METHODS: Cancer patients from the out-patient clinic who were off treatmentfor > or = 3 months were eligible for the study. The EORTC QLQ-C30 wasgiven to the patients when they presented for their visit. The second questionnairewas received by the patients 4 days later. Of 291 eligible patients, 270(93%) agreed to participate and 190 (73%) completed both questionnaires.

RESULTS: The test/retest reliability measured by Pearson's correlationcoefficient was high for all functional scales, with a range from .82 forcognitive and role function to .91 for physical function. The r value forglobal HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue,and pain--the coefficients were .63, .83, and .86, respectively. The single-itemcoefficients ranged from .72 for diarrhea to .84 for financial impact.The Spearman rank correlation was in the same range for all dimensions.

CONCLUSION: The EORTC QLQ-C30 seems to yield high test/retest reliabilityin patients with various cancer diagnoses whose condition is not expectedto change during the time of measurement.

METHODS AND MATERIALS: The cancer-specific EORTC Core Quality of LifeQuestionnaire (30 item version; the EORTC QLQ-C30) and a 19 item head andneck cancer-specific questionnaire were mailed to the 245 surviving patientsof the trial. The EORTC QLQ-C30 is comprised of six multi-item functionscales, three symptom scales, and six single items which assess both symptomsand economic consequences of the disease. Two hundred and four patients(83%) completed the questionnaire. The two groups of patients (N = 103and N = 101) treated by different fractionating schedules, were comparablewith regard to sociodemographic variables, tumor site, treatment variables(including different types of surgical treatment), and secondary primarycancers. Patients in the conventional group had more advanced disease anda higher recurrence rate compared to patients in the hypofractionated group.

RESULTS: Unexpectedly, patients in the hypofractionated group, reportedsimilar or better quality of life compared to patients in the conventionalfractionated group. Patients in both groups described a high level of symptoms,like dryness in the mouth and mucus production. Clinical and sociodemographicvariables did not explain variance in social function, emotional functionor fatigue, except for the type of surgery performed, which significantlyinfluenced the patients' emotional function.

CONCLUSION: Long-term survivors of head and neck cancer reported a highlevel of disease and treatment related symptoms. Emotional function wassignificantly influenced by the type of surgical procedure. Strategiesfor future trials in head and neck cancer should continue to attempt tostress conservative surgical approaches and coordinated adjuvant therapyto maximize local regional control and quality of life. Functional andemotional outcome are important parameters which should prospectively beevaluated in future clinical trials in head and neck cancer.

METHODS: Patients with histologically confirmed esophagogastric carcinomawere treated with ECF (epirubicin 50 mg/m2 and cisplatin 60 mg/m2 every3 weeks with continuous infusion of 5-fluorouracil (5-FU) 200 mg/m2/d).Responses were evaluated with computed tomography (CT) scan and endoscopy.QL was assessed using the European Organization for Research and Treatmentof Cancer QLQ-C30 questionnaire.

RESULTS: A total of 235 patients were treated, 173 with metastatic diseaseand 62 with LAD. The mean number of cycles delivered was 6 (range: 1-11)and patients were followed-up for a median of 8 months. Response was observedin 135 of 220 (61%) evaluable patients, with a complete response (C(R)),11% of the patients and a partial response in 50% of the patients. Patientswith moderately differentiated adenocarcinomas and LAD responded most favorably.Symptomatic improvement was achieved in the majority of cases (63-78% dependingon the symptom). Toxicity was generally only mild to moderate, with severenon hematologic toxicity in less than 12% of the patients and only 6 (2.5%)treatment related deaths. QL assessment showed no significant negativeimpact on emotional functioning and good symptomatic control. Surgery followingresponse to ECF was performed in 29 of the LAD patients, and in 19 cases(66%) a potentially curative resection was possible, with histologic CRin 32% of the patients.

CONCLUSIONS: ECF is a highly active regimen with acceptable toxicityin patients with esophagogastric adenocarcinoma. In a proportion of patientswith LAD, chemotherapy enabled potentially curative surgery to be performed.The results justify further investigation of this regimen in a neoadjuvantsetting.

METHODS: Patients who attended our unit with histologically confirmedadvanced colorectal cancer were randomized to receive either PVI 5-FU 300mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly,or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks,with a 2-week gap for reassessment of all parameters. Quality of life (QL)was measured by the European Organization for Research and Treatment ofCancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatmentand every 6 weeks thereafter.

RESULTS: A total of 160 patients were randomized, with 155 eligiblefor assessment. Radiologic response was observed in 43 patients (28%):17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22PRs) (difference not significant). Symptomatic improvement occurred inthe majority of patients, and equally in both arms: 61% to "80%" dependingon the symptom. There was no significant difference between the two groupsin failure-free survival (median, 161 v 193 days) or overall survival (median,328 v 357 days). However, patients who received IFN did experience significantlymore toxicity in the form of leukopenia (P = .001), neutropenia (P = .04),mucositis (P = .008), and alopecia (P = .0002). There were no toxic deathsand few notable differences in QL between the two arms.

CONCLUSION: This study confirms that PVI 5-FU is effective in treatingthe symptoms associated with metastatic colorectal carcinoma, with onlymild to moderate toxicity and maintenance of QL. IFN 5 MU three times weeklydoes not enhance these palliative benefits.

METHODS: The questionnaire was administered before treatment and onceduring treatment to 305 patients with nonresectable lung cancer from centersin 13 countries. Clinical variables assessed included disease stage, weightloss, performance status, and treatment toxicity.

RESULTS: The average time required to complete the questionnaire wasapproximately 11 minutes, and most patients required no assistance. Thedata supported the hypothesized scale structure of the questionnaire withthe exception of role functioning (work and household activities), whichwas also the only multi-item scale that failed to meet the minimal standardsfor reliability (Cronbach's alpha coefficient > or = .70) either beforeor during treatment. Validity was shown by three findings. First, whileall interscale correlations were statistically significant, the correlationwas moderate, indicating that the scales were assessing distinct componentsof the quality-of-life construct. Second, most of the functional and symptommeasures discriminated clearly between patients differing in clinical statusas defined by the Eastern Cooperative Oncology Group performance statusscale, weight loss, and treatment toxicity. Third, there were statisticallysignificant changes, in the expected direction, in physical and role functioning,global quality of life, fatigue, and nausea and vomiting, for patientswhose performance status had improved or worsened during treatment. Thereliability and validity of the questionnaire were highly consistent acrossthe three language-cultural groups studied: patients from English-speakingcountries, Northern Europe, and Southern Europe.

CONCLUSIONS: These results support the EORTC QLQ-C30 as a reliable andvalid measure of the quality of life of cancer patients in multiculturalclinical research settings. Work is ongoing to examine the performanceof the questionnaire among more heterogenous patient samples and in phaseII and phase III clinical trials.