Abstract
ABSTRACT Background Chemotherapy is widely used for advanced, unresectable neuroendocine tumours (NETs) but only four randomised trials are published. The first combined streptozocin (strep) and 5fluorouracil (5FU), reporting 63% response rate (RR), but subsequent retrospective studies had lower RRs (6-45%). Cisplatin has been combined with strep + 5FU in a retrospective study with promising activity in NETs and capecitabine (cap) has been effectively substituted for 5FU in many tumours. The NET01 trial was designed to investigate whether cap + strep ± cisplatin warrant further evaluation. Methods Patients (pts) with histologically confirmed, unresectable, advanced and/or metastatic NETs of foregut, pancreatic or unknown primary site were randomised (1:1) to 6 cycles of 3-weekly cap 625 mg/m2 po bd daily (D1-21), strep 1.0g/m2 IV (D1), with cisplatin 70mg/m2 IV (D1) (Cap-strep-cist) or without (Cap-strep). The primary outcome measure was RR using RECIST criteria. 84 pts were required to test a RR of 60% with a significance level of 5% and 80% power in each arm. Central pathology review and 10% of central radiology review were performed. Results 86 pts (58% male, median age 59 years) were randomised (44 Cap-strep, 42 Cap-strep-cist) with primary site – foregut 20%, pancreatic 48% and unknown 33%. The grade was low 12 (17%), intermediate 43 (62%) and high 14 (20%). Baseline characteristics were balanced between the 2 arms. 59% Cap-strep and 33% Cap-strep-cist pts received ≥6 cycles. 18 Cap-strep and 26 Cap-strep-cist pts experienced grade ≥3 toxicities. Outcome results are summarised in the table. Cap-strep-cist Cap-strep Response PR SD PD n = 38 13% 61% 26% n = 40 8% 73% 20% PFS No. progressions/deaths, n(%) Median (mo) n = 42 35 (83%) 9.7 n = 44 34 (77%) 10.2 OS No. deaths, n(%) Median (mo) n = 42 22 (52%) 27.5 n = 44 25 (57%) 26.7 Conclusions The novel Cap-strep ± cisplatin regimens were associated with overall disease control and survival durations consistent with published studies. Cap-strep was better tolerated than Cap-strep-cist. Further prospective randomised trials are needed to determine optimal NET chemotherapy. Disclosure D. Cunningham: Research Funding: Amgen, Roche. Astra Zeneca Expert testimony: Amgen (Uncompensated) Honoraria: None Advisory: Amgen Roche (Uncompensated). All other authors have declared no conflicts of interest.
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