NEC rarely arises in extra-pulmonary sites. Although chemotherapeutic regimens for small cell lung cancer (SCLC) are empirically administrated for unresectable extra-pulmonary NEC in the first-line setting, the 2nd line treatment is not established because of its rarity. Amrubicin has clinical relevance for platinum-refractory SCLC and gastrointestinal NEC. However, there is no data for non-gastrointestional extra-plumonary NEC.
In this retrospective study of two hospitals, eligible patients 1) had a definitive diagnosis of non-gastrointestinal extra-pulmonary NEC, 2) were refractory to platinum-based chemo, and 3) were treated between January 2008 and December 2014 with 4) amrubicin monotherapy at a dose of 40mg/m2 on days 1 to 3 every 3 weeks. The platinum-free interval was defined as the duration from the last day of platinum administration to the first progression.
Fourteen eligible patients including 6 men (42.9%) were extracted with the median age of 62 years (range 43-86). Primary sites included genitourinary organs in 5, gynecological organs in 2, thymus in 2 and others. Results included ORR of 40%, median PFS and OS of 181 and 319 days respectively. Platinum-free interval over 90 days was a significant factor for favarable PFS (p = 0.0022). Grade 3/4 adverse events were neutropenia (80%) and febrile neutropenia (30%). Treatment related death was observed in one with febrile neutropenia.
Amrubicin showed modest efficacy for patients with platinum-refractory non-gastrointestinal extra-pulmonary NEC with modestly frequent adverse events.
Clinical trial identification
Legal entity responsible for the study
Y. Takiguchi: I received lecture fee by Nipponkayaku.
All other authors have declared no conflicts of interest.