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Intensification regimen 2 for advanced head and neck squamous cell carcinomas.

J C Grecula1, D E Schuller, C A Rhoades

  • 1Division of Radiation Oncology, Arthur G. James Cancer Hospital, The Ohio State University Comprehensive Cancer Center, Columbus 43210, USA.

Archives of Otolaryngology--Head & Neck Surgery
|December 22, 1999
PubMed
Summary

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This study found that while patient compliance and local control were promising for advanced head and neck cancer, the intense treatment regimen caused unacceptable toxicity. Modifications were made to improve the paclitaxel delivery.

Area of Science:

  • Oncology
  • Head and Neck Cancer Research
  • Clinical Trials

Background:

  • Advanced, resectable head and neck squamous cell carcinomas require effective treatment strategies.
  • Intense perioperative chemotherapy and radiotherapy regimens are being explored for improved outcomes.

Purpose of the Study:

  • To assess the feasibility, toxicity, and compliance of an aggressive treatment regimen in patients with advanced, previously untreated, resectable head and neck squamous cell carcinomas.
  • To evaluate local control and distant metastatic rates associated with this intensive approach.

Main Methods:

  • A prospective, nonrandomized, controlled clinical trial (Phase 1/2) involving 43 patients.
  • The regimen included hyperfractionated radiotherapy, cisplatin, surgical resection with intraoperative radiotherapy, and paclitaxel with granulocyte colony-stimulating factor support.

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  • Key outcome measures were toxicity, compliance, local control, and distant metastasis rates.

    • Main Results:

    • Patient compliance was high (91%), but protocol compliance was lower (58%) due to significant systemic toxicity.
    • Grade 3-5 hematologic toxicity occurred in 65% of patients.
    • Local-regional control was achieved in 92% of patients who completed the protocol, with an 8% distant metastatic rate.

    Conclusions:

    • The intensive regimen demonstrated encouraging local control and patient compliance but exhibited unacceptable systemic toxicity.
    • Modifications, specifically altering the paclitaxel regimen to a weekly schedule, were implemented to mitigate toxicity while aiming to maintain efficacy.