Background

Oral mucositis related pain during CTRT in head and neck cancers is a common problem. Unfortunately, in spite of it being common, there is limited evidence for selection of systemic analgesic in this situation. Hence, this study was designed to compare the analgesic effect of an NSAID (diclofenac) versus a weak opioid (tramadol).

Methods

This was an open-label, parallel design, superiority randomized controlled study. In this study head and neck cancer patients undergoing radical or adjuvant chemoradiation, who had grade 1 or above mucositis (in accordance with CTCAE version 4.03) and had pain related to it were randomly assigned to either diclofenac or tramadol for mucositis related pain control. The primary endpoint was analgesia after the 1st dose. The secondary endpoints were the rate of change in analgesic within 1-week, adverse events, and quality of life.

Results

128 patients were randomized, 66 in diclofenac and 62 in tramadol arm. The median AUC for the diclofenac arm and the tramadol arm were 348.936 units (Range 113.64-1969.23) & 420.87 (101.97-1465.96) respectively (p=0.05619). Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic (p=0.184). There was no statistically significant difference in any adverse events between the 2 arms. However, the rate of any grade of renal dysfunction was numerically higher in diclofenac arm (10.6% versus 4.8%, p=0.326).

Conclusions

In this phase III study, evaluating diclofenac and tramadol for CRIM pain, the analgesic efficacy of both analgesics was found to similar, but diclofenac was associated with a higher rate of renal dysfunction.

Clinical trial identification

CTRI/2016/09/007302.

Legal entity responsible for the study

Tata Memorial Hospital.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.

Background

Colorectal cancer (CRC) is the third most commonly diagnosed cancer globally and the second cancer in terms of mortality. The prevalence of sarcopenia in patients with CRC ranges between 12%-60%. It has been described that there is an association between sarcopenia and numerous poor short-term CRC outcomes like increased perioperative mortality, postoperative sepsis, prolonged length of stay, and physical disability. In this study, we review the evidence regarding the impact of sarcopenia and low muscle mass on chemotherapy toxicity and survival among colorectal patients who underwent chemotherapy.

Methods

A systematic review was performed according to PRISMA guidelines. A literature search was conducted by two independent reviewers on all studies that included sarcopenia in colorectal cancer patients who underwent chemotherapy using PubMed, PubMed central, and Google Scholar databases. Study included elderly population was excluded. Outcome of interest included chemotherapy toxicity and overall survival. Data synthesis and statistical analysis were carried out using Review Manager software.

Results

A total of 2206 patients from 14 studies were included in our meta-analysis. In our overall analysis of chemotherapy toxicity, we indicated that CRC patients with sarcopenia would have higher incidence of chemotherapy toxicity (OR = 1.91, 95% CI = 1.37 – 2.67, P < 0.001) including grade 3/4 neutropenia, peripheral neuropathy, nausea and vomiting, also diarrhea. Regarding survival outcomes, our results showed that sarcopenia associated with a decreased overall survival (HR = 1.64, 95% CI 1.36 – 1.98, P < 0.001). These effects of sarcopenia and low muscle mass on chemotherapy toxicity and overall survival were observed among various chemotherapy regimens and across disease stages.

Conclusions

Sarcopenia and low muscle mass can give negative impact on chemotherapy toxicities and survival outcomes for colorectal cancer patients who underwent chemotherapy. Prospective studies with a uniform definition of sarcopenia are still needed to update our findings.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

We initial aimed to investigate pre/post-treatment inflammatory biomarkers (pre/post-IBs) and their dynamic changes (delta-IBs) on short-term effect (STE). Furthermore, a nomogram was built to provide accurate prediction of STE in patients with esophageal squamous cell carcinoma (ESCC) who received radiotherapy.

Methods

The IBs included absolute lymphocyte counts (ALC), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR). All pre/post-IBs and delta-IBs of 398 ESCC patients at Shandong Cancer Hospital between 2015 and 2019 were analyzed. The nomogram was then constructed that forecasted STE based on logistic regression analyses.

Results

At 1 month after radiotherapy, 261 patients (65.6%) achieved remission, and 137 patients (34.4%) achieved un-remission. The pre-ALC and pre-LMR significantly increased, pre-NLR and pre-PLR significantly decreased during radiotherapy (all P<0.001). Meanwhile, there was a positive correlation between delta-NLR as well as delta-PLR and delta-LMR (r=0.621 and 0.613, respectively), whereas a negatively correlated between delta-LMR and delta-PLR (r=-0.573). Multivariate analysis indicated that gender [OR, 0.473; 95%CI, 0.274-0.816; P=0.007], pre-ALC [OR, 0.554; 95%CI, 0.335-0.915; P=0.021], pre-NLR [OR, 3.176; 95%CI, 1.733-5.823; P<0.001], post-NLR [OR, 2.418; 95%CI, 1.271-4.600; P=0.007] and delta-NLR [OR, 1.929; 95%CI, 1.035-3.595; P=0.039] were statistically significant with STE. Nomogram for STE was established by combining all independent predictors and the concordance indexes for STE were 0.770 [95%CI, 0.719–0.820].

Conclusions

In conclusion, pre-NLR and pre-ALC, post-NLR, and delta-NLR could predict STE in ESCC patients. Further, pre-NLR had the best predictive value, and the developed nomogram with superior prediction ability for STE could assist in patients counseling and guide to make treatment decisions.

Legal entity responsible for the study

Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan 250117, Shandong, People’s Republic of China.

Funding

This work was supported by the National Natural Science Foundation of China (81972864), Academic Promotion Program of Shandong First Medical University (2019RC002), Science and Technology Support Plan for Youth Innovation Teams of Universities in Shandong Province (2019KJL001) and Science and Technology Plan of Jinan (201907113).

Disclosure

All authors have declared no conflicts of interest.

Background

Photodynamic Therapy (PDT) is an FDA approved cancer treatment. Hexyl-ALA, one of the 5-aminolevulinic acid (ALA) derivatives, induces higher protoporphyrin IX (PpIX) accumulation in cancer cells through the disrupted heme pathway. Upon specific light activation with oxygen, reactive oxygen species will be released for cancer cell destruction. Studies also revealed that ALA induced higher PpIX accumulation with hormonal supplement. Uterine sarcoma is a hormonal dependent gynecological cancer. Addition of hormones with ALA-PDT might be a new therapeutic approach.

This study aimed to demonstrate the effect of progesterone on hexyl-ALA-PDT in uterine sarcoma cells; the in-depth mechanism related to heme pathway is yet to be explored.

Methods

The intracellular PpIX generation and the phototoxicity mediated by Hexyl-ALA-PDT with progesterone were determined by flow cytometry and MTT assay respectively in the proposed cells.

Results

The PpIX generation and accumulation induced by hexyl-ALA in the proposed cells were increased in 10% and 30% when supplemented with progesterone and with progesterone and ferrochelatase inhibitor respectively. The progesterone enhanced hexyl-ALA-PDT effect from lethal dose of 20 (LD₂₀) to lethal dose of 60 (LD₆₀) at 2J/cm².

Conclusions

Progesterone significantly enhanced hexyl-ALA-PDT efficacy in uterine sarcoma cells. Progesterone might enhance the efficacy of Hexyl-ALA-PDT through the modulation of heme biosynthetic pathway; thus in-depth mechanistic studies of hormonal enhancement on Hexyl-ALA-PDT efficacy deserved to be explicit.

Acknowledgement

Hexyl-ALA was kindly provided by Photocure ASA. This study was fully supported by a grant from the Research Grants Council (RGC) of the Hong Kong Special Administrative Region, China (Project no.: UGC/FDS17/M06/19).

Background

Liposomal irinotecan + 5-fluorouracil/leucovorin (5-FU/LV) is approved for adults with metastatic pancreatic ductal adenocarcinoma following progression with gemcitabine-based therapy. We report results from an open-label phase I/II study (NCT02551991) of adults with untreated, unresectable, locally advanced/metastatic PDAC receiving liposomal irinotecan + 5-FU/LV + oxaliplatin (NALIRIFOX).

Methods

Eligible patients were adults with ECOG performance status (PS) ≤ 1 and adequate organ function who received NALIRIFOX (liposomal irinotecan 50 mg/m² (free base), 5-FU 2400 mg/m², LV 400 mg/m², oxaliplatin 60 mg/m²) on days 1 and 15 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included progression-free survival (PFS), overall survival (OS), best overall response, overall response rate (ORR), disease control rate at 16 weeks (DCR₁₆) and duration of response (DoR). RECIST v1.1 was assessed at screening, every 8 weeks and at treatment end.

Results

Overall, 32 patients were included (median [range] age 58.0 [39–76] years; 43.8% men; 87.5% metastatic disease; 56.3% ECOG PS 1). In total, 22 patients experienced grade ≥ 3 treatment-emergent adverse events (TEAEs): neutropenia (31.3%), febrile neutropenia (12.5%), hypokalemia (12.5%), diarrhea (9.4%), nausea (9.4%) and decreased neutrophil count (9.4%). Serious TEAEs were reported in 17 patients: nausea (9.4%) and febrile neutropenia (9.4%). TEAEs led to 3 deaths (none treatment-related), to dose adjustment in 26 and discontinuation in 8 patients. Median (95% CI) PFS and OS were 9.2 (7.69–11.96) months and 12.6 (8.74–18.69) months, respectively. One patient, with locally advanced disease, had complete response, 10 partial response, and 15 stable disease. ORR (95% CI) was 34.4 (18.6–53.2) %, DCR₁₆ was 71.9 (53.3–86.3) % and median (95% CI) DoR was 9.4 (3.52, NE) months.

Conclusions

First-line NALIRIFOX raised no new safety signals in patients with locally advanced/metastatic PDAC; anti-tumour activity was promising. The randomized phase III NAPOLI-3 study (NCT04083235) will compare NALIRIFOX with gemcitabine + nab-paclitaxel.

Clinical trial identification

NCT02551991.

Editorial acknowledgement

Alison Chisholm of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines.

Legal entity responsible for the study

Ipsen.

Funding

Ipsen.

Disclosure

A. Dean: Non-remunerated activity/ies: Shire; Non-remunerated activity/ies: Specialised Therapeutics; Travel/Accommodation/Expenses: Amgen. T. Bekaii-Saab: Advisory/Consultancy: Amgen; Advisory/Consultancy: Bayer; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Celgene; Advisory/Consultancy: Genetech/Rpche; Advisory/Consultancy: Glenmark; Advisory/Consultancy: Lilly; Advisory/Consultancy: Merrimack; Advisory/Consultancy: NCCN; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Research to Practice; Advisory/Consultancy: Sirtex Medical; Advisory/Consultancy: Taiho Pharmaceutical; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Merck; Advisory/Consultancy: Polaris. P.M. Boland: Research grant/Funding (self): Boehringer Ingelheim; Research grant/Funding (self): Merck; Research grant/Funding (self): Boston Biomedical; Research grant/Funding (self): Genentech; Research grant/Funding (self): Cascadian Therapeutics; Research grant/Funding (self): Advaxis; Advisory/Consultancy, Research grant/Funding (self): Bayer; Honoraria (self): Sirtex; Advisory/Consultancy: Merrimack. F. Dayyani: Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstarZeneca; Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Exelixis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Taiho Pharmaceutical; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Advisory/Consultancy: Foundation Medecine; Advisory/Consultancy: Genetech; Advisory/Consultancy, Speaker Bureau/Expert testimony: Natera; Advisory/Consultancy: QED Therapeutics; Speaker Bureau/Expert testimony: Deciphera Pharmaceuticals; Speaker Bureau/Expert testimony: Sirtex Medical; Spouse/Financial dependant: Roche Diagnostics. T. Macarulla Mercade: Honoraria (self), Advisory/Consultancy: Genzyme; Honoraria (self), Speaker Bureau/Expert testimony: Sanofi; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): Tesaro; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Shire; Honoraria (self): Lilly; Honoraria (self): Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Advisory/Consultancy: QDE; Advisory/Consultancy: H3B; Advisory/Consultancy: Baxalta; Advisory/Consultancy: Incyte; Advisory/Consultancy: Servier; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Agios; Research grant/Funding (institution): Aslan; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Genetech; Research grant/Funding (institution): Halozyme; Research grant/Funding (institution): Immonomedics. K. Mody: Research grant/Funding (institution): Agios; Research grant/Funding (institution): Senwha Biosciences; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): ArQule; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Puma Biotechnology; Research grant/Funding (institution), (NIH) award # NCI/NIH P50 CA210964: National Cancer Institute (NCI) of the National Institutes of Health; Advisory/Consultancy: Bayer; Advisory/Consultancy: Celgene; Advisory/Consultancy: Eisai; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Merrimack; Advisory/Consultancy: Vicus. B. Belanger: Full/Part-time employment: Ipsen. F. Maxwell: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. Y. Moore: Leadership role, Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. A. Thiagalingam: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. T. Wang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. B. Zhang: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Ipsen. Z.A. Wainberg: Advisory/Consultancy, Research grant/Funding (institution): Five Prime Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Plexxikon; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Merck; Advisory/Consultancy: QED Therapeutics.

Background

RAS mutations are the most prominent oncogenic driver mutations in cancers, including colorectal cancer. Patients with metastatic colorectal cancer (mCRC) with mutant RAS are ineligible for anti-epidermal growth factor receptor (EGFR) therapy, as RAS mutations activate downstream pathways independently of EGFR and induce primary resistance. In particular, mutations in the amino acid at position 12 in the KRAS protein are common, and the KRAS p.G12C mutation occurs in ∼3% of CRC cases and is often associated with poor prognosis. Nevertheless, no agent directly targeting mutant RAS has been clinically approved. The CodeBreak 100 trial revealed that a novel KRASG12C inhibitor, AMG510, has an attractive anti-tumor effect against KRASG12C-mutant solid tumors, including mCRC. However, there are no data about the clinical and prognostic features in Japanese patients with detailed RAS/BRAF V600E-mutant mCRC including KRASG12C. The aim of this multicenter retrospective study was to investigate the clinical and prognostic features in Japanese patients with detailed RAS/BRAF V600E-mutant mCRC.

Methods

Between August 2018 and July 2019, chemotherapy-naïve patients with mCRC from whom samples were collected and investigated for all RAS/BRAFV600E statuses were included in this study. The RAS/BRAFV600E status was determined using the MEBGEN RASKET-B kit, PCR-rSSO method.

Results

In total, 152 patients with mCRC (median age, 71 years; male, 71%; left-sided primary, 67.1%) were enrolled from three tertiary cancer centers. Of the patients, RAS/BRAF mutations were detected in 54.6% (KRAS codon 12, 27.0%; KRAS codon 13, 11.8%; minor RAS, 9.2%; BRAFV600E, 6.6%). BRAFV600E-mutant tumors were predominantly located on the right side (77.8%, p=0.005), and minor RAS-mutant tumors were located predominantly on the left side (92.9%, p=0.037). Minor RAS-mutant tumors were associated with significantly shorter survival times than those associated with RAS wild-type {hazard ratio (HR)=2.65 [95% confidence interval (CI), 0.99 to 7.07], p=0.043} and major RAS-mutant tumors (HR=5.15 [95% CI, 1.56 to 16.98], p=0.003).

Conclusions

This multicenter study revealed the clinical and prognostic features in Japanese patients with detailed RAS/BRAFV600E-mutant mCRC.

Legal entity responsible for the study

Hironaga Satake.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

To investigate the clinical significance of urine protein quantitative test UPCR (ratio of urinary protein amount measured and creatinine concentration in urine) when anti-angiogenesis inhibitors are used.

Methods

From January 2018 to December 2018, a survey was conducted based on the medical records of gastric cancer and colorectal cancer cases with urine protein qualitative value test (QV) of 2+ or higher during the use of anti-angiogenesis inhibitors at 9 institutions participating in Onconephrology Consortium. The primary endpoint was the ratio of UPCR worst value less than 2 (Low UPCR) in QV 2+ cases. The secondary endpoints were comparison of Low UPCR and UPCR worst value2 or higher (High UPCR), the use status of angiogenesis inhibitors, changes in urine protein test values (qualitative/quantitative), subsequent treatment information, and patient background factors and other relationships.

Results

Among 71 cases enrolled, the proportion of Low UPCR in QV 2+ cases (n=53) was 66% (n=35). In a comparison between Low (n=36) and High UPCR cases (n=24), High UPCR tended to occur in cases of heavy body weight, and its cut-off value was 52.45 kg (OR 4.25, 95%CI 1.30-13.86, p=0.017). A significant correlation was also observed between UPCR levels and the single dose of bevacizumab (p=0.033) or ramcirumab (p=0.018).

Conclusions

The relationship between UPCR levels and body weight or single dose was shown, but there is a possibility that physical disparity and the amount of creatinine excretion may have an effect.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

M. Nakamura: Honoraria (self): Daiichi Sankyo; Honoraria (self): Lilly; Honoraria (self): Chugai; Honoraria (self): Mochida; Honoraria (self): Bristol Myers Squibb; Honoraria (self): Taiho. T. Funakoshi: Research grant/Funding (institution), TF belongs to an endowed department sponsored partly by Chugai Pharmaceutical Co., Ltd.: Chugai. E. Baba: Honoraria (self): Lilly; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): Chugai. Y. Mihara: Honoraria (self): Chugai. M. Muto: Honoraria (self), Research grant/Funding (institution), MM belongs to an endowed department sponsored partly by Chugai Pharmaceutical Co., Ltd.: Chugai; Research grant/Funding (self): Sanofi. M. Yanagita: Honoraria (self): Chugai; Honoraria (self): Kyowa Hakko Kirin; Research grant/Funding (institution): Kyowa Hakko Kirin; Research grant/Funding (institution): Tanabe Mitsubishi; Research grant/Funding (institution): Nippon Boehringer Ingelheim; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Baxter; Research grant/Funding (institution): Chugai; Research grant/Funding (institution): Kyowa Hakko Kirin; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Takeda. All other authors have declared no conflicts of interest.

Background

Lymph node status is among the most important predictors of recurrence after curative gastrectomy. However, the impact of lymph node status on recurrence patterns remains unclear. We aimed to analyse recurrence patterns in completely resected gastric cancer (GC) with negative (pN0) or positive (pN+) lymph nodes.

Methods

We retrospectively assessed 1694 patients who underwent curative gastrectomy from January 2010 to August 2014. Patients were divided into pN0(n=655) and pN+(n=1039) cohorts. Timing and site(s) of recurrence were examined.

Results

Of all,517(30.5%) patients developed recurrent disease, and complete data on recurrence could be obtained in 493 patients.For the pN0 cohort, the patterns of recurrence were different according to pT stage: locoregional recurrence was the most common in patients with pT1-2 disease (57.1%), distant was the most common in patients with pT3 disease (57.1%), and peritoneal was the most common in patients with pT4a disease (66.7%). For the pN+ cohort, distant metastasis was the most common pattern irrespective of pT stage. The site-specific trend of recurrence showed that locoregional recurrence increased within 5 years in patients with pN0-2 disease but plateaued 3 years after surgery in patients with pN3 disease. Time to recurrence was significantly longer for the pN0 cohort compared with the pN+ cohort (median:25 vs 16 months=0.001). Moreover, post-recurrence survival was significantly better for the pN0 cohort than for the pN+ cohort (median:12 vs 6 months<0.001), especially in patients with non-peritoneal recurrence, late recurrence, single recurrence, and receipt of potential curative treatment.

Conclusions

There was a significant difference in recurrence patterns survival between node-negative and node-positive patients. For node-negative patients, follow-up strategies should be considered according to pathologic T stage, while the key to follow-up for node-positive patients is distant metastasis.

Legal entity responsible for the study

The authors.

Funding

Scientific and Technological Innovation Joint Capital Projects of Fujian Province.

Disclosure

All authors have declared no conflicts of interest.

Background

A significant proportion of newly diagnosed advanced NSCLC patients does not receive a first-line platinum doublet due to unfavorable clinical characteristics.

Methods

We retrospectively collected data on 221 EGFR/ALK negative and PD-L1 <50% patients [median age 79 (range 56-92) years, M/F 165(74.6%)/56(25.4%), PS 0/1/≥2 23(10.4%)/94(42.5%)/103(47.1%), adenoK/squamous/large-cell/NOS 107(48.4%)/94(42.5%)/9(4.1%)/11(5%), median of 2 serious comorbidities] with stage IIIB-IV NSCLC treated with a first-line single agent. Clinicians were asked about the criteria according to which treatment selection was made and what percentage of patients did not receive a first-line platinum-based chemotherapy.

Results

A median of 25% (range 10%-30%) of newly diagnosed NSCLC did not receive a first-line platinum combination. The main clinical criteria according to which decision was made were older age (76.5%), comorbidities (72%), low PS (55.2%) and familiar or social issues (10%). Single-agent treatment consisted of gemcitabine (Gem 10%), oral standard vinorelbine (Vin 8.2%), oral metronomic vinorelbine (MetV 78.6%) and other (O 3.2%). Median time-to-progression (TTP) and overall survival (OS) of single agent treatments were Gem 4.5, Vin 4.5, MetV 5, O 5 months and Gem 9, Vin 9, MetV 10, O 10.5 months respectively. Overall grade 3-4 toxicities were lower with MetV (8%) than with Gem (13.6%), Vin (16.6%) and O (14.3%). Median TTP and OS without grade 3-4 toxicity were Gem 5, Vin 4.5, MetV 6.5, O 5.5 months and Gem 10, Vin 10, MetV 12, O 12 months respectively. Dose delays (Gem 41%, Vin 16.6%, MetV 13.8%, O 28.6%) and dose reductions (Gem 31.8%, Vin 33.3%, MetV 17.8%, O 28.6%) were less frequent with MetV.

Conclusions

We confirmed that up to 30% of newly diagnosed advanced EGFR/ALK negative and PD-L1 <50% NSCLC patients do not receive a first-line platinum doublet. Main clinical selection criteria were older age (>70years), comorbidities and low (≥2) PS. An oral treatment was frequently proposed with MetV being the preferred alternative chosen by clinicians due to the excellent safety profile.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Lymphomas are the most common testicular malignancy in elderly male with DLBCL being most common subtype. Less common histological subtypes include Burkitt lymphoma and follicular lymphoma. Testicular DLBCL has poor treatment outcomes than nodal DLBCL due to high risk of relapse in opposite testes, CNS and other sites.

Methods

From the database, patients diagnosed as testicular lymphoma over a period of five years from January 2013 to December 2017 at department of Madras Medical College, Chennai were retrieved and analysed.

Results

8 patients were found to have testicular lymphoma with all being DLBCL subtype. Median age of diagnosis was 61 years. 25% (n=2) patients had B symptoms. 4 patients had stage IE, 2 patients had stage II and 2 patients had stage IV. LDH was elevated in stage IV patients. None developed contralateral testicular lymphoma. All patients underwent high inguinal orchidectomy of involved testis. 3 patients had removal of opposite testis after completion of whole treatment and 5 patients received radiotherapy of 30Gy to contralateral testes. All patients received R-CHOP once in 21 days for 6 cycles along with intrathecal methotrexate of 12.5mg except 1 patient receiving 4 cycles only due to poor PS. 2 patients had febrile neutropenia during chemotherapy and got recovered. 2.5 year DFS was 62.5%(n=5) and 2.5 year OS was 75%(n=6) with a median follow up period of 56 months.

Conclusions

Due to rarity of this tumour standard treatment regimen remains unknown. R-CHOP gives treatment outcomes comparable to the literature.

Legal entity responsible for the study

Sivasubramaniam.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

HCC is a leading global cause of cancer mortality, particularly in the Asia-Pacific region (APAC). An understanding of RW tx patterns and outcomes in APAC may inform current disease management. Here we report tx patterns and survival outcomes in a RW population of pts from Taiwan and Singapore with intermediate/advanced HCC.

Methods

This secondary data study from the HCC Registry in Asia (NCT03233360) used third-party (IQVIA) de-identified pt-level data collected retrospectively and prospectively from electronic health records from Taiwan and Singapore, including for pts newly diagnosed with HCC from Jan 2013 to Dec 2019. Descriptive statistics were used to summarize tx patterns (sequence, frequency) and pt characteristics by country and BCLC staging B or C; the Kaplan-Meier method was used to estimate median overall survival (mOS).

Results

Pt characteristics by stage and country are in the table. In Singapore in pts with BCLC B (n = 26), TARE/Y90 was the most common 1st tx (50%) followed by resection (19.2%). In BCLC C pts (n = 22) systemic therapies were common (68.2%). In Taiwan, BCLC B pts (n = 51) were often treated with resection (43.1%) or TACE (31.4%); BCLC C pts (n = 46) were most often treated with systemic therapy (41.3%). mOS in BCLC B pts was 21 mo in Singapore and 25 mo in Taiwan. In BCLC C pts mOS was 4 mo in Singapore and 6 mo in Taiwan.

Conclusions

This study showed utilization patterns of available tx options in and characteristics of HCC pts in Singapore and Taiwan despite the limited sample size. HCC RW data from APAC are scarce. This registry’s data collection, still ongoing outside Taiwan and Singapore, provides useful insights into RW practice and outcomes and illustrates urgent need for new tx options for HCC. As new txs emerge such as atezolizumab + bevacizumab for 1st line tx of unresectable or metastatic HCC, future RW studies extending this work will help reveal their RW impact on pts Table: 180P

Pt characteristics, tx frequency and tx sequence in Singapore and Taiwan

Clinical trial identification

NCT03233360.

Editorial acknowledgement

Medical writing assistance for this abstract was provided by Chris Lum, PhD of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

S.P. Choo: Honoraria (self), Advisory/Consultancy: eisai; Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Speaker Bureau/Expert testimony: DKSH; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Ipsen. S.K. Mhatre: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech, Inc. A. Ferro: Full/Part-time employment: Genentech/Roche. R. Machado, D.H-C. Liu, N. Irahara: Full/Part-time employment: Roche. V.E. Gaillard: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. All other authors have declared no conflicts of interest.

Background

Patients with haematologic malignancies, including diffuse large B cell lymphoma (DLBCL), have the highest COVID-19 severity and mortality. It is thus important to balance minimising nosocomial COVID-19 transmission with treatment of aggressive DLBCL. At the National Cancer Centre Singapore (NCCS), we implemented these changes: 1. Reduce outpatient visits for patients on surveillance through telemedicine consultations 2. Low threshold for prophylactic granulocyte stimulating factors (GCSF) to reduce febrile neutropenia 3. Low threshold for antimicrobial prophylaxis 4. Subcutaneous instead of intravenous rituximab to reduce “chair time” in suitable patients 5. Outpatient chemotherapy where possible (including for rituximab with dose-adjusted etoposide, prednisone, vincristine, doxorubicin and cyclophosphamide; DA R-EPOCH for double/triple hit lymphomas) 6. Central Nervous System International Prognostic Index (CNS-IPI) to determine high risk patients requiring CNS prophylaxis; delay CNS prophylaxis with intravenous methotrexate (MTX) to later cycles We then reviewed the data to see if these outcomes had been achieved.

Methods

Data from DLBCL patients between 1 March to 30 April 2019 and the same period in 2020 were reviewed retrospectively and compared. Statistical analysis was performed using the chi-square test (Stata version 16.0, StataCorp, Texas, USA).

Results

There was no nosocomial COVID-19 infection. Inpatient admissions and outpatient visits showed numerical decrease, with significant reduction in surveillance visits (p<0.001). Patients still received appropriate curative treatment. CNS prophylaxis was given when indicated; MTX was given intrathecally during staging lumbar puncture and intravenously later. Most on treatment received GCSF as primary prophylaxis. All who received R-EPOCH also received antimicrobial prophylaxis. There was no difference in number of patients receiving radiation or palliative care.

Conclusions

In- and outpatient visits were successfully reduced with no compromise to treatment and supportive care, with no nosocomial transmission of COVID-19. With no end from the pandemic in sight, this strategy for the management of DLBCL is useful in the “new normal” and for future pandemics of similar nature.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.