01.12.2017 | Research article | Ausgabe 1/2017 Open Access

High-dose chemotherapy and autologous stem cell transplantation of patients with multiple myeloma in an outpatient setting
- Zeitschrift:
- BMC Cancer > Ausgabe 1/2017
Background
Methods
Study design and data collection
Inclusion and exclusion criteria and safety issues
HD chemotherapy and ABSCT
Monitoring and Supportive Care
Monitoring
Antiemetic prophylaxis
Hydration and prophylaxis of stomatitis
Antiviral and antibiotic prophylaxis and treatment
Criteria for inpatient admission and discharge
Assessment of haematological reconstitution and remission status
Assessment of patient satisfaction
Statistical Analysis
Results
Patients’ characteristics
Parameters
|
Overall cohort
|
Outpatient treatment
|
Hospital admission
|
P-value
|
---|---|---|---|---|
Patient number, n
|
21
|
14
|
7
|
/
|
Gender, n (%)
|
0.61
|
|||
Male
|
15 (71)
|
9 (64)
|
6 (86)
|
|
Female
|
6 (29)
|
5 (36)
|
1 (14)
|
|
ECOG, n (%)
|
||||
0–1
|
21 (100)
|
14 (100)
|
7 (100)
|
1.00
|
Social conditions, n (%)
|
besser
|
0.33
|
||
Accompanying person available
|
20 (95)
|
14 (100)
|
6 (86)
|
|
Single
|
1 (5)
|
0 (0)
|
1 (14)
|
|
Implanted port catheter, n (%)
|
0.53
|
|||
yes
|
19 (90)
|
12 (86)
|
7 (100)
|
|
no
|
2 (10)
|
2 (14)
|
0 (0)
|
|
Diagnosis of MM
|
||||
Age at first diagnosis, years
|
58 (43–67)
|
57 (43–67)
|
59 (47–66)
|
0.85
|
Stage at first diagnosis III, n (%)
|
1.00
|
|||
A
|
21 (100)
|
14 (100)
|
7 (100)
|
|
B
|
0 (0)
|
0 (0)
|
0 (0)
|
|
Heavy chain type, n (%)
|
0.34
|
|||
IgG
|
11 (52)
|
9 (64)
|
2 (29)
|
|
IgA
|
9 (43)
|
5 (36)
|
4 (57)
|
|
Light chain only
|
1 (5)
|
0 (0)
|
1 (14)
|
0.33
|
Light chain type, n (%)
|
1.00
|
|||
κ
|
13 (62)
|
9 (64)
|
4 (57)
|
|
λ
|
8 (38)
|
5 (36)
|
3 (43)
|
|
Induction therapy, n (%)
|
0.61
|
|||
PAD
|
10 (48)
|
5 (36)
|
5 (71)
|
|
VAD
|
2 (10)
|
2 (14)
|
0 (0)
|
|
VCD
|
8 (38)
|
6 (43)
|
2 (29)
|
|
Other
|
1 (5)
|
1 (7)
|
0 (0)
|
|
Mobilization therapy, n (%)
|
1.00
|
|||
1xCAD
|
20 (95)
|
13 (93)
|
7 (100)
|
|
Other
|
1 (5)
|
1 (7)
|
0 (0)
|
|
PBSC collection
|
||||
Age at PBSC collection, years
|
59 (44–67)
|
57 (44–67)
|
59 (47–67)
|
0.79
|
Collected CD34+ cells × 10
6/kg
|
11.8 (7.4–24.8)
|
9.7 (7.4–24.8)
|
13.7 (9.1–23.0)
|
0.20
|
HD chemotherapy and ABSCT
Parameters
|
Overall cohort
|
---|---|
ABSCT number, n
|
21
|
Age at ABSCT, years
|
59 (51–70)
|
Therapy line, n (%)
|
|
First line therapy
|
15 (71)
|
Salvage therapy
|
6 (29)
|
Remission prior HD/ABSCT, (%)
|
|
CR
|
0 (0)
|
nCR
|
5 (24)
|
VGPR
|
6 (29)
|
PR
|
8 (38)
|
MR
|
0 (0)
|
SD
|
1 (5)
|
PD
|
1 (5)
|
HD chemotherapy
|
|
HD melphalan n, (%)
|
20 (95)
|
Dose modification, n (%)
|
1 (5)
|
ABSCT
|
|
Transplanted CD34+ cells × 10
6/kg
|
3.3 (2.1–6.5)
|
PBSC storage duration, months
|
2 (0–144)
|
Remission post HD and ABSCT
|
|
CR
|
2 (10)
|
nCR
|
8 (38)
|
VGPR
|
3 (14)
|
PR
|
7 (33)
|
MR
|
0 (0)
|
SD
|
1 (5)
|
PD
|
0 (0)
|
Post-ABSCT treatment, toxicities and supportive care
Infectious complications
Parameters
|
Overall cohort
|
Outpatient treatment
|
Hospital admission
|
P-value
|
---|---|---|---|---|
ABSCT number, n
|
21
|
14
|
7
|
/
|
Treatment duration
|
||||
Overall, days
|
21 (18–31)
|
21 (18–25)
|
22 (19–31)
|
0.38
|
Days as outpatient
|
19 (8–25)
|
21 (18–25)
|
15 (8–19)
|
<0.01
|
Days as inpatient
|
0 (0–18)
|
/
|
5 (2–18)
|
<0.01
|
Reason for hospital admission, n (%)
|
/
|
|||
Neutropenic fever ≥72 h
|
4 (19)
|
/
|
4 (57)
|
|
Grade III stomatitis
|
2 (10)
|
/
|
2 (29)
|
|
Other
|
1 (5)
|
/
|
1 (14)
|
|
Toxicities
|
||||
Stomatitis, n (%)
|
||||
I
|
17 (81)
|
13 (93)
|
4 (57)
|
|
II
|
2 (10)
|
1 (7)
|
1 (14)
|
|
III
|
2 (10)
|
0 (0)
|
2 (29)
|
|
Neutropenic fever
|
||||
n, (%)
|
14 (67)
|
8 (57)
|
6 (86)
|
0.34
|
No. of days with fever
|
3 (1–10)
|
2 (1–7)
|
4 (2–10)
|
0.14
|
Diarrhoea, n (%)
|
1 (5)
|
1 (7)
|
0 (0)
|
1.00
|
Pulmonary infection, n (%)
|
0 (0)
|
0 (0)
|
0 (0)
|
1.00
|
Urinary tract infection, n (%)
|
1 (5)
|
0 (0)
|
1 (14)
|
0.33
|
Positive blood cultures, n (%)
|
||||
Peripheral
|
4 (19)
|
1 (7)
|
3 (43)
|
0.09
|
Central
|
0 (0)
|
0 (0)
|
0 (0)
|
1.00
|
Port catheter infection, n (%)
|
||||
Suspicion of
|
3 (14)
|
0 (0)
|
3 (43)
|
0.03
|
Proven
|
0 (0)
|
0 (0)
|
0 (0)
|
1.00
|
Port catheter explantation
|
3 (14)
|
0 (0)
|
3 (43)
|
0.03
|
SAE, n (%)
|
0 (0)
|
0 (0)
|
0 (0)
|
1.00
|
Support/Intervention
|
||||
Red cell transfusion, n (%)
|
6 (29)
|
3 (21)
|
3 (43)
|
0.35
|
Platelet transfusion, n (%)
|
15 (71)
|
9 (64)
|
6 (86)
|
0.61
|
i.v. antibiotics
|
||||
In case of neutropenic fever, n (%)
|
14 (67)
|
8 (57)
|
6 (86)
|
0.34
|
At subfebrile temperature, n (%)
|
5 (24)
|
4 (29)
|
1 (14)
|
0.62
|
Overall, days
|
7 (4–14)
|
7 (4–10)
|
8 (4–14)
|
0.61
|
Days as outpatient
|
6 (1–10)
|
7 (4–10)
|
1 (0–6)
|
/
|
Days as inpatient
|
5 (2–14)
|
/
|
5 (2–14)
|
/
|
Hematopoietic reconstitution
Parameters
|
Overall cohort
|
Outpatient treatment
|
Hospital admission
|
P-value
|
---|---|---|---|---|
Days to L <1.0 × 10
9/L
|
4 (2–5)
|
4 (3–5)
|
4 (2–5)
|
0.83
|
Days to L ≥1.0 × 10
9/L
|
14 (11–20)
|
15 (13–20)
|
13 (11–16)
|
0.11
|
Days in aplasia
|
10 (7–15)
|
11 (8–15)
|
9 (7–11)
|
0.11
|
Days to N ≥0.5 × 10
9/L
|
14 (12–20)
|
14 (13–20)
|
14 (12–16)
|
0.23
|
Platelets ≥20 × 10
9/L
|
||||
Platelet transfusion, n (%)
|
15 (71)
|
9 (64)
|
6 (86)
|
0.61
|
Analysed ABSCTs, n (%)
|
6 (29)
|
5 (36)
|
1 (14)
|
/
|
Days to platelets ≥20 × 10
9/L
|
10 (9–16)
|
10 (9–11)
|
16
|
/
|
Platelets ≥50 × 10
9/L
|
||||
Days to platelets ≥50 × 10
9/L
|
14 (11–25)
|
14 (11–22)
|
14 (11–25)
|
0.97
|