Neck Cancers Human papillomavirus Humans Neoplasm Staging Oropharyngeal Neoplasms - drug therapy Oropharyngeal Neoplasms - radiotherapy Oropharyngeal Neoplasms - surgery Oropharynx cancer Papillomaviridae Papillomavirus infections Papillomavirus Infections - pathology Patient outcomes Robotic surgery Robotic Surgical Procedures Systemic Inflammatory Response Syndrome Throat cancer Transoral robotic surgery |
| Title | De‐Escalated Adjuvant Therapy After Transoral Robotic Surgery for Human Papillomavirus‐Related Oropharyngeal Carcinoma: The Sinai Robotic Surgery (SIRS) Trial |
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