FIRSTMAPPP: sunitinib for metastatic progressive phaeochromocytomas and paragangliomas
In the first randomised trial in these rare tumours, sunitinib kept 36 percent of patients free of progression at one year against 19 percent on placebo.
Overview
Academic, multicentre, double-blind, placebo-controlled phase 2 trial at 14 European centres: 78 adults with progressive metastatic phaeochromocytoma or paraganglioma were randomised to sunitinib 37.5 mg daily or placebo. The primary endpoint was progression-free survival at 12 months.
14 of 39 sunitinib patients (36 percent) and 7 of 39 placebo patients (19 percent) were progression-free at 12 months, meeting the primary endpoint. Grade 3 or 4 asthenia (18 against 3 percent) and hypertension (13 against 10 percent) were the common toxicities; one death from rectal bleeding was drug-related.
- Progression-free survival at 12 months 36 percent (90% CI 23 to 50) with sunitinib versus 19 percent (11 to 31) with placebo.
- Grade 3 or 4 asthenia 18 versus 3 percent; hypertension 13 versus 10 percent; one drug-related death.
Sunitinib has the highest level of evidence of any drug for progressive metastatic phaeochromocytoma and paraganglioma, alongside the later approval of belzutifan.
- Small phase 2 with a single-arm-style primary endpoint; the placebo arm validated the design rather than providing a formal superiority test.
Similar pages
not linked directly; found by shared links- Key paperFIRSTMAPPP: sunitinib for metastatic progressive pheochromocytomas and paragangliomas
Shares Metastatic pheochromocytoma and paraganglioma, Sunitinib, The Lancet.
- TrialStudy of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
Shares Metastatic pheochromocytoma and paraganglioma, Pheochromocytoma and paraganglioma (PPGL).
- Key paperSunitinib in advanced gastrointestinal stromal tumour after failure of imatinib
Shares Sunitinib, The Lancet.
- TrialBelzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL
Shares Metastatic pheochromocytoma and paraganglioma, Pheochromocytoma and paraganglioma (PPGL).
- TermAdrenalectomy
Shares Metastatic pheochromocytoma and paraganglioma, Pheochromocytoma and paraganglioma (PPGL).
- Key paperGRID: regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib
Shares Sunitinib, The Lancet.
- Key paperPAPMET (SWOG 1500): cabozantinib versus sunitinib for metastatic papillary renal cell carcinoma
Shares Sunitinib, The Lancet.
- Treatment131I-MIBG (iobenguane I-131) therapy
Shares Metastatic pheochromocytoma and paraganglioma, Pheochromocytoma and paraganglioma (PPGL).