Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: results from a large German community-based observational cohort study.

BACKGROUND: After approval of bevacizumab in Germany in 2005 for the treatment of unresectable advanced or refractory colorectal cancer (CRC), this observational cohort study was initiated to assess the efficacy and safety of bevacizumab with various chemotherapy regimen in patients with metastatic CRC (mCRC). MATERIAL AND METHODS: To facilitate enrolment of a typical mCRC population, eligibility criteria were minimised. Choice of chemotherapy regimen was at the physicians' discretion, but influenced by current registration status. Predefined endpoints were treatment characteristics, response rate, progression-free survival (PFS), overall survival (OS) and adverse events assessed as potentially related to bevacizumab treatment. Patients were followed for up to four years. RESULTS: In total 1777 eligible patients were enrolled at 261 sites from January 2005 to June 2008. Median age: 64 years (range 19-100); male 62%; ECOG performance status 0-1/≥ 2 89%/11%. Chemotherapy choice was fluoropyrimidine (FU) 12%, FU/oxaliplatin 18%, FU/irinotecan 64%, no chemotherapy concurrent to bevacizumab 2% and other 4%. Best investigator-assessed response rate was 60% (complete response 10%, partial response 51%). Median PFS was 10.2 months and median OS was 24.8 months. CONCLUSIONS: The efficacy and safety profile of bevacizumab in this population of mCRC patients with different chemotherapy regimens is consistent with that observed in other patient registries/non-randomised trials and also corresponds well with data from similar treatment arms of phase III trials.

Bevacizumab in first-line treatment of elderly patients with metastatic colorectal cancer: German community-based observational cohort study results.

BACKGROUND: To evaluate the efficacy of first-line bevacizumab-based chemotherapy for untreated metastatic colorectal cancer (mCRC) based on age. METHODS: Eligibility criteria focused on M1 disease without prior palliative chemotherapy. Choice of chemotherapy regimen was at the physician's discretion. Predefined efficacy endpoints were response rate, progression-free and overall survival (PFS, OS). Patients were analysed by age (<70 vs. ≥70 years, <75 vs. ≥75 years). RESULTS: Of 1777 patients, 27% and 12% were ≥70 and ≥75 years, respectively. PFS was shorter in elderly patients (<70 vs. ≥70 years: 10.5 vs. 9.5 months, p = 0.074; <75 vs. ≥75 years: 10.5 vs. 8.9 months, p = 0.00019), as was OS (<70 vs. ≥70 years: 25.8 vs. 22.7 months, p < 0.0008; <75 vs. ≥75 years: 25.8 vs. 20.8 months; p < 0.0001). In the groups <70 and <75 years, PFS was longer in those receiving oxaliplatin-/irinotecan-containing regimens vs. those receiving 5-FU/capecitabine (<70 years: 10.6 vs. 9.0 months; p = 0.0065; <75 years: 10.6 vs. 9.2 months; p = 0.028); no difference in PFS was observed between oxaliplatin-/irinotecan-containing regimens vs. 5-FU/capecitabine regimens in both elderly age-group comparisons (≥70 years: 9.7 vs. 9.2 months; ≥75 years: 8.3 and 9.0 months). CONCLUSION: First-line bevacizumab-based chemotherapies were effective in German mCRC patients ≥75 years of age, but PFS and OS were significantly shorter in this age group vs. younger patients.

First-line treatment of pancreatic cancer patients with the combination of 5-fluorouracil/folinic acid plus gemcitabine: a multicenter phase II trial by the CONKO-study group.

PURPOSE: This open-label, multi-center phase II study investigated the efficacy and safety of the combination of 5-fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients with advanced pancreatic cancer. The study is based on our completed dose finding phase I trial. METHODS: A total of 90 patients (pts) were recruited between 02/2000 and 04/2002 to receive 5-FU 750 mg/m(2) (24 h, i.v.), FA 500 mg/m(2) (2 h, i.v.) and gemcitabine 1,000 mg/m(2) (30 min, i.v.) on days 1, 8, 15, and 22. Treatment was repeated on day 43 until disease progression. The primary objective was the 1-year survival rate. The trial was conducted in compliance with the Declaration of Helsinki. RESULTS: The 1-year survival rate was 25% [95% CI: 16-34], median overall survival was 6.8 months [95% CI: 5.13-8.45], 9 patients showed partial responses (PR) so that the overall response rate was 10.3%. Overall control rate (PR + stable disease for at least 6 months) was 56%. Median time to progression was 4.6 months [95% CI: 3.68-5.52]. In 402 GFF cycles, we observed adverse events grade 3 in up to 10% of patients and grade 4 below 5% of patients. CONCLUSIONS: The GFF combination appears to be effective and well tolerated. This intravenous regimen represents an intensified therapy with low frequency of toxicities and seems to be convenient for patients who are unable to get oral anti-neoplastic medication. After these encouraging results, the German CONKO-002 trial investigated the GFF regimen versus single-agent gemcitabine.

[Specialist-centred model of care using oncology as example]. / Facharztzentrierte Versorgung am Beispiel der Onkologie.

During the last ten years the management of oncological patients has been shifted almost entirely from the inpatient to an outpatient setting, but without increasing the financial budget for ambulatory medical care. This is why new contracts should be established according to Sect. 140 et seqq, especially if the number of outpatients in oncological care continues to increase. Not only should these contracts aim at optimizing the organizational links between outpatient and hospital care with respect to treatment paths and increasing treatment quality, but also at creating a solid financial foundation for ambulatory oncological care by adjusting salaries to the number of patients treated. Whether the current competitive system, which has been proposed by the social health insurances and which is based on integration contracts according to Sect. 140 et seqq, should also apply to life-threatening oncological diseases or whether the care of cancer patients should rather be negotiated within the basic medical system--with the participation of the newly aligned (regional) physicians' associations, if necessary--remains to be determined by the medical self-governing bodies.