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Combined therapy for resectable head and neck cancer. A phase 3 intergroup study
D E Schuller1, G Laramore, M Al-Sarraf
1Department of Otolaryngology, Ohio State University, Columbus 43210.
Archives of Otolaryngology--Head & Neck Surgery
|March 1, 1989
Summary
This phase 3 trial evaluated chemotherapy for advanced head and neck cancer. While toxic reactions were tolerable, patient accrual faced challenges, impacting the study
Area of Science:
- Oncology
- Clinical Trials
- Head and Neck Cancer Research
Background:
- Advanced stage squamous cell carcinoma of the head and neck presents a significant treatment challenge.
- Multimodality treatment approaches are often necessary for resectable disease.
Purpose of the Study:
- To evaluate the role of chemotherapy in previously untreated, advanced stage, resectable squamous cell carcinoma of the head and neck.
- To assess the efficacy and toxicity of combined modality treatment including surgery, chemotherapy, and radiation therapy.
Main Methods:
- Phase 3 randomized prospective trial.
- Involved multiple cooperative oncology groups.
- Analysis of 266 patients with 133 in each treatment group.
Main Results:
- Surgical, chemotherapy, and radiation therapy toxic reactions were generally in the tolerable range.
- The most severe toxic reactions were observed in patients receiving both surgery and radiation therapy.
- Challenges in patient accrual included positive surgical margins, patient refusal, and surgical complications.
Conclusions:
- Chemotherapy can be integrated into the treatment of advanced resectable head and neck cancer.
- Careful management of toxicities is crucial, particularly with combined modality treatments.
- Improving patient accrual and addressing reasons for non-randomization are essential for future clinical trials.