PMID- 28723233 OWN - NLM STAT- MEDLINE DCOM- 20180129 LR - 20211204 IS - 1651-226X (Electronic) IS - 0284-186X (Linking) VI - 56 IP - 12 DP - 2017 Dec TI - Treatment patterns and clinical outcomes with pazopanib in patients with advanced soft tissue sarcomas in a compassionate use setting: results of the SPIRE study(). PG - 1769-1775 LID - 10.1080/0284186X.2017.1332779 [doi] AB - BACKGROUND: A named patient program (NPP) was designed to provide patients with advanced soft-tissue sarcoma (aSTS) access to pazopanib, a multitargeted tyrosine kinase inhibitor. The SPIRE study was a retrospective chart review of participating patients. PATIENTS AND METHODS: Eligibility criteria for the NPP and SPIRE mirrored those of the pivotal phase-III study, PALETTE, which compared pazopanib with placebo in patients >/=18 years with aSTS and whose disease had progressed during or following prior chemotherapy or were otherwise unsuitable for chemotherapy. Outcomes of interest included treatment patterns, treatment duration, relative dose intensity, progression-free survival (PFS), overall survival (OS), clinical benefit rate, adverse events (AEs) and reasons for treatment discontinuation. RESULTS: A total of 211 patients were enrolled (median age 56 years; 60% female). Most patients received pazopanib in second- and third-line therapy (28.0% and 28.4%, respectively), followed by fourth line (19.0%) and >/= fifth line (18.5%). The median duration of pazopanib treatment was 3.1 months (95% CI: 2.8-3.8), with a mean daily dose of 715 mg equating to 92% of recommended dose. Median OS was 11.1 months and clinical benefit rate was 46%. There was evidence of some clinical benefit across most histological subtypes. At study end, 40% of patients were alive and of these, 18% remained on pazopanib. Thirteen percent (13%) of patients discontinued pazopanib due to AEs. CONCLUSIONS: The SPIRE study demonstrated activity of pazopanib in heavily pretreated aSTS patients in a compassionate use setting. No new safety concerns were noted. Reassuringly, the relative dose intensity of pazopanib was 92%. FAU - Gelderblom, Hans AU - Gelderblom H AD - a Department of Medical Oncology , Leiden University Medical Centre , Leiden , the Netherlands. FAU - Judson, Ian R AU - Judson IR AD - b Sarcoma Unit , The Royal Marsden NHS Foundation Trust , London , UK. FAU - Benson, Charlotte AU - Benson C AD - b Sarcoma Unit , The Royal Marsden NHS Foundation Trust , London , UK. FAU - Merimsky, Ofer AU - Merimsky O AD - c Unit of Bone and Soft Tissue Oncology , Tel-Aviv Sourasky Medical Center and Tel-Aviv University Sackler School of Medicine , Tel-Aviv , Israel. FAU - Grignani, Giovanni AU - Grignani G AD - d Divisione Oncologia Medica , Candiolo Cancer Institute - FPO I.R.C.C.S. , Candiolo , Italy. FAU - Katz, Daniela AU - Katz D AD - e Hadassah-Hebrew University Medical Center , Jerusalem , Israel. FAU - Freivogel, Klaus W AU - Freivogel KW AD - f United BioSource (Germany) GmbH , Loerrach , Germany. FAU - Stein, Dara AU - Stein D AD - g United BioSource Corporation , Quebec , Canada. FAU - Jobanputra, Minesh AU - Jobanputra M AD - h bluebird bio , London , UK. FAU - Mungul, Arron AU - Mungul A AD - i Bristol-Myers Squibb , Uxbridge , UK. FAU - Manson, Stephanie C AU - Manson SC AD - j Novartis Oncology , East Hanover , NJ , USA. FAU - Sanfilippo, Roberta AU - Sanfilippo R AD - k Adult Mesenchymal Tumor Medical Oncology Unit , Fondazione IRCCS Istituto Nazionale Tumori , Milan , Italy. LA - eng PT - Journal Article DEP - 20170719 PL - Sweden TA - Acta Oncol JT - Acta oncologica (Stockholm, Sweden) JID - 8709065 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Indazoles) RN - 0 (Pyrimidines) RN - 0 (Sulfonamides) RN - 7RN5DR86CK (pazopanib) SB - IM MH - Angiogenesis Inhibitors/*therapeutic use MH - Compassionate Use Trials MH - Disease-Free Survival MH - Female MH - Hemangiosarcoma/drug therapy/pathology MH - Humans MH - Indazoles MH - Leiomyosarcoma/drug therapy/pathology MH - Lung Neoplasms/drug therapy/secondary MH - Male MH - Middle Aged MH - Pyrimidines/*therapeutic use MH - Retrospective Studies MH - Sarcoma/*drug therapy/pathology MH - Sarcoma, Synovial/drug therapy/pathology MH - Solitary Fibrous Tumors/drug therapy/pathology MH - Sulfonamides/*therapeutic use MH - Survival Rate MH - Time Factors MH - Uterine Neoplasms/drug therapy/pathology EDAT- 2017/07/21 06:00 MHDA- 2018/01/30 06:00 CRDT- 2017/07/21 06:00 PHST- 2017/07/21 06:00 [pubmed] PHST- 2018/01/30 06:00 [medline] PHST- 2017/07/21 06:00 [entrez] AID - 10.1080/0284186X.2017.1332779 [doi] PST - ppublish SO - Acta Oncol. 2017 Dec;56(12):1769-1775. doi: 10.1080/0284186X.2017.1332779. Epub 2017 Jul 19.