[Multiple myeloma: abdominal pain during treatment]. / Bauchschmerzen unter Therapie bei Multiplem Myelom.

A 77 year-old man suffering from adominal pain and urinary retention with a long history of a multiple myeloma was admitted to the emergency room. The previous clinical course during various chemotherapies was affected by several serious infections. Surprisingly, the diagnostic investigation including ultrasound and computed tomography showed an acute appendicitis.

Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer.

BACKGROUND: An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory. METHODS: Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m(-2) plus vinorelbin 25 mg m(-2) on days 1+8 (GemVin), or plus cisplatin 30 mg m(-2) on days 1+8 (GemCis), or plus capecitabine 650 mg m(-2) b.i.d. orally days 1-14 (GemCap), q3w. The primary end point was response rate. RESULTS: A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ≥grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand-foot syndrome in 2.0% of the GemCap patients (per patient analysis). CONCLUSIONS: This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.

A patient-specific measure of change in maximal function.

We designed a short, patient-specific index that measures changes in maximal physical, mental, and emotional function. A baseline component, given at the initial interview, documents the patients' usual activities that require the most physical exertion and mental effort, as well as the patients' ability to cope with stress. A transition component assesses the subsequent change from these patient-specific norms. The index was evaluated in two separate studies involving medical and surgical patients. In the first study, the index was administered twice to 40 patients. Reliability was excellent for all three aspects of function. The transition index had a high degree of internal consistency. In a second study of 43 hospitalized patients, the validity of the index was assessed by comparing its performance with the Sickness Impact Profile; high correlations were found. In addition, the overall patterns of change differed in the expected directions in the medical and surgical groups. This index is unique in its ability to measure change directly, is interpretable in individual patients, and could be easily applied in clinical practice and research.

Can the Sickness Impact Profile measure change? An example of scale assessment.

The Sickness Impact Profile is a well known measure of functional status which has been validated as a measure of differences in function between patients, but not as a measure of within-patient change. To evaluate its performance as a measure of change, the Sickness Impact Profile was compared to a transition index that directly assesses intra-patient differences in maximal physical and emotional function. With the index, patients rate themselves as much better, slightly better, the same, slightly worse or much worse as compared to a previous assessment. When compared to the corresponding index ratings, Sickness Impact Profile subscale score changes for a rating of worse were of greater magnitude than those for a rating of better. The inherent variability of the Sickness Impact Profile score was estimated using the standard deviation of the score change for the index rating "the same". For patients to be regarded as changed they had to lie outside the probability limits of this score change. Defined in this way, only patients who stated they were worse on the index were detected. Receiver operator characteristic curves were constructed and also demonstrated that deteriorations in function were more accurately detected. Using different score cutoffs, the best true positive rate (71%) was obtained using a one point change on the psychosocial subscale. This was accompanied by a 39% false positive rate. No score value appeared sufficiently accurate to be useful. Its apparent inability to detect improvements and deteriorations equally, and the wide standard deviations for a given change in function, may limit the use of the Sickness Impact Profile for following individuals over time.(ABSTRACT TRUNCATED AT 250 WORDS)