[Prognostic factors in operated non-small cell cancer of the lung. Study from a randomized therapeutic trial]. / Facteurs pronostiques du cancer du poumon opéré non à petites cellules: étude à partir d'un essai thérapeutique randomisé.

This article presents the results of a prognostic study of primary resected lung cancer (non-small cell). The data result from a randomised clinical trial of immunotherapy with a non-specific adjuvant; the follow-up was between four to seven years. Thirty-five clinical, biological and anatomo-pathological parameters were gathered at the time of inclusion in the trial. The response criteria used were survival without recurrence and total survival. A multivariate analysis using the Cox's model was carried out for each criterion. At the reference date of the 1st April 1985, 125 relapses and 132 deaths were counted amongst 219 patients; there was only one patient lost to follow-up and only 39 missing data were observed. The negative therapeutic results of the immunotherapy used were confirmed by this new intermediate analysis. The rate of survival without recurrence at 5 years was 43% and the overall survival at five years was 42%. The use of Cox's model to show the prognostic information at the 5% level for survival without recurrence could be summarised by five factors: main staging (the prognostic factor), leucocytosis, the cutaneous reaction to proteus, Karnofsky index and presence of physical signs. For stages I and II the outcome was identical and no factor was predictive at the 5% level. For stage III the cutaneous reaction to proteus and leucocytosis were prognostic. For overall survival, the prognostic information at the 5% level could be summarised by five factors: staging (main prognostic factor), leucocytosis, Karnofsky index, presence of physical signs and lymphocytosis. For stages I and II whose outcome was identical only Karnofsky index and lymphocytosis were predictive at the 5% level.(ABSTRACT TRUNCATED AT 250 WORDS)

Prognostic factors from a randomized clinical trial in resected lung cancer.

Prognostic information has three main uses: prediction of the course of evolution of disease, decisions about treatment and limitation of complementary tests. Using data from a randomized controlled clinical trial of immunotherapy in resected lung cancer, we identified factors of prognostic importance. In particular we demonstrated that a time-consuming and expensive cell-mediated immunity test is not of prognostic value. Our cooperative group decided to cancel this test in the routine examination of patients with resected lung cancer. Disease stage was confirmed as the main prognostic factor.

[Therapeutic importance and tolerance of coated 50 mg Vectarion tablets (almitrine bismesylate) at a dosage of 100 mg/day. Study of blood gas, clinical and biological results after a year of long-term treatment]. / Intérêt thérapeutique et acceptabilité du Vectarion 50 mg comprimés enrobés (bismésilate d'almitrine) à la dose de 100 mg/jour. Etude des résultats gazométriques, cliniques et biologiques en traitement prolongé pendant 1 an.

The objectives of this study, in which Almitrine bismesylate was administered for one year in chronic bronchitics with obstructive hypoxia, were to assess its clinical and gasometric efficacy and its clinical, laboratory, spirometric and electrocardiac acceptability. The blood gas results show a significant rise in PaO2 (p less than 0.001) rising by 5.5 mmHg after 6 months (T6) and by 6.0 mmHg after 12 months (T12) in comparison with the value at the study's onset. The PaCO2 fell by 3.3 mmHg at T6 and 2.7 mmHg at T12 (p less than 0.001). The dyspnoea of the patient, scored by the doctor on a scale of severity from 0 to 5 was situated on a mean of 3.3 points at the beginning of the study. It was significantly reduced by 0.8 points at T6 and by 0.9 points at T12 (p less than 0.001). The percentage of patients hospitalised during the course of the study fell significantly in comparison with the previous year, from 68% to 49% (p less than 0.001). The improvement in clinical status and in blood gases bore no relation to changes in respiratory function. The clinical acceptability of the product was good; few side effects were observed and the respiratory, digestive and neurological problems were often pre-existing. They only led to cessation of treatment in three cases. The electrocardiogram was unchanged. The laboratory investigations was unchanged, with the exception of a fall in red blood cells in relation to the correction of the hypoxaemia in polycythaemic patients.

Adjuvant immunotherapy with nonviable Mycobacterium smegmatis in resected primary lung carcinoma. A randomized clinical trial of 219 patients.

Two hundred and nineteen patients with resected lung carcinoma were randomized 3 weeks after surgery between two treatment arms: a control group (110 cases) and an immunotherapy group (109 cases). The immunostimulant was a nonviable saprophytic mycobacterium, M. smegmatis, given monthly by subcutaneous injection in four sites. The two groups were equivalent in terms of prognostic factors, including a nonsignificant difference favoring the control group based on the N (node) classification. This interim analysis was carried out on June 1, 1981. Treatment comparison by the log-rank test did not show any significant differences between these two groups in regards to disease-free interval and overall survival. There was no significant difference between the two groups after stratification of the comparison according to the N classification or adjustment with a subset of eight prognostic parameters through the Cox model. The initially expected difference (20% 1-year survival) will probably not be achieved, given these interim results, but patients will continue to be treated and followed-up according to the protocol as to allow further evaluation of this nonspecific immunotherapy.

[Negative results of a randomized therapeutic trial of nonspecific immunotherapy in primary, surgically-treated non-small cell bronchial cancer]. / Résultats négatifs d'un essai thérapeutique randomisé d'immunothérapie non spécifique dans le cancer bronchique primitif non microcellulaire opéré.

Between March 1978 and May 1981, 219 patients suffering from non-small cell primary bronchial carcinoma underwent surgical excision which was intended to be curative. Three weeks later the patients were randomised into two groups: 1. A control group, with no other treatment following excision (110 patients). 2. A non-specific immunotherapy group (109 patients). The immunostimulant used was an aqueous suspension of heat killed mycobacterium smegmatis administered subcutaneously once a month. The trial was analysed on December 1, 1982. There were 117 recurrences and 112 deceased. There was no significant difference as regard survival without relapse or overall survival; all causes of death were included.

[Long-term results of a trial of short-term chemotherapy. French study 6.9.12]. / Résultats lointains d'un essai de chimiothérapie de courte durée. L'enquête française 6.9.12.

The relapse rate after short course chemotherapy is usually assessed by cases that are available for analysis, with a delay which rarely exceeds 3 years from the time of instituting therapy. This level may be disputed if too many are lost to follow up or non-compliers appearing late. To understand the true failure rate we strove to trace every patient in a trial carried out between 1969 and 1973, consisting of three groups of patients treated with the same chemotherapy: Isoniazid (450 mg/day), Rifampicin (600 mg/day) given every day but for differing durations: 6 months (Group A), 9 months (Group B), 12 months (Group C), with either daily Ethambutol or Streptomycin in addition for the first three months. Amongst the 356 patients in the trial 86 were eliminated for failure to comply with the protocol, either due to a mishap or change of treatment. Amongst the 270 remaining patients, 248 were traced with a mean delay of post-therapy follow up of 101 months for patients still living and of 72 months for patients who had died in the intervening period, but of non-tuberculous disease. In the 242 old patients whose disease could be evaluated, the number of bacteriological relapses was 4/81 (6.2 %) in group A, and 2/85 (2.3 %) in group B and 2/76 (2.6 %) in group C. There was no significant differences between the groups. From these results it is seen that the Isoniazid/Rifampicin combination given daily for 6 months is a powerful combination with few failures. Maintaining such chemotherapy for 12 months does not seem to yield substantial gains. In conclusion nine months of chemotherapy with this regime offers a sufficiently ample guarantee of cure.

[Staged bronchial biopsies in the preoperative evaluation of primary bronchial cancer]. / Les biopsies bronchiques etagées dans le bilan pré-opératoire du cancer bronchique primitif.

The systematic biopsying of the carina overlying a tumour, the main carina and of a contralateral carina was made a part of the work up in some patients with bronchial carcinoma, to assess operability. Different studies show that despite a normal macroscopic appearance these biopsies often reveal sub-mucous invasion. This microscopic extension might modify the resection planned, and even end in inoperability in the case of tracheal or contralateral tracheal invasion. We have studied the notes of 110 patients with primary bronchial carcinoma who have had systematic biopsies. All had a normal endoscopic appearance in the carinas biopsied and none revealed invasion by tumour. Of 110 patients, 37 had operations. In 1/3 (13/37) there was a discordance between the pre-operative bronchoscopic assessment and the local extension at thoracotomy, since 7 patients were subjected to a more extensive dissection than planned, 4 were exploratory thoracotomies only and in 4 the bronchial stumps were found to be invaded. Thus negative biopsies of healthy carinas overlying a tumour have proved to be false security and did not allow us to confirm the absence of tumour extension at peri-bronchial level in the local lymph nodes or in the mediastinum.

[Double paraneoplastic syndrome and anaplastic carcinoma of the lung. ADH and ACTH levels in the tumoral tissue (author's transl)]. / Double syndrome paranéoplasique au cours d'un carcinome anaplasique du poumon. Dosage de l'ADH et de l'ACTH dans le tissu tumoral.

A double paraneoplasic syndrome with hypersecretion of ADH and ACTH revealed the presence of a small cell bronchial cancer in a man aged 62 years. Water and electrolyte anomalies due to the hypersecretions were of such a degree that an occlusive syndrome occurred. Very high levels of ADH and ACTH were found in the tumoral tissue. The measurement of these levels is rarely conducted at the present time but was able to define the mechanism of abnormal secretion of these two hormones in this case.

[A control trial of home I.P.P.B. therapy in patients with chronic obstructive respiratory insufficiency. Protocol and state of the study (author's transl)]. / Présentation d'un essai thérapeutique en cours concernant la ventilation assistée à domicile chez les insuffisants respiratoires chroniques de type obstructif.

Because a previous retrospective study did not allow any conclusion as to the efficacy of home IPPB therapy in patients with chronic airflow obstruction, a control trial has been started. The protocol includes definition of patients, modalities of treatment, criteria for evaluation. Among criteria for a patient to enter the trial is a chronic hypercapnia (with PaCO2 greater than or equal to 48 mmHg) observed over a preliminary period of 4 months. At the end of this period patients are allocated at random into two groups with and without IPPB at home (at least 1 to 2 hours daily through a mouthpiece); medical prescriptions are same in the 2 groups so as surveillance which is planned for 2 years. Evaluation should be based upon 5 predetermined criteria. This trial is in progress.

[Nasopharyngeal fibroma (author's transl)]. / Le fibrome naso-pharyngien.

The authors report 17 cases nasopharyngeal fibroma treated between 1966 and 1978. Half of the cases developed before the age of 16, the other half occurring between 16 and 28 years. Arteriography was performed in only 8 cases and embolisation in 4 cases with 2 vascular accidents. Surgery was performed in 16 cases (15 Rouge Denker, 1 paralatero nasal). Invasion of the pterygomaxillary fossa was invariably found at operation. Amongst the patients treated by surgery, there was only one local recurrence and reoperation was successful. Finally, one patient with a very large fibroma with invasion of the temporal fossa was successfully treated by radiotherapy at a dose of 4 000 R.

[The surgical treatment of thyrotoxic exophthalmos using Ogura's operation (author's transl)]. / Le traitement chirurgical de l'exophtalmie basedowienne par l'intervention d'Ogura.

Ogura's operation consists of resection via De Lima's approach of the bony floor of the orbit and the lateral wall of the ethmoid. The orbital periosteum is then incised in order to allow the orbital fat to enter the sinuses and thus decompress the orbit. In most cases the operation is performed on both sides at the same time. It is used in cases of malignant or severe thyrotoxic exophthalmos, or in the presence of optic neuritis. The results obtained were good in 9 cases with a marked reduction in exophthalmos and rapid cure of optic neuritis. An additional ophthalmological procedure is sometimes necessary in order to perfect the anesthetic result.