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418P - Lessons learnt from treatment of foot sarcomas: Analysis from dedicated sarcoma clinic in North India
- Satyajit J. Pawar
- Satyajit J. Pawar
- Sameer Rastogi
- Ekta Dhamija
- Adarsh Barwad
- Venkatesan Kumar
- Rambha Pandey
- Sorun Shishak
- Kaushal Kalra
- Aditi Aggarwal
- Arun Garg
- Asit R. Mridha
- Jigyasa Chaubey
- Shah Alam Khan
Abstract
Background
There is sparse data available on foot sarcomas treated on contemporary protocols.
Methods
This retrospective analysis involved 27 cases of foot sarcomas managed with multi-modality treatment under Sarcoma Clinic, at tertiary care hospital between January 2014 to May 2019. Baseline demographics, radiographic tumour characteristics, histological diagnosis, type of treatment received and oncological outcomes were noted for all cases. Statistical analysis was done by STATA version 13.0. Survival curves were analyzed by Kaplan Meir test and univariate analysis was done by Log Rank test.
Results
Median age was 26 years (range: 20 – 46 years). Median duration of symptoms were 11 months (Range: 5 – 24 months). Radiologically mean largest diameter of tumour was 6.5 cm (CI: 1.1 – 12 cm). Seven tumours (26%) arose from bone and 20 form soft tissue (74%). In tumours arising from bone, metatarsal was most commonly site of involvement (3 out of 7). Most common histology was synovial sarcoma (44%) f/b Ewing’s sarcoma (26%) f/b others (RMS, DFSP, MPNST, angiosarcoma). Ten patients (37%) had metastatic disease at presentation, lung being most common site (80%). Histological discordance with review diagnosis was seen in 50 % cases. Amputation was needed in 10 cases (37%) (palliative - 5, curative - 5) while limb salvage surgery was done in 10 (all curative). Adjuvant radiation was given in 7 out of 10 cases (70%). At last follow up 16 out of 27 patients (60%) were alive without disease, 4 (11%) with disease while 8 (29%) have died. With median follow-up of 43 months (Range 8 - 63 months) median PFS was 22 months. Median PFS in non-metastatic group was 48 months, while in metastatic group it was 8 months. On univariate analysis, median OS was significantly different between metastatic vs non-metastatic group (HR 10.93, p = 0.03).
Conclusions
Foot sarcomas happen in young adults irrespective of pathology with synovial sarcoma and Ewing’s sarcoma being most common histologies. Amputation rates are quite high even considering small size, owing to anatomy of the region as noted in previous studies. The treatment required for non metastatic disease is multimodality including use of radiation. If treated in multidisciplinary clinic outcomes can certainly be improved.
Legal entity responsible for the study
Sameer Rastogi.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
269O - Efficacy and safety of isatuximab plus pomalidomide and dexamethasone in East Asian patients with relapsed/refractory multiple myeloma: A subgroup analysis of ICARIA-MM study
- Takashi Ikeda
- Takashi Ikeda
- Kazutaka Sunami
- Shang-Yi Huang
- Ming-Chung Wang
- Young Il Koh
- Chang Gi Min
- Su-Peng Yeh
- Morio Matsumoto
- Michihiro Uchiyama
- Satoshi Iyama
- Chihiro Shimazaki
- Je Hoon Lee
- Ki Hyun Kim
- Hitomi Kaneko
- Jin Seok Kim
- Tung-Liang Lin
- Frank Campana
- Keisuke Tada
- Shinsuke Iida
- Kenshi Suzuki
Abstract
Background
The phase 3 ICARIA study demonstrated that isatuximab (Isa) plus pomalidomide and dexamethasone (Pd) significantly improved progression free survival (PFS) compared with Pd in patients (pts) with relapsed/refractory multiple myeloma (RRMM) (HR = 0.596, 95%CI 0.44-0.81, P = 0.001). We evaluated the efficacy/safety of Isa-Pd in the East Asian pts (13 Japanese, 9 Korean and 14 Taiwanese pts) of ICARIA.
Methods
RRMM pts who had received ≥2 prior lines of therapies, including lenalidomide (len) and at least a proteasome inhibitor (PI), and were refractory to their last therapy were enrolled. Pts were randomized into either Isa-Pd arm who received Isa 10 mg/kg IV weekly for the first 4 weeks (wks) followed by biweekly or Pd arm, and all pts received Pom (4mg PO days 1-21) and dex (40mg [20mg if older than 75 yrs] PO or IV weekly) in 28 day cycle until disease progression or unacceptable toxicity.
Results
Data from 36 East Asian pts (21 Isa-Pd, 15 Pd) including Japanese pts (9 Isa-Pd, 4 Pd) were analyzed. Patient’s characteristics were similar in the East Asian subgroup and the entire population of ICARIA study (n = 307). Of these pts, median age: 65 (range, 41-85) yrs; median prior lines of therapy: 3 (range, 2-7); 91.7% and 69.4% were refractory to len and PI, respectively; and 13.9% had high-risk cytogenetics. After median follow-up of 11.6 months, median PFS was not reached yet in Isa-Pd arm and was 7.9 months in Pd arm (HR 0.517 [95% CI 0.19-1.39]). ORR (≥PR) was 71.4% in Isa-Pd arm 60% in Pd arm. The VGPR rate or better was 61.9% and 13.3% in Isa-Pd and Pd arm, respectively. Median time to first response was 32 days and 59 days for Isa-Pd and Pd arm, respectively. Grade ≥3 AEs were observed in 90.5% and 73.3% pts in Isa-Pd and Pd arm, respectively and which caused 9.5% pts in the Isa-Pd arm and 0 % in Pd arm to discontinue their treatment. Infusion associated reactions were reported in 57.1% pts receiving Isa-Pd but none of them were grade 3-4.
Conclusions
This subgroup analysis of ICARIA demonstrates that the efficacy and safety of Isa-Pd in East Asian population, including Japanese pts, are comparable with the entire population of ICARIA. Isa-Pd is a novel treatment option for East Asian pts with RRMM.
Clinical trial identification
Clinical trial information: NCT02990338.
Legal entity responsible for the study
Sanofi.
Funding
Sanofi.
Disclosure
K. Sunami: Speaker Bureau / Expert testimony: Sanofi; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: GlaxoSmithKline; Speaker Bureau / Expert testimony: Janssen Pharmaceutical. M. Matsumoto: Speaker Bureau / Expert testimony: Celgene Co., LTD; Speaker Bureau / Expert testimony: Janssen Pharmaceutical Co., LTD; Speaker Bureau / Expert testimony: Bristol-Myers Squibb K.K.; Speaker Bureau / Expert testimony: Ono Pharmaceutical Co., LTD. C. Shimazaki: Speaker Bureau / Expert testimony: Ono Pharmaceutical Co. Ltd.; Speaker Bureau / Expert testimony: Celgen Co. Ltd.; Speaker Bureau / Expert testimony: Fujimoto Pharmaceutical Co. Ltd. F. Campana: Full / Part-time employment: Sanofi. K. Tada: Full / Part-time employment: Sanofi. S. Iida: Speaker Bureau / Expert testimony: Ono; Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony: Celgene; Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: Takeda; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Daiichi-Sankyo; Speaker Bureau / Expert testimony: Chugai; Speaker Bureau / Expert testimony: Kyowa Hakko Kirin; Speaker Bureau / Expert testimony: Sanofi; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Daiichi Sankyo; Speaker Bureau / Expert testimony: Gilead; Speaker Bureau / Expert testimony: AbbVie. K. Suzuki: Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Celgene; Speaker Bureau / Expert testimony: Ono; Speaker Bureau / Expert testimony: Fujimoto; Speaker Bureau / Expert testimony: Takeda; Speaker Bureau / Expert testimony: Sumitomo Dainippon ; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Sanofi. All other authors have declared no conflicts of interest.
Precision medicine and ESMO Scale for Clinical Actionability of molecular Target (ESCAT) biomarkers
- Fabrice André
- Fabrice André
182P - Durable response to second-line m-FOLFIRINOX for advanced pancreatic adenocarcinoma in patients with performance status of two or less
- Adarsh Das
- Adarsh Das
- Andrew Dean
- Nicholas Travers
- Mikael Johansson
- Ian Yusoff
Abstract
Background
The efficacy of FOLFIRINOX in the treatment of pancreatic adenocarcinoma is well known and documented. However, most published data involves young patients with a performance status ≤1 (ACCORD study). Thus, traditionally FOLFIRINOX has been regarded as a first line only treatment for patients with good performance status. Patients requiring second line therapy are not regarded as being fit enough to receive FOLFIRINOX. We have previously published our experience that m-FOLFIRINOX can be utilised safely in these individuals, with appropriate dose reductions. Our position has been supported by a subsequent systematic review (Tong et al.). This updated report of our dual institution experience adds further evidence supporting the use of m-FOLFIRINOX as a second line treatment for pancreatic adenocarcinoma.
Methods
A retrospective analysis was conducted on patients with locally advanced or metastatic pancreatic adenocarcinoma from two institutions who received first-line gemcitabine plus nab-paclitaxel, followed by second-line m-FOLFIRINOX between December 2011 and July 2019. All patients had an ECOG performance status of 2 or less. Overall survival (OS) was estimated via the Kaplan-Meier method.
Results
We identified 85 patients in our analysis, with 64% patients having metastatic disease at diagnosis. The median age of our patients at diagnosis was 65 (range, 26 – 81). The dose intensity of m-FOLFIRINOX was the following: 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-fluorouracil (5-FU) and 68% for infusional 5-FU. The median OS of all patients was 46.0 months (95% CI, 35.0 – 68.0). The median OS of locally advanced and metastatic pancreatic cancer from diagnosis was 68.0 months (95% CI, 45.0 – 68.0) and 23.0 months (95% CI, 19.0 – 49.0), respectively.
Conclusions
Our expanded case series continues to demonstrate the growing role of m-FOLFIRINOX as a second line therapy for advanced metastatic pancreatic cancer, after the failure of first-line gemcitabine plus nab-paclitaxel. We continue to suggest that formal clinical trials are needed to further investigate this efficacy.
Legal entity responsible for the study
St John of God Hospital, Subiaco.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Bladder
- Ravindran Kanesvaran
- Ravindran Kanesvaran
454P - Predictors of severity and comparison of CTCAE V3.0 vs V4.3 in assessing chemotherapy induced extravasation injuries
- Sangana S. Reddy
- Sangana S. Reddy
- Shalaka Somayaji
- Mamatha Krishna Murthy
- Vinayak V. Maka
Abstract
Background
Extravasation is an important Adverse Event in chemotherapy, which is evaluated using CTCAE (Common Terminology Criteria for Adverse Events) grading scale. This study focuses on predicting risk factors and comparing CTCAE v3.0 and 4.3 in assessing chemotherapy-induced extravasation.
Methods
An observational study was conducted in medical oncology wards of a tertiary care hospital among adult patients receiving parenteral chemotherapy. European society of medical oncology – European oncology nursing society (ESMO-EONS) guidelines was used to classify chemotherapeutic agents. Significant risk factors were determined using binary logistic analysis. Spearman’s rank correlation coefficient and Wilcoxon’s sign rank test was applied to evaluate the difference between CTCAE v3.0 and v4.3.
Results
A total of 46 patients were enrolled in the study. According to CTCAE v4.3, amongst the 46 patients who experienced extravasation 30 presented with Grade II and the rest 16 with Grade III severity. Patients aged above 60 years showed significance (OR: 2.236, p = 0.007), and females were prone to severe extravasation injury (OR: 2.713, p = 0.010). Ambulation was found to be a major risk factor (OR: 4.66, p = 0.001). Patients with comorbidities had higher chances of getting severe extravasation (OR: 3.009, p = 0.029) and irritants were found to be predominant in worsening it (OR: 2.24, p = 0.007). The Spearman’s rank correlation coefficient established a good association in EV grades between both versions of CTCAE (rho=0.877, p = 0.000). Wilcoxon’s Rank test revealed a significant difference between the two. (p = 0.0003).
Conclusions
The severity of EV depends on early identification of symptoms, patient related factors and nature of drug. This information is pivotal to work towards a scenario of better-prevented and managed events of EV. The updated versions of CTCAE (v4.3 and v5) are better fit to use for accurate scoring of severity.
Legal entity responsible for the study
All Authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
393O - Timeliness of lung cancer treatment utilizing the rapid access lung cancer clinic in a regional Australian Hospital
- Nguyen M. Chau
- Nguyen M. Chau
Abstract
Background
Patients in remote and rural areas of Australia are disadvantaged in receiving and accessing healthcare. Lung cancer incidence and mortality is increased in remote areas compared to metropolitan regions. The rapid access lung cancer (RALC) clinic was established in 2017 in order to optimize timeliness to treatment and improve patient outcomes.
Methods
Retrospective audit of all patients diagnosed with lung cancer in 2018 within the Ballarat Health service and was stratified according to stage of cancer. Mean timeframes were derived from the Australian optimal care pathway (OCP) for people with lung cancer and analysed using descriptive statistics.
Results
Total of 84 patients were diagnosed with lung cancer in 2018, with 72% being seen in the RALC clinic. Overall 77.3% met the OCP timeframe of referral to treatment in less than 42 days as compared to only 48.5% in 2015-2016. Stage I/II, III and stage IV patients had mean referral to treatment intervals of 53, 40 and 22 days respectively. Stage IV RALC patients compared to general clinic patients, proceeded to treatment faster after diagnosis (7 days vs 28 days, p = 0.04) and were presented at MDT more frequently (44.5% vs 13.5%). In Stage I/II and stage III patients who had delays from diagnosis to treatment, main reasons were waiting times for surgery, radiotherapy and further diagnostic test. Limitations of a regional centre include having to refer externally for both EBUS and complex surgery offered only in metropolitan hospitals.
Conclusions
RALC clinics have reduced time to definitive treatment. Early stage patients require more complex work up and multi-modality treatment, so have a longer time to first treatment over advanced stage patients. Despite the obstacles of a regional centre, the time to treatment were shorter that of metropolitan public hospitals. Longer follow-up will determine if improved timeliness will lead to better patient outcomes.
Legal entity responsible for the study
Ballarat Health Service.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Welcome, introductions and objectives of the session (ID 1801)
217P - Neutrophil-to-lymphocyte ratio is a useful biomarker for predicting worse clinical outcome in chemo-resistant urothelial carcinoma patients treated with pembrolizumab
- Koichiro Ogihara
- Koichiro Ogihara
- Eiji Kikuchi
- Takashi Okabe
- Seiya Hattori
- Ryo Yamashita
- Syunsuke Yoshimine
- Suguru Shirotake
- Kazuhiro Matsumoto
- Ryuichi Mizuno
- Satoshi Hara
- Masafumi Oyama
- Masashi Niwakawa
- Mototsugu Oya
Abstract
Background
No reliable biomarker is available for predicting worse clinical outcome in chemo-resistant urothelial carcinoma (UC) patients treated with pembrolizumab. We focused on the neutrophil-lymphocyte ratio (NLR), which is reported to be a simple index of systemic inflammation and a possible biomarker for predicting prognosis in various malignancies, including UC. Our aim was to evaluate whether a high NLR level could predict subsequent clinical outcomes in chemo-resistant UC patients treated with pembrolizumab.
Methods
We identified 74 cases treated with pembrolizumab for chemo-resistant UC between December 2017 and April 2019 at our 5 institutions. We investigated the association between NLR levels and their prognosis. We defined patients with NLR of > 3.37 as the high NLR group according to a calculation by receiver-operating curve analysis.
Results
The high NLR group consisted of 30 cases (40.5%). The 6-month progression-free survival (PFS) rate for the high NLR group was 10.0±5.5%, which was significantly lower than that for their counterpart (44.8±7.8%, p < 0.001). Multivariate Cox regression analysis revealed that elevated NLR (p < 0.001) and liver metastases (p = 0.003) were independent indicators for disease progression. Furthermore, the 6-month cancer-specific survival (CSS) rate for the high NLR group (64.5±9.1%) was significantly lower than that for their counterpart (88.8±5.3%, p = 0.004). Multivariate analysis revealed that an elevated NLR was the only independent indicator for cancer-specific death (p = 0.008). The change of NLR level before and after pembrolizumab was elevated in 46 cases. The 6-month PFS and CSS rate for the increased NLR group (17.8±6.0% and 71.9±7.3%) was significantly lower than that for their counterpart (47.0±10.6% and 90.9±6.1%, p = 0.012 and p = 0.009).
Conclusions
Elevated NLR could identify a population with a poor response to pembrolizumab treatment among chemo-resistant UC patients.
Legal entity responsible for the study
Koichiro Ogihara.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Paranasal sinus: Case presentation
- Rahul Nagadia
- Rahul Nagadia
489P - Overall survival in patients with EGFRm+ NSCLC receiving sequential afatinib and osimertinib: Updated analysis of the GioTag study
- Maximilian J. Hochmair
- Maximilian J. Hochmair
- Alessandro Morabito
- Desiree Hao
- Cheng-Ta Yang
- Ross A. Soo
- James C-H Yang
- Rasim Gucalp
- Balazs Halmos
- Lara Wang
- Angela Märten
- Tanja Cufer
Abstract
Background
Identifying the optimal sequence of EGFR TKIs is important to maximise survival in EGFR mutation-positive (EGFRm+) NSCLC. The observational GioTag study (NCT03370770) investigated outcomes in patients (pts) with EGFRm+ NSCLC who were treated with sequential afatinib and osimertinib in a ‘real-world’ clinical setting, including pts with poor prognosis (ECOG PS ≥ 2: 15%; stable brain metastases: 10%).1 In the primary analysis, time to treatment failure (TTF) was 27.6 months in the overall population, 30.3 months in Del19-positive pts, and 46.7 months in Asians. Here we report overall survival (OS) and updated TTF.
Methods
Data were retrospectively collected from Dec 2017–June 2018 for 203 pts with EGFRm + (Del19, L858R) NSCLC who were T790M positive after first-line afatinib and subsequently received osimertinib. TTF was the primary outcome; OS analysis was exploratory. Data were collected from electronic health records (EHRs; n = 126) or medical charts (n = 77). For logistical reasons, this interim analysis includes updated data (at April 2019) from pts with available EHRs (all USA; n = 94); final analysis with updated data from manual chart reviews is anticipated in early 2020.
Results
After median follow-up of 30.3 months, median OS was 41.3 months (90% CI: 36.8–46.3) in the overall dataset (n = 203) and 45.7 months (90% CI: 45.3–51.5) in Del19-positive pts (n = 149); 2-year OS was 80%. OS in Asians was immature. Updated median TTF was 28.1 months (90% CI: 26.8–30.3) in all pts, and 30.6 months (90% CI: 27.6–32.0) in Del19-positive pts. Median TTF with osimertinib was 15.6 months (90% CI: 13.8–17.1) in the overall dataset, and 16.4 months (90% CI: 14.9–17.9) in Del19-positive pts. Median time from osimertinib discontinuation to death was 8 months. In 168 pts starting on afatinib 40 mg, median OS was 45.3 months (90% CI: 37.6–47.6); median TTF was 28.1 months (90% CI: 26.8–30.6).
Conclusions
Encouraging OS and TTF was seen in pts with EGFR T790M-positive NSCLC with sequential afatinib and osimertinib, especially Del19-positive pts. Of note, prior afatinib treatment did not preclude prolonged TTF with second-line osimertinib. 1. Hochmair MJ, et al. Future Oncol. 2018;14:2861–74.
Clinical trial identification
NCT03370770.
Editorial acknowledgement
Lynn Pritchard of GeoMed, an Ashfield company, part of UDG Healthcare plc.
Legal entity responsible for the study
Boehringer Ingelheim.
Funding
Boehringer Ingelheim.
Disclosure
M.J. Hochmair: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Merck Sharp & Dohme; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis. A. Morabito: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Sharp and Dohme. D. Hao: Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca. R.A. Soo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Ignyta; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Taiho; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy: Yuhan. J.C-H. Yang: Honoraria (self): Merck Sharp and Dohme; Advisory / Consultancy: Merck Serono; Honoraria (self): Novartis; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merrimack; Advisory / Consultancy: Yuhan Pharmaceuticals; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Ono pharmaceuticals; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: Hansoh Pharmaceuticals; Advisory / Consultancy: Takeda Pharmaceuticals; Advisory / Consultancy: Blueprint Medicines; Advisory / Consultancy: G1 Therapeutics; Honoraria (self): Pfizer. B. Halmos: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy, Research grant / Funding (self): Merck Sharp and Dohme; Advisory / Consultancy, Research grant / Funding (self): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Advisory / Consultancy: Genentech; Advisory / Consultancy: Spectrum; Advisory / Consultancy: Ignyta; Research grant / Funding (self): Takeda; Research grant / Funding (self): Guardant Health; Research grant / Funding (self): Mirati; Research grant / Funding (self): AbbVie; Research grant / Funding (self): Novartis; Research grant / Funding (self): GSK; Advisory / Consultancy: Foundation Medicine; Advisory / Consultancy: Guardant Health. L. Wang: Full / Part-time employment: Boehringer Ingelheim. A. Märten: Full / Part-time employment: Boehringer Ingelheim. T. Cufer: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Merck Sharp and Dohme; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim. All other authors have declared no conflicts of interest.