Latest database descriptions

An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

August 23 2022

Primary objective: To describe the systemic safety and local tolerability of subcutaneous Herceptin® (SC) in patients with HER2-positive early breast cancer (eBC), naive and non-naive of HER2+ treatment, treated in the neoadjuvant and adjuvant setting in routine clinical practice use.

Secondary objective:
To describe the quality of life (QoL) of patients (using the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 questionnaire)
- The description of the baseline and disease characteristics of patients with HER2+ eBC initiating a treatment with Herceptin® SC;
- The description of use of Herceptin® SC (treatment duration, frequency of injections and sites of injection).

A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients ...

August 23 2022

Primary objective: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years.

Secondary objectives:
The secondary objectives of this study were to describe:
- The progression-free survival, time to progression and patients overall survival;
- Modalities of use of trastuzumab, the duration of treatment and the reasons leading to treatment discontinuation;
- Antineoplastic treatments in combination with trastuzumab and after discontinuation of trastuzumab treatment;
- Relevant biological tumor markers;
- The safety of trastuzumab treatment.

Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A

August 23 2022

Primary objective: To describe in CKD patients on dialysis the impact of comorbidities* on hemoglobin stability** after 6 months of treatment with Mircera® in routine clinical practice
* Patients’ comorbidities will be analyzed on the basis of the CCI.
** Hemoglobin stability is defined as a variation of +/- 1g/dL of hemoglobin level between the first Mircera® injection and the 6th month of treatment, without red blood cells transfusion during this period.

Secondary objectives:
- In the overall study population and in each subgroup of patients defined by a range of the Charlson comorbidity index (<=3, [4-5], [6-7], >=8):
- - To describe baseline characteristics of the patients;
- - To describe the monthly changes in hemoglobin level;
- - To describe monthly Mircera® dose.
- To describe patients’ vital status and all adverse events over the observation period with Mircera®;
- To describe the hemoglobin stability after 6 months of treatment with Mircera®, according to subgroups of Liu comorbidity index (<=3; [4-6]; [7-9]; >=10);
- To describe the proportion of patients with an Hb level within the range 10-12 g/dL with or without hemoglobin stability after 6 months of treatment with Mircera®, according to the subgroups of Charlson and Liu comorbidity indexes.

Pharmaco-epidemiological observational study of the clinical beneft of Neorecormon® in cancer patients with anaemia, according to early response to treatment

August 23 2022

Primary objective: To describe in real-life conditions the clinical benefit (i.e. transfusion sparing, maintenance of general health status, and professional and social activities) of NeoRecormon® in anaemic cancer patients, according to early response to treatment.
- Early response to NeoRecormon® was defined as an increase of hemoglobin concentration of at least 1 g/dL, 4 to 6 weeks after treatment initiation.

Secondary objectives:
In the total population and in each sub-population of patients [type of pathology (solid tumor, hematological malignancy or autograft), cancer pathology]:
1. to describe patients’ characteristics at inclusion;
2. to describe the use of NeoRecormon® and the compliance to current guidelines [Market Authorization (MA), EORTC];
3. to describe the evolution of hemoglobin (Hb) level;
4. to describe the evolution of iron status and vitamin supplementation;
5. to describe Adverse Events (AEs) and serious AEs (targeted and non-targeted AEs).

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