Background
Methods
Patients characteristics
Study design and dose modifications
Statistical plan
Response and toxicity assessment
Results
Response and survival
Characteristics
|
No. of patients (%)
|
---|---|
Total number | 42 (100%) |
Male/Female | 26/16 (61.9/38.1) |
Age (years) | |
median | 73 |
range | 70–81 |
Performance Status | |
ECOG 0 | 18 (42.8) |
ECOG 1 | 24 (57.2) |
Tumor differentiation | |
Well differentiated | 10 (23.8) |
Moderately differentiated | 13 (30.9) |
Poorly differentiated or undifferentiated | 19 (45.3) |
Locally advanced disease | 10 (23.8) |
Metastatic disease | 32 (76.2) |
Number of metastases | |
1 | 16 (38.2) |
2 | 19 (45.2) |
3+ | 7 (16.6) |
Sites of metastases | |
Liver | 20 (47.6) |
Peritoneum | 9 (21.4) |
Nodes | 22 (52.4) |
Local | 15 (35.7) |
Other | 6 (14.3) |
Prior adjuvant chemotherapy | |
None | 35 (83.3) |
Yes | 7 (16.7) |
Patients with metastases at the diagnosis | 18 (42.8) |
Number of cycles | |
Total | 540 |
Median | 12 |
Range | 3–24 |
Objective responses
|
Number (%)
|
Overall response rate
|
Overall tumor control rate
|
---|---|---|---|
Complete Response | 2 (4.7%) | 19 (45.2%) | 32 (76.2%) |
Partial Response | 17 (40.5%) | ||
Stable Disease | 13 (31.0%) | ||
Disease Progression | 10 (23.8%) |
Side effects
|
Number of patients with toxicity (%)
| ||||
---|---|---|---|---|---|
Grade 1
|
Grade 2
|
Grade 3
|
Grade 4
|
All grades
| |
Hematological
| |||||
Anemia | 4 (9.5%) | 0 | 0 | 0 | 4 (9.6) |
Leucopenia | 4 (9.5%) | 2 (4.8%) | 0 | 0 | 6 (14.2%) |
Neutropenia | 1 (2.4%) | 1 (2.4%) | 2 (4.8%) | 0 | 4 (9.6%) |
Thrombocytopenia | 2(4.8%) | 2 (4.8%) | 0 | 0 | 4 (9.6%) |
Non-hematological
| |||||
Nausea/Vomiting | 5 (11.9%) | 11 (26.2%) | 0 | 0 | 16 (38.1%) |
Mucositis | 7 (16.7%) | 5 (11.9%) | 1 (2.4%) | 0 | 13 (31.0%) |
Neurotoxicity | 8 (19.0%) | 5 (11.9%) | 1 (2.4%) | 0 | 14 (33.3%) |
Diarrhoea | 8 (19.0%) | 7 (16.6%) | 2 (4.8%) | 0 | 17 (40.4%) |
Asthenia | 15 (35.7%) | 11 (26.2%) | 3 (7.1%) | 0 | 29 (69.0%) |
Hyperbilirubinemia | 1 (2.4%) | 3 (7.1%) | 0 | 0 | 4 (9.5%) |
Anorexia | 5 (11.9%) | 3 (7.1%) | 0 | 0 | 8 (19.0%) |
Safety
Treatment modifications
|
No. of patients
|
%
|
---|---|---|
Any dose reduction | 18 | 42.8% |
Any cycle delay | 20 | 47.6% |
Toxicity-related withdrawals | 3 | 7.1% |
Time to treatment modification
|
Months
|
Range
|
Median time to reduction | 2.0 | 1.0–5.3 |
Median time to first delay | 1.3 | 0.5–3 |
Median time to toxicity-related withdrawal | 3.9 | 1.8–6.0 |