Health-related quality of life in patients with hormone refractory prostate cancer receiving gefitinib.

OBJECTIVES: Improvements in quality of life (QoL) and disease-related symptoms are key goals in the treatment of hormone refractory prostate cancer (HRPC). Our aim was to evaluate the impact of gefitinib on QoL of patients with HRPC. METHODS: Patients with HRPC received gefitinib 250 mg daily in addition to antiandrogen plus luteinizing hormone-releasing hormone (LHRH) analogue for at least 2 months or until disease progression. QoL was evaluated monthly by the European Organisation for Research on the Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Pain was assessed daily by patients and scored by visual analogue scale and analgesic consumption in a diary. Monthly pain intensity was estimated using the McGill-Melzack questionnaire. RESULTS: Analysis of global health status according to EORTC QLQ-C30 showed an improvement of the status in only 6 patients (26%). The greatest benefit in the patients was in the subscale representing prostate-specific concerns (including appetite, pain, physical comfort, and genitourinary function). Improvement of symptoms was correlated with antiandrogen withdrawal. Global health status and QoL decreased during treatment according to tumor progression. CONCLUSIONS: Among HRPC patients treated with gefitinib, improvement of symptoms preceded evidence of biochemical response of prostate-specific antigen following antiandrogen withdrawal. These findings suggest no beneficial effect of gefitinib in QoL improvement.

Factor v leiden mutation in patients with breast cancer with a central venous catheter: risk of deep vein thrombosis.

BACKGROUND: The objective of this study was to analyze the influence of the prothrombotic factor V Leiden (FVL) and G20210A prothrombin mutations on the frequency of the first episode of catheter-related deep vein thrombosis (DVT) in a cohort of patients with locally advanced or metastatic breast cancer during continuous venous insult (infusion of 5-fluorouracil-based chemotherapy). PATIENTS AND METHODS: Between January 1999 and February 2001, we retrospectively analyzed the incidence of first DVT in 300 consecutive patients with locally advanced or metastatic breast cancer treated at a single institution with a combination of chemotherapy administered continuously through a totally implanted access port. We identified 25 women (study group) with catheter-related DVT. For each of the 25 patients, we selected 2 women eligible for identical chemotherapy who had similar age, stage of disease, and prognostic features as a control group. The prothrombotic FVL and prothrombin mutation G20210A genotype analyses were performed in all patients. Analyses were performed on blinded samples, and all patients signed a specific informed consent form. A total of 25 cases (with thrombosis) and 50 frequency-matched controls were evaluated for FVL. RESULTS: Five cases and 2 controls were found with the mutation in the FVL, for incidences of 20% (95% CI, 9%-39%) and 4% (95% CI, 1%-14%), respectively. Thus, the frequency of the mutation was significantly higher in the cases than in controls (P = 0.04), and a logistic regression analysis, adjusted by age, yielded an odds ratio of 6.1 (95% CI, 1.1%-34.3%; P = 0.04). Time from start of infusion chemotherapy to thrombosis was not significantly different between those with the mutation (median, 31 days) and without the mutation (median, 43 days; P = 0.6). Only 1 subject (in the case group) was found with the G20210A mutation in the prothrombin gene. CONCLUSION: Factor V Leiden carriers with locally advanced or metastatic breast cancer are at high risk of catheter-related DVT during chemotherapy. Clinicians should be aware of this increased risk, and alternative cytotoxic treatments not requiring continuous infusions should be considered for these patients.

Perception that oral anticancer treatments are less efficacious: development of a questionnaire to assess the possible prejudices of patients with cancer.

We developed and pilot tested a 12-item questionnaire, to approach the issue of patients' perception on efficacy of oral chemotherapy. An additional question was on 'trade-off' between treatment efficacy and the ease of oral administration. The motivating underlying hypothesis was that oral drugs might be perceived by patients as less effective than when drugs were delivered by injection. The questionnaire was given to 59 patients with advanced breast cancer who received oral chemotherapy. Ninety-percent of patients considered clear and completed the questionnaire. Oral chemotherapy was positively viewed by most patients, perceiving it as advantageous (58%), able to help them feel less ill (77%) and to reduce the effort in coping with the disease (67%). The most important feeling elicited was the sense of freedom. Younger patients (<45 years) required bigger effort to face their illness and expected the most from oral chemotherapy. The questionnaire was shown to be robust, reliable and reproducible instrument in assessing patients' prejudices towards oral anticancer treatments.

Quality of life in breast and colon cancer long-term survivors: an assessment with the EORTC QLQ-C30 and SF-36 questionnaires.

AIMS AND BACKGROUND: Although the long-term survival of cancer patients has risen during the last decades, little is known about their quality of life. Assessment of the long-term effect of disease and treatments on subjective qualitative aspects of life that are related to health may be important for identifying specific long-term sequelae of cancer and treatments. In order to better understand the outcomes on a long-term survivor population, a sample of breast and colon cancer patients was evaluated using state-of-the-art health-related quality of life (HRQoL) approaches and instruments PATIENTS AND METHODS: EORTC OLQ-C30 and SF-36 HS questionnaires were mailed to a sample of subjects with a diagnosis of breast or colon cancer recruited in two randomized clinical trials with a median follow-up of 65 and 100 months, respectively. Data obtained with the SF-36 HS questionnaire were compared with data from a representative sample of the Italian population, whereas the EORTC QLQ-C30 data were evaluated across relevant subgroups. RESULTS: Out of 2208 subjects, 1772 were randomized to receive the different types of questionnaires and 921 answered (52%). According to the findings, if no serious comorbidity or relapse appeared, long-term cancer survivors reported having a substantially satisfying HRQoL, not much different from (age and sex) comparable controls. The most intriguing findings were those obtained from breast cancer patients. They reported a somewhat higher level than comparable Italian women of limitations in activities, when describing their role, as due to physical problems. In addition, breast cancer patients also reported lower scores (worse health perception) in two EORTC scales describing activities of daily living than colon cancer patients. When data were plotted according to the type of medical therapy, hormone therapy versus chemotherapy, a higher HRQoL was reported by the former than the latter group. CONCLUSIONS: Our study supports the hypotheses that the impact of cancer on quality of life over a period of time is not necessarily devastating in survivors. As regards the impact of different medical strategies, although our data are consistent with other research supporting the hypotheses that hormone therapy does not cause a decrease in long-term quality of life, differences we observed between hormone and chemotherapy might be caused by the action of confounds we were not able to control for or by the distortion introduced by the design of the present study.