Maintenance sunitinib (MS) or observation (O) in metastatic pancreatic adenocarcinoma (MPA): Clinical and translational results of a phase II randomized trial (NCT00967603).

Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Poster Discussion Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr 4017)
Michele Reni, Stefano Cereda, Michele Milella, Anna Novarino, Alessandro Passardi, Andrea Mambrini, Giuseppe Di Lucca, Laura Ferrari, Carmen Belli, Marco Danova, Francesca Bergamo, Enrico Franceschi, Bianca Rovati, Clara Fugazza, Domenica Ceraulo, Eugenio Villa; San Raffaele Scientific Institute, Milan, Italy; Department of Oncology, San Raffaele Scientific Institute, Milan, Italy; Regina Elena National Cancer Institute, Rome, Italy; Centro Oncoematologico Subalpino Molinette Hospital, Turin, Italy; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; Department of Oncology, Carrara City Hospital, Carrara, Italy; Saronno Hospital, Saronno, Italy; Azienda Ospedaliero-Universitaria di Udine, Udine, Italy; Fondazione IRCCS S. Matteo, Pavia, Italy; Istituto Oncologico Veneto, IRCCS, Padova, Italy; Medical Oncology Department, Bellaria-Maggiore Hospital, Azienda USL of Bologna, Bologna, Italy; Scientific Institute San Raffaele, Milano, Italy

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Abstract Disclosures


Background: Combination chemotherapy (CT) prolonged progression-free survival at 6 months (PFS6) of patients (pts) with MPA from <20% with gemcitabine (GEM) to >50%. To prolong CT over 6 months has unproven benefit and is hampered by cumulative toxicity. This open-label, randomised, multi-centre phase II trial explored the role of MS in pts with MPA without progressive disease (PD) after CT, using an O group as calibration arm. The role of circulating endothelial cells (CEC) as biomarker of MS activity was explored. Methods: Adult pts with pathologic diagnosis of MPA, performance status (PS) >50%, without radiological PD or CA19.9 raise >20% after 6 months of CT were stratified based on PS and previous CT and randomized to O (arm A) or MS at 37.5 mg daily until PD or a maximum of 6 months (arm B). Primary endpoint was PFS6. Sample size (H0 10%; H1 30%; a .10; b .10) was 26 pts per arm and MS had to be considered of interest with >5 pts PFS6. CEC were evaluated by flow cytofluorometry on a baseline peripheral blood sample. Results: 56 pts (29 arm A; 27 arm B) were enrolled. One arm B pt had kidney cancer and was excluded. Pts characteristics were (A/B): median age 64/61 years; median PS 90/100; median CA19.9 45/32; previous CT: GEM 3/3; combination CT 26/22. Main grade 3-4 toxicity in arm B was 15% neutropenia; 12% thrombocytopenia and hand-foot syndrome, 8% diarrhea. Second line CT was given to 76% of pts in both arms. One arm A (3%) and 6 arm B pts (23%; p=.01) were PFS6; 2y overall survival (OS) was 4% and 25% (p=.09). Blood sample for CEC analysis was available for 46 of 55 pts (84%). In arm A, median PFS was longer for pts with CEC number <30 (lower terzile group) when compared to >30 (2.9 versus 1.9 months; p.08). MS significantly increased PFS in CEC >30 group (3.4 months; p=.01). No PFS difference between arms was observed in <30 group (2.3 months). Conclusions: This is the first randomized trial on maintenance therapy in MPA. In arm B, the primary endpoint was fulfilled and 2y OS was remarkably high, suggesting that MS may have a role in pts with MPA. The number of CEC may be useful to predict benefit from MS.