Forty-eight bronchial carcinoma patients in clinicoanatomical stage 4 of the disease (advanced disease) were randomly assigned to groups for radiotherapy, chemotherapy (cyclophosphamide) and placebo treatment, respectively. The results were assessed by the survival time and quality of survival. The median survival time was 4.7 months for radiotherapy, 4.7 months for cyclophosphamide and 1.7 months for placebo. The median total sum of vitagram points was 28.1 for radiotherapy, 20.7 for cyclophosphamide and 6.8 for placebo. When calculated per month, the median sum of vitagram points was 5.9 for radiotherapy, 5.7 for cyclophosphamide and 4.8 for placebo. Statistically the results give no reason to believe that placebo is better than radiotherapy, but it cannot be excluded that radiotherapy patients could have a much longer survival. As for cyclophosphamide versus radiotherapy, the differences are to uncertain for any conclusion to be drawn.
A range for the airway resistance (R), reference resistance (Rref), quotient (R/Rref) measured by whole body plethysmography is given for unspecific inhalative provocation in asthmatic patients. 1. In patients with an initial R/Rref value less than 2 (R about 0,6 kPa/l/s) the non allergic reaction did not exceed an R/Rref quotient of 2,7. 2. Those patients with an initial R/Rref quotient greater than 2 but less than 5 reached an R/Rref value of 8.5 after non allergic provocation, which equals an R of about 1,75 kPa/l/s. It is recommended to provoke only those patients in whom the initial R/Rref quotient is in the beginning smaller than 2; because it is otherwise difficult to separate allergic from non allergic reactions and the necessary allergen induced bronchospasm might be harmful. Reference values for specific airway resistance have the advantage that we do not need a panting manouvre against a closed shutter which is often difficult to achieve especially with children during an asthmatic attack.
No prospective clinical investigations of unselected total materials of bronchial carcinoma have been reported. The clinical profile of 273 patients with histologically verified bronchial carcinoma from a Swedish county during 1971-1976 is presented. The difficulties in making valid comparisons with other literature reports makes it necessary to describe in detail the total material. Such a description is given in the present paper. In order to avoid different selection mechanisms an attempt was made to collect an almost total material. No patients were lost in the follow-up. Autopsy was performed in 95% of the deceased patients. The distribution of the histological WHO groups in the total material was: 44% group I, 18% group II, 29% group III and 9% group IV. The material was used for randomized investigations of radiotherapy, chemotherapy and placebo treatment in inoperable patients with the purpose of studying the quality of survival in addition to survival time. For the measurement of the quality of survival the Carlens vitagram index was used (Carlens et al. 1970). The influence of a general health survey with mass miniature chest X-ray was also studied, since such a survey was performed in the region of the study. The expected 5-year survival is estimated to be 7%. Only 20 patients with resectional therapy without known signs of metastases are expected to survive. Nine (45%) of these patients were discovered by mass miniature chest X-ray and thus for a limited number of patients the detection by the general health survey gives a better prognosis.
Fifty-four bronchial carcinoma patients in clinico-anatomical stages 1-3 of the disease (localized disease) were randomly assigned to groups for radiotherapy, cyclophosphamide and placebo treatment, respectively. The results were assessed by the survival time and the quality of survival. The median survival time was 6.7 months for radiotherapy, 12.4 months for cyclophosphamide and 11.3 months for placebo. The median total sum of vitagram points was 44.5 for radiotherapy, 90.2 for cyclophosphamide and 81.8 for placebo. When calculated per month, the median sum of vitagram points was 6.2 for radiotherapy, 6.6 for cyclophosphamide and 7.0 for placebo. No significant differences were found between the treatment groups with respect to average survival time and and average vitagram point sums.
In small cell anaplastic carcinoma with localized disease the median survival for radiotherapy, single drug chemotherapy or operation was 10.1 months. The median survival for radiotherapy or single drug chemotherapy for small cell anaplastic carcinoma with extensive disease was 2.8 months and for untreated controls 0.5 months. The difference in the quality of survival was moderate, 2.0 vitagram points per month. Untreated epidermoid carcinoma patients with localized disease had a median survival of 11.4 months, which is the level reached by most non-surgical therapeutic regimes today.
The validity of the Carlens Vitagram Index for measuring the quality of survival in bronchial carcinoma was further tested on the basis of the result of therapy in 48 patients with advanced disease, 54 patients with localized disease and 34 deceased patients surgically. Different approaches for index construction are discussed and the "MaxMin" correlation method, in which the highest of the lowest correlations is sought, is presented. The principal algorithms of the method are given, and the mathematical proof and the procedures are described and exemplified. By finding the "MaxMin" correlation a new index was constructed with weights of 20, 12.36, 12.36, 8.18, -6.15 and 0 points. The corresponding weights of the Carlens index are 20, 16, 12, 8, -4 and -2 points. Thus the Carlens index lies very close to the optimal index found with the "MaxMin" method. This result gives further proof that the Carlens index is valid for use in the types of bronchial carcinoma described above.
The validity of the Carlens Vitagram Index was tested by using the result of therapy in 48 patients with bronchial carcinoma in advanced disease, 54 patients with localized disease and 34 deceased treated surgically. The Carlens Vitagram Index, which is additional and composed of six items, was correlated to a set of additive indexes including the same items but other item weights, which were chosen with non-controversial pre-specified restrictions. The lowest correlation achieved was an indicator of the lowest degree of consistency that could be attributed to the Carlens Index given. The definition of the index was operationalized so far that each item in the set of six items included in the index was regarded as valid, and it was also considered reasonable that only these six items should be included; that each item had a weight; that the index was obtained as a product (weight x item value) sum and that the pre-specified conditions were accepted. By using restrictive conditions the lowest correlation between the index giving the lowest correlation and the Carlens Index for the 48 patients with localized disease was 0.98, for the 54 patients with localized disease 0.91 and for the surgically treated ones 0.83. In addition to the total index, the average index per month was also studied and the corresponding correlations were 0.96, 0.86 and 0.81 respectively. The Carlens Index and its application per month was found to have good validity for inoperable patients and acceptable validity for surgically treated patients. The Carlens Index was shown to be robust and there is reason to believe that it lies close to the optimal index.
