Students with an autonomous role in hospital care - patients perceptions.

BACKGROUND: There have been calls to enhance clinical education by strengthening supported active participation (SAP) of medical students in patient care. This study examines perceived quality of care when final-year medical students are integrated in hospital ward teams with an autonomous relationship toward their patients. METHODS: We established three clinical education wards (CEWs) where final-year medical students were acting as "physician under supervision". A questionnaire-based mixed-method study of discharged patients was completed in 2009-15 using the Picker Inpatient Questionnaire complemented by specific questions on the impact of SAP. Results were compared with matched pairs of the same clinical specialty from the same hospital (CG1) and from nationwide hospitals (CG2). Patients free-text feedback about their hospital stay was qualitatively evaluated. RESULTS: Of 1136 patients surveyed, 528 (46.2%) returned the questionnaire. The CEWs were highly recommended, with good overall quality of care and patient-physician/student-interaction, all being significantly (p < 0.001) higher for the CEW group while experienced medical treatment success was similar. Patient-centeredness of students was appreciated by patients as a support to a deeper understanding of their condition and treatment. CONCLUSION: Our study indicates that SAP of final-year medical students is appreciated by patients with high overall quality of care and patient-centeredness.

First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice.

BACKGROUND: The combination of nab-paclitaxel and gemcitabine is a new effective first-line chemotherapy for patients with metastatic pancreatic cancer. This was demonstrated in the phase III MPACT trial. PATIENTS AND METHODS: Four patients with metastatic pancreatic cancer from our clinical practice received combination chemotherapy with nab-paclitaxel at doses from 100 to 125 mg/m(2) and gemcitabine at doses from 800 to 1,000 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. Two patients had elevated serum levels of total bilirubin, one older patient had significant comorbidities, another older patient had an Eastern Cooperative Oncology Group performance status of 2. RESULTS: Treatment was manageable. Patients showed clinical remission or disease stabilization. Overall, combination chemotherapy was well tolerated. CONCLUSION: Patients with metastatic pancreatic cancer that did not meet all criteria, as patients treated in the registration trial, were safely and effectively treated with first-line combination of nab-paclitaxel and gemcitabine.

Phase II trial with carboplatin and bendamustine in patients with extensive stage small-cell lung cancer.

BACKGROUND: Bendamustine is an alkylating agent with hybrid activity and proven efficacy in small-cell lung cancer associated with a favorable toxicity rate. This phase II study of carboplatin/bendamustine was conducted to evaluate the efficacy of this combination in patients with extensive disease small-cell lung cancer (ED-SCLC). METHODS: Fifty-six untreated patients with ED-SCLC were enrolled. Their median age was 63 years. Sixty-seven percent of patients were male and 18% had a World Health Organization performance status of 2. Bendamustine was administered as a 30- to 60-minute infusion at a dose of 80 mg/m2 on days 1 and 2, and carboplatin was given at an area under the curve of 5 on day 1 of a 21-day cycle. RESULTS: Fifty-five patients were assessable for response and toxicity. The overall response rate was 72.7% (95% confidence interval: 59%-84%), with one complete remission (1.8%). The median time to progression was 5.2 months (95% confidence interval: 4.2-5.6). At the time of evaluation, 71% of the patients had died. The median survival time reached 8.3 months (95% confidence interval: 6.6-9.9). The major toxicity of this regimen was myelosuppression, including grade 3 or 4 neutropenia (46%), thrombopenia (26%), anemia (15%), and infections (11%). Toxic death was recorded in two patients (3.6%). CONCLUSIONS: The carboplatin/bendamustine regimen is a well-tolerated cytostatic combination in ED-SCLC with activity comparable with that of other platinum-based regimens. Further investigations, such as a phase III trial, are currently planned.

Second-line chemotherapy of advanced disseminated gastric cancer after cisplatin, infusional 5-fluorouracil, folinic acid (PLF): benefit dependent on progression-free interval after first-line therapy.

BACKGROUND: The role of second-line chemotherapy in gastric cancer is not yet established. We analyzed patients receiving second-line treatment after chemotherapy with cisplatin, infusional 5-fluorouracil, folinic acid (PLF). PATIENTS AND METHODS: 27 patients took part in this retrospective analysis. The second-line chemotherapy consisted of different regimens depending on the recommendations of the attending physician based on response to and toxicity of first-line treatment. RESULTS: In 3 of 27 patients, partial response was achieved (11%, 95%-confidence interval 0-23%). The progression-free survival and overall survival was 3.1 (2.1-4.3) and 5.1 (3.8-6.6) months, respectively. Progression-free intervals (PFI) of more than 7 months after first-line therapy were a predictor for patients who may benefit from the treatment (median survival from the start of second-line therapy: 10.6 (6.6-13.1) months). CONCLUSION: Second-line chemotherapy after cisplatin / 5-FU rarely induced tumor response, and progression-free survival as well as overall survival remained short. Based on our data, we hypothesize that the PFI after first-line treatment may be a selection criterion for patients suitable for second-line chemotherapy.

Application of adjuvant chemotherapy in colorectal cancer -- a survey in the region of Essen, Germany.

BACKGROUND: The value of adjuvant chemotherapy (AC) in colorectal carcinoma (CRC) is definitely proven and its application is clearly recommended by the German Cancer Society (GCS). The goal of this study was to investigate whether these findings and recommendations have been introduced in daily practice and whether this might depend on the specialization of the treating physicians. PATIENTS AND METHODS: Patients presenting with CRC in the department of oncology of the Kliniken Essen-Mitte between 1997 and 2002 who had started AC until the end of 2001 were evaluated. Data on AC were collected retrospectively from patients' records and prospectively by patient interviews. We investigated whether the guidelines of the GCS were followed and whether 5-fluorouracil (5-FU) was applied properly and we correlated the results with the treating institution. RESULTS: 133 patients were analyzed for correlation of their treatment with the guidelines of the GCS. In 81% the AC met these guidelines. This was significantly more frequent in oncologic institutions than in non-specialized ones (96 vs. 9%, p < 0.001). Regarding dose and infusion time chemotherapy was properly administered to 83% of the patients (109/132) treated with 5-FU. Again, correct treatment was significantly correlated with specialization of the physicians (98 vs. 9%, medical oncology vs. other, p < 0.001). CONCLUSIONS: The results of our random search in the region of Essen, Germany, lead to the hypothesis that a quality-assured chemotherapy is best provided by specialized oncologic institutions, even if the treatment has been established for years. This should be proven by a large epidemiologic study.

Carboplatin in Combination with Bendamustine in Previously Untreated Patients with Extensive-Stage Small Cell Lung Cancer (SCLC).

BACKGROUND AND OBJECTIVE: Bendamustine is an alkylating agent with high efficacy in non-Hodgkin's lymphoma and multiple myeloma. Even in solid tumours, monotherapy with bendamustine has resulted in subjective remissions and has been associated with a low rate of side effects. The current dose-finding study was designed to determine the maximum tolerated dose (MTD) of combined carboplatin/bendamustine in previously untreated patients with extensive-stage small cell lung cancer (SCLC). PATIENTS AND METHODS: Carboplatin was administered as a 1-hour infusion on day 1 at increasing dose levels, and bendamustine was administered as a short infusion on days 1 and 2 at increasing dose levels (80-120 mg/m(2)). The regimen was administered every 3 weeks. Four dose levels were planned, starting with 80 mg/m(2) bendamustine and carboplatin area under the curve (AUC) 5 (dose level I). The other dose levels were 100 mg/m(2) bendamustine and carboplatin AUC 5 (dose level II), 100 mg/m(2) bendamustine and carboplatin AUC 6 (dose level III), and 120 mg/m(2) bendamustine and carboplatin AUC 6 (dose level IV). A minimum of three patients were enrolled at each dose level. RESULTS: Dose-limiting toxicities, which included fatigue, infection and tachyarrhythmia, were observed at dose level III. The recommended dose for phase II studies was therefore established at dose level II. The majority of haematological and non-haematological toxicities observed were only mild (grade 1 or 2) in patients at dose levels I and II. None of the patients developed severe alopecia. Objective responses were observed in eight of the ten patients involved in this trial. CONCLUSION: Because of its acceptable toxicity and favourable preliminary antitumour efficacy, the combination of carboplatin and bendamustine appears to be a potentially useful chemotherapeutic option in patients with extensive SCLC.