Azzouqa, Abdel‐Ghani

Background: Chemotherapy-induced peripheral neuropathy (CIPN) from oxaliplatin and taxane drugs is a bothersome toxicity. Palmitoylethanolamide (PEA) has been reported to improve myelinated nerve fiber function in patients experiencing painful CIPN. We conducted a double-blind, placebo-controlled, randomized trial of PEA in patients with established CIPN. Methods: Eligible patients were adults who had pain, numbness, tingling, or other symptoms of CIPN for at least three months following completion of paclitaxel, oxaliplatin, or cisplatin-based chemotherapy. Study patients were randomized to one of the two treatment groups (PEA versus placebo, both administered either once or twice daily). The CIPN20 questionnaire was assessed weekly. Results: A total of 17 males and 71 females participated in the study; most had neuropathy from paclitaxel. Most (85%) finished 8 weeks of treatment. There was no suggestion that either of the PEA arms did any better than the combined placebo arms. There was no signal of significant toxicity differences between the three study arms. Quality of life outcome measures were similar between the study arms, as were cognitive function evaluations. Discussion: PEA failed to improve established CIPN. Future trials might explore whether PEA may be effective in preventing CIPN or cognitive changes based on data that suggest it may be helpful in this situation. Conclusions: PEA failed to improve established chemotherapy-induced neuropathy.

AbstractBackgroundThe objective of this study was to evaluate the efficacy of gemcitabine plus nab‐paclitaxel in patients with recurrent ovarian cancer.MethodsWe performed a single institution retrospective review of patients with recurrent ovarian cancer who were treated with gemcitabine plus nab‐paclitaxel from 2012 to 2018 at the Mayo Clinic in Florida.ResultsTwenty patients were identified and the median PFS for patients treated with gemcitabine plus nab‐paclitaxel was 9 months (95% CI, 5.7–20.7). Overall, 17 of the 20 patients (85%) achieved a clinical benefit (complete response 5%, partial response 55%, or stable disease at 3 months 25%). For platinum‐sensitive disease and platinum‐resistant disease, the median OS were 38.7 months (95% CI, 5.8–63.1) and 31.2 months (95% CI, 12.8–51.8), respectively (p = 0.4306).ConclusionThis well‐tolerated regimen shows promising activity in recurrent ovarian cancer and is a viable option for patients who are intolerant to paclitaxel or carboplatin because of allergic reactions.

Abstract Background: Sex differences in non-small cell lung cancer (NSCLC) outcomes have been described. Immune-related adverse events (IRAEs) have emerged as a serious clinical problem in the use of immune checkpoint inhibitors (ICI). Risk factors for IRAEs and their association with response to therapy remain controversial. Sex differences in innate and adaptive immune responses have been observed but the association of these differences with IRAEs remains unclear. Therefore, we studied sex differences in IRAEs and their association with response to therapy. Methods: All patients with metastatic NSCLC treated with anti-PD1 and anti-PDL1 therapy at Mayo Clinic Rochester and Florida from 2015 to 2018 were reviewed. Patients receiving treatment at an outside facility with history autoimmune disorders or radiation-induced pneumonitis were excluded. Chi-square test was used to estimate differences in categorical data. Kaplan-Meier method was used for time-to-event analysis. Results: A total of 231 patients were identified; 120 (52%) were women and 111 (48%) were men. Baseline characteristics and ICI distribution were similar among groups. Women were more likely to experience IRAEs compared to men (48% vs. 31%, p<0.008). Among patients with IRAEs, women were more likely to be prescribed systemic steroids (63% vs. 41%, p<0.02). On the other hand, no significant differences were observed in the administration of intravenous steroids. Women were more likely to develop pneumonitis (23% vs. 12%, p<0.03) and arthralgias (17% vs. 3%, p<0.04). However, dermatologic toxicities (35% vs. 9%, p<0.002) were more commonly seen in men. In 17% of women the ICI was discontinued due to toxicity (men 7%). Besides sex, no other clinical characteristic was associated with increased IRAEs. Women with IRAEs were more likely to have a radiographic response compared with women without IRAEs (78% vs. 23%, p<0.0001), although this was not observed in men (37% vs. 26%, p>0.22). Better PFS was observed in women with IRAEs (10 months vs. 3.3 months, p<0.0006) compared to women without IRAEs. Conclusions: Women with metastatic NSCLC are more likely to experience IRAEs compared to men. We also observed sex differences in the frequency of certain IRAEs. In addition, an association between IRAEs and response to therapy was observed in women. Larger studies are needed to investigate the mechanisms underlying these associations. Citation Format: Narjust Duma, Abdel-Ghani Azzouqa, Siddhartha Yadav, Kahterine Hoversten, Clay Reed, Andrea Sitek, Elizabeth Enninga, Jonas Paludo, Lisa Kottschade, Aaron Mansfield, Rami Manochakian, Roxana Dronca, Alex Adjei. Sex differences in tolerability and response to immune checkpoint inhibitors in non-small cell lung cancer patients [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A120.

9058 Background: Lung Cancer is the leading cause of cancer related deaths in the USA. NSCLC comprises about 85% of lung cancer cases. Although timeliness of care in patients with NSCLC is considered an important aspect of quality care, there are conflicting data about its impact on clinical outcomes. The primary objective of this study is to determine if there is an association between TTI and survival in patients with NSCLC. Methods: In this retrospective study, we reviewed data from our multi-site Mayo Clinic Cancer Center registry and identified patients with newly diagnosed NSCLC from 2000 to 2016. TTI was calculated from time of diagnosis to time of first treatment (surgery, radiation therapy or systemic therapy). Analyses were performed by SAS software 9.4. Log-Rank test was used to compare survival. Cox regression multivariate model was used to evaluate the prognostic value of variables to survival. Results: 10010 patients (53% males and 47%) were reviewed. Median age at diagnosis was 70. Median TTI was 12 days for stage I, and 20 days for stage II, III and IV. We compared outcomes of patients with TTI > 20 days to TTI ≤20 days. Outcomes were stratified based on age, gender, grade, and stage. Median Overall Survival (OS) was significantly better for patients with TTI ≤20 days compared to TTI > 20 days (39.1 vs 28.6 months P-value < 0.0001). Further stratification, based on stage, showed significantly better OS for stage I and II patients with TTI ≤20 days compared to TTI > 20 days (103.4 vs. 63.9 months P-value < 0.0001 and 72.3 vs. 46.8 months P-value 0.0014 respectively). OS for stage III patients with TTI ≤20 days was not significantly different from patients with TTI > 20 days (30.6 vs. 28.5 months P-value 0.118). Interestingly, stage IV patients had worse OS if TTI ≤20 days compared to TTI > 20 days (8.3 vs. 12.8 months P-value < 0.0001). Conclusions: Our study showed an association between TTI and survival of patients with NSCLC. Shorter TTI was associated with better survival in stage I and II patients and worse survival in stage IV patients. Our study further highlights the controversy surrounding the topic of impact of timeliness of care on survival in patients with cancer, specifically NSCLC across different stages.

Abstract INTRODUCTION: Autologous hematopoietic stem cell transplantation can heavily impact the quality of life (QOL) of an individual. However, this procedure may be the only hope for a cure or a longer life for some individuals. When these patients develop severe neutropenia during transplantation, protective isolation is recommended to reduce the risk of infection. During protective isolation, patients may be confined to their hospital room which can decrease their physical activity. For autologous hematopoietic stem cell receipts (AHSCR), severe neutropenia may last several days to weeks. During this time, patients often experience social isolation, emotional encumbrances and also physical deconditioning.Data is inconsistent whether protective isolation does reduce the incidence of infections. In this study, we sought to investigate the impact of physical activity during hospitalization on Quality of Life in AHSCR with severe neutropenia using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire. METHODS: We conducted a prospective observational study of 15 patients admitted to Mayo Clinic Florida during November 2017 to May 2018 for autologous hematopoietic stem cell transplantation, wherein we monitored the activity of each patient during hospitalization by recording the number of steps taken each day by using an activity tracker worn by the patient. Informed consent was obtained on admission before enrolling patients. Patients completed a Quality of Life (QOL) questionnaire (FACT-BMT version 4) on admission and prior to discharge from the hospital. RESULTS: Of the 15 patients that were enrolled, 5 walked ≤ 100 steps/day (group A, median, 71) and 10 walked > 100 steps/day (group B, median, 406). While there was no difference in the median time to engraftment and length of hospital stay, the mean QOL score decreased from 89.2 on admission to 81.4 on discharge in less active neutropenia patients compared to the ones who were more active. (Table 1; Figure 1) CONCLUSION: Lack of physical activity decreases QOL in AHSCR. During hospitalization, AHSCR should be encouraged to increase their activity to improve QOL. Having an activity tracker may make it easier for patients to monitor their activity, and thus lead to a better QOL. Figure. Figure. Disclosures Sher: Affimed: Research Funding. Ailawadhi:Pharmacyclics: Research Funding; Janssen: Consultancy; Takeda: Consultancy; Amgen: Consultancy; Celgene: Consultancy.

AbstractBackgroundMobilization regimen choice is a significant contributing factor for successful hematopoietic progenitor cell (HPC) collection by leukocytapheresis and reaching the target CD34+ cell dose. How mobilization regimen affects collection efficiency and the quality of products collected using the Spectra Optia apheresis instrument is not fully known.MethodsWe evaluated the impact of granulocyte‐colony stimulating factor (GCSF) and GCSF/plerixafor mobilization regimens on CE and product composition. We studied 373 leukocytapheresis HPC collections for 147 autologous transplants from January 1, 2010 to December 31, 2014. Patients were categorized in two groups; good mobilizers, mobilized with GCSF only (GM) and poor mobilizers, mobilized with GCSF and Plerixafor (PM).ResultsOverall, compared with PM group, total nucleated cell (TNC) yield was significantly lower in GM group (P = <.001). In contrast, median percent mononuclear cell (MNC) collected from GM (86.5%) was significantly higher than products collected from PM group (79.5%; P < .001). Compared with GM group, CD34+ cell CE was about 10% lower in PM group (P < .008). In addition, daily CD34+ cell/Kg yield was significantly higher in GM (2.08 × 10/Kg) compared with PM group (1.64 x 10/Kg, P = .019). Overall, the median number of collections per patient was two for GM and three for PM (P = .004).ConclusionProducts collected from PM group contained higher TNC content relative to GM group but had lower MNC enrichment, CD34+ cell CE and daily CD34+ cell yield per Kg.