Treatment-related Side Effects Research Articles

Efficacy of Gemcitabine, Paclitaxel, and Oxaliplatin Protocol in the Treatment of Relapsed or Refractory Germ Cell Tumours.

To determine the survival endpoints and treatment-related adverse events after the use of the gemcitabine, paclitaxel, and oxaliplatin (GemPOx) protocol in relapsed/refractory germ cell tumours (GCTs) who had previously received multi-line systemic treatments including high-dose chemotherapy. Observational study. Clinic of Medical Oncology, Gulhane School of Medicine, Ankara, Turkey, between January 2017 and August 2021. Clinical characteristics of adult patients with relapsed/refractory GCTs treated with the GemPOx protocol were recorded from the hospital's patient registry database. Patients without a medical record were not included in the study. Objective response rate (ORR), progression-free survival (PFS), overall survival (OS), one-year PFS rate, one-year OS rate, and treatment-related haematological side effects were determined after GemPOx. Fifty-three adult patients were included (47 of them were male). Seventy-eight percent had Stage 3 at initial diagnosis. Twenty-four percent of the patients received more than four lines of systemic chemotherapy. Ninety-six percent of the patients received high-dose chemotherapy prior to GemPOx. ORR, which is the sum of the complete and partial response rates, was 69.8%. PFS was determined as 8.5 ± 5.4 months. The one-year PFS rate was 30.3%. OS was 15.9 ± 10.6 months. The one-year OS rate was 72.6%. Febrile neutropenia was observed in 15.1% of the patients. In patients with relapsed/refractory GCTs receiving multi-line systemic chemotherapy, significant PFS and OS are achievable, and a manageable spectrum of haematological side effects is observed with GemPOx. Gemcitabine, Paclitaxel, Oxaliplatin, Germ cell tumour.

Dutch Physician's Perspectives on Diagnosis and Treatment of Waldenström's Macroglobulinemia Before and After the Implementation of a National Guideline.

Waldenström’s macroglobulinemia (WM), a rare low-grade B-cell non-Hodgkin lymphoma (NHL), has a distinct clinical presentation and different treatment-related side effects compared with other NHL. Currently, a wide variety of therapeutic agents are available for the treatment of WM but there is no consensus on optimal treatment in first line and/or at relapse. The aim of this survey was to evaluate the current knowledge and perspectives of hematologists on diagnosis and treatment of WM. Also, we compare these results to a similar survey done before the publication of the first Dutch national guideline, in order to evaluate the impact of the implementation of a national guideline. A link to an online survey was sent out to all registered hematologists and hemato-oncologists in the Netherlands with the request to participate. The survey contained questions regarding the preferred diagnostic and treatment methods in patients with WM as well as treatment goals. We also compared physicians preferred treatment goals to those of patients (as studied in a recent nationwide patient questionnaire). Ninety-five responses (30% response rate) were obtained, out of which 82 (86%) surveys were complete. The respondents most commonly used dexamethasone-rituximab-cyclophosphamide as first-line treatment. For second-line treatment, bendamustine with rituximab and ibrutinib monotherapy were the most frequently applied. Compared with the initial survey, serum IgM M-protein was determined in all cases, MYD88 mutation analysis was currently widely implemented, prevention of an IgM “flare” was uniformly managed by the respondents and use of rituximab-cyclophosphamide-vincristine-prednisone was entirely abandoned. Physicians differed somewhat from patients with regard to most important treatment goals. The approach to diagnostic methods and treatment options in WM was more consistent with international guidelines and was more homogeneous after implementation of the national guideline. These data indicate an increase in knowledge on WM diagnosis and treatment. This may have resulted from implementation of a local guideline or the global rise in awareness and attention for WM.

Efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand tadalafil for erectile dysfunction

ABSTRACT Objective To compare outcomes of low-intensity extracorporeal shock wave therapy (LIESWT) versus 20 mg of Tadalafil in Erectile dysfunction (ED) patients. Materials and Methods We performed a prospective study of 51 men with ED. Twenty-five were in the LIESWT group and 26 in the Tadalafil group. Patients in the LIESWT group received 6 sessions (2 per week) with an average of 6,000 shocks per session with the PiezoWave2 unit. Other patients self-administered Tadalafil on demand. The outcomes were assessed using the International Index of Erectile Function (IIEF-5) score, Erection Hardness Score (EHS) and Self-Esteem And Relationship (SEAR) questionnaire before, at 6 and 12 weeks after treatment. Treatment-related side effects and costs were recorded too. Results The mean age in the LIESWT group was 43.7 years old, and in the Tadalafil group was 47 years old. After the 6 and 12-week follow-ups, both groups showed significant improvement when comparing the baseline values to the follow-up variables for all IIEF-5, EHS, and SEAR (P < 0.05). There was a notable statistical difference between the two groups regarding the side effects, as the shockwave group was with mild side effects (8%), while the Tadalafil group (44%) of patients had side effects (p < 0.05). This cost difference is statistically significant (p < 0.001). LIESWT is more costly compared to Tadalafil. Conclusion LIESWT has a comparable short-term therapeutic efficacy with higher safety outcomes than on-demand 20 mg of Tadalafil for ED patients.

Cancer treatment and survivorship statistics, 2022.

The number of cancer survivors continues to increase in the United States due to the growth and aging of the population as well as advances in early detection and treatment. To assist the public health community in better serving these individuals, the American Cancer Society and the National Cancer Institute collaborate triennially to estimate cancer prevalence in the United States using incidence and survival data from the Surveillance, Epidemiology, and End Results cancer registries, vital statistics from the Centers for Disease Control and Prevention's National Center for Health Statistics, and population projections from the US Census Bureau. Current treatment patterns based on information in the National Cancer Database are presented for the most prevalent cancer types by race, and cancer-related and treatment-related side-effects are also briefly described. More than 18 million Americans (8.3 million males and 9.7 million females) with a history of cancer were alive on January 1, 2022. The 3 most prevalent cancers are prostate (3,523,230), melanoma of the skin (760,640), and colon and rectum (726,450) among males and breast (4,055,770), uterine corpus (891,560), and thyroid (823,800) among females. More than one-half (53%) of survivors were diagnosed within the past 10 years, and two-thirds (67%) were aged 65 years or older. One of the largest racial disparities in treatment is for rectal cancer, for which 41% of Black patients with stage I disease receive proctectomy or proctocolectomy compared to 66% of White patients. Surgical receipt is also substantially lower among Black patients with non-small cell lung cancer, 49% for stages I-II and 16% for stage III versus 55% and 22% for White patients, respectively. These treatment disparities are exacerbated by the fact that Black patients continue to be less likely to be diagnosed with stage I disease than White patients for most cancers, with some of the largest disparities for female breast (53% vs 68%) and endometrial (59% vs 73%). Although there are a growing number of tools that can assist patients, caregivers, and clinicians in navigating the various phases of cancer survivorship, further evidence-based strategies and equitable access to available resources are needed to mitigate disparities for communities of color and optimize care for people with a history of cancer. CA Cancer J Clin. 2022;72:409-436.

Intrathecal methotrexate in combination with systemic chemotherapy in glioblastoma patients with leptomeningeal dissemination: A retrospective analysis.

BACKGROUNDGlioblastoma (GBM) is one of the most common and aggressive primary malignant brain tumors with severe symptoms and a poor prognosis. Leptomeningeal dissemination (LMD) is a serious complication of GBM that often results in dire outcomes. There is currently no effective treatment.AIMTo estimate the clinical outcomes of combination therapy in GBM patients with LMDMETHODSA retrospective analysis was conducted using data collected from GBM patients diagnosed with LMD from January 2012 to December 2019 at our institution. All these patients had received at least one cycle of a combination therapy consisting of intrathecal methotrexate (MTX) and systemic chemotherapy. Clinical and pathological data were analyzed to explore the outcome of GBM patients with LMD and to determine the most effective treatment.RESULTSTwenty-six patients were enrolled in this study. The median time from GBM diagnosis to LMD development was 9.3 mo (range: 2-59 mo). The median overall survival of LMD patients from diagnosis to after receiving systemic chemotherapy in combination with intrathecal MTX was 10.5 mo (range: 2-59 mo). In the Cox univariate analysis, gross resection of tumor (P = 0.022), Karnofsky performance status (KPS) > 60 (P = 0.002), and Ommaya reservoir implant (P < 0.001) were correlated with survival. Multivariate analysis showed that KPS > 60 (P = 0.037) and Ommaya reservoir implant (P = 0.014) were positive factors correlated with survival. Myelotoxicity and gastrointestinal reactions were the common toxicities of this combination therapy. According to Common Terminology Criteria of Adverse Events 4.03, most of the patients presented with toxicity less than grade 3.CONCLUSIONIntrathecal MTX administration combined with systemic chemotherapy is a potentially effective treatment for patients with GBM and LMD, with mild treatment-related side effects.

Potential role of tryptophan catabolism in cancer-related cognitive impairment

Oncology may be the most rapidly expanding field in medicine, with several innovative diagnostic and therapeutic procedures appearing daily. Advances in oncology have improved the survival rate for patients with cancer and promoting quality of life is now one of the goals in the care of these patients. Patients face a variety of disease- and treatment-related side effects, including anorexia, nausea, vomiting, recurring infections, and sleep difficulties. Cancer-related cognitive impairment (CRCI) is an overlooked clinical condition found in oncologic practice, particularly in patients with breast cancer. Although several potential mechanisms for CRCI have been hypothesized, to our knowledge, the exact mechanism is still unknown. Alterations in the tryptophan kynurenine pathway have been shown to impair cognitive skills in several mental illnesses. However, its possible function in CRCI has yet to be investigated. The aim of this was to examine the possible interactions between tryptophan catabolism and CRCI.

Lower-Neck Sparing Using Proton Therapy in Patients with Uninvolved Neck Nasopharyngeal Carcinoma: Is It Safe?

Undifferentiated carcinoma of the nasopharynx (NPC) is a rare disease, which usually occurs in the Asian population. Due to its anatomic location, it is characterised by rich lymph node drainage and has a high incidence of cervical node metastasis. However, cervical nodal metastasis commonly involves retropharyngeal nodes and level II nodes, followed by level III nodes. In recent years, innovations in terms of systemic treatments and radiotherapy techniques have improved oncological outcome and treatment-related toxicities. Therefore, there is a growing interest in de-intensification strategies of reducing volumes and treatment-related side effects, especially in patients with NPC with N0–N1-stage disease. Proton therapy could represent a valid alternative to Intensity Modulated Radiotherapy (IMRT) in the management of NPC in this setting. With this Commentary, we aim to explore the feasibility of Intensity Modulated Proton Therapy (IMPT) in upper-neck irradiation of NPC N1-stage disease. We selected an NPC patient with N1 disease and compared the original IMRT plan with the IMPT plan in terms of dosimetric parameters. IMPT offers a minimal dosimetric advantage over IMRT in the bilateral lower-neck sparing. Clinical trials are needed to evaluate the significance of these proposed suggestions and their applicability in non-endemic areas.

Efficacy and safety of palbociclib in treatment of HR-positive advanced breast cancer patients: A single center real-world experience.

e13035 Background: With an estimated 2.3 million new cases (11.7% of all cases), female breast cancer is the leading cause of cancer globally as of 2020. Metastatic or advanced breast cancer is an incurable disease with a 5-year overall survival rate of 28.1%. Palbociclib, a cyclin-dependent kinase 4/6 inhibitor combined with an aromatase inhibitor, is approved to treat HR+/HER2- metastatic breast cancer (MBC). The present single-arm study evaluates the real world experience of efficacy and safety of Palbociclib-Letrozole for the treatment of HR+/HER2- MBC in the Indian population. Methods: MBC patients with or without prior chemotherapy and hormone therapy were treated with Palbociclib 125 mg once daily (3/1 schedule) plus Letrozole 2.5 mg once daily. The efficacy was recorded as objective response or disease control rate based on the response as per the RECIST criteria. The study also reports the incidence and severity of adverse events during the treatment duration. The tolerability was assessed per Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 and coded using Medical Dictionary for Regulatory Activities (MedDRA) v.21.0. Results: A total of 102 patients were treated from 2017 to 2020 at the tertiary cancer center. The efficacy response is captured as per the investigator's assessment of the disease response. The response is as captured for 100/102 patients (two patients lost to follow-up) and are represented in Table. About 17% (23/100) patients achieved an objective response, while 54% (57/100) showed disease control. The tolerability was assessed as treatment-related side-effects (adverse events (AEs) and severe adverse events (SAEs)) as reported by the treating oncologist. Overall, 61 adverse events were observed in 40/102 (39.22%). The most-reported AE, neutropenia, was reported in 13 patients, followed by chest pain and breathlessness. Conclusions: In the present study, Palbociclib + Letrozole reported good clinical response at the end of treatment duration with a manageable tolerability profile in the Indian population.

The BC Generations Project as a tumor tissue resource for cancer research.

e22512 Background: Population-based cohort studies can be a resource for tumor specimens, annotated with demographic, lifestyle, and health history data, that support innovative studies of cancer. These data are increasingly important for clinical studies as they can be useful predictors of prognosis and treatment response (1,2) Our aim was to establish and test a process for accessing tumor samples, held at pathology laboratories around British Columbia (BC), for participants of the BC Generations Project (BCGP). Methods: Through the BC Cancer Registry, pathology reports linked with each BCGP solid cancer case were manually reviewed to extract information (e.g., location of pathology laboratory, sample type (i.e., biopsy or excision), and accession number) needed to request tumor samples. From among the successfully abstracted pathology reports, we randomly selected a total of 200 breast, lung, bladder, and pancreatic cancer cases for which to attempt retrieval of formalin-fixed, paraffin-embedded (FFPE) blocks from pathology laboratories across BC. We selected these cancer sites as they capture a representative range of cancer characteristics (e.g., tumor sizes) with which to evaluate the effectiveness of our access process. Results: We successfully identified pathology reports for 1,100 (93%) of the 1,180 incident solid cancer cases diagnosed in BCGP as of 2019 and we successfully retrieved 183 (92%) of the 200 FFPE that we requested from pathology laboratories. No important differences in retrieval rates by cancer site, sample location (Greater Vancouver vs. Outside Greater Vancouver), sample type (biopsy vs. excision) or year of diagnosis were identified. Conclusions: This linkage exercise demonstrates the tremendous potential for BCGP to serve as a population-based resource for highly annotated tumor tissue samples. A text mining solution recently implemented by the Registry will allow us to automate the process for data abstraction and should capture pathology reports for 100% of all newly diagnosed BCGP cancer cases moving forward. This will further enhance the utility of BCGP as a high-quality tumor tissue research resource.

The novel preventive effect of a Japanese ethical Kampo extract formulation TJ-90 (Seihaito) against cisplatin-induced nephrotoxicity

Background and purposeChinese herbal medicine has been developed as the traditional Japanese Kampo medicine, and it has been widely used to cure various symptoms in clinical practice. However, only a few studies are currently available on the effect of the Kampo medicine on renal disease. Nephrotoxicity is one of major side effect of cisplatin, the first metal-based anticancer drug. In the present study, we examined the effect of the Kampo medicine against cisplatin-induced nephrotoxicity (CIN). MethodsFirst, we screened the ethical Kampo extract formulation having positive effect against CIN using HK-2 cells. Next, we examined the preventive action of the selected ethical Kampo extract formulation against CIN in vivo using a mouse model. ResultsCisplatin-induced cell death was significantly suppressed by TJ-43 (Rikkunshito) and TJ-90 (Seihaito); however, cisplatin-induced cleaved caspase-3 expression was inhibited only by TJ-90. In an in vivo mouse model of cisplatin-induced kidney injury with dysfunction and increased inflammatory cytokine expression, TJ-90 showed amelioration of these damaging effects. Cisplatin-induced apoptosis and superoxide production were inhibited by treatment with TJ-90. The expression of cleaved caspase-3, 4-hydroxynonenal, and MAPK phosphorylation increased after cisplatin administration, but decreased after the administration of TJ-90. Among 16 crude drug extracts present in Seihaito, Bamboo Culm (Chikujo in Japanese) inhibited cisplatin-induced cell death and cleaved caspase-3 expression in HK-2 cells. Moreover, the anti-tumor effect of cisplatin was not affected by TJ-90 co-treatment in cancer cell lines. ConclusionTJ-90 might have a novel preventive action against CIN through the suppression of inflammation, apoptosis, and oxidative stress without interfering with the anti-tumor effect of cisplatin. Collectively, these findings might contribute to innovations in supportive care for cancer treatment-related side effects.

CDKL5 Deficiency Disorder-Related Epilepsy: A Review of Current and Emerging Treatment.

Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a developmental and epileptic encephalopathy with infantile-onset epilepsy. Most individuals with CDD develop refractory epilepsy with multiple seizure types. Management of seizures in CDD remains challenging for clinicians given the highly refractory nature of seizures and the limited number of disease-specific studies that offer a high level of evidence. Epileptic spasms are the most common seizure type in CDD and are more often refractory to standard first-line treatment than are spasms of other etiologies. In other seizure types, the effectiveness of antiseizure medications is limited and wanes over time. Ketogenic diet and palliative surgical treatments have both had mixed results in observational studies. When treating refractory seizures in CDD, we recommend carefully balancing seizure control and treatment-related side effects to optimize each individual's overall quality of life. Clinical trials of medications targeting epilepsy in CDD have been conducted, and additional investigational small molecules, gene therapy, and other disease-modifying therapies are in development for CDD.

Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02

BackgroundDespite recent changes in the treatment landscape, there remains an unmet need for effective, tolerable, chemotherapy-free treatments for patients with advanced/metastatic urothelial carcinoma (mUC), especially cisplatin-ineligible patients. ObjectiveTo evaluate the immunostimulatory interleukin-2 cytokine prodrug bempegaldesleukin (BEMPEG) plus nivolumab in patients with advanced/mUC from the phase 2 multicenter PIVOT-02 study. Design, setting, and participantsThis open-label, multicohort phase 1/2 study enrolled patients with previously untreated locally advanced/surgically unresectable or mUC (N = 41). InterventionPatients received BEMPEG 0.006 mg/kg plus nivolumab 360 mg intravenously every 3 wk. Outcome measurements and statistical analysisThe primary objectives were safety and the objective response rate (ORR) in patients with measurable disease at baseline and at least one postbaseline tumor response assessment (response-evaluable). Secondary objectives were overall survival (OS) and progression-free survival (PFS). Exploratory biomarker analyses via univariate logistic regression were performed to test the association between potential biomarkers (CD8+ tumor-infiltrating lymphocytes, tumor mutational burden, and IFN-γ gene expression profile) and response. Results and limitationsThe ORR was 35% (13/37 evaluable patients) and the complete response rate was 19% (7/37 patients); the median duration of response was not reached. Median PFS was 4.1 mo (95% confidence interval [CI] 2.1–8.7) and median OS was 23.7 mo (95% CI 15.8–not reached). Overall, 40/41 patients (98%) experienced at least one treatment-related adverse event (TRAE); grade 3/4 TRAEs occurred in 11 patients (27%), most commonly pyrexia (4.9%; 2 patients). Exploratory biomarker analyses showed no association between biomarkers and response. Limitations include the small sample size and single-arm design. ConclusionsBEMPEG plus nivolumab was well tolerated and showed antitumor activity as first-line treatment in patients with locally advanced/mUC. Patient summaryWe investigated an immune-stimulating prodrug called bempegaldesleukin plus the antibody nivolumab as the first therapy for patients with advanced or metastatic cancer of the urinary tract. This combination had manageable treatment-related side effects and was effective in a subset of patients.This trial is registered at ClinicalTrials.gov as NCT02983045.

130P Dosimetric evaluation of continuous positive airway pressure with deep inspiratory breath hold for left sided breast cancer

Breast surgery, systemic chemotherapy and radiotherapy is the mainstay trimodal way of treating a breast cancer. Treatment-related side effects such as cardiotoxicity is worrisome. Long-term cardiac toxicities are key components to predict breast cancer survivorship. Hence it is very pertinent to limit the dose to the heart as much as possible and the same has been achieved to a large extent with conformal radiation, deep inspiratory breath hold, gating, and cardiac sparing. However, still in many patients especially with thin chest wall, the heart is very close to the chest wall and so the dose received by the heart is invariably high in an attempt for optimal planning target volume (PTV) coverage.

"Your Body Is Not At All Where You Left It": Adolescent and Young Adult Cancer Survivors' Experiences Transitioning Back Into Physical Activity After Treatment.

Physical activity (PA) can help manage cancer treatment-related side effects and improve well-being following treatment; however, resuming PA after a period of inactivity due to cancer can be challenging. The purpose of this study was to explore adolescents and young adults (AYAs) experiences transitioning back into PA after a period of inactivity due to cancer treatment. Twelve previously active AYAs (Mage = 30 ± 5.8 years) were purposefully sampled and engaged in a semi-structured interview. The following four themes were generated through a reflexive thematic analysis: PA is described as important and valuable; navigating one's appearance and fitness changes after cancer treatment within the PA context; supportive care is essential to successful PA transitions; and juxtaposed environments: fitness facilities, cities, and green spaces. Developing strategies aimed at gradually transitioning into PA should be a priority to improve AYAs' well-being through survivorship.

Combination Neoantigen-Based Dendritic Cell Vaccination and Adoptive T-Cell Transfer Induces Antitumor Responses Against Recurrence of Hepatocellular Carcinoma.

A high rate of recurrence after curative therapy is a major challenge for the management of hepatocellular carcinoma (HCC). Currently, no effective adjuvant therapy is available to prevent HCC recurrence. We designed a personalized neoantigen-loaded dendritic cell vaccine and neoantigen-activated T-cell therapy, and used it as adjuvant therapy to treat 10 patients with HCC who had undergone curative resection or radiofrequency ablation in the first stage of a phase II trial (NCT03067493). The primary outcomes were safety and neoantigen-specific immune response. Disease-free survival (DFS) was also evaluated. The immunotherapy was successfully administered to all the patients without unexpected delay and demonstrated a reasonable safety profile with no grade ≥3 treatment-related side effects reported. Seventy percent of patients generated de novo circulating multiclonal neoantigen-specific T-cell responses. Induced neoantigen-specific immunity was maintained over time, and epitope spreading was observed. Patients who generated immune responses to treatment exhibited prolonged DFS compared with nonresponders (P = 0.012), with 71.4% experiencing no relapse for 2 years after curative treatment. High expression of an immune stimulatory signature, enhanced immune-cell infiltration (i.e., CD8+ T cells), and upregulated expression of T-cell inflammatory gene profiles were found in the primary tumors of the responders. In addition, neoantigen depletion (immunoediting) was present in the recurrent tumors compared with the primary tumors (7/9 vs. 1/17, P = 0.014), suggesting that immune evasion occurred under the pressure of immunotherapy. Our study indicates that neoantigen-based combination immunotherapy is feasible, safe, and has the potential to reduce HCC recurrence after curative treatment.

P303 Development of a Behçet’s disease specific patient concerns inventory

Abstract Background/Aims Behçet’s Disease (BD) is a rare multi-system variable vessel vasculitis. It is characterised by oral ulcers, genital ulcers and ocular involvement; however, expression can vary, with patients experiencing a range of symptoms affecting several body systems. This creates the need for an individual and holistic approach to management in order to optimise patient care. A patient concerns inventory (PCI) is a validated tool used to encourage patient-led reviews by exploring areas of concern and unmet needs, and has shown to increase patient satisfaction in oncology and rheumatology consultations. The aim of this study was to develop a novel BD-specific PCI and to assess the impact of this tool in clinic following ethical approval. Methods Phase I: Literature search conducted to identify concerns and areas of unmet need in BD patients to create an initial PCI across four separate domains, including physical and functional well-being, psychological and emotional well-being, social care and social well-being, and treatment related side effects. Phase II: PCI presented to the BD multi-disciplinary team for feedback and refinement. Members were asked to rate each item based on how frequently that issue was discussed in consultations, from ‘never’, to ‘sometimes’, ‘most of the times’ or ‘every time’. Phase III: Updated version of PCI presented to patient groups in association with Behçet’s Society UK. Patients were asked to rate on an identical scale. Collective feedback allowed for a final version of the PCI to be created. Phase IV: Pilot study to test the effectiveness of the PCI in BD clinics. Pre- and post-PCI groups will be created. The mean differences in consultation time, number of concerns and patient satisfaction will be compared. Results Phase I: Following the application of an inclusion and exclusion criteria, 35 papers yielded a total of 54 items for the initial PCI. Phase II: 12 responses were received, which led to the exclusion of 9 items based on 60% of the respondents reporting this issue was ‘never’ discussed in clinic. A total of 2 items were added, which led to a 47-item PCI. Phase III: 239 responses received from BD patients. 3 items eliminated and 4 added on. Final 48-version PCI created. Phase IV: Pilot study will commence following ethical approval. Conclusion A PCI is a holistic tool used to improve communication and encourage patient-led consultations. Phases I to III have led to the creation of a 48-item BD-specific PCI which will be tested in clinic as a pilot following ethical approval. We hope to demonstrate an increase in patient satisfaction following the introduction of a PCI in BD clinics. Disclosure S. Mukhtar: None. R. Moots: None.

Review: Neurological Complications From Therapies for Pediatric Brain Tumors.

Surgery, chemotherapy and radiation have been the mainstay of pediatric brain tumor treatment over the past decades. Recently, new treatment modalities have emerged for the management of pediatric brain tumors. These therapies range from novel radiotherapy techniques and targeted immunotherapies to checkpoint inhibitors and T cell transfer therapies. These treatments are currently investigated with the goal of improving survival and decreasing morbidity. However, compared to traditional therapies, these novel modalities are not as well elucidated and similarly has the potential to cause significant short and long-term sequelae, impacting quality of life. Treatment complications are commonly mediated through direct drug toxicity or vascular, infectious, or autoimmune mechanisms, ranging from immune effector cell associated neurotoxicity syndrome with CART-cells to neuropathy with checkpoint inhibitors. Addressing treatment-induced complications is the focus of new trials, specifically improving neurocognitive outcomes. The aim of this review is to explore the pathophysiology underlying treatment related neurologic side effects, highlight associated complications, and describe the future direction of brain tumor protocols. Increasing awareness of these neurologic complications from novel therapies underscores the need for quality-of-life metrics and considerations in clinical trials to decrease associated treatment-induced morbidity.

Outcome after Radiotherapy for Vestibular Schwannomas (VS)-Differences in Tumor Control, Symptoms and Quality of Life after Radiotherapy with Photon versus Proton Therapy.

Simple SummaryThe standard of care for radiotherapy of symptomatic or progressive vestibular schwannomas (VS) is photon beam single-dose radiosurgery (applying 1 × 12 Gy) or (hypo)fractionated radiotherapy (applying 3 × 6 Gy up to 32 × 1.8 Gy). Only few centers also enable irradiation with protons. Proton therapy offers unique physical properties whereby healthy tissue around the tumor can be protected although a very high dose is applied to the target lesion. In patients with benign brain tumors such as vestibular schwannomas reduction of treatment-related side effects is very important. Few data comparing photon vs. proton beam radiotherapy for patients with VS are available. Thus, a detailed evaluation of differences in tumor control, symptoms and quality of life in patients with VS after photon beam vs. proton beam radiotherapy is needed.Background: To evaluate differences in local tumor control (LC), symptoms and quality of life (QOL) of 261 patients with VS after stereotactic radiosurgery/hypofractionated stereotactic radiotherapy (SRS/HFSRT) vs. fractionated radiotherapy (FRT) vs. fractionated proton therapy (FPT) were studied. Methods: For SRS/HFSRT (n = 149), the median fraction dose applied was 12 Gy. For FRT (n = 87) and FPT (n = 25), the median cumulative doses applied were 57.6 Gy and 54 Gy (RBE), respectively. FRT and FPT used single median doses of 1.8 Gy/Gy (RBE). Median follow-up was 38 months. We investigated dosimetry for organs at risk and analyzed toxicity and QOL by sending out a questionnaire. Results: LC was 99.5% at 12 months after RT with no statistical difference between treatment groups (p = 0.19). LC was significantly lower in NF2 patients (p = 0.004) and in patients with higher tumor extension grade (p = 0.039). The hearing preservation rate was 97% at 12 months after RT with no statistical difference between treatment groups (p = 0.31). Facial and trigeminal nerve affection after RT occurred as mild symptoms with highest toxicity rate in FPT patients. Conclusion: SRS/HFSRT, FRT and FPT for VS show similar overall clinical and functional outcomes. Cranial nerve impairment rates vary, potentially due to selection bias with larger VS in the FRT and FPT group.

Nutrition Impact Symptoms in Relation to Head and Neck Cancer Survivor’s Vegetable Intake and Use of Seasoning

Background: Most head and neck cancer (HNC) patients undergoing aggressive treatments with chemoradiotherapy and surgical resection of tumors suffer from symptoms long after treatment is completed that hinder adequate oral food intake, collectively known as Nutrition Impact Symptoms (NIS). Our aim was to examine the correlations between NIS and HNC survivors’ vegetable intake and use of seasoning. Methods: We conducted a 29-item telephone administrated survey to collect vegetable intake and seasoning habits among HNC survivors (n=22, age 61.4 ± 9.8 years, mean ± standard deviation) who received radiation therapy between 6 months and 10 years before recruitment identified through the cancer registry at Carle Foundation Hospital. Treatment-related side-effects (11 items) including difficulty swallowing, dry mouth, and mouth sores reflected NIS. A mean composite score was created for all the symptoms where higher scores indicated greater NIS. Spearman correlations examined the relationships between NIS, vegetable intake, and seasoning. Results: Half (50%) of the participants reported no change in their vegetable intake since diagnosis of cancer, and on average, ate 1 cup/day of total vegetables. Higher NIS scores associated with higher pumpkin and sweet potatoes intake (r (20) = .43, p&lt;0.05), and there was a trend for higher scores of difficulties swallowing to be associated with lower corn and peas intake (r (20) =-.37, p=0.08). Participants with higher scores of problems with teeth and gums were less likely to use seasoning (r (20) = -.42, p&lt;0.05). Conclusion: The findings support that HNC treatment can affect vegetable intake long after completion of radiotherapy. However, it would be premature for any recommendations to be derived from the present study for health professionals. A larger, observational study with a longer follow-up is therefore needed to examine these correlations.

Systemic Treatment of Soft Tissue Sarcomas in the Geriatric Population.

As the population ages, there will be an increase in the incidence and prevalence of soft tissue sarcoma (STS) within the geriatric population. As this disease disproportionately affects older adults, the percentage of adults >65 years old is expected to increase in the coming years. Geriatric patients are often more vulnerable to disease-related symptoms and have more difficulty tolerating treatment-related side effects. While there are no formal existing guidelines to direct the care of this geriatric patient population, it is of utmost importance to consider each patients' fitness and co-morbidities when selecting treatment plans. This review focuses on the current state of research of older adults with advanced or metastatic soft tissue sarcoma, highlighting the lack of representation of this patient population in clinical trials. Given that chronological age does not necessarily equate to physiologic age, integration of comprehensive geriatric and quality of life assessments is needed in the care of geriatric patients to help guide therapeutic decisions.