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and a vinca alkaloid as initial therapy, with 59% receiving mitomycin as well; me-
dian performance status = 80 and age = 55. As antiemetic regimens all pts received: M 3 mg/kg i.v. 30 mins before cisplatin and 90 mins after, plus dexamethasone 20 mg i.v. plus, either diphenhydra~ine 50 mg i.v. (MDD) or lorazepam 1.5 mg/m i.v. (MDL). The 3 latter agents were given 10-15 mins before the first M. Pts were asked to rate nausea, confort and satisfaction (SATIS) on 100 mm visual analog scales and if they would wish to receive the same antiemetic again. Results are below:
% WITH 0-2 ANY M£D|AN SUBJECTIVE SCORES: PTS £M£T|C EPISODES SEDATION NAU$1:A SAILS COMFUR]
MDD " ~ BOZ 76Z 11 84 48 MOL 42 88% 100% 4 96 79
69% of pts on MDL and 60% of pts on MDD had no emesis. Toxicity included restless- ness (14%), diarrhea (12%), and acute dys- tonic reactions (2%). 95% of pts on MDL and 77% on MDD wanted the same antiemetic regimen again. We conclude: i) both MDD and MDL offer good objective control of emesis; 2) toxicity was minor with more sedation observed with MDL; and 3) the ad- dition of lorazepam improved subjective acceptance of cisplatin containing regimens. Supported in part by A.H. Robins Company and CA-05826.
Prevention of Cytotoxic Drug-lnduced Skin Ulcers With Dimethyl Sulfoxide (D~ISO) and
a-Tocopherol. Ludwig, Ch.U., Stoll, H.R., Obrecht, J.P. Div. of Oncology, Department of Internal Medicine of the University, Basle, Swit- zerland.
Accidental subcutaneous extravasation of several antineoplastic agents may pro- voke skin ulceration for which there has been so far no simple and effective treat- ment. Since January 1983 we have treated all patients in our institution sustain~ ing extravasation by a cytotoxic drug with a combination of DMSO and ~-Tocopherol. During the first 48 hrs after extravasation a mixture of 10% ~-Tocopherol acetate, 90% DMSO and an em~lqa£o~ were topically applied. The bandage was changed every 12 hrs. Of 12 patients treated, 8 were fully evaluab- le. 4 patients had to be excluded from evaluation, as the amount of extravasation was indeterminable.
Pat. Drug Amour Concen- Locali- Skin ul-
No. paraven, tratlon sation ceration
2 Adriamycln 2-3 ml 2 mg/ml cubital none 7 Adr£amycin i-2 ml 2 mg/ml cubical none 12 Adriamycin 2-3 ml 2 mg/ml cubital none
4 4-Deoxydoxo- I - 2 ml .45 mg/ml forearm none
r u b ~ c z n 5 3 ml .45 mg/ml foreamu none
11 Vincristln I ml ! mg/ml forearm none 3 Vindesin 1-2 ml | mg/ml cubital none
1 Mitomycin 2 ml .16 mg/ml forearm none
The only toxic effect from DMSO and ~-Toco-
pherol was a minor skin irritation. Since we have used this treatment, we have not observed any skin ulceration, functional or neuromuscu- lar impairment in any patients with cytotoxic drug extravasation.
Subjective Evaluation in Non-Small Cell Lung Cancer: Comparison of Karnofsky Performance
Status With a Patient Generated visual Analogue Scale Measuring Activity. Burke, M.T., Gralla, R., Kris, M., Howard, J., Monras, P. Memorial Sloan-Kettering Cancer Center, New York, NY 10021, U.S.A.
Karnofsky performance status (KPS) is recog- nized as a prognostic factor in the response rate and survival for patients with non-small cell lung cancer. As part of an ongoing study of subjective evaluation, 40 patients with stage III non-small cell lung cancer were as- sessed for KPS prior to beginning chemotherapy with cisplatin and vindesine ~ mitomycin-C. In addition, each patient was given a I00 mm visual analogue scale (VAS) and sked, "how much has your illness affected your ability to car- ry out your normal activities?". Objectives were i) to determine the feasibility and re- liability of the VAS; 2) to test the correla- tion of the VAS with the KPS; and 3) to obser- ve for correlation of the VAS and KPS with re- sponse rates. The test is easily conducted and has high patient acceptance; correlation was high (correlation coefficient r = 0.86), p< 0.01) when the test was given at two diffe- rent periods pretreatment. The relative validi- ty, comparing VAS scores with KPS was good (r = 0.59), p<0.01). There is a trend toward greater predictibility of response with pre- treatment VAS scores than with KPS (for those with a KPS > 80 the response rate was 43%: for those w~th a VAS > 80 the response rate was 57%. The response rate for those with a KPS < 80 was 41%, and the response rate for those with a VAS < 80 was 34%). We conclude that in patients with non-small cell lung can- cer: I) The VAS of patient activity is feasib- le and reliable, 2) the VAS shows validity when compared with KPS, and 3) there is a trend toward greater predictibility of response with the VAS than with the KPS. Supported in part by NCI grant no. CA 29184-04 (N2).
Assessment of Quality of Life in Lung Cancer Patients Using a Diary Card. Dones, L., Hill, E., Quinn, H., Souhami, R.L., Spiro, S.G., Harper, P.G., Tobias, J.S,, Geddes, D.M., Birkhead, B. The London Chest Hospital, Bonner Road, London E2 9JX, England.
This study compared a daily diary card with other measures of quality of life in patients with lung cancer. 31 patients receiving treat- ment with cyclical chemotherapy for small cell lung cancer completed a diary card daily and the EORTC questionnaire every I0 days. A re-
search nurse completed a Spitzer Quality of Life index assessment every io days alterna-
ring hospital assessment with home visits and completed diary card assessment at
each home visit. The diary card scored sickness, vomiting, appetite, pain, sleep, general well being and activity on a 4 point scale.
For the daily diary card patient com- pliance was good. i. Comparison with EORTC questionnaire show-
ed good convergent validity according to Campbell & Fisk criteria for all questions apart from sickness and gene- ral well being.
2. The same 6 variables showed divergent validity for correlations between but not within instruments chiefly because different aspects of the same variable eg. sickness, vomiting, appetite were recorded.
3. Inter-rater reliability was satisfac- tory (significantly different from zero) for all variables.
4. Comparison with the Spitzer Quality of Life index for corresponding vari- ables showed satisfactory convergent validity.
5. The diary card showed short term chan- ges related to treatment which would not be detected by less frequent mea- sures. We conclude that a daily diary card is
a simple and satisfactory alternative to other Q of L measures which has the advan- tage of detecting transient changes.
A Multidimensional Approach to the Measu- rement of Quality of Life in L~g Cancer Clinical Trials. Aaronson, N.K., Bakker, W., Stewart, A.L., van Dam, F.S.A.M., van ZandwiJk, N., Yarnold, J.R., Kirkpatrick, A. EORTC Lung Cancer Coopeartive Group and Study Group on Quality of Life.
This study reports on the development of a brief self-report questionnaire for the measurement of the quality of life of patients participating in a multi-center, cross-cultural, randomized clinical trial comparing the relative effect of 5 versus 12 courses of chemotherapy (cyclophospha- mide, dozorubicin and etoposide) in ex- tending the disease-free interval, sur- vival, and quality of life of patients with small-cell lung cancer.
A 2 page questionnaire, intended for multiple administration, was constructed with 3 goals: i) to include items tapping a broad range of quality of life issues; 2) to minimize the demand placed on both patients and medical personnel; and 3) to derive quality of life scales exhibiting acceptable levels of validity and relia- bility.
The statistical analysis, based on the first 80 patients to complete the question- naire at baseline, indicate s that valid
and reliable measures of physical symptoms of lung cancer (coughing, shortness of breath, pain), functional status (a self-report ana-
log of performance status indices), fatigue and malaise, psychological distress, sense of well-being, and perceived social support can be derived from the questionnaire.
Current work is underway to further valida- te the questionnaire with data derived from administrations at 12 weeks, 24 weeks, 33 weeks, and one year.
Advantages of Arterio Venous by By-Pass and Fistulae in Patients Submitted to Prolonged Chemotherapy for Lung S~lid Tumour.~ de La Fa~e-,_ D., Airiau. '2J'' Zabbe-,. CI.2 ' Jeffredo , Ph., Evellleau , C., Clavler , J. i. Department of Vascular Surgery. 2. Depart- ment of Pneumology, C.H.R.U. 29200 Brest, France.
Venous access problems occurring in prolon- ged chemotherapy infusions in solid tumours can be reduced by many vascular surgical tech- niques thus allowing easier access to the vein network.
Authors carried out 30 distal arteriovenous fistulae and 25 proximal arteriovenous by- passes, using prothetic grafts, in upper limb of patients with solid tumours requiring pro- longed chemotherapy. Advantages of these techniques are reported:
- no important post operative complications - durability of venous access - low risk of infection - simplicity of access for nursing staff.
Our results indicate two different possibili- ties:
- early arteriovenous fistulae where there is a good superficial vein network, if a prolonged chemotherapy is decided.
- later arteriovenous by-pass where superfi- cial vein network has been destroyed by anterior cytostatic infusions.
Quality of Life Evaluation of Patients Treat- ed fo[ Lung Cancer: A methodo½0gical Study. 1 Kaasa , ~., N~ss , S., Ol~nes , B.T. l Thorud-, E., H~st-, H., Mastekaasa-, A., Lund , E. i. General Department, The Norwegian Radium Hospital. 2. Institute of Applied Social Research. 3. Neuropsychological Sect. XIV. Department, Oslo City Hospital, Oslo, Norway.
Quality of life assessment represents an im- ( portant challenge in modern oncological treat- ment. Parallel with the development of more effective anti-tumor treatment, the side-ef- fects tend to increase and are often not ne- glectible. In addition, little attention has been paid to the evaluation of the patient's total situation. This is mainly due to lack of good, reproducible and discriminating methods.
In this study patients with non-resectable non-small cell lung carcinoma of limited ex- tension were randomised to A) combination