Konference: 2015 40th Congress ESMO a 18th ECCO - účast ČR
Kategorie: Gastrointestinální nádory
Téma: Postery
Číslo abstraktu: P332/2370
Autoři: Prof. M.D. Alexandria T. Phan; Prof. M.D. Martyn E. Caplin, FRCP; Prof. Dr. Marianne E. Pavel, M.D.; Prof. M.D. Jaroslaw B. Cwikla; M.D. Markus Raderer; MUDr. Eva Sedláčková, MBA; Prof. M.D. Guillaume Cadiot, Ph.D.; MD Edward M. Wolin; MD Jaume Capdevila; M.D. Lucy R. Wall ; M.D. Guido Rindi, Ph.D.; Alison Langley; Edda Gomez-Panzani; Prof. M.D. Philippe B. Ruszniewski
Background: In the CLARINET study (NCT00353496), progression-free survival (PFS) of patients with metastatic pancreatic and intestinal neuroendocrine tumours (NETs) was significantly increased with lanreotide Autogel (Depot in USA) 120mg vs placebo (hazard ratio [HR] for progressive disease [PD]/death 0.47 [95% confidence interval CI: 0.30, 0.73]). We now present detailed analysis of the safety and tolerability data from CLARINET evaluating the relative risk of adverse events.
Methods: Patients with metastatic grade 1/2 (Ki-67 <10%) non-functioning pancreatic and intestinal NETs received lanreotide Autogel 120mg (n=101) or placebo (n=103) for 96 weeks or until death/disease progression. The relative risks and 95%CIs of any adverse event occurring in ≥5% of patients in either group were calculated post hoc for lanreotide vs. placebo.
Results: The overall incidence of adverse events was similar for lanreotide- and placebo-treated patients (88% vs 90%). The most common adverse events were gastrointestinal disorders, which occurred in 67% of the lanreotide-treated group vs. 63% of the placebo-treated group (RR 1.1 [0.9, 1.3]). Of these, diarrhoea was the most common individual adverse event (35% vs 35%; RR 1.0 [0.7, 1.4]). None of the adverse events occurring in ≥5% of either group were statistically significantly different between the lanreotide and placebo treated patients when based on the RRs although the CIs for the RRs were wide in several cases (lower limit of CIs were ≤1). The most frequent adverse events in either group are shown in the Table.
Conclusions: No new safety signals for lanreotide were identified in the CLARINET study supporting its favourable benefit–risk profile in patients with pancreatic and intestinal NETs.
| Adverse event | Lanreotide, n (%) (N=101) | Placebo, n (%) (N=103) | RR (95%CI) |
|---|---|---|---|
| Gastrointestinal | |||
| Diarrhea | 35 (34.7) | 36 (35.0) | 1.0 (0.7, 1.4) |
| Abdominal pain | 24 (23.8) | 17 (16.5) | 1.4 (0.8, 2.5) |
| Vomiting | 19 (18.8) | 9 (8.7) | 2.2 (1.0, 4.5) |
| Nausea | 14 (13.9) | 14 (13.6) | 1.0 (0.5, 2.0) |
| Constipation | 12 (11.9) | 13 (12.6) | 0.9 (0.5, 2.0) |
| Flatulence | 12 (11.9) | 9 (8.7) | 1.4 (0.6, 3.1) |
| Musculoskeletal | |||
| Headache | 16 (15.8) | 11 (10.7) | 1.5 (0.7, 3.0) |
| Back pain | 12 (11.9) | 11 (10.7) | 1.1 (0.5, 2.4) |
| Hepatobiliary | |||
| Cholelithiasis | 14 (13.9) | 7 (6.8) | 2.0 (0.9, 4.8) |
| Vascular | |||
| Hypertension | 13 (12.9) | 5 (4.9) | 2.7 (1.0, 7.2) |
| General and administration site | |||
| Fatigue | 10 (9.9) | 15 (14.6) | 0.7 (0.3, 1.4) |
| Infections and infestations | |||
| Nasopharyngitis | 9 (8.9) | 16 (15.5) | 0.6 (0.3, 1.2) |
For significant difference between treatment groups, lower limit of CIs would need to be >1.
Conflict of interest: Ownership: Authors Langley and Gomez-Panzani are employees of Ipsen, France.
lanreotide
neuroendocrine tumour
safety
Datum přednesení příspěvku: 28. 9. 2015
