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RELIABILITY AND VALIDITY OF THE FUNCTIONAL ASSESSMENT OF CANCER THERAPY-LUNG (FACT-L) QUALITY OF LIFE INSTRUMENT. D.F. Cella,’ A.E. Bonomi,’ S. Lloyd,’ D. Tulsky: P. Bonomi,’ E. Kaplan. I ‘Rush Cancer Institute, Chicago, IL, and *The Psychological Corporation, San Antonio, TX, USA.

The FACT-L is a 43-item self-report inshument which measures multidiiensional quality of life. Available in English, Spanish and French, it is currently being used in several Phase II and Phase III clinical trials. Data on sensitivity and meaningfulness of change are necessary when planning sample size for clinical trials and when evaluating the results of treatment. Although reliability and validity of the 33-item FACT-General (FACT-G) have been published, data on the 9-item lung cancer-specific subscale await publication. The 9 lung cancer items were administered along with the FACT-G to 58 patients with lung cancer (all stages). The internal consistency (alpha) coefficient was improved from 0.52 to 0.66 by dropping two items which were uncorrelated with the others. The resulting ‘I-item scale was retested in a new sample of 41 lung cancer patients with stage III or IV disease. Internal consistency was stable (alpha=O.67). Patients were tested at two month intervals to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the ‘I-item lung cancer- specific subscale. Using a linear test for trend, significant sensitivity to change in ECOG PSR was obtained with the Total score @=.032), the Physical well-being subscale (~=.016), the Lung cancer-specific subscale @=.034), and (marginally) the Functional well-being subscale (p=.O5 1). Mean lung cancer-specific subscale scores m 2.0 points (S&=6.2) in the 6 patients whose PSR improved, &Q.@ 0.48 points (S&=3.1) in the 23 patients whose PSR remained unchanged, and M 2.75 points (S&=5.2) in the 12 patients whose PSR declined. Inasmuch as a change of one point or more in ECOG PSR is clinically meaningful, we would consider a change in two points on the 7-item lung cancer-specific module to be clinically meaningful.

PROGNOSTIC FACTORS CONTRIBUTING THE LONG-TERM RELAPSE-FREE SURVIVAL IN PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) WHO ACHIEVED COMPLETE RESPONSE (CR). S. Hirakil, T. Ohnosh?, H. Ueokaz, H. Kameiz, M. Tabataz, T. Shibayamaz, K. Miyatakez, I. KimurP. 1Dcpartment of Medicine, Okayama Red Cross Hospital, ZDepartment of Medicine, Okayama University Medical School, Okayama, Japan.

After introduction of the intensive chemotherapy with or without chest irradiation (Chest RT) in the treatment of SCLC, CR rate has been improved, however, the majority of responders relapse and long-term survivors arc less than 20%. In order to assess the factors affecting the relapse-free survival, 11 pretreatment factors including regimen of chemotherapy, Chest RT and prophylactic cranial irradiation (PCI) were analyzed in 102 patients who achieved CR from 1981 to 1992. Univariate analysis using generalized Wilcoxon test showed that extent of disease, performance status (PS), regimen, Chest RT and PC1 were elucidated to be the statistically significant prognostic factors. By multivariate analysis using Cox’s proportional hazard model, extent of disease (p=O.O28) was the most significant factors contributing to the long-term relapse-free survival, and CEA (p=O.O42) and PS (p=O.O47) were also statistically significant factors. Immunohistochemical staining was performed on transbronchially biopsied specimens obtained at diagnosis from 36 patients who achieved CR, using antibodies to NSE, CEA, GRP, Chromogranin A, CD57 and P-glycoprotein (P-gp). Nineteen patients whose tumors were stained with GRP showed a long-term relapse-free survival as compared with 17 patients having tumors with GRP negative staining. Positive satining with P-gp, CEA and/or CD57 were also suggested to be poor prognostic predictors.

The EORTC QLO-LC13: a Wulr Su

The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials, composed of a core quality of life questionnaire, the EORTC QLQ-C30, and additional disease- or treatment-specific questionnaire modules. A lung cancer specific questionnaire module, the EORTC QLQ-LC13, was generated to supplement the core questionnaire in lung cancer trials. We report here the results of an evaluation of the clinical validity of the lung cancer questionnaire module.

The 13-item lung cancer questionnaire comprises measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnoea, and pain) and side-effects from conventional chemo- and radiotherapy (hair loss, neuropathy, sore mouth, and dysphagia). In two international field studies, a total of 735 lung cancer patients recruited from 17 countries, who were receiving chemo or radiotherapy, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. The decrease in symptom scores was most pronounced in pa- tients with small cell lung cancer receiving chemotherapy. With the exception of a sore mouth, the change of toxicity measures over time was related specifically to either chemo- or radiotherapy. The hypothesized scale structure of the questionnaire was partially supported by the data.

In conclusion, the results from international field testing lend support to the EORTC QLQLC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EDRTC Core Quality of Life Questionnaire.

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LONG TERM SURVIVORS IN PATIENTS WITH STAGE IV ADENOCARCINOMA OF THE LUNG. T. Shinkai, K. Eguchi, T. Tamura, Y. Ohe, F. Oshita, H. Arioka, J. Shiraishi, N. Yamamoto, N. Nomura, M. Andoh, M. Fukuda, N. Saijo. National Cancer Center Hospital, Tokyo, Japan.

The pretreatment characteristics of three-year or five-year survivors were analyzed in 177 patients with stage IV adenocarcinoma of lung for the detection of any specific prognostic factors. All patients without prior therapy received chemotherapy according to the protocols for phase II or III trials at the National Cancer Center, Japan, between 1981 and 1989. Median survival time for all patients was 8.5 months ranging from 0.9 months to 105.3 months. Thirteen (7.3%) and two (1.2%) patients survived for more than three and five years, respectively. All three patients survived more than 4 years were female with performance status 0 or 1 and the presence of pulmonary metastasis as the sole metastatic site. Multivariate regression analysis revealed that performance status (P = 0.0001) and sex (P = 0.0002) were most significant pretreatment factors of longer survival.