WJOG 4007 is a phase III multicentre randomised open label trial involving 223 patients comparing paclitaxel with irinotecan in patients with metastatic or recurrent gastric adenocarcinoma.
Between August 2007 and August 2010, 111 patients were randomised to receive paclitaxel (paclitaxel 80 mg/m2 d1, 8, 15 every 28 days) and 112 patients were randomised to receive irinotecan (irinotecan 150 mg/m2 d1, 15 every 28 days).
The primary end point was overall survival and secondary end points were progression-free survival, response rate, adverse events, and proportion of patients who received third-line chemotherapy.r
Efficacy
After a median follow up of 17.6 months, the median OS was 9.5 months in the paclitaxel group vs 8.4 months in irinotecan group (HR=1.13; CI 95% 0.86 to 1.49 ; p=0.38). Median PFS was 3.6 months in the paclitaxel group and 2.3 months in the irinotecan group (HR=1.14; CI 95% 0.88 to 1.49; p=0.33). Response rate was 20.9% in the paclitaxel group and 13.6% in the irinotecan group (p=0.24)1. There was no statistically significant difference in OS and PFS observed in two groups.
Kaplan-Meier curves of (A) overall survival and (B) progression-free survivalr
© Journal of Clinical Oncology 2013
Toxicity
Common grade 3 to 4 adverse events were neutropenia (paclitaxel group, 28.7%; irinotecan group, 39.1%), anaemia (21.3%; 30.0%), and anorexia (7.4%; 17.3%). Grade 3 or 4 sensory neuropathy was observed in the paclitaxel group (7.4%) only. Treatment-related deaths occurred in two patients (1.8%) in the irinotecan group only.r
Adverse Event
Grade 3/4r |
Weekly Paclitaxel (n=108)
% |
Irinotecan (n=110)
% |
Leukocytopenia |
20.4 |
19.1 |
Neutropenia |
28.7 |
39.1 |
Haemoglobin |
21.3 |
30.0 |
Thrombocytopenia |
0.9 |
1.8 |
Febrile neutropenia |
2.8 |
9.1 |
Nausea |
1.9 |
4.5 |
Vomiting |
2.8 |
0.9 |
Anorexia |
7.4 |
17.3 |
Diarrhoea |
0.9 |
4.5 |
Neuropathy (sensory) |
7.4 |
0 |
Bilirubin |
2.8 |
3.6 |
AST |
3.7 |
8.2 |
ALT |
2.8 |
2.7 |
Hyponatraemia |
3.7 |
15.5 |
Treatment-related death |
0 |
1.8 |