title: Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study.
abstract: Therapeutic options to cure advanced, recurrent, and unresectable thymomas are limited. The most important factor for long-term survival of thymoma patients is complete resection (R0) of the tumor. We therefore evaluated the response to and the induction of resectability of primarily or locally recurrent unresectable thymomas and thymic carcinomas by octreotide Long-Acting Release (LAR) plus prednisone therapy in patients with positive octreotide scans. In this open label, single-arm phase II study, 17 patients with thymomas considered unresectable or locally recurrent thymoma (n = 15) and thymic carcinoma (n = 2) at Masaoka stage III were enrolled. Octreotide LAR (30 mg once every 2 weeks) was administered in combination with prednisone (0.6 mg/kg per day) for a maximum of 24 weeks (study design according to Fleming´s one sample multiple testing procedure for phase II clinical trials). Tumor size was evaluated by volumetric CT measurements, and a decrease in tumor volume of at least 20% at week 12 compared to baseline was considered as a response. We found that octreotide LAR plus prednisone elicited response in 15 of 17 patients (88%). Median reduction of tumor volume after 12 weeks of treatment was 51% (range 20%-86%). Subsequently, complete surgical resection was achieved in five (29%) and four patients (23%) after 12 and 24 weeks, respectively. Octreotide LAR plus prednisone treatment was discontinued in two patients before week 12 due to unsatisfactory therapeutic effects or adverse events. The most frequent adverse events were gastrointestinal (71%), infectious (65%), and hematological (41%) complications. In conclusion, octreotide LAR plus prednisone is efficacious in patients with primary or recurrent unresectable thymoma with respect to tumor regression. Octreotide LAR plus prednisone was well tolerated and adverse events were in line with the known safety profile of both agents.
authors.affiliation: Department of Neurology, University of Regensburg, Regensburg, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Kirzinger
authors.affiliation: Department of Neurology, University of Regensburg, Regensburg, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Boy
authors.affiliation: Department of Nuclear Medicine, University of Regensburg, Regensburg, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Marienhagen
authors.affiliation: Institute of Neuroradiology, BKR, Regensburg, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuierer
authors.affiliation: Department of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
authors.forename: Reiner
authors.initials: R
authors.lastname: Neu
authors.affiliation: Department of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Ried
authors.affiliation: Department of Thoracic Surgery, University of Regensburg, Regensburg, Germany.
authors.forename: Hans-Stefan
authors.initials: HS
authors.lastname: Hofmann
authors.affiliation: Department of Cardiac and Thoracic Surgery, University of Muenster, Muenster, Germany.
authors.forename: Karsten
authors.initials: K
authors.lastname: Wiebe
authors.affiliation: Institute of Pathology, University of Goettingen, Goettingen, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Ströbel
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: May
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Kleylein-Sohn
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Baierlein
authors.affiliation: Department of Neurology, University of Regensburg, Regensburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Bogdahn
authors.affiliation: Institute of Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Marx
authors.affiliation: Department of Neurology, University of Regensburg, Regensburg, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Schalke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D015282:Octreotide / Q000008:administration & dosage* / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D013945:Thymoma / Q000188:drug therapy* / Q000473:pathology; D013953:Thymus Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D015282:Octreotide; D011241:Prednisone