A prospective phase II trial of concomitant chemotherapy and radiotherapy with delayed accelerated fractionation in unresectable tumors of the head and neck Journal Article


Authors: Harrison, L. B.; Raben, A.; Pfister, D. G.; Zelefsky, M.; Strong, E.; Shah, J. P.; Spiro, R. H.; Shaha, A.; Kraus, D. H.; Schantz, S. P.; Carper, E.; Bodansky, B.; White, C.; Bosl, G.
Article Title: A prospective phase II trial of concomitant chemotherapy and radiotherapy with delayed accelerated fractionation in unresectable tumors of the head and neck
Abstract: Background. Our study is a prospective evaluation of unresectable malignant cancers of the head and neck treated with concomitant chemotherapy and radiotherapy (RT) using delayed accelerated fractionation (concomitant boost). Methods: Between January 1988 and March 1995, 82 patients with unresectable cancers of the head and neck were enrolled in this phase II study. Of these, 52 patients were treated and followed for a minimum of 3 years and are the subject of this analysis. All patients had T-4 lesions and were stage IV according to the American Joint Committee on Staging Criteria (AJCC). Patients received RT with accelerated fractionation to a total of 70 Gy in 6 weeks using a concomitant-boost technique. Concomitant cis platin (100 mg/M2) was given on days 1 and 22 of RT. Twenty-seven patients received mitomycin-C (7.5 mg/M2) on days 1 and 22, and 1 patient received mitomycin- C on day 1. In addition, 27 patients received adjuvant chemotherapy with cis platin and vinblastine. The mean follow-up was 45 months (range, 36-72 months). The minimum follow-up for surviving patients is 3 years. Results. At 3 years, the local control rate was 58%. Three-year local control rates for paranasal sinus, nasopharynx, oropharynx, and larynx/hypopharynx were 78%, 78%, 64%, and 100%, respectively. For all patients, the distant-metastasis- free survival was 56%, and the overall survival rate was 36%. Patients with oral cavity cancers experienced worse overall survival versus other sites, 0% versus 47% (p = .03). Salivary cancers also showed worse survival versus other sites, 0% versus 47%, but was not statistically significant. Severe acute complications occurred in 34% of patients. Treatment-related toxicity also resulted in the death of 2 patients. Severe late complications occurred in 7% of patients. Conclusions. Treatment of this poor prognostic group of patients with aggressive chemotherapy and RT produced surprisingly good local control and survival.
Keywords: adolescent; adult; cancer survival; treatment outcome; aged; middle aged; survival rate; major clinical study; clinical trial; cancer localization; cisplatin; dose response; combined modality therapy; chemotherapy; neoplasm staging; prospective studies; palliative care; metastasis; lung toxicity; phase 2 clinical trial; mucosa inflammation; antineoplastic combined chemotherapy protocols; drug administration schedule; radiotherapy; vinblastine; cancer inhibition; head and neck cancer; head and neck neoplasms; pilot projects; radiation dose fractionation; mitomycin c; inoperable cancer; dose fractionation; antibiotics, antineoplastic; radiation-sensitizing agents; brain necrosis; blindness; meningitis; bone necrosis; head and neck carcinoma; granulocytopenia; unresectable; cerebrospinal fluid fistula; mitomycins; humans; prognosis; human; male; female; priority journal; article
Journal Title: Head & Neck
Volume: 20
Issue: 6
ISSN: 1043-3074
Publisher: John Wiley & Sons, Inc.  
Date Published: 1998-09-01
Start Page: 497
End Page: 503
Language: English
DOI: 10.1002/(sici)1097-0347(199809)20:6<497::aid-hed2>3.0.co;2-h
PUBMED: 9702535
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 12 December 2016 -- Source: Scopus
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MSK Authors
  1. Michael J Zelefsky
    754 Zelefsky
  2. Dennis Kraus
    268 Kraus
  3. Ashok R Shaha
    698 Shaha
  4. Stimson P Schantz
    115 Schantz
  5. David G Pfister
    389 Pfister
  6. Jatin P Shah
    722 Shah
  7. George Bosl
    430 Bosl
  8. Elliot W Strong
    97 Strong
  9. Ronald H Spiro
    105 Spiro
  10. Louis B Harrison
    123 Harrison
  11. Adam Raben
    24 Raben