Common Acute Side Effect Research Articles

Proton Therapy for Management of Pediatric Hodgkin Lymphoma Involving the Mediastinum: Evaluation of Toxicity and Evolution of Therapy Over 7 Years of Experience

Clinical trial design in pediatric Hodgkin lymphoma has prioritized identification of patients who respond rapidly and completely to systemic therapy and can safely forego radiation therapy. However, this comprises a small number of patients overall and many require consolidative radiation therapy to provide durable disease control. Given the excellent projected long-term survival in this patient population, proton therapy is an appealing approach to minimize long-term and late toxicity. Here, we present our 7-year experience with proton therapy. Patients with Hodgkin lymphoma receiving mediastinal radiation between 2011-2017 were evaluated. Demographics, treatment details, and therapy-related toxicity were collected. Survival was recorded as time from diagnosis to last contact or death, using Kaplan-Meier estimates for progression free (PFS) and overall survival (OS). Patients with 3 or more years of follow up were reviewed for late toxicities. Sixty-six patients were evaluated, with median age of 16 (range 7-20) and slight female predominance (55%). The majority of patients had stage II disease (63%), with 25% presenting with B symptoms, and 50% with bulky disease. All patients had disease involving the mediastinum, with additional neck involvement in 61%, disease below the diaphragm in 27%, and bone in 6% of patients. Patients were treated with mixed proton-photon plans through 2013, using double scattered protons over the mediastinum with matched 3DCRT or IMRT photons for treatment of the neck. Full pencil beam scanning plans were standard by 2015. This variation was the result of differences in technology available at our center based on treatment era. Common acute side effects were fatigue (50% of patients) and radiation dermatitis (39%), however the majority were grade 1 and mild. There were no grade 3 toxicities. Acute toxicity frequency did not change as proton planning methods evolved. Relapses occurred in 14 patients (21%) with in-field recurrence in 10 of the cases (15%). Median follow up time was 3.5 years. Three and 5 year PFS were 79 and 71%, respectively, and OS was 98% at both intervals with only one death in a patient with refractory disease. Thirty-six patients (55%) had 3 or more years of follow up. Echocardiography and pulmonary function tests were available in 42 and 67% of those patients, respectively, with no documented changes other than pulmonary changes following bleomycin. There were no other reported late toxicities. Hodgkin lymphoma involving the mediastinum can be consolidated with proton therapy, achieving control rates similar to historical measures. The greatest benefit of proton therapy will likely be a decrease in late toxicities by reducing the amount of normal tissue exposed to radiation; this clinical sparing is suggested by these early data, and longer follow up with this cohort is planned.

Development and validation of NTCP models for acute side-effects resulting from proton beam therapy of brain tumours

BackgroundThe limited availability of proton beam therapy (PBT) requires individual treatment selection strategies, such as based on normal tissue complication probability (NTCP). We developed and externally validated NTCP models for common acute side-effects following PBT in brain tumour patients in effort to provide guidance on optimising patient quality of life. MethodsAn exploration cohort including 113 adult brain tumour patients who underwent PBT was investigated for the following endpoints: alopecia, scalp erythema, headache, fatigue and nausea. Dose–volume parameters of associated normal tissues were used for logistic regression modelling. Statistically significant parameters showing high area under the receiver operating characteristic curve (AUC) values in internal cross-validation were externally validated on two cohorts of 71 and 96 patients, respectively. ResultsStatistically significant correlations of dose–volume parameters of the skin for erythema and alopecia were found. In internal cross-validation, the following prognostic parameters were selected: V35Gy (absolute volume receiving 35 Gy) for erythema grade ≥1, D2% (dose to 2% of the volume) for alopecia grade ≥1 and D5% for alopecia grade ≥2. Validation was successful for both cohorts with AUC >0.75. A bivariable model for fatigue grade ≥1 could not be validated externally. No correlations of dose–volume parameters of the brain were seen for headache or nausea. ConclusionWe developed and successfully validated NTCP models for scalp erythema and alopecia in primary brain tumour patients treated with PBT.

(P44) Visual Outcomes in Patients With Metastatic Disease to the Eye

30,000 to 100,000 cancer patients develop ocular metastasis each year, yet clinical data remains limited. Historically, the most common primary tumors resulting in ocular metastasis are breast and lung, with radiotherapy as the most predominant palliative treatment. The purpose of this study was to report clinical features of ocular metastasis and the results of using external beam radiotherapy as treatment. A retrospective chart review was performed on 18 patients at Hahnemann University Hospital and Wills Eye Institute in Philadelphia, Pennsylvania from 2011 to 2016. Treated Patients were selected solely on prior diagnosis of ocular metastasis and treatment by external beam radiation therapy. Patients were treated using four-field 3D conformal radiotherapy in the majority of cases. The cohort included 10 females and 8 males. Median age was 58 (38-85) with 78% Caucasian and 22% African American. The most common source for ocular metastasis was lung (39%), followed by breast (33%), unknown primary (16%), esophageal (6%), and renal (6%). Additional systemic metastases were present in 67% of patients. Ocular metastasis was present in the left eye of 6 patients (33%) and the right eye of 4 patients (22%), with bilateral metastasis in 8 patients (45%). A change in visual acuity with blurring or field of vision loss was the most common presenting symptom, occurring in 15/18 patients, followed by pain, floaters, retinal detachment, and photophobia occurring in the remainder of the group. The median dose was 30.75 Gy (17.5 – 46), with a median daily dose of 2.1 Gy (2 – 2.7). The median treatment duration was 23 days (13-35). The location of ocular metastasis was the choroid (82%), retina (6%), ciliary body (6%), and the orbit (6%). The short-term side effect profile consisted of skin erythema and conjunctivitis (67%), eyelash loss (5%) with 28% of patients asymptomatic. The long-term side effect profile consisted solely of dry eye (5%). The majority of patients completing treatment developed a cataract. 9 patients (50%) experienced improvement of visual acuity and 5 patients (28%) had stable vision post-treatment. One patient died during treatment and was not able to be evaluated (6%), 2 patients (10%) had local disease progression and one patient (6%) experienced improved pain post-treatment. The most common source of the choroidal metastasis was related to lung and breast cancer, with the majority of patients presenting with other metastatic sites as well. Bilateral metastasis was as common as unilateral metastasis and a change in visual acuity with blurring was the most common symptom in this cohort of patients. The treatment course was a median of 23 days with most patients tolerating treatment with minimal sequelae. The most common acute side effects were erythema and conjunctivitis. The majority of patients experienced a favorable response to radiation treatment. External beam radiation is an important palliative modality to consider in patients with choroidal metastasis due to a low side effect profile, overall short treatment time, and stable or improved vision in the majority of patients.

Visual Outcomes and Local Control After Fractionated Stereotactic Radiotherapy for Optic Nerve Sheath Meningioma.

To review the outcomes of patients with optic nerve sheath meningiomas (ONSM) treated with fractionated stereotactic radiotherapy. Patient characteristics, treatment, and outcomes were analyzed for all patients with primary and secondary ONSM treated from 2001 to 2012. Clinically significant visual acuity change was defined as a 2-line change on the Snellen eye chart from pre-fractionated stereotactic radiotherapy. Forty-one patients were treated: 23 patients with primary ONSM and 18 patients with secondary ONSM. The median age at diagnosis was 56 years. The median visual follow up was 3.8 years and the median radiologic follow up was 4.4 years. At diagnosis, 36% had normal vision (20/20-20/40), 10% had mild impairment (<20/40-20/60), 20% had moderate visual impairment (<20/60-20/200), 27% had severe impairment (<20/200), and 7% had no light perception. Common acute side effects were headache (32%) and nausea (15%); 15% of patients required corticosteroids during stereotactic radiotherapy. Chronic toxicities included retinopathy (7%), pituitary dysfunction (13%), chronic ocular pain (5%), and cataracts (2%). Visual acuity was stable in 65%, improved in 27%, and decreased in 8% of patients. Visual fields were stable in 70%, improved in 21%, and reduced in 9%. Actuarial 5-year local control rates were 100% for primary ONSM and 88% for secondary ONSM. Actuarial 5-year visual preservation rates were 100% for primary ONSM and 86% for secondary ONSM. Fractionated stereotactic radiotherapy for primary and secondary ONSM was well tolerated and provides excellent local control and visual preservation. Longer follow up is required to determine the risk of late ocular and pituitary sequelae.

Effect of Probiotics for the Prevention of Acute Radiation-Induced Diarrhoea Among Cervical Cancer Patients: a Randomized Double-Blind Placebo-Controlled Study

Radiotherapy is the mainstay treatment of cervical cancer and the most common acute side effect is radiation-induced diarrhoea (RID), which can affect up to 80% of the patients. The most frequently used probiotics for the RID in previous studies with somewhat positive results are Lactobacillus and Bifidobacterium strains. This study was aimed to investigate the effect of a probiotic containing live Lactobacillus acidophilus LA-5 plus Bifidobacterium animalis subsp. lactis BB-12 for the prevention of acute (RID) among cervical cancer patients. Patients receiving external beam pelvic radiotherapy with or without concurrent chemotherapy were randomized into probiotic or placebo groups and were double-blinded. The probiotic group received the capsules containing 1.75 billion lyophilized live bacteria to be taken one capsule three times daily beginning from the first day until the end of radiotherapy, and the placebo group received identically appearing capsules containing starch with the same schedule. Every patient received the standard dietary recommendations. The patients were assessed daily during radiotherapy and follow-up weekly for 3weeks after radiotherapy. Total 54 patients were analyzed. The incidence of diarrhoea was reduced in the probiotic group than the placebo group (53.8 and 82.1%, p < 0.05). The mild-to-moderate and severe diarrhoea were significantly reduced in the probiotic group (p < 0.05). The use of loperamide as an anti-diarrhoeal medication was significantly reduced in the probiotic group than the placebo group (p < 0.01). The difference in grade 2 abdominal pain and episodes of abdominal pain in days were also significant (p < 0.001). Therefore, supplementation of probiotic is an easy and effective way to reduce the incidence and severity of RID in cervical cancer patients.

Definitive Intensity-modulated Radiation Therapy in Elderly Patients with Locally Advanced Oropharyngeal Cancer.

To evaluate the treatment tolerance and clinical outcomes in patients aged 70 years and older with locally advanced oropharyngeal cancer treated by definitive intensity-modulated radiation therapy (IMRT). We retrospectively analyzed 15 consecutive elderly patients, with histologically-proven squamous cell carcinoma of the oropharynx, staged T3-4 with or without involved lymph nodes at diagnosis, who received definitive sequential IMRT (70 Gy; 2 Gy/fraction). Adult Comorbidity Evaluation-27 (ACE-27) score was calculated and its influence on treatment tolerance and clinical outcomes was analyzed. A total of 15 patients were included with a median age of 77 years (range=70-88 years). At baseline, 8 patients (53.3%) had an ACE-27 score of 1, and the remainder (n=7, 46.7%) had a comorbidity index of 0. All patients completed programmed IMRT treatment, without any reduction of total dose. Oral pain and mucositis were the most common acute side-effects, classified as grade 3 in 6 patients (40%) only. Xerostomia was reported in 13 patients (86.7%), without severe manifestation. There was no hematological toxicity. ACE-27 score was not related to higher severe acute toxicity. No patients experienced grade 3 or more late toxicity. Five-year overall survival and disease-free survival rates were 63.6% (95% confidence interval=32.7-83.3%) and 55% (95% confidence interval=24.4-77.6%), respectively. Comorbidity score did not influence survival outcomes, both overall survival (p=0.46) and disease-free survival (p=0.55). Treatment tolerance, as well as survival outcomes were good in elderly oropharyngeal cancer patients treated with definitive sequential IMRT. Due to age and comorbidity, no dose or volume reduction for IMRT should be considered in this setting of patients. A prospective randomized trial with a large sample size should be conducted to confirm our results.

Prospective assessment of oral mucositis and its impact on quality of life and patient-reported outcomes during radiotherapy for head and neck cancer.

Oral mucositis (OM) is a common acute side effect during radiotherapy treatments for head and neck cancer (HNC), with a potential impact on patient's compliance to therapy, quality of life (QoL) and clinical outcomes. Its timely and appropriate management is of paramount importance. Several quantitative scoring scales are available to properly assess OM and its influence on patient-reported outcomes (PROs) and QoL. We prospectively assessed OM in a cohort of HNC patients submitted to radiation using the Oral Mucositis Assessment Scale (OMAS), while its impact on PROs and QoL was evaluated employing the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN) and the Functional Assessment of Cancer Therapy-Head and Neck Cancer (FACT-HN). Evaluation of OMAS scores highlighted a progressive increase in OM during treatment and a partial recovery after the end of radiation. These trends were correlated to PROs and QoL as evaluated with OMWQ-HN and FACT-HN questionnaires. In the present study, we provided a quantitative assessment of OM, PROs and QoL in HNC patient undergoing radiotherapy, potentially useful for future comparison.

Antineoplastic Drugs: Occupational Exposure and Side Effects

Abstract Due to their adverse effects, antineoplastic drugs (cancer chemotherapy drugs) are considered as a potential health risk for nurses and nursing assistants. The aim of this study was to review and summarise information about acute side effects of antineoplastic drugs in two major cancer centres in Latvia. In total 51 nurses and nursing assistants participated in the study, all working in chemotherapy ward at least for 12 months. The research was conducted in Pauls Stradiņš Clinical University Hospital and Rīga East University Hospital, Oncology Centre of Latvia. 56.86% of respondents reported at least one side effect since working in the department of chemotherapy (DC). Headache was the most common acute side effect (37.25%), followed by irritation of eyes (25.49%) and irritation of skin (19. 60%). Headache (p = 0.021), dizziness (p = 0.018), irritation of mouth and throat (p = 0.043), and irritation of eyes (p = 0.004) had statistically significant positive association with years of working in DC, suggesting that those working for longer time in DC are more likely to have headache, dizziness, irritation of mouth, throat and eyes.

Clinical analysis of multimodal treatment for orbital organ preservation in T4b squamous cell carcinoma of nasal cavity and paranasal sinuses

To investigate the efficacy of induction chemotherapy (ICT) followed by concurrent chemotherapy and helical tomotherapy (HT) in the patients with T4b squamous cell carcinoma of nasal cavity and paranasal sinus (SCCNP) for orbital organ preservation and high quality of life. A total of 26 patients with the orbital involvement of T4b SCCNP between May 2008 and March 2013 were analyzed retrospectively. There were 17 males and 9 females; the average age was 54.7 years. The median follow-up time was 25 months (range 4-77 months). The patients received 1-2 cycles ICT with TP (docetaxel 70 mg/m(2) on day 1 and cisplatin 40 mg/m(2) on day 1-2, every 3 weeks) or TPF (docetaxel 70 mg/m(2) on day 1 and cisplatin 70 mg/m(2) on day 1-2, 5-fu 700 mg/m(2) on day 1-5, every 3 weeks), followed by concurrent HT (60-70 Gy) and chemotherapy with TP and/or epidermal growth factor receptor (EGFR) inhibitor. The Kaplan-Meier method was used to determine the 3-year overall survival rate and local control rate. Side-effects were evaluated with the established common terminology criteria for adverse events (CTCAE) version 4.0 criteria. All patients completed the planned chemotherapy and 96.2%(25/26)patients completed the planned radiotherapy. The 3-year overall survival rate, the local control rate and real orbital preservation rate were 56.7%, 79.5% and 80.0% respectively. The most common acute side effects higher than grade 2 were oral mucositis, radiodermatitis and dry eye syndrome. The strategy including ICT followed by CCRT and/or EGFR inhibitor is an effective treatment for T4b SCCNP patients, with minimal toxicities, higher 3-year OS rate and orbital preservation rate, and also provides a new treatment option for T4b SCCNP patients.

The Role of Radiotherapy in the Treatment of Primary or Recurrent Desmoid Tumors and Long-Term Results.

Desmoid tumors are uncommon and benign mesenchymal neoplasms. The optimal treatment of patients with desmoid tumors is still controversial. Surgery is the primary treatment for locally invasive or recurrent desmoid tumors. Also, radiotherapy is a treatment option for patients at high risk for local failure such as those with positive margins or recurrent and unresectable tumors. To report our institutional experience and long-term results of patients with desmoid tumors who received radiotherapy. Retrospective cross-sectional study. Between 1980 and 2009, 20 patients who received radiotherapy (RT) in our institution were analyzed. The majority of patients (80%) were referred with a recurrent tumor after previous surgery. Thirteen patients underwent marginal resection, 4 had wide local excision and 3 patients had only biopsy. Resection margin was positive in 15 (75%) patients. All patients received radiation therapy. The median prescribed dose was 60 Gy. Five patients received less than 54 Gy. The median follow-up time was 77.5 months (28-283 months). Nine patients developed local recurrence after RT. Seven local failures (78%) were in field. Time to local recurrence ranged from 3-165 months (median 33 months). The 2-5 year local control (LC) rates were 80% and 69%, respectively. On univariate analysis, the 5 year local control rate was significantly better in the patients treated with ≥54 Gy than in patients who received <54 Gy (p=0.023). The most common acute side effect was grade 1-2 skin toxicity. As a late side effect of radiotherapy, soft tissue fibrosis was detected in 10 patients and lymphangitis was seen in 1 patient. One patient developed radiation-induced sarcoma. According to our results, radiotherapy is especially effective in recurrent disease and provides a high local control rate in the patients received more than 54 Gy.

Effective analysis of non-surgical combined treatments for laryngeal organ preservation in locally advanced laryngeal carcinoma

To evaluate the therapeutic effects, larynx preservation and adverse events of non-surgical combined treatments for laryngeal organ preservation in locally advanced laryngeal squamous cell carcinomas(SCCs). Forty-six patients with locally advanced laryngeal carcinoma (T2-4, N0-N3) were treated individually with non-surgical combined treatments for larynx preservation (LP). These treatments included concurrent chemoradiotherapy (CCRT)(±epidermal growth factor receptor (EGFR) inhibitor), induction chemotherapy (ICT) followed by CCRT(± EGFR inhibitor), or concurrent radiotherapy and EGFR inhibitor. Radiation therapy was given to a total dose of 60-70 Gy. The Kaplan-Meier method was used to determine the overall survival. Side-effects were evaluated with the established Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The average follow-up time was 31.8 months (range 6-95 months). All patients completed the planned radiotherapy without treatment breaks, and 45(97.8%) of 46 patients completed the planned chemotherapy.The 3-year and 5-year overall survival rates were 87.3%and 67.2%, respectively.The 5-year larynx preservation rate was 100.0%. The 3-year and 5-year progression free survival rates were 95.1% and 87.7%, respectively. The most common acute side effect in grade 3 was oropharyngeal mucositis. After treatment, tracheotomy was still required in 2 patients with glottis cancer for laryngeal edema or stenosis. No patient depended on a percutaneous gastrostomy and experienced speech impairment. Patients with locally advanced laryngeal cancer can be offered non-surgical combined treatments for laryngeal preservation and the high quality of life, showing a higher laryngeal preservation survival rate with minimal toxicities.

Clinical Outcomes of Volume-Modulated Arc Therapy in 205 Patients with Nasopharyngeal Carcinoma: An Analysis of Survival and Treatment Toxicities.

BackgroundTo investigate the clinical efficacy and treatment toxicity of volume-modulated arc therapy (VMAT) for nasopharyngeal carcinoma (NPC).Material and Methods205 VMAT-treated NPC patients from our cancer center were prospectively entrolled. All patients received 68–70 Gy irradiation based on the planning target volume of the primary gross tumor volume. Acute and late toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 and Radiation Therapy Oncology Group Late Radiation Morbidity Scoring Criteria.ResultsThe median follow-up period was 37.3 months (range, 6.3–45.1 months). The 3-year estimated local failure–free survival, regional failure–free survival, locoregional failure–free survival, distant metastasis–free survival, disease–free survival and overall survival were 95.5%, 97.0%, 94.0%, 92.1%, 86.8% and 97.0%, respectively. Cox regression analysis showed primary gross tumor volume, N stage and EBV-DNA to be independent predictors of VMAT outcomes (P < 0.05). The most common acute and late side effects were grade 2–3 mucositis (78%) and xerostomia (83%, 61%, 34%, and 9% at 3, 6, 12 and 24 months after VMAT), respectively.ConclusionsVMAT for the primary treatment of NPC achieved very high locoregional control with a favorable toxicity profile. The time-saving benefit of VMAT will enable more patients to receive precision radiotherapy.

The Value of Qualitative Research in Dysphagia in the Head and Neck Cancer Population: What Can We Learn From the Survivors' Perspective?

Dysphagia is a common acute and long-term side effect of curative, non-surgical treatment for head and neck cancer (HNC). Despite what is known about dysphagia associated with HNC treatment in terms of its prevalence, severity, physiological characteristics, and the associated effects on quality of life (QoL), our understanding of the key factors which impact on HNC survivors is only just emerging. Whilst quantitative research studies have demonstrated that most people experience dysphagia in the early post-treatment period, and that many people continue to have ongoing swallowing issues for months and years following treatment, emerging qualitative research in this field has provided insights into the extent to which the presence of dysphagia impacts on the everyday lives of people with HNC. By exploring issues from the perspectives of people living with dysphagia, qualitative research has highlighted those factors that have the greatest impact on oral intake, raised issues for service provision, and highlighted the need for additional professional involvement and better long term supportive care.

Abstract P1-15-18: Evaluation of separation techniques and dosimetry of the inframammary fold during whole breast radiation therapy

Abstract Purpose/Objectives: The majority of patients receiving radiation therapy will experience some form of skin reaction, ranging from localized erythema to moist desquamation. Radiation dermatitis of the inframammary fold (IMF), the most common acute side effect of supine whole breast radiation therapy (WBRT), can be mitigated by separating the breast from the chest wall. The purpose of this analysis was an objective evaluation and comparison of practical and inexpensive separation techniques. Materials/Methods: A breast phantom was created on a human torso phantom using tissue-equivalent bolus material. Four separation techniques were evaluated: 1) taping the inferior aspect of the breast to the shoulder or placing 2) 6" x 2" rolled bubble wrap, 3) a 6" x 1" x 1" styrofoam block, or a 4) 50 mL 2" diameter plastic conical tube in the IMF. For the control setup, the breast was not taped and nothing was placed in the IMF. Written and pictorial simulation instructions recorded by one radiation therapist were independently used by additional therapists to reproduce each setup, with medial and inferior measurements taken for comparison. Dosimetry of identical tangent 100 cGy WBRT fields was evaluated with thermoluminescent dosimeters (TLDs) placed at each of four locations: the ipsilateral IMF, the ipsilateral chest wall 5 cm inferior to the IMF, and 5 cm superior to the nipple of both the ipsilateral and contralateral breasts at the 12:00 position. Measurements and TLD data are reported as mean ± standard error of the mean of 3 separate TLD readings. One-way ANOVA and posthoc analyses were used to determine significance between groups with α for significance set at p ≤0.05. Results: Compared to simulation, the average differences measured medially and inferiorly among the conical tube (10 ± 6 mm medial; 0.6 ± 0.2 mm inferior), styrofoam block (13 ± 8 mm medial; 1.2 ± 0.2 mm inferior), and bubble wrap (18 ± 4 mm medial; 0.6 ± 0.1 mm inferior) setups were not significant. The taping technique (0.2 ± 0.1 mm) was more reproducible inferiorly than the styrofoam block setup (p &amp;lt;0.01), but no different from the conical tube and bubble wrap setups. TLD readings demonstrated that the IMF received less of the prescribed dose with the taping (108 cGy ± 1.4%), styrofoam block (109 cGy ± 0.9%), or bubble wrap (110 cGy ± 0.9%) techniques compared to either the control (120 cGy ± 1.1%) or conical tube (121 cGy ± 0.4%) setups (each p &amp;lt;0.01). TLD readings from the three other locations were not significantly different between any of the setups. Conclusions: The taping, styrofoam block, and bubble wrap setups were most effective in sparing dose to the IMF. The only difference in reproducibility was between the inferior aspects of the taping and styrofoam block setups, but taping had the disadvantage of being more invasive than the other setups. While this unique analysis did not reveal a single superior solution, the taping, styrofoam block, and bubble wrap separation techniques should be considered by radiation oncologists seeking practical, inexpensive, and easily-implemented solutions to mitigate IMF dermatitis in WBRT patients. Citation Format: Guy Jones, Peter Guion, Jason Cheng, Aparna H Kesarwala. Evaluation of separation techniques and dosimetry of the inframammary fold during whole breast radiation therapy [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-15-18.

Assessment of radiation-induced xerostomia: validation of the Italian version of the xerostomia questionnaire in head and neck cancer patients.

Xerostomia is the most common acute and late side effect of radiation treatment for head and neck cancer. Affecting taste perception, chewing, swallowing and speech, xerostomia is also the major cause of decreased quality of life. The aims of this study were to validate the Italian translation of the self-reported eight-item xerostomia questionnaire (XQ) and determine its psychometric properties in patients treated with radiotherapy for head and neck cancer. An observational cross-sectional study was conducted in the Radiotherapy Unit of the Veneto Institute of Oncology - IOV in Padua. The XQ was translated according to international guidelines and filled out by 102 patients. Construct validity was assessed using principal component analysis, internal consistency using Cronbach's α coefficient and test-retest reliability at 1-month interval using the intraclass correlation coefficient (ICC). Criterion-related validity was evaluated to compare the Italian version of XQ with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire (QLQ-C30) and its Head and Neck Cancer Module (QLQ-H&N35). Cronbach's α for the Italian version of XQ was strong at α = 0.93, test-retest reliability was also strong (0.79) and factor analysis confirmed that the questionnaire was one-dimensional. Criterion-related validity was excellent with high association with the EORTC QLQ-H&N35 xerostomia and sticky saliva scales. The Italian version of XQ has excellent psychometric properties and can be used to evaluate the impact of emerging radiation delivery techniques aiming at preventing xerostomia.

Effect of insulin-induced hypoglycaemia on the peripheral nervous system: focus on adaptive mechanisms, pathogenesis and histopathological changes.

Insulin-induced hypoglycaemia (IIH) is a common acute side effect in type 1 and type 2 diabetic patients, especially during intensive insulin therapy. The peripheral nervous system (PNS) depends on glucose as its primary energy source during normoglycaemia and, consequently, it may be particularly susceptible to IIH damage. Possible mechanisms for adaption of the PNS to IIH include increased glucose uptake, utilisation of alternative energy substrates and the use of Schwann cell glycogen as a local glucose reserve. However, these potential adaptive mechanisms become insufficient when the hypoglycaemic state exceeds a certain level of severity and duration, resulting in a sensory-motor neuropathy with associated skeletal muscle atrophy. Large myelinated motor fibres appear to be particularly vulnerable. Thus, although the PNS is not an obligate glucose consumer, as is the brain, it appears to be more prone to IIH than the central nervous system when hypoglycaemia is not severe (blood glucose level ≤ 2 mm), possibly reflecting a preferential protection of the brain during periods of inadequate glucose availability. With a primary focus on evidence from experimental animal studies investigating nondiabetic IIH, the present review discusses the effect of IIH on the PNS with a focus on adaptive mechanisms, pathogenesis and histological changes.

Pretreatment Information on Dysphagia: Exploring the Views of Head and Neck Cancer Patients

ContextSwallowing difficulties (dysphagia) are a common acute and chronic side effect of head and neck cancer (HNC) treatment. Dysphagia is associated with medical concerns such as malnutrition and pulmonary health as well as quality of life outcomes. Providing information on the likely changes to swallowing is an important component of pretreatment preparation. There is little research providing the patients' perspective in this area. ObjectivesThis is a qualitative study to describe patients' views on pretreatment information regarding changes to eating, drinking, and swallowing after chemoradiotherapy treatment for HNC. MethodsA purposive sample of 24 patients with HNC with a range of post-treatment dysphagia severity, up to two years after chemoradiotherapy, was selected to participate in focus groups or semistructured interviews. Thematic analysis was conducted by two researchers, and results were verified with three participants. ResultsHalf of the participants presented with mild dysphagia, with the remainder having moderate to severe dysphagia. Mean age was 59 years, and mean time post-treatment was 10 months. Data were grouped into three main themes and subthemes: expectations about treatment outcomes and whether information correlated with pretreatment information; presentation of information, including the format and delivery; and the difficulties with absorption and retention of information. ConclusionPatients require information on the impact and prognosis for their swallowing ability. There was a general preference for verbal information, from someone knowledgeable about dysphagia. However, there are also individual preferences for the manner and pace at which this information is delivered. Further research is indicated to explore ways of providing information that is individually tailored to patients' needs and preferences.

Abstract P6-08-07: Out-of-pocket spending, dermatologic quality of life, and treatment satisfaction in breast cancer radiotherapy patients

Abstract Objective: Skin toxicity is one of the most common acute side effects of breast cancer radiotherapy (RT). Past research has largely neglected non-medical out-of-pocket (OOP) spending associated with this side effect. We therefore developed a Skin Toxicity Costs (STC) questionnaire to assess such spending. The primary goal of the present study was to use the STC to estimate non-medical out-of-pocket spending associated with acute skin toxicity in breast cancer RT patients. Secondary goals included exploration of the associations between the STC, dermatologic quality of life, and satisfaction with RT. Methods: 185 consecutive female breast cancer RT patients (Stage 0-III) participated in the research from 2008 to 2013. All participants received a course of standard fractionated external beam RT. Demographics: mean age = 55.4; 74% White, 10% African American, 16% Other; and 10% Latina. In regard to employment, 46% reported working full-time, 12% part-time, and 42% were not employed. 68% had at least a college degree and 66% reported a household income of ≥ $60,000/year. On their penultimate day of RT, participants completed the STC, the Dermatologic Life Quality Index (DLQI), and a Patient Satisfaction Questionnaire (PSQ). Patients also completed a demographics questionnaire and an Importance of Appearance Scale (IAPP) at the commencement of RT. Note: all patients were provided with skin creams free of charge through the clinic. Results: Analyses revealed no differences in the STC, DLQI, or PSQ based on recruitment site (all ps &amp;gt; .45). Results revealed that 83% of the sample reported OOP spending associated with skin toxicity. Mean STC spending was $245.11 (95% CI: 135.34 to 354.87; Median = $75.00). Multiple regression of demographic factors (ethnicity, race, marital status, employment, education, income) and IAPP revealed that IAPP and marital status uniquely predicted STC spending (ps &amp;lt; .02; total model R2 = .24), such that increased STC was associated with increased importance of appearance and being unmarried. Controlling for IAPP and marital status, STC was significantly associated with DLQI (p&amp;lt;.001), such that increased STC was associated with decreased dermatologic quality of life. Lastly, we examined whether the STC was associated with treatment satisfaction controlling for IAPP, marital status, and DLQI. Results revealed that only STC was uniquely associated with patient satisfaction (p&amp;lt;.001; total model R2 = .39), such that patients with higher STC scores were less satisfied with their RT. Discussion: Results are consistent with recent research suggesting that OOP spending can be considered a “financial toxicity” of cancer treatment, and is associated with lower levels of satisfaction with cancer care. However, the present study is the first to examine this issue with a focus on skin toxicity-related spending in breast cancer patients. The results suggest that OOP spending is linked to patient satisfaction with care. OOP may be a marker of skin toxicity. Future research seeking to manage skin toxicity may have the beneficial downstream consequence of reducing OOP spending and improving overall satisfaction with RT. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-08-07.

Mometasone Furoate Significantly Reduces Radiation Dermatitis in Patients Undergoing Breast Radiation Therapy: A Double-Blind Randomized Control Trial in 120 Patients

The most common acute side effect of patients receiving radiation therapy to the breast/chest wall is radiation induced dermatitis. Despite this, there is no accepted intervention to prevent or treat it. A previous study by Bostrom et al showed Mometasone Furoate (M) cream was superior to Diprobase (D) in a study of 50 breast cancer patients. We sought to repeat this study in a larger cohort of 120 patients.

Comparing intensity modulated radiotherapy and conventional external beam radiotherapy in cervical cancer.

5610 Background: To compare Intensity-modulated radiation therapy (IMRT) with conventional external beam radiation therapy (CXRT) regarding morbidity, tumor response, and quality of life (QOL) in cervical cancer patients. Methods: Between 8/2009-2/2010, 50 patients (pts) with age range 20-85, with FIGO Stage IIA- IIIB were prospectively randomized 2:1 to CXRT and IMRT at Indo-American Cancer Institute. Both groups received concurrent chemotherapy (weekly cisplatin 30-40mg/m2) with external beam radiation (EBRT), 50Gy/25fractions followed by intracavitary brachytherapy at 21Gy/3fractions. Complications and QOL were evaluated during treatment and in follow-up with CTC 4.0 and EORTC QLQ-C30, and disease recurrence was based on pelvic exam. Analysis used Chi square(X2) at a significance level of 0.05. Results: Average time to completion was 49 and 48 days in CXRT and IMRT arms (p&gt;.05). Four pts did not complete the treatment in the CXRT. Two months after completion 31/35 (89%) of CXRT and 15/15 (100%) of IMRT had complete response (p&gt;.05). At 5 months, 30/35 (86%) of CXRT, and 14/15 (100%) of IMRT had no loco-regional disease (LRD); 1 IMRT pt died from distant metastasis (DM). At 18 months, 25/35 (72%) in CXRT and 14/15 (93.5%) in IMRT had no LRD or DM. Most common acute side effects in the CXRT were Grade 1 vomiting/cystitis/diarrhea and Grade 2 nausea/skin reactions/proctitis. One pt developed vesicovaginal fistula (VVF) after 50Gy by EBRT. Most common acute side effects in the IMRT were Grade1 nausea/vomiting/cystitis/proctitis/diarrhea. Two pts had grade 3 neutropenia in the 5th week of RT. QOL was better in IMRT (p &lt;.01) based on functional, symptom, single items, and global scales except for pain, insomnia, loss of appetite. Diarrhea, financial problems were worse in the CXRT (p&lt;.05). Chronic complications such as radiation induced proctitis in 5 patients, and sub-acute intestinal obstruction in 2 patients during follow-up period in CXRT vs. IMRT (p &lt; 0.001). Conclusions: IMRT is superior to CXRT with fewer chronic side effects and similar acute side effects and treatment responses. This is the first randomized clinical trial of these treatments in cervical cancer.