Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma

Daniel J. Ma, Katharine A. Price, Eric J. Moore, Samir H. Patel, Michael L. Hinni, Joaquin J. Garcia, Darlene E. Graner, Nathan R. Foster, Brenda Ginos, Michelle Neben-Wittich, Yolanda Isabel Garces, Ashish Chintakuntlawar, Daniel L. Price, Kerry D. Olsen, Kathryn M. Van Abel, Jan Kasperbauer, Jeffrey R. Janus, Mark Waddle, Robert Miller, Satomi ShiraishiRobert L. Foote

Research output: Contribution to journalArticle

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Abstract

PURPOSE: The purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL). PATIENTS AND METHODS: MC1273 was a single-arm phase II trial testing an aggressive course of RT de-escalation after surgery. Eligibility criteria included patients with p16-positive oropharyngeal squamous cell carcinoma, smoking history of 10 pack-years or less, and negative margins. Cohort A (intermediate risk) received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week. Cohort B included patients with extranodal extension who received the same treatment plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day. The primary end point was locoregional tumor control at 2 years. Secondary end points included 2-year progression-free survival, overall survival, toxicity, swallow function, and patient-reported QOL. RESULTS: Accrual was from September 2013 to June 2016 (N = 80; cohort A, n = 37; cohort B, n = 43). Median follow-up was 36 months, with a minimum follow-up of 25 months. The 2-year locoregional tumor control rate was 96.2%, with progression-free survival of 91.1% and overall survival of 98.7%. Rates of grade 3 or worse toxicity at pre-RT and 1 and 2 years post-RT were 2.5%, 0%, and 0%. Swallowing function improved slightly between pre-RT and 12 months post-RT, with one patient requiring temporary feeding tube placement. CONCLUSION: Aggressive RT de-escalation resulted in locoregional tumor control rates comparable to historical controls, low toxicity, and little decrement in swallowing function or QOL.

Original languageEnglish (US)
Pages (from-to)1909-1918
Number of pages10
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume37
Issue number22
DOIs
StatePublished - Aug 1 2019

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Adjuvant Chemoradiotherapy
Oropharynx
Squamous Cell Carcinoma
Radiotherapy
Deglutition
Quality of Life
docetaxel
Disease-Free Survival
Neoplasms
Adjuvant Radiotherapy
Survival
Enteral Nutrition
Smoking

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma. / Ma, Daniel J.; Price, Katharine A.; Moore, Eric J.; Patel, Samir H.; Hinni, Michael L.; Garcia, Joaquin J.; Graner, Darlene E.; Foster, Nathan R.; Ginos, Brenda; Neben-Wittich, Michelle; Garces, Yolanda Isabel; Chintakuntlawar, Ashish; Price, Daniel L.; Olsen, Kerry D.; Van Abel, Kathryn M.; Kasperbauer, Jan; Janus, Jeffrey R.; Waddle, Mark; Miller, Robert; Shiraishi, Satomi; Foote, Robert L.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 37, No. 22, 01.08.2019, p. 1909-1918.

Research output: Contribution to journalArticle

Ma, DJ, Price, KA, Moore, EJ, Patel, SH, Hinni, ML, Garcia, JJ, Graner, DE, Foster, NR, Ginos, B, Neben-Wittich, M, Garces, YI, Chintakuntlawar, A, Price, DL, Olsen, KD, Van Abel, KM, Kasperbauer, J, Janus, JR, Waddle, M, Miller, R, Shiraishi, S & Foote, RL 2019, 'Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 37, no. 22, pp. 1909-1918. https://doi.org/10.1200/JCO.19.00463
Ma, Daniel J. ; Price, Katharine A. ; Moore, Eric J. ; Patel, Samir H. ; Hinni, Michael L. ; Garcia, Joaquin J. ; Graner, Darlene E. ; Foster, Nathan R. ; Ginos, Brenda ; Neben-Wittich, Michelle ; Garces, Yolanda Isabel ; Chintakuntlawar, Ashish ; Price, Daniel L. ; Olsen, Kerry D. ; Van Abel, Kathryn M. ; Kasperbauer, Jan ; Janus, Jeffrey R. ; Waddle, Mark ; Miller, Robert ; Shiraishi, Satomi ; Foote, Robert L. / Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019 ; Vol. 37, No. 22. pp. 1909-1918.
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title = "Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma",
abstract = "PURPOSE: The purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL). PATIENTS AND METHODS: MC1273 was a single-arm phase II trial testing an aggressive course of RT de-escalation after surgery. Eligibility criteria included patients with p16-positive oropharyngeal squamous cell carcinoma, smoking history of 10 pack-years or less, and negative margins. Cohort A (intermediate risk) received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week. Cohort B included patients with extranodal extension who received the same treatment plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day. The primary end point was locoregional tumor control at 2 years. Secondary end points included 2-year progression-free survival, overall survival, toxicity, swallow function, and patient-reported QOL. RESULTS: Accrual was from September 2013 to June 2016 (N = 80; cohort A, n = 37; cohort B, n = 43). Median follow-up was 36 months, with a minimum follow-up of 25 months. The 2-year locoregional tumor control rate was 96.2{\%}, with progression-free survival of 91.1{\%} and overall survival of 98.7{\%}. Rates of grade 3 or worse toxicity at pre-RT and 1 and 2 years post-RT were 2.5{\%}, 0{\%}, and 0{\%}. Swallowing function improved slightly between pre-RT and 12 months post-RT, with one patient requiring temporary feeding tube placement. CONCLUSION: Aggressive RT de-escalation resulted in locoregional tumor control rates comparable to historical controls, low toxicity, and little decrement in swallowing function or QOL.",
author = "Ma, {Daniel J.} and Price, {Katharine A.} and Moore, {Eric J.} and Patel, {Samir H.} and Hinni, {Michael L.} and Garcia, {Joaquin J.} and Graner, {Darlene E.} and Foster, {Nathan R.} and Brenda Ginos and Michelle Neben-Wittich and Garces, {Yolanda Isabel} and Ashish Chintakuntlawar and Price, {Daniel L.} and Olsen, {Kerry D.} and {Van Abel}, {Kathryn M.} and Jan Kasperbauer and Janus, {Jeffrey R.} and Mark Waddle and Robert Miller and Satomi Shiraishi and Foote, {Robert L.}",
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T1 - Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma

AU - Ma, Daniel J.

AU - Price, Katharine A.

AU - Moore, Eric J.

AU - Patel, Samir H.

AU - Hinni, Michael L.

AU - Garcia, Joaquin J.

AU - Graner, Darlene E.

AU - Foster, Nathan R.

AU - Ginos, Brenda

AU - Neben-Wittich, Michelle

AU - Garces, Yolanda Isabel

AU - Chintakuntlawar, Ashish

AU - Price, Daniel L.

AU - Olsen, Kerry D.

AU - Van Abel, Kathryn M.

AU - Kasperbauer, Jan

AU - Janus, Jeffrey R.

AU - Waddle, Mark

AU - Miller, Robert

AU - Shiraishi, Satomi

AU - Foote, Robert L.

PY - 2019/8/1

Y1 - 2019/8/1

N2 - PURPOSE: The purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL). PATIENTS AND METHODS: MC1273 was a single-arm phase II trial testing an aggressive course of RT de-escalation after surgery. Eligibility criteria included patients with p16-positive oropharyngeal squamous cell carcinoma, smoking history of 10 pack-years or less, and negative margins. Cohort A (intermediate risk) received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week. Cohort B included patients with extranodal extension who received the same treatment plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day. The primary end point was locoregional tumor control at 2 years. Secondary end points included 2-year progression-free survival, overall survival, toxicity, swallow function, and patient-reported QOL. RESULTS: Accrual was from September 2013 to June 2016 (N = 80; cohort A, n = 37; cohort B, n = 43). Median follow-up was 36 months, with a minimum follow-up of 25 months. The 2-year locoregional tumor control rate was 96.2%, with progression-free survival of 91.1% and overall survival of 98.7%. Rates of grade 3 or worse toxicity at pre-RT and 1 and 2 years post-RT were 2.5%, 0%, and 0%. Swallowing function improved slightly between pre-RT and 12 months post-RT, with one patient requiring temporary feeding tube placement. CONCLUSION: Aggressive RT de-escalation resulted in locoregional tumor control rates comparable to historical controls, low toxicity, and little decrement in swallowing function or QOL.

AB - PURPOSE: The purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL). PATIENTS AND METHODS: MC1273 was a single-arm phase II trial testing an aggressive course of RT de-escalation after surgery. Eligibility criteria included patients with p16-positive oropharyngeal squamous cell carcinoma, smoking history of 10 pack-years or less, and negative margins. Cohort A (intermediate risk) received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week. Cohort B included patients with extranodal extension who received the same treatment plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day. The primary end point was locoregional tumor control at 2 years. Secondary end points included 2-year progression-free survival, overall survival, toxicity, swallow function, and patient-reported QOL. RESULTS: Accrual was from September 2013 to June 2016 (N = 80; cohort A, n = 37; cohort B, n = 43). Median follow-up was 36 months, with a minimum follow-up of 25 months. The 2-year locoregional tumor control rate was 96.2%, with progression-free survival of 91.1% and overall survival of 98.7%. Rates of grade 3 or worse toxicity at pre-RT and 1 and 2 years post-RT were 2.5%, 0%, and 0%. Swallowing function improved slightly between pre-RT and 12 months post-RT, with one patient requiring temporary feeding tube placement. CONCLUSION: Aggressive RT de-escalation resulted in locoregional tumor control rates comparable to historical controls, low toxicity, and little decrement in swallowing function or QOL.

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