Background
Methods
Study design
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Firstly, real-life patient data from case report forms. Data were collected on the first series of consecutive patients seen on a visit, with an expected number of 4 to 8 patients per center, up to a maximum of 10 patients in a given center during the study period. Registered patients had to fit the inclusion criteria: age over 18 years, locally advanced or metastatic UC, pre-treatment with a platinum-based chemotherapy (regardless of its setting: neoadjuvant chemotherapy, adjuvant chemotherapy or palliative first-line in advanced/metastatic disease), having shown progression to the platinum-based treatment. Patients having received prior platinum-free systemic chemotherapy only were excluded.Information collected included: initial patient characteristics and prior treatments, patient characteristics and comorbidities at the time of progression, disease management in the post-platinum setting.
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Secondly, a questionnaire was filled by all participating physicians regarding their practices, at the time of patient inclusion. Physicians were asked how in theory he/she should manage the patient (anticancer treatment or alternatives) according to the patient characteristics after one systemic platinum-based chemotherapy regimen.
Results
Centers and patients characteristics
Reason(s) for cisplatin-ineligibility n = 76 | |
---|---|
Single reason |
66 (87 %)
|
Renal impairment only | 44 (58 %) |
PS ≥ 2 only | 9 (12 %) |
Single reason not specified | 7 (9 %) |
Heart failure only | 5 (7 %) |
Hearing impairment only | 1 (1 %) |
Multiple reasons |
10 (13 %)
|
PS ≥ 2 + renal impairment | 5 (7 %) |
PS ≥ 2 + heart failure | 1 (1 %) |
PS ≥ 2 + other | 1 (1 %) |
Renal impairment + Hearing impairment | 1 (4 %) |
Renal impairment + other | 1 (1 %) |
Renal impairment + Hearing impairment + other | 1 (1 %) |
Patient profile at time of post-platinum treatment decision (number of available patients) |
N
| % |
---|---|---|
Age (n = 218) | ||
≥ 75 years | 33 | 15 |
ECOG PS (n = 213) | ||
PS 0/1 | 76/101 | 36/47 |
PS ≥ 2 | 36 | 17 |
Renal impairment (n = 217) | ||
Creatinine clearance < 60 mL/min | 95 | 44 |
Creatinine clearance < 40 mL/min | 25 | 12 |
Low hemoglobin value (n = 217) | ||
< 10 g/dL | 35 | 16 |
Neutropenia (or leucopenia) (n = 217) | 6 | 3 |
Hepatic metastases (n = 216) | 28 | 13 |
Hepatic impairment (n = 217) | 6 | 3 |
Clinically relevant cardiac toxicity (n = 217) | 13 | 6 |
Initial platinum-based chemotherapy n, (%) | Neo/adjuvant setting, n = 76 | Advanced setting, n = 137 |
Cisplatin-based | 50 (66 %) | 71 (52 %) |
Carboplatin-based | 26 (34 %) | 66 (48 %) |
Subsequent chemotherapy n, (%) |
58 (76 %)
|
114 (83 %)
|
Single agent |
23
|
80
|
Vinflunine/Taxanes |
15/5
|
57/18
|
Gemcitabine/Other agent |
2/1
|
2/3
|
Combination therapy |
35
|
34
|
cisplatin-based |
11
|
5
|
carboplatin-based |
14
|
22
|
Other |
10
|
7
|
Subsequent management by BSC n, (%) |
7 (9 %)
|
11 (8 %)
|
Pending decision or othera n, (%) |
11 (14 %)
|
12 (9 %)
|
Usual practices for first systemic chemotherapy (according to physician’s questionnaire)
Usual physician chemotherapy regimen for 1st systemic anti-cancer therapy in patients eligible to cisplatin | Set of Physicians N = 51 |
---|---|
As neoadjuvant or adjuvant chemotherapya | |
Missing | - |
MVAC | 3 (5.9 %) |
HD-MVAC | 1 (2.0 %) |
GEM-cisplatin | 42 (82.4 %) |
GEM-cisplatin or (HD)-MVAC | 3 (5.9 %) |
Other | 3 (5.9 %) |
As palliative first-line chemotherapy | |
Missing | - |
MVAC | 2 (3.9 %) |
HD-MVAC | - |
GEM-cisplatin | 46 (90.2 %) |
GEM-cisplatin or (HD)-MVAC | 2 (3.9 %) |
Other | 1 (2.0 %) |
Usual physician chemotherapy regimen for 1st line anticancer systemic therapy in patients ineligible to receive cisplatin | Set of Physicians N = 51 |
---|---|
As neoadjuvant or adjuvant chemotherapy | |
Missing | - |
Single agent |
-
|
Chemotherapy doublet |
43 (84.3 %)
|
Gemcitabine-carboplatin | 40 (78.4 %) |
Paclitaxel-carboplatin | 1 (2.0 %) |
Docetaxel-carboplatin | 1 (2.0 %) |
Gemcitabine-Paclitaxel | 1 (2.0 %) |
Other |
1 (2.0 %)
|
None | 7 (13.7 %) |
As palliative first-line chemotherapy | |
Missing | - |
Single agent |
2 (3.9 %)
|
Gemcitabine | 2 (3.9 %) |
Carboplatin (carboplatin) | - |
Chemotherapy doublet |
49 (96.1 %)
|
Gemcitabine-carboplatin | 44 (86.3 %) |
Paclitaxel-carboplatin | 2 (3.9 %) |
Docetaxel-carboplatin | 1 (2.0 %) |
Gemcitabine-Paclitaxel | 1 (2.0 %) |
Other | 1 (2.0 %) |
Factors impacting treatment decisions following progression or relapse to a first platinum-based therapy (according to physician’s questionnaire)
Reason(s) for choosing vinflunine for management of a patient after progression/relapse to an initial platinum-based chemotherapy, n = 51 physicians (0 up to a maximum of 3 reasons could be given) | |
---|---|
Phase III evidence | 34 (66.7 %) |
Safety profile | 21 (41.2 %) |
Survival benefit | 15 (29.4 %) |
Drug approval | 13 (25.5 %) |
Guidelines | 12 (23.5 %) |
Progression free survival | 11 (21.6 %) |
Convenience of administration | 9 (17.6 %) |
Good prior experience | 6 (11.8 %) |
Best efficacy expectations | 5 (9.8 %) |
Symptoms control | 4 (7.8 %) |
Quality of life | 3 (5.9 %) |
Simple scheme | 3 (5.9 %) |
Handable schedule | 2 (3.9 %) |
Disease stabilization rate | 1 (2.0 %) |
Patient/family request/other reason | - |