Background:  Cancer is the second leading cause of death globally. Up to 86% of advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription of opioids resulted in 33,000 deaths in the US in 2015. Both reduce patients’ functional status and quality of life. While cancer survival rates are increasing, therapeutic options for chronic opioid refractory pain are still limited. Esketamine is the s-enantiomer of ketamine, with superior analgesic effect and less psychotomimetic side effects. Intranasal esketamine was approved by the FDA for treatment-resistant depression. However, its use in chronic cancer pain has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial to evaluate the efficacy and safety of intranasal esketamine in chronic opioid refractory cancer pain. Methods and analysis: We will recruit 120 subjects with chronic opioid refractory pain, defined as pain lasting more than 3 months despite optimal therapy with high dose opioids (>60 mg morphine equivalent dose/day) and optimal adjuvant therapy. Subjects will be randomized into two groups: intranasal esketamine (56mg) and placebo. Treatment will be administered twice a week for four consecutive weeks. The primary outcome is defined as reduction in the Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS reduction after four weeks, the number of daily morphine rescue doses, functional status and satisfaction, and depression. Conclusion: This study may extend therapeutic options in patients with chronic pain, thus improving their quality of life and reducing opioid use. Trial registration: Clinical Trials.gov, NCT04666623. Registered on 14 December 2020

The Palliative Prognostic Index (PPI) was developed to improve survival prediction for advanced cancer patients. However, there is limited data about the PPI application in a real-world scenario. This study aimed to assess the accuracy of PPI > 6 in predicting survival of cancer inpatients.Methods: A prospective observational cohort in an inpatient palliative care service at a tertiary hospital in São Paulo-SP, Brazil, between May 2011 and December 2018. Results:We included 1,376 critically ill cancer inpatients. Patients were divided into three PPI subgroups: PPI ≤ 4, PPI 4-6, and PPI ≥ 6. Their respective medium overall survival values were 44 days (95% confidence interval [CI] 35.52-52.47), 20 days (95% CI 15.40-24.59), and 8 days (95% CI 7.02-8.98), (p < 0.001). PPI ≥ 6 predicted survival of <3 weeks with a positive predictive value (PPV) of 72% and an negative predictive value (NPV) of 68% (sensitivity 67%, specificity 72%). PPI > 4 predicted survival of <6 weeks with a PPV of 88% and an NPV of 36% (sensitivity 74%, specificity 59%). When PPI was <4, the mortality rate over 3 weeks was 39% with a relative risk (RR) of 0.15 (95% CI 0.11-0.20; p < 0.001), and the 6-week mortality rate was 63% with a RR of 0.18 (95% CI 0.13-0.25; p < 0.001) compared to PPI ≥ 4.Conclusions: PPI was a good discriminator of survival among critically ill cancer inpatients and could assist in hospital discharge decision. PPI may help healthcare policymakers and professionals in offering high-quality palliative care to patients.

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e15066 Background: Obesity is linked to an increased risk of cancer development. The excess of body fatness seems to be associated with alterations in hormonal, metabolic and inflammatory pathways, that may lead to activation of the carcinogenesis process. Previous studies suggested this obesity pro-inflammatory state could improve ICI clinical efficacy. Methods: Baseline characteristics and clinical outcomes were retrospectively collected from advanced cancer patients of any primary site, and treated with ICI in our institution. The BMI was determined for all pts and categorized into 2 groups: obese (BMI≥30) and non-obese (BMI < 30). Primary outcomes were the association of BMI category with overall survival (OS) and progression free survival (PFS) assessed by log-rank statistic, and both were stratified by sex, age, treatment agent and primary tumor site using the Cox-regression. Secondary outcome was the association of BMI with objective response rate (ORR). Results: We collected data from 448 advanced cancer pts - 192 (43%) as normal weight, 159 (36%) as overweight, 78 (17%) as obese and 19 (4%) as underweight. A total of 370 pts (83%) were included in the non-obese group (BMI < 30) and 78 (17%) patients in the obese group (BMI≥30). The majority of pts (387 - 84%) received anti-PD-1/anti-PD-L1; 128 pts (28%) were treated at 1st line and 200 pts (44%) at 2nd line. The obese group experienced longer mOS than the non-obese group - 21.8 months (95% CI NR - NR) vs. 14.9 months (95% CI 8.3 -21.5); HR = 0.82, (95% CI 0.57-1.18, P = 0.28). However, this was not statistically significant and even after stratification. The obese group had an inferior mPFS than the non-obese group - 4.7 months (95% CI 3.8- 5.7) vs. 5.3 months (95% CI 3.45-7.15); - HR = 0.99, (95% CI 0.76 -1.30), P = 0.95. There was no significative difference in mPFS and ORR according to BMI. Conclusions: Although study did not report an improved OS among high BMI pts treated with ICI, our results suggested a trend in survival benefit. The BMI should be explored as a stratification variable in the design of prospective trials with advanced cancer pts and ICI treatment.