Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx

A Phase 1 Dose-Escalation Study

Alan C. Hartford, Thomas H. Davis, Jay C. Buckey, Robert L. Foote, Mark S. Sinesi, Benjamin B. Williams, Anna K. Fariss, Philip E. Schaner, Paul L. Claus, Scott Heitaka Okuno, James R. Hussey, Richard E. Clarke

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose To explore, in a dose-escalation study, the feasibility of hyperbaric oxygen (HBO) treatments immediately before intensity modulated radiation therapy in conjunction with cisplatinum chemotherapy for squamous cell carcinoma of the head and neck (SCCHN). Methods and Materials Eligible patients presented with SCCHN (stage III-IV [M0]), life expectancy >6 months, and Karnofsky performance status ≥70. Enrollees received intensity modulated radiation therapy, 70 Gy in 35 fractions over 7 weeks with weekly cisplatinum. Patients received HBO—100% oxygen, 2.4 atmospheres absolute (ATA) for 30 minutes—twice per week initially. Subsequent patients were escalated to 3 and then 5 times per week. Intensity modulated radiation therapy began within 15 minutes after HBO. Patients were followed for 2 years after RT with quality-of-life questionnaires (Performance Status Scale–Head and Neck Cancer and the Functional Assessment of Cancer Therapy–Head and Neck Cancer) and for 5+ years for local recurrence, distant metastases, disease-specific survival, and overall survival. Results Twelve subjects enrolled from 3 centers. Two withdrew during radiation therapy and 1 within 14 weeks after radiation therapy. The remaining 9 had primary oropharyngeal disease and were stage IVA (7) or IVB (2). No dose-limiting toxicities were observed with daily HBO. Two patients (22%) required pressure equalization tubes. The average time between HBO and radiation therapy was 8.5 minutes, with 2 of 231 administrations delivered beyond 15 minutes (0.5%). Per-protocol analysis showed a clinical complete response in 7 and a pathologic complete response without tumor in salvage neck dissections in 2. With minimum follow-up of 61 months, per-protocol 5-year overall survival was 100%, local recurrence 0%, and distant metastases 11%. Patient-reported outcomes for quality of life (Functional Assessment of Cancer Therapy–Head and Neck Cancer) were comparable to published results for chemoradiotherapy without HBO. Conclusions While acknowledging the study's small size and early attrition of 3 patients, our in-depth review of the acquired data indicates the feasibility of combining HBO with chemoradiation.

Original languageEnglish (US)
Pages (from-to)481-486
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume97
Issue number3
DOIs
StatePublished - Mar 1 2017

Fingerprint

Radiation-Sensitizing Agents
Oropharynx
Head and Neck Neoplasms
Squamous Cell Carcinoma
cancer
Oxygen
Radiotherapy
dosage
radiation therapy
oxygen
radiation
metastasis
Survival
Quality of Life
Neoplasm Metastasis
Karnofsky Performance Status
Recurrence
Hyperbaric Oxygenation
Neck Dissection
Feasibility Studies

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx : A Phase 1 Dose-Escalation Study. / Hartford, Alan C.; Davis, Thomas H.; Buckey, Jay C.; Foote, Robert L.; Sinesi, Mark S.; Williams, Benjamin B.; Fariss, Anna K.; Schaner, Philip E.; Claus, Paul L.; Okuno, Scott Heitaka; Hussey, James R.; Clarke, Richard E.

In: International Journal of Radiation Oncology Biology Physics, Vol. 97, No. 3, 01.03.2017, p. 481-486.

Research output: Contribution to journalArticle

Hartford, AC, Davis, TH, Buckey, JC, Foote, RL, Sinesi, MS, Williams, BB, Fariss, AK, Schaner, PE, Claus, PL, Okuno, SH, Hussey, JR & Clarke, RE 2017, 'Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx: A Phase 1 Dose-Escalation Study', International Journal of Radiation Oncology Biology Physics, vol. 97, no. 3, pp. 481-486. https://doi.org/10.1016/j.ijrobp.2016.10.048
Hartford, Alan C. ; Davis, Thomas H. ; Buckey, Jay C. ; Foote, Robert L. ; Sinesi, Mark S. ; Williams, Benjamin B. ; Fariss, Anna K. ; Schaner, Philip E. ; Claus, Paul L. ; Okuno, Scott Heitaka ; Hussey, James R. ; Clarke, Richard E. / Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx : A Phase 1 Dose-Escalation Study. In: International Journal of Radiation Oncology Biology Physics. 2017 ; Vol. 97, No. 3. pp. 481-486.
@article{46ae11aa12ff4a049b3f1555ac153030,
title = "Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx: A Phase 1 Dose-Escalation Study",
abstract = "Purpose To explore, in a dose-escalation study, the feasibility of hyperbaric oxygen (HBO) treatments immediately before intensity modulated radiation therapy in conjunction with cisplatinum chemotherapy for squamous cell carcinoma of the head and neck (SCCHN). Methods and Materials Eligible patients presented with SCCHN (stage III-IV [M0]), life expectancy >6 months, and Karnofsky performance status ≥70. Enrollees received intensity modulated radiation therapy, 70 Gy in 35 fractions over 7 weeks with weekly cisplatinum. Patients received HBO—100{\%} oxygen, 2.4 atmospheres absolute (ATA) for 30 minutes—twice per week initially. Subsequent patients were escalated to 3 and then 5 times per week. Intensity modulated radiation therapy began within 15 minutes after HBO. Patients were followed for 2 years after RT with quality-of-life questionnaires (Performance Status Scale–Head and Neck Cancer and the Functional Assessment of Cancer Therapy–Head and Neck Cancer) and for 5+ years for local recurrence, distant metastases, disease-specific survival, and overall survival. Results Twelve subjects enrolled from 3 centers. Two withdrew during radiation therapy and 1 within 14 weeks after radiation therapy. The remaining 9 had primary oropharyngeal disease and were stage IVA (7) or IVB (2). No dose-limiting toxicities were observed with daily HBO. Two patients (22{\%}) required pressure equalization tubes. The average time between HBO and radiation therapy was 8.5 minutes, with 2 of 231 administrations delivered beyond 15 minutes (0.5{\%}). Per-protocol analysis showed a clinical complete response in 7 and a pathologic complete response without tumor in salvage neck dissections in 2. With minimum follow-up of 61 months, per-protocol 5-year overall survival was 100{\%}, local recurrence 0{\%}, and distant metastases 11{\%}. Patient-reported outcomes for quality of life (Functional Assessment of Cancer Therapy–Head and Neck Cancer) were comparable to published results for chemoradiotherapy without HBO. Conclusions While acknowledging the study's small size and early attrition of 3 patients, our in-depth review of the acquired data indicates the feasibility of combining HBO with chemoradiation.",
author = "Hartford, {Alan C.} and Davis, {Thomas H.} and Buckey, {Jay C.} and Foote, {Robert L.} and Sinesi, {Mark S.} and Williams, {Benjamin B.} and Fariss, {Anna K.} and Schaner, {Philip E.} and Claus, {Paul L.} and Okuno, {Scott Heitaka} and Hussey, {James R.} and Clarke, {Richard E.}",
year = "2017",
month = "3",
day = "1",
doi = "10.1016/j.ijrobp.2016.10.048",
language = "English (US)",
volume = "97",
pages = "481--486",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx

T2 - A Phase 1 Dose-Escalation Study

AU - Hartford, Alan C.

AU - Davis, Thomas H.

AU - Buckey, Jay C.

AU - Foote, Robert L.

AU - Sinesi, Mark S.

AU - Williams, Benjamin B.

AU - Fariss, Anna K.

AU - Schaner, Philip E.

AU - Claus, Paul L.

AU - Okuno, Scott Heitaka

AU - Hussey, James R.

AU - Clarke, Richard E.

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Purpose To explore, in a dose-escalation study, the feasibility of hyperbaric oxygen (HBO) treatments immediately before intensity modulated radiation therapy in conjunction with cisplatinum chemotherapy for squamous cell carcinoma of the head and neck (SCCHN). Methods and Materials Eligible patients presented with SCCHN (stage III-IV [M0]), life expectancy >6 months, and Karnofsky performance status ≥70. Enrollees received intensity modulated radiation therapy, 70 Gy in 35 fractions over 7 weeks with weekly cisplatinum. Patients received HBO—100% oxygen, 2.4 atmospheres absolute (ATA) for 30 minutes—twice per week initially. Subsequent patients were escalated to 3 and then 5 times per week. Intensity modulated radiation therapy began within 15 minutes after HBO. Patients were followed for 2 years after RT with quality-of-life questionnaires (Performance Status Scale–Head and Neck Cancer and the Functional Assessment of Cancer Therapy–Head and Neck Cancer) and for 5+ years for local recurrence, distant metastases, disease-specific survival, and overall survival. Results Twelve subjects enrolled from 3 centers. Two withdrew during radiation therapy and 1 within 14 weeks after radiation therapy. The remaining 9 had primary oropharyngeal disease and were stage IVA (7) or IVB (2). No dose-limiting toxicities were observed with daily HBO. Two patients (22%) required pressure equalization tubes. The average time between HBO and radiation therapy was 8.5 minutes, with 2 of 231 administrations delivered beyond 15 minutes (0.5%). Per-protocol analysis showed a clinical complete response in 7 and a pathologic complete response without tumor in salvage neck dissections in 2. With minimum follow-up of 61 months, per-protocol 5-year overall survival was 100%, local recurrence 0%, and distant metastases 11%. Patient-reported outcomes for quality of life (Functional Assessment of Cancer Therapy–Head and Neck Cancer) were comparable to published results for chemoradiotherapy without HBO. Conclusions While acknowledging the study's small size and early attrition of 3 patients, our in-depth review of the acquired data indicates the feasibility of combining HBO with chemoradiation.

AB - Purpose To explore, in a dose-escalation study, the feasibility of hyperbaric oxygen (HBO) treatments immediately before intensity modulated radiation therapy in conjunction with cisplatinum chemotherapy for squamous cell carcinoma of the head and neck (SCCHN). Methods and Materials Eligible patients presented with SCCHN (stage III-IV [M0]), life expectancy >6 months, and Karnofsky performance status ≥70. Enrollees received intensity modulated radiation therapy, 70 Gy in 35 fractions over 7 weeks with weekly cisplatinum. Patients received HBO—100% oxygen, 2.4 atmospheres absolute (ATA) for 30 minutes—twice per week initially. Subsequent patients were escalated to 3 and then 5 times per week. Intensity modulated radiation therapy began within 15 minutes after HBO. Patients were followed for 2 years after RT with quality-of-life questionnaires (Performance Status Scale–Head and Neck Cancer and the Functional Assessment of Cancer Therapy–Head and Neck Cancer) and for 5+ years for local recurrence, distant metastases, disease-specific survival, and overall survival. Results Twelve subjects enrolled from 3 centers. Two withdrew during radiation therapy and 1 within 14 weeks after radiation therapy. The remaining 9 had primary oropharyngeal disease and were stage IVA (7) or IVB (2). No dose-limiting toxicities were observed with daily HBO. Two patients (22%) required pressure equalization tubes. The average time between HBO and radiation therapy was 8.5 minutes, with 2 of 231 administrations delivered beyond 15 minutes (0.5%). Per-protocol analysis showed a clinical complete response in 7 and a pathologic complete response without tumor in salvage neck dissections in 2. With minimum follow-up of 61 months, per-protocol 5-year overall survival was 100%, local recurrence 0%, and distant metastases 11%. Patient-reported outcomes for quality of life (Functional Assessment of Cancer Therapy–Head and Neck Cancer) were comparable to published results for chemoradiotherapy without HBO. Conclusions While acknowledging the study's small size and early attrition of 3 patients, our in-depth review of the acquired data indicates the feasibility of combining HBO with chemoradiation.

UR - http://www.scopus.com/inward/record.url?scp=85010007269&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85010007269&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2016.10.048

DO - 10.1016/j.ijrobp.2016.10.048

M3 - Article

VL - 97

SP - 481

EP - 486

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 3

ER -