The value of follow-up in patients treated for squamous cell carcinoma of the head and neck.

Clinical findings, treatment and results have been recorded prospectively in 661 patients with carcinoma of the head and neck. With an average follow-up of 3 years 7813 follow-up consultations revealed 220 recurrences. The overall "recurrence pick-up rate" and subsequent "cure rate" was 1:36 and 1:113 consultations, respectively. Laryngeal carcinomas treated with radiotherapy and oral carcinomas receiving radiotherapy and limited resections showed recurrence "cure-rates" of 1:89 and 1:110, respectively. For other tumour sites the average "cure-rate" was 1:238. Only 39% of the recurrences were detected through physical examination. Follow-up consultations revealed 9.1% of second primaries. More time should be spent on training patients to recognise symptoms and signs of recurrence. Routine follow-up is rarely indicated beyond the third year after completion of treatment, or in patients for whom we have little to offer in terms of curative treatment.

Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial.

A group of 222 consecutive patients admitted with squamous cell carcinoma of the upper aero-digestive tract were studied in a prospectively randomized and stratified clinical trial. One-half of the patients received bleomycin injected intramuscularly 1 hour before the radiation treatment daily for 5 days a week; the other half received radiation therapy without the added chemotherapy. The total dose of radiation in both groups was about the same, and was given with curative intent even to the patients with advanced tumors who constituted the majority in both groups. Interstitial radiation as boost therapy or surgery was added in patients with residual tumor if the lesions were considered operable and the patient's condition would allow surgery. The addition of bleomycin did not increase the combined local and regional tumor control rates nor did it improve the survival, but did significantly increase the morbidity and the complication rate.

The distribution of type I and type II cells in the cristae ampullaris of the guinea pig.

The sensory epithelium of the crista ampullaris can be divided both structurally and as regards sensitivity to noxious agents into a central and a peripheral zone. The question is, whether this differentiation is also reflected in the distribution of the two types of sensory cells. The present electron microscopic study, based on morphometric investigations of longitudinal and transverse sections through the crista, shows that in the guinea pig, the relative distribution of the two cell types is uniform throughout the sensory epithelium. There are about 60% type I and about 40% type II cells in both the central and peripheral areas of the crista.

Squamous cell carcinoma of the respiratory tract following laryngeal papillomatosis.

With the object to disclose an association between laryngeal papillomatosis and laryngeal carcinoma, we reviewed 102 patients with laryngeal papillomatosis treated between 1950 and 1979. Seven cases of laryngeal carcinomas were recorded and 1 patient with spread of papilloma to the bronchial tree developed a bronchial carcinoma. The time between onset of papilloma and diagnosis of carcinoma was 4-55 years (mean 24 years). For laryngeal carcinoma the ratio of observed to expected cases was 88. Of the 8 patients developing respiratory tract carcinoma, 2 had received treatment with radiation and 2 had been treated with Bleomycin. Four of these 8 patients were known smokers. This study shows that papillomatosis is more often associated with laryngeal carcinoma than previously reported. It appears, however, that laryngeal papillomas alone seldom induce carcinomas. Apart from irradiation and smoking, Bleomycin could be an important co-factor.

Scientific quality of clinical research. An analysis of 40 research projects in pharmacology/pharmacotherapy.

OBJECTIVE: The scientific quality of research is an important ethical issue. To clarify the quality of research projects in pharmacotherapy/pharmacology, 40 randomly selected research projects in pharmacotherapy/pharmacology submitted to a research ethics committee were reviewed. RESULTS: Eight of the projects would not have contributed new knowledge nor were they necessary as controls for the results of previous research. Fifteen of the research protocols were of good quality, 15 could be used after revisions, and 10 were unfit for use. Eleven of the research projects were not finished 5 years after they were started. A written report was produced from 26 of the projects. Nine were of good quality and could be accepted for publication in a medical journal, 10 of the reports were in need of revision before publication, and 7 should not be accepted for publication. CONCLUSION: Research in this field ought to be improved, and ways to improve the standard of clinical trials in pharmacotherapy are discussed.

[Laser surgery in otorhinolaryngologic diseases]. / Laserkirurgi ved sykdommer i øre-nese-halsregionen.

This survey is based on our own experiences and a study of the literature. The CO2 laser has certain advantages in the surgical treatment of otosclerosis, both in the primary operation and in reoperation. In rhinal surgery the argon laser has been used with good results in Osler's disease. Laser surgery is not recommended for vasomotoric rhinitis and polyposis. The CO2 laser has improved the quality of treatment of laryngeal papilloma. With high precision and minimal bleeding the postoperative voice is better than with conventional surgery. The CO2 laser can also be used to exstirpate small malignant tumours of the tongue and leukoplasia of the oral mucosa. Healing is rapid and involves relatively little pain. The postoperative functional result is usually good, due to moderate formation of scars.

Value of routine follow-up in patients treated for squamous cell carcinoma of the head and neck.

The records of 214 consecutively registered, previously untreated patients with squamous cell carcinoma of the head and neck region were reviewed. Among the 157 patients considered "free of disease" following the primary treatment 54 developed recurrences - all but three within three years. Only in patients with carcinoma of the larynx treated with radiation alone did follow-up disclose recurrences for which further treatment resulted in a significant number of cures. For these patients the cure rate was one in 79 routine appointments compared to only one cure in 325 appointments for patients with carcinoma in other localizations. It seems that our routine follow-up procedure for most types of carcinoma is too extensive and that follow-up beyond three years mainly will be of value for the possible detection of second primary malignancies.

Treatment of T3 laryngeal carcinoma. Clinical evaluation after 50 Gy, is it of any value?

29 patients with T3 carcinoma of the larynx were evaluated after irradiation with 50 Gy with special emphasis on the mobility of the vocal cord. 10 of the patients with fixation of the vocal cord were assumed to have unsatisfactory response to treatment and were therefore advised laryngectomy. In 4 of the patients the fixation was due to fibrosis. One patient also had a fixed vocal cord, but was discarded from the investigation because of inoperable regional metastases. 18 patients with improved mobility of the vocal cord continued the irradiation to 70 Gy. 6 of these patients later developed local recurrences. It is concluded that the mobility of the vocal cord after 50 Gy is of dubious prognostic value.

Transitory IgA-deficiency, persistent IgE deficiency and recurrent respiratory tract infectious disease after splenectomy.

In a 14 year old boy, a ruptured spleen was removed. Two months after the splenectomy he developed recurrent infections of the respiratory tract. A deficiency of IgA and IgE in his blood serum was found. His impaired resistance to respiratory tract infections responded well to substitution therapy with IgA. Spontaneous clinical recovery occurred during 3 years after the splenectomy, and was parallelled by a slow return of IgA to normal levels, whereas the absence of IgE persisted. The identical twin brother of the patient, who had his spleen intact, had normal levels of serum IgA and did not suffer from frequent respiratory tract inflammations.

Clinical research: the influence of the pharmaceutical industry.

OBJECTIVE: The aim of the investigation is to throw light on the influence of the pharmaceutical industry on clinical research in Norway. The files of the five regional medical research ethics committees, which contain the application forms and the protocols of all the research projects on humans, were used as source for the statistics. The projects were first classified and registered in two groups: pharmacology/pharmacotherapy and others. Then the pharmacology/pharmacotherapy group was divided into projects sponsored or initiated by the industry and others. RESULTS: In the 3 years 1988-1990, the yearly average number of projects was 360. Sixty-two percent of the projects were pharmacology/pharmacotherapy; seventy-nine percent of these projects were conducted by the industry. The corresponding figures for the year 1997 were 747, 40% and 68%, respectively. We have not been able to find similar statistics from other countries. CONCLUSION: Our conclusion is that research in pharmacology/pharmacotherapy should be more independent of industry.