To assess late effects and quality of life in patients treated by three times daily (t.i.d.) radiotherapy with or without alternating chemotherapy for locally advanced squamous cell carcinoma of the head and neck.
Between 1986 and 1991, 153 patients with locally advanced tumors have been included in a phase I/II study consisting of t.i.d. radiotherapy (4 h. between fractions) of 2 Gy/fraction to a total dose of 60 Gy, alternated or not with combination chemotherapy. The first group of patients received radiotherapy alone, the other group received combined modality. Ninety-two patients were eligible for late effect assessment: 61 in the combined modality group and 31 in the radiation therapy only group. The median follow-up was 45 months. All patients have been assessed according to the follow-up clinical records using the RTOG/EORTC classification. Twenty-nine patients, who were alive at the time of our study, received a questionnaire on their quality of life, and were invited for a clinical evaluation using the SOMA-LENT scale.
Ninety percent of the patients treated by radiation therapy alone developed one or more late complications. Overall, 47% of the patients have developed severe complications (grade III and IV): 42% in the group treated by radiation therapy alone and 49% in the group treated with combined modality. In the group treated by radiation therapy alone, the most commonly damaged organs were the mucosa (83%), skin (51%) and salivary glands (42%). We observed one case of osteonecrosis and one case of radiation myelitis. In the combined modality group, 95% of patients developed one or more late sequelae, of which 79% had skin, 51% mucosa and 42% salivary gland late effects, respectively. We observed four cases of osteonecrosis. Quality of life and overall physical condition of the patients have been judged to be average by self-questionnaire. Assessment according to the SOMA-LENT scale showed serious late effects mainly at the level of the salivary glands, mandibles and teeth. Correspondence between the RTOG/EORTC and the SOMA-LENT scale was mediocre.
This unconventional 4-h three times daily radiotherapy protocol resulted in very severe late effects on normal tissue. However, combination with chemotherapy resulted in minimal additional toxicity. We emphasise that the SOMA-LENT scale is neither simple to use nor easy to interpret. Quality of life is a very subjective notion and is not necessarily correlated with the objective seriousness of complications.