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Cited by 41Head and Neck Cancer StudiesRadiation Therapy and DosimetryOral health in cancer treatment

A phase I/II study of the hypoxic cell sensitizer misonidazole as an adjunct to high fractional dose radiotherapy in patients with unresectable squamous cell carcinoma of the head and neck: A RTOG randomized study (#79-04)

Lee, Ding-Jen, Pajak, Thomas F., Stetz, Joanne, Order, Stanley E., Weissberg, Joseph B., Fischer, James J.·1989·International Journal of Radiation Oncology*Biology*Physics
DOI 10.1016/0360-3016(89)90343-x
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Abstract

A randomized prospective trial was performed to study the toxicity and efficacy of the hypoxic cell sensitizer, misonidazole (MISO), used as an adjunct to high fractional dose radiotherapy in the management of unresectable Stage III and IV squamous cell carcinomas of the oral cavity, oropharynx and hypopharynx. From June 1979 to February 1983, 42 patients were randomized with 40 patients available for analysis. In the radiotherapy (RT) only group, 19 patients received a short course of high fractional dose radiotherapy with 400 rad per day, 5 days per week, to a total of 4400 to 5200 rad. In the radiotherapy plus misonidazole group (RT + MISO) 21 patients received the same radiotherapy plus 1.5 gm/m2 of misonidazole 3 times a week for a total of 7 doses. The observed side effects associated with misonidazole were: persistent numbness and paresthesia (1 patient), transient peripheral nerve paresis and persistent paresthesia (1 patient), and nausea and vomiting (2 patients). The treatment related morbidities were similar in both groups. Acute mucositis was seen in 4 of 19 patients in the RT group and 3 of 21 patients in the RT + MISO group. Acute airway obstruction requiring tracheotomy was seen in 2 patients with massive tumor in the base of tongue (1 in each group). Severe dysphagia requiring NG tube feeding was seen in 3 patients in the RT + MISO group and 3 patients in the RT group. The initial complete response rate in the RT group was 53%, versus 48% in the RT + MISO group. The estimated 2-year loco-regional control rates were 10% for RT alone and 17% for RT + MISO (no significancy). These results indicate that the addition of misonidazole does not improve the efficacy of high fractional dose radiotherapy for management of unresectable head and neck carcinomas. However, high fractional dose radiotherapy can be administered for the management of advanced head and neck carcinomas with acceptable morbidity and thus, is a useful regimen for future clinical trials of hyperbaric oxygen or new hypoxic cell sensitizers.

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  • In a phase I/II study, MISO as an adjunct to high-fractional dose radiotherapy for unresectable stage III and IV oral, oropharyngeal, and hypopharyngeal squamous cell carcinoma did not improve efficacy.

    “In the phase I/II study, the hypoxic cell sensitizer misonidazole (MISO) was used as an adjunct to high‐fractional dose radiotherapy for unresectable stage III and IV oral, oropharyngeal, and hypopharyngeal squamous cell carcinoma. 360 However, the study showed that MISO does not improve the efficacy of high fractional dose radiotherapy.”

    From Hypoxia signaling in cancer: Implications for therapeutic interventions (2023) · cites this paper as [360]

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Authors
Lee, D.-J., Pajak, T. F., Stetz, J., Order, S. E., Weissberg, J. B., & Fischer, J. J.
Affiliations
  • American College of Radiology (US)
  • Yale University (US)
Corresponding author
Lee, Ding-Jen
Venue
International Journal of Radiation Oncology*Biology*Physics
Publisher
Elsevier BV
Published
1989-02
Volume
16
Issue
2
Pages
465-470
ISSN
0360-3016 (ISSN-L)
DOI
10.1016/0360-3016(89)90343-x
OpenAlex
W2124376738
Cited by
41
References
24
Citations by year
2026: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2017: 1 · 2015: 1 · 2014: 3 · 2013: 1
FWCI
2.53
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • International Journal of Radiation Oncology*Biology*Physics (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Cancer Institute (CA 32115, CA-21661, CA29536)
Topics
  • Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Radiation Therapy and Dosimetry
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Oral health in cancer treatment
Keywords
hypoxic cell radiosensitizers, head and neck squamous cell carcinoma, unresectable tumors, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, radiotherapy toxicity, acute mucositis, dysphagia, locoregional control, hyperbaric oxygen therapy, RTOG
MeSH terms
Aged, Carcinoma, Squamous Cell, Clinical Trials as Topic, Combined Modality Therapy, Female, Head and Neck Neoplasms, Humans, Male, Middle Aged, Misonidazole, Prospective Studies, Radiotherapy, Radiotherapy Dosage, Random Allocation, Multicenter Studies as Topic

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