Table 1.
Randomized trials of chemotherapy in GEP NECs
| Trial and author | N | Primary site | Treatment | Primary Endpoint | ORR (%) | PFS (median) | OS (median) |
|---|---|---|---|---|---|---|---|
| First-line therapy | |||||||
|
TOPIC NEC
Morizane et al |
170 | GEP (100 GI, 70 HBP) |
CDDP + etoposide CDDP + irinotecan |
OS | 54.5% 52.5% |
5.6 mo 5.1 mo |
12.5 mo 10.9 mo |
| Zhang et al | 66 | GEP | CDDP + etoposide CDDP + irinotecan |
ORR | 63.2% 61.5% |
6.4 mo 5.8 mos |
11.3 mo 10.2 mo |
| Second-line therapy | |||||||
|
NET-02
McNamara et al |
58 | GEP (40) Other EP NECs (11) UKP NECs (7) |
Nal-IRI + 5FU docetaxel |
6 mo | 10.3% 10.3% |
3 mos (31% 6-mo PFS) 2 mo (14% 6-mo PFS) |
9.0 mo 5.0 mo |
|
PRODIGE 41 (BEVANEC)
Walter et al |
126 | GEP UKP |
FOLFIRI + Beva FOLFIRI |
6 mo OS | 25.5% 18.3% |
3.7 mo 3.5 mo |
7.0 mo (52.5% 6- mo OS) 8.9 mo (58.2% 6-mo OS) |
Abbreviations: CDDP, cisplatin; EP-NEC, extrapulmonary neuroendocrine carcinoma; GEP, gastroenteropancreatic; GI, gastrointestinal; HBP, hepatobiliopancreatic; IRI, irinotecan; NEC, neuroendocrine carcinoma; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.