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Welcome address by the President of the Singapore Society of Oncology
- Su Pin Choo
- Su Pin Choo
Keynote 1 - Cancer burden in the Asia-Pacific region
- Elisabete Weiderpass
- Elisabete Weiderpass
Welcome address by the ESMO President
- Josep Tabernero
- Josep Tabernero
Presentation of Token of Appreciation to the endorsing National Oncology Societies
- Josep Tabernero
- Josep Tabernero
Keynote 2 - Innate immunity, inflammation and cancer: The long journey to bedside
- Alberto Mantovani
- Alberto Mantovani
Welcome address by the Senior Minister of State, Ministry of Transport & Ministry of Health
- Pin Min Lam
- Pin Min Lam
Scientific address
- Rebecca Dent
- Ian Chau
- Rebecca Dent
- Ian Chau
Singapore Cultural Dance performance
Discussion led by moderators
- Tom Wei-Wu Chen
- Silvia Stacchiotti
- Aisha Miah
- Tom Wei-Wu Chen
- Silvia Stacchiotti
- Aisha Miah
Discussion led by moderators
- Tom Wei-Wu Chen
- Silvia Stacchiotti
- Aisha Miah
- Tom Wei-Wu Chen
- Silvia Stacchiotti
- Aisha Miah
403O - The efficacy of eribulin methylate for patients with taxane-resistant cutaneous angiosarcoma: Final results from a multi-center, prospective, observational study
- Yasuhiro Fujisawa
- Yasuhiro Fujisawa
- Koji Yoshino
- Taku Fujimura
- Yuki Yamamoto
- Hiroshi Uchi
- Hiroo Hata
- Atsushi Otsuka
- Takuya Miyagi
- Takeru Funakoshi
- Shigeto Matsushita
Abstract
Background
Although taxanes (TAX) are effective for advanced cutaneous angiosarcoma (CAS) and stand as a current first-line treatment, no standardized second-line treatment has yet been established. Eribulin methylate (ERB), a non-taxane microtubule inhibitor, improved the overall survival (OS) of patients with advanced sarcoma compared to dacarbazine in a randomized, phase 3 trial. Based on this study, ERB was approved to use for all types of sarcoma in Japan. We hypothesized that ERB would be most active in patients with TAX-resistant CAS as both TAX and ERB target microtubules but through different mechanisms.
Methods
We designed a single-arm, prospective observational study of ERB administered at a dose of 1.4mg/m2 on days 1 and 8 in a 21-day cycle. Advanced, TAX-resistant CAS patients scheduled for ERB use were enrolled. The primary endpoint was OS and the secondary endpoints were response ratio (RR), progression-free survival (PFS), and toxicity assessment.
Results
The last patient was enrolled in January 2018 and the data was locked at the end of March 2019. In total, 25 patients with CAS (median age 74) were enrolled. All patients had prior TAX exposure and 5 patients had 2 or more prior therapy courses. All patients except 1 had their primary tumours in the head and neck while 10 patients had distant metastasis. Performance status (PS) was generally good; 14 were PS0, 8 were PS1, and 3 were PS2. The median follow-up period was 250 (16-849) days. The rate of OS and PFS at 6 months estimated by Kaplan-Meier method was 67% and 24%, respectively. Median OS and PFS were 8.6 and 3.0 months, respectively. RR at week 7, 13, and 25 were 24% (6/25), 16.7% (4/25) and 13% (3/23), respectively. Although 10 patients experienced severe toxicity (8 had neutropenia, 2 had anemia and 1 had a retroperitoneal abscess), they all recovered.
Conclusions
ERB showed a promising and durable response and was well-tolerated in TAX-resistant CAS. Both RR and OS were comparable to previous results where ANGIOTAX was used as a second-line treatment. The most common toxicity was neutropenia but this was manageable. Taken together, this study provides evidence to support ERB use in TAX-resistant CAS cases.
Clinical trial identification
UMIN000023331.
Legal entity responsible for the study
The authors.
Funding
Maruho Takagi Dermatology Foundation.
Disclosure
All authors have declared no conflicts of interest.
404O - A phase II single arm study of nivolumab and ipilimumab (Nivo/Ipi) in previously treated Classical Kaposi Sarcoma (CKS)
- Alona Zer
- Alona Zer
- Oded Icht
- Oded Jacobi
- Eyal Fenig
- Sivan Shamai
- Ofer Merimsky
- Ronnie Shapira
- Hanna Bernstine
- Rony Weitzen
- Olga Vornikova
- Eytan Ben-Ami
- Gil Bar-Sela
- Salomon M. Stemmer
- Michal Lotem
Abstract
Background
CKS is an angioproliferative mesenchymal neoplasm causatively associated with human herpes virus 8 infection. Though recombinant IFNa is approved for treatment of AIDS-related KS, data is limited regarding the role of immune modulation. Based on favorable responses in viral-induced cancers, we hypothesized that CTLA-4 and PD-1 blockade can induce tumor regression in CKS. We present pre-planned interim analysis of a phase II study of Nivo/Ipi in previously treated (tx) progressive CKS.
Methods
CKS pts with progressive disease after > 1 line of systemic tx and measurable disease by PET/CT and/or physical exam received nivolumab 240mg d1,15,28 and ipilimumab 1mg/kg d1 q42 days until progression or toxicity. The primary endpoint (EP) was overall response rate (ORR), secondary EP include 6-months progression free survival rate (PFS) and safety. Exploratory EP included PD-L1/MMR IHC, DNAseq (596 genes)/RNAseq (whole transcriptome) of tissue and matched blood to explore CKS genomic traits and IO correlates: TMB, MSI, dMMR, PD-L1, immune gene expression (PD1, CTLA4, etc) (Tempus Labs, Chicago, IL, USA).
Results
Twelve patients were enrolled and evaluable between Apr2018-Jun2019 and 11 were evaluable for response. Median age 72 (61-81). At a mFU of 6 months ORR was 45% (4 pts PR, 1 pt CR, 6 pts SD). mPFS was not reached, 6-mo PFS rate was 91% (1 out of 11 patients had PD). The safety profile was as expected with three patients with G2 toxicity (1 ALT/AST increase, 1 asymptomatic lipase increase) and two patients with G3 toxicity (1 colitis, 1 asymptomatic lipase increase) . One SAE was reported (TIA considered not related to therapy) and treatment was discontinued in one pt (G2 LFT increase. maintaining CR 4 months after treatment discontinuation). Correlative results are available for four patients showing negative PDL1 IHC in all, low TMB, MS-S, but marked overexpression of CTLA4, PD1 and PDL1.
Conclusions
The interim analysis in this prospectively designed phase II study of nivo/ipi demonstrate promising activity in progressive CKS, with 45% ORR and a 6mo PFS rate of 91%. Toxicity profile as expected in this class of drugs. Correlative studies are preliminary but warrants further investigation into immune gene expression profiles.
Clinical trial identification
NCT03219671.
Editorial acknowledgement
None
Legal entity responsible for the study
The authors.
Funding
BMS Rabin Medical Center.
Disclosure
A. Zer: Honoraria (self), Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AZ. All other authors have declared no conflicts of interest.